HHS Seeks Science Advice to Match Bush Views

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HHS Seeks Science Advice to Match Bush Views

By Rick Weiss

Washington Post Staff Writer

Tuesday, September 17, 2002; Page A01

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.

In the past few weeks, the Department of Health and Human Services has

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 against the real-life

Brockovich.

The changes are among the first in a gradual restructuring of the system

that funnels expert advice to Health and Human Services Secretary Tommy G.

.

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 Reagan took

office in 1981.

HHS spokesman 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 has irritated some HHS veterans with his " top

down " approach to reshaping the department, but he defended '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 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 s 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 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 Gelsinger, who became a member of the

committee after his son, , 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. 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.

Burke, the s 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 new appointees are well known for their connections to the chemical

industry.

They include 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 Co. when the

utility was sued for allowing poisonous chromium to leach into groundwater.

The case was made famous in the movie " 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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