Medicine and Conflicts of Interest: Creating A New MoralityAmericans are pretty trusting. They read or hear statements by economists, corporate presidents and even sports figures and believe most of what they are told. Judging by recent developments, though, we are starting to identify one group of people who apparently cannot readily be taken at face value: physicians.
Michael Weber, M.D.
Medical Progress Today
October 4, 2006
According to medical societies, scientific journals and the lay press, physicians—particularly those involved in medical research or education—are beset by conflicts of interest that seriously threaten their credibility.
Underlying this assertion is the fact that many of the new developments in medicine are generated from research that is fully or partly supported by industry: pharmaceutical companies, device manufacturers and the like. Inevitably, since most of this research must be carried out by academic physicians and scientists, typically in collaboration with their colleagues in industry, we are told to suspect the possibility of bias when results are reported.
After decades of productive research that has dramatically extended the length and quality of life around the world, the fuss over conflict of interest is not truly based on new-found ethical concerns. It is based on economics. Private and government health plans find themselves ever more challenged to fund the care of aging populations. Exacerbating their concerns, information about the latest developments in medicine is abundantly available in the lay press or on the internet, creating a clamor for expensive new tests and treatments. Rather than address fiscal concerns head–on, there has emerged a growing movement to stifle information available to physicians and patients.
Organized Medicine to the Rescue
Physicians, individually and collectively, are nothing if not helpful. To demonstrate their self–policing talents, most major medical societies and medical journals have developed what are termed conflict of interest policies.
Physicians and scientists wishing to present or publish their work must publicly disclose their financial relationships with industry. But, for many journals, particularly those run by medical societies, authors must go further: they are asked to identify not only companies relevant to the work being reported, but their relationships with all companies—regardless of what those relationships entail—and even approximations of the dollars involved.
Information about the researchers' family members is often required as well—along with any dealings with industry by the medical schools, hospitals or other institutions that the researchers are affiliated with. It is hard to imagine that any other group of professionals, business people, journalists or even elected officials would be willing to preface each of their public statements by similarly detailed lists of disclosures, most of them irrelevant to the matters at hand.
It is perfectly reasonable to expect medical researchers and teachers to be transparent about the funding for work they are presenting, and to acknowledge any relationships they might have to the sources of that funding. Even so, the harshness and detail of the newly–emerging conflict of interest rules has little to do with transparency. Bluntly put, these rules are mainly intended to disparage industry supported research and suppress information that could contribute to increased health care costs.
Medical Journals: Conflicts at Work
Strangely enough, editors and organizations that publish medical journals have conflicts that are more apparent than those of their authors. One obvious reason is financial. For many journals the commercial sales of reprints of key articles and the publication of sponsored supplements are vital sources of income.
When selecting articles for publication from among the many submitted for consideration, editors must surely be aware of those—typically describing new devices or drugs—that are likely to result in lucrative reprint orders. Likewise, in deciding whether to publish industry sponsored supplements, do editors exercise the same rigorous criteria that they apply to regular submissions?
Let’s be perfectly clear about this. There is nothing intrinsically wrong with reprints or supplements, nor is there anything wrong with generating revenues that help good journals survive. But given the temptations and conflicts involved, shouldn't professional journals—which are so essential to disseminating medical progress—follow the same rules they prescribe for their authors and disclose their financial dealings?
For major journals another conflict is at play. Their reputations depend on public visibility, their ability to publish breakthrough research that gets the journal mentioned in newspapers and other media. Editors of journals are adept at identifying major clinical trials that are about to announce their results, and they are proactive in soliciting the publications for their journals.
Again, perfectly understandable. Yet, since most major trials are sponsored by industry, the journals are eagerly allying themselves with the very people they implicitly condemn in their conflict of interest rules. However, since most trials are at least partly overseen by academic researchers, it is tenable for journals to maintain the illusion that they are dealing with independent investigators rather than with industry.
But in a world of transparency, why can't journals acknowledge reality? By and large, contemporary research by industry is rigorously conducted and analyzed, and in the prevailing climates of regulatory oversight and legal liability, is reliable and responsible.
Government and Conflicts
If not industry, who else can support medical research that is free of conflict of interest? The government? Hardly. When it comes to drugs and devices, governments and the healthcare agencies they support are major purchasers of these products. They are highly sensitive to calls by elected officials to control costs. Clearly they have a powerful interest in sponsoring and publishing research that shows—or can be interpreted as showing— that cheaper is better.
So investigators engaged in doing government research must be at least as deeply conflicted as those who work with industry. In fact, more so. After all, most academic researchers in industry-sponsored trials are free agents; those in government-sponsored work may actually owe their jobs or promotions to the perceived success of their research in furthering their employer's agenda. Put another way, there is no inherent reason to assume that work sponsored by government agencies is any more credible than that supported by industry or other financial sources.
Research Grants and Conflict
The same concerns over conflict apply to investigators who get competitive research grants from government agencies like the NIH or VA, or from major non–profit organizations. In fact, from a professional point of view the stakes are actually higher than with industry grants. For instance, having NIH grants implies a measure of recognition that, quite apart from the funding benefit, is critical in advancing careers, promotions and tenure status in the academic world.
In reality, getting these grants, and equally as important, getting them renewed, is a major preoccupation and priority for academics. So, if journals and scholarly societies are to be consistent in providing readers and listeners with relevant conflict information, they should require investigators to go beyond simply disclosing their grants. To ensure transparency, authors should provide such information as the dollar value of their grants, their own tenure status, the relationship of the grant to the work being published, and details on the dates of the grant’s expiration and renewal that could allow readers to make informed judgments about the credibility of the work.
Another often overlooked point: official treatment guidelines are sometimes written by medical societies, sometimes by government agencies. In either case, conflicts of interest can obviously emerge. Individual writers contributing to guidelines, of course, should disclose relevant relationships. Even more important, the underlying motivation of the sponsor should be revealed, particularly in the case of government agencies that use guidelines for promoting cost–effective (read: cost saving) recommendations.
Health Care Organizations and Conflicts
Conflict of interest goes further than the worlds of academia, government and industry. One obvious additional candidate: healthcare organizations. Why is it that published articles produced by physicians or scientists employed by health maintenance organizations (HMOs) and other such entities seem to focus so often on cost–effectiveness issues?
This is a relevant and important issue. But, once more, what has happened to the disclosures? Surely in the spirit of transparency it should be pointed out explicitly by the authors that they are employed by organizations whose financial well–being depends on minimizing expenditures on medical goods and services.
Conflicts of interest involving HMOs and similar plans are not confined to publications. When, for instance, they compose their drug formularies and create policies for patient access to other medical services, how do they explain these decisions to patients? Do they fall back on the selective misuse of so–alled evidence based medicine to justify their rationing? Or do they use the pretense of keeping down the costs to patients? When was the last time, if ever, that a health plan was forthright enough to disclose to the public that the plan was limiting costs so as to improve profitability for its shareholders and bonuses for its executives?
Even the Doctor's Office
Perhaps most troubling in this context is what happens in the doctor' office. Many physicians are dependent to varying extents on HMOs and similar plans for practice revenues. In some cases, almost all income—even employment—comes from these sources. Income is often affected by the compliance of physicians with policies regarding the availability of drugs and other outside services to patients.
This potentially creates the most uncomfortable of all conflicts of interest: doctors in direct financial competition with their own patients. How can this be properly disclosed? If apostles of the new morality had their way there should be a sign posted in the doctor' waiting room: Warning! Please be aware that the revenues of this practice can depend on limiting access of patients to tests, procedures and drugs.
This is, in fact, a sobering but not unlikely scenario given the assumptions driving current disclosure rules.
Financial conflicts are usually easy to describe and—even in the absence of disclosures—pretty obvious to all concerned. But perhaps of greater importance in contemporary times are the conflicts related to non–inancial matters.
Major medical journals are increasing the number of articles they publish on social, political and economic issues. This focus can be perfectly legitimate, particularly when health-related issues are involved. Still, wouldn't it be more important than ever—in our new spirit of disclosure—for writers to acknowledge conflicts that could influence their opinions on sensitive or contentious public issues? Clearly there are situations where it would be relevant—far more so than financial disclosures—for readers to know where the writers live; what political parties they support; what their religious preferences might be; and even their sexual orientation.
However obnoxious this requirement may sound, such disclosures would be entirely within the spirit of the new academic guidelines on conflict.
Let's Face Reality
It is obvious that government, academia, industry, health care organizations and even individual medical practices are all operating in an environment rife with hypothetical conflicts. And, equally so, are the individuals who have relationships with these entities. We must assume that conflict is intrinsic to organized medicine—indeed, to all organized human endeavors.
There are two broad ways of dealing with it. One, which sadly right now seems to be the prevailing trend, is to set progressively more onerous rules designed to weed out ever more tangential conflicts. But apart from the important issues surrounding freedom of speech implicated in this heavy–handed approach, the obsession with conflicts will ultimately be paralyzing for medical research and innovation. In this regard, one need only glance at the predicament of the FDA: it is becoming nearly impossible to find experts with relevant knowledge and experience to serve on its advisory boards owing to the witch hunts conducted to exclude those with even the most trivial or indirect conflicts of interest.
There is a better alternative we can fall back on: trust. Disclosures that are directly relevant to the research or communications at issue must continue to be disclosed, and violations of such policies should be punished harshly. And, as ever, there is a compelling obligation on the part of writers and speakers to be scrupulously faithful to their data and objective in its interpretation.
But we must be aware that there is only a very fine line between stringent conflict rules and outright repression and censorship. Rules that are based on sustaining a researchers' reputation for integrity promote the public weal more than the frenzied search for conflicts, which only suppresses information based on the pursuit of a misguided ideal.
Michael A. Weber, MD is Professor of Medicine at the SUNY Downstate College of Medicine in Brooklyn, New York. He received his medical degree from Sydney University in Australia.
His career has been focused primarily on hypertension and preventive cardiology. He has published numerous research articles in the medical literature and has authored or edited 16 books. Together with Dr. Suzanne Oparil, he is responsible for the widely used reference volume, Hypertension.
Dr. Weber has also provided consulting and speaking services to major pharmaceutical companies.