Saturday, June 15, 2013

Is FDA About to Greenlight a Drug Banned in Other Countries?

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Is FDA About to Greenlight a Drug Banned in Other Countries?

warning-fda-approvedIf enough people raise their voices in protest, we can
prevent it. Action Alert!

Remember the controversial diabetes drug Avandia? In 2010 we told you about
two FDA drug safety reviewers who warned the agency that Avandia posed
serious risks of heart attack and heart failure when compared with other
diabetes drugs. Since then, the drug has been removed from the market in most
countries and has been under severe restrictions in the US.

In a combined meeting of separate FDA advisory committees, 20 of 26 panelists
voted to recommend removing or modifying Avandia’s highly restrictive label
and distribution system. Five voted to keep the restrictions in place, while one
panelist voted to remove the product from the market altogether.

There has been only one large, randomized trial for the safety of
rosiglitazone, the drug that is marketed as Avandia. That trial—sponsored by
GlaxoSmithKline (GSK), the drug’s manufacturer—was called RECORD
(Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in
Diabetes). Serious flaws were found in RECORD’s methodology, its results were
questioned, and the trial was widely discredited.

In 2010, FDA required GSK’s RECORD results to be reexamined and re-
adjudicated. What was the FDA’s motivation for reviewing Avandia? GSK didn’t
request that the drug be reviewed. Could it be, as Steve Nissen suggests in
Forbes, because FDA “is seeking to avoid accountability for its role in the
Avandia tragedy”? FDA’s official position is that they asked for the re-
adjudication because of “the public interest in Avandia, the extensive
history of the product, and the continued uncertainty of the risk surrounding
this drug.”

Duke University’s Clinical Research Institute (DCRI) was selected for the
re-adjudication, and they found that the risk for cardiovascular death,
myocardial infarction (MI), and stroke to be virtually the same as the
original study concluded. Because these new results reaffirmed GSK’s
findingsthat the drug was no more unsafe than other diabetes products in
its class,

The panelists were sufficiently reassured that the drug was safeenough
to lift restrictions.

Unfortunately, other data paint a very different picture:

    In 2005 and 2006 GSK secretly conducted an analysis of cardiovascular
safety of Avandia, and concluded that the drug increased the risk of heart
attacks and related events by 30%. Since two-thirds of diabetics eventually
die of cardiovascular complications anyway, this 30% hike is terrifying.

    In 2006 GSK informed the FDA’s Center for Drug Evaluation and Research
(CDER) of the secret analysis, but FDA and CDER agreed to conceal this hazard
from patients and practitioners.
    During a public hearing, independent FDA statisticians reported an 80%
increased risk of heart attack. Avandia is estimated to have caused 83,000
heart attacks in the United States alone.

    Adverse effects caused by the drug are currently the subject of over
13,000 lawsuits against GSK. As of July 2010, GSK has agreed to settlements
on more than 11,500 of these suits.

    Last year, GSK pled guilty of criminal conduct, partially for concealing
the hazards of Avandia. The company paid a $3 billion fine—the largest in US

In addition, the re-adjudication process itself was biased. GSK prepared the
study materials before submitting them to Duke for analysis, rather than
allowing the university to review the raw data. (On the widespread problem of
publication bias, see our article in this issue.)

On top of that, key members of the 2010 advisory committee that decided to
place restrictions on Avandia in the first place were not part of the 2013
meeting. Of the twenty-seven member panel, fourteen of the experts were on
the panel last time, and they were the people with a more favorable attitude
toward Avandia. This is in contrast to the other experts who did not serve on
the panel a second time—like Steven Nissen, who was one of the most outspoken
critics on the panel. FDA claims all panelists were invited, it does not
appear they made a huge effort to ensure their participation; Nissen says he
was not re-invited. With all of the big nay-sayers out of the picture, it’s
no surprise the panel voted to lift the restrictions on this dangerous drug.

FDA should focus more on advisory panelists who have true conflicts of
interest. A 2007 law placed caps on the number of waivers that could be
granted allowing experts with conflicts of interest; a 2012 law removed those
safeguards. When there are no restrictions on experts with conflicts of
interest serving on FDA advisory panels, more drugs with dangerous side
effects could certainly enter the market.

God Bless Everyone & God Bless The United States of America.

Larry Nelson
42 S. Sherwood Dr.
Belton, Tx. 76513

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