Yaz and Gallbladder Disease

The oral contraceptives sold many years ago carried a risk of gallbladder disease. But Yaz, a new low-estrogen birth control pill, promised women a reduced risk. Yet, women on Yaz are reporting gallbladder disease at record rates. 

Gall bladder disease can be painful.  It can cause fever, nausea, and vomiting. Ultimately, if the gallbladder needs to be removed, it can result in life-long digestive trouble. 

There are different types of gallbladder disease. They include:

  • Gallstones in the gallbladder (cholelithiasis); 
  • Gallstones in the gallbladder's cystic duct or common bile duct (biliary colic);
  • Inflammation of the gallbladder (cholecystitis) -- with or without stones;
  • Calcification of the gallbladder ("Porcelain gallbladder") --  with or without stone; and
  • "Chronic acalculous gallbladder disease" -- A condition where the gallbladder doesn’t move properly. 

Yaz may bring about gall bladder disease by causing stones to form.  Or it mGall stones by Polski: Kamienie z pęcherzyka żółciowegoay adversely affect the musculature of the gall bladder so that the gallbladder cannot function properly.  As a result, the gallbladder may become inflamed and painful ("chronic acalculous gallbladder disease").

Many of us have gallstones and don't even know it. But 90 percent of the time, they will never cause any trouble. It now appears that Yaz may cause stones that would otherwise be asymptomatic to become painful.  Gallbladder removal may thus be required within months of first taking Yaz.  

Gallbladder removal can usually be performed laparoscopically, which involves removal of the gallbladder through very small incisions in the abdomen using small, specialized instruments, including a camera that allows the surgeon to view the inside of the body on a TV monitor. After gallbladder removal surgery, some women report feeling much better and relieved of their gallbladder disease symptoms. Other women, however, continue to suffer symptoms such as indigestion and abdominal discomfort long after the surgery as a result of having no gallbladder in which to store bile.

 

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

 

Sacramento CBS 13 and CW 31 News Story Features Yaz Stroke Victim and California Yasmin Attorney Mike Danko

Yaz On Trial author and California Yasmin Attorney Mike Danko and client, Susan, were featured by Sacramento’s CBS 13 and CW 31 news stations, discussing the Yaz lawsuits and the potentially life-threatening side effects of this birth control pill. Susan was the happily married mother of three year old twins when she began taking Yaz. She took Yaz for about a month when she suffered a Yaz stroke which changed her life forever. She shares her experience in the video below, and as the story reports “while Susan can't get her old life back, she says she can warn women not to risk their lives.”

Sacramento CBS 13 and CW 31: California Yaz Stroke Victim and Yasmin Lawsuits

 

 

Susan also shared her Yaz stroke experience in another news story in late 2009.
 

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?

"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. 
 

Yasmin Label Change in the European Union (EU)

On Friday, March 26, 2010, Bayer announced that it will update the Yasmin label in the European Union (EU). The new Yasmin label will include the results of four epidemiological studies (epidemiological studies are conducted to figure out what factors affect the health and illness of a population).

Two of those studies found that oral contraceptive pills which contain the hormone drospirenone (such as Yaz, Yasmin and Ocella) are associated with a significantly increased risk of venous thromboembolism, a medical term used to describe a blood clot in a vein, which can lead to more serious injuries including pulmonary embolism or stroke. The studies, conducted in Denmark and the Netherlands, were published last year in the British Medical Journal.

After viewing these reports, the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) (a section of the European Medicines Agency) concluded that users should be informed of this new risk information and became the driving force behind the addition of these two independent studies to the new Yasmin label.

The other two studies to be included on the new label (EURAS and Ingenix studies) were sponsored by Bayer, the maker of Yasmin and Yaz. Unsurprisingly, the Bayer-sponsored studies concluded that the risk of blood clots in Yasmin users is comparable to the risk found for women who use historically safer oral contraceptives which contain the hormone levonorgestrel.

At this point, the Yasmin label change is only due to go into effect in Europe and the exact language for the new label has not yet been revealed.

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.

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