Friday, August 12, 2011
Greed, corruption and medical procedures: ignoring or suppressing the evidence?
One of the challenges for physicians who seek to advocate for patients by championing cost-effective, evidence-based medicine is opposition from the medical community itself. Physicians and other health care providers, as individuals, may practice evidence-free medicine, continuing to do things that have been shown not to work, to cost more than treatments that are equally effective, and sometimes to do harm. Sometimes this comes from ignorance of the evidence, because it may seem to be too hard to keep up. Sometimes it is because practitioners have “always” done it this way”, taught years or decades ago by their teachers. Or they may think that “their” patients are different from the ones who were studied; that “their” practice has shown them what works; that there is an “art” of medicine separate from the science. Maybe they are sometimes right, but usually they are wrong.
Yes, many important studies from which evidence-based guidelines are derived do not include all types of patients. For years poor and minority people were the main substrate for research (see “Tuskeegee”). More recently, perhaps in overcompensation, poor and minority people have been left out of research trials, which funders interested in health disparities (including the National Institutes of Health, NIH) are trying to change. But the fact that the patients you take care of were not included in these studies is not sufficient evidence for the results not applying to them. And, importantly, providers caring for exactly the population of patients who were studied are no less likely to ignore the results.
It is good to learn from your teachers. Hey, I’m a teacher. But new evidence emerges, and your patients count on you to be aware of it, to use it, to be on top of the knowledge that they cannot be. Does it take time? Sure. But that is the job. And for doctors that is one of the reasons that they are well-paid. To keep up. But what about one’s own personal experience? Experience is a good guide, in the absence of other evidence, but rarely does one provider have sufficient experience to have stronger evidence than large clinical trials. Moreover, “anecdotal” experience (“I once had a patient who X treatment didn’t work for”, or more likely “I once had a patient where Y treatment worked great”) has its own pitfalls. Mainly, it is usually wrong, even in the context of that individual provider’s practice. We have a tendency to remember the unusual, and to remember that for use in our future practice rather than the usual. I remember, while working in an urgent care center before the advent of “rapid step tests”, I had to review yesterday’s throat culture results. I would see a positive result and say “Ha! I knew that patient had strep!”, but not consider all the negative tests on patients for whom I may have thought the same thing. This is why we do large clinical trials. The “art” of medicine is important, especially in areas where there is no, or insufficient, evidence, and in translating that evidence into what the patient should do. The art of medicine is not, however, in ignoring the evidence.
Much more serious, however, is when greed causes physicians refuse to abide by the evidence because it shows that something that they are doing, which makes them money, is not indicated. This too can be subconscious, because if you have been doing a procedure for a long time believing it works, it is hard to suddenly change your mind because of new evidence. It is easy for your subconscious to deny that this resistance has anything to do with your own economic benefit, and is rather the result of your knowing it works. But when large groups of physicians, professional societies, get involved, it is no longer subconscious. It is financial protectionism pure and simple.
A good example of this is the recent opposition to recommendations by the Institute of Medicine (IOM) suggesting how the Food and Drug Administration should make rules governing the use of medical devices. Some manufacturers and physician groups began to criticize them before they were even published (“Study of medical device rules is attacked, unseen”, Barry Meier, NY Times, July 28, 2011). The failure of many medical devices currently on the market, including artificial joints and defibrillators, was the impetus for this report. The IOM, a group of independent physicians and scholars convened by the National Academy of Sciences, are tasked with making recommendations on a wide variety of medical issues. Many of their most well-known reports focus on quality and patient safety, such as “To Err is Human: building a safer health system”. As Meier reports, a business group representing many of the device manufacturers went for the old “the best defense is a good offense” strategy and attacked the rules before they were promulgated. It is self-serving, but not surprising: “With millions of dollars of product sales at stake, the experts said, it is not surprising that the device industry and others would want to avert what they see as potentially restrictive new rules. Still, the lobbying has taken on a tone akin to Washington infighting over an issue like bank regulation, rather than patient health, they said.” Guess what? With millions of dollars at stake, it is exactly like attacking new bank regulations rather than focusing on patient health! (For those who are interested, the actual IOM recommendations on medical devices, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years is available on line.)
Of greater concern than these actions by the Washington Legal Foundation (additional information available in Wikipedia), a “pro-business group”, representing the self-interest of manufacturers, is the involvement of physicians. WLF’s attorney, Richard Samp, “… said his organization took action after the issue was brought to its attention by a lawyer who works at a firm that represents device makers. Shortly after filing its petition, the legal foundation was contacted by an official of the American Academy of Orthopaedic Surgeons, which represents doctors who perform joint replacements, who congratulated it for ‘taking the bull by the horns,’ Mr. Samp said.”
This is not the first time that orthopedics organizations (which for some reason choose to use the British-style diphthong “orthopaedics” despite being Americans who do not make a practice of using other medical diphthongs such as haemorrhage, oesophagus, anaemia or oedema) have chosen to attack evidence-based rules by political means. When, back in 1995, the Agency for Healthcare Policy and Research (now the Agency for Health Quality and Research, AHRQ) issued evidence based guidelines that recommended that certain popular (and remunerative) surgeries for back pain were not very effective, the orthopedic groups were able to convince Rep. Henry Bonilla (San Antonio) to introduce legislation to de-fund the agency! (“Agency’s report provokes a revolt”, by Neil A. Lewis, NY Times September 14, 1995).That’s playing hardball! However, the procedure, vertebroplasty, was overused, usually didn’t work and often caused harm. Interestingly, mounting evidence of its inutility continues to this day, recently for vertebral fracture in the British Medical Journal , the results of which summarized by the editors of Journal Watch General Medicine.
I don’t want to pick especially upon orthopedists (or orthopaedists), although as high-income procedural specialists, they have been involved in more than their share of these issues. Many of the IOM’s recommendations involve procedures done by other specialists, including cardiologists. Indeed, we need to applaud the work of the academic cardiologists who have done the studies that show that many of these procedures that constitute a major source of income for their practicing colleagues (the pâté and vichyssoise if not the bread and butter) are not indicated.
The researchers doing this work are some of the true heroes of medicine. Those who hold on to evidence-free procedures because they make a lot of money from them need to be careful that they do not join the villains.
 Staples MP et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: Meta-analysis. BMJ 2011 Jul 12; 343:d3952. Medline abstract (Free)
 Wilson DJ. Vertebroplasty for vertebral fracture: On the basis of current evidence, cannot be recommended as the first line treatment. BMJ 2011 Jul 12; 343:d3470
 “The results do not support routine use of vertebroplasty in patients with vertebral compression fractures, including those with recent-onset pain or severe pain at baseline. Strengths of this meta-analysis include its use of individual patient data and the blinding of patients to vertebroplasty or sham procedures. As noted by the authors, lack of blinding overestimates treatment benefit, which casts doubt on the results of a recent nonblinded randomized trial that suggested vertebroplasty is superior to conservative treatment (JW Gen Med Sep 2 2010).”