Tuesday, December 14, 2010

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

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.

Wednesday, December 8, 2010

Two Treatments For Macular Degeneration – At Wildly Divergent Costs

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.

Wednesday, December 1, 2010

Replacing the Aortic Valve Without Open Surgery!

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?

Sunday, November 14, 2010

Teamwork Improves Surgical Safety and Reduces Mortality

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.

Wednesday, November 10, 2010

Leadership In Medicine – New Expectations

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.

Tuesday, October 26, 2010

New Finding May Aid Alzheimer’s Treatment Options

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.

Tuesday, October 19, 2010

The Implications of Chronic Disease

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.

Friday, October 15, 2010

Encapsulated Pig Islet Cells For Diabetes Type 1 – A Trial

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.

Monday, September 27, 2010

More on Transplanted Pig Organs – Xenotransplantation

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

Wednesday, September 22, 2010

Transplanted Organs From A Pig

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.

Tuesday, September 14, 2010

Thought Controlled Artificial Limbs

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. 

Monday, September 13, 2010

Are Physicians Knights, Knaves or Pawns?

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.”

Sunday, August 22, 2010

What should We Eat?

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.

Saturday, July 10, 2010

Time to Rethink How We Pay for Medical Care and Healthcare

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.

Thursday, July 1, 2010

Today’s Health Insurance Has Perverse Incentives

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.

Thursday, June 24, 2010

A Disease Industry vs. A Healthcare System

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.

Thursday, June 10, 2010

The Future of Medicine - Megatrends in Healthcare

Turbulence Ahead in Health Care

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.

Friday, May 14, 2010

Cut Health Care Costs With Prevention

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

Tuesday, May 4, 2010

Further Disruptive Trends in Medicine

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.

Sunday, April 25, 2010

Disruptive Changes Are Coming to the Delivery of Medical Care

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?

Monday, April 19, 2010

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

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?

Tuesday, April 13, 2010

Teamwork Can Help Avert the Pending Cost Crisis in Health Care

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.

Sunday, February 28, 2010

King Tut and Genomics

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.

Wednesday, February 24, 2010

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

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.

Sunday, February 21, 2010

We Have Become An Obese Nation

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.

Wednesday, January 27, 2010

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

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.

Thursday, January 14, 2010

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

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.

Wednesday, January 6, 2010

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

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.

Monday, January 4, 2010

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

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.

Praise for Dr Schimpff

The craft of science writing requires skills that are arguably the most underestimated and misunderstood in the media world. Dumbing down all too often gets mistaken for clarity. Showmanship frequently masks a poor presentation of scientific issues. Factoids are paraded in lieu of ideas. Answers are marketed at the expense of searching questions. By contrast, Steve Schimpff provides a fine combination of enlightenment and reading satisfaction. As a medical scientist he brings his readers encyclopedic knowledge of his subject. As a teacher and as a medical ambassador to other disciplines he's learned how to explain medical breakthroughs without unnecessary jargon. As an advisor to policymakers he's acquired the knack of cutting directly to the practical effects, showing how advances in medical science affect the big lifestyle and economic questions that concern us all. But Schimpff's greatest strength as a writer is that he's a physician through and through, caring above all for the person. His engaging conversational style, insights and fascinating treasury of cutting-edge information leave both lay readers and medical professionals turning his pages. In his hands the impact of new medical technologies and discoveries becomes an engrossing story about what lies ahead for us in the 21st century: as healthy people, as patients of all ages, as children, as parents, as taxpayers, as both consumers and providers of health services. There can be few greater stories than the adventure of what awaits our minds, bodies, budgets, lifespans and societies as new technologies change our world. Schimpff tells it with passion, vision, sweep, intelligence and an urgency that none of us can ignore.

-- N.J. Slabbert, science writer, co-author of Innovation, The Key to Prosperity: Technology & America's Role in the 21st Century Global Economy (with Aris Melissaratos, director of technology enterprise at the John Hopkins University).