RESTRUCTURING OF COMMITTEES THAT GUIDE
FEDERAL POLICY WORRISOME

by Rick Weiss

The Bush administration has begun a broad restructuring of the scientific advisory committees that guide federal policy in areas such as patients’ rights and public health, eliminating some committees that were coming to conclusions at odds with the president’s views and in other cases replacing members with handpicked choices.

[During September], the Department of Health and Human Services (HHS) retired two expert committees before their work was complete. One had recommended that the Food and Drug Administration expand its regulation of the increasingly lucrative genetic testing industry, which has so far been free of such oversight. The other committee, which was rethinking federal protections for human research subjects, had drawn the ire of administration supporters on the religious right, according to government sources.

A third committee, which had been assessing the effects of environmental chemicals on human health, has been told that nearly all of its members will be replaced—in several instances by people with links to the industries that make those chemicals. One new member is a California scientist who helped defend Pacific Gas and Electric Co. against the real-life Erin Brockovich.

The changes are among the first in a gradual restructuring of the system that funnels expert advice to HHS Secretary Tommy G. Thompson.

That system includes more than 250 committees, each composed of people with scientific, legal or academic expertise who volunteer their services over multiyear terms.

The committees typically toil in near anonymity, but they are important because their interpretation of scientific data can sway an agency’s approach to health risk and regulation.

The overhaul is rattling some HHS employees, some of whom said they have not seen such a political makeover of the department since Ronald Reagan took office in 1981.

HHS spokesman William Pierce said he could not provide a tally of the number of committees that had been eliminated or changed so far, but he denied that the degree of change was out of the ordinary for the first years after a change of administration.

He acknowledged that Thompson has irritated some HHS veterans with his “top down” approach to reshaping the department, but he defended Thompson’s prerogative to hear preferentially from experts who share the president’s philosophical sensibilities.

“No one should be surprised when an administration makes changes like this,” Pierce said. “I don’t think there is anything going on here that has not gone on with each and every administration since George Washington.”

Routine or not, the restructuring offers a view into how tomorrow’s science policies are being constructed—and how the previous administration’s influence is being quietly dismantled.

One example of the recent changes is the Secretary’s Advisory Committee on Genetic Testing, created during the Clinton administration after a major federal report concluded that the public was at risk of being harmed by the emerging gene-testing industry.

One of the first topics tackled by the committee was how to deal with the proliferation of so-called home-brew genetic tests, which are offered by a growing number of companies and doctors.

The blood tests can detect DNA variations that may increase a person’s odds of getting a disease or affect a patient’s response to medicines.

The Food and Drug Administration has long asserted that it has the authority to regulate these tests, but it has opted not to do so—in part because of a lack of resources. As a result, companies are free to market tests for genes even if those genes have no proven role in disease susceptibility or any proven usefulness at all. A growing number of companies are doing just that—at no small expense to consumers—in some cases needlessly alarming people with meaningless results and in other cases offering false reassurance.

The committee convinced the FDA to use its authority to oversee the marketing of these tests, and the agency was developing rules when the Bush administration took over. Suddenly the FDA’s stance changed: The agency was no longer certain it had the regulatory authority in question. Oversight plans stalled. Today the FDA is still mulling whether it has authority, Pierce said, and last week members learned that the committee’s charter, which just expired, will not be renewed.

“This is a real turnaround. It’s bad. It’s terrible,” said Neil A. “Tony” Holtzman, a Johns Hopkins University professor emeritus who chaired the HHS task force that led to the committee’s creation.

Wylie Burke, who chairs the department of medical history and ethics at the University of Washington and was a member of the committee, said gene-test oversight is needed now more than ever because companies are starting to advertise tests directly to consumers and are offering questionable services over the Internet.

“People need to know what they’re getting,” Burke said. “We were making real headway with informed-consent issues and with categorizing levels of risk. It would be a shame if that does not get completed.”

Pierce said the committee’s demise had nothing to do with its recommendations or regulatory approach. Rather, he said, HHS intends to create a new committee that will deal with a broader range of genetic technologies. The department has not said who will sit on that committee.

Another example is the National Human Research Protections Advisory Committee, created under President Bill Clinton after a series of government reports found serious deficiencies in the federal system for protecting human subjects in research. The call from HHS to disband “came out of the blue,” said committee chair Mary Faith Marshall, a professor of medicine and bioethics at the University of Kansas in Kansas City.

Some sources suggested the committee had angered the pharmaceutical industry or other research enterprises because of its recommendations to tighten up conflict-of-interest rules and impose new restrictions on research involving the mentally ill.

“It’s very frustrating,” said Paul Gelsinger, who became a member of the committee after his son, Jesse, died in a Pennsylvania gene therapy experiment that was later found to have broken basic safety rules. “It’s always been my view that money is running the research show,” he said. “So with this administration’s ties to industry, I’m not surprised” to see the committee killed.

Other sources said the committee had run afoul of religious conservatives when it failed to support an administration push to include fetuses under a federal regulation pertaining to human research on newborns. Some within HHS said they’d heard the department may reconstitute the committee with a purview that includes research on human fetuses or even embryos—a change seen by some as part of a larger administration effort to bring rights to the unborn.

Consistent with that possibility, HHS officials recently told committee members they hope to name Mildred Jefferson to a reincarnated version of the committee that the department hopes to create. Jefferson is a medical doctor who helped found the National Right to Life Committee and who three times served as that organization’s president.

Pierce said HHS had allowed the committee to expire not because of the direction of its work but because, as with the genetic-testing committee, the department wants to create a new panel with a broader, as yet undetermined, charge. That committee has yet to be created or its members named.

Yet another committee caught up in the recent upheaval is one that advises the Centers for Disease Control and Prevention’s National Center for Environmental Health on a range of public health issues from pollution to bioterrorism.

Thomas Burke, the Johns Hopkins public health professor who has chaired the committee for almost five years, recently learned that 15 of its 18 members are to be replaced. In the past, he said, HHS had asked him to recommend new members when there were openings. This time, he said, a list of names was imposed. He was among those who were let go.

Burke said he was not offended that his own membership, which was expiring, was not renewed. “There’s constant turnover on these boards,” he said. “What’s of concern though is to see so much turnover at one time, especially at such a critical time for the CDC.”

He mentioned another concern: One of the committee’s major endeavors has been to assess the health effects of low-level exposures to environmental chemicals, yet as first reported by Science magazine last week, several of the nsew appointees are well known for their connections to the chemical industry.
They include Roger McClellan, former president of the Chemical Industry Institute of Toxicology, a North Carolina research firm supported by chemical company dues; Becky Norton Dunlop, a vice president of the Heritage Foundation who, as Virginia’s secretary of natural resources, fought against environmental regulation; and Lois Swirsky Gold, a University of California risk-assessment specialist who has made a career countering environmentalists’ claims of links between pollutants and cancer.

The committee also includes Dennis Paustenbach, the California toxicologist who served as an expert witness for Pacific Gas and Electric when the utility was sued for allowing poisonous chromium to leach into groundwater. The case was made famous in the movie “Erin Brockovich.”

“It’s in the nation’s interest to avoid any appearance of a conflict of interest on these committees,” said Burke, the former chairman. “To see friends of the administration…clearly that’s what we’re seeing here. It’s wholesale change. The complexion has changed.”

HHS’s Pierce said the committee remains balanced overall, and no prospective member of any advisory committee is subjected to political screenings.
“It’s always a matter of qualifications first and foremost,” Pierce said.“There’s no quotas on any of this stuff. There’s no litmus test of any kind.”

At least one nationally renowned academic, who was recently called by an administration official to talk about serving on an HHS advisory committee, disagreed with that assessment. To the candidate’s surprise, the official asked for the professor’s views on embryo cell research, cloning and physician-assisted suicide. After that, the candidate said, the interviewer told the candidate that the position would have to go to someone else because the candidate’s views did not match those of the administration.

Asked to reconcile that experience with his previous assurance, Pierce said of the interview questions: “Those are not litmus tests.”

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Rick Weiss is a Washington Post staff writer.“HHS Seeks Science Advice to Match Bush Views,” Sept. 17, 2002. Reprinted with permission.

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