By Lisa Seachrist
BETHESDA, Md. - Calling the oversight record of the Recombinant DNA Advisory Committee (RAC) "shameful," Jeremy Rifkin, president of the Foundation of Economic Trends, challenged the RAC Friday to place a moratorium on all gene therapy trials using viral vectors except in cases when the therapy is a treatment of last resort.
The RAC heard Rifkin's proposal, established a working group to respond and ultimately decided a moratorium was unnecessary, and that limiting gene therapy research only to terminal patients was ethically questionable.
"Speaking for myself here, I have to say Mr. Rifkin's proposal comes perilously close to saying terminally ill patients are expendable," said working group chair Nancy King, associate professor of social medicine at the University of North Carolina in Chapel Hill. "There is an enormous tendency to overpromise the potential of Phase I research. The exception for treatment of last resort can't solve that problem."
Rifkin took offense at King's statement, saying, "I was trying to posit some avenue for the research to move forward. If someone wants to do something to advance the therapy for altruistic reasons, they should have the opportunity to do so. What I was trying to prevent is the death of another Jesse Gelsinger, who was relatively healthy. We want to proceed with a little caution. The careful approach is always the best approach."
Rifkin noted that 10 years ago, when the RAC was considering moving gene therapy into its first clinical trials, he advised against it because there was insufficient preclinical work, serious potential for complications as a result of using viral vectors, inherent conflicts of interest and a regulatory framework that was inadequate.
"Now we have one known death, hundreds and hundreds of adverse events and conflicts of interest greater than I could have imagined," Rifkin said. "We need to take one small step backward."
King noted the RAC had spent the bulk of its meeting devising plans to enhance the oversight of gene therapy trials, with an eye to minimizing the risks associated with the research. She said a moratorium such as the one proposed by Rifkin would be overinclusive because it would halt or postpone some low-risk but potentially valuable research. In addition, the proposal could be not inclusive enough since it would exempt non-viral vectors. The working group preferred a case-by-case examination of gene therapy protocols.
Rifkin maintained the financial potential of such research is straining the research endeavor. "There's money to be made even if these trials don't work. Getting approval to enter Phase I trials allows a company to secure venture capital or put out an IPO. There is a lot of greed here," he said.
While concerned about the corrupting influence of money on the research enterprise, the RAC earlier in the day focused on requiring investigators to disclose any financial interest to research participants before they enter a trial.
The RAC also heard from patients who've participated in gene therapy research and industry representatives. Michael Werner, bioethics counsel for the Biotechnology Industry Organization, said "This proposal is ill-advised and short-sighted and could halt a promising area of research."