FDA Scientists Pressured

PRESS RELEASE
By Eric Young, Emily Robinson, and Rich Hayes
Union of Concerned Scientists, JULY 20, 2006
Straight to the Source
PRESS RELEASE JULY 20, 2006 2:28 PM

CONTACT: Union of Concerned Scientists
Eric Young ,Press Secretary, 202-331-5439 eyoung@xxxxxxxxxx
Emily Robinson, Press Secretary, 202-331-5427 erobinson@xxxxxxxxxx
Rich Hayes, Media Director, 202-331-5437 rhayes@xxxxxxxxxx


FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear
Retaliation for Voicing Safety Concerns Public Health and Safety Will
Suffer without Leadership from FDA and Congress

WASHINGTON - July 20 - The Union of Concerned Scientists (UCS) today
released survey results that demonstrate pervasive and dangerous
political influence of science at the Food and Drug Administration
(FDA). Of the 997 FDA scientists who responded to the survey, nearly
one-fifth (18.4 percent) said that they "have been asked, for
non-scientific reasons, to inappropriately exclude or alter technical
information or their conclusions in a FDA scientific document." This is
the third survey UCS has conducted to examine inappropriate
interference with science at federal agencies.

"Science must be the driving force for decisions made at the FDA. These
disturbing survey results make it clear that inappropriate interference
is putting people in harm's way," said Dr. Francesca Grifo, Senior
Scientist and Director of UCS's Scientific Integrity Program. "FDA
leaders should act now to improve transparency and accountability and
renew respect for independent science at the agency."

The UCS survey, which was co-sponsored by Public Employees for
Environmental Responsibility, was sent to 5,918 FDA scientists. Forty
percent of respondents fear retaliation for voicing safety concerns in
public. This fear, scientists say, combines with other pressures to
compromise the agency's ability to protect public health and safety.
More than a third of the respondents did not feel they could express
safety concerns even inside the agency.

"This is more than just a bureaucratic problem within the agency," said
Kim Witczak, WoodyMatters.com, who lost her husband due to side effects
of a dangerous anti-depressant.

"It has real human impacts which can be devastating. My husband paid
the ultimate price for FDA's lack of accountability."

The survey also revealed other compelling points of concern:

61 percent of the respondents knew of cases where "Department of Health
and Human Services or FDA political appointees have inappropriately
injected themselves into FDA determinations or actions." Only 47
percent think the "FDA routinely provides complete and accurate
information to the public." 81 percent agreed that the "public would be
better served if the independence and authority of FDA post-market
safety systems were strengthened." 70 percent disagree with the
statement that FDA has sufficient resources to perform effectively its
mission of "protecting public healthSand helping to get accurate
science-based information they need to use medicines and foods to
improve their health." "The FDA regulates products vital to the
well-being of all Americans, including food, drugs, vaccines, and
medical devices," said Dr. Grifo. "To fully protect public health and
safety, the FDA must have the best available independent scientific
data."

To address the concerns raised by FDA scientists, UCS recommends:

­ Accountability: FDA leadership must face consequences if they side
with commercial or political interests and not with the American
people. ­ Transparency: Scientific research and reviews should be open
so any undue manipulation is immediately apparent.

­ Protection: Safeguards must be put in place for all government
scientists who speak out.

"What we see at the FDA, while dramatic and frightening, is all too
common at many federal agencies," said Dr. Grifo. "All federal
scientists need protections so they can speak out when their science is
manipulated, and all federal agencies need fully functioning
independent advisory committees. FDA leadership must understand and
support independent science and it is up to Congress to hold them
accountable."

.

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