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
health…and 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."