Administration to expand monitoring of medical research

May 24, 2000
Web posted at: 3:42 p.m. EDT (1942 GMT)

In this story: Policies focus on consent, ethics Gene therapy controversy cited RELATED STORIES, SITES

From staff reports

WASHINGTON (CNN) -- Federal monitoring of gene-therapy tests and other medical research will expand in an attempt to reassure Americans of the integrity of scientific investigations, the head of the U.S. Department of Health and Human Services announced Tuesday.

HHS Secretary Donna E. Shalala also urged presidents of research universities and hospitals, members of boards that review scientific research and clinical investigators themselves "to follow internationally accepted ethical standards and federal guidelines."

"These clinical trials are going to be more numerous in the future as more products come on line, and to continue this extraordinary effort that we've had in science we need people to feel comfortable going into clinical trials," Shalala said.

New policies will be issued to require that a researcher’s financial interest in a clinical trial -- testing a new cancer or heart medicine, for example -- be disclosed to patients and others before they sign agreements to participate, she said.

Dr. Jane E. Henney, commissioner of the U.S Food and Drug Administration, said, "We must ensure that patients are well protected and properly informed when they choose to enroll in a clinical trial.

"By maintaining high standards and requiring that all investigators adhere to them, we can be sure that the nation's biomedical research enterprise will continue to earn the trust of research subjects."

The federal officials also announced an expansion of ethics training for clinical investigators and members of review boards and a clarification in the procedure for explaining risks to people before they sign "informed consent" agreements to participate in a study.

"Recent reports of problems in gene-transfer trials have highlighted the new pressures facing researchers," Secretary Shalala said.

Gene therapy involves transferring healthy genes into the cells of a patient to replace or repair genes linked to disease. To get past the body's defenses, the genetic material may be delivered attached to a virus, which can cause illness and, in one reported case, death.

Last September, 18-year-old Jesse Gelsinger died while participating in a University of Pennsylvania gene therapy trial for a rare liver disorder. The FDA halted subsequent clinical trials at the institute, citing serious violations of federal research rules.

The university's Institute for Human Gene Therapy, which conducted the Gelsinger trial, announced Wednesday it is suspending human clinical trials, though such research will continue in other divisions of the university.

The Clinton Administration plans to pursue legislation that would allow the FDA to impose civil fines for such violations. The maximum proposed fines are $250,000 for a clinical investigator and $1 million for a research institution.

But critics said even with fines, the new measures are an inadequate response to the problems with gene therapy trials.

It's not just about more data and more reporting," said Jeremy Rifkin, author of "The Biotech Century." "The real issue here is why are some people becoming ill and even dying after they are subjected to gene therapy. Until we get the answer to that question, we ought to have at least a partial moratorium on some of these experiments."

Some researchers have suggested only allowing patients who have no other treatment options to participate in gene therapy trials.

Federal officials acknowledge that some of these measures could be problematic, because they rely on already overloaded investigators for enforcement.

CNN Medical Correspondent Eileen O'Connor contributed to this report.

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U.S. Department of Health and Human Services
U.S. Food and Drug Administration

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