"Why Did My Doctor Ever Put Me On Yaz?"

That's a question we hear a lot. Studies have shown that Yaz may be more dangerous than other oral contraceptives, yet it is no more effective in preventing pregnancy. The FDA has even warned Bayer that its commercials were overstating the drug's benefits, while understating its risks. It seems that the drug's risks are now apparent.  "If the drug is bad, why did my doctor prescribe it? Why didn't she put me on something else instead?"

The bottom line is that,  just as the consumers are being duped by the drug companies, so are the doctors. Here's what happens:

In prescribing a drug, a doctor doesn't review all the medical literature about the drug's risks and side effects. She just doesn't have time. For the most part, she relies on the information provided to her by drug company representatives, called "detailers." The detailers visit the doctor in her office, and explain to the doctor the particular drug's risks and benefits. The detailers often leave free samples of the drug with the doctor, and suggest that she distribute them to her patients.

The detailers are obligated by law to be truthful with the doctors. Medical Ghostwriting - pubmedUnfortunately, the information that the detailers give to the doctors is not necessarily objective.

For example, the detailer may hand to the doctor a research study touting the benefits of the drug. The study will have been published by a prestigious research institution or medical center. The reputation of the institution -- or that of the listed authors -- goes far to reassure the doctor that the drug is safe. As it now turns out, however, many of these studies were actually "ghostwritten" by the drug manufacturers themselves, not by the listed authors. It's no surprise, then, that the study casts the manufacturer's drug in a favorable light. But because the study appears to the doctor to be independent, the doctor prescribes the drug to her patients. As a result, people are needlessly injured.

The questionable practice of medical ghostwriting, and its negative effect on the health of the public, was placed in the spotlight a few months ago by an article appearing in PLoS Medicine. The authors explained that medical ghostwriting is "dangerous to public health" because it results in prescribers being misinformed about risks:

academic medical centers enable the pharmaceutical industry to covertly shape the medical literature in favor of commercial interests. When a pharmaceutical salesperson hands a clinician an article reprint, the name of the institution on the front page of the reprint serves as a stamp of approval. The article is not viewed as an advertisement, but as scientific research; the reprint is an effective marketing tool because peer-reviewed journal articles generated in academia are perceived to be the result of unbiased scientific inquiry.

Consumer groups have called upon the drug industry to stop its practice of "ghostwriting" research papers about their own drugs. Unfortunately, though it may appear that the practice in unethical, there are no laws against the practice.  We don't expect the drug companies to stop.  There is too much potential profit on the line. 
 

Direct filing into the Yaz and Yasmin MDL

Legal news! In a recent Case Management Order (CMO) signed by Judge Herndon, any new plaintiffs in the Yaz and Yasmin litigation can now file their individual cases directly in the MDL proceeding.

As you may recall from our earlier blog post, in October 2009 all federal lawsuits concerning Yaz, Yasmin and Ocella were centralized and coordinated into a special kind of case known as an MDL (MDL is an abbreviation for MultiDistrict Litigation). The purpose of an MDL is to take all pending federal cases throughout the country that deal with a similar issue and transfer the cases to one federal judge for coordinated pretrial proceedings to save time and resources. The MDL concerning Yaz, Yasmin and Ocella is called In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, MDL Case No. 2100, and it is being overseen by the Honorable Chief Judge David R. Herndon of the Southern District of Illinois.

Before this new Case Management Order (CMO) lawsuits were being filed by women in their state then transferred to the MDL. Now the CMO allows any new plaintiffs to file their cases directly into the MDL, which is a big time and money saver for all involved.

Here’s a blurb from the CMO:
“In order to eliminate delays associated with transfer to this Court of cases filed in or removed to other federal district courts, and to promote judicial efficiency, any plaintiff whose case would be subject to transfer to MDL 2100 may file his or her case directly in the MDL Proceedings in the Southern District of Illinois.”

Bayer's 2009 Annual Report: 1,100 Yaz and Yasmin Lawsuits Filed, Huge Profits Earned, and New Versions of Yaz and Yasmin Birth Control on the Way

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.

Yaz: Little Pill, Big Profit

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.

Yaz in the News Again

Claudia Coffey of Fox 5 in Washington D.C. just reported on a story about another young woman, Jessica, who suffered from a blood clot in her leg after taking Yaz. Jessica says that her leg swelled up about twice its normal size and started turning purple. She was in the ICU for three days and in the hospital for six days. The story also mentions the FDA warning letter for Yaz regarding possible quality control problems in a factory in Germany. (You may remember that this is not the first time the FDA has warned the makers of Yaz.) Ms. Coffey also reported that the FDA sent her an email confirming that they are aware of adverse event reports with Yaz, but that they are unable to disclose whether specific label negotiations to the medication are being conducted.

Watch the Fox 5 news story: Locals Join Lawsuit Against Bayer's Yaz