There are many valid explanations for this worrisome slowdown in drug development:changing business models, shifting subject populations in clinical trials, an evolving regulatoryenvironment, worldwide concerns about escalating healthcare costs, etc.
But a recent development that troubles me is the growing rift between talented experts inbiomedical research and the development process.
In the last few years, there have been legitimate and shocking stories about conflicts of interestamong some researchers and academics. As a result of This has led to intense media focus andscrutiny in the U.S. Senate., As a result, the NIH, the FDA, journals, professional societies, anduniversities rapidly constructed elaborate and often cumbersome mechanisms to avoid theslightest hint of taint. It’s now very difficult for the most knowledgeable experts to advise theNIH, the FDA, or the pharmaceutical industry, or to work on treatment guidelines and the like.Because of restrictions on research, paperwork, and fear of embarrassment if they consult withindustry, many experts stay home and focus on their science. And so we get less of the healthydynamic—the flow of knowledge and perspective—that enhances new-product development.
Pendulums swing. I worry about the unintended consequences of how far this one has swung.This challenge for our society is vaguely analogous to the need to strike a balance between civilliberties and public safety. How can our regulatory systems reasonably leverage the power ofacademic knowledge and expertise while, at the same time, safeguarding all of us against therogue scientist who would put personal gain above the welfare of fellow citizens?
- Alan J. Gelenberg, M.D.
Editor, Biological Therapies in Psychiatry
Professor and Chair, Psychiatry, Penn State University
Editor-in-Chief, Journal of Clinical Psychiatry