http://www.washingtonpost.com/wp-dyn/articles/A26554-2002Sep16.html

===========================================================

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 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 Health and Human Services 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 new 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."






--------------------------------------------------------------------------------