Surgeon general: Investigate The Hutch
The Seattle Times
BETHESDA, Md. - Two controversial clinical trials conducted at Seattle's Fred Hutchinson Cancer Research Center deserve further investigation by the federal government, says the nation's top doctor.
Speaking to the National Human Research Protections Advisory Committee, which met in Bethesda the past two days, Surgeon General David Satcher said the public's confidence in clinical trials had been shaken in recent years and needs to be restored.
In an interview after his Monday speech, Satcher specifically urged government scrutiny of the Hutchinson-center trials. Last month, The Seattle Times reported that patients had died prematurely in the two experiments, both of which involved financial interests by The Hutch and its doctors.
In one, a trial involving leukemia patients, at least 20 people died of graft failures, cancer relapses and new cancers directly attributable to the experimental treatment. Hutch researchers held stock in a company that held the license to some of the drugs being tested, and some members of the hospital's internal-review board believed their concerns about potential conflicts of interest and about the dangers of the experiment were not adequately addressed.
In the other trial, breast-cancer patients were given a drug that was supposed to protect them against the ravages of high-dose chemotherapy, even though some of the researchers involved had concluded that the drug didn't work. At least four women died of that treatment.
"I certainly think that we have to make sure that the systems are in place to make sure that that doesn't happen again at this particular research center, which as you know has been a very productive center in many ways," Satcher said.
Satcher was quick to praise the overall performance of The Hutch, which receives more money than any other research center from the National Cancer Institute.
"These were more the exception than the rule in terms of its work, but that's a struggle that we face," he said.
Whether the trials get further investigation is still in question, however. Although Satcher has significant influence as surgeon general, he has no control over the office that investigates such cases.
That authority lies with Dr. Greg Koski, director of the Office for Human Research Protections of the Department of Health and Human Services. Koski, also at the two-day meeting of the advisory committee, said he would need "compelling reasons" from a preliminary staff review that is under way to open full investigations into the cases.
"At this point, we don't have any specific plans," Koski said.
Koski, appointed from Harvard University to the watchdog post last year, said he is most interested in looking forward, not backward.
"We have to focus really to prevent harm rather than to look back and punish," he said.
The surgeon general was bothered by Koski's indication that the cases might not get a closer look.
"It's hard for me to believe that he would say that we were not interested in what happened in those cases and didn't want to understand them in detail, and the implications of it in terms of that center, whether there does need to be changes," Satcher said. "I would say that we need to look at it that way."
Satcher and Koski agreed that the filing of a class-action lawsuit two weeks ago on behalf of families of 82 people enrolled in the blood-cancer experiment, known as Protocol 126, would make it more difficult for the federal government to dive into the Hutch case.
The human-research committee is helping the Bush administration assess the necessity for reforms in human clinical trials. Among those attending the meeting were the two sisters and the daughter of Becky Wright, an Alabama woman who died in Protocol 126.
The daughter, Mindy Pritchard, 13 years old at the time of her mother's death in 1987, is now a photographer, substitute schoolteacher and mother of two. She drove 850 miles from Heflin, Ala., to hear what officials would say about her mother's case.
One of Wright's sisters, Cheryl Chambers, had donated her bone marrow for transplantation to her ill sister. But as part of the experiment, that marrow was treated in a way that made Wright more vulnerable to graft failure.
Chambers told the committee she felt misled by Hutch doctors and disappointed that a cursory investigation by the federal government in the late 1990s brought no action.
"Why was not something done about this?" Chambers asked. "As a sibling, I cannot sue in the state of Washington, so I am here to state my case."
Chambers, an algebra teacher in Virginia, said she never thought to ask Hutch doctors about how many people had died in the experiment (eight to that point) or whether the doctors themselves had financial interests in the trial.
"When somebody is sick, you can't sit there and say, `Do you have any financial investment in this? If you do, let us know.' You don't ask any questions about it. Your mind is not in that framework. What I would like to see done is all have financial disclosure immediately," Chambers said.
Hutchinson-center officials have insisted that financial interests played no part in the medical decisions in the clinical trials.
The committee, which is to meet again July 30-31, is expected to recommend changes to rules or laws, as are other blue-ribbon groups and members of Congress in a momentum toward reforming human protections in clinical research.
Meanwhile, the Hutchinson center itself is gathering a blue-ribbon committee to assess its policies and to recommend any needed changes.
Hutch officials did not return calls for comment.
One of the most outspoken of the national-committee members, Adil Shamoo of the University of Maryland School of Medicine, said research centers are flouting the law that requires them to notify the federal government of injuries and deaths attributable to their research.
He said researchers reported only eight deaths among 70 million Americans in human-research studies during the past 10 years, based on his survey of official government reports.
"Hundreds if not thousands of reportable deaths go unreported," Shamoo said.
Koski, who is supposed to receive such reports of deaths and injuries in clinical trials, later said he did not know the exact numbers but agreed there was widespread underreporting.
"There's no doubt in my mind that the adverse-event process in place is in need of work, and there's work under way," Koski said. "It's critically important."
Another committee member, Abbey Meyers, president of the National Association for Rare Disorders, termed the Hutchinson cases "another body-slam to research."
"But the whole field is a sewer," she said. "What happened at The Hutch is not unusual. This is the problem."
Meyers said The Hutch should have stopped the blood-cancer study much earlier than it did.
"If I had a relative who was harmed in one of those experiments," she said, "I would sue."