Yaz On Trial : Yaz Birth Control Lawsuit : Info on Yasmin & Ocella Side Effects

Bayer recently released its Annual Report for 2009. The report is 274 pages long. Here are the highlights:

• By Bayer's count, as of February 15, 2010, about 1,100 lawsuits were filed against it by women injured by Yaz or Yasmin (that sure is a lot of people, and most only expect that number to grow in the future).

• Yaz and Yasmin are Bayer’s best-selling pharmaceutical products for at least the second year in a row (this goes back to our post last week about the huge profits Bayer has made from the sale of Yaz and Yasmin over the years).

• Bayer has been creating new versions of Yaz and Yasmin. Bayer has submitted new Yaz and Yasmin oral contraceptive pills containing folate (a natural source of vitamin B) to the FDA for approval for sale in the United States. Bayer is calling these new versions “Yaz Plus” and “Yasmin Plus.” In addition to these new pills, Bayer has also created a contraceptive patch, which it calls “Yaz Flex.” The FDA still needs to approve these new versions of Yaz and Yasmin before Bayer can release them to the market. We will be watching the development of these new products. 

So despite the filing of approximately eleven hundred Yaz lawsuits by women who have suffered life-changing injuries or by their families, Bayer continues to reap huge profits from the Yaz franchise and has plans for new ways to squeeze even more money from the drugs in the future.

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Even though thousands of women have suffered severe injuries after taking Yaz and hundreds of lawsuits have already been filed, Bayer Pharmaceuticals is still airing commercials and running full page ads touting Yaz as the #1 most dispensed oral contraceptive in the U.S. with over 26 million prescriptions filled as of December 2009.

The number #1 most dispensed oral contraceptive in the U.S. – 26 million prescriptions – these things mean money, big money. The New York Times reported that the Yaz and Yasmin franchise had worldwide sales of about $1.8 billion in 2008. That same New York Times article has a graph showing the top-selling oral contraceptives between January and June 2009, which includes Yaz, Yasmin and Ocella in the top five. In fact, Bayer itself has a list of its top 20 best-selling products in 2009, and the Yaz and Yasmin products are number one on that list.

But Bayer wasn’t the only one to cash in on the success of these pills. Teva Pharmaceuticals who owns Barr Laboratories which distributes Ocella, the generic version of Yasmin, has made serious profits off this pill. In this press release, Teva said Ocella was launched in July 2008, and sales for that year were $170.2 million. Just this month Teva reported that its sales in North America for the fourth quarter had increased 35% compared with the fourth quarter of last year and that these sales benefited from the launch of the generic version of Yasmin.

So it seems like it’s a pretty simple equation for these pharmaceutical companies: little pill = big profit.

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When I first learned that Yaz was the top selling birth control pill in the country I thought about what made it so popular. Of course many of us remember the multimillion dollar commercials, but what also stuck out in my mind was an old Yaz promotion by Bayer Pharmaceuticals called “The YAZ: Step Up and Go Beyond Contest” with Project Runway Judge and Marie Claire fashion director Nina Garcia. 

As Garcia described it, “We're taking an iconic accessory—the birth control case—and asking aspiring designers to take a shot at redesigning it into a chic, more sophisticated carrying case that they could slip into their purses." Contest winners were announced during Fashion Week in fall 2008 and the contest winner received a $10,000 prize to enroll in design classes or purchase of special design materials and software, courtesy of Bayer HealthCare, Garcia, and Step Up Women's Network.

It’s a great idea and innovative advertising – but the problem is that Yaz isn’t just something stylish to carry around – it’s a drug – a medication that could have potentially dangerous side effects, including strokes, pulmonary embolisms, deep vein thrombosis, and gall bladder disease. I’ve spoken to many women who have suffered these side effects needlessly. Bayer’s advertising is very clever, but it doesn’t do enough to let women know about the risks of Yaz. Women have a right to know not just what they are putting in their purses, but what they are putting in their bodies.

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All of the hormones that go into Yaz and Yasmin are manufactured in a laboratory. In that respect, the drugs are no different than any other birth control pill. What makes Yaz and Yasmin so unique is that they contain the hormone drospirenone, or "DRSP."  DRSP, which has never before been used in a birth control pill, is "synthetic." A synthetic hormone is one formulated to be molecularly similar to a hormone found in the human body, but not "bio-identical" to it. 

DRSP was designed to be molecularly similar to the naturally occuring human hormone progesterone. DRSP is no more effective at its job than either progesterone or one of the man-made hormones in other birth control pills that are bio-identical to progesterone. However, DRSP is more dangerous and more frequently causes serious side effects, including clotting.

                         Progesterone                                                 Drospirenone (DRSP)

 

Why would Bayer use a synthetic hormone if it is more dangerous, but no more effective, than an easily manufactured bio-identical hormone? The short answer is money. A drug company can't patent a bio-identical hormone, since is an exact copy of what nature produces. Only a synthetic hormone can be patented. And only with a patent can a drug company protect the market share its advertising campaign wins over.

No synthetic hormone means no patent. No patent means no huge profits.
 

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At this point you probably know that Yaz, Yasmin and Ocella are related birth control pills, but do you know how they’re related? Here’s a little background info we’ve picked up in our research.

Yasmin was originally developed in 2001 by a German pharmaceutical company called Berlex Laboratories. Yasmin was unique in that it contained a new type of hormone known as drospirenone, or “drsp.” The same drsp hormone was used by Berlex again when it developed the birth control Yaz several years later.

Yaz hit the U.S. market in 2006 and shortly thereafter Bayer Healthcare bought Berlex, acquiring the Yaz and Yasmin birth control pills in the process. As reported by Natasha Singer in an article in the New York Times, Bayer marketed Yaz as a different kind of birth control and touted it as effective not only in preventing pregnancy but also as a treatment for PMDD (Premenstrual Dysphoric Disorder) and moderate acne. Bayer advertised Yaz as a way to “Go Beyond Birth Control with Yaz” and promoted the new pill as a quality of life medication.

Yaz and Yasmin are two of Bayer’s best selling medications and, according to Ms Singer's article, the company earned $1.8 billion on the successful positioning of Yaz and Yasmin in the last year alone.

In July 2008, another drug manufacturer, Teva Pharmaceutical Industries Ltd., jumped in on the action when it released a generic version of Yasmin called Ocella, which also contains the drsp hormone.

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