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Aegis Note: Some organizations involved in the wireless radiation debates have used the content of this paper as a comparison of events surrounding the controversy, particularly as it relates to SAR standards. A slightly different version was published in the Legal Times, October 16, 2000, page 83.

Regulating Dr. Frankenstein: Money, Lax Ethics & Clinical Trials
Center For Science In The Public Interest
By: Ronald Collins
November, 2000

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. Alan Milstein, lead counsel for the plaintiffs, filed the lawsuit 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 this murky realm of science and ethics. The Gelsinger complaint alleges the appearance of substantial conflicts of interest; Milstein 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 “consent” form used in it) has drawn considerable public, press, and regulatory attention.

Swirl of Activity
There has been a swirl of official activity (sometimes dizzying) since Mr. Gelsinger died last September. The focus has been on clinical trials such as the gene transfer one 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 the increasing number of medical experiments. The system — including federal oversight — is flawed and thus 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 E. Shalala, Secretary of Health and Human Services (HHS), who a few months ago called on the National Institutes of Health (NIH) 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 (NAS) is also conducting a 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), 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, Congressman Dan Burton (R-Indiana), Chair of the Committee on Government Reform, sent a letter (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 (FDA) or on a Center for Disease Control advisory committee. His letter was followed up with a 46-page committee report (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 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 trump possible federal regulation or accelerate and enhance it in significant ways. 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 Mr. Milstein win the case in court, the precedent would rock the medical and educational establishments. Whatever actions the federal government might take (short of preempting 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 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, which are rarely disclosed to the public or the press.

What to do
In a powerful speech to the NIH (Aug. 16, 2000), Dr. Marcia Angell, the former editor of the New England Journal of Medicine, outlined six things that should be done to remedy the problems typified by the Gelsinger case. In brief, Dr. Angell suggested the adoption of the following guidelines: (1) medical “investigators who receive grant support from industry should have no other financial ties to those companies” (e.g., equity stakes in those companies); (2) “institutions should not accept grants with strings attached. 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) “institutions should not become outposts for industry by allowing investor-owned companies to set up teaching or research centers in their hospitals and giving them access to the students, house officers and patients”; (5) “institutions and the 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.

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