Business' research funding elicits backlash

New guidelines seek to protect people who volunteer for clinical trials.

By Myrle Croasdale, AMNews staff. Oct. 21, 2002.

The Assn. of American Medical Colleges and the Institute of Medicine have released reports aimed at reforming oversight of research involving human subjects.

The AAMC focused on conflicts of interest within research institutions, while the IOM recommended broadening federal authority to include research not currently under the government's jurisdiction

Sen. Edward Kennedy (D, Mass.) has introduced legislation in support of the IOM recommendations.

Research on human participants gained national attention due to a series of incidents, including the death of 18-year-old Jesse Gelsinger in 1999 during a gene-therapy experiment at the University of Pennsylvania, Philadelphia. It was later discovered that the researchers and the school had financial ties to the study. The university and the lead researcher denied that their financial involvement had any impact on patient care.

But the brouhaha led to congressional hearings on gene therapy and research on humans, and an acknowledgement that reform of the oversight process was sorely needed.

David Korn, MD, senior vice president of the AAMC Division of Biomedical and Health Sciences Research, explained that the biotech boom was a significant contributor to the growth in research being done with private dollars and the increase in conflicts of interest.

"Over the last decade, the amount of commercial interaction with biomedical research has grown enormously," Dr. Korn said.

"That's a good thing, because it means that much of the scientific discovery going on has the potential for practical applications, such as new ways to prevent or treat disease. [The downside is that] in our country the only pathway, outside of the defense industry, to get a research discovery into a commercial development path is with private money." [...]