More than
a third of Food and Drug Administration scientists
who responded to a survey said agency officials
cared more about speeding new drugs and medical
devices to market than ensuring the products were
safe.
Thirty-nine percent said the agency wasn't "acting
effectively to protect public health," according
to results released Thursday by the Union of Concerned
Scientists, an advocacy group.
Whistle-blowers, members of Congress and interest
groups have for several years attacked the agency,
saying it has been weakened by industry and political
influence at the expense of sound science and
public health.
In the questionnaire, 15% of the 997 FDA scientists
who responded said they had been asked to "inappropriately"
exclude or alter information or conclusions in
agency documents for nonscientific reasons. Thirty-two
percent said the FDA didn't routinely provide
complete and accurate information to the public.
And 37% said FDA leaders weren't as committed
to product safety as to approving products for
sale.
FDA spokeswoman Susan Bro sharply disputed the
findings, criticizing the "unscientific rigor"
of the survey and stressing that the agency was
committed to protecting the public health.
"This is a counterproductive exercise based on
leading questions and innuendo," Bro said.
But congressional critics of the FDA said the
survey provided further evidence that the agency's
mission of ensuring the safety of drugs and medical
devices had been lost.
Senate Finance Committee Chairman Charles E. Grassley
(R-Iowa), who has led a hearing into safety issues
with the painkiller Vioxx and is leading an investigation
of the antibiotic Ketek, called in a statement
for a "major overhaul and a culture change at
the highest levels" of the FDA.
The agency, Grassley said, "needs to reestablish
its relationship with its own scientists and distance
itself from the drug industry. The FDA needs to
get rid of its mind-set that it's a facilitator
for the drug industry and become regulator once
again. The FDA's focus should be only on science
and the public good."
The Union of Concerned Scientists is a nonpartisan
group that has been critical of the Bush administration's
treatment of government scientists.
Its survey was mailed to 5,918 scientists.
Reference Source 130
July
21, 2006