July 21, 2006

Some FDA scientists claim interference

By Lisa Richwine

WASHINGTON (Reuters) - Fifteen percent of about 1,000 U.S.
Food and Drug Administration scientists say they have been
wrongly asked to withhold or alter information or their
conclusions in agency documents, according to a survey released
on Thursday by an advocacy group.

The liberal-leaning Union of Concerned Scientists said the
results were further evidence of interference with science at
federal agencies.

But an FDA spokeswoman dismissed the findings, saying they
were "based on leading questions and innuendo."

The group sent questionnaires to nearly 6,000 FDA
scientists. Of the 997 who responded anonymously, 15 percent
said they had been "asked, for non-scientific reasons, to
inappropriately exclude or alter technical information or my
conclusions in an FDA scientific document."

"That number should be zero," said Francesca Grifo, head of
the group's scientific integrity program.

Seventeen percent said they had been asked by FDA officials
"to provide incomplete, inaccurate or misleading information to
the public, regulated industry, media or elected/senior
government officials."

Forty percent said they feared retaliation if they voiced
concerns about product safety in public.

Two FDA scientists have publicly stated in recent years
that their concerns about medicines were downplayed or
dismissed by superiors. Another top FDA women's health official
resigned to protest what she said was political interference
with science.

FDA spokeswoman Susan Bro called the survey a
"counter-productive exercise based on leading questions and

"For centuries, science has depended on rigorous and
disciplined processes to distill truth from exploration and
debate. These principles above all others guide our daily work
at the FDA on behalf of the American public health," she said.

The agency regulates about one-quarter of the U.S. economy,
including drugs, medical devices, most foods and other

The survey was co-sponsored by Public Employees for
Environmental Responsibility, a group created to promote
environmental ethics and accountability.

In a 2002 survey by the Department of Health and Human
Services inspector general, about 20 percent of FDA scientists
said they were pressured to approve or recommend approval of a
medicine despite reservations about risks or effectiveness.