Bayer’s Yaz birth control: greater risk, no more effective
Wednesday, December 9, 2009
The trendy Yaz and Yasmin birth control pills are Bayer‘s most popular drugs. And they are the world’s most popular birth control pills, having grown to annual sales of more than $1.8 billion. The drugs’ success has been the result of Bayer’s aggressive marketing campaign — a campaign aimed especially at young women that touts the pills as a lifestyle-enhancing drug that will cure everything from acne to pre-menstrual syndrome.
Unfortunately, the pills may be dangerous. They contain a new synthetic hormone, drospirenone, which has never before been used in a birth control pill. Some women who take Yaz or Yasmin have suffered harmful side effects. One of the most common is blood clots. That, in turn, may lead to strokes, pulmonary emboli and heart attacks. Women on Yaz or Yasmin have also been stricken by disease and damage to the gallbladder, liver, and pancreas, among other conditions.
Of course, all birth control drugs carry risks. But the problem with Yaz and Yasmin is that, because they contain drospirenone, the risks appear to be greater than those of other birth control pills. Although the drugs carry additional risk, they are no more effective than traditional birth control pills. That’s according to two recent studies involving Dutch and Danish women published in the British Medical Journal. For that reason, the consumer advocacy group Public Citizen warns women against using either Yaz or Yasmin, and instead suggests more traditional pills from other manufacturers that do not contain drospirenone.
And what about Bayer’s aggressive advertising? The U.S. Food and Drug Administration has repeatedly ruled that Bayer’s television commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. As the FDA explained in its 2008 Warning Letter:
These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over promise the benefits and minimize the risks associated with YAZ.
The FDA has required Bayer to change its commercials. It even required Bayer to run a ”corrective” ad campaign. However, according to some, the “corrective” commercials, like this one, are too confusing and jargon-filled to be effective.
Lawyers Mike Danko of the Danko Law Firm and A.J De Bartolemeo of Girard Gibbs represent more than 50 women who have been seriously injured by Yaz and Yasmin. They also represent the families of some of those killed. “The damage these pills have wrought has been devastating,” says Danko. ”Bayer just isn’t telling women what they need to know. No woman would take Yaz if she knew that it was no more effective than other birth control pills but was more risky.”
One of Danko’s clients is Susan Galinas of Newark, California. She took the drug because it was being promoted as a way to ease pre-menstrual symptoms. It left her with brain damage after a debilitating stroke. Her injuries have changed her life and that of her family forever.
Galinas has sued Bayer in federal court. Her suit, along with more than one hundred others, are now part of a multidistrict legislation proceeding pending before the Southern District of Illinois. Bayer has agreed to turn over more than 30 million pages of documents in that suit. Danko and De Bartolomeo will soon begin combing through the documents to determine what Bayer knew of the risks, and why it failed to disclose them.
Danko hopes that the lawsuit will result in the Yaz and Yasmin being pulled from the market. But for now, Bayer continues to promote the drugs to women worldwide. Why? According to Danko, there is just too much money to be made.
Tags: drug safety, Food and Drug Administration, Medical negligence, pharmaceutical companies, pharmaceuticals;
Category: Issues; Medical Negligence;