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Law gives ethics power. That is, it may make ethics enforceable. Case in point: Gelsinger v. Trustees of the University of Pennsylvania, a bioethics torts suit filed last month in the Philadelphia Court of Common Pleas. The action was brought by the family of Jesse Gelsinger, who died last year from gene-transfer therapy conducted at the University of Pennsylvania, against the university and Arthur Caplan (its director of bioethics), among others. The action is significant for several reasons, one of which is the impact it could have on possible federal regulations of experimental research on humans. Charges of conflicts of interest are an important element of the case, and such charges could very much affect the direction of the law in the murky realm of science and ethics. The Gelsinger complaint alleges the appearance of substantial conflicts of interest. It claims 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. That aspect of the case (and the questionable consent form used in it) has drawn considerable public, press, and regulatory attention. SWIRL OF ACTIVITY There has been a swirl of official activity since Gelsinger died last September. The focus has been on clinical trials like the one involving gene transfers that took the life of the 18-year-old. In the wake of the young man’s death, it seems that everyone is suddenly concerned about how best to protect human subjects in such trials — and how to avoid ethical breaches related to conflicts of interest. Stricter standards are needed to protect subjects in the increasing number of medical experiments. The system — including federal oversight — is flawed and needs to be revised. So argued Dr. Greg Koski, the new director of the Office of Human Research Protections. That concern is shared by Donna Shalala, secretary of Health and Human Services (HHS), who a few months ago called on the National Institutes of Health to “clarify its regulations” concerning such matters. Responding to that charge, last August the NIH convened a two-day conference on “Human Subject Protection and Financial Conflicts of Interest.” The National Academy of Sciences is also conducting a study of the conflict problem, as is the Association of American Universities. More recently, Secretary Shalala, writing in the Sept. 14 issue of the New England Journal of Medicine, announced that the Department of Health and Human Services would “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.” Meanwhile, on a related front, Rep. Dan Burton, R-Ind., chair of the House Committee on Government Reform, sent a letter on Aug. 10 to Secretary Shalala requesting that the HHS adopt new and firm policies to disqualify anyone with a conflict of interest from sitting on a Food and Drug Administration or on a Center for Disease Control advisory committee. His letter was followed up with a 46-page committee report, on Aug. 21, quite critical of the ties between advisory committee members and industry. (The report stems from the FDA’s controversial approval of a rotavirus vaccine.) COMMON-LAW ETHICS In the face of such calls for reform, along comes Gelsinger v. Trustees of the University of Pennsylvania. The lawsuit, which seeks general and punitive damages, claims that the defendants acted negligently, recklessly, and fraudulently. The eight-count complaint alleges wrongful death, strict products liability, intentional assault and battery, lack of informed consent, intentional and negligent infliction of emotional distress, and fraud. One count even alleges fraud against the FDA in how it went about approving the gene transfer study that ended in the death of Gelsinger. The Gelsinger case could accelerate or enhance the gestating federal regulations in significant ways and might even trump them. Either way, the case may prompt the kind of long overdue ethical norms too regularly ignored by too many universities, scientists, physicians, and government regulators. Should Gelsinger’s family win the case in court, the precedent could rock the medical and educational establishments. Whatever actions the federal government might take (short of pre-empting such lawsuits), the possibility of 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 case is settled out of court (as is likely), the proverbial cat is out of the bag — the courts may be asked to punish those who do not give people involved in medical experiments their full due of information and care. Alternatively, the lawsuit may prove to be a milestone if it spurs federal regulators to adopt meaningful regulations to better protect and inform medical research subjects. Furthermore, it 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, which are rarely disclosed to the public or the press. In a powerful speech to the NIH this summer, Dr. Marcia Angell, a former editor in chief of the New England Journal of Medicine, outlined six reforms that should be undertaken to remedy the problems typified by the Gelsinger case. She suggested the adoption of the following guidelines: (1) Medical investigators who receive grant support from industry should have no other financial ties, such as equity stakes, in the companies; (2) institutions should not accept grants with strings attached; instead, investigators should design and analyze their own studies, write their own papers, and decide about publication; (3) consultancy arrangements need to be carefully limited; (4) research institutions should not become outposts for industry, and so should not allow investor-owned companies to set up teaching or research centers in hospitals, or give such companies access to the hospitals’ students and patients; (5) institutions and their senior officials should not have investments in any health care industry; and (6) institutions need to get together on this issue and develop a common policy. Before the lawsuit against Penn, some found Dr. Angell’s 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. In light of so many recent developments, her recommendations — and others — may one day become the official norm. Scientists and universities have had their chance to adopt and actively promote meaningful and fair standards of ethical conduct concerning conflicts of interest. Judging from the Gelsinger case, they have done too little for far too long. Now the law — regulatory, common law, or both — must step in and protect the public welfare against those entrusted with discovering ways to improve the public well-being. Ronald Collins directs the Integrity in Science Project at the Center for Science in the Public Interest, a nonprofit group in Washington. The group’s Web site is www.cspinet.org; his e-mail address is [email protected]

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