Hearing on medical-testing protection delayed

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A congressional watchdog agency says the federal government is moving too slowly to improve protections for people who participate in medical clinical-research trials.

Notably, even the Senate hearing at which that finding was to be presented was postponed yesterday. Members of the Senate Subcommittee on Public Health were instead kept on the Senate floor throughout the morning, casting a series of votes on tax-cut bills.

Testimony The Seattle Times obtained written versions of testimony that was to have been presented, including an 11-page statement (2.9MB PDF) by the United States General Accounting Office outlining recent government actions on patient-consent and financial conflicts-of-interest in clinical trials, and expressing concern about the lack of progress in key areas.

The Seattle Times obtained written versions of the testimony that was to have been presented yesterday.

Sen. Bill Frist, R-Tenn., chairman, said the subcommittee would reschedule the hearing, entitled, "Human Subject Research: Are Patients Protected?" Scheduled to speak were witnesses from inside and outside the government - including, as the opening witness, the sister of a woman who died in a controversial experiment at Seattle's Fred Hutchinson Cancer Research Center.

Even if Democrats take control of the Senate and the subcommittee chair, this topic will remain front and center: Sen. Edward Kennedy of Massachusetts, the top-ranking Democrat, has joined Frist in supporting new legislation on clinical trials.

Congressional concern about protections for patients in clinical trials has grown dramatically in recent months, as several published reports - including stories in The Times in March - have described experiments in which patients were not fully informed about risks and in which researchers had private financial interests.

'Fill the gaps'

In her written testimony, Janet Heinrich, director of the General Accounting Office's health-care division, described a patchwork oversight system.

"At three key levels of human-subjects protection - federal agency, research institution, and individual investigator - more could be done to fill the gaps in protection efforts," she wrote.

While Heinrich welcomed efforts by the Department of Health and Human Services, she added: "We have some concerns about the pace and scope of the department's efforts to ensure the safety and protection of participants in clinical trials."

The federal government "appears to have lost momentum" in its initiative to conduct on-site reviews of clinical trials, Heinrich said, noting that not a single such visit has been made since October.

"In addition," Heinrich said, "while HHS has begun to examine the issues relating to financial conflicts of interest at research institutions, it is not yet clear how, or how quickly, the department plans to move to address these serious concerns."

'We trusted ... the doctors'

The Times' articles described problems with patients' informed consent and potential conflicts of interest by researchers in two major clinical trials at the Hutchinson Center. In one of those, 80 of 82 people died, including at least 20 from causes directly attributable to the experimental treatment.

Cheryl Chambers of Richmond, Va., whose sister, Becky Wright, died at The Hutch after enrolling in that clinical trial, was to be the first witness called yesterday. In her written testimony, Chambers called for the Department of Health and Human Services' Office of Human Research Protections to reopen an investigation into The Hutch.

"We looked to the doctors and the medical institutions as a source of hope," she said in prepared remarks. "Our family researched and discussed treatment options at length, and finally, we did what most people who are sick do - we trusted the advice and counsel of the doctors."

Alan Milstein, an attorney who has sued three medical centers, including The Hutch, alleging violations of patient-protection laws, accompanied Chambers to the hearing.

"I think those guys got nervous," Milstein said after the hearing was cancelled. "A lot of these people other than the first witness, who was Cheryl, were the drug companies and others that were going to say everything's fine.... It's all politics with them."

In other prepared testimony:

• Dr. David Korn, a senior vice president of the Association of American Medical Colleges (AAMC), representing most major U.S. and Canadian medical schools and major teaching hospitals, appealed to Congress to give those institutions more time to fix themselves.

"We are troubled by recent reports of lapses in the oversight of clinical research in some of our most prestigious members, reports that threaten public confidence in our nation's system for protecting research participants," Korn said in his prepared statement. "And we are disturbed by allegations that the financial interests of faculty investigators or their institutions may have compromised their independence and credibility, and threatened the welfare of research participants as well as scientific integrity."

He said AAMC was within 18 months of finishing "two major new initiatives": a voluntary accreditation program for internal-review boards at research centers, and a task force studying ways to manage, disclose and possibly ban financial conflicts.

• Alexander Morgan Capron, a member of the National Bioethics Advisory Commission, called for legislation to strengthen oversight and create an independent federal office to oversee human research.

• Bernice Welles, representing the Biotechnology Industry Organization, warned that increased regulation could stifle innovation in the field of pharmaceuticals research, but conceded that "reform of the existing system is not only necessary and desirable, but appears inevitable."