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It's said that it takes 22 FDA safety officers to change a light bulb: 12 to defend the decision to install it, 8 to call it another "lighting option," 6 to quote Big Pharma studies and one to say it doesn't need changing, it just needs a better label. This week's hearings into birth control pills Yaz, Yasmin, Beyaz and Safyral confirm the FDA's dedication to pharmalateralism.
Bayer launched Yaz in 2006 as a pill that goes "beyond birth control" to treat acne and severe PMS, all the while avoiding the water retention of traditional birth control pills. But soon, previously healthy teenagers experienced "beyond birth control" effects they hadn't expected. Fifteen-year-old Katie Ketner had her gallbladder removed after taking Yaz, Susan Gallenos had a stroke and part of her skull removed and Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli, according to published reports.
The FDA could have held hearings into the safety of the Yaz ingredient, drospirenone, as early as 2002, instead of this week. That's when the newsletter, Worst Pills Best Pills, warned that drospirenone, just approved in the pill Yasmin, "has never before been marketed in the US," and could cause "serious heart and other health problems such as a change in acid balance of the blood and muscle weakness."
But instead of investigating the drug nine years ago, the FDA decided to ban the newsletter's editor, Sidney Wolfe , MD, head of the Public Citizen Health Research Group from voting at this week's Yaz hearings , because the newsletter had termed the drug a "do not use." The FDA accused Wolfe of an "intellectual conflict of interest."
This is not the first time the FDA has silenced Wolfe. During 2010 hearings about Jazz Pharmaceuticals' fibromyalgia drug Rekinla, Wolfe's microphone was turned off when he asked why the manufacturer's guilty plea and $20 million penalty for illegal marketing a different drug was never brought up at the hearings. Was it not relevant?
Jazz's off-label marketing, "is a matter related to compliance and it's not a matter that's related to the topic under discussion today," explained Bob Rappaport, MD, director of the FDA Division of Anesthesia & Analgesia Products. The only significance of bringing up the wrongdoing case would be to, "impugn the sponsor in the hopes that the committee would be punitive towards them in your deliberations and recommendations regarding this application," said Rappaport. Why should a $20 million guilty plea affect future approvals?