Protections in clinical trials still seen as lax.(Little Change In Regulations)

WILMINGTON, DEL. -- Despite the controversy following the death of University of Pennsylvania patient Jesse Gelsinger, little has changed in the regulation of clinical trials since then, according to Arthur Caplan, Ph.D., director of the Center for Bioethics at the university in Philadelphia.

The long-term impact of Jesse Gelsinger's death on efforts to better monitor human experimentation has been "absolutely nothing," Dr. Caplan said at the annual meeting of the American Society of Law, Medicine and Ethics. "In fact, I'd argue that in some ways, human subject protection is worse than it was when Jesse died."

In September 1999, Mr. Gelsinger participated in a clinical trial designed to test a potential gene therapy for ornithine transcarbamylase deficiency. He suffered multiple organ failure 4 days after genetically altered viruses were injected into his liver, and his family decided to withdraw life support. This occurred during a trial that had been approved by four different peer-review entities, "the most reviews ever done" for a clinical trial, Dr. Caplan noted.

Peer review is just one method used to protect patients during a clinical trial, but it has not changed much since Mr. Gelsinger's death, he continued. "The amount of money spent on institutional review boards (IRBs) today is probably the same as it was when Jesse Gelsinger died."

In fact, little attention is directed to what IRBs actually do, said Carl Coleman, associate professor of law at Seton Hall Law School in Newark, N.J. "Decisions are made by a relatively small group of people who tend to come from very similar backgrounds. They are made behind closed doors; the process is exclusive and secretive."

IRBs are not required to justify their decision to approve a study. "The regulations only require reasons for rejecting a protocol, which is ironic given that if it's rejected, there's no study," said Mr. Coleman. "The potential for arbitrariness is significant."

And because decisions can vary ...