Since Jesse Gelsinger died in 1999 as a result of a Penn-sponsored gene therapy experiment, his father, Paul, has worked for stricter federal regulations on human gene testing.
Now he fears that three years of advocacy are being dismantled, although other experts are not sure that this will be the case.
Gelsinger's death brought the Institute for Human Gene Therapy, which sponsored the trial in which Gelsinger was enrolled, under close scrutiny and resulted in a temporary FDA ban on all clinical trials at Penn.
In an effort to affect change, Paul Gelsinger joined a working group which offered recommendations to the Committee on Informed Consent, an advisory committee to the National Department of Health and Human Services.
But now, recent changes in the infrastructure of HHS have eliminated the committee on which Gelsinger served.
HHS receives reports and recommendations from its 258 advisory committees. Each of these committees has a charter with a time limit. Upon the charter's expiration, the current administration has the obligation to appoint new members and evaluate the effectiveness of the committee.
The charter for the Committee on Informed Consent has expired and the administration has opted to replace many of its current members.
"It's a step backwards," Paul Gelsinger said. "People were well along the path to creating changes and now it won't happen... it's very frustrating.
"They were the best people in the country to be recommending changes," Gelsinger said of the committee. "Now, there will be a new committee that is hand-selected by this administration."
HHS spokesman Bill Pierce denied that the appointments will be biased. In fact, many old committee members' terms will be renewed, according to Pierce.
"The [appointment] process we go through is first and foremost... looking at people who are highly qualified and will provide balance" to our committees, Pierce said.
George Annas of the Boston University Department of Health Law explained that advisory committees have no authority to enact legislation or change policy.
"It's not likely to affect [genetic testing] at all," he said.
The effectiveness of the restructuring "remains to be seen," according to Annas. "It would be too optimistic to say that it is a good thing -- it's neutral."
According to University of Pennsylvania Health System spokeswoman Rebecca Harmon, the changes that have been made over the past three years in how Penn regulates human gene testing were a result of initiatives from University President Judith Rodin's office, rather than HHS policy.
A recent change at Penn is the formation of the Office of Human Research, which will work to avoid another tragedy like the death of Jesse Gelsinger.
"The office is designed to educate and train our staff in all areas of clinical research oversight," Harmon said. "We also launched innovative online research" training.
Harmon said the University has taken great strides to "monitor patients' safety," and added she hopes Penn "can serve as the national model for programs in academic medicine."
