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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.

Sources included:

http://www.anh-usa.org/fda-huge-conflicts-of-interest-with-big-pharma/
http://www.washingtonmonthly.com/ten-miles-square/2012/01/the_yaz_men_members_of_fda_pan034651.php
http://www.allgov.com/Controversies/ViewNews/FDA_Panel_Judging_Bayer_Contraceptive_Risk_Had_Ties_to_Bayer_120112
http://www.naturalnews.com/034443_FDA_advisory_panel_corruption.html