Conflict of interest regulations are also adversely affecting the relationship between physicians and industry by limiting the use of marketing, consulting, and education in the pharmaceutical industry. As Richard A. Epstein, a visiting scholar at the Manhattan Institute, explained in his report on How Conflict-of-Interest Rules Endanger Medical Progress and Cures, “strict conflict of interest regulations on promotion and marketing “will increase the cost of getting a new drug to market and thus delay its effective use.”
Our previous articles discussed the origin of Epstein’s report and the initial discussion of conflict of interest (COI) regulations in government and academia. This article will discuss Epstein’s analysis of COI regulations in drug and device marketing.
COI Regulations in Drug and Device Marketing
The clear problem COI regulations aimed at reducing drug and device marketing is that when “a company is not able to market the drugs, they cannot afford to make them.” Epstein points out that marketing is necessary because new drugs are complex chemical products that require a close understanding, and because research and development often involve the creation of new products. Epstein recognizes however, that the creation of new products, however successful, “will produce enduring social gains only if the producers of pharmaceutical products and medical devices can sell these products in the broader market.”
Marketing is also an important function because it ensures that “people in the profession are aware that a new drug has made its way through to the marketplace.”
Consequently, Epstein maintains that sending out representatives from the company or from medical practice to explain what their complications might be, and how they should be addressed, is clearly appropriate. Company representatives are making public statements about these products. If cases arise where such interactions are unethical, the company could easily suffer substantial exposure to tort liability or regulatory sanctions, which has happened for several companies over the past few years.
Additionally, companies are not marketing products and devices to “naïve audiences.” Companies speak to “physicians who face their own reputational and liability risks when they prescribe drugs. In most of these sessions, physician questioning plays a prominent role, and there is little reason to think that companies will push risk-making claims that could lead to improper uses giving rise to serious tort liability.”
Everyone involved in the debate of COI regulations understands that making drugs give “rise to life-and-death questions.” If companies and agencies do not protect patients through clinical trials, tests, or post-market surveys, people die. However, as Epstein points out, enacting stringent COI policies can “stifle the marketing and promotion of new drugs that outperform their rivals, and their tardy arrival could spell death or serious injury to the people who cannot obtain the desired relief from existing drugs.” Therefore, he recognizes the need for COI policies to take into account both chances for error.
As Epstein explains further, errors from delaying drugs because of stringent COI policies are also social issues that can have long-term effects. While the public attempts to justify such restrictions by crying “better safe than sorry,” Epstein notes that this “image does not carry over to issues of pharmaceutical research, where regulations routinely deny even prudent individuals and firms a “safe harbor,” where they can collaborate without fear of sanction.”
The problem that arises is that people with dangerous conditions for which there are no known acceptable therapies and treatments suffer because strict COI policies impose obstacles “in the path of new drug marketing and development.” Such obstacles are significant because they affect the “speed with which needed new products get to the market.” For example, patients depend on the institutional arrangements that guide drugs from initial conception to ultimate commercialization. Since the relevant processes to get a drug from discovery into production is never “in the control of a single individual, let alone a single firm,” policies that hinder such relationships and collaboration “prevent sick people from getting much needed treatment in timely fashion.”
Moreover, product development is also dependent on “developing close connections among all individuals in the production cycle so that the insights learned at one stage can be made available to people working at either a previous or subsequent stage,” and that information is reliable. However, the “adoption of aggressive conflict-of-interest regulation can exert deleterious effects on both aspects of information transfer” (speed and reliability). As a result, Epstein notes that these policies have “placed unnecessary bumps in the road to sound product development and commercialization.”
He uses the example of the so-called Pharmaceutical and Medical Device Manufacturer Conduct Act, which is now in effect in Massachusetts, to show a policy that is having a deleterious effect on information transfers between industry and physicians. The law tries to impose on companies a fair code of conduct. The problem with this law is that the legislature made no real inquiry into how marketing and industry meetings work for conveying information to physicians, which is evident by the ambiguous and confusing language of the legislation. Another weakness of the code is that it cuts “so deeply into customary ways of doing business, despite the absence of evidence of systematic abuse.”
Conclusion
Epstein’s approach to COIs is that there should be trade-offs, not moral absolutes. He asserts that we should accept COIs “as a necessary part of doing business and manage to the point that the last dollar spent in seeking to prevent error generates the same return as the last dollar spent on any other phase of medical research.”
Nevertheless, as Epstein thoroughly describes, “the current conflict rules that are ordered by such key organizations as the NIH, the FDA, and various medical schools and medical societies have passed the point of good sense and have entered an area where we can predict serious difficulties.” These policies have made it harder for industry to help researchers and to exchange information. Although “it is perfectly appropriate to devote more resources to the monitoring of conflicts of interest,” Epstein recognizes that “a few incidents of misbehavior should not lead to a total reorientation of attitudes and policies.”
In the end, “severe and broad conflict-of-interest regimes sweep before them even highly regarded, well-motivated professionals, denying society the benefits of the knowledge they possess.” The restrictive policies that these individuals and agencies have enacted are unnecessary because such conflicts can “be managed through a judicious combination of disclosure and oversight.”
Since 1945, “we have had the benefit of these collaborations without having seen any sign of the systematic abuse that could justify the tough bans that have been put into place today.” By continuing to create and uphold intrusive and unwise policies and injunctions on physician-industry collaboration, agencies are only “throwing sand into the gears of progress at every stage of the drug production cycle, from basic research through final sale.”
Continuing down this path will only hurt patients and future generations. As such, agencies and institutions should seriously consider Epstein’s recommendations before it is too late for patients.