How Conflict of Interest Rules Endanger Medical Progress and Cures
Over the past several years, pharmaceutical and device companies have been facing significant legal and regulatory challenges that have resulted in corporate integrity agreements with the federal government, and increased transparency and disclosure requirements. Additionally, new regulations and rules stemming from potential financial conflicts of interest have started to increase at academic medical centers (AMCs), professional organizations, and a number of states. More recently, the National Institutes of Health (NIH) proposed changing its rules regarding transparency in publicly funded research.
In response to the changing landscape of regulations affecting physician-industry collaboration, Richard A. Epstein, a visiting scholar at the Manhattan Institute, examined “How Conflict-of-Interest Rules Endanger Medical Progress and Cures.” The published report, which came out this week, was part of the Manhattan Institute’s “Project FDA,” which is a committee of physician-scientists, economists, medical ethicists, and policy experts. The committee’s mission is to examine the current framework and direction of federal and state regulation and to promote the development of a robust medical innovation pipeline.
The writings of Richard A. Epstein span a broad array of fields, including common law subjects of property, contracts, and torts. Professor Epstein’s influence is profound: he is one of the three most cited law professors in the United States and the most cited professor writing largely in private law. In his report, Epstein tackles the sweeping conflict-of-interest regulation that the Food and Drug Administration (FDA), as well as leading research institutions like the NIH, say is necessary to protect the public. The report answers the following questions:
– Why are one-third of all FDA drug approval committees empty?
– Are industry scientists and government scientists forbidden to share research?
– Can being too safe actually hurt people’s health?
Background
Since the first academic-industry-physician collaboration helped produce insulin over eighty years ago, American’s have enjoyed a “high standard of living, including their state of health and the medical discoveries and treatments that have steadily improved it.” This “active partnership between science and commerce” has created a “wide-ranging and productive exchange of knowledge and information.” Over the past several years however, this partnership has been constantly jeopardized by “A mounting wariness toward collaborations between employees of research institutions and public agencies and those working for pharmaceutical companies and the like.” The wariness has expressed itself in the form of “increasingly broad conflict-of-interest rules and prohibitions,” which threaten to disrupt the beneficial collaboration industry and physicians have enjoyed for decades.
Due to this recent trend, Epstein asserts that such policies are “likely to degrade the quality of research and delay the provision of lifesaving medicines and treatments” mainly because such policies were created without carefully weighing the impact of such harms. For example:
– NIH has forbidden almost all contact between its scientists and those in the private sector. Yet an industry scientist may be the world expert in an NIH scientist’s area of research, and others could facilitate the translation of basic research into useful technologies, which is supposed to be one of the agency’s goals.
– FDA is demanding extensive public disclosure of the financial ties and payments of experts appointed to committees that review the licensing of new drugs and their accompanying warnings, despite the fact that a third of these positions are unfilled.
– Universities have become leery of cooperation with drug companies out of concern to preserve the single-mindedness of pure research. Yet they do not hesitate to patent fee-producing devices invented in their laboratories with federal financial assistance, as 1980’s Bayh-Dole Act permits them to do.
– The parent organization of two Harvard-affiliated hospitals has placed strict limits on per diem compensation for service on corporate boards, which only encourages physicians to devote more time to activities beyond their hospital duties.
– Leading medical societies are considering whether to prohibit their physician members from accepting fees from drug companies to inform medical audiences about medicines the companies are marketing. Yet such presentations occur before informed, professionally skeptical audiences that may contain representatives of competitors well-equipped to contradict false or misleading claims.
– Massachusetts has enacted the Pharmaceutical and Medical Device Manufacturer Conduct Act, which imposes a sweeping prohibition against gifts, including training sessions, from such businesses. The net effect, however, will be to move such valuable activities beyond the state’s borders.
For Epstein, there are two main problems with these kinds of policies, which attempt to censor what physicians can do with industry. First, they assume that parties with any kind of financial interest, no matter how trivial, are “inevitably, purveyors of bad information.” Second, “that reliance on information from such sources, or even on information that is actually bad, is worse than an absolute reduction in the amount of available information, which occurs when industry sources are closed off.”
As he points out however, “Except in egregious cases, conflicts of interest are a necessary part of doing business in an interconnected world, and virtually every line of business and professional life, individuals are forced to make decisions in which their personal interest is in conflict with duties of loyalty owed to other individuals.” For example, “Lawyers and agents owe duties of loyalty to their clients, similar to physicians who owe duties of loyalty to their patients.”
While such duties in the past were handled in a variety of ways, Epstein explains that it is only “in the last generation or so that the regulation of COI has turned into a regulatory growth area.” This growth, according to Epstein, was “sparked by widespread public uneasiness and distrust of individuals in places of power, and is partly driven by revelations of supposed misconduct by persons in high places.” What has resulted in this “regulatory expansion, is expensive administrative sanctions to create dubious incentives for efficient conduct, both in government regulators and the private parties whom they regulate.”
As a result, Epstein uses his paper to “attack the modern reaction against the many inevitable conflicts of interest that arise in the research, development, production, and marketing of pharmaceutical products.” One of the main reasons he uses to support his argument is that the increased use of stringent regulation is doing more harm than good (i.e. 215 vacant seats on 49 FDA advisory committees).
Later this week we will publish a series of articles summarizing the specific sections and areas of COI regulation that Epstein uses to analyze the examples above.