Understanding Pharmaceutical Relations and the Limits of Regulatory Reform

SmithKline & French pharmaceuticals

In the Organic Chemistry Section of SmithKline & French Laboratories, Dr. Wilfred H. Lindell, Professor of Pharmaceutical Chemistry of the University of London, England, (right), examines the yield of a new pharmaceutical with Dr. Maurice L. Moore, Director of the Research Laboratories of SKF (center), and Dr. Glenn E. Ullyot, Director of Organic Chemistry (left). Professor Lindell was on a four-week scientific visit to the United States as a guest of SmithKline & French.

The relationship between the pharmaceutical industry, the biomedical sciences, and government regulators has recently been a hot topic in Washington, D.C. For more than 50 years the industry and academic research institutions have been developing a complex network of funding, research interests, and political influence. This network has resisted changes proposed by those who would increase regulations on prescription drugs and extricate the industry from involvement in regulating bodies. To improve the overall system, we must first understand its 50-year history.

Over the past two years the U.S. Food and Drug Administration (FDA) and Congress have sought to break the pharmaceutical industry’s influence over the regulatory system. In August 2008 the FDA enacted new rules barring researchers from serving on its advisory committees if they receive more than $50,000 either from a company whose product is being discussed or from that company’s competitors. And in the fall of 2007 the Senate and House passed bills that restrict the number of conflict-of-interest waivers permitted on each FDA advisory committee. These waivers allow experts with otherwise “disqualifying financial interest” to serve on an FDA advisory committee.

Academics are also concerned about their relationships with drug companies. In April 2008 the New York Times reported that some prominent academic researchers, troubled by ethical conflicts, have decided to stop accepting payments from drug companies.

While these efforts to limit the industry’s influence over the regulatory system are certainly admirable, they are not a comprehensive solution to a problem that has been with us for half a century. The American drug industry has been the subject of persistent critique and the target of a significant pharmaceutical reform movement since the mid-1950s. Between 1959 and 1979 Democratic legislators, with the aid and support of labor groups, consumer groups, and patient advocates, undertook a series of congressional investigations into the American pharmaceutical industry. During the legislative phases of these hearings, the reformers pushed for legislation that would increase competition and lower prescription drug prices. The legislation would reduce the patent term on prescription drugs, establish a federal center of drug development to conduct all preclinical and clinical drug testing, and make it mandatory for physicians to prescribe by generic name only.

At every turn the legislation faced staunch opposition from the drug industry, the American Medical Association (AMA), and a cadre of leading academic physicians. Together, this alliance of industry and the medical profession defended the current system of drug development and regulation, putting forward a series of powerful arguments against greater regulation of the American drug industry. One of the most persuasive of these arguments was that the government’s increasing encroachment on private enterprise in the health-care field signaled America’s ready sprint toward socialized medicine—a system that the pharmaceutical industry and the medical profession have warned every American to fear.

Through lobbying efforts, congressional testimony, and a massive public-relations campaign, the industry and its allies reminded legislators and interest groups of the incredible innovativeness of the U.S. drug industry since World War II. The industry, after all, had produced a vast array of highly efficacious therapeutic agents—antibiotics, corticosteroids, psychotropic drugs, and new vaccines, for example—that had significantly reduced mortality and morbidity and decreased human suffering. The industry and its allies highlighted these achievements to argue that increasing government regulation of the pharmaceutical industry would stultify drug innovation in the United States. Legislators in favor of greater government controls were faced with the problem of appearing to vote against the potential for developing new “wonder drugs.”

The relationships between the drug industry and the medical profession have extended beyond politics. Since the 1930s such research-based drug companies as Merck, Lilly, Abbott, Upjohn, and Parke-Davis have relied on collaborations with academic researchers to develop and maintain innovative research programs. Through these partnerships drug firms gained access to the work being done in academic laboratories and the invaluable insights of those at the forefront of biomedical research. In return the academic researchers who worked with drug firms received critical research funding and the opportunity to have their research translated into new therapeutic agents. Moreover, academics and their institutions drew on these relationships and called on drug firms for help in addressing their common issues: decreasing numbers of students and scientists entering the biomedical fields and increasing federal authority over medical education and practice. From the 1940s through the 1970s, in response to these shared problems, drug companies established postdoctoral fellowship programs and funded the establishment of clinical pharmacology programs. In the late 1950s, for example, the drug industry’s trade association helped establish the first clinical pharmacology programs in the country by funding annual training fellowships at Johns Hopkins University and the University of Pennsylvania. This, industry and academia hoped, would encourage young researchers to enter the pharmaceutical research field and provide medical schools with a nongovernmental funding source with which to train the next generation of pharmaceutical researchers.