The Force of Law: Monitoring Ethics, Money, and Scientific Research
by Ronald Collins

Sometimes it takes the force of law to move people, who should otherwise know better, to a higher moral ground. That, at least, is Alan Milstein’s message in a landmark lawsuit he filed against the University of Pennsylvania and Arthur Caplan, its director of bioethics.

The action was brought by the family of Jesse Gelsinger, who died last year from gene-transfer therapy conducted at Penn. One notable aspect of the case is the appearance of substantial conflicts of interest — Milstein alleges that the University and its lead scientist, James Wilson, had equity stakes in a company with a financial interest in the experimental virus being tested. The lawsuit is significant for several reasons, one of which is the impact it could have on possible federal regulation concerning experimental research on humans.

Since Gelsinger died last September, there has been a swirl of activity (sometimes dizzying) about how to protect human subjects in clinical trials such as the gene transfer one that took the life of the 18-year-old. A few months ago, Donna E. Shalala, Secretary of Health and Human Services, called on the National Institutes of Health (NIH) to “clarify its regulations” concerning such matters. Responding to that charge, last month the NIH convened a two-day conference on “Human Subject Protection and Financial Conflicts of Interest.” Echoing that concern, the National Academy of Sciences (NAS) is conducting its own study of the conflicts problem, as is the Association of American Universities.

More recently, Secretary Shalala, writing in the New England Journal of Medicine (Sept. 14), ordered the Department of Health and Human Services to “hold public discussions with universities and academic medical centers to find new ways to minimize or eliminate conflicts of interest. On the basis of these public forums,” she added, “the NIH, FDA, and other agencies will work together to develop new guidelines.”

In the face of efforts by universities and industries to derail or minimize any government action, along comes Gelsinger v. Trustees of the University of Pennsylvania. The lawsuits claims that the defendants acted negligently, recklessly, and fraudulently. The eight-count complaint — replete with allegations of wrongful death, intentional assault, lack of informed consent, and fraud — could either trump possible federal regulation or accelerate and enhance it in significant ways. Either way, the case filed last Monday in the Philadelphia Court of Common Pleas may prompt the kind of long overdue ethical norms too regularly ignored by too many universities.

Should Mr. Milstein win his lawsuit in court, the precedent would rock the medical and educational establishments. Whatever actions the federal government may take (short of preempting such lawsuits), the possibility of general and punitive damages would surely ignite ethical reforms. Undoubtedly, university lawyers would insist on more substantial protections to safeguard patients if failure to do so could result in crippling damage awards. And even if the Gelsinger case is settled out of court (as is likely), the proverbial cat is out of the bag — i.e., the courts may be asked to punish those who do not give people involved in medical experiments their full due of care and information.

Alternatively, the Gelsinger lawsuit may prove to be a milestone if it spurs federal regulators to adopt meaningful regulations better to protect and inform medical research subjects. Furthermore, the lawsuit may encourage some kind of bold action to remedy the out-of-control problem created by conflicts of interest as more and more universities entangle themselves in all sorts of business arrangements, the kinds of which are rarely disclosed to the public or the press. In a powerful speech to the NIH last month, Dr. Marcia Angell, the former editor of the New England Journal of Medicine, outlined six things that the federal government should do to remedy the problems typified by the Gelsinger case. Before the lawsuit against Penn, some found her recommendations rather fanciful. But now the world looks different — for what was yesterday dismissed as an idealistic solution may tomorrow be adopted as a pragmatic one.

Left unchecked, money corrupts medicine. That is, above all, the tragic lesson in the death of Jesse Gelsinger.