Curbing Conflicts of Interest in Medicine

In my role as director of the Integrity in Science project at the Center for Science in the Public Interest, I gave testimony yesterday before an Institute of Medicine committee considering how best to manage conflicts of interest in medicine. Here's my initial presentation:

Conflicts of interest in medicine are widespread, have negative consequences and are poorly regulated. The time has come for the profession to set a higher standard.

There isn’t a corner of modern medicine unaffected by conflicts of interest. Two-thirds of medical research is industry-funded; a third of institutional review board members have ties to industry; drug and device firms’ salespersons shower practitioners with gifts; half of physicians’ continuing medical education is financed by medical suppliers; industry-funded clinicians dominate many clinical practice guideline-writing committees; and doctors with conflicts of interest make up one-fifth to a quarter of government advisory panels.

The medical literature has documented numerous negative consequences associated with this extensive industry involvement with the medical profession. They include suppression of negative research results; delays in publication; failure to report serious adverse events in clinical trials; the slanting of systematic reviews of medical evidence; and a systematic bias in research results that favors the outcome desired by study sponsors.

In a time of rising concern about escalating health care costs, financial conflicts of interest have become a major driver of waste and underperformance within the U.S. health care system. They help create an environment where physicians over-prescribe useful drugs; engage in or fall prey to “disease mongering”; discourage use of cheap generic medicines; over-utilize diagnostic and imaging tests; and engage in self-referrals for procedures and operations. Clinical practice guidelines underwritten by industry have led in some cases to the propagation of unsound advice for practitioners.

And what is the larger purpose of all this industry-medical profession interaction? Beyond sales, the rationale most often given, and the one embedded in the charge to this committee, is that it fosters innovation. Yet innovation in medicine – at least as measured by the number of new drugs and biologics approved by the FDA – has fallen fairly steadily over the past decade, a time marked by a growing financial interaction between these two ostensibly independent spheres.

One hypothesis this committee might consider is that excessive financial entanglements between physician-researchers and the private sector is actually harming innovation by channeling scarce scientific resources into medically insignificant research endeavors; inhibiting scientific collaboration; fostering a culture of secrecy; and creating an anti-commons effect through the extensive early-stage patenting of basic science insights and research tools.

Given this background, the questions before this panel are crucial to the future of the profession and the health of the American people. Even if one grants that intellectual collaboration with industry is an important activity worth preserving because it fosters innovation, the question remains what principles should govern those arrangements. Jerome Kassirer, in his concluding chapter in “On the Take,” laid out a set of first principles, which I think are sound:

• Financial considerations must never compromise patient care or the safety of human subjects in medical research;
• Physicians’ medical information must be free of bias generated by financial entanglements;
• The profession should work to ensure that commercial influence does not make the cost of care prohibitive; and
• Physicians should aspire to eliminate financial conflicts of interest.

Given the importance of private enterprise in the U.S. innovation system, individual companies will inevitably generate medical evidence through financial support of some basic, much applied, and most clinical science. These companies inevitably use outside researchers, scientists and educators to supplement their internal efforts. Since this interaction is inevitable, it is crucial that industrial support in whatever form be fully disclosed in the academic literature, in regulatory filings, during continuing medical education activities, to physicians and to their patients. These disclosures must be uniform, universal and accessible to the public.

To meet this standard, publishers should adopt a uniform code of conflict of interest disclosure rules and adopt penalties for failure to comply. And the federal government should require private companies register all payments to researchers, physicians, and other health care personnel on a government-run, publicly available database. The National Library of Medicine’s PubMed and the National Institutes of Health should explore adopting rules that will facilitate proper disclosure within abstracted articles and by the government’s extramural grantees.

But generating new technologies and clinical evidence, their approval by regulatory agencies and their reporting in the medical literature, are only the first steps in the process of diffusing new technology and elevating the practice of medicine. And it is here – diffusion – that a line in the sand should be drawn.

The system for:
• Evaluating medical evidence (beyond peer review, where disclosure rules should apply);
• Reviewing the body of evidence in a field;
• Deriving best practices from systematic reviews;
• Writing clinical practice guidelines;
• Conducting and evaluating comparative research; and
• Evaluating evidence for regulatory purposes;
must be entirely free from conflicts of interest.

Continuing medical education must be weaned from its dependence on industry support. It is entirely reasonable to expect physicians to pay for their own continuing medical education at a level sufficient to adequately reimburse the institutions and individuals who specialize in and prepare those activities.

Similarly, the practice of industry sales personnel offering physicians an endless shower of free gifts, meals and other gratuities whose ultimate purpose is fostering sales of specific products must come to an end. Professional codes of conduct should be amended to prohibit these ubiquitous practices.

The bottom line is that the relationship between physicians, whether as evaluators of medical evidence or practitioners in the field, with any firm with a financial stake in the outcome of the evaluation or individual medical decisions, should be the same as the relationship between financial and political journalists and the companies and politicians they cover. Journalists are strictly prohibited from any engagement, financial or otherwise, with the subjects they cover. In the regulatory arena, advice and decisions must be offered by medical scientists whose relationship to regulated firms are the same as officials at the Federal Reserve Board are to regulated banks and financial institutions. Again, none are allowed.

Why should medicine be held to a lower standard than either of these professions? Where there is total financial independence, there can be no questions about objectivity.

Posted by gooznews at March 14, 2008 07:41 AM