Subject: FDA approved? Not as comforting as you think
From: "Danielle Brian, Project On Government Oversight" <[email-masked]>
To: John Podesta <[email-masked]>
Date: Mon, 21 Dec 2015 10:16:53 -0600

Project On Government Oversight
http://getinvolved.pogo.org/site/R?i=FTUJoB4EKwmUM4webNLQ6Q
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Dear John,

If you're like 70 percent of Americans, you take at least one
prescription medicine a day. And if you're like most people, the
words "FDA approved" on that drug offer a measure of comfort.
After all, the Food and Drug Administration keeps dangerous,
unproven medicines off the market. Right?

But just how safe are we? That's a question that we've been
thinking about a lot.

In October, we published our two-year investigation into the FDA's oversight 
of the blockbuster blood thinner Pradaxa, a drug that has been named in 
thousands of the FDA's "adverse event" reports, including cases involving patient
deaths. What we found was deeply disturbing.
( http://getinvolved.pogo.org/site/R?i=1X9RgFVRIbKJw7cvqeSxDg ) 

The issues ranged from questionable oversight of the blood
thinner's clinical trial to possible conflicts of interest
between members of FDA advisory committees and the pharmaceutical
company that makes Pradaxa.

We trust the FDA to keep us safe, but the way the agency handled
Pradaxa does little to inspire confidence.

Almost immediately after our report was published, the FDA
approved a much-needed antidote for Pradaxa, saying that the antidote was 
necessary in situations when bleeding can't be controlled. 
( http://getinvolved.pogo.org/site/R?i=RAfJO-Zy2I08ie_ar115sQ )

While an antidote is welcome, it doesn't solve the systemic
problems at the FDA. Since our initial report, we've continued to
dig, breaking a story that now raises questions about President
Obama's nominee to lead the FDA.

Last month, we reported that Robert Califf, Obama's FDA nominee, 
helped lead a clinical trial of another blood thinner,
Xarelto, that FDA scientsts said was biased in favor of the drug. 
( http://getinvolved.pogo.org/site/R?i=FmOxNdqvZWn0TKLlR12hSw )

The questions we raised prompted Duke University to re-examine
the clinical trial to determine whether the use of potentially malfunctioning
medical devices affected the results.
( http://getinvolved.pogo.org/site/R?i=pX2DcBvO-E2XZQ5S9CQVMg )  

In turn, FDA's counterpart in Europe, the European Medicines Agency, also
announced it would take a second look at the Xarelto trial.
( http://getinvolved.pogo.org/site/R?i=K_U37tpzzBKNIEG0GfBP4Q )

This is the kind of investigative reporting that we've been doing
for nearly 35 years. But for us, it's not just about exposing
problems, it's also about exploring solutions. That's why we're
also working with lawmakers to advance needed reforms.

Thank you for your continued support.

Sincerely,

Danielle Brian
Executive Director

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