Responses to last issue's Q&A with Paul Gelsinger, whose son died during a flawed clinical trial:
Given the exceptionally raw emotions that the loss of a child evokes, Paul Gelsinger put a face on the very real risks of clinical trials, and in particular, this tragedy has been used to focus attention on researcher conflicts of interest. Spurred into action by Gelsinger’s heartbreak, the political and regulatory domains of government together drove a wholesale revamping of IRB processes, resulting in the creation of a thicket of regulation around the issue of physician conflict of interest. Fearful of running afoul of these new rules, and possibly jeopardizing the largesse emanating from their NIH overlords, leading medical schools responded by placing even more stringent (than the government) restrictions on the financial activities of clinical faculty involved in patient research. In calming the public furor that accompanied allegations of investigator conflict of interest, medical academia seemed to give only slight regard to the delicate balance needed for innovation and translational research to occur.
For physicians in the research trenches, the flip side of Jesse Gelsinger’s tragic death has been the skyrocketing challenges to performing novel clinical studies inside U.S. academia; while seeking to eliminate perverse financial incentives, medical schools have eliminated important incentives for clinical faculty to innovate. Can altruism, by itself, motivate many academic physicians to take out a second mortgage on their home to fund the development of critical technology, as I once did? In today’s overly regulated environment, I am quite certain that the clinical research I did in the 1990s and which created the field of image-guided radiation would not be possible at Stanford today. Meanwhile leading-edge medical device companies, for example right next door in Silicon Valley, no longer even consider performing the critical and most creative phase-1 studies inside U.S. medical schools. More-permissive regional hospitals have largely usurped this traditional role of American academia, while growing numbers of clinical trials are being ‘”off-shored” to medical schools in less-regulated countries. Both trends serve to reinforce the growing irrelevance of U.S. academia to the development of medical devices. Is this really what we as a society want? Do the moral demands of human subject research and conflict of interest really make the current situation inevitable?
Thanks in large part to the generosity of the American public, the basic research enterprise inside U.S. medical schools remains robust. However, after once dominating the world in cutting-edge clinical innovation, these institutions have simply given away their historic role in technology development. As a consequence, countless patients with incurable diseases can at present no longer expect American medical schools to produce the clinical advances they so desperately seek. Who speaks for these faceless millions? Jesse Gelsinger has been used repeatedly to justify much of the new clinical research environment. If Jesse, the heroic young man who gave his life in an effort to advance medical innovation, were alive today, what would he say about the current balance of regulation and pace of medical innovation?
John Adler, MD
Stanford professor of neurosurgery
The perspective and feelings of Mr. Gelsinger are understandable. Such occurrences should never happen. Unfortunately, we know they happen even with the most stringent regulations. It is impossible to regulate all things. Occasions of bad judgment, dishonesty, inappropriate assumption and unbridled enthusiasm in an attempt to make things better will continue to occur regardless of regulation.
Yet there are unintended consequences to rules and regulation made because of situations like Gelsinger. At present, many hospitals and clinicians are reticent to enter into any clinical trial because of bad press and conflict-of-interest issues. Conflicts of interest are real. Conflicts can be managed in many ways. Any proposal that deters the best institutions from being involved in clinical research is not in the best interest of patients or students.
The problems brought to light in the Gelsinger case would most likely not have happened if full disclosure were made during the entire clinical study. Rules and regulations are in place that address most of these difficulties. More regulation is not always better.
Tom Fogarty, MD
Stanford adjunct clinical professor
Fogarty Institute for Innovation, Founder