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FDA Bans Critic’s Right to Vote on Yaz in Panel Meeting

By December 28, 2011July 10th, 2019Uncategorized

A recent article posted on summed up the FDA’s official mode of operation with accuracy when the author posted: “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 in another lighting option, 6 to quote Big Pharma studies and one to say it doesn’t need changing, it just needs a better label.” The FDA’s recent panel meeting about Yaz resulted in a vote saying that all that is needed to protect the public against the drug’s harmful side effects is to write better and clearer warnings.

Bayer’s “magic birth control pill” was launched in 2006 and marketed as a cure for everything from acne to PMS. The problem with that is that women began suffering from serious side effects after taking it. Yaz and its sister pill Yasmin started causing women to developed blood clots (which led to heart attacks, strokes, thromboembolisms and pulmonary embolisms) and gallbladder disease. These serious and life-threatening side effects are what caused the newsletter Worst Pills Best Pills to warn the public that drospirenone, the main ingredient in Yaz and Yasmin, could cause “serious heart and other health problems such as a change in acid balance of the blood and muscle weakness.”

The FDA had an opportunity to investigate the dangers of Yaz and Yasmin nine years ago; instead, regulators decided to ban the newsletter’s editor, Sidney Wolfe, MD, head of the Public Citizen Health Research Group, from participating in the vote that took place recently during a panel advisory meeting on the drug. The FDA based its decision on the fact that it deemed Wolfe to have an “intellectual conflict of interest” since he deemed Yaz a “do not use” drug.

This is not the first time that the FDA tried to stop Wolfe from speaking, either. Back in 2010, during the hearings about Jazz Pharmaceuticals’ drug Rekinla, the regulators turned off Wolfe’s microphone after 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.”

Since the FDA refuses to recall Yaz or Yasmin, and Bayer stubbornly stands by the safety of the drugs, the lawsuits likely won’t stop anytime soon as women will continue to suffer the serious and potentially deadly consequences of taking the pills.