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Speaker: Marcia Angell, Senior Lecturer in Social Medicine, Harvard Medical School
Professor Angell's lecture can be viewed online. Also, an adaptation of Angell's lecture was published in the May/June 2010 issue of Boston Review.
Marcia Angell began her lecture by recalling an editorial that she penned as editor-in-chief of the New England Journal of Medicine back in May of 2000 entitled "Is Academic Medicine for Sale?" As Angell recalled, that editorial received one particularly humorous but biting response: "Is academic medicine for sale?" the respondent asked, rhetorically. "No, the current owner is very happy with it."
Over the course of the discussion, Angell described a relationship between academic medicine and the pharmaceutical industry that has, over the past few decades, grown increasingly and, some might say, disturbingly intimate. Although these two institutions have, at least nominally, two fundamentally distinct purposes (academic medicine: to educate the next generation of doctors, to conduct scientifically important research, and to take care of the sickest and neediest members of society; the pharmaceutical industry: to maximize shareholder value). Angell observed that, as boundaries between the two institutions have dissolved, their effective aims have become ever more consonant.
In describing the evolution of the relationship between the academy and industry, Angell focused on two specific domains. The first was that of clinical research. Because the FDA requires for approval that pharmaceutical companies demonstrate the safety and effectiveness (as compared to a placebo) of their products through trials involving live human subjects, and because those companies lack ready access to live human subjects, it has, for many years, been standard practice within the pharmaceutical industry to outsource these trials to academic medical centers. As recently as the mid-1980s, Angell recounted, this outsourcing took the form of companies giving money to medical centers to test their products and hoping for the best. In other words, companies took no role in designing or analyzing the trials involving their products, or in authoring and publishing the results. Clinical research funding was, as Angell put it, "at arm's length."
As time went on, however, and as the pharmaceutical industry's financial clout increased, "arm's length" funding was steadily replaced by a much more hands-on counterpart, as it has now become entirely standard for pharmaceutical companies to have a direct hand in both the design and analysis of clinical trials, and in the authorship and (non)publication of results. Academic physicians are often, as Angell puts it, reduced to the role of "hired hands," carrying out trials as they are told and signing their names to ghost-authored reports.
In addition to this shift in the character of clinical trials, Angell continued, direct financial ties between industry and both individual academic physicians and academic medical centers as wholes have become ever more pervasive. In a recent poll, Angell observed, a staggering 94% of surveyed physicians acknowledged receiving financial compensation of some form from pharmaceutical companies, ranging from small perks such as free gifts and meals to stipendiary speaking invitations and salaried positions as industry consultants. Academic medical centers, for their part, have been hesitant to clamp down on these apparent conflicts of interest insofar as they too have developed such direct financial ties, both in the form of a dependence on industry for research funding and in the form of potential compensation by industry for in-house discoveries. The prospect for the latter, Angell described, arose with the passage of the Bayh-Dole Act of 1980, which permitted universities to patent the discoveries stemming from federally funded research, and to license those discoveries exclusively to companies in return for royalties (prior to Bayh-Dole, all such discoveries became part of the public domain). Bayh-Dole thus created a direct financial incentive for academic medical centers to aim for discoveries that were likely to be of interest to (shareholder value maximizing) industry rather than, say, discoveries that were likely to benefit the public at large. And as a result, Angell argued, industry has taken an ever-increasing role in setting the research agendas for those centers. Moreover, she went on, by ingratiating themselves to individual practitioners, pharmaceutical companies have created a well-documented systematic bias in favor of their products amongst those responsible for carrying out clinical trials (Angell cited studies showing that industry-supported studies are far more likely to produce results favorable to the product being tested than are those financed by the NIH), as well as a direct influence over the shape of practice guidelines and FDA standards (Angell noted that, e.g. 95 of 170 contributors to most recent edition of the DSM-IV had financial ties to drug companies, with all contributors to section on schizophrenia and mood disorders having such ties).
With the picture already bleak, Angell went on to make it bleaker by moving on to her second specific domain of interest, that of medical education. As Angell observed, medical practitioners, like other professional practitioners (e.g. lawyers), are required to participate in continuing education programs so as to stay abreast of advances in medical practice. Whereas other professionals (e.g. lawyers) are expected to self-finance this continuing education, however, it has become the norm for medical practitioners to have their continuing education subsidized if not financed entirely by the pharmaceutical industry. Through the conduit of so-called "medical education companies" or MECs, pharmaceutical companies regularly design and fund continuing education programs for the obvious reason that, Angell claimed, "doctors write prescriptions" and, hence, need to be won over. Angell dismissed these MEC-run programs as "marketing masquerading as education," arguing that such programs served primarily to convince practitioners of, e.g. the superiority of expensive brand-name drugs over their cheaper generic counterparts.
Having described what she perceived to be a state of near-total industry capture, Angell concluded her discussion with three specific proposals for reform:
- First, Angell insisted that members of medical school faculties who conduct clinical trials ought not to accept any payments from drug companies other than research support, and that support should have "no strings attached," i.e. that there be a return to "arm's length" funding.
- Second, Angell proposed that physicians be required to cease accepting any and all gifts from pharmaceutical companies, and to self-finance any and all continuing education.
- Third and finally, Angell recommended that academic medical centers return to the practice of placing their discoveries in the public domain or, at the very least, begin licensing those discoveries for nominal fees.
Angell acknowledged that her proposals would be difficult for some to swallow insofar as accepting them would require the medical profession to walk away from a very lucrative arrangement with industry. However, Angell argued, insofar as medicine fails to do so, it does so at the cost of losing public confidence. In addition, Angell acknowledged, adopting these proposals would involve a major shift in the sense of entitlement pervasive today amongst medical practitioners. In response to this, Angell closed the discussion by reminding physicians that they "are not entitled to anything [they] want just because [they] are very smart."
Ryan Doerfler, Graduate Fellow in Ethics 2009-10