Patient Centered Outcomes Research--a good start

The affordable care act, in its 2000 plus pages, provided for many projects with the potential to improve health care delivery in the US. The most actively debated part of the bill, the mandate to insure just about everyone, may not turn out to be the most important piece. The problems the affordable care act attempted to address are the fact that American health care spending is too high and buys too little, including poor outcomes for those who do get health care and the fact that too few people who need health care actually receive it. All of these issues are addressed in some way or another in the myriad provisions of the bill.

One rarely advertised provision of the bill is the Patient Centered Outcomes Research Institute (PCORI).  This is a private institute, publicly funded, which includes a huge diversity of players, from patients to providers and sundry others, who are charged with figuring out exactly what Patient Centered Outcomes Research is, and then making it happen and disseminating the results. According to a recent article in the New England Journal of Medicine, they have been holding meetings, many of them public, just to figure out what it is that they feel they should do and how they will most effectively do that thing. At this point the groundwork is mostly done.

The PCORI has decided that its prime directive is to help patients answer these 4 questions:

1. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?”
2. “What are my options and what are the benefits and harms of those options?”
3. “What can I do to improve the outcomes that are most important to me?”
4. “How can the health care system improve my chances of achieving the outcomes I prefer?

Given the present scurrying behavior of most physicians to try to  develop systems to help them practice evidence based medicine which will theoretically pay them more for reaching certain benchmarks in treating various common diseases, these patient centered questions are very relevant and an absolute necessity. As we as physicians begin to see our paychecks depend upon whether our diabetic patients are getting statin medications to prevent heart attacks and maintaining certain blood glucose levels, we vitally need to be reminded that our job is truly to improve patients' lives. That means adjusting what we do to respond to those patients' educated preferences. Results of patient centered outcomes research may help us do that.

I have some misgivings about the PCORI. It is very large. I can't quite figure out how large, but large enough that it sounds as if decision making is slow going. That will not slow the research that they fund, since that can be done by small groups with good ideas. Still, implementing change based on new research may be slow. I also wonder how information that helps doctors and patients make individualized decisions about care will interact with the freight train of "pay for performance" based on scientific evidence which usually demands strict adherence to a protocol. 

I presently choose to have faith that the process of patient centered outcomes research will eventually meet up with pay for performance and we will actually be paid for the performance of individualized care for patients who are undeniably individuals with individual needs and preferences. It is just possible that the truth shall set us free.

Physician non-compete clauses--another way to gut rural health care

Lately I have been dealing with the painful process of separating from my medical group. I have been part of this group since its inception, about 12 years ago. It serves two small towns in adjacent states and has about 30 employees and 12 providers, mostly located in the larger of our two clinics, in which I do not work.  We originally came together from 3 primary care practices in order to share resources and reduce overhead. Cultures and values were somewhat different, but we did all care about delivering good quality medicine, letting our physicians have autonomy in decision making, and about making sure that each one of us could have lives that were humane, valuing family time or outside interests and covering each others' patient's needs so that care would not suffer.

When we came together we wrote a contract which was longer and more formal than any I had signed before and had various elements that made me somewhat uncomfortable. One was the "buy-in". This was an amount of money that we all agreed to put in to essentially buy the practice. I balked at the size of this, since my location of practice was very inexpensive, and the physicians in the larger office were "buying in" to a large and brand new medical office building. My concerns were respected, and my buy-in was smaller, as was that of my two partners.  The other issue was a non-compete clause, which I was told was standard and non-negotiable. This clause in the contract stated that if my employment with the corporation ended, I would not practice medicine within 20 miles for 2 years.

Physician non-compete clauses are strongly disfavored by the American Medical Association and considered unethical. They restrict choice of practice and they penalize patients when a physician is at odds with his or her employer.  They are hard to enforce and void in some states, most prominently California. They have been viewed as restrictions on trade, though various interpretations of this have arisen from court cases. They remain a common component of physician contracts. They are particularly hard to enforce if it can be shown that the physician is needed in his or her community and that enforcement of the clause will harm patients.

In the case of me and my clinic partner, who are obliged to sever our connection to our parent organization because our clinic is no longer viable after loss of half of our provider staff, there are a multitude of reasons why a non-compete clause is going to be unenforceable. The most important of these involves the patients in the community. Our town of just over 20,000 people now will have 2 rather than 4 internal medicine physicians, which is inadequate for our aging population. In another practice in town which has an even more restrictive non-compete clause, physicians are unable to make changes that might be in everyone's best interest, since if they leave the practice they must also leave the community and most of them are strongly tied to it, with children in school and spouses with jobs.

If a non-compete clause is unenforceable, unethical and disfavored by our national organization, why do we even worry about it? It is very common for an organization to threaten to enforce a non-compete clause, and to have this happen would be painful or disastrous. Court cases such as these cost 10s of thousands of dollars to complete and result in frequent and unpredictable time commitments that make it difficult or impossible to concentrate on a medical practice.

I have chosen to do a 2 year sabbatical at the end of my association with my present group for many reasons, and mostly because I really want to and think that the experience and knowledge I will pick up will be positively transforming in ways that I can't predict. But I would like to be able to fill in here or there in my community if I am needed during those two years. I can do the exile thing, but it is hardly good for my patients or colleagues, including those at the corporation I am leaving. Nevertheless, sabers are rattling and threats being spoken. My colleague is experiencing the same constraints. It affects both the community and our families, who will be mightily disrupted by our departure or frequent absences.

I have learned an important lesson, which I will not have trouble remembering. I will NEVER sign another contract which contains a non-compete clause.

http://www.wahcnews.com/newsletters/wa-jshore1210.pdf  provides a lawyerly review of some of the issues.

http://www.gklaw.com/news.cfm?action=pub_detail&publication_id=842 presents a bit more on the AMAs position.

http://www.doctoremploymentlawyer.com/2011/08/physician-non-competes-being-e.html recognizes the power of the threat of enforcement.

Who wants me?

Today was filled with the usual stuff, which is actually never the same from day to day. My first patient of the day dropped in because she was having a stroke. She was actually my partner's patient, but I knew her pretty well from a previous visit and was happy to be able to help her out. I was also wickedly late for my first scheduled patient who just needed a preventive physical exam. Both were good interactions, understanding people with commendable patience (especially the one who waited an hour) and despite being clearly way behind for the rest of the day, it was what I love to do.

I have been more late, of late, because all of my routine appointments involve an explanation of what I'm doing when I quit my job next month, a recommendation for what to do for any health care needs, including a pretty exhaustive review of all of the doctors in the community who might be appropriate matches and some kind of heartfelt recognition of the length and depth of our doctor-patient relationship. This takes awhile, but is necessary and valuable. I have taken care of some of my patients for 17 years, and that means lots of stories told and heard, trust won and compromises hammered out. These are mini-divorces. They are not acrimonious, but they are intense. And then, of course, there is also the problem that the patient is having at the moment to be heard and maybe solved. My agenda at these appointments also involves looking at the whole set of problems and trying to make sure that we both have a clear view of the best strategies for getting them solved and that any loose ends are tied up.

The number of patient for whom a physician is responsible is difficult to glean from our medical records, due to the fact that many patients see a doctor only rarely, or see different doctors based on availability. But based on my official patient panel size when I worked for Group Health, and based on information from an internal medicine preceptor of mine many years ago, a full time physician might have 1800-3000 patients who regard them as "my doctor." The doctor patient relationship is important to most of these patients, even if they are seen infrequently, I am finding out.  Some of the people who are most unhappy to see me go are people I see at most once a year. They don't come in with every ailment, but the fact that I exist and know them is really important to their feeling safe. At least that's what it sounds like.

But I'm not just doing this important doctor patient stuff, I'm also trying to find a job.

A primary care internist who is well educated, board certified, speaks English and hasn't done anything reprehensible is in demand in the US. I will find a job. The easiest of jobs to find will be in places that are very hard to get to, in rural areas where there are desperate doctor shortages.

When I first decided to contact a locum tenens recruiter, I went to the organization which had an excellent reputation with a locum tenens surgeon who I respected. I called them and was immediately put in contact with a man who told me a little bit about the whole process. He told me which states really needed physicians, what different jobs paid, that sort of thing, and tactfully tried to ascertain what awful skeleton in my closet was leading me to look for work. I told him my story of planned adventure, and he told me that anything was possible. He failed to outright relieve me of my misapprehensions about how I could get a really short term job anywhere I wanted whenever I wanted and be home with my family lots. He did that acquiescent groveling thing that representatives of drug companies do when they try to get me to use medications of dubious utility and ridiculously high cost. I tried to be reassuring so he would treat me like a regular person and give me straight advice, but it took over a month for me to realize that unless I wanted to go somewhere and work really hard for 3 or more months straight and then consider moving there, I was going to be looking at 12 hour hospital shifts or really remote locations with really not enough doctors to handle the patient volumes.

Just two days ago I finally decided I needed to contact a larger company with more job opportunities. I was immediately put in contact with two people who seemed more than capable of making me understand how the process works. There were several jobs that sounded possible, if not perfect. And today, through the first guy, I got a call from a very jolly, clearly English as a second language family practitioner from a microscopic town in Wisconsin not far from the Canadian border, and frankly it sounds pretty sweet. We shall see what comes of all of this.

Walk, sing, practice medicine

I have worked as a primary care internal medicine doctor in a small university town for the last 17 years and have loved it more each year. I like my office, I feel at home and appreciated at the hospital across the street where I care for patients I know and for some who I eventually get to know through doctoring them. I can do intensive care medicine, take care of patients with delicate social situations and pick up the medical pieces with patients who have surgeries or injuries. It is never dull and it only rarely makes me feel sad or frustrated. I know the nurses well, count on them and am almost never disappointed. My relationships with my fellow physicians are warm and I respect them.

On October 31 of this year I am quitting my job. I am not old, so I am not retiring. It's just time to do something else. Various things happened which were the universe's way of telling me that I needed to do something different. My nurse practitioner partner with whom I shared an office, a world view and plans for future brilliant schemes, died suddenly in April, and one of 3 remaining partners in my clinic decided to take a job elsewhere as a kind of partial retirement. It is not possible to effectively hire another internal medicine doctor for a clinic such as ours in a small town such as ours with any degree of certainty, and my remaining partner and I were becoming swamped. It is possible to keep up with the level of work we were doing for a few months, but not for the rest of my work life.

My plan is to get as many experiences as possible practicing medicine as many places and settings as I can for the next two years. I want to see how other people do what I do, how other systems work, how they don't work, what they smell like, feel like, taste like. I would also like to take long walks in places I've never been, and since I'm asking for what I want, sing. I love singing with people and it is a hobby that is not hard to indulge. I especially like singing with small groups in harmony. But more about that later, perhaps. I bet I'll be able to squeeze some good music into the next year or two. I will also take lots of delicious continuing medical education courses and learn from academics how to do things that I don't know how to do.

I'm calling it a sabbatical. The term "walkabout" would also be accurate. That term, as I understand it, refers to native Australian's need to leave what they are doing and do something else, somewhere else, for a time. It's a fascinating concept, but it is not entirely clear how it's going to work. I have started to look into my options by signing up with a locums company, a group that will find me jobs in places where they desperately need a doctor to fill in for a time. Ideally, these positions would be for just long enough for me to experience a new place and get familiar with their routines, meet new people, explore my new communities. I'm finding out, though, that jobs want me for as long as possible, as full time as possible, and preferably they would like me to eventually move there and take the job full time.

I would also like to go back to Haiti, to La Gonave, and work with the communities that I have started to get to know on public health issues such as birth control, safe sex, contraception and building healthcare teams. This is expensive for me, but will be less expensive when I am not having to pay a staff and an office to run in my absence.

I also plan to work in a rather remote clinic in Alaska where a friend of mine has worked for years, intermittently, but probably not starting in the dead of winter. I will work this out myself, with the help of the hospital administrator there.

Locum tenens companies, like the one I signed up with, take care of the details of credentialing, malpractice insurance, arranging licenses, travel, housing and any money negotiations that have to happen. They also charge a lot of money for doing this, which is absorbed by the poor desperate hospital or clinic that uses their services to fill a slot. This means that, by participating in this process I will be directly contributing to high health care costs. I do like the idea of having everything arranged, but in the best of all possible worlds, I will find at least some of my own jobs and negotiate the details myself.

Other than the fact that I am leaving my patients and community in a lurch, this is a great plan. I get the idea, though, that it won't go particularly smoothly. It seems entirely possible that I won't get exactly what I want, and sometimes not vaguely what I want. I am expecting that by the process of trying various things, failing and succeeding, I will learn lots of amazing stuff, including how to do this thing that I'm going to be doing. If I do figure that out, maybe it will make this kind of thing easier for other physicians to do. The reason that it is a great idea is that medical practices are kind of like little Galapagos islands, developing procedures, tricks, solutions that they never share with other groups. Deliberately learning new stuff and sharing it just has to be something that holds hope for improving medical care and efficiency.

I will be using this blog to document my adventures, should I have them, and the perils and pitfalls of getting this stuff all arranged. I will also continue to write about the wonderful tidbits of American medical care in its glory and absurdity as I have been doing.

Is Lipitor good for you?--putting statins on the hot seat

In 1971, as medical science was wrestling with the observation that elevation of cholesterol levels was associated with heart attacks, a Japanese chemist named Akira Endo discovered a substance that inhibited the enzyme HMG CoA reductase and thus lowered cholesterol levels. His original chemical was never introduced due to significant muscle toxicity and the fact that it caused tumors, but not long after, a less toxic version was introduced under the brand name Mevacor (Lovastatin.) This drug was significantly more powerful in lowering cholesterol levels than the unpleasant and relatively ineffective drugs that came before. These are still used today, but are difficult to take, including ones that taste like sand and absorb cholesterol from the gut as well as high dose niacin which causes itching, flushing, worsens diabetes and exacerbates gout.  Lovastatin could be dosed once daily, was an innocuous capsule, and lowered cholesterol strikingly.

Since that time, many more HMG CoA reductase inhibitors (statins) have been released, and they all work pretty well. That is, they all work pretty well to lower cholesterol. It is true that high cholesterol is strongly associated with vascular disease, especially heart attacks and strokes, and that use of these drugs does reduce the risk of these things. Unfortunately, it is not entirely clear that these drugs make most people healthier or make them live longer.

Many good controlled trials have shown that statins, pretty much all of the statins, and there are quite a few, reduce the risk of vascular disease AND DEATH in people who have had heart attacks or vascular procedures to prevent heart attacks. But if statins were only used in those already affected, sales would not have topped $12 billion for lipitor (atorvastatin.) A recent meta-analysis evaluating all good studies of all statins did show that normal people with elevated cholesterol who were treated with statins did not live longer than those who were not treated.

There have been many many studies that have addressed the effectiveness of statins, partly due to the fact that there is so much money going into paying for these drugs, some of which can be routed back into science. The studies address risk of all kinds of diseases, vascular and otherwise, in all kinds of people, especially sicker subpopulations. It appears, for instance, that the very old who have had heart attacks do live longer if given statins. Diabetics, at least some diabetics, have less heart attacks and strokes, and live longer when given statins regardless of their cholesterol numbers.

Statins are very powerful drugs. They work to keep the liver from making cholesterol, but they also have some pretty diverse other effects, including stabilizing blood vessels and reducing inflammation that can cause heart attacks.  They also are somewhat toxic to mitochondria, the tiny cells within cells that are responsible for   the health of a myriad of different tissues in our bodies.  Because they sometimes injure mitochondria, they can cause muscle pain, and in some cases dangerous breakdown of muscle tissue.  The muscle pain is associated with damage that can be seen on muscle biopsy, which is usually, but not always, reversible when the drug is stopped. Other tissues that can be affected include liver, kidneys, gut and brain, and a small percentage of patients who take these drugs have symptoms that arise from these effects.  Muscle pain, however, is not rare, and in my practice requires stopping the statin drug in about 1/4 of patients who would like to be able to take these medications. Symptoms associated with statins can be really subtle and many patients who experience them assume that they are just getting old. Physicians are not very sensitive to the possibility of side effects with these drugs, partly because they are such an easy way to get cholesterol down.

If an evil alien race wanted to take over the world, statin drugs might be just the ticket. They would make those who are already damaged by heart disease live longer, and cause some portion of the rest of those taking them to become weak, flatulent and stupid. A drug that was indicated for a condition such as high cholesterol, that affects nearly 1/4 of people in developed countries and offers to reduce their risk of heart attacks and strokes would be so very tempting that most of us would take it. Clever aliens.

There is near consensus among academic physicians that statins are good for us, and that complaints about side effects are overblown and irrelevant. I am having trouble trying to find support for this in the literature, and real trouble ignoring the side effects that I see in my office. It is hard to ignore the power to sway us that may be wielded by a drug company that makes 9 billion dollars in a year on one of these drugs, as Pfizer does on Lipitor.

A couple of other matters deserve note. There are quite a few statins, from the less potent pravastatin, lovastatin and fluvastatin, up through the most powerful, simvastatin, atorvastatin, rosuvastatin and pitavastatin. Several are generic, and of these, the most popular is simvastatin due to its low cost and high potency. All of the statins can cause adverse reactions, but some are worse than others. Simvastatin is probably the most likely of all of them to cause muscle pain and to interact with other drugs in ways that increase those side effects. Drugs that interact with some or all statins include various antibiotics, warfarin, antifungal and AIDS drugs and as little as a cup of grapefruit juice. Higher doses lower the cholesterol more and increase adverse effects more, and only occasionally are shown to be more effective at reducing vascular disease. The most dramatic adverse effect of statins is a severe breakdown of muscles, called rhabdomyolysis, and that is more common in the elderly, those with underlying organ dysfunction and those who take medications to lower the triglyceride levels (fibrates.)

A recent article came out in the European Heart Journal, looking at long term followup of treatment with atorvastatin in a study of various medications for high blood pressure with or without cholesterol lowering drugs. The results were nearly impossible to understand, showing that people who were initially placed on atorvastatin who had high blood pressure did live longer, but primarily due to the fact that they were less likely to get pneumonia. Huh? In addition to that, after the two or so years that the study continued ( it was stopped early because the patients on atorvastatin had so many fewer heart attacks and strokes) nearly all of the patients in either treatment or control group were put on statins, so they were pretty much identical in all ways except for the first two years. As I read this, it would suggest that taking lipitor for 2 years, 11 years ago reduces your risk for pneumonia in subsequent years, which just doesn't make a reasonable amount of sense.

Bottom line: Lipitor is probably good for you if you have had angina or a heart attack and don't want it to happen again. It can cause a myriad of side effects, some of which can be pretty subtle but can significantly impact a person's life. If your cholesterol is just high, but your heart and vessels are fine, Lipitor (or other statins) might be very good for you, and might be bad for you, and it is kind of hard to know from the studies whether to take it. It is unlikely that Lipitor was invented by evil aliens, but if it was, they are really raking in the bucks.

Preventing Alzheimer's disease and sudden death--can it be this easy?...and other stories of disease prevention

Reading through the Internal Medicine News today was surprisingly uplifting. This is a large format free journal that highlights studies presented in journals or in meetings around the world.  This time the most interesting articles were about prevention of disease.

Deborah Barnes and her associates calculated, using recent reviews on the subject, that improvement in various health and lifestyle conditions could potentially avert millions of cases of Alzheimer's disease.  These conditions, in order of importance, are physical inactivity, depression, smoking, hypertension, obesity, low educational attainment and diabetes. She calculates that half of the more than 36 million cases worldwide are at least partially due to these risk factors. This information is especially nice since all of these conditions are independently important and strongly impact a person's health and happiness in other ways.

Sudden death is usually due to a heart attack, though pulmonary embolus, ruptured aneurysms and major strokes are also culprits. It turns out that women who maintain a healthy weight, don't smoke, exercise regularly and eat a healthy diet have a 92% lower risk of sudden cardiac death than those who do none of these things. That's big! and if one combines this with the news about Alzheimer's disease, it sounds like good health habits might be a really good idea!

In addition to not dying of a heart attack and not getting Alzheimer's disease, it would be really nice not to get HIV. HIV and AIDS are now treatable as a chronic disease, and some of the misery suffered by those who are infected with it can be averted by regularly taking medications to kill the virus. Nevertheless, HIV infection is not fun. Safe sex, that is protection against contact with the body fluids of someone who is infected with HIV by either abstaining from contact or using condoms or other protective equipment is effective in preventing transmission. But safe sex is not always practical, as in the case of marriages or partnerships where only one member has the infection. It turns out that taking a regular daily dose of a combination HIV antiviral medication can reduce the incidence of infection of the non-infected partner by over 70% according to a study done in Kenya. The most effective preventive drug, Truvada, is not cheap and does have some significant side effects, which may limit the overall impact of this finding.

Preventing health catastrophes--what works?

Today in the Journal of the American Medical Association David Jenkins MD and colleagues from Toronto, Ontario reported that certain dietary interventions really do help reduce cholesterol levels. Most patients believe, because we have told them, that improving their diets by eating less fat will significantly lower their cholesterol levels. According to a really well done study published in 1998, that is not true. Combining such a diet with exercise is helpful in reducing cholesterol, and probably also reduces many other bad health outcomes, such as diabetes, obesity and death. In Dr. Jenkins' study, however, patients were not told just to eat less fat, they were also instructed in what foods to add to their diets to reduce cholesterol. The study participants were instructed to eat a vegetarian diet and to add plant sterol containing margarine, soluble fiber (such as psyllium, oats or barley), soy protein products such as tofu and soy milk and peanuts or tree nuts. Simply being nagged to eat this way (2 sessions, total of 1 3/4 hours) lowered the cholesterol over 20 points (13%). The low fat diet, which was the control group, made almost no difference. Patients who actually followed the study diet had the best results, which is at it should be.

But having high cholesterol is hardly a health catastrophe. Heart attacks are catastrophes, and every year over a quarter of a million people die of heart attacks. We know that elevated cholesterol levels are a risk factor for heart attacks, but there has been no study that I can find that proves that lowering cholesterol levels by diet reduces heart attack. Perhaps it doesn't hurt, but even that is unclear. Cholesterol lowering drugs, such as the pharmacological blockbuster lipitor, definitely do lower cholesterol and lower risk of dying of a heart attack, but that may be due to any of a number of mechanisms, including lowering inflammation.

One of the most devastating catastrophes of aging is a bone fracture. As people age, bones become weaker and with relatively minimal trauma, such as with a low impact fall, can break. The most significant of these fractures is of the hip. Most hip fractures are fatal if untreated, and surgery to stabilize them is not a small thing. In the year following a hip fracture 15-20% of patients die, and many more require long nursing home stays.

People with osteoporosis are most likely to sustain hip fractures, and osteoporosis is increasingly common as our population ages. It is common to get a bone density study done after menopause to identify osteoporosis and physicians are often asked to prescribe medicine to strengthen bones when the bone density study shows that the risk of fracture is increased. Medicines such as fosamax (alendronate, now generic) can increase the bone density and reduce the risk of fractures, but all medicines for osteoporosis have side effects,  from esophageal ulcers to unintended bone fractures and jaw bone death. The side effects are infrequent, but that is no consolation to the occasional patient who gets the side effect. Because the medicines for osteoporosis are hard to love, we physicians often recommend to patients with waning bone density that they start calcium and vitamin D supplementation. These are inexpensive and pretty much natural, but there is no evidence that I can find that they actually work to prevent fractures. A 1998 study in the New England Journal showed that supplementation with calcium 1000-1500 mg  and vitamin D 400 IU daily slightly increased bone density, but did not reduce hip fractures. On the strength of that study, we physicians temporarily stopped recommending calcium and vitamin D, but we are back at it again, based only on some vaguely applicable studies of vitamin D alone in nursing home populations.

Of course, getting scientific proof of what works and what doesn't is closely attached to both funding and practicality. Drug trials can be performed in a double blind, placebo controlled manner, the most scientifically trustworthy design, whereas lifestyle and diet changes cannot be tested that way at all. It is very expensive to carry out a well designed trial of any sort, but big pharma has that kind of money, and can afford to spend it on science since the return on a positive study is very significant (Lipitor (atorvastatin) earned Pfizer 9 billion dollars in 2009).

What is a person to do? Should we as physicians stop giving health advice that is of dubious accuracy? Since people sometimes actually do listen to us and do what we recommend, should we work harder to produce some kind of guidelines for good health behaviors that will be easy to understand and of minimal complexity?