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 |  Subject: Scandal at the FDA: board members with drug maker ties voted to approve drug that's killing women  Wed 31 Oct 2012, 10:06 | |
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Scandal
at the FDA: board members with drug maker ties voted to approve drug that's
killing women
by Tony Isaacs
(The Best Years in Life)
An investigation by the Washington
Monthly and the British Medical Journal determined that at least four
members of an FDA advisory board which voted to approve a drug used in
the birth control pills Yaz and Yasmin had either done work for the
drugs' manufacturer or received research funds from the manufacturer.
Though the four committee members disclosed their ties to the FDA, the
FDA decided that the ties did not matter and did not make the
disclosures public. Tragically, the drugs the committee endorsed have
been killing the women who take them.
The birth control pills Yaz and
Yasmin contain a drug called drospirenone, which the FDA advisory
committee endorsed last December. According to the Alliance for National
Health (ANH), women who take drospirenone are nearly seven times more
likely to develop thromboembolism (obstruction of a blood vessel by a
blood clot, which can cause deep vein thrombosis, pulmonary embolism,
stroke, heart attack, and death) than women who do not take any
contraceptive pill. Women who take drospirenone have twice the risk of
developing thromboembolism than women who take widely prescribed
contraceptive pills containing levonorgestrel.
FDA OK's votes by members with financial ties to drug makers but not members who oppose dangerous drugs
Each of the four advisory board
members with ties to the pills manufacturer voted in favor of the pills.
The committee's decision that the drug's benefits outweighed the risks
was decided by a four-vote margin. Interestingly, while the FDA allowed
the four members with financial ties to vote on the drug, it barred
another member and former researcher, Sidney M. Wolfe, from voting on
the grounds that he had "an intellectual conflict of interest". Based on
several years of data, Wolfe had advised his readers six years earlier
not to take Yaz. Because of this "conflict", he was barred from voting.
In other words, the FDA apparently
believes that there is no conflict when someone gets paid by a drug
manufacturer but there is a conflict when someone has researched a drug
and found it to be dangerous.
The FDA also failed to provide the
panel with recently unsealed court documents which revealed that former
FDA commissioner David Kessler had accused Bayer of hiding data on blood
clot risks associated with the birth control pills. The court documents
also revealed that Kessler reported that Bayer paid $450,000 to a high
profile gynecologist to sponsor the pill, including off-label use of the
drug, during her book tour.
It is far from the first time that
the FDA has approved a dangerous drug or overlooked conflicts of
interest. It is also far from the first time that drug companies have
hid evidence of harm. Think of Vioxx, Fosamaxx, Avandia, and Gardasil to
name just a few examples.
It is a common practice for drug
companies to pay doctors and scientists to endorse their drugs, the same
as it is common for drug companies to offer kickbacks and rewards to
doctors who prescribe their drugs. Drug companies also pay doctors,
researchers, and other medical experts for "consulting jobs" and
speaking engagements to the tune of several hundreds of millions of
dollars - which is considered legal despite the obvious blatant conflict
of interest.
With Yaz being the top-selling
birth control pill in the US, Bayer has quite the strong vested interest
in getting endorsements for Yaz and Yasmin. Though thousands of women
have filed lawsuits against Bayer, saying they were injured by Yaz or
Yasmin, as we have seen with other highly profitable dangerous drugs,
drug makers typically consider such lawsuits merely part of the price of
doing business.
Source:-
http://www.tbyil.com/FDA_Scandal_Drospirenone.htm
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