Generic version of Yaz released by Maker of Ocella (generic form of Yasmin)

Yaz and Yasmin, manufactured by Bayer Pharmaceuticals, are some of the top selling birth control pills in the United States. But as is often the case with such popular brand name drugs, another pharmaceutical company is trying to cash in on some of the success of these pills. Teva Pharmaceutical Industries, Ltd. signed a licensing agreement with Bayer and released a generic form of Yasmin marketed as “Ocella” in July 2008. In Ocella’s first financial year, Teva reported that U.S. sales were $170.2 million.

Well, it looks like Teva is at it again – this time with Yasmin’s sister birth control Yaz. The Associated Press reported that Teva has now released a generic version of Yaz. Yaz, a slightly lower dose of the same hormones used in Yasmin, had sales in the U.S. of $782 million in 2009. Earlier this year in April, Teva received approval from the FDA to market its generic version of Yaz, which Teva is calling “Gianvi.”

Bayer, however, is not too pleased with Teva’s early release of the generic Yaz. As part of Teva’s earlier agreement with Bayer, Teva was not supposed to launch a generic Yaz pill until July 2011. In response to Teva’s decision, the German drugmaker filed a lawsuit against Teva for patent infringement.

As we wrote in an earlier Yaz blog post, these little pills mean big profits for original manufacturer Bayer and now Teva, with its generic forms of Yaz and Yasmin. Despite hundreds of lawsuits filed by women who have suffered life-changing injuries, Bayer and Teva continue to market and profit from the sale of these pills.

Los Angeles CBS 2 and KCAL 9 News Story Features Yaz Pulmonary Embolism Victim and California Yaz Lawyer A. J. De Bartolomeo

California Yaz Lawyer A. J. De Bartolomeo and one of her Yaz clients, Alyssa, were featured in Los Angeles news story aired on CBS 2 and KCAL 9 this week talking about the potentially life-threatening side effects of Yaz. Alyssa was just 17 years old when she suffered a bilateral pulmonary embolism after taking Yasmin to treat a cyst.

Los Angeles CBS 2 and KCAL 9: Yaz Pulmonary Embolism Victim and Yasmin Lawsuits

 

FDA Catches On: Drug Companies Mislead Doctors

Doctors rely on drug company representatives for information about a drug's risks and benefits. The information that the drug company provides to the doctors is supposed to be accurate and truthful. Unfortunately, as I wrote here, the representatives sometimes understate a drug’s risks, overstate its benefits, and promote the drug for uses for which it has not been approved, all in an attempt to increase sales and boost profits. The bad information leads doctors to prescribe drugs to their patients when they really shouldn't. As a result, consumers are needlessly injured.


Now the FDA is catching on. On May 11 the FDA announced that it is asking doctors to turn in drug company representatives who provide misleading information about the drugs they are promoting. The FDA is asking doctors to be on the lookout for --  an anonymously report -- the following types of drug company violations:
 

Example of Omission of Risk
You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.
This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.


Example of Unapproved Use

You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.
This presentation would be illegal because it promotes an off-label use.
 

Example of Overstating the Effectiveness
“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”
This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.
 

Why is the FDA asking doctors to help?  Isn't it the FDA's job to police the drug companies?   According to the FDA website:

[Our] traditional surveillance activities have been somewhat limited by [our] inability to monitor drug promotion in settings such as physician offices, local dinner programs, and promotional speaker training sessions. By raising awareness about misleading promotion and providing an easy process for reporting it, FDA can gain the valuable assistance of health care professionals in helping to decrease the number of misleading promotional messages about prescription drugs.

It's good to see that the FDA is finally catching on.  But there's an obvious problem with the program.  The doctors rely on the drug company representatives for information about the drugs.  How can they be expected to know when the information the drug company gives them is false or misleading?

Susan Galinis Tells Her Story

Susan, a client of ours, was recently interviewed by a local news agency. As you will see Susan suffered a stroke a month after she started taking Yaz. Needless to say, Susan’s life has been forever changed.  She asked us to put her story out there so other women would know what she went through after taking Yaz.