Congress takes on medical-trials controversy
Seattle Times staff reporters
WASHINGTON, D.C. - Spurred by questions about clinical medical trials in Seattle and elsewhere, Congress is looking closely at whether patients who participate are being properly informed and protected.
A Senate subcommittee takes up the issue this morning, beginning with testimony about a controversial experiment at Seattle's Fred Hutchinson Cancer Research Center.
The lead witness at the hearing of the Senate Subcommittee on Public Health is the sister of a woman who died in the experiment, called Protocol 126.
Cheryl Chambers, a teacher from Richmond, Va., said she would ask for new laws on protecting patients and guarding against conflicts of interest by researchers. She also planned to ask for a federal investigation of the Hutchinson center.
Chambers says she and her sister, Becky Wright of Heflin, Ala., were misled about the risks of the experimental treatment Wright agreed to in Protocol 126. They also were not told that the researchers in the clinical trial had financial interests in some of the drugs being tested.
In Protocol 126, which took place in various stages at The Hutch from 1981 to 1993, doctors researched whether using certain drugs to deplete T-cells in donated bone marrow would effectively eliminate a problem known as graft-versus-host disease and make bone-marrow transplants more successful.
The result was quite different, however, as The Seattle Times reported in March. Eighty of 82 people died in the experiment, including at least 20 from causes directly attributable to the treatment. Many of those, including Wright, had a good chance of survival with conventional bone-marrow transplants.
The three lead researchers and a Hutch-affiliated foundation held stock in a Seattle firm that held the commercial license to some of the drugs being tested. The researchers, now the subject of a federal class-action suit by families of some of the patients, insist they did nothing wrong.
Chambers, who donated bone marrow to Wright, says she was "shocked at the deception involved in my sister's care."
Today's Senate hearing is titled "Human Subject Research: Are Patients Protected?" Other scheduled witnesses include:
• Dr. Greg Koski, new director of the federal Office for Human Research Protections. He is promoting better training and certification of research-review boards. Critics want Koski's office divorced from the Department of Health and Human Services because of the conflicts inherent in both promoting and policing human experiments.
• University of Southern California medical ethicist Alex Capron. He represents the National Bioethics Advisory Commission, which recently called for requiring doctors to reveal their financial interests to patients.
Both the top Republican and the top Democrat on the subcommittee support reform. Sens. Bill Frist, R-Tenn., and Edward Kennedy, D-Mass., are collaborating on new legislation for patient protection in human research.
"They've been working together on it pretty well," said Margaret Camp, spokeswoman for Frist, the subcommittee chairman who is also a cardiologist. "They both think something needs to be done."
In the House of Representatives, meanwhile, Rep. Diana DeGette, D-Colo., is rounding up support for a new, broader version of the proposed Human Research Subject Protections Act, which languished last year.
"We're optimistic," DeGette's chief of staff, Lisa Cohen, said yesterday. "There's been sort of a renewed emphasis on this issue. The problem you faced in Seattle and a situation in Denver, which sparked the congresswoman's interest, have certainly percolated through the Congress. There's certainly movement."
Between 1986 and 1995, federal spending for health research doubled to $13.4 billion, and industry spending tripled to $18.6 billion. Clinical research is one of the few programs being expanded in President Bush's 2002 budget. More than 10,000 programs and 45,000 researchers conduct medical research on humans in the United States.
Dr. Mary Faith Marshall, a University of Kansas bioethicist and chairwoman of the National Human Research Protections Advisory Committee, calls this a "golden moment" for reform.
But Vera Hassner Sharav, president of a patient-advocacy group, Citizens for Responsible Care & Research, isn't so sure. She worries that industry influence won't allow real change in Congress. "It is a public outcry that has to happen. It is not going to come from within."
In the two months since The Times published its series on clinical trials at The Hutch - titled, "Uninformed Consent: What patients at 'The Hutch' weren't told about the experiments in which they died" - the cancer center has been assuring this state's congressional delegation that its procedures and patient protections are sound.
One of the first things Hutch President Dr. Lee Hartwell did after publication of the series was to fly to Washington, D.C., for meetings.
"They seem to be treating this with the care and importance that this demands," said Rep. Jay Inslee, D-Bainbridge Island, who said Hutch officials have displayed "exquisite sensitivity" to the concerns raised.
Inslee also applauded Hutch officials for appointing a panel to review its policies and practices. The panel, chaired by former Seattle University President the Rev. William Sullivan, is meeting privately and plans to issue a report later this year.
Audio of the Senate Subcommittee on Public Health's hearing on human-subject research can be heard on the C-SPAN web site www.capitolhearings.org/