Regulating financial conflicts of interest in medicine: A solution in search of a problemThis presentation was originally delivered at the Hofstra University Conference on Biomedical Ethics and the Law, October 4-5, 2006.
Thomas P. Stossel, M.D.
Medical Progress Today
October 10, 2006
Please see the complete slide presentation at the bottom of this page.
Slide 1. As we have heard this morning and will hear throughout this conference, a prevalent perception is that many of us in medical practice, medical education and medical research are behaving very badly. The code words for this wrongdoing are: "financial conflicts of interest."
Slide 2. The dictionary definition of conflict of interest, a conflict, has escalated to stand for any situation in which someone receives remuneration for any activity involving a private enterprise, and, according to critics, only the imagination limits the extent to which such conflicts compromise the integrity of medicine. As illustrated, the imagery of corruption and greed accompanies the accusations. Critics aver, and politicians echo that the most grievous casualty of conflict of interest–indeed of even the appearance of it–is the public "Trust." As this trust erodes, suposedly with it dissipates public support for the medical profession and for publicly subsidized biomedical research and education. These apocalyptical indictments have led to substantive actions, and the actions have consequences.
Slide 3. One action, euphemized as "disclosure" or "transparency" has become an invasion of personal privacy. In the past we named sponsors of our research and education efforts to honor them. Now, all disclaimers to the contrary, we are forced to itemize sponsors so that the beholder can discount our words and our work and to satisfy a prurient interest in our earnings. The disclosure requirements are confusing and largely unenforceable and therefore breed cynicism. They have created an informant culture, in which conflict of interest vigilantes, activists or persons with grievances, scan what we do or do not disclose for opportunities to embarrass us.
Slide 4. Nothing better illustrates how what we disclose demeans us than the call to have only the second best and the not so bright, persons free from all commercial interests, serve in advisory roles.
Furthermore, the very idea that commercial relationships obligatorily drive us from objectivity to the moral low ground has handed the media free license to punish us—and it does–almost totally squashing dissent.
Slide 5. The second major action is prophylactic law or what I call "red light" regulation. Red light rules are like preventing speeding by forbidding ownership of fast cars. My university, for example, severely restricts researchers' ownership rights and equity incentives in the commercialization of their inventions. Anecdotally these rules have prevented companies from in–licensing Harvard technologies. Some research institutions restrain themselves to "yellow light" regulations, overseeing academic–corporate interactions with discretion, but activists criticize them for their relative leniency.
Slide 6. Media–inspired conflict of interest concerns have led the National Institutes of Health to forbid all corporate consulting by intramural researchers, the ultimate in red light regulation. I know of companies that suffer from a lack of their expert advice. Colleagues at the NIH tell me that the rules have negatively impacted recruitment and retention.
Nevertheless, Congress continues to accuse NIH of ethical laxness and low integrity.
Slide 7. Last week I learned at a Midwest AMA–sponsored meeting on continuing medical education that restrictive regulations concerning corporate sponsorship of CME not only are universally regarded as impeding education fundraising, but also have caused a net reduction in medical education activities. These alarming revelations need to be examined on a national scale.
The actions in response to conflict of interest concerns are causing problems. Do they solve any? I don't think so.
Slide 8. Among my supervisors during medical residency nearly 40 years ago were Mike Brown and Joe Goldstein, future Nobel Laureates. Many other of my erstwhile colleagues hold prominent positions in American medicine. But despite this intellectual firepower (I was the control), we practiced, by today's standards, terrible–and unsafe–medicine. Heart attack victims languished on our wards for a month–imagine what that would cost today! While far from perfect and confounded by the oddities of our culture, today's medicine compared to the past is near miraculous. Today's much more effective, innovative and safe medicine did not arise because physicians have become smarter or more professional–that's impossible. It has emerged entirely from technologies developed by private companies abetted by entrepreneurial physicians and scientists, a partnership spectacularly epitomized by the biotechnology revolution. In its first decade during, which biotechnology companies generated spectacular products, almost no one even thought about conflict of interest. Having had the privilege to participate in that revolution, I see a harmony, not a conflict, of interests in the growing commercialism.
Slide 9. A year ago in The New England Journal of Medicine I laid out how facts do not justify the attitudes or rules concerning conflicts. The allegations that they have compromised research are untrue and violate the very standards of scientific rigor they purport to protect. Conjecture and a strikingly small number of anecdotes are put forth in support of commercial conflicts causing harm. There is no evidence that more adverse outcomes arise from commercial influence than in its absence, or that institutions with yellow–light regulations have more ethical problems than those with red–light ones. To my knowledge, not a single case of misconduct reported to the federal Office of Research Integrity has involved a private company.
Polls uniformly reveal that the public is far more interested in "results" than "research." A majority believes it is entirely appropriate that researchers profit from their discoveries, and, even an overwhelming majority of patients enrolled in clinical trials don't care whether their physicians have a financial stake in those trials.
Then why do we have such a glaring discrepancy between objective analysis and experience on the ground—and the prevailing mindset?
Slide 10. One reason is that the immediacy of the scandals and the inevitability of temporary failure overshadow the high risks, the drudgery and the boredom underlying technological advances that emerge inexorably but far too slowly to accommodate the attention span of the media and the public. Another is that the scandals and mistakes that entrance the media endanger managerial tenure and encourage protective overregulation. But the most important reason, I believe, is a muddled ideology, and I discuss two of its tenets.
Slide 11. First, a prominent contributor to the ideological muddle is "scientism, a false and damaging misconception of science." Scientism posits a utopian world where robotically objective experts austerely seek and impart absolute truths. No credible and self–aware working researcher or educator believes this picture.
Slide 12. More importantly, scholars of the philosophy and sociology of science have formally rejected it. Scientists do not seek Truth with a capital T–they solve puzzles, they try to impress and out compete one another, and they exhibit a wide range of behaviors, some sometimes quite ugly. We reluctantly tolerate such comportment—and nevertheless, we make progress.
Slide 13. The second ideological attitude is that influential medical authorities concede that we need interactions between companies, medical researchers, educators, and practitioners. But they harbor a bizarre conceit that the "scientific" production and "—commercial elements of private enterprise are separable. They demand that physicians and researchers wall themselves off from the "commercial" aspects of companies. For example, they call for the collectivization of corporate sponsored research and education, recommendations that if enacted, predict less research and education.
Interestingly, these authorities exempt the principal source of money exchange in medicine—clinical practice—from the segregation of production and promotion, even though promotion of clinical services is routine. This exemption reflects the fact that these authorities represent physician organizations, and to attack physicians' commercial behavior would jeopardize their leadership positions. Rather, by preaching abstract "professionalism," while specifically bashing companies, they pander to the widespread misconception that medicine is a zero–sum game in which someone always has to lose. Rising product utilization must mean less physician reimbursement.
Nowhere is the contempt for promotion more apparent than in a haughty disdain the authorities exhibit toward company sales forces. The call to separate science and business is being put into practice by banning pharmaceutical gifts and sales personnel from the academic medical center, and otherwise respectable academic centers have accommodated such discriminatory recommendations.
If I seem to be testy about this, it's because I sleep with a drug rep.
Slide 14. My wife, Doctor Kerry Maguire, is the Professional Advocacy Director for Tom's of Maine, (no relation), a company with FDA-approved products, that believes in high ethical values. She is a dentist with a degree in public health, who has held faculty positions. It's outrageous that she now can't mingle freely with fellow professionals at Upenn, Stanford or Yale.
Has anyone here ever been a drug rep?
Well I have.
Slide 15. You should try it and experience the gratification of educating your colleagues about worthwhile products. I go to dental meetings with Kerry to learn what it's like to work the sales booth. It doesn’t feel at all undignified or sleazy to me, an academic physician, a professor—a Member of the National Academy of Sciences, to promote toothpaste to interested professionals and give away samples.
Now—if you brush your teeth with such samples are you sacrificing the public "trust?" In politics and public relations, "appearance is everything." This is one reason why politicians so readily buy into the idea that even the "appearance" of conflict of interest is unacceptable in medicine.
Clearly politics and public relations are manifest in medical practice, education and research. But if medical practice, education and research are equivalent to politics and public relations, then the world is flat—because it appears so. But medicine is not politics. Most of medicine's activities are absolutely commercial and therefore fall under the commercial definitions of trust.
Slide 16. In the commercial context, trust comes from your individual track record, from honoring contracts and delivering promises—not from who pays you or how much. The growing interaction between medical practitioners, educators and researchers and companies is an evolutionary adaptation to opportunity for all, not a diabolical commercial conspiracy. Let's celebrate the commercialism that has so improved medicine and shift our energies from bashing it to making it work better.
Slide 17. I absolutely believe that we need safeguards, and disclosure within limits can be reasonable. But let's appreciate its limitations and exercise common sense. Many deterrents to misbehavior, some listed, exist. But let's have fewer red light rules than some medical journals and academic institutions have imposed. Inappropriate promotion can be censured, with due process. Let's stop agonizing over subliminal messages and give medical practitioners a little more credit for their ability to process information. For quality control, let's focus on what people say and what they do—not on their motives. In research we operate with a narrow definition of misconduct, and we tolerate a lot of behavior some don't like, because we progress best with freedom.
Slide 18. In the current regimen of disclosure, I present to you my "conflicts of interest." As you peruse them, I also confess that I find the prevalent sanctimony arrogant and frankly repellent. In many cases, it is hypocritical. It is not Mother Theresa and the Dalai Lama preaching asceticism to medical practitioners, educators and researchers. Rather it is some of the highest–paid and most powerful people in medicine, people for whom the most onerous rules conveniently accommodate doing very well while very feeling superior—or, as Edward Gibbon put it, applying "the motives of virtue as instruments of ambition."
No one will feel sorry for me, if I can't profit from my conflicts, should I do so, however, I will give back.
Slide 19. My wife and I have started a foundation to provide dental care for HIV–orphaned kids in Zambia, and we work there every year. I want to take you all with me. It would be a much better use of our time than what we are debating about at this conference. Certainly if pundits and the press put as much energy into explaining how public and private support of medical research and education lead to advances in medical care as they now do posturing about the corruption of medical research and education, we might actually have more research and education—and more progress.
I thank you for your attention.
View Slide Presentation