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[1] [2], the results of which summarized by the editors of Journal Watch General Medicine.[3]

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.

 

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[1] 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)

[2] 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

[3] “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).”

Conflict of interest 2: Clinical practice guidelines and Deans

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My last blog post was about conflict of interest (COI) in medicine; there has been some recent literature on the subject, so I am providing a second posting on the topic.

In “Conflicts of interest in cardiovascular clinical practice guidelines”^[1], in the March 28, 2011 issue of Archives of Internal Medicine, Mendelson and colleagues reviewed the 17 most recent guidelines regarding the diagnosis and management of heart disease promulgated by the American College of Cardiology (ACC) and the American Heart Association (AHA), the most important issuers of such guidelines. These clinical practice guidelines (CPGs) are important, as not only do physicians use them as authoritative sources to inform their patient care, but increasingly payers – and courts -- are looking at whether they were followed to determine payment and bonuses, or culpability in malpractice cases. While thorough review of the published (and unpublished) evidence is required (indeed is a sine qua non) in the issuance of guidelines, these panels of experts are convened to allow their collective experience and knowledge fill the gaps where there is no evidence. The authors point to the 2009 Institute of Medicine (IOM, a group of distinguished physicians and medical scientists convened by the National Academies, which are private citizens gathered with federal support to advise on science and technology) report from its Committee on conflict of interest in medical research, education and practice, which states that there is insufficient study of COIs in guideline reporting, as the fact that both ACC and AHA have “recently placed restrictions on official participation in educational events and guidelines production”.

Using the concept of an “episode” to mean that 1 person participated 1 time in production of 1 guideline, there were a total of 651 episodes by 498 people in the production of the 17 guidelines. Overall, 56% of individuals (277) had some COI, and (coincidentally) a COI was present in 56% (365) of the total episodes, with a range among the 17 guidelines of 13% (2 of 15) to 87% (13 of 15). Interestingly, actual members of the guideline committees, as opposed to those who just reviewed the guidelines (“peer reviewers”) were more likely (63%, a level reaching statistical significance for those who care, p=.006) to have COIs, as were the chairs of the committees (or first authors) compared to committee members, 81% (p=.03). Only 6 of the 17 guideline committees reported whether the COIs were “modest” or “significant”; the authors found that of those 54% were modest and 29% significant. Perhaps more important, according to the authors, was that it was only a few companies, presumably those with the greatest economic stake in the outcomes, who were involved in most of the COIs. They also note that this is “a particular cause for concern given the fact that many of the newest ACC/AHA guideline recommendations are based more on expert opinion than on clinical trial data”.

Dr. Steven Nissen, commenting on the article in the same issue (“Can we trust cardiovascular practice guidelines?”^[2]), calls the “depth and breadth of industry relationships reported in this article…extraordinary,” in that they go beyond scientific collaboration to include significant stock ownership and serving as promotional speakers, and states that “no conceivable logic can defend [this] practice.” He continues “Such relationships are so antithetical to the academic mission that many medical schools have now forbid such relationships for their faculty. To allow such individuals to write CPGs defies logic.” I imagine his use of the word “extraordinary” is in the sense of “amazing”; since this is the first such study, we do not know if such COIs are indeed “extraordinary” in the sense of “well out of the ordinary”, or if they are, indeed, quite typical. Indeed, Mendelson et al cite a 2002 study by Choudry et al[3] in which the found that of the 52% of the authors of 100 CPGs for a variety of adult diseases who responded to their survey, 87% had “some type of relationship with the pharmaceutical industry” (and we would not imagine that the 48% who didn’t respond had fewer!) Dr. Nissen, who is from the Cleveland Clinic, reveals his own potential COIs, including research support from a number of companies and honoraria for speaking which he has turned directly over to charity. As covered in the New York Times (Duff Wilson, “Study finds conflict among panels’ doctors”, March 28, 2011), Dr. Nissen calls for “banning most of these conflicts rather than just disclosing them”.

But sometimes COIs are not even disclosed. The same issues of Archives of Internal Medicine contains a “research letter” titled “Failure by deans of academic medical centers to disclose outside income”^[4]. The authors, Freshwater and Freshwater, looked at holdings of deans of allopathic and osteopathic medical schools on the Morningstar directory of US corporate directors and executives, and EDGAR, the Securities and Exchange Commission database. They found that while there were only a few deans who served as directors of public companies involved in health care (9 of 161, with one serving as a director of 2 companies and one of 4), this information was not always disclosed on the schools’ websites, nor was the compensation received. This compensation for each directorship ranged from $11,250 to $386,439 with a mean of $217,454, with one dean who served on multiple companies receiving $640,038. “One dean’s official Web page disclosed the 2 directorships, but it did not disclose the compensation. Two medical schools’ Web sites disclosed 3 directorships, with one dean holding 1 and the other 2 directorships; however the Web sites underreported the deans’ compensation by 39%, 56%, and 80% compared with the compensation calculated from the companies’ EDGAR forms.” These deans are the same people who are expected to enforce the rules against COIs that Nissen refers to above. In a commentary[5], Lo (who was the chair of the 2009 IOM committee) et al, say that disclosure is not enough, and that “Some relationships need to be managed or even prohibited”. They do not go so far as to suggest that all should be banned, although I would note that 152 of 161 deans seem to do OK without serving as corporate directors.

So should all such conflicts, whether deans serving on boards of directors, guideline authors having financial relationships such as major stock holdings or speakers’ fees, or receiving grants from corporations, be disclosed or prohibited? I think that there is clear consensus that disclosure is the de minimis requirement. As I have noted before, without disclosure there is no way for the consumer of information in a research study to decide if their might be bias; this is at least as important for are those writing CPGs or presiding over our academic medical centers. But, as Nissen states explicitly and Lo hints at, disclosure is not sufficient. To extend the metaphor of the judge referred to by Howard Brody in his article Professional Medical Organizations and Commercial Conflicts of Interest: Ethical Issues and cited by me in The AAFP, Coca-Cola, and Ethics: Serving the public interest? August 20, 2010, knowing that a judge in a case you are party to owns large amounts of stock in the company you are suing is not sufficient to make you feel alright about her presiding in the case.

Mendelson et al note that “It has also been argued that relationships with industry may also bring a breadth of perspective and experience, especially if individuals have relationships with multiple different companies. Theoretically, these individuals may be less conflicted than those with fewer industry affiliations…”. Right. Taking graft from many sources makes you less beholden to any one of them. Unfortunately, if you buy this argument, then their study should disappoint you, as only a much smaller percentage of the CPG authors had more than one COI.

Come on. Prominent scholars take money from industry for the same reason that others do. They like the money. Perhaps they are eminent enough that their heads are so swelled that they can believe both that they are being paid solely for their wisdom, and not for any bias they might bring to the deliberations of academic groups like those writing CPGs or in the administration of medical schools, and that, in any case, they are so distinguished that there is no way they would demonstrate such bias. If so, they are deluded. No one else believes it, most especially the companies giving them money. These COIs need to be completely banned if we are to be able to trust their academic integrity and intellectual honesty.

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[1] Mendelson TB, et al, “Conflicts of interest in cardiovascular clinical practice guidelines”, Arch Int Med 28Mar2011;171(6):577-85. (only abstract available on line without subscription).

[2] Nissen SE, “Can we trust cardiovascular practice guidelines?” Arch Int Med 28Mar2011;171(6):584-5.

[3] Choudhry NK et al, “Relationships between authors of clinical practice guidelines and the pharmaceutical industry”, JAMA 2002;287(5):612-17.

[4] Freshwater DM and Freshwater MF, “Failure by deans of academic medical centers to disclose outside income”, Arch Int Med 28Mar2011;1717(6):586-7.

[5] Lo B, Kelch RP, Grady D, “Illuminating physicians’ financial relationship with industry”, Arch Int Med 28Mar2011;1717(6): 587-8.