Monday, April 24, 2006

Under Bush the FDA is selling you out to big pharma.

Since the beginning, the Bush Regime has been intent on revising the job of the FDA from a consumer safety watchdog, into a big pharma profits watchdog.

The Government Accountability Office is starting to take notice.

The Food and Drug Administration is sometimes too slow in picking up safety
problems once drugs are on the market and in responding to emerging danger
signals, a federal study concluded in a report to be released today.

The review by the Government Accountability Office found that the FDA does
not have clear policies for addressing drug safety issues and that it sometimes
excludes its best safety experts from important meetings.

The report also calls on Congress to consider expanding the FDA's authority
to require that drug companies conduct studies of already-approved products. The
agency's ability to order post-market studies is now limited, and many drug
companies have been slow to conduct studies that they had agreed to undertake as
a condition of gaining FDA approval.

The question is, why did it take so long?

In 2004, 20 year FDA employee Dr. David Graham became the whistleblower that got Merck to take Vioxx off the market.

"Today, the United States of America is worse off when it comes to drug safety
than it was a year ago when I testified," Graham says. That's because the FDA's
recent drug safety initiatives serve only as window dressing, diverting
attention away from real solutions, such as an independent Office of Drug
Safety, Graham says.

An article from JAMA states:

An article in this week's Journal of the American Medical Association supports
Graham's assessment of the FDA. Especially in the past five years, writes Howard
Markel, a University of Michigan pediatrician and history of medicine professor,
the FDA has been heading downward "from a sterling - albeit very human -
regulatory agency into one much more tarnished, politicized, and increasingly
disputed by the very people it was designed to protect."

How does the FDA respond?

Susan Bro, senior communications adviser in the FDA commissioner's
office, responded via e-mail:

"Who's the 'we' behind the FDA? Thousands of cutting-edge scientists,
physicians, pharmacists and public health experts who consult with their
colleagues and outside experts to make sound medical decisions and
recommendations each and every day. To characterize the work being done here as
anything less than substantial, forward-looking and ambitious is simply not

And how did the FDA thank Dr. David Graham for his public service?

Fearing for his job, Dr Graham sought the help of the Government
Accountability Project, a public interest group that protects whistleblowers in
order to promote governmental and corporate accountability.

But the group received another request from an anonymous whistleblower at
the FDA who was being "bullied" by Dr Graham. The caller also said that Dr
Graham's study could reflect scientific misconduct. After some investigation,
the "anonymous" call was found to come from FDA management, attempting
to discredit Dr Graham.

Not surprising from the folks that brought you the Iraq War.

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I did not mean that Conservatives are generally stupid; I meant, that stupid persons are generally Conservative. I believe that to be so obvious and undeniable a fact that I hardly think any hon. Gentleman will question it.

John Stuart Mill (May 20 1806 – May 8 1873)