Medical Megatrends and the Future of Medicine

More On Wellness Programs To Improve Health and Reduce Costs

2012-01-24T13:16:00.000-08:00

Since about 60% of the insured population has their insurance from their employer, there is a super opportunity for a win-win – to improve the employee’s (and spouse’s) health while lowering the costs of health insurance to the employer.

Some companies have used wellness programs to very good effect. General Mills has indicated their satisfaction with their programs. Safeway began a wellness program in 2005. As of the end of 2010, it total costs were about the same as 5 years before – a time period when most corporations were experiencing 30-40% increases.
Steven Burd, CEO of Safeway, in a Wall Street Journal Op-Ed explained that Safeway has made wellness programs available to all of its 30,000 nonunionized personnel. Its program is based on two insights: 70 percent of all medical costs result from adverse behaviors, such as smoking, overeating, and lack of exercise; and 74 percent of all costs are related to four chronic illnesses—cardiovascular, cancer, diabetes, and obesity—and that are, for the most part, preventable with behavior modifications.
An article in the Washington Post challenged Burd on his contention that incentives were a key to success. Safeway responded that it began a wide ranging program including aggressive use of generics drugs, etc plus a wellness program that included dollar incentives to its employees. Not all of the cost management resulted from financial incentives; indeed, those only began in 2008. As of the end of 2010 Safeway had held total all-inclusive per-employee health-care costs at 2005 levels, whereas most other large American companies have seen a cumulative increase of about 50 percent over the same time period. Safeway points out that had the company not actually expanded benefits, its costs would have fallen by 5 percent from 2005 to 2009. (Note that I discuss this in some detail in “The Future of Health Care Delivery.” See http://www.medicalmegatrends.com/ )
Orriant, a company that manages wellness programs for corporations, has amassed substantial data on how large an incentive is needed to drive action. They can closely predict the percentage of employees who will participate based on the level of the incentive.
They find that over time an increasing per cent of staff will become “healthy” based on objective measures. For example, at one large company that has used wellness programs for 7 years, the medical care costs have been flat, i.e., the same as 7 years ago. 31% of staff are now measured as “healthy” compared to only 11% eight years ago.
Orriant looked at the data for 4 years (2007-2010) of 4 client companies. Each company had about 800 staff. On average 64% of employees chose to participate while 36% did not. Although one might expect that only the healthiest would sign up, in fact some 68% of participants had at least one significant health issue or health risk. But they were likely healthier than the nonparticipants because in the first year the claims paid for the participants was about $1200 whereas it was about $3000 for the non participants. But the value was in the long term impact. By the fourth year, the claims paid for participants had risen to about $2000 compared to $6000 for the non participants. This relative difference held true for hospital claims paid, physician claims and pharmacy costs. The total claims paid by the 4 companies’ declined during the last of the four years by 1.3%; a time when the USA average rose by 6.9%

Wellness programs seem to work best when the incentive is connected to accountability, i.e., the participant needs to set goals with a health coach and then work toward them
The end results with wellness programs are healthier workers who are generally more productive and have less sick days and also report increased job satisfaction. At the same time the employee has a meaningful increase in take home pay while the company enjoys a significant savings as represented by lowered increase (or even flat or declining) in health care costs from year to year.

Wellness Programs To Improve Health and Reduce Corporate Expenses

2012-01-19T11:55:00.000-08:00

Some 80% of healthcare costs go to just a few very serious complex chronic diseases including the likes of diabetes and heart failure. But these are all largely preventable with lifestyle adjustments. Unfortunately, we Americans are an over fed (on non-nutritious diets), under exercised, chronically stressed population with 20% of us still smoking. One third of us are frankly obese and another one third are overweight.

Health care costs could plummet if we could only become a health conscious society where these chronic illnesses became much less common. But we can adjust our lifestyles – if given the proper incentives. Of course, we all hope to live a long time, we cannot change our genes and all too many of us live in socio-economically deprived communities. And as an aging society, “old parts will wear out.”
Incentives work best if there is a noticeable reward in a short time frame – these help to keep us on track. I love the story I heard on NPR’s “All Things Considered.” A lady (an economist) wanted to lose some weight and do it over the Thanksgiving, Christmas and New Year’s period – surely a difficult time to do so. She created a personal incentive by asking a good friend to agree to accept $500 of she did not lose the prescribed weight on time. The message was that her friend had to accept the money if the weight was not off and she was to purchase something special (jewelry, iPad, etc) and flaunt it. The result was that the person paid attention to every thing she ate. Each ice cream temptation was now worth $500. And $500 was an amount which was meaningful to her although not enough to cause real financial deprivation. It worked and she lost the weight.
Another, and very effective approach is a workplace wellness program. I discuss them extensively in The Future of Health Care Delivery. In their basic formulation, the employer offers various programs such as smoking cessation, fitness, dietary stress management, etc. The employee is free to volunteer or not and in return sees a decrease in his share of the healthcare premium of the company.
Assume that a company spends $15,000 annually (the approximate national average) for a married employee’s health premium and normally expects the employee to pay one third or $4500 per year or $375 per month deducted from his pay check. But if he participates the company will reduce his share by a much as $3000 (i.e., the law allows up to 20% of the total to be reduced from the employee’s share for participation) which brings his monthly deduction down to $125 or a $250 per month incentive reflected in increased take home pay per month. This creates a strong incentive to participate in the wellness program.

But accountability is key. This means that the employee must not just attend sessions but actually follow through on, say, a smoking cessation or a fitness program with a health coach.

Here is a link to an article that outlines some of these concepts in more detail.

What happens? Employees sign up, they participate, they accept accountability in return for the incentive and they become healthier. The company’s health care costs stabilize or possibly even decline. They certainly do not rise like their competitors’ costs do. The staff is healthier, they are more productive and have less sick days and satisfaction scores rise. Clearly a win-win.

Gene Therapy Is Back And Is Working for Some Patients

2012-01-03T14:11:00.000-08:00

A decade ago there was much hope and hype for gene therapy. Then came the death of Jesse Gelsinger , an 18 year old, as a result of uncontrolled infection from the viral vector used to insert the gene change. That led to a near total stop of gene therapy clinical trials and the development of multiple new regulations, especially multiple levels of extensive reviews.

Now some new developments are coming to fruition and there is some legitimate reason for enthusiasm that gene therapy may prove viable for some of the most series of genetic disorders.

Some 28 of 30 patients with the rare Lebers’s congenital amaurosis blindness treated with an adeno-associated virus vector delivering a potentially curative gene have had improved eyesight. Gene therapies for two other diseases that cause blindness are under evaluation.
The much more common hemophilia B is also being studied with a gene therapy given with the adeno-associated virus approach. In this disease, the individual cannot produce the blood clotting protein called Factor IX and so must receive frequent IV infusions The virus with the inserted gene for Factor IX production is given intravenously and goes to the liver where it infects the patient’s liver cells which then produce the needed Factor IX protein.. So far in six patients who have gotten the gene therapy have had Factor IX rise from zero to 2-12% of normal. Low but enough to prevent bleeding in four patients and enough that two others could reduce the frequency of their regular intravenous infusions of Factor IX.

Kids with severe combined immune deficiency (SCID) have been treated with gene therapy and found to have much reduced infection risk. The same for a few children with Wiskott-Aldrich syndrome, another severe form of immune deficiency. In an NIH sponsored symposium, (October 7, 2011 issue of Science,) it was reported that 86 patients had by then received gene therapy and been improved.
There are many issues to be resolved before gene therapy becomes commonplace. Among them are concerns that the viral vector can produce cancer by turning on an oncogene. But, now a decade later, it appears that the promise of gene therapy will become a reality in the not too distant future. Chalk this up to terrific innovation. It will ultimately be a transformative medical megatrend.

What Really Needs To Be Done About the Critical Shortages of Cancer Drugs

2011-12-09T09:50:00.000-08:00

The following is an Op Ed written by myself and colleague Dr Curt Civin and published December 7, 2011 in the Baltimore Sun.

Hospitals nationwide are experiencing shortages of critical generic intravenous drugs. We believe a fundamental reason for this national shortage is government price controls. With these limits there is little incentive to invest in new facilities and technologies, leading to equipment failures. Manufacturers have little economic incentive to prepare proactively for the quality assurance issues that routinely arise in the manufacturing of a sterile injectable compound. To reincentivize this process, the market needs to be free. spurring more manufacturers to produce these drugs, encourage reinvestment in facilities and the stockpiling of reserves.
The drugs in shortest supply include those used in critical care units such as norepinephrine for shock, antibiotics for infections, and cancer chemotherapy. Almost all are generics and manufactured by a just few companies. Among the oncology drugs in short supply are cytarabine and leukovorin. Cytarabine is the best single drug for acute myeloid leukemia. Leukovorin is used in childhood acute lymphoblastic leukemia. These are older “off patent” drugs. As generics, they are far less expensive that newer drugs. They have stood the test of time, are still used extensively and are necessary for optimal patient care. Individual patients need exactly the right drugs on precisely the right schedule – no substitutes; now, not later. As pointed out in Congressional testimony and a Wall Street Journal editorial, these shortages are having a major negative impact for ongoing clinical trials designed to improve cancer treatment results.
Another critically needed cancer drug is Doxil, a drug used for the treatment of many cancers. It is sold by Johnson and Johnson (J&J) and until recently it had been manufactured on contract for J&J by Ben Venue Laboratories. Unfortunately, Ben Venue is exiting the contract drug business. Thus, Doxil is not currently available.
Prior to 2003, Medicare paid for cancer chemotherapy injectables based on the average wholesale price. But with no transparency, some distributors or physicians could reap huge profits. To combat this and with the best of intentions, a new system was developed as part of the Medicare Modernization Act of 2003, based instead on the average selling price updated quarterly. Oncologists, who purchase the drugs from distributors and then administer them, are reimbursed the ASP plus a 6% administrative fee. This would at first glace seem perfectly reasonable. Not quite. In effect, it means that Medicare allows a maximum of only a 6% increase per year; any more and the reimbursement would be less than the cost. In the generic drug business prices can decline tremendously. If the price drops too low, some manufacturers simply cease producing it and use their capacity to make other more profitable drugs. The remaining producers cannot raise their prices more than 6%, so they have little incentive to make up for lost capacity by investing in new plant or equipment. The system has broken and needs to be fixed soon or patients will die.
President Obama recently signed an executive order requiring manufacturers to notify the FDA at least six months in advance of discontinuing a critical injectable sterile medication. This will be useful in a few situations, such as Doxil, but it will be of little help when companies must suspend manufacturing immediately due to finding a contaminant, having an equipment breakdown, etc. The New York Times called the President’s measures “useful first steps,” but emphasized that Congress needs to take up long stalled legislation. We agree but believe that the legislation needs to focus on raising the profit margin allowed under Medicare. This could be done by permitting the marketplace to set the value of these critical drugs in a transparent manner.
Concurrently, oncologists should be paid an appropriate administrative fee based on the time and effort required per specific drug rather than a flat percentage of the cost. This would eliminate the temptation noted recently in the New England Journal of Medicine to substitute a more expensive drug (6% of a higher priced drug means a greater income than 6% of a lower cost drug).
With our recommendation, prices will still be very cheap compared to on patent drugs yet rise to the point sufficiently profitable for the generic producers to invest in their manufacturing capacity, create redundant production lines and encourage more manufacturers to enter the marketplace. Combined, these changes will reduce quality control issues, create backup options, and maintain a stable supply of these vital drugs for the patients who desperately need them.

Curt I Civin, MD, writing in his personal capacity, is professor of pediatrics and physiology, director of the Center for Stem Cell Biology & Regenerative Medicine, and associate dean for research at the University of Maryland School of Medicine. Stephen C Schimpff, MD is former CEO of the University of Maryland Medical Center, professor of medicine and author of “The Future of Health Care Delivery – Why It Must Change and How It Will Affect You,” to be published in February by Potomac Books.

We Are Ruining Our Children’s Future Health

2011-11-21T13:11:00.000-08:00

Our children (and grandchildren) are the future and we are responsible for their growth and development. As responsible parties, we are clearly failing.

That is my interpretation of the report issued a few days ago by the Centers for Disease Control (CDC) on seven criteria known to the associate with ideal cardiovascular health as part of the National Health and Nutrition Examinination Survey. They are defined, briefly, as 1) a diet with 4 ½ servings of fruits and vegetables per day, 3 servings of whole grains per day, fish twice per week, no more than 1500 mg of sodium (salt) per day, and less than 36 oz of sweetened drinks per week. Also 2) a normal body mass index (BMI) which roughly means not being overweight, 3) not smoking, 4) having at least one hour of physical activity per day, 5) a normal level of cholesterol, 6) normal blood pressure and 7) normal blood glucose (blood sugar.)

Infants start out life with a normal risk for heart disease but risk increases rapidly from preteens and into adolescence. We have known for some time that kids are getting less and less exercise, even less as they progress into the teenage years.

But this new report is striking. Not one child out of 4157 aged 12 to 17 in the study group monitored between 2003 and 2008 was in the “ideal” category for diet. And only 16% of the boys and 11% of the girls were in the ideal range for all of the remaining six categories.

Looked at differently, 20% were obese (not just overweight); about 20% smoked; about 50% had too little physical activity; cholesterol was elevated in about 30%; and glucose was somewhat high in about 40%. One bright spot – blood pressure was elevated in less than 10%.

This report is important for at least two reasons. We know that atherosclerosis begins to build up in childhood and young adults even though angina and heart attacks are not common until a few decades later. It is essential to maintain a healthy lifestyle and this needs to begin in childhood. Second, we know that the 7 criteria are each associated with a lessening of heart disease risk when kept to the normal or ideal level (diet, weight, not smoking, etc) and that each, when not meeting the standards, add together to increase the risk of cardiovascular disease in later life.

These are not impossible standards to meet. Diet might be most difficult, especially for kids in urban or rural poor areas who have less access to fresh fruits and veggies but there is little excuse for over indulging in salt and sodas. One big problem is the ready availability of processed foods – foods high in salt, fat and sugars including high fructose corn syrup – along with ubiquitous sodas, often in very large containers.

Parents – they are your children. They need good food, they need lots of activity, and they need parental support to avoid tobacco and processed foods. They are your (and all of our) future.

Frailty – Common In Older Ages But Is It Preventable?

2011-11-18T12:56:00.000-08:00

Americans are aging – fast. And that means more chronic illnesses like arthritis, heart failure and cancer. It also means more falls, more osteoporotic fractures, poorer hearing and vision and myriad other problems we equate with aging. It also means some older folks become “frail,” irrespective of chronologic age.

You know a person is frail when you see him or her – instinctively you will think a person is “frail” if they are “skinny,” weak, tired, inactive and slow. But frailty can actually be measured. Among the systems is one developed by the Cardiovascular Health Study, a longitudinal program that evaluated cardiovascular risk factors with annual examinations from 1989 to 1999 for individuals over age 65. This was followed through to the present with annual telephone follow-ups. Their “frailty indicator variables” include unintentional weight loss of more than ten pounds (as some measure of loss of muscle mass), grip strength,(as a measure of weakness) , fatigue score on a standardized test (as a measure of tired), physical activity (measure of inactivity), and walking speed (“slowness.”)

Using this approach, and if we define “frail” as having three or more of these five characteristics, about 7% of adults over age 65 living in the community will be regarded as frail. Importantly, frailty is not the result of co-morbidities but co-morbidity is a risk factor for frailty and disability is a frequent outcome of frailty.

With this definition of 3 or more characteristics, frail individuals will be found to have more falls, more hospitalizations, more fractures, increased sleep disordered breathing and more difficulty with the activities of daily living. They also, on average, demonstrate certain biological differences such as elevated C-reactive protein.

One person – otherwise healthy – might become frail in his 70’s whereas someone else might not until his 90’s or even after 100. That would suggest a possible genetic component and some preliminary studies as consistent with this theory.

We know that our bodies begin to “decline” with aging beginning in middle age. Bone mineral density for example declines about 1% per year. So too does cardiac function, muscle mass, lung capacity, etc. These processes are “normal” but can be slowed. Regular aerobic and weight bearing exercise will help maintain all of these functions. The decline will continue but at a slower rate.

What can we each do now? After checking in with your health care provider, a reasonable regimen might include:

Daily aerobic exercise for about 30 minutes
Resistance exercises (weights, Nautilus, etc)
Balance training

A personal trainer or physical therapist might be useful to give guidance and check out if the exercises are being done correctly and with enough intensity.

Then it might be good to add in a

Nutrition consultation to be sure your diet is appropriate for your age and lifestyle. For example, do you get enough protein in your diet?

And you might want to include some mental exercises to complement your physical ones. Studying a foreign language, playing chess or bridge, or Sudoku challenges your brain – but not TV watching or mindless books (even if they are interesting.)

This approach will slow the normal aging process and it may even help prevent the onset of frailty and is sequela. And for certain you will feel better, have fewer falls and other problems common with older age.

Reasonable Goals for Health Insurance Coverage and Defining Medical Necessity

2011-11-07T08:29:00.000-08:00

Health care should be a right but it needs to be paired with some responsibility – some share of the cost, especially for routine care, and some attention to maintaining a reasonably healthy life style. To do so will not only lead to better health but reduced expenses overall – positive outcomes for all.
One of the major goals of the Affordable Care Act is to reduce the number of uninsured from the current about 50 million people (or 16+% of the US population) by both offering Medicaid to many more individuals and creating state-based insurance exchanges for individuals who cannot obtain insurance at their worksite. Medicaid will be available for those at <133% of the federal poverty rate (currently $22,050). The insurance exchanges will be available to everyone but those with income below 400% of the poverty level ($88,200 for a family of four) will be eligible for tax credits based on actual income. Unlike Medicaid which has essentially no cost sharing by the individual, insurance from the exchanges will be purchased at one of four levels – 60, 70, 80 or 90% of the approved covered expenses will be paid by the insurance; the remainder will be the individuals’ responsibility. Higher deductibles will likely correspond to lower premiums.

The Institute of Medicine (IOM), at the request of the Department of Health and Human Services, formed a committee to consider the process for defining “essential health benefits” which ultimately will translate into what is covered or not by the insurance from the exchanges. The IOM, wisely in my opinion, emphasized he need for affordability rather than just comprehensiveness. They argued that coverage should be “evidence-based, specific and value promoting over time.” They proposed that medical necessity should be based upon clinical appropriateness, best scientific evidence and a likelihood of providing an “increased health benefit…that justifies an added cost.” [For a fuller discussion of the IOM recommendations, see John Iglehart’s article in the New England Journal of Medicine, Oct 20, 2011]

These seem like wise and sensible proposals. Too often there has been a “push” to insist on very comprehensive coverage, little attention to evidence-based criteria and little or not cost sharing by the patient.

My own hope is to see insurance that carries high deductibles to encourage each of us to personally monitor our health expenditures. When we have our own money at stake, we are more likely to ask our physician if that MRI, procedure or specialist visit is really needed of if it is “just to be complete.” That high deductible may also encourage us to maintain a better life style and maintain our health. That is good for us and reduces the overall costs further.

My new book discusses these topics in detail – “The Future of Health Care Delivery, Why It Must Change and How It Will Affect You” will be published in Feb, 2012 by Potomac Books

Kudos for Electronic Medication Ordering But Problems with Electronic Physician Documentation

2011-11-01T07:55:00.000-07:00

I toured a major medical center recently to get a look at the robots in the pharmacy and to understand how the electronic medical record worked there. I was particularly interested in the new robot that made up “injectables,” the fluid bags filled with medications to be given intravenously, such as antibiotics. There was also a robot that selects pills and tablets based on bar code technology. A third robot actually delivers the medication to the individual nursing units, a little “R2D2.” The robots depend on the electronic medical record (in this case purchased from a major vendor oriented toward large hospitals and academic medical centers) for input. It begins with the physician placing an order that includes the drug name, dose, route and frequency of administration. The pharmacist reviews the order and then sends it to the appropriate robot for production. It is a terrific system that reduces errors, coaches the physician during the ordering process, and allows the pharmacist to spend more time using his or her knowledge rather than in preparation activities.

I then asked to see a physician using the electronic medical record to enter an order. The doctor showed me how it was done and how it helped her to avoid mistakes. Basically she was very complimentary of the new system.

So I then asked if she also found it effective for writing her medical documentation such as history and progress notes. Medical documentation is the essential communication tool providers use to collaborate on patient treatment. “No way,” was the immediate response. “It [Electronic Physician Documentation] is too cumbersome, takes much too much time, does not allow me to enter information in a logical manner – basically it wants me to use [the computer’s] logic, not mine. So I just hand-write my notes.” Not a good recommendation, so I asked a few more physicians at different locations and got the same response. I checked with the hospital CIO and learned that few physicians actually used the “physician documentation” part of the system although they gave high marks to the other elements such as ordering tests and reviewing results and images. Since then I have asked similar questions at multiple hospitals, using different major vendor systems, always with about the same response. Clearly, there is a problem here.

The long standing written methodology for physician documentation works sort of like this: the doctor writes an “Admission Note” which includes the patient’s history of the present illness, social and medical history, examination findings, diagnostic test findings, a presumed diagnosis, further testing to be done and a treatment plan. Concurrently, the doctor writes “Orders” such as bed rest, frequency of vital signs to be collected, type of diet and drug orders. Thereafter, the doctor enters “Progress Notes” on a daily or greater basis that summarizes the patient’s status since the last physician visit, new information, supplemental orders for additional testing and new treatment approaches. With an electronic medical record many commercial systems try to adjust this process to use “Check offs” and to eliminate or markedly reduce typing which cannot be readily manipulated for later analysis. Some details are readily done by “check offs” such as age, race, gender and even much of the examination. But the “history,” especially that of a person with one or more chronic illnesses, is by nature a narrative not readily amenable to check offs. A second issue is that the physician deals with the patient and therefore with the chart in a discontinuous manner. For example, he or she might visit each patient early in the morning, then go to radiology to review the films with the radiologist, then to pathology to look at slides with the pathologist, etc. Meanwhile the nurse calls with a problem to be resolved with a verbal order or an electronic order urgently. Each of these encounters may need an update to the medical record and so it needs to be adaptable to that requirement. In teaching hospitals, the intern and residents need a simple manner to sign out to each other with a list of problems for each patient – absent that it means taking notes at a sign out conference. Each of these are issues that most of the current commercial vendors have not resolved which is why the doctor I queried responded “No way.” This problem needs to be resolved promptly if electronic medical records are to gain their full potential.

There is hope, however, with innovative niche companies and new technologies to solve these problems where the vendor market has traditionally been unable to do so. Companies such as Salar, Inc., which have carefully observed how physicians work, have found ways to extend hospital EMR’s to deliver a more flexible templating solution. [Disclosure: I was a Salar board member for five years.] Furthermore, advances in voice recognition and natural language processing give promise of allowing physicians to continue to document in their own methods (allowing for narrative and flexible workflow) while coding the information and delivering the information to the EMR.

I believe that once good systems are in place for physician documentation, the electronic medical record will be rapidly adapted with the attendant advantages for patient, doctor, hospital and insurer. This will be especially important as we increasingly need to care for patients with multiple chronic illnesses with the multi-disciplinary team-based approach. The question at hand is why have the major vendors not corrected/improved their systems to make physician documentation easy and thorough for the doc? I suspect that it is because they have large bureaucracies with software written by those who have not actually observed how physicians work. Hopefully this will change.

My new book “The Future of Health-Care Delivery: Why It Must Change and How It Will Affect You,” from which this post is adapted, will be published Feb 28, 2012 by Potomac Books

Targeted Therapies Lead To Exciting Improvements in the Treatment of Melanoma Patients

2011-10-20T07:30:00.000-07:00

Melanoma is the most virulent form of skin cancer with a rapidly rising incidence due to prior sun exposure. About 40,000 men and 30,000 women per year in the USA develop melanoma. In addition to sun exposure, there are independent genetic risk factors such as a variation in the “red hair” gene that increases in frequency the further one’s ancestral home is north of Africa.

Melanoma, as with all cancers, has its own genotype variations. There are at least five melanoma genotypes which can be detected with molecular profiling (for more information look at Vanderbilt’s “My cancer genome”). Each type has its own different mutations.

Just fewer than 50% of melanomas have a mutation in BRAF, a cell signaling pathway. Approximately 90% of the BRAF mutations produce a substitution of glutamic acid for valine at codon 600 in the gene product. This is apparently a critical factor in the development and aggressiveness of melanoma cells. About 20% of melanomas have an NRAS mutation, 1% have both BRAF and NRAS and 30% have neither mutation. Interestingly, among patients 20-30 years old, 86% will have the BRAF mutation but only 22% of those over 70 years have it. As a result, the new drugs that target the BRAF mutation gene product will be of relatively more utility in younger than in older individuals.
One of the new targeted drugs is an inhibitor of the BRAF mutated gene product called Vemurafenib – the name based on “V600E mutated BRAF inhibitor.” Vemurafenib (Zelboraf) decreased the relative risk of death by 63% and the risk of tumor progression by 74% when combined with dacarbazine (an alkylating agent also known as DTIC or imidazole carboxamide which has been the long time standard of care for metastatic melanoma) compared to dacarbazine alone in a large cohort of patients with the BRAF V600E mutation in their melanoma. The FDA approved this drug for treating melanoma in August, 2011 for BRAF mutation positive patients as determined with a companion diagnostic device called the BRAF V600 Mutation Test.
In this phase 3 trial of 675 patients, there as 48% response rate and a 5.3 month median progression free survival with Vemurafenib compared with dacarbazine with its 5% response rate and 1.6 month progression free survival median. Exciting as this sounds, it is no panacea and certainly not a cure although some patients had both excellent tumor shrinkage and long survivals, both rarely seen with dacarbazine. Side effects were acceptable but squamous cell skin cancers developed in some and activity declined over time. To deal with the latter, new trials are evaluating combined targeted therapy by adding a MEK gene product inhibitor. In early results, there was increased activity and fewer skin tumors developing.
The cost, according to the manufacturer, Genentech, will be about $60,000 for a course of therapy over about six months. Vemurafenib tends to have rapid responses and so might be especially important for patients with extensive disease or severe symptoms. Despite the enthusiasm for a drug that actually has real benefit, it is not curative therapy nor does it produce truly long lasting responses. Still it is a major improvement and offers real benefits and hope to patients, a testament to the concept of targeted therapy based on genomic information.
Another drug, ipilimumab (Yervoy) also has shown substantial activity against metastatic melanoma. Ipilimumab is a monoclonal antibody that binds to the cytotoxic T-lymphocyte antigen 4 (CTLA 4) and acts to enhance T-cell activation. In other words, it activates the immune system. It was approved by the FDA in March, 2011. The basic clinical trial that led to approval had 502 poor prognosis patients yet with good performance status. Patients randomized to ipilimumab plus dacarbazine had a longer time of progression free survival and the responses that developed persisted longer (19.3 vs. 8.1 months) than those who received dacarbazine alone. Overall survival was 11.2 months compared to 9.1 months but there were about 25% alive at four years which is quite noteworthy. Unfortunately, it can cause or exacerbate autoimmune disease because it allows T-cells to stay activated. The manufacturer, Bristol Meyers Squibb, at the request of the FDA, has sent a booklet to all medical oncologists to guide attention to these potentially serious side effects. It costs about $120,000 for a course of treatment.

So these are encouraging improvements for a tumor that has been exceptionally resistant to new approaches to treatment over the years. The key has been to understand the genetic mutations in the tumor, then to analyze the gene product and finally to create a drug that inhibits the gene product’s activity – genomic targeted therapy. Going forward, treatment will probably be a combination of compounds that interact with various mutations’ effects, hopefully augmenting the activity shown by these two drugs to date.

Primary Care Physicians Can Greatly Reduce The Costs Of Care, Especially For Chronic Diseases

2011-10-13T06:49:00.000-07:00

In an earlier post I described the problem of excessive and inappropriate drug prescribing when a patient with multiple chronic illnesses did not have good care coordination by a single primary care physician. In this post I will relate the story of a lady who had an excellent primary care physician but the communication system broke down when she went elsewhere for a single visit. In her case the problem was the recommendation of an inappropriate medical technology for her chronic condition.

Ellen is an elderly lady who had been going to the same primary care physician (PCP) for over twenty years. On nearly every visit she said that she felt “tired.” Repeated history and exam revealed no cause nor did logical tests such as those for anemia or hypothyroidism. She then developed syncopal episodes – times she would black out and fall to the floor, once bruising her head when she fell against the stove, and then waking up in a few minutes. Evaluation showed that she had intermittent episodes of bradycardia, or very slow heart rate, resulting in the drop attacks. In consultation with a cardiologist, it was decided to insert a single lead pacemaker. The pacemaker senses the electrical action in the heart and when the rate drops below a set level, it immediately begins to send out an electrical stimulus – on demand - to the heart muscle so that it will contract at a normal rate. The pacemaker is expensive and the procedure to place it is expensive as well. But it worked perfectly and she no longer had the attacks that were not only scary and medically dangerous but seriously impacting her quality of life. A good return on investment.

A few months later during a visit to her daughter, she went to that daughter’s internist for an unrelated reason; he urged her to see a cardiologist colleague. Both the internist and the new cardiologist heard the usual complaint of “being tired” and assumed it related to her cardiac status. This cardiologist in turn recommended that she needed a “dual lead” pacemaker instead of the single lead one she had. [It has been found that having more than one lead can sometimes improve the heart’s output for very carefully selected patients with heart failure.] When the PCP much later received the cardiologist’s mailed consult report, he disagreed, noting she did not have heart failure, just syncopal attacks – an electrical not a mechanical problem in her heart. Further, the current pacemaker was only needed about 10% of the time meaning that her heart beat at a normal rate at least 90% time, so the pacemaker was not even active most of the day. This lady did not need the proposed new, even more highly expensive pacemaker. No pacemaker, no procedure, no risk of insertion, no risk of post operative infection or bleeding. A lot of money could be saved and the patient could be spared a straight forward yet somewhat risky procedure – which she did not need. The fundamental problem was the lack of care coordination. One would like to believe that had her medical record been easily available digitally, the newly involved internist would have never even suggested the need for a cardiologist opinion and even if sent on, the cardiologist would have rapidly recognized the lack of need for the new device.
The lesson is one doctor needs to be the orchestrator of all of the patient’s care. A good PCP, like this one, coordinates the care of his or her patients with chronic illnesses and in so doing avoids excess referrals, tests, procedures and hospitalizations along with unneeded drugs or devices – all the elements that drive up the total cost of care – and in the process assures quality care, safer care and a close doctor-patient relationship. But sometimes a patient is elsewhere, sees a new physician and the medical history is not readily available. All too often as in this case, the patient ends up getting tests, images or procedures that he or she just does not need.
One of the most effective ways to reduce medical care costs is with good coordination of the care of individuals with chronic illnesses. As the story of Ellen above and of Henry from the earlier post exemplify, there is a strong tendency today for patients with chronic illnesses to either be referred to various specialists or else to go on their own. When this occurs without coordination, the visits add up, the number of tests and images ordered go up, the number of drugs prescribed rises rapidly and the number of procedures and even hospitalizations climb. Unfortunately, many of these are simply not needed – excessive and wasteful, not the best quality and obviously very costly. The value of a good digital medical record in both of these patients is obvious because communication among providers is critical to optimal care.

The primary care physician is in the best position to coordinate care. He or she knows the patient, the patient’s family and socio-economic situation and of course the patient’s various illnesses. Ellen did not need to see a second cardiologist and did not need the dual lead pacemaker. The PCP knew that “tired” was just her normal statement at every visit; not a reason to do more tests, add a drug or do a new procedure. It was unfortunate, indefensible but not at all uncommon that the new cardiologist did not make the effort to call the long time PCP. It would have been quickly determined that Ellen did not need a very expensive new pacemaker.

Henry suffered because he did not have a PCP. Instead he had four doctors, each one dealing with all of his problems and none communicating with the others. Once he had a single PCP, his prescriptions plummeted from 23 to seven, he felt better, had fewer drug-induced side effects and both he and his insurers were saving a lot of money.

Care coordination is critical; it improves the quality of care; it reduces risk; it reduces the costs of care; and it ultimately improves patient satisfaction. A good PCP (or occasionally a specialist) is needed to the orchestrator of that coordination. The electronic medical record has an integral part to play in robust care coordination.
Why, with all of these attendant advantages, do not all PCPs engage in excellent care coordination? I believe it is twofold – dollars and lack of training.

My new book, “The Future of Health-Care Delivery: Why It Must Change and How It Will Affect You,” from which this post is adapted, will be published in February, 2012 by Potomac Books

Care Coordination Is Critical For Those With Chronic Conditions Like Diabetes or Osteoarthritis

2011-10-10T05:45:00.000-07:00

This is the fourth post in a series on care coordination; this time focusing on other examples of team-based care. Patients with diabetes not only have to deal with the diabetes itself and its management, such as insulin and drugs, but they have to deal with nutrition, weight and exercise. They need to cope with potential side effects of the diabetes, such as damage to their eyes or kidneys or the blood vessels running into the lower legs that can lead to ulcerations, infections and even amputations. The current approach is for an internist to be the patient’s primary care physician and then to send the patient on to a specialist whenever a problem arises. A much better approach is the one developed by the Joslin Clinic in Boston, which has now been “franchised” across the country. The internist refers the patients to a Joslin Center for consultation. There the patient has a nurse as their coordinator and advocate, an endocrinologist to work out the specifics of their diabetic drugs and insulin, an exercise physiologist to help them with an exercise plan, a nutritionist to review their dietary needs, an on-site ophthalmologist expert in diabetic complications of the eye, and a podiatrist to deal with foot issues. The point is that all of these professionals are available in a single location. The patient comes to one place and one place only and from there can go to individual adjacent offices to see whomever they need to see. Whenever they come back to see, say, the exercise physiologist, if there is an issue or problem they immediately can be referred across the hall to the appropriate specialist. They key is that these healthcare providers are all working as a team and bring to bear all of the different disciplines necessary to the treatment of this complex and complicated disease for this individual patient. And by using an electronic medical record, the data is all present all of the time as the patient goes from one provider to another within the Center but also back home with his or her primary care physician. The result is better care, more coordinated care and a much more satisfied patient. It also costs much less because there is less duplication, less unnecessary testing or X-rays, and fewer hospitalizations because the patient is better cared for.

So as time goes on, more and more of these disease-based programs will emerge for the care of complex, chronic diseases. To some degree this may seem to threaten the primary care physician in the community. But it is really a benefit and an adjunct to both the physician and the patient. The primary care physician still sees the patient for the bulk of their individual care but knows that he or she and the patient have an expert team available to help either occasionally or more often as necessary.

Here is an example of team based care in orthopedics. Marshall Steele, III, MD is an orthopedic surgeon in Annapolis, Maryland who did a lot of knee and hip replacements. He was frustrated that the system just was not efficient nor was it patient or provider friendly or convenient. So he and some collaborators worked with their hospital, Anne Arundel Medical Center, leadership to devise a totally new approach to total joint replacement. Briefly, it works like this. A unit of the hospital was set aside solely for total joint replacement patients with its own dedicated staff. A single leader who had full responsibility but also the needed authority was placed in charge, eliminating the traditional silos that exist in most hospital management systems. Instead of being focused entirely on the inputs which dominates organizations structured in departments, this new model focuses first on the outputs (outcomes) of their work from the perspective of all stakeholders. All patients for the week are brought in the week before to meet each other, meet the staff, tour the facility and attend a class taught by a nurse navigator or coordinator of what will transpire during their stay. They are then all brought to the hospital for surgery the same day, necessitating that extra ORs be available for the orthopedists. After surgery the patients are put into a wellness environment outside of their hospital room. There they are brought together for some meals each day and for beginning physical therapy. They even return as outpatients for physical therapy together.

These steps plus many others have markedly improved physician, nurse and physical therapist coordination and satisfaction while working as a multi-disciplinary team, each with their own expertise unleashed for the care of these patients. The patients are much more satisfied and work together as a support group. At a formal luncheon one month later, patient and family input is sought and programs changed to respond to their needs and those of their families. Length of stay is down and complications have been reduced. Important hospital reported metrics are collected and shared with the team on easy to understand electronic dashboards. Patient reported metrics are collected on how effective the procedure was in reducing pain and return to desired activities. As word got around, more and more patients, many from great distances, sought out the team. Hospital revenues rose and the orthopedists became very busy. Other hospitals have tried to emulate this approach. But many fail. Why? Because, as Dr Steele points out, what is needed is a transformational change but most physicians, hospital staff and hospital managements are only able to muster incremental change. Incrementalism where transformation is needed just doesn’t work.

As medicine becomes more and more disease/patient-oriented, the traditional departments of medicine and surgery within a hospital will tend to be de-emphasized and in their place will come centers for cardiac care, cancer care, diabetes care, stroke care, joint replacement and the like. A multidisciplinary team approach to care will become much more common. Just as with the primary care physician, this shift will appear to many practicing specialists to be a “threat” to their autonomy and certainly to their long-held practice patterns. To be effective they must have an effective electronic medical record system. Moreover, insurers do not like to pay for a team to see a patient. Their approach is to pay one physician for one consult or one patient visit. To pay for three doctors to see one breast cancer patient all at once is anathema, and, in general, they may refuse payment. Hospital managers, like physicians, are “conservative” and traditional, with functions organized in a format that was effective many years ago but which is no longer. But change is difficult and as pointed out in the story above on joint replacement, the change needed is transformational, not incremental. The electronic medical record, critical to success of these arrangements, must be part of the transformational change. Change will not come easily; but it must occur and so it will, but not quickly. But the hospitals who figure this out first will have a competitive advantage.

These stories raise the question as to why it is so difficult for physicians and hospitals to change their ways when the new approach can be shown to be so much more effective in delivering improved quality of care at a reduced cost?

My new book, “The Future of Health-Care Delivery: Why It Must Change and How It Will Affect You,” from which this post is adapted, will be published February 28, 2012 by Potomac Books. You can find it now at Amazon at http://tinyurl.com/

Lack of Care Coordination Leads to Patient Frustration and Poor Care

2011-09-29T12:09:00.000-07:00

This is the third post in a series on care coordination and the importance of the electronic medical record to effect that coordination.

Medical images such as CT scans, MRI and pathology specimens are largely all digitized today so they can be transmitted to any location in an instant. This means that the most experienced physician at a distant institution can be called upon to review, say, a mammogram that has raised questions for the initial local reviewers or for a pathology specimen which is of an unusual type. It also means that when a patient goes for a specialty visit, his records could go simply and instantly and be available for the specialist(s.) This obviously will save time and improve patient care at limited increased cost. But it is largely not what happens today. Here is an example of what actually happens now.

A gentleman, I will call him Otto, who lives in a remote area in northern Pennsylvania developed a chronic cough. He went to his primary care physician, who diagnosed bronchitis and gave him a prescription for an antibiotic. But the doctor was clearly concerned and told Otto to “come back in two weeks if the cough is not gone.” Two weeks later, the patient returned unchanged. He was sent to the closest hospital, about an hour away, for a CT scan of his lungs. The result was not good; it looked like lung cancer. To definitively confirm the diagnosis he was told to come back in four weeks [!] for a biopsy to be done by inserting a needle into his chest. Why four weeks? Because the specialist at that rural hospital only did these biopsies every other Friday and he was booked up until a month later. So Otto had to be “patient” and came back as scheduled. The biopsy, sent to another hospital a hundred miles away for review, confirmed lung cancer. Now he was referred to a surgical specialist in yet another distant city, an academic medical center. That took a few weeks to arrange and, when he met the doctor, he was told that to make a good plan for treatment it would be necessary to get a PET scan. “OK,” he said, and it was arranged for two weeks later – the PET center just down the hall being booked up until then. So he drove home and then back two weeks later. Once the scan was done, a call came from the surgeon’s office that his return appointment had to be postponed for a month since the surgeon would be out of town. His wife, protesting that that was too long to wait, arranged for a visit to be “fit in” in two weeks rather than four.

By chance we happened to visit them that day and heard his story. I called my former University of Maryland Greenebaum Cancer Center colleagues and was told that he could be seen concurrently by a team of surgeon, radiation oncologist, medical oncologist and nurse practioneer in just three days time. But he would need to bring his medical record, his CT scan, the PET scan and the pathology report. So he had to call and then drive to each of the hospitals and pick up the materials. What he picked up were not pictures or films but CDs of his CT and PET scans and his pathology report; in other words they were already in digital format. Too bad these hospitals were not yet capable of just sending them via the Internet to the cancer center in the third city. This is supposed to be a story about the problems of getting information from one physician or hospital to another, but you will have also realized that it was about remarkably less than good care for him – waiting weeks to get the biopsy, more weeks to get the PET scan and then the absurdity of being told he could not be seen by the surgeon for another four weeks. What Otto needed was a well-coordinated, team-based approach to care, which he eventually got – but which he certainly should have gotten long before. This happens all too often in American medicine today.

This is the typical way most patients get treated for cancer (and most other chronic illnesses.) Go to one doctor and then once he or she is done with his/her recommendation, get shunted off to the next physician, and then the next, etc. The patient may be sent to another physician for a “second opinion” but never do the doctors actually sit down together and talk through the issues. When a team jointly discusses the patient’s situation, jointly listens to the patient’s (and family’s) needs and then jointly offers a plan, you can bet that the plan will be far superior – and there is not second guessing later. And as treatment progresses, the team can monitor progress and make course corrections as necessary. The multidisciplinary care coordination approach is not just better, it is far superior. If you develop a chronic illness and your doctor wants to refer you to a specialist, insist on a team-based approach.

Sharing information is a critical element of this approach. Today hospitals (and doctors) do not share medical information among themselves readily, such as when a patient is discharged from one hospital but then ends up in the emergency room of another hospital days or weeks later. Similarly, if a patient has a test at one hospital but then is referred to another for a procedure, it is nearly impossible, as we have seen in the story above, to electronically send that data from hospital to hospital. Instead, the patient usually has to act like “Federal Express” and pick up the information and hand deliver it to the other location, just like Otto. Not a good arrangement – it takes time and it only adds to the patent’s sense of anxiety when the systems should be working to reduce patient angst. Once the electronic medical record is available on a universal basis this difficulty should be abated. Meanwhile hospitals that determine how to share information now will find that they are benefiting patients and in the end benefiting their institution. They will be recognized as providing better care and be rewarded with patient referrals.
But this story raises the question as to why with the information in digital format and the Internet ubiquitous that records like Otto’s cannot readily be transmitted today?

Mesothelioma – A Poorly Understood Cancer

2011-09-26T12:20:00.000-07:00

Today is national mesothelioma awareness day which is fitting because so few know what mesothelioma is or its impact on its victims. Mesotheliomas are rare tumors caused predominantly by exposure to asbestos. This cancer is hard to diagnose early and harder still to treat effectively but there are advances coming and multi-disciplinary care along with good palliative care can markedly improve overall treatment.

They mostly occur on the lung lining (pleura) but can occasionally develop on the heart lining (pericardium) or elsewhere. Although the latency period from exposure to diagnosis is usually very long, often 50 years or more, once symptoms occur, the disease is often aggressive and rapidly fatal. Many people were exposed to asbestos either at work or from home exposure to a worker, but only a small minority develops the disease. The type and quantity of exposure along with some genetic predisposing factors and possibly a co-carcinogen in the form of the simian virus 40 (SV 40 was found in polio vaccines in the 1950s and 1960s because the vaccines were manufactured in monkey cells that harbored the virus) are important. Once inhaled, asbestos fibers are not removed by the lung clearance mechanisms and some may make their way to the pleura where they can slowly lead to cancer development. (It should be noted that asbestos also predisposes to lung cancer and in combination with smoking the incidence of lung cancer rises substantially.)

Mesothelioma lies dormant for years and symptoms begin only when the disease has progressed substantially. Most early symptoms are very nonspecific such as chest pain or shortness of breath. The symptoms are often related to the development of a pleural effusion (fluid between the chest wall and the pleural lining of the lung), itself a sign that the disease has progressed. There are no good early diagnostic tests. Chest X-rays and CT scans are used but by the time the cancer is visible, it is often far progressed.

Unfortunately, treatment of mesothelioma is at best disappointing. Most individuals die within a short time after diagnosis. Surgery alone has a limited role because the disease has too often progressed for surgery to be useful but as noted below it is important to “debulk” the tumor before beginning drug therapy. Radiation therapy alone as well has limited value because of the spread of disease but has a role in local control. A more systemic approach is generally needed with chemotherapy but no drug or drug combination has been found to have truly major effects. That said, the combination of cisplatin and pemetrexed has been found to give an objective response in nearly 50% of patients, a doubling of the best response rates seen previously with a single drug. Responding patients live longer and have an improved quality of life despite the temporary side effects of the drugs. Other combinations are being tested continuously and there is reason to hope for further improvements. The use of genomic analyses and from that a more targeted drug approach may well be developed in the coming years. Since it has been shown that reducing the bulk of the tumor improves survival, most treatment today combines surgery to remove as much tumor as possible followed by radiation to further eradicate the tumor locally and chemotherapy for the disease beyond their reach.

An important element in care is to be treated by a multi-disciplinary team. Look for it and accept no substitutes. For example, at the University of Maryland Greenebaum Cancer Center, a patient with suspected or known mesothelioma is seen concurrently by a thoracic surgeon, a radiation oncologist, a medical oncologist and a nurse practioneer. After examining the patient and reviewing all of the laboratory and radiographic tests, the team presents their combined recommended plan of care, taking into account the patient’s preferences and family situation. It is definitely better care and I recommend that anyone with a chronic illness, not just cancer, seek out care in a team based environment, in concert with your primary care physician as the quarterback.

All patients can benefit from a good program of supportive or palliative care, begun at the time of diagnosis. Support groups, attention to pain management, assistance in finding financial and insurance assistance and psychosocial assistance to both patient and family can markedly improve the quality of life. Complementary medicine approaches can be very helpful as well such as acupuncture or relaxation exercises to help reduce the sense of breathlessness that can accompany mesothelioma progression.

In sum, mesothelioma is a disease that is difficult to diagnose early and once symptoms occur is difficult to treat effectively. Nevertheless, there is a lot of research underway looking at prevention, early diagnosis and improved methods of treatment along with maximizing supportive care. So there is real reason to be upbeat about the future. In the meantime, there are groups that offer education and support including Mesothelioma Resource Online (sponsored by a law firm) and sites such as that of the Mayo Clinic that have good overviews. And treatment centers that use the multi-disciplinary team approach can offer superior care.

Taking 23 Drugs From 4 Different Doctors – Lousy But Expensive Care

2011-09-18T05:03:00.000-07:00

Lack of Care Coordination of Chronic Illnesses Leads to Excess Prescriptions, Suboptimal Care and High Expenses

Henry is a 69-year-old living alone in a small town about 60 miles from the nearest metropolitan area. He has healthcare coverage via Medicare, Medigap, and Medicare Part D. He had recently been discharged from the hospital after an ICU stay for a urinary tract infection and called to ask for some advice. He was taking twenty-three -- yes, 23 -- different prescription drugs; some once, some twice and some three times per day along with one by shot monthly. He was not certain why many of them had been prescribed and stated that despite them he did not feel well. Here is a partial list: two for heart failure (he did not know that he had heart failure!,) two for diabetes, three for high blood pressure, one to lower his cholesterol, a monthly shot of testosterone for impotence, one to shrink his prostate and one for depression.

I asked him who his primary care physician was and learned that he did not have one but rather went to four different doctors, each of whom treated different issues and none of whom shared all of his information and none of whom used electronic medial records. Whenever one of them checked his blood pressure, it would be elevated, so that doctor would either add a drug or increase the dosage. He told me that when he went to the local drug store and checked his blood pressure, it was always normal.

Henry’s story represents much of what is not working in the delivery of medical care today. He has four complex, chronic illnesses – heart failure, diabetes, hypertension and depression. These all require careful attention and care coordination, preferably by a single primary care physician who knows the patient’s home and social setting as well as his direct medical issues. The blood pressure medication story is representative. He was getting many too many drugs that he did not need and had become impotent as a result. Rather than looking for the cause, one of the doctors had given another drug [testosterone] that probably had no value but was likely enlarging his prostate. As a result he had developed an infection that had almost killed him. And all these drugs were expensive, both to him and to his Medicare Part D insurance plan.

Heart failure and diabetes together consume more than 50% of our healthcare dollars and here is a person whose care is not being adequately monitored; rather he is getting one drug after another without attention to what else is going on. This lack of care coordination is a prime reason why the costs are so high yet quality so low.

My first suggestion was that Henry needed a primary care physician, one to call his own. He found one who had just started his practice, had the time and inclination to coordinate his care and had installed an electronic medical record system. A few months later Henry called and told me that he was now taking just seven medicines and felt much better!

Henry still has four serious chronic conditions. But with a single physician serving as orchestrator rather than just intervener, one who uses an electronic medical record and who actually pays attention to Henry’s medical plus social and home life, Henry has better quality medical care, he has a much higher quality of life, he is spending less of his money and much less of Medicare, Medigap and Medicare Part D’s money. In short good care coordination is a win-win for all concerned.

And yet, care coordination is not appreciated for its importance by most physicians, insurers nor patients. Why is that?

Complex, Chronic Illnesses Last a Lifetime and Consume 70% of the Healthcare Dollar

2011-09-08T13:37:00.000-07:00

Medical care is organized to treat acute conditions but the need today is to prevent, diagnose and treat chronic illnesses. Unfortunately, we are sorely lacking in a good chronic care management system. this will be the first in a series of six posts on this issue.

Our medical care system has developed over decades and even centuries around diagnosing and treating acute illnesses such as pneumonia, a gall bladder attack or appendicitis. The internist gives an antibiotic for the pneumonia and the patient gets better. The surgeon cuts out the gall bladder or the appendix and the patient is cured. One patient; one doctor. But as the population ages, more and more individuals are developing what I will call complex, chronic diseases like heart failure, diabetes, chronic lung disease or cancer. These are diseases that once developed usually remain with the individual for life. These patients with chronic illnesses need a different approach to care. They need long term care, not episodic care. They need a multi-disciplinary, team-based approach where one physician serves as the orchestrater or quarterback and manages the myriad physician specialists and the other caregivers along with all of the tests and procedures to allow for a unified, coordinated care management approach. Not only are these diseases likely to last a lifetime, they are difficult to manage, have an adverse impact of both quality of life and mortality, and they are usually quite expensive to treat. Today 70% of our medical care expenditures go toward their treatment. As I will describe in detail later, it will take a new approach to organizing the care of these patients to both improve care and reduce the costs and this will require high quality health information technology.

However, it is valuable to first understand the implications of chronic disease. Most of us are just not aware that their incidence is rising - and rapidly. The Milken Institute (http://bit.ly/lGHFqP ) quantified some of these issues in a research report a few years ago. They evaluated cancer, diabetes [presumably type 2], hypertension, stroke, heart disease, pulmonary conditions and mental disorders. Here are some of the key findings:

• “More than 109 million Americans report having at least one of the seven diseases, for a total of 162 million cases.

• The total impact of these diseases on the economy is $1.3 trillion annually.

• Of this amount, lost productivity totals $1.1 trillion per year, while another $277 billion is spent annually on treatment.

• On our current path, in 2023 we project a 42 percent increase in cases of the seven chronic diseases.

• $4.2 trillion in treatment costs and lost economic output.

• Under a more optimistic scenario, assuming modest improvements in preventing and treating disease, we find that in 2023 we could avoid 40 million cases of chronic disease.

• We could reduce the economic impact of disease by 27 percent, or $1.1 trillion annually; we could increase the nation's GDP by $905 billion linked to productivity gains; we could also decrease treatment costs by $218 billion per year.

• Lower obesity rates alone could produce productivity gains of $254 billion and avoid $60 billion in treatment expenditures per year.”

To me the most telling and important finding is that “each has been linked to behavioral and/or environmental risk factors that broad-based prevention programs could address.” Restated, we as individuals need to take responsibility for our own health. Not every chronic illness is preventable, but most are. It is up to us to eat a nutritious diet in moderation, exercise our bodies, seek ways to reduce chronic stress and avoid tobacco. These four steps will make a huge difference in our health and our lives. Adding in dental hygiene, avoiding sexually transmitted diseases, using seat belts and not drinking and driving will further prevent many illnesses. Many do not appreciate either that following a more appropriate lifestyle will actually slow the normal aging process that ultimately leads to many of these chronic illnesses.

Meanwhile, when chronic illness does strike, it is imperative to have a single care provider take responsibility for care coordination. Someone to not only recommend tests, procedures, images and specialist visits but who will actively ensure that each provider is properly attuned to the patient’s needs and that all of the information is collected and aggregated in a meaningful manner. When this is done the quality of care rises markedly, many fewer adverse events occur, the patient is more satisfied and the costs of care are dramatically reduced. In most cases, a primary care physician is the appropriate one to coordinate care although sometimes a specialist is better equipped for this role (e.g., a very complex cancer treatment plan). To be effective, the PCP or specialist needs to have not only the willingness and interest but also the time available to actually do the care coordination – time that is not available for most PCPs today. This coupled with limited digitized health information leads to today’s inadequate care of many individuals with chronic illnesses. In future posts I will describe today’s problems with lack of care coordination and how it can be corrected.

I wonder what others think abut why the problem of chronic illnesses and the need for care coordination is just not well recognized?

Your Lifestyle Can Prevent Sudden Cardiac Death

2011-07-23T05:07:00.000-07:00

Adhering to a moderate yet healthy lifestyle can reduce the risk of sudden cardiac death by about 90% according to a new study. It is well known that high blood pressure, high cholesterol, and diabetes correlate with coronary artery disease. Life style factors do as well – a combination of a Mediterranean style diet, moderate regular exercise, appropriate weight and non smoking all correlate with less coronary artery disease, less stroke, less high blood pressure, less diabetes, less cancer and multiple other chronic conditions and lower (or later) mortality overall.

These same factors have now been demonstrated to also reduce risk for sudden cardiac death, i.e., a sudden arrhythmia that leads to death in less than an hour from symptom onset.
S. E. Chiuve, etal of Harvard and the Brigham and Women’s Hospital in Boston (JAMA, July 6, 2011, p62) evaluated sudden cardiac death (SCD) among 82,000 participants in the Nurses Health Study between 1984 and 2010. 321 individuals had SCD during those 26 years at an average age of 72.

The authors set out four criteria for low risk lifestyles: not smoking, BMI <25, exercise >30 minutes per day and being in the top 40th percentile of the alternate Mediterranean diet score. In essence, the latter is a diet rich in fresh vegetables and fruits, nuts, whole grains, legumes and fish with moderate intake of alcohol.

The results were clear. The more risk factors, the greater the rate of SCD. Stated differently, “a low risk life style (not smoking, exercising regularly, having a prudent diet and maintaining a healthy weight) was linearly and inversely associated with risk of SCD among women.” Those women who had all four low risk lifestyle attributes experienced a 92% lower risk of SCD compared to those who had no low risk attributes. This suggests that the vast majority of SCD could be prevented by life style modifications.

The study authors point out that although 80% of women do not smoke today, adherence to the other three factors is low. Less than 40% of middle aged women have a BMI <25, 25% drink light to moderate alcohol and only 22% exercise regularly. And although the data on diet habits is limited, a simple observation of what is purchased in the supermarket is telling.

It is evident from this study – and many others – that managing lifestyle factors can prevent serious chronic illnesses including coronary artery disease, cancer, stroke, high blood pressure and diabetes along with sudden cardiac death. This is true even for those with a genetic predisposition – “your genes need not direct your fate.”

AIDS Stages of Care – Three So Far; Will Number Four Come Soon?

2011-06-29T06:55:00.000-07:00

It was just 30 years ago in June 1981 when the first cases of what came to be known as Acquired Immune Deficiency Syndrome (AIDS) were published by the Centers for Disease Control (CDC) in its Morbidity and Mortality Weekly Report (MMWR.) These were men who had a wasting illness and died of unusual infections, ones of the types seen mostly in “immunocompromised hosts.” These were infections with which I was very familiar in my work treating and preventing infections in aggressively treated cancer patients at a branch of the National Cancer Institute. They included pneumocystis, cyrptococcus, toxoplasma, candidia, zoster, disseminated herpes simplex and others. They tended to develop in patients who had a type of cancer that suppressed their cellular immune function as in chronic lymphocytic leukemia, lymphoma, Hodgkin’s or after bone marrow transplantation. Some of these same infections occurred in patients who received drugs to prevent rejection after kidney, heart or lung transplants. So it was immediately clear that what would become known as AIDS was a disease that markedly affected the cellular immune function of these patients.

It would be only a few years, 1984, until the causative agent was discovered to be a retrovirus (Dr Robert Gallo and Dr Luc Montaginer) and a test was developed (Gallo) to render the blood supply safe. Meanwhile the initial years of what soon was recognized to be an epidemic were spent treating these opportunistic infections in these patients with a rapidly fatal disease once it was diagnosed as AIDS. In retrospect this was the first stage or phase of disease management; it would evolve over the years.

By 1987 the first of the antiviral drugs zidovudine (or AZT) to actually treat the underlying HIV infection was approved by the FDA after studies began at Burroughs Welcome by David Barry, MD and others and at the National Cancer Institute by Samuel Broder, MD and others. Approval came within 25 months of initial studies; a record at the time. Soon came many other drugs and by 1996 there were multiple active agents which when combined produced HAART or Highly Active Anti Retroviral Therapy. This was a distinct turning point because for the first time this lethal disease became a controllable chronic illness where one could survive for decades or possibly more. But if one stopped the drugs once immune function returned toward normal, the disease rapidly recurred in force. So it was suppressed but definitely not cured. Now the key was to get the drugs to the patient, get good compliance and give careful follow-up. Getting the drugs to the patient is no mean feat since they are inherently expensive and many patients are uninsured or underinsured. Taking multiple drugs many times per day is difficult for anyone but harder still if the person is living in poverty or is homeless or is a child with perhaps drug addicted parents. And careful follow-up is difficult for all of the same reasons plus others. And of course the challenges are perhaps even more difficult in many developing countries where the stigma of AIDS is high and the logistical means of getting both the drug and the caregiver to the patient are immense, yet this is just where the vast majority of infected individuals live.

Now a third stage has evolved. With many patients living very long times, caregivers are witnessing a set of new challenges. These are the consequences of long term chronic illness and long term drug treatment. Many patients develop a unique change in body habitus with loss of fat in the face and limbs but an increase in abdominal adipose tissue deep in and around the viscera. The metabolic syndrome is frequent and it is followed by diabetes in many. And late onset cancers of many types are being increasingly recognized. Early onset coronary artery disease is another manifestation of the changing nature of this disease and its treatment. Some believe that the chronic infection leads to chronic inflammation which in turn drives the intimal development of plaque in the coronary arteries and others like the carotids. Early onset osteoporosis is also common with 50 to 67% having osteoporosis or osteopenia well before the expected age. With continued loss of bone mineral density, the risk of fracture at an earlier age with its attendant implications for loss of mobility, hospitalization and death is high.

So for the physician, the change in these evolving stages has been from spending 90% time managing infections to 90% managing the complexities of therapy, its many complications and the long term complications of the chronic infection. Today, the HIV patient on HAART needs regular evaluations for coronary artery disease, metabolic syndrome and osteopenia with life style adjustments and possibly further drug interventions as preventive measures.

There are over 25 licensed antivirals for HIV infection and more are on the way. But whichever ones are used, they must be continued. Stopping has repeatedly proven to be linked to relapse and earlier death.

What will the forth stage be and when will it begin? Let us hope it is the discovery of a vaccine. Only a vaccine will ultimately drive the epidemic down and possibly even contain or eradicate it the way smallpox was or polio and measles could be. The HIV has proven to be very difficult to conquer with a vaccine. Some of the problems include that the initial infection usually goes unnoticed and then it remains latent for many years until the earliest evidence of AIDS appears. Another is the ubiquity of the virus and its ability to undergo sufficient change to escape immune detection. Once the T cell is infected, it is infected for life so a vaccine must be used before, not after, exposure. Of course, there has never been a vaccine produced before to a retrovirus so this in itself is a new hurdle with limited knowledge from former vaccine research to base today’s work upon. The vaccine must block the virus’ ability to enter the cell suggesting an antibody rather than a cellular immune-based vaccine. Dr Robert Gallo, Director of the Institute of Human Virology - believes the target must be the virus envelope – the “fingers” that attach to the T lymphocyte. He and his colleagues recently received over $24 million from the Gates Foundation and the military to further research in this direction.

With about 2,700,000 new infections per year worldwide, a vaccine cannot come too soon. But even when it does, the logistics of getting it to the world’s neediest will be fraught with difficulties. If getting susceptible children immunized against polio and measles has been difficult, HIV will be much more so.

Improving Cancer Patient Care While Markedly Reducing Costs

2011-06-08T10:49:00.000-07:00

It is often difficult to appreciate that improving the care of patients can actually reduce the costs of care. Last year Dr H Brody wrote in the New England Journal of Medicine (vol 362, p283-5) about “Medicine’s ethical responsibility for health care reform – the top five list.” In essence he challenged physicians to be first to find ways to rationally reduce health care costs by identifying the top five tests or treatments in any given specialty or subspecialty that could be markedly reduced or even eliminated without harm to the patient. He made some specific suggestions to get things started.

Now Drs.Thomas Smith and Bruce Hillner, two oncologists from the Massey Cancer Center in Virginia, have accepted the challenge and published in the same journal (vol 364, p21, May 26, 2011) a proposed list of five suggested changes in medical oncologist’s behaviors and five changes in attitudes and practices. Their proposal is noteworthy because it directly addresses some of the most important issues that affect cancer patient care yet inordinately increases the cost of that care.

I will not repeat each of their suggestions but will comment on a few. One change in behavior is to limit chemotherapy to patients with a good performance status (with an exception for those with highly responsive disease.) It is well known that a person’s performance status is a very strong predictor of whether a patient will respond to a treatment or have any meaningful extension of survival. The authors point out that their proposal is in line with current guidelines by national oncology organizations. They make the simple recommendation that a patient should not be given chemotherapy if he or she cannot walk into the clinic unaided. Unfortunately, many oncologists today push ahead with further treatment despite their patient’s performance status.
Another suggestion is to “replace the routine use of white blood cell stimulating factors with a reduction in chemotherapy dose in metastatic solid tumors.” The hematopoietic colony stimulating factors (CSFs) are very valuable in pushing the bone marrow to recover white blood cell numbers after aggressive treatments. The concept is that infection is common when the white blood cell count drops below 500 per ul. This is a common occurrence in the treatment of acute leukemia and some other situations where very aggressive chemotherapy is used and the CSFs can be lifesaving in those patients. But they are not needed for modest reductions in WBC counts. In truth, drops below 500/ul rarely happen in the treatment of patients with most solid tumors such as breast, prostate, lung or colon cancer. Yet these very expensive stimulants are used routinely but at high cost. Smith and Hillner suggest that at about $3500 per injection, the sales by oncologists to their patients’ amount to some $1.25 billion per year.
And there is the rub – to change these two practice patterns would be to substantially reduce the oncologist’s income. Oncologists earn a decent but not high income from basic care of their patients. But fully another one half comes from the administration of chemotherapy and support medications such as drugs for nausea and vomiting and drugs to boost the bone marrow to produce red blood cells (erythropoietin) and white blood cells ( pegfilgrastim, Neulasta). In effect they serve as a pharmacy for these drugs, buying them wholesale from distributors, preparing them and administering them while collecting a markup for their effort. This brings their incomes to among the highest among internists. To cut back on chemotherapy or Neulasta administration would have a telling financial impact.
Another suggestion, this one a change in attitude, is to address the importance of end-of-life discussions. The authors point out the truism that such discussions are a critical perquisite to good care planning by both doctor and patient and family. But they point out that far too often, oncologists wait until new symptoms appear or until they feel there is nothing else that can be done before entering this type of discussion. But when such discussions are held at an appropriate time, there is greater use of hospice and “less depression or anxiety, less aggressive end-of-life care and [patients] rarely die in an intensive care unit or on a ventilator.” Further “it allows the surviving caregiver to have a better quality of life and would save our society millions of dollars.” And yet, such discussions are all too infrequent or come too late. It is the physicians’ obligation to their patients and patients’ families to be honest and direct, albeit caring and compassionate at the same time.

With these changes (and some of the others that Smith and Hillner recommend) in behaviors and attitudes, the care of cancer patients would be greatly improved yet the costs would be very greatly reduced. That is a good exchange. Let’s hope these suggestions become the norm of care and that physicians in other specialties take up Brody’s challenge as effectively.

Using Genomics to Improve Treatment of Lung Cancer

2011-06-03T08:22:00.000-07:00

Drug companies can use genomics to create targeted drugs like imatinib (Gleevec) and trastuzumab (Herceptin.) Physicians can then use the results of genomic studies to guide prescribing. As discussed in prior posts, a person with Philadelphia chromosome-positive (i.e., having the BCR-ABL translocation with its aberrant tyrosine kinase) chronic myelocytic leukemia will likely respond to Gleevec. And a woman whose breast cancer shows high levels of the Her2neu receptor will likely respond to Herceptin. There would be no reason to treat a Philadelphia chromosome-negative CML patient with Gleevec nor a breast cancer patient without Her2neu receptors with Herceptin.

Recently the treatment of lung cancer has advanced considerably as a result of genomic analysis of the tumor and the development of targeted drugs. Lung cancer is divided into a number of different categories based on the microscopic appearance under the microscope. One type is called small cell and the others are usually “lumped” together as “non small cell” lung cancer because the former is treated much differently than the latter group. The non small cell lung cancers can be genomically evaluated to determine if there are certain common genetic mutations such as KRAS, EGRF, MEK and other mutations or the EML4-ALK translocation.

Patients with the EML4-ALK translocation respond reasonably well to the tyrosine kinase inhibitor crizotinib (somewhat similar to the one used for CML). As with the translocation seen in CML, this is a fusion gene that occurs during a translocation of two parts of two chromosomes that lead to a portion of the normal EML4 gene being fused next to the normal ALK tyrosine kinase gene. When this happens the new gene transcribes a variant tyrosine kinase protein which leads in part to the development or progression of lung cancer. Studies to date indicate it to occur mostly in the subtype called adenocarcinoma, in those with prior treatment, in younger patients and those who have no or a minimal smoking history. Although this represents just a small subset of all lung cancer patients, treatment of them in a Phase 1 trial with crizotinib resulted in a confirmed response in 57% (47 of 82) of patients with another 33% (27 of 82) having stabilized disease. [Kwak et al, New England Journal of Medicine, Oct 28, 2010] Although not a randomized trial, it is well known that most second line treatment regimens have no better than a 10% response rate so this would appear to be a breakthrough of sorts. Certainly it is not a panacea, nor a cure. But with minimal side effects these patients received some useful benefit and probably will have a lengthened survival Further studies will need to be done but if it is correct that about 5% of lung cancer patients have this fusion gene, then about 9000 patients per year would potentially benefit form crizotinib or similar ALK kinase inhibitors. Concurrently, one would not choose to use this drug in patients without this fusion gene and its abnormal protein. It also appeared that some patients had a further mutation such that crizotinib was not effective in them. [Note: Crizotinib is not yet approved by the FDA so access to the drug is via clinical trials.]

Patients who have the EGRF mutation appear to be distinct from those who do not as to response to the drugs erlotinib (Tarceva) and gefitinib (Iressa). EGRF is a tyrosine kinase that when mutated appears to play a role in lung cancer development and progression. Those who do have this mutated gene and its transcribed protein will respond to these two drugs in about 70% of cases with progression free survival of about a year and total survival of about two years. This would appear to be superior to standard drug therapy used today. Without this mutation, the patient will do much better treated with chemotherapy. So the treatment of a new patient with lung cancer today should include genomic analysis of the tumor so that the patient can receive the most appropriate first line treatment and then reanalysis later to determine if there are further mutations or translocation that would direct second line treatment options.

This is just one more example of how genomics is making medical care more custom-tailored, one of the five key medical megatrends.

Mitral Valve Repair Without Open Surgery – Exciting Development in Medical Devices

2011-04-20T14:14:00.000-07:00

The mitral valve separates the heart’s left atrium from the left ventricle. When the ventricle contracts to send blood to the aorta and out to the body, the mitral valve closes to prevent blood rushing backward into the atrium and back to the lungs. The mitral valve can become stiff and tight, called stenosis or it can become unable to close tightly, called regurgitation. Once the regurgitation becomes sufficiently severe to cause heart failure, the death rate reaches about 5% per year. Most such individuals are referred for cardiac surgery to either try to repair the valve, replace the valve or do a procedure that in effect lessens the amount of regurgitation without actually replacing the valve. The latter procedure, although not curative, can be quite successful and alleviate the heart failure and the symptoms leading to a longer and better quality life.

A new procedure has now been reported in the New England Journal of Medicine, April 14, 2011 that does not use open surgery to repair the mitral valve leak. The process is to insert a catheter via the large femoral vein in the groin and pass it up to the heart. From the right atrium it crosses over to the left atrium and then is positioned at the opening of the mitral valve. This mechanical device, manufactured by Abbott Vascular, is able to grasp the two sides of the mitral valve and clip the two leaflets together. It does not create a tight seal but in most cases can markedly reduce the amount of regurgitant flow back into the atrium.

The study randomly allocated patients with grade 3+ or 4+ (i.e., serious) mitral valve dysfunction to either the customary open repair or replacement (the specific procedure at the surgeon’s discretion based on the valve status) or to have a percutaneous repair done with the new device. The study endpoints were freedom from death, freedom from surgery for mitral valve dysfunction and freedom from grade 3+ or 4+ regurgitation at the end of 12 months. The primary safety end point was freedom from major complications during the 30 days post procedure.

The study ws performed at 37 institutions in the United States and Canada. 279 patients were randomized with a 2:1 ratio of percutaneous vs. open procedures. 21 patients withdrew consent before the procedure was done, leaving 258 treated patients.

After the procedure, 41 of 178 (23%) patients who had the percutaneous procedure still had grade 3+ or 4+ regurgitation and were therefore referred for open surgery. Among those 80 patients who initially had open surgery, all had less that 3+ regurgitation after the procedure. By the 12 month end of study time, the composite of freedom from death, from surgery or from grade 3+ or 4+ valve dysfunction for all randomized patients were 55% vs. 73%. If one looks only at those who actually were treated per the protocol (i.e., did not exclude themselves, etc) then the rates were 72% vs. 88%. As to safety, the rates of major adverse events (most often the need for transfusion) as of 30 days were 15% vs. 48%. Quality of life improved in both groups of patients over the 12 months although there was a decrease at 30 days for the open surgery patients.

What these results suggest is that open surgery is more likely to greatly relieve the mitral regurgitation than will the percutaneous catheter procedure. However, the percutaneous procedure is safer, requires less time in the hospital, and is associated with improved quality of life and improved ventricular function from baseline. Many patients might therefore decide to choose the percutaneous catheter-based procedure on the grounds that it greatly relieves the problem in almost three quarters of the patients, is less invasive and is safer than surgery. Then if that individual patient was not among the success stories, he or she can choose to have the follow-up open surgery.

Further, although not mentioned in this article, there are patients who simply cannot tolerate open surgery for any number of reasons who might still be able to undergo the catheter-based procedure. This might then open up an option for repair not otherwise available today with open surgery. Not discussed in the article was cost. This might become a deciding factor as well once the procedure is on the market.

In an accompanying editorial, Otto and Verrier suggest that the decision on surgery (and which surgical procedure) or one of a number of catheter-based procedures (assuming logically that others will undoubtedly arrive soon) should rest on the advice of not one physician but the joint opinion of a multi-disciplinary team of, at least, a nonprocedural valve-disease specialist, and interventionalist cardiologist and a cardiac surgeon, each with substantial expertise in mitral valve disease. To this team I would add the patient’s primary care physician and principal cardiologist – both of whom will have known the patient and his or her overall health and family situation over the years. The other addition to the team is the patient --whose opinions should be incorporated from the beginning of the evaluation and advice process.

Ultraprocessed Foods Lead to Chronic Illnesses

2011-04-18T06:43:00.000-07:00

Much of today’s foods are “ultraprocessed,” lead to obesity and its ultimate diseases such as diabetes, coronary artery disease, hypertension, many cancers and worsening of diseases such as osteoarthritis.

Ultraprocessed foods originate from just a few grains, namely corn, wheat and soy but these then undergo extensive chemical and mechanical manipulation resulting in compounds that humans have never eaten before. Just look at the ingredients list on many store products and notice first how many ingredients are listed and second how few of them you recognize. Further they are concentrated as to sugars, salt and calories while deficient or totally lacking in the fiber, micronutrients and phytochemicals found in fresh or frozen grains, vegetables fruits and unadulterated meats and fish.

David Ludwig MD, PhD of Boston Children’s Hospital wrote a cogent article on ultraprocessed foods in the April 6, 2011 edition of the Journal of the American Medical Association and upon which the proceeding was based. He explains that there have been three major breakthroughs in food technology. The first came perhaps 2 million years ago with the development of stone tools and the use of fire for cooking. This allowed the human who did not have the running speed of large carnivores nor the digestive tract attributes of herbivores like cattle and sheep to expand his diet. The second big technology breakthrough was domestication of grains – agriculture. This led to civilization in the sense of larger more stable communities because domesticated grains such as wheat and corn greatly increased calories available and no longer required migration to hunt or gather. He makes the interesting observation that human stature dropped a few inches with this change because grains carry fewer micronutrients and protein per gram than do animal meats and nuts.

The industrial Revolution was the third breakthrough technology which led to refined flours and concentrated sugars along with grain-fed rather than grass fed cattle, sheep and hogs. Such animals are heavy with saturated fats although their protein content and ready availability has resulted in a return of greater stature in recent generations. More recently have come ultraprocessed foods.

These ultraprocessed foods are high in calories from sugars and fats – often hydrogenated and trans fats – yet low in micronutrients. They are found in supermarkets’ “middle aisles” as processed foods such as cereal with added sugar, cheese “spreads”, “macaroni and cheese,” soups high in salts and calories, “sticky buns,” and of course sugared sodas. And ultraprocessed foods are readily available in many fast food outlets where a muffin may have 400 calories with high contents of sugars and saturated fats. A bacon cheeseburger, large fries and large soda can contain well more than one half of a day’s caloric needs yet be deficient in nutrients.

Ludwig concludes with “the problem is the creation of a dietary pattern based on factory-made, durable, hyper-palatable, aggressively marketed, ready-to-eat or heat foodstuffs composed of inexpensive, highly processed ingredients and additives. Reducing the burden of obesity-related chronic disease requires a more appropriate use of technology that is guided by public health rather than short-term economic benefit.”

What can we do? We need to cut back on the ingestion of these ultraprocessed foods. But this will not be easy. For this to work I believe we need incentives. After all, that bacon cheese burger tastes good – sugar and fat are pleasing in our mouths. So we need more than just knowledge that we are eating well and thereby preventing future disease while improving our health. Knowledge is important because most people just do not realize the extent of the harm that comes from over consumption of ultraprocessed foods. With knowledge we can follow the advice of Pollan in his “In Defense of Food” to never buy a product that has more than five ingredients or has ingredients that we have never heard of or cannot pronounce. But knowledge alone is just not incentive enough to overcome the temptations.

Some thoughts: Government can help with how it subsidizes agriculture, incenting the growth of a broader array of crops and not marking the fattest meat as “prime.” And it can continue to insist that restaurants, especially fast food outlets, display calorie counts. Business can help with wellness programs that reduce the employee share of health insurance premiums in return for weight reduction or exercise programs. Insurance can offer incentives as well. Schools can offer only quality foods – good in itself but also a lesson in good dietary habits for our children in their formative years. And we each need to create our own incentives – as I typed this I also ate a chocolate chip cookie. I enjoyed it but have set myself a limit of one per day. My treat for finishing this blog post.

Surprise – Adolescent Obesity Leads To Later Heart Disease and Diabetes

2011-04-11T14:43:00.000-07:00

Well, probably not a surprise at all. The seeds of coronary artery disease (CAD) are laid down early and over long periods. But given our current pandemic of obesity beginning in childhood, should we worry about an epidemic of chronic disease like diabetes and CAD in the years to come? The clear answer is a resounding “Yes.”

There has been a long term study of military men in the Israeli Defense Force. An article in the New England Journal of Medicine, April 7, 2011 reports on what happened over an average follow-up of 17 years after army induction at age 17 for those who chose to remain in the military after the required three years. This amounted to 37,674 healthy men followed for about 650,000 person years. Among them, 1173 developed diabetes type 2 over time and 327 developed angiography-proven CAD. All by the age of 45.

Here is the baseline data:

Blood pressure, resting heart rate, fasting blood sugar, and low density lipoprotein (LDL – the “bad stuff”) and smoking incidence progressively increased with increasing BMI (BMI, a calculated ratio of weight and height) among the 17 year old inductees. High density lipoproteins (HDL – or the “good stuff”) declined as did the amount of weekly exercise with increasing BMI.

Here is the follow-up data:

Since this was a study of men beginning at age 17 and lasting an average of 17 years, it follows that the 327 cases of CAD and 1173 of diabetes were among relatively young men – aged 25-45 years old. When the investigators adjusted for age, family history of CAD, blood pressure, smoking status, LDL, HDL and triglycerides they found that an elevated BMI at age 17 was a significant independent risk factor for CAD. Indeed the risk increased by 12% for each increment of 1 unit of BMI. They also noted that CAD occurred even in those with BMIs that are generally considered within the acceptable range today.

BMI at age 17 also predicted for the later development of diabetes mellitus type 2 (DM) with risk increasing about 10% for each additional 1 unit of BMI. But with diabetes, it was the adult level (age 25 and beyond) that was associated with a greater increase in diabetes relative risk. Said differently, higher levels of BMI at age 17 correlate with higher risk of CAD and diabetes in early adulthood. Persistent elevations of BMI increase that risk. Elevation in early adulthood increases the risk of DM during early adulthood whether or not the person had a higher BMI at age 17.

My takeaway:

It is imperative to intervene now in the growing pandemic of childhood and adolescent obesity. Even modest increases BMI can predispose to later CAD and DM. Once developed, these are chronic illnesses that persist for life, are challenging to manage, are expensive to treat and have a high impact on both quality of life and longevity. Our children are our future; it is our obligation to protect them. And if that is not reason enough, then think of your wallet. The high costs of their care will have a very significant impact on each of us in our taxes and our insurance premiums.

Bringing Down the Costs of Medical Care

2011-03-26T13:27:00.000-07:00

It is currently popular for government officials to single out the insurance companies for the rising cost of healthcare. Not that the insurers are without fault but the real reasons for cost increases are rarely addressed and therefore not appreciated. We are a country with an aging population (“old parts wear out”) and of many adverse behaviors (e.g., overweight, sedentary lifestyle, stress and 20% still smoke.) Combined, these are driving a rapid increase in chronic diseases such as diabetes type 2, cardiovascular disease including heart attacks, heart failure and strokes, high blood pressure, and cancer.

These are illnesses that, once developed, are usually with the individual for life, have a major impact on quality of life and are inherently expensive to treat. The Milken Institute did a comprehensive study of chronic diseases. Among their findings: 109 million Americans have a chronic illness now [that’s about one third of us!] and many have more than one for a total of 162 million. The costs of care today are about $275 million and the total economic costs are well over a trillion dollars per year in lost productivity, etc. They estimate that we are on a track for a 42% increase in these chronic diseases by 2023 (as a result of aging and behaviors,) not that long from now. And if we do nothing to change the way we care for these patients, the costs of medical care will be $790 billion and the total economic costs will be over 4 trillion dollars.

There are two things to do to reverse this trend. These are illnesses that by and large are caused by our behaviors or are the result of aging. We can’t stop aging. So, the first step is to have an active program in behavior modification. Easier said than done, of course but here are some principles. We need to individually accept responsibility for our own health. But we need to understand what we are doing and how it impacts us over the long term. Government can help here with educational programs, rules about school lunches, requiring restaurants to post calorie and fat contents, labeling food packages with a more realistic total calorie assumption (today packages imply that the average person needs a 2000 calorie diet) and other steps. Incentives, primarily monetary ones, can have a big impact. Incentives need to be large enough to be useful yet focused enough to drive toward the desired end. Our employer can help with wellness programs to assist us to stop smoking, loose weight, improve our nutrition or deal with stress more effectively. The incentive here can be asking the employee who is successful to pay a lower portion of their health insurance premium. Insurers can create incentives directly for following a healthier lifestyle by lowering premiums for those who don’t smoke or are at a reasonable weight.

The second major step is to ensure that those who do have a chronic illness get very good care coordination. Unfortunately, this is just not the case for most patients today. They end up with multiple doctors, each doing their own thing, excess specialist consultations, too many medications, unnecessary tests and procedures and sometimes even unneeded hospitalizations. This drives up the cost of care dramatically. When one has a primary care physician that takes the time to fully coordinate all the elements of care, the use of specialists declines as do tests, procedures and hospitalizations and drug therapy is well managed.

Unfortunately, most primary care physicians have too many patients under their care to allow adequate time for prevention sessions or the time needed for care coordination. They need to care for fewer patients meaning they will need to receive a higher fee for each visit and this must include a reasonable payment for preventive activities and coordination efforts. Added to this they need to be paid to take the time to respond to emails and to use other technologies that can keep the patient out of the office unless really necessary. Some docs are doing just this by limiting their practice to about 500 patients (rather than the usual 1200-1400) and charging a flat fee for all care for a year. Others are refusing to accept insurance, both commercial and Medicare, and instead are billing the patient just as a lawyer or accountant or other professional would. The billing includes time spend in prevention and coordination. These may well be the future of primary care reimbursement and a means to assist the patient to first prevent chronic illnesses from occurring and second to assist in good coordination of the care when one does develop.

But all of this raises critical questions. What should and what will government do to help us modify our behaviors? Will insurers be allowed and will they accept the responsibility of a two tiered premium pricing system? Will employers accept the added chore of developing wellness programs? Will physicians, even if they are offered adequate payments, actually spend the time needed for good prevention and good care coordination? And, most importantly, will we as citizens accept our responsibility to lead a reasonably healthy lifestyle?

Getting Nurse Staffing Right Is Critical – Patient Mortality Depends On It.

2011-03-18T12:49:00.000-07:00

When I was the CEO of a large academic hospital we were constantly concerned to properly balance nurse staffing. More staff than needed meant wasted money and too little staffing risked lesser quality care and nurse disharmony and even resignations. But adjusting the staffing levels of multiple units, each with differing patient types and needs was a major effort and easily thwarted by rapidly varying census numbers, patient admissions and transfers to other units, nurse shortages, and many other factors. In retrospect it is remarkable that it worked as well as it did. But the risk management group was ever concerned that if the staff levels were too thin it was possible that adverse events could occur.

Now there is a new study reported in this week’s New England Journal of Medicine that links deficiencies in nurse staffing with increases in patient mortality. The investigators evaluated an unnamed academic hospital with a strong record of high quality and lower than expected patient mortality. They looked shift by shift and noted whether that shift was at targeted levels based on patient acuity, over or under. They also looked at the level of patient turnover during each shift. Quoting from the article, “In an institution with a history of success in meeting staffing levels and with a level of patient mortality that was substantially below that predicted by its case mix, we found that the risk of death increased with increasing exposure to shifts in which RN hours were 8 hours or more below target staffing levels or there was high turnover. We estimate that the risk of death increased by 2% for each below target shift and 4% for each high turnover shift to which the patient was exposed.” [Italics mine]

The take away message to me is that hospital executives and boards need to be sure that they are managing nurse shift decisions carefully. In any hospital, personnel constitute about 60% or more of expenses and nurses represent about one half of that so the dollars are not inconsequential and need to be managed appropriately. Clearly, “appropriately” also means assuring that each unit has the necessary complement of registered nurses on each shift. From the article, “Our findings suggest that nurse staffing models that facilitate shift to shift decisions on the basis of an alignment of staffing with patients needs and the census are an important component of the delivery of care.” It also means that hospitals need to look at their approach to transferring patients from unit to unit. Often times this is necessary such as movement of an unstable patient to an ICU. But this study makes the point that excess transfers can be detrimental to patient welfare and may require more than the usual staff numbers. “Our results suggest that both target and actual staffing should be adjusted to account for the effect of turnover on patient outcomes.”
How a hospital aligns its nurse staffing is an important element of quality in addition to cost management. Getting staffing right is critical. When it is correct, mortality will be lower. Further, although not measured, if mortality came down in this study, it is fairly safe to assume that other quality measures were improved as well.

Surviving Cancer As A Teenager – It’s Not Just The Treatments

2011-03-14T12:22:00.001-07:00

When Clarissa was 13 she entered Johns Hopkins Hospital to be treated for relapsed acute leukemia knowing full well that she had only a 40% chance of survival. Today she is 16 and in excellent health. But it took 2 ½ years of incredibly rigorous treatments to get there. Equally importantly it meant riding an emotional roller coaster for her and her parents.

Clarissa had been treated for leukemia when she was 2 and had been fine for a decade when the relapse occurred. She found there was not much available to read about coping with the emotional issues that come with a cancer diagnosis during the teenage years nor was there a support group of teens who had faced the same challenges. Consider that a teen wants to be more and more independent but that is just impossible when you now need your parents even more than ever and must depend on doctors and nurses for life itself. Teens are focused on their appearance but what if you have no hair and an intravenous catheter sticking out from your skin – pretty hard to hide. Friends want to be friends but don’t know whether to visit or not and when they do they find you wearing a mask to protect against infection and must shun the instinct to hug. These and other issues surfaced over her two and one half years of treatment, years in which she spent much of the time in the hospital and lost well over a year of school, again much of that to avoid contact with infection while her immune system was at its lowest. With the help of at home tutoring, she kept up with her assignments and now is back in school with her classmates, getting good grades and enjoying the life of a high school student while thinking about college and the future.

Clarissa persevered and now wants to help other teens who develop cancer to cope with what lies ahead. She has started a blog, gives frequent talks and plans to write a book on coping later this year.

A friend of mine, a twenty five year survivor of adult leukemia, told me after reading her first blog entry: “Wow! I am sitting at my desk with tears in my eyes - she is so beautiful - inside and out. So brave - so inspiring. I am coming up on 25 years and have no courage compared to this young woman.”

If you know a teen ager with cancer, I encourage you to direct them to Clarissa’s blog at http://www.teen-cancer.com/

Palliative Care Teams – A Big Improvement in Quality of Life

2011-02-21T13:17:00.000-08:00

During the healthcare reform debate there was the unfortunate reference to “death panels.” No such thing was ever in the proposals but it meant that an important part of medical care was set aside as too “toxic” to discuss. But end of life counseling is very important. Indeed it is good to have realistic discussions at the beginning of a serious illness; indeed it is only fair to the patient and the patient’s family.

Palliative care (I don’t like the term; it seems to imply only end of life care and so I prefer “supportive care”) is designed to achieve the best possible quality of care and the least suffering possible. This is not limited to pain management but also to psychosocial support, spiritual needs, the treatment of any symptoms, and assistance or at least support for decision making. It might be a complicated pain management program or a simple cup of tea in the afternoon to talk over important issues. Ideally it uses a team approach including physicians, nurses, social workers, psychologists, chaplains and others all working together. Palliative care teams have demonstrated their value in improving care and, interestingly, substantially reducing medical care costs.

There was a recent report of a controlled trail of palliative care. 151 patients with lung cancer entered a randomized trial when they first came to be treated in a thoracic oncology practice. It compared standard care to the same care plus a palliative care team. The results were clear that palliative care added to the patients’ quality of life; reduced the frequency of depression, the number of hospital days and even extended the survival by 2.7 months.

My experience, and others report the same, is that many physicians are uncomfortable with palliative care and tend not to refer their patients or if they do, not until very late in the patients’ course. Perhaps it gets at the deep inner concern that they do not want to be seen as “giving up” on the patient and perhaps it even forces them to admit that they cannot always cure every patient. Whatever, it is unfortunate because many people who could benefit from early referral to the palliative care team are not getting that benefit. Most large hospitals now have such teams; it behooves the patient or family to ask about them.

Protocol Medicine – It Is Time For Doctors To Recognize Their Value

2011-02-09T12:16:00.001-08:00

We hear that doctors do not like “protocol medicine” – they do not want to follow a “cookbook” when every patient is different. It is not a good understanding of the issues.

Some years ago when I worked in a branch of he National Cancer Institute and then the University of Maryland Cancer Center, we admitted many patients with acute leukemia. The treatment approach including the necessary special tests to obtain, chemotherapy drugs, steps to prevent infection, prevent kidney problems, etc was complicated. So I wrote out a set of admission orders, had them typed up, xeroxed and kept at the nurses’ station. When a new patient was admitted, the physician took one of those order sheets and either accepted each individual order or made changes. But the doctor now would not forget something important such as a drug, its dose or the number of times per day. This worked much better than depending on memory yet any specific order could be eliminated or modified as needed for the individual patient. This was not a “cookbook” but rather an improvement in both safety and quality.

Peter Pronovost and colleagues from the Johns Hopkins Bloomberg School of Public Health have worked on designing similar protocols for ICU patients for those needing the insertion of a central intravenous catheter to reduce the frequency of hospital acquired infections. This is basic stuff like gown and glove, use a disinfectant on the skin, use sterile materials, etc. It works; the infection rate falls by 60% if the guidelines are followed. Indeed in the Michigan hospitals where the technique was evaluated, the rate dropped to zero.

Remarkably, many doctors at hospitals across the country rebel at having those steps to follow using the same argument of “protocol medicine.” And equally remarkably, most hospital executives are hesitant to insist. They will need to become more assertive and physicians must accept the new standards. It is a matter of rights and responsibilities.

If physicians want the public (and elected representatives) to be supportive of malpractice tort reform, they will first have to accept “protocol or “cookbook” or “checklist” approaches that are tried and proven to improve quality and safety.

The Incidence Of Kidney Failure Due To Diabetes Is Down – But We Should Not Be Pleased

2011-01-17T09:27:00.000-08:00

Diabetes mellitus is the most common cause of kidney failure that progresses to end stage renal disease (ESRD,) meaning that the person requires dialysis or kidney transplant. ESRD is chronic and life long, is complicated to treat, has a major negative effect on quality of life and the costs are high.

So it was good news when the Centers of Disease Control reported that the incidence of ESRD among diabetics had declined by about 35% over the ten years ending in 2007. The reasons for the decline are not known but a few assumptions seem reasonable. More and more patients now keep good control of their blood sugar with careful monitoring and many also keep their blood pressure under control with anti-hypertensive medications. Further, it has been shown that angiotensin-converting enzyme inhibitors (or ACE inhibitors) and angiotensin-receptor blockers (or ARBs) slow the decline of kidney function in those with diabetes and early kidney failure. It is believed that as many as 80% of these patients are taking ACE or ARBs – a good thing. All of these may be the factors that have led to this decline of diabetes to kidney failure; or there may be others as yet not appreciated.

But the news really is not so good. The decline in kidney failure incidence was offset by a much increased absolute number of individuals with diabetes developing kidney failure. Why? Because there are so many more individuals developing diabetes now than just a decade ago – so there are more people at risk of and therefore developing kidney failure.

We can be pleased that secondary prevention approaches are slowing the onset of kidney failure among those with diabetes but we should be aghast that so many of our fellow citizens are setting themselves up for a high risk of diabetes as a result of obesity.

The message - the real need is to accelerate efforts to stop the epidemic of obesity (excess consumption of not very nutritious food compounded with a sedentary lifestyle, including in adolescents.) Obesity is the primary culprit leasing to the rapidly rising number of individuals with diabetes.

The Shingles (Herpes Zoster) Vaccine Really Works But Many Older Folks Don’t Receive It - They Should

2011-01-14T12:46:00.000-08:00

Herpes zoster (or shingles) is caused by the same virus that causes chicken pox. Zoster increases in incidence with advancing age. It is estimated that over 1 million Americans get shingles annually with the resulting acute discomfort and often chronic pain thereafter. A vaccine was introduced by Merck in 2006; the initial studies of 38,546 patients indicated that it reduced the incidence by about 50% and for those who still got shingles, the severity was lessened substantially. But acceptance of the vaccine has been slow. It seems that this is due to a combination of lack of knowledge that it is available and is effective; failure of physicians to inform their patients; and a fairly high cost of about $200, often not covered by insurance.

A new study was reported in JAMA January 12, 2011. Kaiser Permanente, Southern California and Centers for Disease Control and Prevention investigators evaluated 75,761 Kaiser members who had no underlying immunological disorder and who had been vaccinated between January, 2007 and December 2009. These were compared to a control group of 227,283 age matched members who had not been vaccinated.

Among the unvaccinated individuals, this study showed that, as anticipated, shingles incidence goes up with age from - 60-64 years of age (9.7 infections per 1000 person years) to over age 80 (17.3 per 1000 person years).

Vaccination reduced the frequency by about 50% from a total of 13.0 per 1000 person years to 6.4 per 1000 person years. This halving of incidence was found at all age intervals, indicating that the vaccine works as well in the very elderly as in “younger” individuals. The incidence of zoster was steady over time. For example, at one year, slightly more that 1% of the unvaccinated individuals had developed zoster compared to less that 0.05% in the vaccinated group; at two years the numbers were about 2 ½ % and 1%, respectively. During the time of patient follow-up, this can be stated as one case of herpes zoster was prevented with each 71 vaccinated. However, since the follow up was only about 1 ½ years for most individuals and since it is estimated that beginning at age 60 a person has a 20% lifetime risk of zoster, it is my presumption that it actually takes many fewer individuals vaccinated to prevent one episode of zoster over the rest of one’s life.

Not part of this study, the original Merck investigation demonstrated that many older people do not respond well to the vaccine with increases in antibody production. This finding is consistent with many others that those over 60 years of age respond much less well than do those who are younger. This raises the question as to whether it would be useful to measure antibody production after vaccination to determine who has and who has not responded well. Perhaps those who do not should get a second vaccination. This is an important issue for all vaccines in older people. The same occurs with influenza vaccine which is why, this year, the dose for older people was doubled. But perhaps there are other approaches as well to improving the response rates for those at increased risk in their older years who respond less well to vaccines.

The study makes clear that this vaccine is effective, including for those over 80 years of age where the incidence is the highest. Given the implications of herpes zoster in immediate and longer term suffering and the attendant costs, I believe this is a vaccine that essentially everyone over the age of 60 (other than immunocompromised individuals) should receive. Insurance should pay for it just as with the influenza vaccine.

Even if paid for out of pocket, it is worth it. Patients need to ask for it and doctors need to encourage it.

To Scan or Not To Scan for Early Lung Cancer

2011-01-11T13:30:00.001-08:00

Lung cancer is the most common cancer other than skin cancer. The survival rate is still dismal so early diagnosis presumably could make an impact. Chest x-rays just do not have the sensitivity to find early lung cancer. Computed tomography (CT Scans) can detect very small lesions in the lung. Another study has now been completed and it was able to find many early cancers.

The National Cancer Institute funded this study that randomly allocated some 53,500 men and women at high risk (i.e., smoked about 1 pack or more cigarettes per day for 30 or more years) to either standard chest X-rays or low dose CT scans. Each person had a screening image taken annually for three years and were followed for an additional five years.

As of October, 2010, there were 649 cancers detected and 354 deaths in the CT group compared to 279 cancers and 442 lung cancer deaths in the X-ray group (obviously many of these latter cancer deaths were due to cancer NOT detected by the routine chest X-ray). The implication is that low dose CT scans detected cancer earlier resulting in successful therapy for many.

Lung cancer mortality per 100,000 was 246 and 308 for the CT group and the X-ray group respectively for a 20% reduction in lung cancer mortality.

But there are “buts” to the study. To save one life required 300 people to be screened. A CT scan costs at least $300 each, often much more. This means it cost $90,000 to save one life. Another “but” is CT screening detects lesions that are often not cancer. Indeed the false positive rate was about 25%. Since it requires a biopsy to prove it is benign, this adds not only risk and costs, but anxiety.

There is more information at http://tinyurl.com/2cutflw

The take away for now is that in high risk individuals, low dose CT scans can pick up early lung cancer. But the combination of high false positives and high costs weigh against its routine use even in these patients.

Hospitals are Unsafe - There Are Still Plenty of Preventable Medical Errors

2010-12-14T08:50:00.000-08:00

Over the past ten years and since the publication of the Institute of Medicine landmark book “To Err Is Human” there have been many attempts to reduce preventable medical errors which are estimated to take about 100,000 lives per year – perhaps many more. The question is whether all of this effort has had a substantial clinical impact.

The results of a recently published study are therefore concerning. A group lead by Dr Landrigan at Harvard evaluated the number of “harms” which occurred at ten randomly selected North Carolina hospitals. They taught a cadre of reviewers to use “triggers” in the medical record to prompt further analysis for an error that caused harm. The harms were categorized into five groups with E being temporary yet requiring an intervention through, F temporary but requiring initial or prolonged hospitalization, G permanent harm, H as life threatening harm and I causing or contributing to death. They then selected 10 records per quarter for the years 2002 through 2007 from each hospital, at random. The records were then reviewed in a random order by multiple internal and external trained reviewers, both nurses and doctors.

They found 588 harms among the 10,415 patient days or 57 harms/1000 days or 25 harms per 100 admissions. About 63% or 364 of the 588 harms were classified as preventable! These included 13 that caused permanent injury, 35 being life threatening and 9 contributing or leading to death.

Similar to prior studies, the harms occurred most frequently after procedures and medications. Most harms fell into categories E (144) and F (163).

It was disappointing to find that the rates of adverse events did not decline over the study time period. This, despite the fact that in North Carolina has an enviable record of a high level of engagement in patient safety programs and studies.

So there are still plenty of adverse events that occur in a hospital, they are most likely to be related to procedures or medications, most are preventable, and all too many are life threatening or lead to death.

This leads to the question of whether the many and various approaches that hospitals have embarked upon are actually doing what they need to do. It may be time for a reappraisal. Certainly a patient should have the expectation of not being harmed when in the hospital.

Two Treatments For Macular Degeneration – At Wildly Divergent Costs

2010-12-08T11:17:00.000-08:00

Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. More than 1 million Americans have neovascular or “wet” AMD and a slightly lower number have “dry” AMD which often progresses to the more severe “wet” form. Since this is a disease of aging, we can expect many more cases as the population expands in the coming years.

Neovascular AMD appears to be related, at lease in part, to excess production of vascular endothelial growth factor (VEGF-A.) A specially developed monoclonal antibody called ranibizumab is available and approved by the FDA for wet AMD. The monoclonal antibody binds to VEGF-A, blocking function and thereby allowing healing of the retina. As a result of decreased vessel growth and decreased leakage, vision can stabilize and frequently actually improve. (See the clinical therapeutics article by Folk and Stone in the New England Journal of Medicine 2010; 363:1648 - 1655 for more details.)

Ranibizumab is injected directly into the eye and an effective concentration lasts for about 30 days. Although not a trivial procedure, it is straight forward in experienced hands and takes but a few minutes in an outpatient setting under topical and local anesthesia. The procedure is repeated in four weeks and in four weeks again. If vision has stabilized or even improved, then the next visit is scheduled in five weeks, then six weeks, etc. It appears that most treatment failures relate to missed follow-ups so attention to timing is very critical.

There is another anti VEGF-A monoclonal antibody, called bevacizumab, approved by the FDA for use in metastatic colon cancer treatment. It costs about $75 for a 1.25 milligram dose whereas ranibizumab costs about $2000 for a comparable dose (0.5 mg.) Although clearly an “off label” use, many retinal specialists will offer bevacizumab as an alternative to ranibizumab and let the patients ultimately decide. Trials comparing the two drugs are underway with results expected in less than a year.

What is clear now is the intraocular injections of anti-VEGF-A monoclonal antibody has substantial efficacy with limited risk.

Replacing the Aortic Valve Without Open Surgery!

2010-12-01T07:25:00.000-08:00

Aortic stenosis (a narrowing and hardening of the heart’s aortic valve) is not uncommon among older individuals. It begins without symptoms and progresses for years but, about 50% will die within 2 years once the fitst symptoms develop. The standard approach is to surgically replace the aortic valve which will improve both heart function and survival. Unfortunately, about 30% of symptomatic individuals cannot undergo surgery because of older age, other heart problems or other medical conditions that render surgery too risky.

A new approach is called transcatheter aortic value implantation (TAVI.) In this procedure, a catheter is inserted into the large femoral artery in the groin and run up to the heart. From the catheter, the patient’s valve is opened wide with an inflatable balloon. Then a bioprosthetic value made from bovine pericardium affixed to a stainless steel support frame is deployed into place via another balloon catheter and secured to patient’s own aortic valve base.

A randomized study of 358 patients with aortic stenosis not considered surgical candidates was completed comparing TAVI to standard therapy at 21 medical centers and reported in the New England Journal of Medicine on October 21, 2010. The results were clearly favorable. Standard therapy was noted to not alter the natural history of aortic stenosis with 51% dead in one year. TAVI was superior with improved cardiac symptoms and good hemodynamic performance of the new valve which persisted for at least the first year of follow-up and with 31% dying during that year, a substantial decline in mortality.

But there is never a “free lunch” and TAVI was associated with a 5% risk of serious stroke (compared to 1% in the control group) and multiple vascular complications, the latter apparently related to the requirement for a large catheter placed into the femoral artery. Further MRI studies of patients suggest that many have new perfusion defects of the brain after TAVI suggesting that emboli from the new valve may be rather common.

But all things considered the improvement in symptoms and the reduced death rate (it took only 5 patients treated with TAVI to avoid one death by 1 year) argue that TAVI is now the appropriate therapeutic approach for those with aortic stenosis who cannot otherwise undergo surgery. Hopefully, coming improvements in the device will lead to fewer complications.

The big question – will this become the approach of choice for those who otherwise are candidates for standard surgery for aortic valve replacement?

Teamwork Improves Surgical Safety and Reduces Mortality

2010-11-14T06:00:00.000-08:00

Like the cockpit, the operating room (OR) is fraught with high intensity, high complexity, high velocity, and high stakes. And as a capital intense location which serves as the financial engine of many or not most hospitals, there is pressure to use the OR efficiently. Like the cockpit, there is hierarchy, and a deep culture which includes strongly held rituals and customs. Unfortunately, there are also errors of omission and commission which lead to adverse outcomes including patient mortality.

Airlines have proven that teamwork in the cockpit improves safety substantially to the extent that commercial airlines demand and licensing now requires evidence of team competency.

Some hospitals have used the airline team training model – called crew resource management – to improve teamwork in the OR. The Veterans Health Administration (VHA) has 130 hospitals providing surgery and in 2006 mandated team training nationwide. Since it took time to arrange the training for each hospital, a study was instituted to compare surgical mortality between those hospitals which had already undergone training and those which had yet to do so (Journal of the American Medical Association, Oct 20, 2010 – both the article and accompanying editorial.)

The mandatory team training included working as a team, challenging each other as to perceived risks or safety lapses, checklist guidance, and preoperative briefing and post operative debriefing. Team members were also taught various communication strategies, how to step back and reassess, how to communicate during care transitions and basic rules of conduct.

The major measure was surgical mortality which was reduced by 18% in the 74 hospitals that had received the training compared to a 7% reduction in the 34 hospitals yet untrained (the controls.) The risk-adjusted mortality rates dropped from 17 per 1000 patients before training to 14 after training.

The study demonstrated the value of team training in reducing mortality. I would add that, although not studied, it is likely that errors were reduced overall. Surgical teams are often excellent at responding to problems including those resultant from human error. Reducing mortality was obviously important, indeed very important, but reducing preventable errors overall – as I will presume occurred – will have meant a better outcome for many patients.

The concept of team training is relevant not just in the OR but in many hospital settings such as bedside patient care rounds and with procedures done in the cardiac As I have written about before, the more team training is fostered, and indeed mandated, the lower will be the rate of preventable errors.

Leadership In Medicine – New Expectations

2010-11-10T13:40:00.000-08:00

What should we expect of a physician leader today? I believe it should be something much different than what leaders do now.

Today, a hospital physician CEO might be expected to develop new or improved clinical programs, in part by recruiting the best and the brightest, by building new wings, and by purchasing new technologies. The measure of success would be improved finances as a result of added admissions. A dean might be expected to develop new research programs by building new facilities and recruiting the needed scientists. The success measure would be rising on the NIH rankings of total research dollars awarded. A pharmaceutical company physician leader might be expected to find new drugs that will be “blockbusters.” His measure of success will undoubtedly be financial as well. A similar picture extends to the CEO of a health insurer.

Are these the right measures? Are our medical leaders really leading? Or at least leading toward truly valuable goals?

Leadership is all about success in three sequential activities, as outlined by John Kotter at the Harvard Business School. The first is generating a vision for what needs to be done. Perhaps it will be the clinical program, new research activities or a new drug. The second step in leadership is to convince others that the goal is worthy. Aligning everyone involved with the desired outcome can be difficult but without alignment there will be no action. And the third, often overlooked, is to get the needed individuals to actually help to achieve the goal, the vision. These are difficult steps, especially in or university setting where lines of authority are diffuse and responsibilities overlapping or in a community hospital where the physicians are mostly in private practice and not hospital employees.

But the question is what should be the vision and what should be the measure of success in achieving that vision?

An article in the Journal of the American Medical Association by Dr Robert Brook [July 28, 2010, pages 465-6] got me to thinking about this issue.

We know that despite spending more per capita on medical care, we still have far from the best care. We do not lead in infant mortality or total life expectancy. We do poorly at coordinating the care of those with chronic illnesses, such as diabetes and heart failure, and the result is less than adequate care and care that is much more expensive than it needs to be. As a society, we have rampant adverse behaviors such as overeating and lack of exercise plus many of us still smoke, all leading to more chronic illnesses, increasingly occurring at an earlier age.

I would suggest, echoing Dr Brook, that real medical leadership today needs to focus on the important outcomes, not the ones that just improve our organization’s financial successes [not withstanding that strong finances are critical in order to accomplish a valuable end – “No money, no mission.”] This means that medical leaders must begin to accept the responsibility for aligning the various constituencies and power brokers both within and without of medicine toward real healthcare progress. Unless medical leaders accept this challenge, it will increasingly be done by others, and done without serious input from physicians and others in the field.

What then are the important issues and outcomes?

I would suggest that we must find a way to first markedly improve prevention of illness. Within medical care itself, this means assuring that primary care physicians are trained and have the incentives to do basic screening, administer vaccines, and give sound advice. It means actually advising about diet and exercise for the person with high cholesterol, not just giving out a routine prescription for a statin. And medical leaders need to take the initiative to change government policy regarding food and nutrition. For example, it makes little sense that the beef with the most saturated fat is marked “prime” by government inspectors or that food processors can label a cereal “healthy” because they have added some vitamins to what is manufactured from non whole grains plus sugar and salt.

Second is to develop methods to assure that every patient who has a chronic illness gets intensive care coordination among all of the providers involved. This means the development of multi-disciplinary teams of physicians, nurses, pharmacists and others who actually work collaboratively and with the patient’s interest foremost. There can be various models but among them is the creation of “centers” (cancer centers, heart centers, trauma centers) at academic medical centers and at community hospitals, developed with real authority to function effectively. Another is to use bundled payments or “capitation” to reward coordination. And most importantly is to have one physician, usually the primary care physician, serve as the coordinator – the orchestrator.

Third, medical leaders need to address the need for care delivery to be customer focused with the recognition that the customer is the patient and the patient’s family. Too often we develop programs or actions that continue the current provider-oriented approach rather than a patient/customer-oriented approach. If medical leaders do not address this now, a rising tide of consumerism will force the issue later. Eventually, patients will hold the physician directly accountable and will expect to pay only if the care is patient-focused.

Having addressed these basics, medical leaders then need to turn to the more global health issues, health not only of the individuals under their care or their institutions’ care but the care of the community, the population at large. This is critical if all Americans are to have a healthy life regardless of social or economic status.

To accomplish this will mean that hospital, insurance company and pharmaceutical company boards of directors and university boards of regents will need to give out new, different and clarified directions to their CEOs, presidents and deans, holding them accountable with new measures that reflect realistic progress toward these goals. Otherwise, although there will be various medical breakthroughs of great value for treating disease, American medicine will continue to stumble along, as it has, without making any real progress in what is truly important.

New Finding May Aid Alzheimer’s Treatment Options

2010-10-26T10:03:00.000-07:00

A protein recently found in the brain -- gamma secretase activating protein or GSAP -- increases the production of beta-amyloid, the presumed culprit in Alzheimer’s disease. In a mouse model, reducing GSAP led to reduced beta-amyloid disposition ( Nature, 2010, 467, pp 95-99.) This prompts in turn the appealing notion that a drug could be found to inhibit GSAP and thereby forestall or prevent the onset of Alzheimer’s disease.

Imatinib (Gleevec, used to treat chronic myelocytic leukemia or CML) does inhibit GSAP and, in laboratory models, reduces beta-amyloid creation. Unfortunately, imatinib does not cross the blood brain barrier so it cannot be used clinically. A search is now on for a compound that acts like imatinib yet can get into the brain. If found, it would be a very exciting discovery.

The Implications of Chronic Disease

2010-10-19T09:10:00.000-07:00

I have written frequently about the importance of chronic illnesses. Most of us are just not aware that their incidence is rising - and rapidly. We tend to think instead about acute illnesses and injury but chronic illnesses are now not only common but last a lifetime once developed and are inherently expensive to treat. On top of that there are enormous losses in quality of life, personal productivity and economic impact on the individual and society.

The Milken Institute quantified some of these issues in a research report a few years ago. They evaluated cancer, diabetes [presumably type 2], hypertension, stroke, heart disease, pulmonary conditions and mental disorders. Here are some of the key findings:

• “More than 109 million Americans report having at least one of the seven diseases, for a total of 162 million cases.

• The total impact of these diseases on the economy is $1.3 trillion annually.

• Of this amount, lost productivity totals $1.1 trillion per year, while another $277 billion is spent annually on treatment.

• On our current path, in 2023 we project a 42 percent increase in cases of the seven chronic diseases.

• $4.2 trillion in treatment costs and lost economic output.

• Under a more optimistic scenario, assuming modest improvements in preventing and treating disease, we find that in 2023 we could avoid 40 million cases of chronic disease.

• We could reduce the economic impact of disease by 27 percent, or $1.1 trillion annually; we could increase the nation's GDP by $905 billion linked to productivity gains; we could also decrease treatment costs by $218 billion per year.

• Lower obesity rates alone could produce productivity gains of $254 billion and avoid $60 billion in treatment expenditures per year.”

To me the important point is that “each has been linked to behavioral and/or environmental risk factors that broad-based prevention programs could address.” Restated, we as individuals need to take responsibility for our own health. Not every illness is preventable, but a very large percentage are. It is up to us to eat a nutritious diet in moderation, exercise our bodies, seek ways to reduce chronic stress and avoid tobacco. These four steps would make a huge difference in our health and our lives.

Meanwhile, we each need to have a primary care physician and that physician needs to accept the responsibility to assist us with our prevention strategies and to coordinate our care should we develop a chronic illness. This will mean better health and much lower costs.

Encapsulated Pig Islet Cells For Diabetes Type 1 – A Trial

2010-10-15T14:38:00.000-07:00

Here is a follow-up to the post on islet cell xenotransplantation for type 1 diabetes mellitus. A group in New Zealand has been studying the use of islet cells derived from pigs which have not been genetically modified. The cells are encapsulated to protect them from immune cells. The company reports that they are self regulating (meaning that they will produce insulin as needed based on the body’s blood sugar levels) and efficient at secreting the insulin produced into the patient’s body. The investigators report on one patient that is now nearly 10 years since transplantation with persistent functioning islet cells. Dr John Baker and Living Cell Technologies are conducting the human trial after having tested their product in multiple animal models. The material below, taken from the US National Institutes of Health Clinical Trials web site [http://tinyurl.com/2fmcnp6 ], was prepared by the company and its investigators:

“Intraperitoneal islet transplantation has the potential to ameliorate type 1 diabetes mellitus and avert the long-term consequences of chronic diabetes which cannot be achieved by conventional insulin treatment.

As donor human islets are not available in sufficient numbers, porcine islets are the best alternative source as they are recognised as the most physiologically compatible xenogeneic insulin-producing cells. Although the use of pig-derived cells raises the risk of xenotic infections, this can be minimised by obtaining cells from designated pathogen-free (DPF) animals bred in isolation and monitored to be free of specified pathogens. The worldwide experience to date in more than 200 patients who have received transplants of pig tissue has not demonstrated evidence of transmitted xenotic infections.

As animal-derived tissues have to be protected from immune rejection when transplanted into humans, transplants are usually accompanied by immunosuppressive therapy. However, porcine islets are preferably transplanted without the use of immunosuppressive drugs which cause significant morbidity. To protect them from immune rejection, the islets can be encapsulated in alginate microcapsules which permit the inward passage of nutrients and glucose and the outward passage of insulin. Alginate-encapsulated porcine islets transplanted without immunosuppressive drugs have survived rejection for many months in animal studies, and have been retrieved from a diabetic patient over 9.5 years after intraperitoneal transplantation and shown to contain viable islets that stain positive for insulin.

DIABECELL® comprises neonatal porcine islets encapsulated in alginate microcapsules. DIABECELL® has been safely transplanted in healthy and diabetic mice, rats, rabbits, dogs and non-human primates. Following DIABECELL® transplants, the requirement for daily insulin was significantly reduced in diabetic rats and non-human primates.

The optimal dose and frequency of transplantation of the current DIABECELL® preparation for the treatment of type 1 diabetes in humans can only be determined in clinical trials. The intention of this phase I/IIa clinical trial is to obtain at least 52 weeks safety and preliminary efficacy data in type 1 diabetic patients following transplantation of a single low effective dose of DIABECELL® into the peritoneal cavity.”

The results of this study, still a few years off, will be of great interest to those whose diabetes is hard to control with standard insulin approaches.

More on Transplanted Pig Organs – Xenotransplantation

2010-09-27T13:54:00.000-07:00

Although xenotransplantation has not progressed far enough to allow transplanting a pig organ to a human, there are other exciting opportunities in the works for xenotransplantation in the not to distant future.

Individuals that develop liver failure often die before a suitable donor can be found or before the damaged liver can heal on its own. There is no artificial liver comparable to the dialysis machine for kidney failure. But using a specially develop pig liver outside the body to cleanse the person’s blood of noxious compounds is a possibility. There have been some positive results using a normal or a genetically modified pig liver for such “extracorporeal” perfusion until a donor organ is available or until the patient’s liver recovers on its own.

Progress has also been made with genetically modified insulin-producing pancreas islet cells for treating diabetes. One approach is to place the transplanted islet cells into a “capsule” that allows insulin to exit out and nutrients like glucose to enter in yet keeps immune cells that would destroy the islet cells at bay outside the capsule.
Further progress in xenotransplantation is likely but there are significant barriers to success. Genetic modification of the pig is possible but it is not yet clear all of the modifications that will be necessary. Concurrently, work is progressing to develop immune modulation with drugs just as is done to suppress the immune system with human to human organ transplants. Further development of encapsulation may aide the process, especially with islet cell transplantation for diabetes.

Despite all of the progress to date, the barriers to success are very real and only time will tell if xenotransplantation will become a truly viable path to organ replacement

Transplanted Organs From A Pig

2010-09-22T07:52:00.000-07:00

There are many more individuals with end stage kidney failure, heart failure, chronic lung disease, or liver failure who would benefit from a transplanted kidney, heart, lung or liver than are available. Similarly, there are many people with unstable, difficult to control diabetes that could benefit from a ready source of pancreatic insulin-producing islet cells.

Today the only option for more organs available for transplant is to encourage more individuals to pre-certify their desire for organ donation should they die in a traffic or other accident.

But another approach, still in the future but gaining traction, is to use organs from an animal – known as xenotransplantation.

Most efforts in xenotransplantation focus on the pig, in part because the organs are near to the same size as humans and the physiology is similar. Very real progress has been made in recent years. The steps required to make this approach effective include genetic modification of the pig so that the human immune system will no longer “reject” the transplanted organ. This has included removing the genes that produce the most important pig carbohydrate antigen that human immune cells recognize. Another step has been to add genes that create certain protective proteins in the complement regulatory system (another part of the body’s mechanism to eradicate “foreign” materials like bacteria, viruses or a cancer.) So far, these steps have been major advances but not sufficient so further efforts will be necessary in order for say, a pig heart or kidney to be successfully transplanted into a primate and eventually into a human. But the progress is real, exciting and promising. Stay tuned.

Thought Controlled Artificial Limbs

2010-09-14T13:07:00.000-07:00

I wrote about the possibility of brain-controlled artificial limbs in “The Future of Medicine” but now there has been real progress. At Johns Hopkins Applied Physics laboratory, scientists have progressed with their design of an artificial limb that will have a brain controlled interface. The model came about through a contract with the Defense Advanced Research Projects Agency (DARPA) which has been looking for a prosthetic arm that would be many leagues advanced from those in use today and which in fact date back to the World War II era.

Not all that much progress has been made over the past few decades in artificial arm development. Perhaps it is because losses of legs are much more common than losses of arms. But the loss of an arm is especially devastating to the individual and a truly useful replacement is of critical need.

The new device will have remarkable dexterity with the degrees of freedom of a human wrist and the ability to control individual fingers. Look at your wrist. It can move in six different directions or “degrees of motion.” When you consider the entire arm, there are 27 degrees of motion and the new limb will have about 22 of them included. It weighs just eight pounds which is about what an average arm weighs yet can hold up to fifty pounds. The motive power comes from a rechargeable battery. These are advances of some great import indeed but the next step is the amazing one – brain control. The first step is to use outputs from the nerves in the shoulder that used to control the arm before the injury and loss. These nerves carry outputs from the brain that can be accessed to drive the various internal motors that operate the artificial arm. Later, the plan is to develop microchips to implant in the brain that will sense the “thought” to, say, “lift the arm” or “push that button.”

Johns Hopkins APL is engaged with multiple other groups to bring this work to fruition. One of the major hurdles is to develop the algorithms that take the signals from the brain or the nerve and convert them into mechanical activity. Signal analysis algorithms have now been developed that take outputs from the motor and the premotor cortex of the brain and decode them into specific dexterous movements such as grasping that can drive the electro-mechanical apparatuses in the limb.

The research needed to move this project ahead are daunting but the principals believe that the technology exists and can be turned to good use here. Perhaps one of the first types of patients to be tested will be quadriplegics because to offer such an advance would be dramatic for the involved patient. It sounds like science fiction but instead it is the result of the combined efforts of many engineering and computer scientists along with rehabilitation physicians and others.

Are Physicians Knights, Knaves or Pawns?

2010-09-13T07:18:00.000-07:00

An interesting article in JAMA [Sept 1, 2010] by Drs. Jain and Cassel referred to the British economist Julian Le Grand who suggested that public policy “is grounded in a conception of humans as knights, knaves or pawns.” Basically, are we motivated by virtue, by self interest or are we just passive victims? The authors suggest that this is a good question not only for physicians to contemplate but for our politicians and the general public to consider as well along with the implications of the answer.

Physicians need to examine whether we are working for the greater good and especially the good of our patients; and if so, then to consider why society generally does not think we are. Or do we work with our own income and other gains in mind as the foremost driver of action and work? Or perhaps do we just go about our daily efforts as unfortunate passive victims of insurer and government dictums?

Often the individual likes their physicians and thinks of him or her as a “knight.” This is the belief that the physician has the patient’s best interests in mind at all times and takes the needed steps to be sure that the patient is always placed first. But society overall does not think this way of physicians. To most, physicians have long ago lost their “Marcus Welby” status and instead are driven by the desire for a high income, reduced work load and less attention to the patient and the patient’s needs. With this sort of attitude, society through its elected officials and through the insurance apparatus erects many polices and procedures to guard against the “knave” doing harm, reaping too much income, etc.

Many physicians think of themselves today as just “pawns” in a large bureaucratic maze, unable to practice medicine as they believe it should be practiced; unable to earn a reasonable salary given the work burdens and the work content; and overwhelmed with paperwork and needless regulations. Unfortunately, society has indeed put the physician all too often in this setting and established regulations that presumably will ensure that the physician does what is needed.

There was a time in the clouded past when physicians were thought of as knights, when they looked upon themselves as members of the middle class with a special and higher calling, and government largely left them alone. But as costs of care have risen, as more safety lapses have been recognized, as quality has not been forthcoming commensurate with new knowledge, the public has come to believe that the physician is the problem and not the solution.

I would echo Jain and Cassel’s urging that physicians need to “thoughtfully consider whether and how they contribute to the perception that they are knights, knaves or pawns.” It is time to look in the mirror and, if the vision is not as desired, then to take the needed actions to make mid course corrections. To do nothing is to allow the system to characterize physicians as “knaves” and then to push them into the role of “pawns.”

What should We Eat?

2010-08-22T05:19:00.000-07:00

Most of the illnesses that occur today are chronic like diabetes, heart disease, cancer or kidney disease. These stay with us for the rest of our lives, are debilitating, and are expensive to treat. But in many cases they are not all that difficult to prevent. Unfortunately, our dietary guidelines are of little or no help in this regard but could be.

In 1941, following studies that demonstrated that certain vitamin deficiencies caused specific diseases [thiamine and beriberi, niacin and pellagra, vitamin D and rickets, vitamin A and blindness, vitamin C and scurvy and iodine and thyroid disease], the US Department of Agriculture issued dietary guidelines for the minimum requirements for various vitamins along with those for protein, calcium, phosphorus and iron. These recommended dietary allowances, or RDAs, became the standard for nutrient targets to prevent deficiency diseases.

There followed the addition, for example, of vitamin D to milk and various vitamins like thiamine and niacin to prepared cereals in an attempt to avoid nutrient deficiencies. It was a successful approach but it is not adequate in today’s time for helping to prevent multiple serious chronic illnesses, many of which are beginning to develop in children and young adults.

An article in the Journal of the American medical Association [JAMA] on August 11, 2010 by Mozaffarian and Ludwig urges that we think in terms of “food” and not in terms of “nutrients.” They point our that we know full well that a diet of fresh fruits, vegetables, whole grains and nuts is associated with a lower incidence of chronic illnesses just as certain fish reduce the risk of heart disease.

We also know that processed foods such as lunch meats, fast foods, salty snacks, and sugared beverages increase disease risk. They argue that our “nutrient-based” current approach “may foster dietary practices that defy common sense.” For example, many packaged, processed foods substitute refined carbohydrates for fat and market them as fat free or low fat which they are but they are certainly not healthy. Similarly, many packaged foods such as soups are very high in sodium. “Taking the nutrient approach to self serving extremes, the food industry “fortifies” highly processed foods, like refined cereals and sugar-sweetened beverages, with selected micronutrients and re-characterizes them as nutritious.”

The authors recommend that we not drop our attention to nutrients levels but that we concurrently lessen the focus on nutrients and emphasize food-based targets such as fruits, vegetables, low fat meats and fish. These foods are inherently healthy, are low in saturated fats, have no trans fats, are low in salt, high in fiber and high in nutrients. This approach would be consistent with scientific data on what is healthful, what is likely to help prevent chronic illnesses, would “mitigate industry manipulation” and help us all to understand what a healthy diet can be.

The Department of Agriculture should take these recommendations and put them into action.

Time to Rethink How We Pay for Medical Care and Healthcare

2010-07-10T14:19:00.000-07:00

Today we mostly have prepaid medical care insurance with some co-pays and deductibles – both with commercial insurance and with Medicare. In other words, our insurance covers essentially everything from basic and routine care to the catastrophic. And the insurance pays out based on units of care – a visit, a test, a procedure, a hospitalization, a prescription. This creates a system in which providers (physicians, hospitals, drug and device companies, others) get paid for a unit of activity – self interest dictates that all providers will offer more and more units of care, especially when providers feel that are underpaid for the individual units. And since insurance pays for care of illness but not at all or not much for disease prevention and health promotion, we can call this a disease industry rather than a healthcare industry. (I accept that, with rare exceptions, each provider attempts to offer the best care possible for each patient but I also am certain that the patient often does not need all of the units of care offered and often does not get the most appropriate units in a well coordinated manner.)

If the basic payment system changes to one that:

-Expects us (patients) to pay for routine, basic and preventive care, including medications, up to a maximum of, say, $1000/year, (offset by tax-advantages HSA accounts for all, including those on Medicare, and tax credits for the less well off)

-This creates a “professional services contract” between the patient and the provider (rather than today’s contract between the provider and the insurer)

-Insurance pays for everything beyond that.

Then three things would happen:

-We would pay attention to what drugs, tests and procedures are offered or suggested and query our provider in much more detail than we do now – because it is our money that is being spent in a direct manner with the provider.

-Providers would be mindful of the “contract” and be careful to recommend drugs, tests and procedures only if truly needed, appropriate and useful; they would think about our pocketbook.

-Insurance would cost much less.

Possibly a fourth thing would happen:

Because we are paying our provider, especially our primary care physician (PCP) directly, as we do our lawyer, accountant or other professional – and paying a price jointly agreed to be acceptable – our PCP would earn enough to:

-Reduce the total number of patients in his/her practice

All of which would result in:

-More time available per patient

-Time available for true preventive care

-Time available to give good coordination of care to those with complex chronic illnesses.

This would not be a panacea and there are other changes also needed to the payment system, but the effect of these few initiatives would be -- less expensive yet better quality care.

And if this does not come to pass, expect primary care physicians to take matters into their own hands by moving to retainer based practices, charging an annual administrative fee, or just not accepting insurance, especially Medicare, anymore.

Today’s Health Insurance Has Perverse Incentives

2010-07-01T05:46:00.000-07:00

Whether we have commercial insurance through our employer or Medicare, the incentives are poorly aligned to lower costs and improve quality. In fact, they actually encourage greater and greater expenditures. In most instances, our insurance covers everything from prevention to basic routine care to complex care of serious illness. Coverage may not be all that good for some things like preventive care and our primary care physician feels underpaid for routine visits but nevertheless we basically have “prepaid medical care” meaning that insurance is designed to go from A to Z. And we are not the client contracting with our physician. We get our insurance through a third party – employer or government – and although we may pay for part of it, we do not feel a contractual arrangement with our physician. Not does the physician. He or she has a “contract” with the insurer, not us.

Since we have “prepaid” care, we have no incentive nor does our physician to look for ways to reduce the costs. Yes, we may have a co-pay or a small deductible but that does not really get us thinking much about what is being proposed for our care.

Take drugs. Let’s say you need an acid suppressor for reflux esophagitis [acid reflux or GERD.] Your doctor could tell you to go to the grocery store and pickup Prilosec for about $30 for a months supply. Or, he or she could give you a prescription for Nexium. It would cost about $150 for a two week supply and is no better than Prilosec. But your insurance will pay for it except for your co-pay of, say, $15. So your doctor will probably suggest Nexium since it will cost you less. But the overall system is paying out a huge amount more than necessary. What a perverse incentive.

Much better if we all had insurance with a high deductible. [In practice this might mean a general insurance policy and a separate medication insurance policy as with Medicare; but each would have its own high deductible.] In that situation we pay less for the insurance and self insure for the deductible, just like car collision insurance. Now we are focused on cost effectiveness. We would purchase the Prilosec at $30 and save $120 off the cost of Nexium. Better still would be having the physician actually spend time with us to talk about preventing the reflux in the first place. Here again, if we were paying out of pocket for our routine primary care, we would expect our physicians to spend the time with us to review the following – don’t eat just before going to bed; avoid caffeine before bedtime; cut back on alcohol; avoid spicy foods; and put the head of the bed up on 4 inch blocks. These don’t cost anything and generally will solve the problem without the need for any medications. Now that is real cost effectiveness.

A Disease Industry vs. A Healthcare System

2010-06-24T07:51:00.000-07:00

Today America does not have a true healthcare system that focuses on wellness and disease prevention. Rather it focuses on disease diagnosis and treatment paid for on a unit basis. Each visit, each procedure, each test, each drug, each hospitalization is charged for. The result is more and more units of care are given rather than a focus on how to give good preventive care and how to coordinate the care of those with complex chronic illnesses. As long as we have a disease industry – driven by our current payment system – we will have rising costs. It is inevitable because providers (and the affiliated hospitals, pharmaceutical firms, medical device manufacturers and others) will find new ways to diagnose and treat – and although these new approaches might be an improvement over what we have today it will also be much more expensive.

Eventually, as pressures mount, there will be a push for a change to a true healthcare system from the current disease-based system. This will probably take a fair length of time given that Congress did not address the payment system in the healthcare reform legislation. Basically on this point, they left it as just more of the same.

But there could be a breakthrough. Some group, some organization or some jurisdictions might create a model, gain some success and that might lead to wider adoption. Some of the large multidisciplinary “clinics” like Mayo, Geisinger, Dean and others which have contracts for “covered lives” have had success in giving more comprehensive care yet reducing costs. And some insurer/provider combined organizations – such as Kaiser-Permanente – have shown the same beneficial effects. Perhaps others will begin to adopt their examples toward better health care at lower cost.

The Future of Medicine - Megatrends in Healthcare

2010-06-10T13:20:00.000-07:00

Turbulence Ahead in Health Care

2010-06-10T10:55:00.000-07:00

The decade ahead is one likely to be full of turbulence. How everything will shake out is anybody’s guess.

But we can be sure that technology advancements will slow for no one. The rate of medical technology advancement now is very fast and the speed will only accelerate. One big problem is that technology advances so fast that there is no time for a purchase – say new CT scanner or diagnostic device in a clinical laboratory – to create any return on the investment before a new or upgraded technology becomes available.

The electronic health record is a case in point. Despite years of work and billions spent, we are essentially still in an early generation of the EHR. It will be years and many more billions before the EHR begins to bring the true value of improved care with increased quality, better safety and reduced costs while improving provider productivity.

America does not have a healthcare system; we have a “disease industry.” We focus on disease and pestilence and do a good job of caring for those with acute illnesses and trauma. But we certainly do not address health well and we are not good at caring for chronic illnesses – which are rapidly overtaking acute illnesses as most common and already they consume the bulk of our healthcare dollars.

At some point we must break from our current disease care model and shift to a health promotion and disease prevention model. Until that occurs, the cost of medical care will continue its rapid rise. As a disease industry, the incentives are all based on doing more and more but there is little or no incentive to work on prevention.

Although it is tempting to blame the current problem on the insurers, the device manufacturers, the drug companies or the providers, the truth rests more in the way we have set up our payment systems for care. Insurers pay for doing “something.” This leads to more and more diagnostic and treatment efforts and it encourages the manufacturers to constantly find new approaches. Not bad in and of it self but the incentive is not there to prevent illness and not there to coordinate the care of those with chronic illness. And without this shift in incentives, the cost of care will just keep rising.

Two good steps for the future would be:

Change the Medicare payment code to encourage prevention, coordination, and primary care. With Medicare taking the lead, commercial insurance would likely follow.

Let everyone have a high deductible policy so that each of us will have a real interest in asking about our care and being sure that each and every recommendation for a test, a procedure or a prescription is really the best and really necessary.

Cut Health Care Costs With Prevention

2010-05-14T11:10:00.000-07:00

On May 12, 2010, the Harvard Business Review ran this post by me on their web site. The original is at http://tinyurl.com/2vnpato

Prevention is the key to both better health and lower health-care costs over the long haul. This is where the nation — and each of us as individuals — needs to put energy and resources. In the long run, it is more important than addressing the high cost of new technologies and drugs or their inappropriate overuse.

Today, the U.S. basically has a medical care system rather than a health care system: We focus on treating illness when it occurs but not on preventing it in advance.

According to a recent New England Journal of Medicine article, there are about 465,000 preventable deaths per year in the U.S. from smoking, 395,000 from high blood pressure, 216,000 from obesity, 191,000 from inactivity, 190,000 from high blood sugar, and 113,000 from high cholesterol.

These are mostly due to our lifestyles: One-third of Americans are overweight, another third are obese, and 20% smoke. We eat too much packaged and prepared food rather than nutritious foods, and we do not exercise. Even children's physical activity now declines with age, from about three hours per day at age nine to less than an hour by age 15.
This helps explain why the U.S. ranks 39th for infant mortality, 43rd for female mortality, 42nd for male mortality, and 36th for life expectancy — but is first for per capita spending on health care.

Clearly, there is something terribly wrong with this picture. And unless we get serious about prevention, there will be a diabetes epidemic and more heart disease, cancer, arthritis and other chronic illnesses. Life spans will shorten rather than lengthen, and the costs will be enormous.

I firmly believe that each of us must each take responsibility for our own preventive health care. That said, other players in society should assist us in the following ways:

Our government should insist that restaurants post calorie counts and fat content and schools restrict the availability of sodas and other non-nutritious foods in cafeterias. In addition, it can provide a food pyramid — recommended diets or eating plans — that is not influenced by vested interests.

Our employers should provide wellness programs like Safeway's, which encourages staff to utilize smoking-cessation, weight-reduction, stress-management, and nutrition counseling at no charge. Those who participate are given a reduction (incentive) of their portion of the health care premium. In a Wall Street Journal op-ed describing the program, CEO Steven A. Burd reported that over four years Safeway's per capita health-care costs (including both the company's and employees' portions) did not rise while those for most American companies had increased 38%. In addition, the company had less absenteeism and higher worker productivity.
Insurance plans should offer subscribers lower premiums for not smoking, for being at reasonable weight, and for exercising.

Physicians, especially primary care physicians, should spend the time necessary to provide good preventive medicine, which includes counseling, screening tests (high blood pressure, weight , cholesterol, cancer), and immunizations.

Prevention is valuable at any age. At the Erickson Retirement Communities, residents can opt for a program that includes health-promotion classes for all (similar to Safeway's) and care coordination for those who do develop a chronic illness. The physicians limit themselves to about 400 patients (compared to about 1,300 to 1,500 for most primary care physicians) and offer same same-day visits and as much time as needed per visit. They use an electronic medical record system, nurses to assist with care coordination, visits to each hospitalized patient, and an automatic office visit within 72 hours of a hospital discharge. The results are striking: fewer hospitalizations, shorter lengths of stay for those who are hospitalized, and a drop in the "bounce rate" (i.e., unplanned readmissions to the hospital in the 30 days after discharge) from the national Medicare average of (an outrageous) 24% to less than 10%. In other words, better health, better care and reduced costs.

In summary, a combination of nudges and incentives can assist us in achieving our responsibilities for health promotion and disease prevention — responsibilities commensurate with the new right of all Americans to have insurance.

This would be a start toward a true health care system and away from a medical care system. What else do you think needs to be done?

Stephen C. Schimpff, MD, is a retired CEO of the University of Maryland Medical Center in Baltimore and is the author of The Future of Medicine — Megatrends in Healthcare. He blogs at this website and can be reached at schimpff3@gmail.com

Further Disruptive Trends in Medicine

2010-05-04T04:38:00.001-07:00

Generally we prefer calm seas but often they don’t get us anywhere. We need disruptions, transformations to make the changes necessary for real progress in medicine. Sometimes it is a new technology; sometimes a cultural change. But then a refinement may occur. The refinement may not seem like a “disruption” but indeed it can be because the refinement may create a demand for change. Here a few more disruptive changes or refinements that are leading to disruptions of the old ways.

Retainer Based Practices – Primary care physicians find that their incomes have been flat or reduced, their work hours increased, their time with each patient shortened and their frustrations with insurers heightened dramatically over recent years. Some are just saying “I can’t take it any longer” and switching to a different type of practice model. Some simply will not accept Medicare, telling their older patients that they must either pay out of pocket or go elsewhere. Others are converting to “retainer-based” practices. Here the patient pays a flat fee each year, often $1500 to $2000, in return for having their PCP available by cell phone 24/7 and responsive by email. Appointments within 24 hours are guaranteed. The physician will see you in the ER, take care of you in the hospital and do home or nursing home visits as needed at no extra charge. But you still need your insurance in case you have need to see a specialist, have tests or imaging studies or are hospitalized. So the cost to you is extra. This is very disruptive of the standard approach today but I predict it will become very common in just a few years.

Smart Phones – Physicians, especially younger physicians and residents, are becoming very reliant, although not dependent, on these devices. They use them as shortcuts to knowledge, to stay well informed, and to communicate, argue, and debate with one another, which is a excellent form of learning. Smart phones keep being refined and as they are, more and more physicians want them, use them, rely on them and become more effective physicians as a result.

Greater Clarity with Imaging – Today’s CT scanners and other devices can produce remarkable images of the body’s internal organs, better than those of a medical illustrator. And the clarity of the images increases dramatically each year with engineering refinements. Virtual colonoscopy using a CT scan, for example, can now be done in a manner such that the viewer can see a high resolution magnified image of the inside of the colon, capable of visualizing small details of a polyp, a diverticula or other anomaly. It can be projected on a large TV screen where a group can review it together and jointly consider the situation and make recommendations for care of the patient.

Surgical Robotics – Today the daVinci robot is used primarily for cardiac surgery, prostate cancer surgery and some gynecologic surgery. But soon it will be used by other surgeons in diverse fields. An otolaryngologist for example, might perform surgery on the base of the tongue to remove a cancer while avoiding the critical nerves and blood vessels in the area. The visualization of the site is much better than with conventional surgical approaches, the margin of safety is improved and the patient’s outcome is bettered with more effective surgery, more salvage of critical anatomy and faster recovery. These refinements in the use of the robot will likely lead to considerable demand from both patients and physicians.

Image Guidance – We tend to think of “X-rays” as being used for diagnostics and the newer technologies have dramatically improved this ability. But think of the surgeon who “wants no surprises” once inside and operating. The greatly improved ability to visualize organs makes no surprises a near reality. But the imaging can also guide the surgeon to improve on his or her technique during the procedure. Intra-operative CT scanning can be used intermittently and at low dose to assist the surgeon to know the location of critical vessels or nerves. Ultrasound can be used to give real time direction to the placement of radioactive seeds into the prostate to treat cancer. These and similar image guidance techniques improve safety and effectiveness.

Fewer General Surgeons – It has been known for some years that there are too few general surgeons; fewer are entering the field and some areas, especially rural and urban poor areas, have all too few general surgeons today. The reasons for the reduced interest of graduating medical students is not completely clear but the trend is obvious.

Reduced Career Time as a Minimally Invasive Surgeon – Laparoscopic or minimally invasive surgery spread across the country and the world with remarkable speed after its introduction some 20 years ago. The patient has smaller incisions, faster recovery time, less time in the hospital and the costs are lessened as well. Surgeons rapidly learned the techniques and patients demanded it. But there is a price not fully expected. Surgeons are developing a variety of occupational problems from carpel tunnel syndrome, to neck disorders, to low back pain. It is all about ergonomics – “the patient is better off but the surgeon is suffering.” Indeed it may well be that their practice lifetimes may be substantially curtailed unless these ergonomics issues are addressed and quickly.

There are many changes coming in medical practice and these are but a few. The ones noted here will have significant and ultimately disruptive effects on the way medicine is practiced today and tomorrow.

Disruptive Changes Are Coming to the Delivery of Medical Care

2010-04-25T13:30:00.000-07:00

The following was an invited posst at Harvard Business Review last Friday.

We have grown accustomed to scientific research producing major medical advances such as those I wrote about in The Future of Medicine — Megatrends in Healthcare. But there are now some very disruptive changes coming in how medical care will be delivered by your doctor or hospital.

Some examples:

Team-based care for chronic illness. The combination of an aging population and adverse behaviors such as obesity and smoking will create epidemics of diabetes, heart failure, and other diseases that last a lifetime and are difficult to treat. They require team-based, multi-disciplinary care. Team-based care is not the norm today, and the lack of it substantially increases the costs and diminishes the quality of care. The primary care physician must become the team coordinator, be more an orchestrator and less an intervener.

Echelons of care for acute illness. Advances in the care of as heart attacks and strokes also demand a different model of care. The role model is trauma — people with minor injuries are sent to a local ER, more severely injured to a regional trauma center, and the most severe to a Level 1 dedicated trauma center. This approach is accepted for trauma but not yet for heart attacks and stroke. Today the standard of care for a heart attack is immediate angioplasty with stent placement to stop the heart attack in progress and reduce heart muscle damage. The patient brought to a small community hospital should be referred on to a larger center equipped with trained interventional cardiologists, an expert staff, and the needed equipment — all available 24/7. This will result in higher-quality care but will disrupt the economics of many doctors and hospitals.

More high-tech hospitals. More serious illnesses means there will be a need for more hospitals, more beds (especially ICU beds), and more operating rooms with highly sophisticated technologies. This marks a departure from recent decades, when the mantra has been "too many hospitals and too many beds." Since smaller hospitals will have difficulty accessing the credit markets to finance expensive technology and facilities, we can expect to see a wave of hospital mergers and fewer stand-alone hospitals.

Patient-centric medicine. There is an emergence of consumerism in health care. ("The patient will no longer be patient.") So, our current provider-oriented culture will have to change to a patient-oriented culture. Patients will insist on prompt service, improved safety and quality, greater respect, much more convenience, and a closure of the current information gap between doctor and patient. Absent satisfaction, patients will go elsewhere. These are very disruptive changes indeed from the present provider-centric approach to care delivery.

Delegation of care. Shortages of physicians will mean more reliance on others to deliver care — e.g., nurse practioneers and physician's assistants for primary care, social workers and psychologists for mental health care, and optometrists for vision care. Physicians will need to change their attitudes toward these providers by involving them and embracing their value.

A new value proposition for technology. We think of new technologies as being of value if they improve diagnosis, treatment, or prevention while providing a decent return on investment. (See my earlier post on this topic.) But in the future, we will also expect a new technology to help health care professionals compensate for shortages of certain kinds of care providers, enhance their responsiveness to more demanding patients, control rather than exacerbate costs, and enhance safety and quality — very different from today's value proposition.

Employee physicians. Professionals' expectations are changing as much as those of patients. While most physicians in the U.S. today are in private practice, a growing number — especially younger ones — want to be employed. They want to spend less time on administrative tasks and want more time for family activities. Women are now 50% of graduates from medical school; many will want time off for child-rearing, further exacerbating the shortage of doctors..

E-health. The internet and digital medical information will have a major disruptive effect on the practice of medicine. Many physicians eschew these technologies today — often because insurers don't reimburse them for the time involved. But they will be expected by their patients to use e-mails, telemedicine and telediagnosis, ePrescriptions, and an electronic medical record. If doctors want to keep their patients, they'll have to change.

These are some of the major changes I see coming down the pike. Do you agree that they will transform the delivery of care? Are there others you would add to the list?

What are the challenges that health care organizations and professionals must overcome to make the transition to this new age? Will there be strong resistance or will change come about smoothly?

Is Technology a Cost Driver or a Cost Saver in Health Care?

2010-04-19T08:34:00.000-07:00

The following was an invited post on the Harvard Business Review at http://blogs.hbr.org/cs/2010/04/is_technology_a_cost_driver_or.html

Pharmaceutical, biotechnology, and medical-device and equipment companies have been extremely effective at producing innovations that have created major benefits for medical care. But the cost of new patented drugs and devices (pacemakers, defibrillators, stents, ventricular assist devices, insulin pumps, laparoscopic surgical instruments, etc.) are high. As a result, many argue that these advances are driving up the costs of health care. This is a distorted view.
In many cases, the cause of rising health-care costs are not the technologies per se; it is a flawed payment system.
Here is an example.
Stomach ulcers are common, mostly caused by a bacterium called Helicobacter pylori, or H. pylori. Discovered about 30 years ago, it lives in the stomach with all of its acid and invades the wall of the stomach. Now we can cure ulcers with antibiotics. A common therapy is clarithromycin and amoxicillin combined with a proton pump inhibitor (i.e., acid suppressor) like Prilosec, Nexium, Protonix, or Prevacid. It is essential to take the three drugs twice a day without fail for 14 days; anything less and the cure rate goes down substantially.
So the makers of Prevacid have come out with a nicely designed package called Prevpac, which contains the two antibiotics and the proton pump inhibitor and clearly labels the morning and evening doses. Frankly, it is a good idea. It cost about $350 at the pharmacy. Not an unreasonable price to pay to eliminate a disease that in the past had been chronic and impossible to cure, a disease that often reduced quality of life and frequently necessitated surgery, right?
Here's the catch: Until recently, Prevacid, one of the drugs in the Prevpac package, was on patent and its price was very high. If one bought the three drugs individually, the price was about $250. (Go figure.) And if one substituted Prilosec (about $30 over the counter) for the Prevacid along with the clarithromycin and amoxicillin, it would bring the price down to under $100. Multiply this by the number of individuals who are found to have stomach ulcerations caused by H. Pylori and you would save some big money nationally.
But that is not the way it works. Your insurance probably has a $15 deductible. So you only pay $15 of the $350, a good bargain for you. If you go the route of buying the three drugs separately for $250, you have to pay $45 ($15 X 3). And if you opt for the Prilosec substitution, the price to you is $60 ($15 X 2 plus $30.)
The point is that our insurance system is full of perverse incentives. So you will choose the Prevpac or your doctor will do so for you to help you save some money. It would be much better if we paid, say, the first $1,000 of our medical bills out of pocket each year and then had insurance kick in. Insurance would be much cheaper and we would become aware of the cost implications, ask our doctor for assistance, and go with the cheaper yet equally effective approach.
The U.S. payment system also impedes the adoption of innovative technologies that could reduce the cost of health care.
For example, distance medicine like telemedicine, teleconsults, telediagnosis, and simple e-mails can reduce the need for visiting the doctor's office and emergency rooms and can prevent unnecessary hospitalizations. These all will obviously reduce overall costs, but currently there is no reimbursement for telemedicine, teleconsults, and the time it takes for physicians to do e-mails. Similarly, there is no reimbursement for tele-diagnostic devices such as the electronic home scale that reports daily weight to the physician's office.
Reimbursement will be necessary if these valuable, cost-saving techniques are to become widely utilized. Or, if you had a high deductible policy, you would save real money by e-mailing your doctor and paying a minimal fee rather than coming into the office.

We can also harness technologies that reduce expenditures by improving safety and quality. Prescribing drugs via e-mail in the office or via the hospital computer (known as computer physician order entry or CPOE) can eliminate illegible handwriting, prevent prescribing to someone who is allergic to a drug, avoid adverse drug interactions, and assist the physician in prescribing the correct dose, number of doses per day, and route of administration (e.g., oral, intravenous, intramuscular injection, rectal, etc).
Other important technologies that can help reduce costs are simulators, robots, and identification devices. Indeed, simulation will profoundly impact the safety and quality of operative procedures, cardiac catheterization, colonoscopy, and many other procedures and, in turn, drastically affect cost management. It can shorten the time it takes to become proficient thereby reducing training time and costs.
These are but a few of the ways technology can actually lead to lower costs.
Questions we need to consider are:
How can we maximize the value of technologies to reduce costs while improving quality and safety?
How can we advance the needed evidence to assure that we only select truly useful technologies?
How can we stimulate physicians to only recommend cost-effective drugs or devices for their patients?
How can we encourage individuals to select high-deductible health plans and then take an active role in making medical decisions?

Teamwork Can Help Avert the Pending Cost Crisis in Health Care

2010-04-13T08:05:00.000-07:00

The following piece by me was posted on the Harvard Business Review blog yesterday. http://blogs.hbr.org/cs/2010/04/teamwork_can_help_avert_the_pe.html

Most health care money in the United States goes largely for the care of people with complex chronic illnesses such as diabetes, heart failure, cancer, lung disease, and the like. We will soon see many more individuals with these illnesses because of two factors: the population is aging ("old parts wear out") and adverse behaviors such as poor nutrition, overeating, lack of exercise, and smoking. This will cause costs to soar, which will force the U.S. to revamp how we care for this population.
Such a revamp is long overdue.
The traditional American approach to medicine is for one physician to take care of the patient's illness. (Think here of the internist treating pneumonia with an antibiotic or the surgeon treating an inflamed appendix with a scalpel.)
But chronic illnesses require a multi-disciplinary team approach to care. The diabetic patient, for example, needs an internist, an endocrinologist, a podiatrist, an ophthalmologist, a nutritionist, an exercise physiologist, and many others to assure comprehensive care of high quality.
The key is to have one person who coordinates all of the various providers to be sure they have the right information, are all working together, and are all following an agreed-to care plan. They need not all be physicians. Indeed other providers are equally important to the team-based approach and they add less costs.
Mostly, this just does not happen today. In part, it is because of the medical culture which needs to change; "it's the way we do it" (and have done it for over a century).
But perhaps the biggest culprit is the lack of a fee structure that encourages the primary care physician to coordinate the care properly. Coordinating the care of a patient with a complicated illness that lasts a lifetime takes a lot of time, but this time is not now compensated by most insurance. Since most primary care physicians are very busy already, and since they are not accustomed to coordinating care, this is a new requirement that, absent a payment structure as incentive, they will just not accept readily.
So today what happens is a lack of coordination and an excessive number of tests, X-rays, procedures, and occasionally hospitalizations. The result is much lower quality care than could or should be provided and much higher costs than necessary.
Consider the retired individual who called me saying he was on 23 medications, some multiple times per day. He stated he was not feeling well despite all the meds. And despite his Medicare, Medigap, and Part D plans, he was spending huge sums of money. The 23 included drugs for diabetes and heart failure. So he clearly had serious underlying diseases.
The prescriptions also included three medications for a problem that probably did not require any medication. But those meds, given by four different physicians and adjusted independently by each of the four, led to a side effect for which another physician prescribed yet another medication. This new drug in turn caused yet another problem that led to a serious infection, hospitalization, and a stay in the intensive care unit. The result was less-than-stellar care (to put it politely) at an incredible expense.
But once he found a primary care physician who took the time to understand what was needed, it was only two months until he was down to seven medications, feeling better, and spending a lot less money (as were his insurers).
The diagnosis is clear. Good care coordination means better quality and less expense. Lack of care coordination for those with complex chronic illnesses means poorer quality and a lot more expense
The treatment is equally clear. Physicians, especially primary care physicians, need to be incented — with money — to provide the care coordination are that patients with chronic illnesses need. This treatment could and should begin now.
It is also important to remember that prevention is always better than having to deal with an illness later. Most of these chronic illnesses are the result of our own adverse lifestyle and behaviors; they do not have to occur. Physicians should therefore be encouraged (again with monetary incentives) to spend the time necessary to offer realistic preventive services to their patients.
The moral of the story is that improving quality will not only mean better health care, it will also substantially reduce the costs. An excellent return on investment.

King Tut and Genomics

2010-02-28T14:03:00.001-08:00

I wrote in The Future of Medicine- Megatrends in Healthcare that genomics was a revolutionary new technology in medicine and that it would lead to disruptive new megatrends in medical care. I was thinking about new approaches to disease prediction, developing targeted drugs, directing the approach to drug prescribing to assure efficacy yet few side effects, and rapid diagnosis.

Many of us enjoy genealogy as a hobby and to learn about our ancestors. Genomics can been used to study our own genealogy – where did we come from and when? At a recent conference the lady sitting next to me told the group that she and her husband had just had their ancient genealogy studied by DNA analysis. In brief, her ancestors began in the north east of Africa, crossed over to the Middle East, then up into the north of the European continent and finally moved westward to Ireland and then to America. Her husband’s ancestors came from Egypt thousands of years ago, moved into the Middle East, then into central Asia and finally to southeastern Europe before immigrating to America. They and their children really appreciated and enjoyed learning about these origins and migrations over the millennia. And it was possible all because of the development of genomic analyses.

Now a group of Egyptologists has used genomic information along with CT scanning to study the ancestry and diseases found in King Tutankhamun and his family. King Tut, as he is often called, lived during the 18th Dynasty of the New Kingdom and died in about 1324 BC after a nine year reign. He followed his father, Akhenaten, who was controversial for his efforts to make major religious change in Egyptian society.

The researchers were able to construct a five generation pedigree. Among the findings – his parents were brother and sister children of Amenhotep III. It was possible to determine which mummy was his grandmother, Nefertiti, and which his father, Akhenaten. Thus these and other previously unidentified mummies can now be given their known names.

King Tut and his father pharaoh Akhenaten were often depicted as markedly feminized in statues and drawings. Did that mean that they had gynecomastia or some other feminizing disease? The genomic and CT skeletal results ruled out many such diseases such as Marfans or Antley-Bixler syndrome. Presumably this was an artistic presentation related to the new religious reforms started by Akhenaten. Other findings on CT scans of the mummies were that King Tut had cleft palate, a mild clubfoot, left foot bone necrosis and a leg fracture. His foot abnormalities on the left forced him to put more weight on the right and probably he had to use a cane. Others in his family tree had cleft palate, scoliosis, club feet and many had dental caries. One mummy had suggestion of metastatic cancer and a few had evidence of trauma – arrow wound to chest, traumatized face and skull. The biopsied materials studied by genomic analysis also identified malaria in King Tut and other mummies, representing the earliest proof of malaria infection to date, some 3300 years ago.

The authors of the article [JAMA, Feb 17, 2010, p638-646 and also a recent program on the Discovery Channel] suggest that a new scientific discipline may be emerging – molecular Egyptology, combining many fields of study including natural and life sciences, humanities, and medicine. For me it is another example of the incredible opportunities developing as we learn more about the use of genomic analyses.

“Front of Package Food Labels – Public Health or Propaganda”

2010-02-24T06:46:00.001-08:00

The current issue of the Journal of the American Medical Association [JAMA, February 24, 2010, pages 771-772] has an interesting editorial of the title here by Drs Nestle and Ludwig about food labeling. “At no point in US history have food products displayed so may symbols and statements proclaiming nutrition and health benefits” is the opening sentence. In brief, the authors suggest that processed food companies have been aggressive in putting information on the front of their packages that suggest or actually tout a health claim. They point out that in 1984, Kellogg got the National Cancer Institute to agree to a health claim for All Bran cereal. The market share of All Bran rose 47%. Clearly, a health claim sells food products.

But what about claims that a food package is “low salt” or “low cholesterol” or “low fat?” Usually this represents a relative statement. If a soup is low salt but if one eats multiple servings per meal, then low salt becomes a lot of salt. If low sugar means just a small bite of the chocolate bar, that is true but who eats just a small bite?

The article noted that the San Francisco city attorney was able to force Kellogg to stop using the statement that sweetened breakfast cereals “help support your child’s immunity.” There was no evidence to support this claim and furthermore, sugared foods raise many other health issues.

Manufacturers naturally want to use health claims; it helps sell the product. But these claims can confuse the shopper and may well suggest to the buyer that the government has somehow endorsed the statement when in fact it has not. Indeed, few claims can be verified because no unbiased evaluation has been done to accept or refute them. Stating that a food is fortified with a vitamin does not mean that it is a healthy food; just that it has had the vitamin added. The important question is whether the food, say a cereal, is made of whole grains and has little or not sugars, salt or fat added.

The authors conclude by recommending that the FDA strictly regulate front-of-package labeling based on sound studies. Seems like a very good idea to me.

We Have Become An Obese Nation

2010-02-21T14:43:00.001-08:00

Fifty years ago about 55% of Americans were overweight as measured by body mass index [BMI which is based on the relationship of height to weight]. Broken down this was 32% “pre-obesity” or “overweight” [meaning BMI between 25.0 and 29.9] and 13% obese [BMI 30 or greater.] Today that 55% has increased to 68% with 34% now in the obese range! Obesity affects all ages and genders. Among adults, 72% of men and 64% of women are pre-obese and 32% and 36%, respectively, are obese. And very disturbing is the trend toward obesity among children and adolescents, with about 32% of school kids above the 85th percentile for BMI. [For more details see three related articles in the Journal of the American Medical Association, January 20, 2010]

Obesity is a predisposing factor to a broad range of chronic illnesses, among them cancer, heart disease, diabetes, chronic lung disease, and stroke. They make arthritis worse and diabetes very difficult to treat. These are lifelong and expensive to treat. Some estimates suggest that 10% of all healthcare costs relate to obesity and others would suggest even much higher amounts. These are chronic illnesses that reduce lifespan and decrease quality of life.

We are witnessing an increasing epidemic of type 2 diabetes largely related to being overweight and it is estimated that coronary artery disease, declining in recent decades, will once again be on the rise as a result of our sedentary life style combined with a non-nutritious, high calorie diet.

The time is here for a concerted national effort on both the population level and the individual level to correct this serious imbalance. Governments need to mandate nutritious foods in schools while eliminating inappropriate foods from vending machines and the cafeteria. Posting calorie counts in fast food restaurants will at lest help individuals realize the implications of the decisions they make. Schools can teach more about healthy lifestyles. The work of the First Lady, Michelle Obama, to foster good eating habits along with healthy food choices and personal gardening are to be strongly commended.

At the individual level, parents need to teach good eating habits beginning in early childhood. All of us need to appreciate the implications of non-nutritious foods and the perils of being overweight. Physicians need to appreciate the power of their influence on patients and take the time to counsel their patients on the importance of a lifestyle that incorporates good food [fresh vegetables and fruit, more fish than meat, whole grains like whole wheat and brown rice, and the avoidance of prepared/packaged foods,] the right amount of food calories per meal and per day, along with adequate exercise and stress management.

In the end, we cannot blame anyone but ourselves for our sedentary habits and obesity but at the same time we can recognize that the “fix” is very difficult and so we must all help each other to lead a healthier lifestyle. Group support whether it is in the family, among friends, at school or at work can be very helpful to each of us to maintain our effort to reach worthy goals.

Watching TV is Bad for Your Health But Sitting Still is the Culprit

2010-01-27T11:42:00.000-08:00

Did you see the stories in the newspapers that TV watching is bad for your health? It is but probably not for the reasons you might think. Certainly being a couch potato is unhealthy and if we sit there for long periods, eating chips, drinking beer and smoking cigarettes, our health will obviously take a turn for the worse. But a new study from Australian researchers observed 8800 adults for over six years and recorded the deaths from heart disease, cancer and all causes. The results were published in Circulation and showed some disturbing trends for those of us that are living in the information age. Sitting is a problem all by itself. Those who sit and watch more than four hours of TV per day are at nearly 50% greater risk of death from any cause than are those who spend less than 2 hours sitting in front of the TV. And those same people have an 80% greater risk of dying from cardiovascular disease than those with less time in front of the TV. And it’s bad for you even if you are relatively healthy, have a normal weight and exercise regularly. All that sitting is bad for your health.

Our forefathers and foremothers spent most of their days in some sort of physical activity - farming, cooking, and hunting. But we hop in our car and drive to work; walk a short distance to our office and sit down again; get up to get lunch and then sit back down before our computer. Then we sit to drive home and sit to eat dinner and sit to watch TV. It turns out that our bodies were designed to move. Not only do moving our muscle burn energy but moving our muscles affects many critical body regulatory mechanisms – such as blood sugar balance. Prolonged sitting disrupts these processes.

The moral of the study is that we need to move around. Watching TV may be OK but not if we are sitting still. And going to the gym for 45 minutes a few times per week cannot make up for all that sitting. What we all need to do is move around. Just a few steps every so often makes a difference. Walk up a few flights at work; park further from the building; make trips to the water cooler which is kept at a distance from your office. Stretch in place and do muscle contractions regularly during the course of the day. Don’t let your day be sedentary; move more, more, more.

Misconception - Primary care physicians do not deal with the expensive aspects of medical care so they can have little impact on reducing medical expenditures.

2010-01-14T14:13:00.001-08:00

Two major reasons for cost escalation are lack of good care coordination of those with complex chronic illnesses and inadequate attention to prevention and screening. PCPs are key to both of these but they have too little time per patient and are not paid for either activity.

About 5% of all healthcare expenditures go to PCPs but they can have a major impact on the other 95%, especially with good care coordination of chronic illness and with a focus on prevention. To fix this, PCPs need to be incented [paid] to deliver care coordination for the chronically ill and good preventive care to all of their patients. This could have a very high return on investment and a huge impact on total costs. It is a logical place to begin to address the high costs of medical care in America.

Misconception– Health care is or should be a right – not a privilege and not a responsibility

2010-01-06T07:08:00.000-08:00

During the presidential debates, Tom Brokow asked “is healthcare a right, a privilege or a responsibility?” The candidates did not answer the question but now would be a good time for Congress and the Obama Administration to balance the rights being offered as part of reform with corresponding responsibilities.
We are the only developed country that does not assure all of its citizens basic medical care insurance access – shame on us. We spend more per capita for medical care than any other developed country yet our outcomes are not the best – shame on us. We mostly use price controls to try to slow rapidly escalating costs. They not only don’t work but leave patients with less than adequate care and huge bureaucratic frustrations – not logical. All too many individuals find that they are denied coverage because of a preexisting condition when they move from one job to another or find themselves unemployed - unacceptable. As a population we have all too many adverse behaviors such obesity, lack of exercise and smoking that are leading to expensive, lifelong chronic illnesses like diabetes and heart failure – killing ourselves. And primary care physicians find that they do not have time to offer good preventive care nor care coordination to those with chronic illnesses because insurance does not pay for these essential activities, thereby resulting in more visits to specialists, more expensive prescriptions when life style changes could have been effective, more procedures and tests - all of which lead to higher total costs of care.
Howard County, Maryland has instituted a program that offers the uninsured access to primary care for a minimal fee along with specialist care given pro-bono and hospital care for no charge. But in return, each patient works with a health coach to develop a set of goals for the year such as weight control, smoking cessation, exercise enhancement or stress reduction. Patients also are expected to receive appropriate vaccines and obtain basic screening such as checks for high blood pressure. The health coach assists the patient to overcome barriers to success such as helping to find a free smoking cessation program or an inexpensive gym. Patients have been pleased with the program and responded well to the responsibility element. It is a model worth emulating.
Congress is rightly seeking to assure all of access to care regardless of ability to pay. It is not inappropriate for the tax payer to expect the individual in return to lead a reasonably healthy lifestyle as a means to not only maintain and improve health but to lessen the cost of care. Congress also plans to ban the practice of insurers excluding individuals with predisposing conditions. A reasonable expectation [responsibility] in return is that everyone participates in insurance so as to keep the risk pool large and the costs down. In another pairing of rights with responsibilities, commercial insurers and Medicare should be able to incent patients to hold down costs with premium reductions for those who do have an appropriate weight, do exercise, do not smoke, do get their vaccinations and do have screenings done.
Primary care physicians should be able to have a reasonable income without a huge patient load nor the necessity of short visit times but in return the insurer/payer should be able to expect excellent preventive services and good coordination of the care of those patients with chronic illnesses. In this model, both doctor and insurer each have their rights and each their responsibilities, resulting in better care, healthier patients and reduced total costs to the system. Government, and therefore the taxpayer, in accepting the responsibility of universal coverage for those who cannot afford it should have the right in return of a reasonably healthy lifestyle by those covered. The result is better health with lower costs over the long term.
This combination of rights and responsibilities can assure that everyone has access to care and incentives to better health. Yet, it will reduce expenditures through improved quality and eliminate many of the current frustrations with the “system.” It satisfies the legitimate arguments of those who insist that medical care is a right with the equally important argument that we all have to accept a meaningful level of responsibility for our health and its costs.

Healthcare Reform Misconception - Giving patients more control of their healthcare expenditures will lead to lower costs

2010-01-04T07:20:00.000-08:00

It makes good sense to have all of us more involved in our healthcare decision-making and with that its payments. But individuals purchase healthcare in a manner unlike any other purchase. Patients or their loved ones do not “shop” for the best price the way they shop for a new washing machine. They shop for the best [as they understand it] physician, hospital, etc. Mostly they accept the advice of their personal physician as to drugs, surgery or rehab. That said it makes sense to have high deductible policies with or without health savings accounts or medical savings accounts (HSAs/MSAs.) We should not be fooled that these will necessarily lead to substantially more prudent purchasing as their proponents believe. Their real value is to give individuals the opportunity to purchase care with pretax dollars, a nice saving, and to help put insurance back to being true insurance for catastrophic expenses and not prepaid total healthcare as is most insurance today.

The biggest drivers of costs are related to the lack of preventive care for many of us and the lack of good care coordination for those of us with complex chronic illnesses (e.g., heart failure, diabetes with complications) as discussed in the previous post. These will not be affected much if at all by patients having more “skin in the game.”

But the more we know about our medical care costs and the more we ask our providers why a test, a drug or a procedure is necessary then the more likely it becomes that there will be a reduction in total costs. Being more directly invested in the costs of our care will ultimately have a market effect. This is particularly important when told to get a test, X-ray or drug. Ask your physician if the test is really important or is just being done to “be complete” (i.e., avoid malpractice litigation.) Will the results really effect what the doctor decides to do next? And as for drugs, is a drug what is needed or is it a life style change such as Lipitor versus a change in diet and exercise? Or is a generic available? Or another drug that is equally as effective as the branded drug? It is our money so it is important to have these discussions. Unfortunately, as patients we still have an information gap relative to our provider and we tend to accept advice without questioning – this needs to change and being directly responsible for dollars spent may just provoke that change.

Healthcare Reform Misconception - Costs are rising because of the avarice and greed or just unregulated “bad guys,” including drug and technology com

2009-12-29T07:54:00.000-08:00

Each of these deserves some approbation and bears some responsibility at the margin, but these are not the major reasons why costs are rising. But it seems that politicians, the media and so many others seem to believe what’s convenient rather than what is accurate.

The real culprits are: 1) the poor coordination of care of those with chronic illness resulting in excess visits to specialists, excess tests, unneeded procedures and even hospitalizations, 2) overuse [often as a result of #1] of expensive drugs, devices or procedures when they are not needed or truly necessary or when a generic drug, older device or no procedure at all would be more than adequate and appropriate, 3) a wide divergence in the use of medical care and technologies based on geographic region with no evidence that those who receive “more” have better health or longer lives 4) an aging population [older people get sick more often and consume more medical care]; and 5) physicians/patients/relatives who are unwilling to accept the inevitability of death and insist on “one last try.”

6) A big driver of high costs is preventable errors. We know that at least 100,000 people die annually of safety lapses like developing a hospital-acquired infection, drug errors, or procedural errors. Many more are harmed. This lack of quality greatly adds to costs.

7) One of the biggest drivers of increasing costs over time will be our own behaviors along with a lack of preventive medicine or wellness programs. We are a nation that is obese, has poor nutrition, lacks exercise, and is over-stressed. We have dangerous habits of smoking, drinking and driving, and not wearing seat belts. Too many of us do not get immunized to common yet often lethal infections such as influenza, nor do we practice good dental hygiene. We avoid basic screenings to detect high blood pressure, high cholesterol, or cancer. Unfortunately, many government policies actually aid and abet us in maintaining these behaviors.

Add these together and our costs are higher than most other developed countries.

Misconception - Universal coverage for all Americans will reduce costs

2009-12-23T08:53:00.000-08:00

Unfortunately that is not the case; indeed it will create substantial added expenditures. Today we spend about $7500 per capita for medical care each year. That is built into our insurance whether it is commercial or Medicare along with co-pays and deductibles. In my view it is unfortunate that Congress has not done much to address the high and rising costs of medical care in the reform bills.

America is the only country in the developed world that does not have some system to ensure everyone of at least basic medical care coverage - shame on us. The bills in Congress now will mean that another 30 million individuals will have some form of insurance – this is certainly good. And those with pre-existing conditions will no longer be denied coverage. And that is certainly good as well. But offering coverage to all will cost someone, you and me, in taxes since the newly insured will presumably now expend the same $7500 each.

Certainly it is true that access to a physician for basic medical care will mean fewer visits to the ER, less hospitalizations, and better overall health for the individual. This will mean better medical care, a healthier population and it will reduce the cost of care some but there are still substantial real costs for getting medical care to 30 million of those not insured today. To think otherwise is to ignore reality.

Misconception – Healthcare reform will fundamentally improve how we receive care going forward.

2009-12-21T11:08:00.000-08:00

This is also not at all likely except for those who do not now have medical care insurance. For the rest of us, medical care delivery will change but it will change not because of reform but because of some fundamental societal and demographic reasons along with a marked change in the types, severity and chronicity of illnesses that is occurring right now. The combination of an aging population and our non-healthy lifestyles (obesity, poor nutrition, lack of exercise, stress and smoking) are leading to epidemics of diabetes and heart failure plus increased numbers of cancers, kidney disease and others – diseases that are lifelong, complex and expensive to treat. What reform may do is protect those of us with “pre-existing conditions” to be able to purchase insurance and do so at a reasonable premium cost. And it may put an end to lifetime limits on insurance and the practice of “rescission” or dropping a person once they develop a serious illness. But the care itself and its delivery to us will probably not change much as a result of reform.

Here is some of what will change in the coming years irrespective of healthcare reform: There will be more people with chronic complex illnesses and these will require more drugs, more technologies, more testing, more imaging, more procedures and more hospitalizations – all of which will cost more money. There will be more hospital beds constructed, more operating rooms built, more intensive care units. At the same time there will be more and more that can be done as an outpatient as or with less invasive approaches than current surgery. There will be a need for newer pharmaceuticals and medical devices; these will be expensive but capable of reducing the cost of care if used wisely. Smaller hospitals will merge into systems to access credit markets so as to purchase technology and to enlarge physical plant. There will be greater use of eMedicine – telemedicine consults, moving medical information from site to site digitally rather than by courier, telediagnosis techniques such as digital weight or blood sugar recordings from home to the doctor’s office for review daily, and electronic submission of prescriptions and with it alerts to the doctor as to allergies or drug-drug incompatibilities.

These are but a few of the changes that are coming in the delivery of healthcare during the next five to fifteen years.

Misconception – The remarkable medical scientific advances are rapidly made available to the care delivery system.

2009-12-16T14:14:00.000-08:00

We should so hope but often that it is just not the case.

Laparoscopic surgery took medicine by storm 20 years ago but some new technologies of great value are slow to be adopted, such as simulation for teaching procedures rather than learning by practicing on the patient. Sometimes it is because the old way is “the way we have always done it” and sometimes it is because those holding the purse strings just do not appreciate the underlying value. Laparoscopic surgery got patients out of the hospital faster with fewer sequela and was endorsed by surgeon, patient and administrator alike.

Simulation – although it will markedly improve safety and quality and even shorten training times – is often perceived as just a “cost” by hospital executives and hence not worthy of investment.

Simulation was key to saving the US Airways plane last January. The captain had practiced landing with no power multiple times in the company simulator. That was crucial since there was no time 3000 feet above New York City to pull out the manual and read up on what to do. Simulation has come late to medicine but now there are many new technologies to teach students, residents and even expert physicians and surgeons. Everything from practicing drawing blood [instead of practicing on your classmate], to using an endoscope for colonoscopy [instead of learning on a patient], to very sophisticated approaches to surgery for the experienced practioneer. This is a revolutionary change in medical education and training and a very disruptive technology. It means that the trainee does not “practice” on a patient until he or she has proven competent on the simulator. For some this might take many trial runs; for others it might be much easier to master. No matter, the test is competency; not “how many times did you practice?” As a patient, you might want to know if the surgical resident assisting the attending surgeon has completed his simulation requirements; don’t be afraid to ask. And for the hospital executive, it is worth noting that simulation can actually shorten the training time required since the simulator is always available whereas the “right” patient may not be admitted until next week or later. And it means much improved patient safety since no one gets to touch a patient until competency has been demonstrated; safer care saves a lot of money.

Simulation is coming but still not fast enough given its value to trainee and patient alike.

Video Conference with Becton Dickinson – The Future of Medicine

2009-12-14T06:29:00.000-08:00

I was recently invited to present my thoughts on the Future of Medicine, based on my book of the same name, to the worldwide medical affairs group at Becton Dickinson, the giant medical device and diagnostics company headquartered in Franklin Lakes, New Jersey. Their senior vice president for medical affairs, Dr David Durack, requested that I review the basic megatrends developing as a result of the scientific advances from genomics, stem cells transplantation, vaccines, pharmaceuticals, medical devices, imaging, operating room technologies and the digital medical record. From these I proposed five basic megatrends that will significantly impact medical care moving forward – the development of custom tailored medicine; much more attention to preventive care; markedly improved ability to repair, restore and replace organs, tissues and even cells; greater safety for patients: and, finally, digital medical information instantly available anytime and anyplace.

BD had me present via videoconferencing which eliminated the need for travel yet allowed them to see me and my slides and I could see/hear them concurrently.

Their group asked many very challenging questions after my presentation and presented some excellent concepts. They suggested, for example, that in addition to positive trends that will improve medicine, I might also consider negative trends and their impact. Examples were government instability in many developing countries, climate change, and the current financial challenges. Each could and probably already has created major adverse consequences for the delivery of medical care worldwide. Another area of interest was the implication of privacy on the development of genomic information; would having genomic data determined on yourself lead to insurance denials or higher priced premiums? A real concern of many despite the legislation that passed last year to limit this possibility. And what was the scientific basis for the use of complementary medicine approaches such as acupuncture, meditation and massage? Here we discussed acupuncture for osteoarthritis, the nausea of chemotherapy and low back pain; massage for neonates in the intensive care unit and mind body approaches combined with diet, exercise and support groups for those with coronary artery disease.

The final question was what would I write differently if doing the book over again? For that one I had an answer – updates of course and some added sections on pharmaceuticals, diagnostics and nanomedicine/biomaterials. But The Future of Medicine only dealt with medical advances, not the myriad problems of getting the new approaches to the patient. There are all too many problems with the delivery of health care today and, to compound them, there are some very powerful forces that will lead to delivery changes in the coming years no matter what happens with health care reform. This bog attempts to address these.

Misconception - “Health care reform” will improve the delivery of care and offer us better care opportunities.

2009-12-12T12:38:00.000-08:00

In fact, healthcare reform is not about healthcare; it is mostly about paying for medical care for the uninsured and only somewhat about the rising costs of medical care. I use the term medical care here to emphasize that today American “healthcare” is all about treating disease and injury and very little about promoting wellness and preventing illness. The reforms being proposed are about addressing the financing of medical care but not the quality, the safety or the way that healthcare will be delivered nor who will deliver it given the coming shortages of professionals at all levels. Certainly it is important to assure access to care for everyone but don’t let that confuse you into thinking your healthcare delivery will be improved. It will not.

Misconception - Healthcare reform will have an impact on the advances in medical science.

2009-12-11T06:49:00.001-08:00

This sounds logical but there are frankly amazing advances in medicine that are around the corner no matter what “reform” occurs. These advances are related to our national commitment to basic science and to engineering and computer science developments and their translation to clinical care. The National Institutes of Health, research organizations such as our medical schools, the pharmaceutical and biotechnology industries and the medical device industry are constantly bringing forth new knowledge and new approaches to care. Among them are advances in genomics, stem cells, transplantation, vaccines, pharmaceuticals, medical devices, imaging modalities, OR technologies and the digital or electronic medical record. [For more of this subject see “The Future of Medicine – Megatrends in Healthcare.”] The reforms being discussed will have little or no impact on the development of these advances; rather they are coming and they will have a major impact on the care we will receive in the near future.

Common Misconceptions About Healthcare Reform

2009-12-09T06:57:00.000-08:00

American medicine must change - and the change will be both substantial and difficult to achieve but change is critical if we are to have a well functioning healthcare system that affords all of us safe, quality care at a reasonable cost in a customer-focused manner.

Today there are many misconceptions about healthcare reform - misconceptions about who will have access, how much it will cost, who will pay the bills, whether it will benefit those who currently have insurance, whether there will be good preventive care and good coordination of chronic illnesses, whether individuals will still be able to lose their insurance if they change or lose their jobs, whether Medicare benefits will be reduced, whether it will include rationing and whether there will be "death panels." Indeed the misconceptions like these and others are rampant and need to be addressed in a realistic, nonpartisan manner. I propose to explain what must change and why and then to dispel the misconceptions with straight forward factual information so that you can be properly informed. In the process I will explain the need to balance rights such as access with responsibilities such as leading a healthy lifestyle. Beginning with this post, I plan to review the common misconceptions, one or two at a time, entering a new post very few days until completed.

Misconception - America has the best healthcare in the world.
Sorry, but this is just not true. As stated before, we have a medical care system not a healthcare system meaning that we focus on disease and pestilence but not health promotion and disease prevention. We do spend more per capita than any other country but our quality does not measure up to what we spend. We have a higher infant mortality rate [6.9 per 1000 live births] than many countries [e.g., Japan – 2.8, France – 3.9] and our lifespan [77.9 years] has not kept up [Japan – 83, Switzerland – 82]. We have lifesaving vaccines available but they go unused by nearly 20% of infants. We are overweight with only about one-third of us at a healthy weight. About 20% of us still smoke. Regular exams are simply not regular and screenings for preventable or reversible problems like high blood pressure, high cholesterol and cancer are all too often not obtained. In short, the American healthcare system responds, and responds fairly well, to illness and trauma but is not focused on preventive medicine as the numbers above document. Further we do not have coordinated care for those with complex, chronic diseases like heart failure and cancer. These diseases cannot be treated appropriately with our current helter-skelter approach with independent physicians referring to each other as the situation warrants instead of a well-coordinated system for addressing all of the patient’s needs in an organized manner with multidisciplinary teams.

We have incredible resources in people, technology and infrastructure but we do not bring them to bear on the problems of healthcare delivery in an effective manner. This needs to change.

Mammograms as a Stalking Horse for Issues in Healthcare Reform

2009-12-07T06:40:00.000-08:00

As we watch the reform movement in Washington, we see and hear so many misconceptions. A current one relates to mammography. A few weeks ago guidelines were published in the prestigious Annals of Internal Medicine stating, in effect, that women between ages 50 and 75 with no history of breast cancer in their family and normal mammograms to date could probably switch from annual to biannual exams. And women between ages 40 and 50 probably did not need to get mammograms as had been previously recommended unless they had certain high risk circumstances. These recommendations were made by an expert, non-partisan panel with no apparent conflicts of interest in the guidelines. The recommendations were made based on careful examination of all of the relevant data on the benefits and risks of mammography to detect early breast cancer. With a lifetime risk of breast cancer being about 9%, women need unbiased advice on what to do to detect cancer early when it is most curable. But they also need advice on when a testis not needed or can lead to unnecessary biopsies, anxieties and expense.
These newly released guidelines from the Preventive Services Task Force ignited some firestorms. The first was from various advocacy groups who have worked for years to assure that women could access mammographic screening programs annually and have the procedure paid for by insurance. Women have begun to understand the importance of routine screening and often set their exam dates by their birthday other annual event. This relatively easy approach to remembering to get a needed test has been useful but might be lost with biannual exams and this worries many advocacy groups. Second, many women chimed in saying that they developed breast cancer at a young age and it was only for the mammogram that it was found at an early stage and hence was cured. A third group, the many providers along with the manufacturers of mammographic equipment, see that reducing the frequency of mammograms will substantially impact their businesses and profits. Some smaller breast evaluation centers might go out of business altogether if procedures drop by 50% as would happen if the guidelines were fully followed. None of these groups want new guidelines that will encourage fewer women from having routine mammograms at the same schedule as formerly advised. But that was only part of the problem with the new guideline recommendations.
Those who want to defeat the current healthcare reform proposal in Congress are using these new guidelines as their "proof" that reform will mean rationing. To them, it represents the “heavy hand” of government making decisions rather than the patient or her physician. This is an excellent approach to raise high levels of concern especially in a population of individuals that tend to vote and tend to contact their elected representatives in Congress. In fact the Task Force did not suggest that insurance standards be changed although one could surmise that insurers might decide to limit reimbursement if the accepted guidelines so suggested. And so the secretary of Health and Human Services felt compelled to state that this would not impact insurance and Senator Barbara Mikulski of Maryland offered the first proposed amendment to the Senate health reform bill to prevent just such a possibility.
These firestorms erupted rapidly when in fact the new guidelines are just a reasonable attempt by a group of nonpartisan experts to offer women and their physicians the best current evidence as to what is most efficacious and least risky so that they, and they alone, can make rational decisions about care.
Truth is that medicine needs more and more efforts to assure that the care of patients is based on solid evidence. All too much of medical care is based on what we learned in medical school years ago, what we read about recently or what our personal experiences have been. This must change and guidelines from well respected unbiased experts can make a big difference in improving the quality of care.

Chronic Fatigue Syndrome Shown to be Caused by Virus

2009-10-21T09:18:00.000-07:00

A very recent discovery may lead to significant advances for the estimated 4 million Americans and 17 million worldwide who suffer with chronic fatigue syndrome. CSF is, like its name suggests, a persistent extreme level of fatigue that does not resolve with rest or sleep. It may also be accompanied by memory lapses and other neurological issues. All too many individuals have been branded as having a “psychological problem” and as not really being ill. No cause had been known although viral infection, immune dysfunction or both had been thought possible. There has been no specific treatment.

Now researchers at the Whittemore Peterson Research Institute in Reno, Nevada have shown that CFS is likely caused by a virus. Known as xenotrophic murine leukemia virus – related virus, or XMVR, it is a retrovirus that is suspected of being transmitted by intimate human contact. The discovery means that a definite diagnostic rest can be created. And hopefully it means that scientists will be able to shortly find or create drugs to both prevent the disease and to treat those who have it. It also means that no loner will these patients be labeled as not having a real medical problem.

The researchers’ early studies suggest that perhaps 4% of us carry the virus. If proven correct, then an immediate goal is for a quick and inexpensive test to screen donated blood so that the virus is not transmitted inadvertently via transfusions. And it raises the intriguing question of why some but not all of those infected go on to develop CSF.

In study done at the Cleveland Clinic, scientists have found the same XMRV virus in prostate cancer samples. It is too soon to say that the virus is causative; if might be just a “passenger.” Additional research will be done to make a clear determination.

Meanwhile, the Whittemore Peterson researchers have suggested a new name – x-associated neuroimmune disease [XAND], a name that clarifies that this is a real disease and suggests some of its implications.

This finding of XMRV as the likely cause of CFS is a major medical advance.

Additional Advances To Expect in Medical Care

2009-09-01T05:30:00.000-07:00

In the last post I referred to the advances in biological sciences and some in engineering and computer science. Here are some more that will have a tremendous impact on your care now and into the future.

With the improvements in imaging devices such as MRI and CT scanners, it is now possible to do many procedures much less invasively in the radiology suite rather than in the OR as before. Uterine fibroids can be destroyed by passing a small catheter [about the size of a spaghetti noodle] into the arteries that feed the fibroid. Then small particles are inserted that block off that blood supply and the fibroid basically withers away. It is a rapid procedure with minimal recuperation time, especially compared to surgical removal of the uterus [hysterectomy.] Another example is resolving an aneurysm in the brain using similar catheters without the need for open neurosurgery.
Some tumors of the brain can be successfully treated with the “gamma knife” which is designed to give a huge dose of radiation to the tumor but not the rest of the brain. It is done in one procedure and the patient goes home the same or the next day. Other new radiation therapy procedures utilize very sophisticated equipment that can deliver the correct dose of radiation to the tumor, say in the prostate, but avoid most of the surrounding tissue such as the rectum and bladder. This makes the treatment more effective yet with fewer side effects.

Slowly but surely, all medical information is being digitized. As this happens it will be finally possible to have a total electronic medical record. This will mean your medical data is available anyplace, anytime. And it will mean that if you are sent to a specialist that your CT scan is available on line and you will not have to go to the radiology office to get it before visiting the specialist. This will save you time; the specialist can make an informed opinion immediately and will mean reduced costs. There are some important hurdles to overcome before this will be a reality but I am confident that they will be solved relatively soon.

With these and other advances medical care will be more custom tailored just for you; there will be a greater focus on prevention; it will be possible to repair, restore or replace a damaged organ; your medical data will be instantly available and medical care will be safer. Big advances.

Medical Megatrends –Expect These Advances in Medicine Soon

2009-08-19T05:19:00.000-07:00

In the book “The Future of Medicine-Megatrends in Healthcare” I refer to several medical megatrends will profoundly affect medical care advances in the coming five to 15 years. Some are due to the explosion of basic understandings of cellular and molecular biology. Others are related to improvements in engineering and computer science. Together they will create huge shifts in medicine: First, medical care will become custom-tailored for the individual patient; second, prevention will come to the fore with the medical model moving from “Diagnose and Treat” to “Predict and Prevent”; third, repairing, restoring or replacing tissues and organs will be much improved; fourth, your medical information will be available, instantly, no matter where you are; and, fifth, medicine itself will become much safer and be of much higher quality.

Here are some of the advances in biological sciences. Genomics is at the heart of many. : Drug companies will be able to develop drugs that are designed from the beginning to be “targeted” to a specific problem – custom tailored. Already there are a number of new cancer drugs that fit this model such as Gleevec for chronic myelocytic leukemia. Today a physician must prescribe a drug knowing only that it works in “most” people but not whether it will work in you nor whether you will be among those to get a side effect. With genomic information, doctors will frequently be able to prescribe a drug for the individual knowing that first it will actually work and second that it will not have unexpected side effects. That will be a major advance. Genomics is already helping to subcategorize patients with the same type of cancer into those with good or poor prognoses – the former may need less aggressive treatment and the latter more aggressive approaches. Genomics also helps in early diagnosis. Imagine taking a sample of pus and knowing in less than an hour if it is infected with “staph” and whether it is resistant to antibiotics or not – a multiday process currently. And being able to predict what diseases a person might develop later in life [e.g. heart disease or colon cancer] would mean that a “prescription” for life style changes could be started to prevent or slow the disease occurrence [e.g., diet, exercise]. Or a drug might be prescribed early in life [e.g., statin to reduce cholesterol] or a procedure begun sooner than usual [colonoscopy for the person at high risk of early colon cancer.] All of these will mean more custom-tailored medicine for you and will change today’s medical paradigm from “Diagnose and Treat” to “Predict and Prevent.” And all of this will occur regardless of whatever healthcare reform emanates from Washington.

Other scientific advances are those of immunology which are making it possible to create new vaccines and improve our ability to transplant organs. There will be more vaccines to prevent many troublesome infections such as the new vaccines that prevent the “shingles” in older individuals and rotavirus diarrhea in infants. There are already vaccines that can prevent hepatoma, a type of liver cancer caused by one of the hepatitis viruses, and cervical cancer, usually caused by the human papilloma virus. And I will predict that there will be vaccines to prevent others cancers soon such as some types of leukemias and lymphomas and perhaps stomach cancer and some cancers of the head and neck. Look for vaccines to prevent or treat some of the most important chronic illnesses such as atherosclerosis and Alzheimer’s – these will be major advances. As to transplants, some day it will be possible to transplant an organ from a pig into a human without it being rejected. No longer will someone have to wait for another person to die to receive a heart, a lung, a kidney or liver.

Engineering and computer science is also advancing medicine rapidly. The new CT and MRI scanners give incredible images of our anatomy in a completely noninvasive manner. This means that diagnosis is much easier and more accurate and a surgeon knows exactly what he or she will find during surgery – a major advance.
Simulators - like those used by airline pilots for practice – will assist trainees before they ever approach a patient and will be used to test for competency and certification.
New technology in the OR will mean less invasive yet more effective surgery with a shorter recuperation time.
And there are many medical devices that have meant a restoration of normal function for many people. Think of the new heart pacemakers that regulate the heart’s rhythm or the defibrillators that prevent sudden death. Look for major advances here in the coming years. And similar devices can be used to reduce the frequency of epileptic seizures and even assist in treating depression.
In time, all medical information will be digitized and this will mean that there will finally be an electronic medical record – one that is available anytime, any place. This will mean much better health care for you, a big improvement for the doctor and a lower cost of care.
These are but some of the advances coming in the next few years. They will mean more custom-tailored medicine, better prevention, an increased ability to repair, restore or replace damaged organs, a medical record that is instantly available anytime or place and much safer medicine. It will be an exciting time to watch as medical care improves for all of us.

World Class Health Care - An Imperative

2009-08-02T06:11:00.000-07:00

In appropriating funds for the new Walter Reed National Military Medical Center and the new Fort Belvoir Community Hospital, Congress determined that the military should receive only “world class healthcare” but did not define the meaning of the term. When the Health Systems Advisory panel of the Defense Health Board described in the previous blog was assembled, it decided that its first order of business was to establish a benchmark for world class. After much discussion, research and debate, a document was prepared and is available at the web site listed below, in Appendix B. Here is a summary of what the panel felt were the key elements of world class.
The principal summary statement would be: A world class facility combines the best of the art and science of medicine in a focused manner, consistently and predictably delivers superior care and value, meaning high quality at a reasonable cost to both patient and society.
World class can be further defined as follows:
“A medical facility achieves the distinction of being considered world class by doing many things in an exceptional manner, including applying evidence-based healthcare principles and practices, along with the latest advances in the biomedical, informatics and engineering sciences; using the most appropriate state of- the-art technologies in an easily accessible and safe healing environment; providing services with adequate numbers of well trained, competent and compassionate caregivers who are attuned to the patient’s, and his or her family’s culture, life experience and needs; providing care in the most condition-appropriate setting with the aim of restoring patients to optimal health and functionality; and being led by skilled and pragmatic visionaries. The practices and processes of a world-class medical facility are models to emulate.”
“A world-class medical facility regularly goes above and beyond compliance with professional, accreditation and certification standards. It has a palpable commitment to excellence. A world-class medical facility has highly-skilled professionals working together with precision and passion as practiced teams within an environment of inquiry and discovery that creates an ambience that inspires trust and communicates confidence. A world-class medical facility constantly envisions what could be and goes beyond the best known medical practice to advance the frontiers of knowledge and pioneer improved processes of care so that the extraordinary becomes ordinary and the exceptional routine.”
The panel further defined all of these issues and those further comments are available at the site below. The critical point to make however is that world-class is not just about buildings, not just about people, not just about technology, not just about specific practices but it is about how all of these and more are interwoven together for the benefit of the patients and the patients’ loved ones in a manner that delivers superior care at a reasonable cost.
These are recommendations that all hospitals [and their boards of trustees] and providers across the country should consider and consider seriously. Nothing less should be acceptable.
http://www.health.mil/dhb/meetings/NCR%20BRAC%20HSAS%20Report%20-%20Final.pdf

World Class Health Care at Walter Reed

2009-07-26T05:20:00.000-07:00

Last fall I was asked by Maryland Senator Benjamin Cardin to join a group evaluating whether the new Walter Reed National Military Medical Center [WRNMMC], when completed in a few years, would be “world class.” The group, a subcommittee of the Defense Health Board, met multiple times to learn about the plans and develop a report for Congress. The report is now available at http://www.health.mil/dhb/meetings/NCR%20BRAC%20HSAS%20Report%20-%20Final.pdf . Here is a brief summary. The Base Realignment and Closure Commission [BRAC] determined five years ago that the current Walter Reed should be closed and the functions moved to two facilities. One would be a community hospital and outpatient facility at Fort Belvoir, VA just south of Mount Vernon. It would give primary and secondary care to active and retired military that live in the southern half of the national capital area. The other would be on the grounds of the current National Naval Medical Center in Bethesda, MD just northwest of Washington. This conjoined facility would be renamed the WRNMMC and would have multiple functions. Primary and secondary care for those military personnel who live in the northern half or the capital area; tertiary care to those from throughout the region and total care for the wounded warrior.
We found that the Fort Belvoir facility was well designed but that the new WRNMMC had some definite deficiencies. Here is a summary. There was never a master facility plan for the campus which currently houses multiple functions and has many older buildings that over time should be replaced in an orderly manner. There was not a “demand analysis” completed to determine what the needs would be in to the future. For example, with the wars in Iraq and Afghanistan, would there be need for more, less or different OR configurations? With a growing retired military population in the area, what would be the new needs? Instead, a static approach was used, shifting the current functions at Walter Reed to the two future facilities. We also found that there would be no in-house simulation laboratories for learning OR procedures, cardiac cath or GI endoscopy techniques. In a modern hospital these are critical and must be immediately adjacent. The campus has externally mandated constraints on parking, logical from a local roadway perspective but not recognizing that staff from one shift cannot leave until the staff from the next shift has arrived – this means more spaces, not fewer. There is a METRO stop at the corner but in the winter it is a long walk to the hospital – some type of tunnel or people mover is needed to encourage ridership.
The report just went to Congress and to date the following has occurred:
House -- FY10 Defense Appropriations
“Medical care in the National Capital Region - The Committee continues to be concerned over the impact of care in this area with the consolidation of WRAMC and Bethesda Naval. Congress’ independent evaluation of DoD’s comprehensive plan was positive, for the most part. They await DoD’s 30-day assessment of that review’s findings and recommendations.”
Senate -- FY10 Defense Appropriations - Amendment by Senator McCain “Requirement for a master plan to provide world class military medical facilities in the National Capital Region” - agreed to by unanimous consent.
It is encouraging that Congress is taking the report seriously.

Maximizing Rights with Responsibilities to Enhance Access and Reduce Total Costs

2009-07-20T07:15:00.000-07:00

Healthcare reform was supposed to be about both access to care and reducing the cost of care. So far it is only about the former and the new costs look to be huge with only a portion of the uninsured actually benefiting. As to cost reductions, the only suggestions have been mostly just about reducing payments to providers with the assumption that they can figure out how to provide good care with less funding. That is not a strategy but just a tactic – and it will backfire.
There does need to be a way to reduce costs and the way to do so is a combination of rights and responsibilities related to the development and the care chronic illnesses. It is possible to reduce health care expenditures without rationing and without draconian across the board cuts to providers. Much of the rapid rise in costs is due to the increase in chronic illnesses that last a lifetime and are expensive to treat – heart failure, diabetes with complications, cancer, etc. Over 70% of healthcare costs go to treat these individuals who are only about 15% of the population. And these illnesses are increasing in prevalence as the population ages and as we persist with adverse behaviors such as smoking, over eating, lack of exercise and stress.
Chronic illness should be addressed from two perspectives – coordinating the care of those who are already ill and preventing new illness from occurring. Both will reduce costs and improve the quality of life.
What has become very clear is that chronic illness needs intensive care coordination to prevent unnecessary specialist visits, procedures, tests and even hospitalizations – the source of excess expenditures. Primary care physicians [PCPs] are in the best position to coordinate care but do not do so because they are not reimbursed for the effort. They receive about 5% of the healthcare expenditures but can have a major impact on the other 95%. Changing the reimbursements to PCPs with the proviso that they coordinate care would have an immediate impact.
Workplace wellness programs that offer reductions in health insurance payments in return for healthy behaviors reduce over-all costs and improve the health of the workforce. Safeway, General Mills and others have convincing data on the value of wellness programs. It’s an incentive toward healthier living.
Similarly, insurance policies should have variable rates for behaviors and preventive medicine – not smoking, weight control and obtaining simple screening tests like blood pressure and cholesterol would mean lower premiums.
Combining rights [access to insurance at lesser cost] with responsibilities [live a healthy life style] for patients and rights [increased pay] with responsibilities [coordinate care] for PCPs will have a major impact on the total costs of care and do so quickly.

Care Coordination in a Retirement Community – Better Care at Lower Costs

2009-07-13T08:43:00.000-07:00

Older individuals tend to have more complex chronic illnesses and they need lots of preventive care. The Erickson Retirement Communities determined to learn if attentive primary care would lead to better quality care, better quality of life and yet lower costs overall. By way of background, their basic goal was to improve the quality of life for their residents – good marketing. So they built in nutrition, exercise and other programs for the residents who live in a campus-like setting. Yet they found that their biggest failure from the retirees’ perspective was medical management. The Community hired a physician who initially spent about thirty minutes with each patient’s visit. The word got around and more and more residents signed up for his care. Once that happened he had to cut back until he was seeing each patient for about ten to twelve minutes per visit. And so the residents were again not satisfied. So the Community hired additional full time primary care physicians and paid them enough in salary over what Medicare paid so that they could afford to take the needed time with each patient. It quickly became apparent that the residents liked this approach but it meant only about 400 or so patients per physician rather than the national average of about 1500+ for a primary care doctor. It was more expensive up front but Erickson found that the number of hospitalizations for this group declined by about 50% suggesting that good coordination of care was effective in not only increasing satisfaction and quality but also in reducing costs. Of course, the reduction benefited Medicare but Erickson still had the extra expense of the added physicians to make the program work. Erickson then went to Medicare and petitioned for a demonstration project. To date over four thousand retirees in multiple retirement communities joined this Medicare Advantage program. The results again confirmed the value of good care coordination, the value of a computerized medical record and orchestration of chronic care by a primary care physician who could spend adequate time with each patient. At one retirement center, inpatient hospital days dropped from a national average of 2096 per 1000 Medicare enrollees per year to less than 500. And since these retirement communities generally have older residents, age adjusting the data meant that it was equivalent to only about 200 hospital days per enrolled resident. Another key metric is an unplanned return to the hospital shortly after discharge. The national rate for Medicare recipients is near 25% but the Erickson plan has kept these to less than 10%.They found that one key to success was having the primary care physician be the “orchestrator” among all of the patient’s specialists, being sure that the patient’s medications were appropriate, not mutually adverse, and in the correct dosage for a geriatric person. The primary care physician attends the resident when hospitalized, bringing the patient’s electronic medical record to the hospital on the doctor’s laptop. [They found that if the patients were cared for only by the hospital-based hospitalist, the tendency was for the acute problem to be well managed but for other issues to get out of control leading to longer lengths of stay and various complications.] As a result, they can assure that the individual continues to get appropriate care for all of their needs, not just the one problem that sent them to the hospital this time. Care coordinators are used as well but in tandem with the primary care physician who has the needed time with each patient. They conduct regularly scheduled programs of health management. There are behavior modification courses as in employer-based wellness programs but also specific programs for monitoring, coaching and prevention for specific high risk diseases. To reiterate, the program provides what a typical primary care physician either does not or cannot provide today [although most would like to provide.] It includes the behavior modification programs, plus the monitoring and coaching for patients with cardiac, chronic lung, diabetes and other diseases found in wellness programs sponsored by employers. To this is added aggressive management of these complex chronic diseases with close care coordination from their very beginning rather than when they become problematic later on. There is extensive use of non-physician providers which helps to keep the costs down but the contact level high. In short it is a wellness program, a care management program and a disease management program all rolled into one.

Disease Prevention For All And Care Coordination For Those With Catastrophic Illness

2009-07-05T13:51:00.000-07:00

The care coordination described in the previous post is a major part of the new CareFirst Blue Cross Blue Shield plan. But there are three other important components.

First, the PCP will receive increased compensation for all of his or her CF-insured patients, not just those with complex chronic illness. Hopefully, this will be enough to assure that every patient gets the time and attention needed for the best possible care. It also means, hopefully, that the PCP will be less inclined to quickly refer to a specialist rather than taking the time needed to sort out the patient’s problem [This happens a lot today and drives ever more specialist visits.] By the same logic, it is anticipated that the physician will do a more complete history and physical exam, negating the need for more tests and procedures. The result is better care for the patient, a more satisfied patient since the doctor will not be in a “rush” and a more satisfied physician. Better care at lower total cost.

Second, CareFirst recognizes that over 90% of their clients remain with them year after year so it is financially logical to try to assure good preventive care. This will cost more today but should pay off in the years to come with lower costs because the patient will remain healthy. So in this new practice arrangement, CareFirst will pay for any preventive/ screening program/ test that is well defined by evidence. This might include cholesterol measurements, mammography and colonoscopy and it might include dietary consultation, or a smoking cessation program. As an added incentive to get this type of preventive care done, CF will waive any co-pays or deductibles that the patient might have to otherwise pay.

Finally, it is recognized that some small percentage of patients will develop a truly catastrophic condition such that the PCP can no longer easily coordinate the care. These are the 5% of patients that consume a very large portion of the healthcare dollar. This is the patient that must be referred to a specialty center or an academic medical center, have major surgery or perhaps receive an organ transplant. My own observations over the years demonstrate that these are the types of patients who get less than the best possible care because the hand offs and referrals among providers are less than satisfactory. This is where quality breaks down, where safety issues arise, and where all too often excess tests and procedures get done. And since no one is orchestrating the entire care program, the patient is left with well intentioned caregivers but less than the best care.
In this situation, CareFirst will develop an incentive-based relationship with the specialty provider – probably a hospital system – to assure care coordination. The hospital system will assign a “navigator” to each such patient. The navigator will have the responsibility to be sure that the care of the patient within the system is well coordinated, just as the PCP does in the community setting. This navigator will work the interface among the myriad specialists, departments, even hospitals and centers that the patient must utilize for his or her care. The result could be much better care quality yet at a substantially reduced total cost.

The whole concept here is to coordinate the care that the patient receives with the expectation that the patient will be better served, the providers will be more satisfied and the total costs will be reduced. It will mean a real change in how the primary care physician functions – a change from being an intervener to be an orchestrator. And a major change for the hospital system in that it will need to become an orchestrator as well, not just a place for specialty care. And it is a change for the insurer, one that accepts that care coordination and disease prevention costs money but recognizes that the end result is better care at a lower cost. This plan uses various incentives to align needs – we could say that it gives rights but with corresponding responsibility.

One Approach To Improving Care Coordination While Assisting PCPs

2009-06-28T11:17:00.000-07:00

Good care coordination will improve the quality of care for the individual patient and yet will reduce costs by eliminating excess visits, tests, procedures and, by improving care quality, it will reduce the need for hospitalizations. With primary care physicians [PCPs] not able to take the time necessary, it is clear that something needs to be done to get care coordination for those with complex, chronic illness.

Here is what one insurer, CareFirst Blue Cross Blue Shield [CF] of Maryland, DC and portions of Virginia is planning. CF knows that about 65% of their medical expenditures go towards the care of just 5% of patients and 80% go for about 15%. These are patients with catastrophic problems in the 5% and complex chronic illnesses for the remainder. CareFirst also knows that primary care physicians receive about 5% of total healthcare expenditures yet they are in a position to impact the other 95%. So the agenda is to create incentives for them to do so in a way to reduce that total while improving the care of the patient. It would work like this [somewhat oversimplified to account for space limitations here.]

PCPs would form into groups of 5 to 10 and enter into an agreement with CareFirst. In return CareFirst would increase their reimbursement by 15% for each visit. There will be another 5% increment in return for using an electronic system provided by CareFirst that will assist with billing. This system will check their submissions, do edits and corrections and then submit the claim to CareFirst [or any insurer], all automatically and electronically. I am told it is easy to use and will greatly improve the doctor’s office productivity thus creating savings. No longer will there be claims denials over billing errors or the need to repeatedly resubmit until the claim is remediated – it will be correct the first time. In addition, Carefirst will agree to pay the physician within one business day, dramatically reducing the need for working capital.

CareFirst will do an analysis of the PCP group’s patients using claims data from the prior year. CF will be able to “flag” the 15% or so of patients that need care coordination.
The PCP’s obligation in this new system is to give the patient whatever added time is needed per visit and to create a good care plan and post it in an electronic medical record. This will serve as automatic preauthorization, no further calls to CF will be needed for tests, procedures, etc. – another major time saver for the PCP and his or her office staff. When the patient needs to see a specialist, the PCP will refer the patient but also call the specialist and clarify expectations and review the results of the referral when done. Finally, CareFirst will make available a “care coordinator” [a nurse] to call the patient as often as necessary to check on medication use, medication side effects, weight gain or whatever that the PCP has built into the care plan. If the care coordinator cannot resolve an issue or sees a developing problem, she will report in to the PCP.

The expectation is that this approach of incentives for giving the patient the care coordination needed will enhance quality yet reduce the overall expenditures for that patient’s care.

To further add to the incentives, CareFirst will do an actuarial analysis of the expected claims for the coming year for the PCP group’s patients. If, at the end of the year, the patients have had fewer claims, CF will give back a portion through yet higher reimbursements. With this added incentive, it is anticipated that the PCP will be sure to carefully coordinate care so that there are no excess specialist visits, no unneeded tests or procedures and, with better care overall, less hospitalizations. The end results, hopefully, will be higher quality care, lower total expenditures for that care, enhanced income for the PCPs and a more satisfying practice. It could be a win for everyone. Of course, the devil is in the details but it seems to be a worthy plan, one that might just have a real impact. It appeals to me because it begins with an attempt to improve quality and improve the PCPs situation as a means of reducing costs – rather than the other way around.

Improving Access to Primary Care and Coordination of Complex Chronic Illness

2009-06-11T07:36:00.001-07:00

Primary care physicians find that their income is flat or declining despite rises in practice costs such as office expenses and malpractice insurance. They generally are in small groups so they have little or no negotiating power with the insurers. And antitrust requirements prevent them from banding together for negotiating purposes. The insurers see their costs rising so they look for ways to keep expenses down, including payments to PCPs.
In order to maintain income levels, they resort to many techniques. One, of course, is to see more patients per day but each for less and less time. This means they spend all too little time taking a through history or physical and instead send the patient off for expensive tests and X-rays or to specialists for referral. If a patient cannot get through to their PCP and instead goes to the ER for an urgent problem, the patient will probably spend hours there and the costs will be much more. The ER physician does not know the patient, does not have access to the old record and as a result feels obliged to obtain multiple tests and images to make the proper diagnosis. This is “nuts” – the person’s PCP might have been able to solve the problem quickly, with fewer or no tests. Better, quicker care for the patient and less expense for the insurer.
PCPs also try to increase income by arranging for tests to be done at their office like stress tests. A technician arrives with the equipment and does the test for which the PCP gets a fee. Are more tests done than truly necessary? Should these tests be done only in consultation with a cardiologist and under their supervision?
Something needs to be done to alleviate these problems. Somehow the PCP needs to have an incentive not to have too many patients and to spend the time needed with each patient. This means a higher per visit reimbursement. But it needs to come with incentives. PCPs receive about 5% of the medical care dollar but can and could greatly affect the other 95%. So there need to be techniques tried to allow and encourage the PCP to give good preventive care, counsel about important issues, meet their patients at the ER, use email and the phone more [neither are currently reimbursed] and coordinate care when the patients needs to be seen by a specialist or have a test or procedure. Coordination of care is especially important for the 5-15% of patients who have complex chronic illnesses and hence need a team of providers to give care. The “team” needs to actually function as a team and it will do so only if someone is orchestrating its work. Primary care physicians need to change from the long held practice of being interveners to being orchestrators, especially for their patients with chronic diseases. This will be a culture change but it will also require monetary incentives – it will not occur otherwise.

A Crisis in Primary Care

2009-05-25T11:18:00.000-07:00

We are entering if not already in a crisis of primary care. Each of us needs a competent, caring and available primary care physician but that is less and less possible. Many can’t find one; others cannot afford one; and others have one but cannot get adequate time and attention from him or her. PCPs will tell you that they do not have enough time with each patient; are overwhelmed with paperwork and mandates; and are earning less and less per year. There are about 1000 graduating physicians entering primary care per year in the USA but about 3-4000 retiring. Average income after about ten years in practice of $150,000 has been stable or decreasing for some years while the costs of practice including staff wages, rent and utilities, malpractice insurance and supplies has been rising. Most medical school graduates have about $155,000 in debt to pay off. To make ends meet and retain the same income, PCPs are seeing more patients with longer days and shorter visits. This is not good for them and it definitely is not good for you. Basically they have a non-sustainable business model today as a result of the reimbursement system through our commercial and governmental insurance system.
To counter the problem, more and more PCPs are taking steps to increase their income while decreasing the number of patients seen per day. Some approaches are frankly disappointing such as the doctor with a sign in the waiting room that you may “only raise one problem per visit.” A colleague told me last week that her internist is no longer taking Medicare. She will have to pay for each visit. Perhaps not a problem if you only go for an annual exam and then once or twice for minor problems. But if you develop a complex chronic illness that requires multiple visits it could add up quickly, especially for someone on a fixed income in retirement. Other PCPs are opting for “retainer-based” practices, sometimes called concierge or boutique practices. Here you pay $1500-2000 [or more] per year and in return your PCP reduces his or her practice from 1800 patients to 500 and guarantees that you can be seen the same or the next day, that he or she will be available by cell phone and email 24/7, will visit you at home, will meet you at the ER as needed, and will care for you in the hospital and the nursing home. And each visit will be as long as needed for you and your issues. This is the way it used to be and is the way it really should be now but is not. Another advantage of this type of system is that it becomes a true relationship again between the doctor and the patient with the patient contracting directly for services from the physician – not through a third party. The downside, of course, -- this is extra money out of your pocket since you will still need your insurance for specialists and hospitalization.
What is clear is that the current system does not work and either PCP reimbursements by insurers will go up or more and more PCPs will either retire early or switch to retainer-based practices.

Putting It Together To Bring Down Costs

2009-05-12T14:23:00.000-07:00

President Obama is working hard to address the issues surrounding health care in the USA. Two days ago he hosted a group representing many of the major providers such as physicians, hospitals and pharmaceutical companies. They promised to work to reduce the rate of rise of costs of care over the coming ten years. No specifics were given out. Here is what I would suggest as the first steps.

If we take the comments from my last few blogs and put them together, we see that a few critical forces have come together to push up the costs of care. To be sure, there are other reasons for the rising cost of care and I will address them in later blogs. But these few are they key ones and are the ones to aggressively address now if we are ever to slow the rise of expenditures much less actually bring them down. Here they are:

Our population is aging – simply stated, “old parts wear out.” We have bad behaviors – poor nutrition, overweight, lack of exercise, stress and tobacco with many of these starting in childhood. Both age and behaviors are leading to the development of complex, chronic diseases [heart failure, diabetes with complications, cancer, etc]. This is much different that the acute illnesses that we generally think of such as appendicitis or pneumonia. In those cases a single physician can treat them and the result is a cure. But these chronic illnesses once developed persist for life and they require the expertise of many providers.

These chronic diseases are expensive to treat – today they consume about 70% of all US health care expenditures although this care is going to only about 10% of the population.
But our care system is poorly coordinated and this results in far too many doctor visits, procedures, test and even hospitalizations. That is the reason for the excess costs and these could be brought down with resulting improved quality of care, safer care and more satisfied patients.

What is needed, more than anything else, is a cadre of primary care physicians [or sometimes specialist a physician] to carefully coordinate the care of those with chronic illnesses. Without question, this approach will bring down costs.

Sounds simple and is in concept but the reality turns out to be not so easy

Personal Behaviors That Damage Our Health

2009-05-02T09:11:00.000-07:00

A very important reason for medical care cost escalation has to do with our own personal behaviors. We are a country of people who are overweight --one-third are overweight and one-third or more are frankly obese --, under-exercised, poorly fed from a nutritional perspective and highly stressed. And it gets worse each year. Even children have progressively declining physical activity from about three hours per day at age nine to less than an hour by age fifteen. And this will correlate to obesity beginning in adolescence. Twenty per cent of us still smoke tobacco. These are some of the major reasons that medical costs will rise in the future. Diabetes will accelerate to epidemic proportions, heart disease will follow, arthritis will be exacerbated by obesity, life spans will be shortened and along the way there will be enormous medical bills to pay. We need a government that encourages good health, regardless of the economic interests that such a program will affect. It will mean less fatty food, less red meat, less whole milk and cheese on our pizza, less sodas [and everything else made with high fructose corn syrup], less prepared and take out meals and more home cooking, more whole grains (whole wheat, brown rice, oatmeal) and a real change in the cereals sold in supermarkets. We need to shop the periphery of the supermarket and leave the aisles with all the prepared foods alone. We still smoke in high numbers with all too many teenagers picking up the habit. They will incur the wrath of lung cancer, heart disease, chronic lung diseases and others in the years to come. And we must finally come to accept that weight gain is a function of the number of calories consumed minus the number expended by exercise. That’s so simple but apparently so difficult that we try all sorts of diets that ultimately don’t work but cost lots of money and frustration. Chronic stress is a cofactor in heart disease, back pain, gastrointestinal disorders and many others. Some alcohol may be good for our heart but it is never good to drink and drive yet all too many do so. At the same time many people do not wear their seatbelts. Add up all these adverse behaviors and they have a very marked effect on the diseases that occur – chronic, complex diseases that last a life time and which are very expensive to treat.

Lack of Care Coordination

2009-04-22T13:18:00.000-07:00

The switch from acute to complex chronic diseases and the wide variation in care patterns are closely related. It is the complex chronic diseases that need the most attention and hence are most expensive to treat. But as a country we have long had the tradition of the independent, autonomous practioneer in the community taking care of us. This was fine for acute illnesses. The physician could either treat you him or herself or else would refer you to a particular specialist for needed care. Maybe to the surgeon to remove your appendix or gallbladder. Once the surgery was done, the problem was “cured.” Not so with chronic illnesses. Often the patients need multiple physicians, each with different skills and expertise such as the cancer patient would need a surgeon, a radiation oncologist and medical oncologist. But these three and the primary care physician are not likely to be well coordinated. They may have offices in different parts of town and possibly use different hospitals for some of their work. Communication is weak and the PCP often does not feel able to serve as the coordinator or quarterback. And, since these chronic illnesses often occur in older individuals, there is a good likelihood that other illnesses will develop concurrently. Maybe high blood pressure, heart failure or diabetes with complications. And so off to more specialists who do not communicate well and who do not understand the implications of the other illnesses, the other medications, etc. the result is often extra doctor visits, extra procedures, tests and X-rays and even extra hospitalizations than would have been necessary with well coordinated care. Unfortunately, this is the way medicine is practiced today and it is a real problem. It means that care is not as good as it should be or could be, not as safe as it should or could be, not as customer [patient] friendly as it should be or could be, and it means that it costs far too much.

Care Costs Vary By Geographic Region

2009-04-09T07:12:00.000-07:00

When thinking about health care reform it is important to realize that there are wide variations in care expenditures from geographic region to region. One might assume that those regions with higher expenditures reap better health but that is simply not the case. Unfortunately, much of medical care is not delivered based on evidence of efficacy but rather on long standing practice, tradition or training many years before. Indeed there is some pretty firm data that suggests that where there are more specialists, and where there is “more capacity” that it will get used more and drive up the total cost of care. Some very interesting studies coming from Dartmouth Medical Center have tracked this over the years. In a recent analysis of Medicare data from 2001-2005, the Dartmouth investigators looked at the last two years of life for Medicare recipients with complex chronic diseases such as heart failure, kidney failure and dementia. They picked those two years of life because they account for about one-third of all Medicare expenditures. What they found was a wide variation in costs or expenditures due to a wide variation in the use of services such as specialists, intensive care unit days, hospital days and so on. And this related directly to local medical care capacity. Where there was more capacity, there was more use and therefore higher expenditures. On average these Medicare patients each accounted for about $46,000 of expenditures by Medicare during those last two years of life. But in states with high capacity like New Jersey the average expenditures per patient were $59,000 and in an area like North Dakota where capacity is relatively low the average expenditure was $33,000. Certainly a wide difference and yet they could find no significant difference in the quality of care or patient outcomes. So they made a suggestion. If the use rate across the country was equivalent to the use rate in Minnesota, which is also where the Mayo Clinic is located, Medicare would have saved $18 billion per year for each of the years 2001-2005. They were not suggesting trying to bring it down to the North Dakota expenditure rate but they were suggesting that there was no reason why it could not be brought down towards the national average, an average which just about everyone would agree can produce a very effective medical result. The Dartmouth investigators pointed out that the “variations allow us to rule out two overly simplistic explanations for spending growth. First ‘technology’ is clearly an insufficient explanation: residents of all US regions have access to the same technology.” Second, these regional differences cannot be caused by “differences in the current payment system” since they all were on fee for service Medicare plans. “The causes must therefore lie in how physicians and other respond to the availability of technology in the context of the fee-for-service payment system.” They studied physicians in various regions and were able to show that physicians in all regions recommended specific evidence-based interventions for similar problems. But those in high consumption of resources areas were much more likely to recommended discretionary services, such as referral to a subspecialist for typical esophageal reflux. It was this use of discretionary services that resulted in the wide variation in per capita spending.

Complex, Chronic Illnesses That Last A Lifetime

2009-03-29T13:12:00.000-07:00

Our medical care system has developed around diagnosing and treating acute illnesses such as pneumonia, a gall bladder attack or appendicitis. The internist gave an antibiotic for the pneumonia and the patient got better. The surgeon cut out the gall bladder or the appendix and the patient was cured. But as the population ages, more and more individuals are developing what I will call complex, chronic diseases like heart failure, diabetes, chronic lung disease or cancer. These are diseases that remain with the individual for life and these diseases and patients need a different approach to care. These patients need long term care, not episodic care; they need a team-based approach where one physician serves as the orchestrater or quarterback and manages the myriad physician specialists and the other caregivers to allow for a unified, coordinated care management approach. And these diseases are very expensive to treat today; 70% of our medical care expenditures go to treat 10% of us, those with these chronic illnesses of health care costs in America. As I will describe in detail later, it will take a new approach to organizing the care of these patients to both improve care and reduce the costs. But the new approach actually exists in some locations – the need is to understand what works and then replicate it nationally.

America Has a Sick Care Not a Health Care System

2009-03-26T07:30:00.000-07:00

We Americans like to pride ourselves as having the best healthcare system the world but unfortunately that is not the case. We have a medical care system, not a healthcare system. We give lip service to prevention and spend only about 3% of our $2 trillion in medical expenditures on public health. By many measures we do not rate favorably compared to many of the other industrialized societies. As citizens we have behaviors that are driving more and more illness, illnesses that at chronic, complex, lifelong and life shortening. That $2 trillion is by far more than other nations spend per capita and it is seriously and adversely affecting businesses, government and each of us. Meanwhile, we may be pleased with our doctor but not the delivery system as a whole. Quality is subpar, preventable errors are rampant and some 47 million of us are without insurance access to medical care – the only such industrialized country. Health care reform is now a topic of great interest but politicians and media focus on the access issues predominantly, cost issues somewhat and the quality, safety and prevention/ public health needs only rarely.
Let’s take a closer look at what we have today. The current system of care focuses on “disease and pestilence.” It is a disease oriented system and certainly not a health management system nor a patient-oriented system. Mostly, this is due to a reimbursement methodology that under-rates the generalists and tilts toward those that do procedures. That is not what we need; what we need is a payment system that rewards the generalist for working in rural or socio-economically deprived areas, for taking the time to listen to the patient, for being attuned to prevention and wellness management. Today, that is just not where we are in America. So we need a change to a system that is focused on disease prevention, health promotion and with ready access to primary care and providers. Then, when necessary, access to specialists, hospitals, rehabilitation and all of the other requirements for good medical care when disease or injury does occur.

Embryonic Stem Cells and the Future of Transplantation

2009-03-10T10:45:00.000-07:00

Stem cell therapies promise to be one of those true scientific breakthroughs that will have an impact on health care in the future. Stem cells will bring us closer to the goal of personalized medicine, just as genomics is doing. With stem cells, projections need to be five, ten, even fifteen years out – because this is truly an emerging science. The course of a disease will change once we have the technology to insert stem cells into the human body to actually create a tissue. For example, a person with a heart attack will not go on to live the rest of his or her life with damaged heart muscle and resultant heart failure. Instead, stem cells will regenerate the heart and make it whole again. Similarly, a person with Parkinson’s disease will recover full faculties thanks to the ability of stem cells to regenerate the damaged area of the brain. The person with type I diabetes will be free of the disease because of the formation of new pancreatic islet cells. The athlete will play again because new cartilage will be created for the worn knee. This is the promise of “regenerative medicine.”
It is a promise that is already being kept with adult stem cells used for treating patients with immune defects, usually children, or those with some cancers. Sometimes doctors use the patients own stem cells to give the bone marrow a “boost” after intensive chemotherapy for cancer [called autologous transplants.] Or the stem cells of a closely matched donor are used for a leukemia patient to not only restore the bone marrow after aggressive therapy but also to attack any remaining leukemia cells [known as allogeneic transplants.]. And adult stem cells are being used today in research studies of patients who have had heart attacks leaving their heart muscle weakened.
The president has just created an important enablement to further research on stem cells. Yes, it is true that much can be done with adult stem cells but science so far suggests that embryonic stem cells hold promise for much more benefit. It will probably be embryonic stem cells that pave the way for replacing the islet cells of the pancreas with new insulin producing cells to cure diabetes or replace the damaged cells in the brain that are key to Parkinson’s disease. Some strongly feel that it is wrong to use cells form embryos. It is important to remember that these are fertilized eggs that were prepared for couples that could not conceive and so had eggs and sperm placed into a dish with special fluids. Experience has shown that success is better if the doctor implants a few embryos into the woman’s uterus rather than just one. But the doctor may have more than enough embryos and the extras will be discarded if the woman becomes pregnant. I look at it this way. Since the embryos will be destroyed anyway, why not use them for creating stem cells that perhaps many people with diverse diseases might benefit from. It is not dissimilar to transplanting the organs of a person who has died in a car accident rather than burying them in the grave. And there is no issue about “human cloning” – that is just not what is being done or proposed. And the embryo, made up of just a few cells, is disrupted so each cell grows independently. Now the cells can be stimulated to become heart cells, liver cells or what ever might be useful in treating a disease. It will take some years but there will certainly be major advances in how we can repair, restore or replace damaged tissues or organs.

Electronic Health Records

2009-03-05T07:14:00.000-08:00

President Obama as part of his health care reform agenda is aggressively pushing the electronic health record [EHR]. will be a major improvement to medical care and to patient safety over time. But there are two major problems that need to be overcome before the EHR will ever be fully functional – interoperability and physician documentation. By interoperability I mean that each of the companies that produce the software do so in a proprietary manner. The result is that they cannot interact. So if a patient is discharged from one hospital today and goes to another hospital’s ER tomorrow, the information from the first hospital will likely not be accessible. This must change and it appears that the federal government is attempting to have standards established for all to follow. That will be a big improvement. There are issues however as to who should set the standards – government or a multidisciplinary working group. Either way, standards are needed.
The second obstacle is that physicians find that most of the current systems actually impede productivity rather than enhance it. This is because the software creators have not spent the time necessary to understand how physician work and are intent on making the document easy to manipulate by the computer. Here is an example. Say a doctor admits a patient with pneumonia. He or she might want to insert the following into the chart: “55 year old nonsmoking male, sudden onset of high fever, shaking chills, productive cough and pain at left lower chest with inspiration. Temp 103, pulse 94, BP 128/74, abnormal breath sounds and dullness to percussion in left lower chest. Chest X-ray shows infiltrate in left lower lobe and sputum exam shows gram positive diplococcic. Diagnosis – pneumococcal pneumonia. Treatment – antibiotic.” Sorry for some “doctor speak” but in essence this is a fairly classical description of a pneumococcal pneumonia. It takes about 30 seconds to say, the same to dictate and perhaps 60 seconds to write or type these words. But to enter it into the chart as per the dictates of the software takes much longer because it requires following a long branching tree of choices. You might liken it to using Word for a document that can be read later versus Excel for a spreadsheet that can be manipulated. Physicians really dislike the extra time it takes and the fact that it is not consistent with the way they “think” about the patient and his or her problem. So they rebel and will not adopt. But this problem, like interoperability, can be overcome.
Once these two issues are resolved, the EHR can become a reality, but not before.

Medical Megatrends and the Future of Healthcare in America

2008-03-16T18:03:00.000-07:00

The current political debate reflects America’s concerns with the status of health care policy, but another aspect of medicine – the inexorable medical progress, which will happen no matter what – isn’t being discussed.

Several megatrends will profoundly affect health care in the coming five to 15 years. Some are due to the explosion of basic understandings of cellular and molecular biology. Others are related to advances in engineering and computer science. Together they will create huge shifts in medicine: Medical care will be custom-tailored for the individual patient; the medical model will move from “Diagnose and Treat” to Predict and Prevent”; repairing or replacing tissue and organs will be much improved; your medical information will be available no matter where you are; and medicine itself will become much safer.

Why will this happen? The science of genomics – a word few knew and fewer still understood at the turn of the century – has opened a new era in medicine. Understanding the DNA code of life will allow us to predict diseases that will occur in later years; to create drugs targeted at a specific molecular focus; to prescribe a drug that will definitively work for an individual with few if any side effects; and to assay whether a disease such as a cancer will recur after a course of therapy. Knowledge of stem cells will advance. Already stem cells are used in the treatment and occasional cure of some leukemias, and preliminary studies are focusing on stem cells administered after a heart attack in hopes of restoring cardiac muscles and small blood vessels. Genomics will allow your physician to select the most appropriate medication for you, not just the one that works for most people. And he or she [more and more she since 50 percent of medical school graduates are now women] will also be able to select a drug that is less likely to cause a side effect in your body – all from knowing your genomic information.

New vaccines, courtesy of advances in immunology, prevent infections such as herpes zoster – the shingles – in later years and cervical cancer in younger women. We can expect more new vaccines and many will be administered by patch, orally or by nasal spray rather than by shots. Eventually, vaccines will prevent cancers and help treat cancer – a prostate cancer treatment vaccine is under review by the FDA and awaiting added clinical trials. Look for vaccines to help treat many chronic diseases like multiple sclerosis and type 1 diabetes and to help prevent Alzheimer’s, atherosclerosis and possibly even drug addiction. A vaccine may be made up specifically for you – a designer vaccine – to treat your specific cancer.

Xenotransplantation – using an organ from an animal rather than a human – will become available so that a person needing a heart or kidney will get it immediately and not need to wait and “hope” for someone else to die.

Just as basic medical science is advancing, so, too, is engineering and computer science. Imaging has progressed dramatically such that today’s CT scanners can produce exquisite pictures of our anatomy. Coronary arteries can be visualized inside to detect obstructions -- once seen only with the more invasive angiography technique – helping emergency room doctors diagnose the cause of chest pain.

Digitally recorded images can be manipulated and visualized in three dimensions; organs can be rendered in different colors – heart, red; lungs, blue; stomach, white; etc, -- all to get a clearer view. Think of the advantages to the surgeon who will now know just what to expect before beginning an operation. Increasingly, molecular changes in the cells can be detected and reported as an image. For example, we will be able to differentiate whether a cancer has spread or whether it has regressed after chemotherapy.

Engineering and computer science advances have created a myriad of medical devices that are smaller and more powerful with long battery life. The vice president’s implanted heart defibrillator is an example. So, too, are similarly implanted devices that go not to the heart but to the vagus nerve which travels down the neck from the brain. A tiny electrical impulse sent upstream can help reduce epileptic attacks or improve serious depression. Pumps the size of a cigarette box on the belt can pump insulin at just the right rate for a diabetic and the newer ones coming – “closed loop” models – will be able to continuously monitor blood sugar and tell the pump how much to inject. No more finger sticks!

The operating room is now a technologic marvel and will become even more so. More surgeries will be done in less invasive manners, such as those performed in the radiology suite where tiny catheters inserted via a vein or artery in the groin advance to a site of disease and correct it without typical surgery. Just two examples are inserting a graft to correct an aortic aneurysm and inserting platinum coils into a brain aneurysm – both done in an hour or so without open surgery and a long hospital stay and recuperation. Just as an airline pilot practices in a simulator before ever sitting in the cockpit, so, too, will surgical trainees demonstrate their competency before ever operating. Master surgeons will use the simulator to practice a specific surgical approach for an individual patient based on the patient’s own CT scan inserted into the simulator for the practice run. Robots will assist the surgeon based on the information uploaded from the simulated practice; the robot never gets tired, does not feel sore from leaning over the operating room table and can be programmed for “no fly zones” – specific areas not to venture into even if accidentally directed by the surgeon who is always in control of the robot.

And, at last, the time will come in five to 15 years when all medical information, from your doctor’s office notes to images for the surgery, will all be digitized and available n your medical record. Wherever you are your medical information will be available instantly – either via the Internet or from a record on a chip on a card in your wallet or on a flash memory device, now worn by our soldiers as a dog tag.

We will see complementary medicine become part of the mainstream of care as it is taught more and more in medical school and is subjected to the same types of scientific analysis as other medical techniques.

Once hospital trustees begin to recognize that they should spend as much time focusing on safety as they do on finances then they will insist that hospital CEOs and staff in turn focus appropriate attention on improving safety and reducing preventable medical errors, now all too common with some 100,000 preventable deaths each year in American hospitals.

Policy changes by government officials to make medical care more available, more affordable, safer and better distributed are moving at a glacial pace. But medical care as outlined above is changing rapidly. And it will continue to do so because of the convergence of laboratory discoveries, engineering skills and computational power, entrepreneurial focus, and the ability to patent intellectual property. The megatrends above are inevitable – albeit the time frame for each will certainly vary. Unfortunately, we cannot be nearly so confident that health policy will keep up with our medical knowledge and abilities.

Stephen C Schimpff, MD
Author “The Future of Medicine – Megatrends in Healthcare That Will Improve Your Quality of Life”
Retired Chief Executive Officer, University of Maryland Medical Center