Yaz, Yasmin, Gardasil: Are Young Women Just Guinea Pigs?

October 27th, 2009. By LucyC

A couple of interesting news releases came across my desk this morning: the first is about two new lawsuits filed against Bayer AG alleging the company’s birth control pills Yaz and Yasmin have caused two young women life-threatening health events. The second is about the Gardasil vaccine—more on that in a minute. 

First the Yaz lawsuits. Short version: Judith M. Woodall and Tasha Marcell allege that they sustained “severe and permanent personal injuries, pain, suffering, and emotional distress as a result of their use of Yaz.” 

To be specific, the news release states: “Ms. Woodall, a resident of Tennessee, first began using Yaz in approximately November 2008. That same month, she suffered a saddle pulmonary embolus and deep vein thrombosis. Ms. Marcell, a resident of Georgia, began taking Yaz in October 2007. She also suffered a pulmonary embolism and deep vein thrombosis shortly after she began using the medication.” Hold that thought. 

Now the Gardasil press release. One of the researchers involved in the development of the HPV vaccine spoke at a medical conference earlier this month, and instead of towing the company line—in this case the company is Merck—she is reported to have said “70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer.” Furthermore, she reportedly said, there have been no efficacy trials in children under the age of 15: “There also is not enough evidence gathered on side effects to know that safety is not an issue.”

The press release goes on to state that “To date, 15,037 girls have officially reported adverse side effects from Gardasil to the U.S. Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots (emboli), brain inflammation and many others. The Centers for Disease Control acknowledges that there have been 44 reported deaths.” 

Maybe I’m being paranoid, but I think there’s a theme emerging here. First of all, Yaz and Yasmin follow some very successful and less risky oral contraceptives onto the market—so did Bayer reinvent the wheel with some not so safe compounds in attempt to get into a very lucrative market? The press release states, “Yaz is the top-selling oral contraceptive in the U.S. Last year, Yaz and Yasmin generated about $1.8 billion for Bayer.” That’s not chump change. 

A similar question could be asked of the HPV vaccine—given the researcher’s math above, how medically necessary is it, really? Or is the math more about making money?

And at what point did safety factor into the decision to approve these agents? Yaz and Yasmin are both made with a type of progestin called drospirenone, which can elevate the body’s potassium levels, which can lead to a condition called hyperkalemia in certain patients. Hyperkalemia may result in potentially serious heart and health problems. Was Bayer not aware of this before they developed Yaz/Yasmin? If they weren’t they surely are now. Adverse events reported to the Food & Drug Administration (FDA) involving Yaz and Yasmin include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.

As for Gardasil, according to the release, Merck studied the vaccine on a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies. Are you kidding? 

Reading this I can’t help but wonder if the testing of these drugs is really over—perhaps there is a larger, observational experiment going on here. And, maybe women need to get more vocal about these “side effects”, because ultimately they could cost you more than the price of the prescription.

Tags: Gardasil, Yasmin, Yaz

This was posted on Tuesday, October 27th, 2009 at 11:05 am and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.