Healthy Skepticism Library item: 5858

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Publication type: news

Barnes K, Elamin A.
FDA red-faced over claims it is suppressing evidence
in-Pharma Technologist.com 2006 Aug 1
http://www.in-pharmatechnologist.com/news/ng.asp?n=69555-fda-ucs-survey-vioxx-ketek

Full text:

FDA red-faced over claims it is suppressing evidence
By Kirsty Barnes and Ahmed ElAmin

01/08/2006 – The Food and Drug Administration (FDA) has been left red-faced
after a survey recently released by the Union of Concerned Scientists (UCS),
found a “disturbing level of interference in the agency’s research”.

According to UCS, the survey “demonstrates a pervasive and dangerous
political influence of science at the FDA .”

Almost 20 per cent of the nearly 1,000 scientists who responded anonymously
to the survey said they had experienced their work manipulated or
suppressed, having been “asked, for non-scientific reasons, to
inappropriately exclude or alter technical information or their conclusions
in an FDA scientific document.”

The scientists in question said they feared retaliation if they expressed
their opinions in public, the UCS reported.

Sixty-two percent of respondents were senior scientists, and nearly
one-third of respondents had been agency employees for more than 15 years.

Most of the allegations levelled by the scientists related to drug research,
and this criticism and the survey’s findings have important implications for
the public’s trust in the FDA’s role in regulating the drug industry, and by
implication in the safety of drug products.

The USC survey found that 61 per cent 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 per cent of respondents think the “FDA routinely provides complete
and accurate information to the public.” About 81 per cent agreed that the
“public would be better served if the independence and authority of FDA
post-market safety systems were strengthened.”

About 70 per cent disagreed 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.”

Many of the complaints were aimed at the agency’s Office of Regulatory
Affairs: one scientist said it should “not ostracise scientists or black
ball them because their foresight sees a problem with a drug, device, food,
biologics, etc. that possess a potential hazard to health now or in the
future.”

Respondents also commented that budget cuts were affecting the agency’s work
and that it was being politicised instead of being based on scientific
evidence.

“We need more money. We need new equipment,” said one scientist. “We should
be using the latest analysis techniques & modern technology instead of
relying on conventional methods.”

Another commentator said: “Over the last several years I have noticed a
significant increase in the number of decisions that have become politicized
(e.g., increasing requests to review even simple regulations and changes,
both by Congress and the Commissioner’s office and to make apparently
politically-motivated changes in language and sometimes to alter bottom line
results), and I think the integrity of scientific work could be improved by
minimising the ‘politics’ of the process.”

Another critic alleged: “I have seen violations that were not prosecuted
because legal staff and/or management knew that the time required to
prosecute some violations would take legal resources away from other
violations that would have more immediate and severe health consequences.”

In a similar vein one of the respondents called for “increasing resources to
permit FDA to maintain itself as a premier regulator of foods, drugs and
cosmetics.”

The FDA is responsible for protecting public health through the regulation
of drugs, food, medical devices, cosmetics, and the blood supply – including
products that, according to the agency, account for 25 cents of every
consumer dollar spent in the US.

However, these latest revelations have further damaged the FDA’s reputation,
already tarnished after its involvement in high-profile safety lapses such
as with Vioxx, the inflammatory drug withdrawn in 2004 after risks of heart
attack and stroke were identified, as well as Ketek, an antibiotic found to
have links to liver failure that was allegedly approved on the back of
fraudulent clinical evidence.