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

As Bayer Pharmaceuticals launches another birth control pill known as Natazia, controversy continues over its top-selling pill, Yaz. National Public Radio reported today about the risks of oral contraceptives, highlighting the story of Katie Anderson, a teenage girl who suffered a pulmonary embolism and blood clot in her leg after taking Yaz. NPR reported that Katie, like many other women, wanted to take Yaz because of all the benefits Bayer promised in its advertisements.

Ruth Day of Duke University advises the FDA on drug advertising. She has never seen a campaign that made such sweeping claims as those Yaz ads. NPR also discussed the FDA's ruling that Bayer's Yaz commercials had minimized the risks associated with Yaz, and how the FDA forced Bayer to run corrective commercials.

2700 women are now suing Bayer over Yaz, accordingly to the NPR story.

Listen to the NPR Yaz/Yasmin news report: "With Birth Control Pills, New Isn't Always Better"

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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.

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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?

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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. Unfortunately, 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. 
 

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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.

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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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I recently stumbled across a story about Yaz describing another one of its clever advertising campaigns. Bayer Pharmaceuticals, the manufacturer of Yaz, hired Lo Bosworth, a young actress on the popular MTV reality show "the Hills" to be the new spokesperson for Yaz in Canada. The story explains that last year the Hills star spent time in "Toronto and then Vancouver doing media interviews, where she focused on the fact that Yaz can lead to fewer symptoms like headaches and cramps during that time of the month."

This isn't the first time Bayer has attempted to promote Yaz as a treatment for "time of the month" symptoms, but it is something that Yaz has come under fire for in the United States previously. In October 2008, the U.S. Food and Drug Administration (FDA) sent a Warning Letter to Bayer stating that a number of Yaz commercials “encourage[d] use of YAZ in circumstances other than those in which the drug has been approved, over-promise[d] the benefits and minimize[d] the risks associated with YAZ.” The FDA, in its 2008 Yaz warning letter, found that the Yaz commercials made it seem as though the drug could treat PMS symptoms like cramps and headaches, when Yaz was only approved to treat the more severe symptoms of premenstrual dysphoric disorder (PMDD). The FDA also took issue with the fact that Yaz was being advertised as a way to "keep skin clear," suggesting that Yaz could be used to treat all forms of acne, when the FDA had only approved its use to treat moderate acne specifically. As a result of the FDA's findings, Bayer had to run a $20 million advertising campaign to clarify the real uses and possible side effects of Yaz.

Not long after receiving the FDA Warning Letter, Bayer hired Lo Bosworth as a Yaz spokesperson for its marketing campaign in Canada, where the FDA has no jurisdiction. The video below, based off of Bayer’s Canadian press release about Yaz, touts a whole laundry list of "benefits" that Yaz purportedly offers. You have to wonder whether these statements would pass muster with FDA, or whether the FDA would find them to be misleading just as it did with some of the US commercials.

As the Yaz spokesperson, Bosworth stated that “I have to be in control of my life at all times – especially my health. I need to make sure I’m taking care of myself..." For most women, staying in control of their lives and health involves knowing the real risks and uses of a birth control pill before they decide to take it.

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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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Lawyer2Lawyer is a legal talk show that brings together lawyers with opposing views from across the country.  On its show devoted to the growing number of Yaz lawuits, Lawyer2Lawyer interviewed Mike Danko and Professor James O'Reilly, from the University of Cincinnati College of Law.  Mike discussed the basis for the lawsuits, while Professor O'Reilly discussed the FDA's role in the drug's approval and its monitoring of Bayer's advertising.

Listen on line, or read the transcipt:

Announcer:

This is Lawyer2Lawyer, the award-winning legal podcast with J. Craig Williams and Robert Ambrogie.

West Coast meets East Coast, and yes! they are attorneys.

Bringing you the latest legal news and observations every week with the leading experts in the legal profession. Produced here on the Legal Talk Network.

Craig:
Welcome to Lawyer2Lawyer on the Legal Talk Network. Thank you for listening today. I’m Craig Williams from a very sunny California.

Bob:
And this is Bob Ambrogie from just outside of Boston, Massachusetts where I practice law and write a couple of blogs…

[sponsor information…]

Craig:
Today’s show is about Bayer Healthcare Pharmaceuticals, who is facing a growing number of lawsuits claiming that the company concealed the health risks associated with top-selling birth control pills Yaz and Yasmin.
 

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Bayer's Yaz commercials are misleading. The FDA determined that they overstated the drug's benefits, and minimized the drug's risks (PDF). So the FDA yanked them off TV.  It also ordered Bayer to televise new commercials that set things straight.  The FDA ordered Bayer to spend $20 million doing it thinking, that way, every woman would get the word.  But did Bayer follow through?

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Drugs can heal, but they can also cause harm. Deciding which drug is best for the patient is something that takes training. That's why drugs must be prescribed by doctors.

The argument for allowing drug companies to advertise on television is that an "educated patient is a better patient." That's true. But drug commercials are not educational. They are designed for marketing purposes.  A commercial's only purpose is to get you to buy something, not to tell you what you need to know to make the best decision as a consumer.

Like commercials for any other product, drug commercials highlight the product's benefits and downplay the risks. When a commercial does include information about risks, the warning is usually wrapped with "emotive imagery" that isn't consistent with the words used.  That blunts the warning's effectiveness.

As a result of drug commercials, doctors are now asked by their patients to prescribe a particular brand drug -- something that was unheard of years ago. A doctor may now find herself in the position of having to explain to the patient how the patient has been misled by the drug company's advertisements.  That can make things uncomfortable for the doctor.  So when the patient has been taken in by the "buzz" that an effective commercial creates, the doctor feels pressure to prescribe a medication that she might not otherwise prescribe. Drug commercials therefore get in the way of the doctor/patient relationship, and disrupt the therapeutic process.

It took us years to realize that tobacco commercials served society no good purpose and so should be taken off television. It's now time to put an end to drug commercials as well.

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Yaz packages come with a "patient package insert."  The insert is supposed to give women the information they need to decide whether they should use Yaz or, instead, use some other birth control pill.  The insert contains lots of information about the drug, including possible side effects. Unfortunately, however, it leaves out the one bit of information women would want to know most:  Yaz is no more effective than other available birth control pills, but is more dangerous.

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Earlier this year, the Food and Drug Administration (FDA), wrote a warning letter to the makers of Yaz about their advertising campaigns, which the FDA characterized as “misleading” because, among other things, many of the Yaz ads “fail[ed] to communicate any risk information” about use of the drug.

Interestingly, this was not the first time the makers of Yaz and Yasmin had received such warnings. In both 2003 and 2008, the FDA sent similar warning letters. Despite all of the FDA’s warnings, the drug manufacturers continued to use the same questionable marketing strategies to promote Yaz.

In the 2009 warning letter, the FDA told Bayer that:

...for promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.

According to the FDA, these Yaz ads did not contain that important risk information. The letter warns that the manufacturers overstated both the benefits of Yaz and the conditions that Yaz was approved to treat, making the ads “incomplete and misleading."

The FDA warning letter concluded that Bayer should immediately pull the ads and discontinue the use of any other similar materials.

Even after receiving two previous warning letters from the FDA about their misleading advertisements, the makers of Yaz and Yasmin continued to use these questionable advertising practices. These ads incorrectly led some women to believe that Yaz was safer than it really is.

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Have you seen the new Yaz commercial? You know, the one that begins with the main actress saying:

You may have seen some Yaz commercials recently that were not clear. The F.D.A. wants us to correct a few points in those ads.

It turns out that the “Yaz commercials” the actress is talking about are the very ads that were the subject of an FDA warning letter (PDF) in 2008 to Bayer (the manufacturer of Yaz and Yasmin). The FDA’s letter addressed two of Bayer’s Yaz commercials, entitled "Not Gonna Take it" and "Balloons.”

The warning letter stated that these commercials were “misleading” and “over-promised the benefits while minimizing the risks associated with Yaz.” The FDA also said that the ads were misleading because they implied that Yaz could treat PMS and “help keep skin clear.” In fact, Yaz was only approved to treat the more severe symptoms of PMDD (Premenstrual Dysphoric Disorder) and moderate acne, as opposed to more severe or less severe forms of acne..

The FDA also noted that, in addition to overstating the benefits of Yaz, Bayer also minimized the risks, which the FDA said was “particularly troubling as some of the risks being conveyed are serious, even life-threatening.”

The warning letter concluded that Bayer should stop running the ads immediately, and work on putting together a corrective campaign about the real uses and risks of Yaz that were both truthful and non-misleading.

So, it was actually in response to this warning letter that the makers of Yaz and Yasmin began to air the new commercial to “clear up” misconceptions! Check out that commercial below.

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You might have read about some of the warning letters the FDA sent to the makers of Yaz and Yasmin for misleading advertising – maybe you’ve even seen the Yaz commercial that clarifies the risks of Yaz at the FDA’s request – but did you know that the FDA has actually been warning the makers of Yaz and Yasmin about this sort of advertising since 2003?

In 2003, the FDA sent the first of three warning letters (PDF) to the manufacturer of Yasmin for its advertisements, stating that the:

TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone.

Yasmin was the first in a line of birth control pills to contain the hormone drospirenone. The FDA’s letter said that the commercial, named “Goodbye Kiss,” over-promoted the effectiveness and safety of Yasmin. Check out this excerpt from the letter:

[The] FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other [oral contraceptives] or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone.

The FDA's warning letter concluded that the makers of Yasmin should remove the ad immediately and stop the use of any other similar promotional materials.

The trend of misleading advertising by the makers of Yasmin, and eventually Yaz, dates all the way back to 2003! It’s been more than five years since the FDA first called them out for minimizing the risks associated with the Yaz/Yasmin hormone drsp. Yet, despite many FDA warning letters about this issue, the makers of Yaz and Yasmin continued to use these questionable advertising practices well into 2009.

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