Call made for reform in medical research

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WASHINGTON - Medical researchers and the agencies that regulate them should seize this "golden moment" to address problems with how human experimentation is conducted in this country, the leader of a blue-ribbon medical-ethics board said yesterday.

Dr. Mary Faith Marshall chairs the National Human Research Protections Advisory Committee, which is helping the federal Department of Health and Human Services assess the necessity for reforms in human clinical trials. Marshall spoke yesterday to more than 200 researchers, medical ethicists and administrators gathered in the nation's capital for an event called the Medical Research Summit.

She told the group that "the good work of journalists" has identified problems in medical research - problems that threaten to undermine the public's confidence.

Marshall specifically cited The Seattle Times' recent investigation of two clinical trials at the Fred Hutchinson Cancer Research Center. That series, and articles by The Washington Post and The New York Times, have raised serious, legitimate questions about such things as doctors' connections with biotechnology companies and the necessity for financial disclosure, she said.

"There is some serious investigational journalism being done in the area of human research protection, and things that are happening that shouldn't happen," she said. "It's incredibly important. The public listens, and because the public listens and is alarmed - rightly so in many instances - then Congress listens and Congress is alarmed.

"If we as a committee don't take advantage of the fact that attention is galvanized and make some real concrete, pragmatic changes in oversight mechanisms, then we have done I think a tremendous wrong," she said. "I think that our time has come."

Changes aren't expected soon

Marshall promised to start producing solutions - "two-page products that make change, not 200-page reports" - at the panel's second meeting April 9-10. But she cautioned that results may take time.

In particular, Marshall said, full disclosure to patients of the financial holdings of researchers and research centers is key to research integrity.

"In order for a research subject to give truly informed consent to participate in a study, he or she has to know about those financial arrangements," she said.

Marshall is a former clinical-care nurse who holds a Ph.D. and directs the program in bioethics at the University of Kansas Medical Center. She was named in December to head the 17-member panel, reporting directly to the secretary of Health and Human Services.

Guy Collier, a D.C.-based attorney speaking on "Investigator and Institutional Conflicts of Interest," said a consensus is emerging in leading research universities to require faculty to disclose their private holdings that might pose a conflict of interest with research credibility.

"It's really a question of disclosure, not outright prohibition," he said, "I would ask you, why WOULDN'T you disclose it in your informed-consent documents?"

Regulations called `a mess'

Also in attendance at the summit was Dr. Thomas Puglisi, former director of compliance for the federal Office of Protection from Research Risks. His office was cited in The Seattle Times' series for conducting an incomplete investigation of one of the trials in question, a blood-cancer experiment in which patients were not fully informed about the risks nor of their doctors' financial connections to the drugs being tested.

The newspaper pointed out that Puglisi's office had failed to interview any of the researchers, patients or review-board members involved.

"We considered the allegations to be very important, very serious," Puglisi said yesterday. "We investigated to the extent that we thought our jurisdiction and resources permitted at the time.

"Today, we're much more sophisticated about conflict-of-interest issues, and I think it's important for the research community to confront the conflict-of-interest issues head on, because they're essential to public trust, and that's essential to continued clinical work."

Puglisi recently left the government to join PricewaterhouseCoopers, privately consulting for clinical research centers.

In a speech, Puglisi described the shelves full of reports gathering dust on problems in clinical trials, and the 17 separate federal agencies charged with regulating trials.

"What we've got from the regulatory standpoint is a mess," he said. "I couldn't say that when I worked for the federal government, but I can say that now."

Duff Wilson can be reached at 206-464-2288 or dwilson@seattletimes.com.