Posts
Drug companies can use genomics to create targeted drugs like imatinib (Gleevec) and trastuzumab (Herceptin.) Physicians can then use the results of genomic studies to guide prescribing. As discussed in prior posts, a person with Philadelphia chromosome-positive (i.e., having the BCR-ABL translocation with its aberrant tyrosine kinase) chronic myelocytic leukemia will likely respond to Gleevec. And a woman whose breast cancer shows high levels of the Her2neu receptor will likely respond to Herceptin. There would be no reason to treat a Philadelphia chromosome-negative CML patient with Gleevec nor a breast cancer patient without Her2neu receptors with Herceptin.
Recently the treatment of lung cancer has advanced considerably as a result of genomic analysis of the tumor and the development of targeted drugs. Lung cancer is divided into a number of different categories based on the microscopic appearance under the microscope. One type is called small cell and the others are usually “lumped” together as “non small cell” lung cancer because the former is treated much differently than the latter group. The non small cell lung cancers can be genomically evaluated to determine if there are certain common genetic mutations such as KRAS, EGRF, MEK and other mutations or the EML4-ALK translocation.
Patients with the EML4-ALK translocation respond reasonably well to the tyrosine kinase inhibitor crizotinib (somewhat similar to the one used for CML). As with the translocation seen in CML, this is a fusion gene that occurs during a translocation of two parts of two chromosomes that lead to a portion of the normal EML4 gene being fused next to the normal ALK tyrosine kinase gene. When this happens the new gene transcribes a variant tyrosine kinase protein which leads in part to the development or progression of lung cancer. Studies to date indicate it to occur mostly in the subtype called adenocarcinoma, in those with prior treatment, in younger patients and those who have no or a minimal smoking history. Although this represents just a small subset of all lung cancer patients, treatment of them in a Phase 1 trial with crizotinib resulted in a confirmed response in 57% (47 of 82) of patients with another 33% (27 of 82) having stabilized disease. [Kwak et al, New England Journal of Medicine, Oct 28, 2010] Although not a randomized trial, it is well known that most second line treatment regimens have no better than a 10% response rate so this would appear to be a breakthrough of sorts. Certainly it is not a panacea, nor a cure. But with minimal side effects these patients received some useful benefit and probably will have a lengthened survival Further studies will need to be done but if it is correct that about 5% of lung cancer patients have this fusion gene, then about 9000 patients per year would potentially benefit form crizotinib or similar ALK kinase inhibitors. Concurrently, one would not choose to use this drug in patients without this fusion gene and its abnormal protein. It also appeared that some patients had a further mutation such that crizotinib was not effective in them. [Note: Crizotinib is not yet approved by the FDA so access to the drug is via clinical trials.]
Patients who have the EGRF mutation appear to be distinct from those who do not as to response to the drugs erlotinib (Tarceva) and gefitinib (Iressa). EGRF is a tyrosine kinase that when mutated appears to play a role in lung cancer development and progression. Those who do have this mutated gene and its transcribed protein will respond to these two drugs in about 70% of cases with progression free survival of about a year and total survival of about two years. This would appear to be superior to standard drug therapy used today. Without this mutation, the patient will do much better treated with chemotherapy. So the treatment of a new patient with lung cancer today should include genomic analysis of the tumor so that the patient can receive the most appropriate first line treatment and then reanalysis later to determine if there are further mutations or translocation that would direct second line treatment options.
This is just one more example of how genomics is making medical care more custom-tailored, one of the five key medical megatrends.
Friday, June 3, 2011
Wednesday, April 20, 2011
Mitral Valve Repair Without Open Surgery – Exciting Development in Medical Devices
The mitral valve separates the heart’s left atrium from the left ventricle. When the ventricle contracts to send blood to the aorta and out to the body, the mitral valve closes to prevent blood rushing backward into the atrium and back to the lungs. The mitral valve can become stiff and tight, called stenosis or it can become unable to close tightly, called regurgitation. Once the regurgitation becomes sufficiently severe to cause heart failure, the death rate reaches about 5% per year. Most such individuals are referred for cardiac surgery to either try to repair the valve, replace the valve or do a procedure that in effect lessens the amount of regurgitation without actually replacing the valve. The latter procedure, although not curative, can be quite successful and alleviate the heart failure and the symptoms leading to a longer and better quality life.
A new procedure has now been reported in the New England Journal of Medicine, April 14, 2011 that does not use open surgery to repair the mitral valve leak. The process is to insert a catheter via the large femoral vein in the groin and pass it up to the heart. From the right atrium it crosses over to the left atrium and then is positioned at the opening of the mitral valve. This mechanical device, manufactured by Abbott Vascular, is able to grasp the two sides of the mitral valve and clip the two leaflets together. It does not create a tight seal but in most cases can markedly reduce the amount of regurgitant flow back into the atrium.
The study randomly allocated patients with grade 3+ or 4+ (i.e., serious) mitral valve dysfunction to either the customary open repair or replacement (the specific procedure at the surgeon’s discretion based on the valve status) or to have a percutaneous repair done with the new device. The study endpoints were freedom from death, freedom from surgery for mitral valve dysfunction and freedom from grade 3+ or 4+ regurgitation at the end of 12 months. The primary safety end point was freedom from major complications during the 30 days post procedure.
The study ws performed at 37 institutions in the United States and Canada. 279 patients were randomized with a 2:1 ratio of percutaneous vs. open procedures. 21 patients withdrew consent before the procedure was done, leaving 258 treated patients.
After the procedure, 41 of 178 (23%) patients who had the percutaneous procedure still had grade 3+ or 4+ regurgitation and were therefore referred for open surgery. Among those 80 patients who initially had open surgery, all had less that 3+ regurgitation after the procedure. By the 12 month end of study time, the composite of freedom from death, from surgery or from grade 3+ or 4+ valve dysfunction for all randomized patients were 55% vs. 73%. If one looks only at those who actually were treated per the protocol (i.e., did not exclude themselves, etc) then the rates were 72% vs. 88%. As to safety, the rates of major adverse events (most often the need for transfusion) as of 30 days were 15% vs. 48%. Quality of life improved in both groups of patients over the 12 months although there was a decrease at 30 days for the open surgery patients.
What these results suggest is that open surgery is more likely to greatly relieve the mitral regurgitation than will the percutaneous catheter procedure. However, the percutaneous procedure is safer, requires less time in the hospital, and is associated with improved quality of life and improved ventricular function from baseline. Many patients might therefore decide to choose the percutaneous catheter-based procedure on the grounds that it greatly relieves the problem in almost three quarters of the patients, is less invasive and is safer than surgery. Then if that individual patient was not among the success stories, he or she can choose to have the follow-up open surgery.
Further, although not mentioned in this article, there are patients who simply cannot tolerate open surgery for any number of reasons who might still be able to undergo the catheter-based procedure. This might then open up an option for repair not otherwise available today with open surgery. Not discussed in the article was cost. This might become a deciding factor as well once the procedure is on the market.
In an accompanying editorial, Otto and Verrier suggest that the decision on surgery (and which surgical procedure) or one of a number of catheter-based procedures (assuming logically that others will undoubtedly arrive soon) should rest on the advice of not one physician but the joint opinion of a multi-disciplinary team of, at least, a nonprocedural valve-disease specialist, and interventionalist cardiologist and a cardiac surgeon, each with substantial expertise in mitral valve disease. To this team I would add the patient’s primary care physician and principal cardiologist – both of whom will have known the patient and his or her overall health and family situation over the years. The other addition to the team is the patient --whose opinions should be incorporated from the beginning of the evaluation and advice process.
A new procedure has now been reported in the New England Journal of Medicine, April 14, 2011 that does not use open surgery to repair the mitral valve leak. The process is to insert a catheter via the large femoral vein in the groin and pass it up to the heart. From the right atrium it crosses over to the left atrium and then is positioned at the opening of the mitral valve. This mechanical device, manufactured by Abbott Vascular, is able to grasp the two sides of the mitral valve and clip the two leaflets together. It does not create a tight seal but in most cases can markedly reduce the amount of regurgitant flow back into the atrium.
The study randomly allocated patients with grade 3+ or 4+ (i.e., serious) mitral valve dysfunction to either the customary open repair or replacement (the specific procedure at the surgeon’s discretion based on the valve status) or to have a percutaneous repair done with the new device. The study endpoints were freedom from death, freedom from surgery for mitral valve dysfunction and freedom from grade 3+ or 4+ regurgitation at the end of 12 months. The primary safety end point was freedom from major complications during the 30 days post procedure.
The study ws performed at 37 institutions in the United States and Canada. 279 patients were randomized with a 2:1 ratio of percutaneous vs. open procedures. 21 patients withdrew consent before the procedure was done, leaving 258 treated patients.
After the procedure, 41 of 178 (23%) patients who had the percutaneous procedure still had grade 3+ or 4+ regurgitation and were therefore referred for open surgery. Among those 80 patients who initially had open surgery, all had less that 3+ regurgitation after the procedure. By the 12 month end of study time, the composite of freedom from death, from surgery or from grade 3+ or 4+ valve dysfunction for all randomized patients were 55% vs. 73%. If one looks only at those who actually were treated per the protocol (i.e., did not exclude themselves, etc) then the rates were 72% vs. 88%. As to safety, the rates of major adverse events (most often the need for transfusion) as of 30 days were 15% vs. 48%. Quality of life improved in both groups of patients over the 12 months although there was a decrease at 30 days for the open surgery patients.
What these results suggest is that open surgery is more likely to greatly relieve the mitral regurgitation than will the percutaneous catheter procedure. However, the percutaneous procedure is safer, requires less time in the hospital, and is associated with improved quality of life and improved ventricular function from baseline. Many patients might therefore decide to choose the percutaneous catheter-based procedure on the grounds that it greatly relieves the problem in almost three quarters of the patients, is less invasive and is safer than surgery. Then if that individual patient was not among the success stories, he or she can choose to have the follow-up open surgery.
Further, although not mentioned in this article, there are patients who simply cannot tolerate open surgery for any number of reasons who might still be able to undergo the catheter-based procedure. This might then open up an option for repair not otherwise available today with open surgery. Not discussed in the article was cost. This might become a deciding factor as well once the procedure is on the market.
In an accompanying editorial, Otto and Verrier suggest that the decision on surgery (and which surgical procedure) or one of a number of catheter-based procedures (assuming logically that others will undoubtedly arrive soon) should rest on the advice of not one physician but the joint opinion of a multi-disciplinary team of, at least, a nonprocedural valve-disease specialist, and interventionalist cardiologist and a cardiac surgeon, each with substantial expertise in mitral valve disease. To this team I would add the patient’s primary care physician and principal cardiologist – both of whom will have known the patient and his or her overall health and family situation over the years. The other addition to the team is the patient --whose opinions should be incorporated from the beginning of the evaluation and advice process.
Monday, April 18, 2011
Ultraprocessed Foods Lead to Chronic Illnesses
Much of today’s foods are “ultraprocessed,” lead to obesity and its ultimate diseases such as diabetes, coronary artery disease, hypertension, many cancers and worsening of diseases such as osteoarthritis.
Ultraprocessed foods originate from just a few grains, namely corn, wheat and soy but these then undergo extensive chemical and mechanical manipulation resulting in compounds that humans have never eaten before. Just look at the ingredients list on many store products and notice first how many ingredients are listed and second how few of them you recognize. Further they are concentrated as to sugars, salt and calories while deficient or totally lacking in the fiber, micronutrients and phytochemicals found in fresh or frozen grains, vegetables fruits and unadulterated meats and fish.
David Ludwig MD, PhD of Boston Children’s Hospital wrote a cogent article on ultraprocessed foods in the April 6, 2011 edition of the Journal of the American Medical Association and upon which the proceeding was based. He explains that there have been three major breakthroughs in food technology. The first came perhaps 2 million years ago with the development of stone tools and the use of fire for cooking. This allowed the human who did not have the running speed of large carnivores nor the digestive tract attributes of herbivores like cattle and sheep to expand his diet. The second big technology breakthrough was domestication of grains – agriculture. This led to civilization in the sense of larger more stable communities because domesticated grains such as wheat and corn greatly increased calories available and no longer required migration to hunt or gather. He makes the interesting observation that human stature dropped a few inches with this change because grains carry fewer micronutrients and protein per gram than do animal meats and nuts.
The industrial Revolution was the third breakthrough technology which led to refined flours and concentrated sugars along with grain-fed rather than grass fed cattle, sheep and hogs. Such animals are heavy with saturated fats although their protein content and ready availability has resulted in a return of greater stature in recent generations. More recently have come ultraprocessed foods.
These ultraprocessed foods are high in calories from sugars and fats – often hydrogenated and trans fats – yet low in micronutrients. They are found in supermarkets’ “middle aisles” as processed foods such as cereal with added sugar, cheese “spreads”, “macaroni and cheese,” soups high in salts and calories, “sticky buns,” and of course sugared sodas. And ultraprocessed foods are readily available in many fast food outlets where a muffin may have 400 calories with high contents of sugars and saturated fats. A bacon cheeseburger, large fries and large soda can contain well more than one half of a day’s caloric needs yet be deficient in nutrients.
Ludwig concludes with “the problem is the creation of a dietary pattern based on factory-made, durable, hyper-palatable, aggressively marketed, ready-to-eat or heat foodstuffs composed of inexpensive, highly processed ingredients and additives. Reducing the burden of obesity-related chronic disease requires a more appropriate use of technology that is guided by public health rather than short-term economic benefit.”
What can we do? We need to cut back on the ingestion of these ultraprocessed foods. But this will not be easy. For this to work I believe we need incentives. After all, that bacon cheese burger tastes good – sugar and fat are pleasing in our mouths. So we need more than just knowledge that we are eating well and thereby preventing future disease while improving our health. Knowledge is important because most people just do not realize the extent of the harm that comes from over consumption of ultraprocessed foods. With knowledge we can follow the advice of Pollan in his “In Defense of Food” to never buy a product that has more than five ingredients or has ingredients that we have never heard of or cannot pronounce. But knowledge alone is just not incentive enough to overcome the temptations.
Some thoughts: Government can help with how it subsidizes agriculture, incenting the growth of a broader array of crops and not marking the fattest meat as “prime.” And it can continue to insist that restaurants, especially fast food outlets, display calorie counts. Business can help with wellness programs that reduce the employee share of health insurance premiums in return for weight reduction or exercise programs. Insurance can offer incentives as well. Schools can offer only quality foods – good in itself but also a lesson in good dietary habits for our children in their formative years. And we each need to create our own incentives – as I typed this I also ate a chocolate chip cookie. I enjoyed it but have set myself a limit of one per day. My treat for finishing this blog post.
Ultraprocessed foods originate from just a few grains, namely corn, wheat and soy but these then undergo extensive chemical and mechanical manipulation resulting in compounds that humans have never eaten before. Just look at the ingredients list on many store products and notice first how many ingredients are listed and second how few of them you recognize. Further they are concentrated as to sugars, salt and calories while deficient or totally lacking in the fiber, micronutrients and phytochemicals found in fresh or frozen grains, vegetables fruits and unadulterated meats and fish.
David Ludwig MD, PhD of Boston Children’s Hospital wrote a cogent article on ultraprocessed foods in the April 6, 2011 edition of the Journal of the American Medical Association and upon which the proceeding was based. He explains that there have been three major breakthroughs in food technology. The first came perhaps 2 million years ago with the development of stone tools and the use of fire for cooking. This allowed the human who did not have the running speed of large carnivores nor the digestive tract attributes of herbivores like cattle and sheep to expand his diet. The second big technology breakthrough was domestication of grains – agriculture. This led to civilization in the sense of larger more stable communities because domesticated grains such as wheat and corn greatly increased calories available and no longer required migration to hunt or gather. He makes the interesting observation that human stature dropped a few inches with this change because grains carry fewer micronutrients and protein per gram than do animal meats and nuts.
The industrial Revolution was the third breakthrough technology which led to refined flours and concentrated sugars along with grain-fed rather than grass fed cattle, sheep and hogs. Such animals are heavy with saturated fats although their protein content and ready availability has resulted in a return of greater stature in recent generations. More recently have come ultraprocessed foods.
These ultraprocessed foods are high in calories from sugars and fats – often hydrogenated and trans fats – yet low in micronutrients. They are found in supermarkets’ “middle aisles” as processed foods such as cereal with added sugar, cheese “spreads”, “macaroni and cheese,” soups high in salts and calories, “sticky buns,” and of course sugared sodas. And ultraprocessed foods are readily available in many fast food outlets where a muffin may have 400 calories with high contents of sugars and saturated fats. A bacon cheeseburger, large fries and large soda can contain well more than one half of a day’s caloric needs yet be deficient in nutrients.
Ludwig concludes with “the problem is the creation of a dietary pattern based on factory-made, durable, hyper-palatable, aggressively marketed, ready-to-eat or heat foodstuffs composed of inexpensive, highly processed ingredients and additives. Reducing the burden of obesity-related chronic disease requires a more appropriate use of technology that is guided by public health rather than short-term economic benefit.”
What can we do? We need to cut back on the ingestion of these ultraprocessed foods. But this will not be easy. For this to work I believe we need incentives. After all, that bacon cheese burger tastes good – sugar and fat are pleasing in our mouths. So we need more than just knowledge that we are eating well and thereby preventing future disease while improving our health. Knowledge is important because most people just do not realize the extent of the harm that comes from over consumption of ultraprocessed foods. With knowledge we can follow the advice of Pollan in his “In Defense of Food” to never buy a product that has more than five ingredients or has ingredients that we have never heard of or cannot pronounce. But knowledge alone is just not incentive enough to overcome the temptations.
Some thoughts: Government can help with how it subsidizes agriculture, incenting the growth of a broader array of crops and not marking the fattest meat as “prime.” And it can continue to insist that restaurants, especially fast food outlets, display calorie counts. Business can help with wellness programs that reduce the employee share of health insurance premiums in return for weight reduction or exercise programs. Insurance can offer incentives as well. Schools can offer only quality foods – good in itself but also a lesson in good dietary habits for our children in their formative years. And we each need to create our own incentives – as I typed this I also ate a chocolate chip cookie. I enjoyed it but have set myself a limit of one per day. My treat for finishing this blog post.
Monday, April 11, 2011
Surprise – Adolescent Obesity Leads To Later Heart Disease and Diabetes
Well, probably not a surprise at all. The seeds of coronary artery disease (CAD) are laid down early and over long periods. But given our current pandemic of obesity beginning in childhood, should we worry about an epidemic of chronic disease like diabetes and CAD in the years to come? The clear answer is a resounding “Yes.”
There has been a long term study of military men in the Israeli Defense Force. An article in the New England Journal of Medicine, April 7, 2011 reports on what happened over an average follow-up of 17 years after army induction at age 17 for those who chose to remain in the military after the required three years. This amounted to 37,674 healthy men followed for about 650,000 person years. Among them, 1173 developed diabetes type 2 over time and 327 developed angiography-proven CAD. All by the age of 45.
Here is the baseline data:
Blood pressure, resting heart rate, fasting blood sugar, and low density lipoprotein (LDL – the “bad stuff”) and smoking incidence progressively increased with increasing BMI (BMI, a calculated ratio of weight and height) among the 17 year old inductees. High density lipoproteins (HDL – or the “good stuff”) declined as did the amount of weekly exercise with increasing BMI.
Here is the follow-up data:
Since this was a study of men beginning at age 17 and lasting an average of 17 years, it follows that the 327 cases of CAD and 1173 of diabetes were among relatively young men – aged 25-45 years old. When the investigators adjusted for age, family history of CAD, blood pressure, smoking status, LDL, HDL and triglycerides they found that an elevated BMI at age 17 was a significant independent risk factor for CAD. Indeed the risk increased by 12% for each increment of 1 unit of BMI. They also noted that CAD occurred even in those with BMIs that are generally considered within the acceptable range today.
BMI at age 17 also predicted for the later development of diabetes mellitus type 2 (DM) with risk increasing about 10% for each additional 1 unit of BMI. But with diabetes, it was the adult level (age 25 and beyond) that was associated with a greater increase in diabetes relative risk. Said differently, higher levels of BMI at age 17 correlate with higher risk of CAD and diabetes in early adulthood. Persistent elevations of BMI increase that risk. Elevation in early adulthood increases the risk of DM during early adulthood whether or not the person had a higher BMI at age 17.
My takeaway:
It is imperative to intervene now in the growing pandemic of childhood and adolescent obesity. Even modest increases BMI can predispose to later CAD and DM. Once developed, these are chronic illnesses that persist for life, are challenging to manage, are expensive to treat and have a high impact on both quality of life and longevity. Our children are our future; it is our obligation to protect them. And if that is not reason enough, then think of your wallet. The high costs of their care will have a very significant impact on each of us in our taxes and our insurance premiums.
There has been a long term study of military men in the Israeli Defense Force. An article in the New England Journal of Medicine, April 7, 2011 reports on what happened over an average follow-up of 17 years after army induction at age 17 for those who chose to remain in the military after the required three years. This amounted to 37,674 healthy men followed for about 650,000 person years. Among them, 1173 developed diabetes type 2 over time and 327 developed angiography-proven CAD. All by the age of 45.
Here is the baseline data:
Blood pressure, resting heart rate, fasting blood sugar, and low density lipoprotein (LDL – the “bad stuff”) and smoking incidence progressively increased with increasing BMI (BMI, a calculated ratio of weight and height) among the 17 year old inductees. High density lipoproteins (HDL – or the “good stuff”) declined as did the amount of weekly exercise with increasing BMI.
Here is the follow-up data:
Since this was a study of men beginning at age 17 and lasting an average of 17 years, it follows that the 327 cases of CAD and 1173 of diabetes were among relatively young men – aged 25-45 years old. When the investigators adjusted for age, family history of CAD, blood pressure, smoking status, LDL, HDL and triglycerides they found that an elevated BMI at age 17 was a significant independent risk factor for CAD. Indeed the risk increased by 12% for each increment of 1 unit of BMI. They also noted that CAD occurred even in those with BMIs that are generally considered within the acceptable range today.
BMI at age 17 also predicted for the later development of diabetes mellitus type 2 (DM) with risk increasing about 10% for each additional 1 unit of BMI. But with diabetes, it was the adult level (age 25 and beyond) that was associated with a greater increase in diabetes relative risk. Said differently, higher levels of BMI at age 17 correlate with higher risk of CAD and diabetes in early adulthood. Persistent elevations of BMI increase that risk. Elevation in early adulthood increases the risk of DM during early adulthood whether or not the person had a higher BMI at age 17.
My takeaway:
It is imperative to intervene now in the growing pandemic of childhood and adolescent obesity. Even modest increases BMI can predispose to later CAD and DM. Once developed, these are chronic illnesses that persist for life, are challenging to manage, are expensive to treat and have a high impact on both quality of life and longevity. Our children are our future; it is our obligation to protect them. And if that is not reason enough, then think of your wallet. The high costs of their care will have a very significant impact on each of us in our taxes and our insurance premiums.
Saturday, March 26, 2011
Bringing Down the Costs of Medical Care
It is currently popular for government officials to single out the insurance companies for the rising cost of healthcare. Not that the insurers are without fault but the real reasons for cost increases are rarely addressed and therefore not appreciated. We are a country with an aging population (“old parts wear out”) and of many adverse behaviors (e.g., overweight, sedentary lifestyle, stress and 20% still smoke.) Combined, these are driving a rapid increase in chronic diseases such as diabetes type 2, cardiovascular disease including heart attacks, heart failure and strokes, high blood pressure, and cancer.
These are illnesses that, once developed, are usually with the individual for life, have a major impact on quality of life and are inherently expensive to treat. The Milken Institute did a comprehensive study of chronic diseases. Among their findings: 109 million Americans have a chronic illness now [that’s about one third of us!] and many have more than one for a total of 162 million. The costs of care today are about $275 million and the total economic costs are well over a trillion dollars per year in lost productivity, etc. They estimate that we are on a track for a 42% increase in these chronic diseases by 2023 (as a result of aging and behaviors,) not that long from now. And if we do nothing to change the way we care for these patients, the costs of medical care will be $790 billion and the total economic costs will be over 4 trillion dollars.
There are two things to do to reverse this trend. These are illnesses that by and large are caused by our behaviors or are the result of aging. We can’t stop aging. So, the first step is to have an active program in behavior modification. Easier said than done, of course but here are some principles. We need to individually accept responsibility for our own health. But we need to understand what we are doing and how it impacts us over the long term. Government can help here with educational programs, rules about school lunches, requiring restaurants to post calorie and fat contents, labeling food packages with a more realistic total calorie assumption (today packages imply that the average person needs a 2000 calorie diet) and other steps. Incentives, primarily monetary ones, can have a big impact. Incentives need to be large enough to be useful yet focused enough to drive toward the desired end. Our employer can help with wellness programs to assist us to stop smoking, loose weight, improve our nutrition or deal with stress more effectively. The incentive here can be asking the employee who is successful to pay a lower portion of their health insurance premium. Insurers can create incentives directly for following a healthier lifestyle by lowering premiums for those who don’t smoke or are at a reasonable weight.
The second major step is to ensure that those who do have a chronic illness get very good care coordination. Unfortunately, this is just not the case for most patients today. They end up with multiple doctors, each doing their own thing, excess specialist consultations, too many medications, unnecessary tests and procedures and sometimes even unneeded hospitalizations. This drives up the cost of care dramatically. When one has a primary care physician that takes the time to fully coordinate all the elements of care, the use of specialists declines as do tests, procedures and hospitalizations and drug therapy is well managed.
Unfortunately, most primary care physicians have too many patients under their care to allow adequate time for prevention sessions or the time needed for care coordination. They need to care for fewer patients meaning they will need to receive a higher fee for each visit and this must include a reasonable payment for preventive activities and coordination efforts. Added to this they need to be paid to take the time to respond to emails and to use other technologies that can keep the patient out of the office unless really necessary. Some docs are doing just this by limiting their practice to about 500 patients (rather than the usual 1200-1400) and charging a flat fee for all care for a year. Others are refusing to accept insurance, both commercial and Medicare, and instead are billing the patient just as a lawyer or accountant or other professional would. The billing includes time spend in prevention and coordination. These may well be the future of primary care reimbursement and a means to assist the patient to first prevent chronic illnesses from occurring and second to assist in good coordination of the care when one does develop.
But all of this raises critical questions. What should and what will government do to help us modify our behaviors? Will insurers be allowed and will they accept the responsibility of a two tiered premium pricing system? Will employers accept the added chore of developing wellness programs? Will physicians, even if they are offered adequate payments, actually spend the time needed for good prevention and good care coordination? And, most importantly, will we as citizens accept our responsibility to lead a reasonably healthy lifestyle?
Friday, March 18, 2011
Getting Nurse Staffing Right Is Critical – Patient Mortality Depends On It.
When I was the CEO of a large academic hospital we were constantly concerned to properly balance nurse staffing. More staff than needed meant wasted money and too little staffing risked lesser quality care and nurse disharmony and even resignations. But adjusting the staffing levels of multiple units, each with differing patient types and needs was a major effort and easily thwarted by rapidly varying census numbers, patient admissions and transfers to other units, nurse shortages, and many other factors. In retrospect it is remarkable that it worked as well as it did. But the risk management group was ever concerned that if the staff levels were too thin it was possible that adverse events could occur.
Now there is a new study reported in this week’s New England Journal of Medicine that links deficiencies in nurse staffing with increases in patient mortality. The investigators evaluated an unnamed academic hospital with a strong record of high quality and lower than expected patient mortality. They looked shift by shift and noted whether that shift was at targeted levels based on patient acuity, over or under. They also looked at the level of patient turnover during each shift. Quoting from the article, “In an institution with a history of success in meeting staffing levels and with a level of patient mortality that was substantially below that predicted by its case mix, we found that the risk of death increased with increasing exposure to shifts in which RN hours were 8 hours or more below target staffing levels or there was high turnover. We estimate that the risk of death increased by 2% for each below target shift and 4% for each high turnover shift to which the patient was exposed.” [Italics mine]
The take away message to me is that hospital executives and boards need to be sure that they are managing nurse shift decisions carefully. In any hospital, personnel constitute about 60% or more of expenses and nurses represent about one half of that so the dollars are not inconsequential and need to be managed appropriately. Clearly, “appropriately” also means assuring that each unit has the necessary complement of registered nurses on each shift. From the article, “Our findings suggest that nurse staffing models that facilitate shift to shift decisions on the basis of an alignment of staffing with patients needs and the census are an important component of the delivery of care.” It also means that hospitals need to look at their approach to transferring patients from unit to unit. Often times this is necessary such as movement of an unstable patient to an ICU. But this study makes the point that excess transfers can be detrimental to patient welfare and may require more than the usual staff numbers. “Our results suggest that both target and actual staffing should be adjusted to account for the effect of turnover on patient outcomes.”
How a hospital aligns its nurse staffing is an important element of quality in addition to cost management. Getting staffing right is critical. When it is correct, mortality will be lower. Further, although not measured, if mortality came down in this study, it is fairly safe to assume that other quality measures were improved as well.
Now there is a new study reported in this week’s New England Journal of Medicine that links deficiencies in nurse staffing with increases in patient mortality. The investigators evaluated an unnamed academic hospital with a strong record of high quality and lower than expected patient mortality. They looked shift by shift and noted whether that shift was at targeted levels based on patient acuity, over or under. They also looked at the level of patient turnover during each shift. Quoting from the article, “In an institution with a history of success in meeting staffing levels and with a level of patient mortality that was substantially below that predicted by its case mix, we found that the risk of death increased with increasing exposure to shifts in which RN hours were 8 hours or more below target staffing levels or there was high turnover. We estimate that the risk of death increased by 2% for each below target shift and 4% for each high turnover shift to which the patient was exposed.” [Italics mine]
The take away message to me is that hospital executives and boards need to be sure that they are managing nurse shift decisions carefully. In any hospital, personnel constitute about 60% or more of expenses and nurses represent about one half of that so the dollars are not inconsequential and need to be managed appropriately. Clearly, “appropriately” also means assuring that each unit has the necessary complement of registered nurses on each shift. From the article, “Our findings suggest that nurse staffing models that facilitate shift to shift decisions on the basis of an alignment of staffing with patients needs and the census are an important component of the delivery of care.” It also means that hospitals need to look at their approach to transferring patients from unit to unit. Often times this is necessary such as movement of an unstable patient to an ICU. But this study makes the point that excess transfers can be detrimental to patient welfare and may require more than the usual staff numbers. “Our results suggest that both target and actual staffing should be adjusted to account for the effect of turnover on patient outcomes.”
How a hospital aligns its nurse staffing is an important element of quality in addition to cost management. Getting staffing right is critical. When it is correct, mortality will be lower. Further, although not measured, if mortality came down in this study, it is fairly safe to assume that other quality measures were improved as well.
Monday, March 14, 2011
Surviving Cancer As A Teenager – It’s Not Just The Treatments
When Clarissa was 13 she entered Johns Hopkins Hospital to be treated for relapsed acute leukemia knowing full well that she had only a 40% chance of survival. Today she is 16 and in excellent health. But it took 2 ½ years of incredibly rigorous treatments to get there. Equally importantly it meant riding an emotional roller coaster for her and her parents.
Clarissa had been treated for leukemia when she was 2 and had been fine for a decade when the relapse occurred. She found there was not much available to read about coping with the emotional issues that come with a cancer diagnosis during the teenage years nor was there a support group of teens who had faced the same challenges. Consider that a teen wants to be more and more independent but that is just impossible when you now need your parents even more than ever and must depend on doctors and nurses for life itself. Teens are focused on their appearance but what if you have no hair and an intravenous catheter sticking out from your skin – pretty hard to hide. Friends want to be friends but don’t know whether to visit or not and when they do they find you wearing a mask to protect against infection and must shun the instinct to hug. These and other issues surfaced over her two and one half years of treatment, years in which she spent much of the time in the hospital and lost well over a year of school, again much of that to avoid contact with infection while her immune system was at its lowest. With the help of at home tutoring, she kept up with her assignments and now is back in school with her classmates, getting good grades and enjoying the life of a high school student while thinking about college and the future.
Clarissa persevered and now wants to help other teens who develop cancer to cope with what lies ahead. She has started a blog, gives frequent talks and plans to write a book on coping later this year.
A friend of mine, a twenty five year survivor of adult leukemia, told me after reading her first blog entry: “Wow! I am sitting at my desk with tears in my eyes - she is so beautiful - inside and out. So brave - so inspiring. I am coming up on 25 years and have no courage compared to this young woman.”
If you know a teen ager with cancer, I encourage you to direct them to Clarissa’s blog at http://www.teen-cancer.com/
Clarissa had been treated for leukemia when she was 2 and had been fine for a decade when the relapse occurred. She found there was not much available to read about coping with the emotional issues that come with a cancer diagnosis during the teenage years nor was there a support group of teens who had faced the same challenges. Consider that a teen wants to be more and more independent but that is just impossible when you now need your parents even more than ever and must depend on doctors and nurses for life itself. Teens are focused on their appearance but what if you have no hair and an intravenous catheter sticking out from your skin – pretty hard to hide. Friends want to be friends but don’t know whether to visit or not and when they do they find you wearing a mask to protect against infection and must shun the instinct to hug. These and other issues surfaced over her two and one half years of treatment, years in which she spent much of the time in the hospital and lost well over a year of school, again much of that to avoid contact with infection while her immune system was at its lowest. With the help of at home tutoring, she kept up with her assignments and now is back in school with her classmates, getting good grades and enjoying the life of a high school student while thinking about college and the future.
Clarissa persevered and now wants to help other teens who develop cancer to cope with what lies ahead. She has started a blog, gives frequent talks and plans to write a book on coping later this year.
A friend of mine, a twenty five year survivor of adult leukemia, told me after reading her first blog entry: “Wow! I am sitting at my desk with tears in my eyes - she is so beautiful - inside and out. So brave - so inspiring. I am coming up on 25 years and have no courage compared to this young woman.”
If you know a teen ager with cancer, I encourage you to direct them to Clarissa’s blog at http://www.teen-cancer.com/
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