“If you’ve seen on TV somebody crying that their daughter died taking birth control pills, and you’re a mom, you may not remember the (particular) birth control pill,” said Diana Zuckerman, president of the National Research Center for Women & Families. “You’ll just say you can’t be on it to your daughter.”
That sentiment couldn’t be more wrongheaded. Of course, we should be talking about the safety of birth control. Indeed, we should shouting at the top of our lungs about the dangers of some oral contraceptives and many medications in general. What good is it to have access to birth control, only to be killed or chronically injured from those pills? Death and grievous injury would seem to defeat the purpose of the entire reproductive rights movement.
We Need Safer Birth Control Options
As we’ve reported previously Yasmin, Yaz and other drospirenone based oral contraceptives (generics Syeda, Ocella, Zarah, Loryna,Gianvi, Safyral and Beyaz) appear decidedly unsafe. No amount of marketing will overcome the safety issues.
As of April, there were over 11,000 lawsuits pending with 14,000 plaintiffs. By October of this year, Bayer, the makers of the Yasmin line of birth control, has agreed to pay $750 million to settle the first 3400 lawsuits. With only 7600 more lawsuits to go, this might be one of the most expensive drugs to date.
The Dangers of Drospirenone
Several large studies (here, here, here) have found that women taking drospirenone based oral contraceptives have a two- to threefold increase in deep vein thrombosis and pulmonary embolism compared to other contraceptives. Bayer contests those results with several company sponsored studies that indicate no such risk. Recent reports of withholding data, question Bayer’s assertions.
AdverseEvents.com, a website that tracks all medication side-effects both from FDA and patient reporting, shows that the Yasmin line of oral contraceptives carry with them a range of very serious side effects, including death.
Yasmin, Yaz and Pulmonary Embolism
Notice the number and percentage of deaths, life threatening conditions and hospitalizations compared to other potent and in some cases, already recalled medications.
Yasmin, Yaz and Deep Vein Thrombosis
Why are These Products Still on the Market?
The Yasmin line of birth control is one of Bayer’s most lucrative product lines with over 4 million women taking these pills monthly. Even with the negative publicity surrounding for these products, revenue for the Yasmin line of products neared 1.1 billion for the first nine months of 2012. After 11 years on the market, total revenue for these products was likely well over $10 billion. If the company pays out $1-2 billion in claims, but makes $10-15 billion, the cost-benefit ratio is skewed in favor of maintaining their market presence. The fines become just another cost of doing business.
What about the FDA?
The FDA relies heavily on some 50 advisory committees to review drug safety. Many of these experts have strong ties to industry. Reports of conflicts of interest abound. In the case of drospirenone, early reports are claiming the decision making was indeed skewed by industry sponsored experts.
At least four and possibly six experts on the panel convened to review the dangers of drosperinone, had financial ties to Bayer. Subsequently, efforts to remove the Yasmin products from the market failed by four votes: 15-11. Instead the panel voted to increase warnings on the labels of these drugs.
Worse yet, unsealed court documents from lawsuits in Illinois indicate the possibility that Bayer knew of the increased dangers associated with the Yasmin products, as early as 2004 and withheld (and continues to withhold) that data from the FDA. According to reporters at Pharmalot and a report by David Kessler, a former FDA commissioner and current advocate for many of the legal cases:
“For instance, in a draft of the August 2004 white paper, Bayer employees wrote: “Compared to the three other (oral contraceptives), Yasmin has a several fold increase in the reporting rates for (deep vein thrombosis), (pulmonary embolism) and confirmed VTEs…When considering only serious AEs, the reporting rate for Yasmin was 10 fold higher than that with the other products which were very similar in magnitude.” Bayer employees argued in a revised draft that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin and other OC users.”
Who to Trust
It is no longer reasonable for patients to blindly assume an FDA approved medication is safe or right for us (Vioxx, for example). Even research in major medical journals is suspect, with publication bias and outright fraud. Medical decision making is not for the faint of heart.
Luckily data are available online and though still convoluted, there is a degree of information availability never before possible. If you look, you can find the information needed to make a decision on almost any medication. We like and trust the data from Adverse Events. Their sole purpose is to expose and make accessible to the public the risks associated with medication.
Demand better. We’ve long since moved away from the age of innocence where medications are concerned. Before deciding on the appropriate birth control method for you or your daughter, do the research, ask the questions and make an informed decision.