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

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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The press continues to get the word out about the potential side effects of the birth control pills Yaz and Yasmin. Yesterday, a California consumer protection group called The Civil Justice Research Project reported on the status of the litigation and the claims brought by women and their families who have suffered after taking Yaz, Yasmin or Ocella. The group reported that some women have suffered strokes, pulmonary emboli and heart attacks after taking these birth control pills.

In addition to the health concerns, the group also reported on Bayer’s “aggressive advertising,” noting that the FDA found that some of the Yaz commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. Although the article acknowledged that Bayer ran a multi-million dollar corrective ad campaign, it also explains that some find those corrective ads to be “too confusing and jargon-filled to be effective.”

Two of the authors of this blog, Yaz attorneys A.J. De Bartolomeo and Mike Danko, and were also mentioned in the article for their work representing injured women in the Yaz and Yasmin lawsuits. Articles like this one really help spread the word about the potential side effects of Yaz, Yasmin and Ocella, and keep people informed about what’s happening with the lawsuits.

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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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Yaz in the News:

As reported by Bloomberg News, in late September 2009, Swissmedic, the Swiss regulatory authority for drugs and medical devices, began an investigation into Yaz after a woman died from a pulmonary embolism while taking the birth control pill.

On October 22, 2009, Swissmedic released the results of its investigation but, unfortunately for us English-speakers, those findings were only released in German. Bayer was quick to offer their translation and issue a press release stating that “Swissmedic Sees No Higher Risk for Drospirenone Pills.” However, as Jim Edwards of BNET pointed out, upon further examination it isn’t clear that Bayer’s translation is 100% accurate.

From our understanding of the Swissmedic report, the study is still subject to peer review and a final report will be released at a later date with more information about the final results. In the meantime, if you are able to read German, feel free to take a look at the current report and let us know what you think.
 

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All birth control pills come with some risk, but what many people don’t know is that there is medical evidence showing that the hormone used in Yaz, Yasmin and Ocella known as drospirenone, or "drsp," substantially increases that risk.

Earlier this year the British Medical Journal published two studies which found that birth controls which contain drsp substantially increase a woman’s risk of blood clots, what doctors refer to as “thrombosis.” One study was conducted in Denmark and the other in the Netherlands.

In addition to these two reports, the British Medical Journal also published a paper about Yasmin. The paper said that it had received reports about women who suffered a “thromboembolism as a suspected adverse drug reaction to the new oral contraceptive Yasmin.”

Why this matters: There is medical evidence showing that the hormone used in Yaz, Yasmin and Ocella can cause blood clots, and blood clots can cause life-threatening health complications such as a stroke or pulmonary embolism. Women and their families need to know the additional risks before taking these drugs.

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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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