(correction appears at end)
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."
Birth of a new drug by Martha Rosenberg
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?
Not only was the Jazz guilty plea irrelevant, the FDA did not even know about it before Wolfe's disclosure said published reports.
Nor is this the first time the FDA's right hand does not know what the FDA's left hand is doing. Just three months before a major label change for the antipyschotic drug Seroquel, Janet Woodcock, MD, head of the Center for Drug Evaluation and Research told Project on Government Oversight a warning about mixing drugs would not happen.
"At this point, there is agreement within CDER that an interaction between quetiapine [Seroquel] and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives," she writes in a rambling, defensive letter. But the ink was barely dry on the letter before the FDA announced that Seroquel "should be avoided" in combination with at least 12 other medicines including heart rhythm drugs, synthetic opioids like methadone, antibiotics, anti-infectives and other antipsychotics. Families' of soldiers and others who died while taking Seroquel had said exactly that for years.
When a reporter asked about the apparent egg on the FDA's face, Sandy Walsh, an FDA spokesperson, said Woodcock's letter was still correct, "because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages." In other words, the deaths were just from drug interactions and overdoses. Whew.
Still the FDA's claim that Wolfe (who received a personal phone call from Woodcock about his Yaz voting rights being suspended) has an "intellectual conflict of interest" reduces anyone who believes in consumer rights or governmental justice to the level of a six-digit pharma lobbyist. Holding an opinion, holding a lucrative pharma consultancy--same idea right?
In fact, FDA advisory committees are so packed with pharma consultants, its Psychopharmacologic Drugs Advisory Committee was actually chaired by a paid AstraZeneca speaker until 2009, even as it reviewed AstraZeneca drugs ! The only reason AstraZeneca speaker Jorge Armenteros, MD was removed from voting and then his chairmanship was because the Philadelphia Inquirer exposed the extreme conflict of interest. The FDA would probably call the Inquirer's reporting an "intellectual conflict of interest."
CORRECTION: The phone call to Dr. Wolfe about suspension of his voting rights came from Jayne Peterson of the FDA's Advisors and Consultants Office. The suspension decision was agreed upon by Dr Woodcock.
