Blog of the Society for Menstrual Cycle Research

“Lives will be saved” – the FDA decision not to ban Bayer’s birth control pill

April 18th, 2012 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall

 

Photo by Monik Markus // CC 2.0

How many of us read the inserts included in a packet of pills? How many decide not to take the pills on the basis of the information enclosed?  The rapidly reeled-off list of side effects stated at the end of a televised advert for a new drug has more comedic value than serious consequence to most. If we do have doubts, many of us will rely on the reassurance of a doctor, and then take the pill anyway.

I recently wrote a piece for Ms. Magazine Blog outlining the FDA reappraisal of top-selling oral contraceptives Yaz and Yasmin. It was discovered that drugs such as these containing drospirenone held a significantly higher risk of causing blood clots. Research by the FDA and other bodies suggested this conclusion was definite, while research funded by the pharmaceutical company behind these billion-dollar products, Bayer, suggested the opposite conclusion to be true: that there was no increased risk evident. A team of experts, some of which had financial ties to the company, voted against having the pills taken off the market when presented with the question of whether the risks of taking these pills outweighed the benefits.

Bayer is facing 11,300 lawsuits from women who have been seriously injured and family members of women who have died after taking one of the company’s bestselling hormonal contraceptives. They have settled the first 500 addressed with a total of $110 million in payouts. When discussing this process with a lawyer representing many of the women I was told that Bayer would do anything to avoid a trial wherein the full spectrum of their marketing strategies would be revealed.

The FDA came to the decision to add into the insert included with these drugs a statement of the discovery of “conflicting” research that suggested the pills had a higher risk of causing blood clots  (up to three times higher) – acknowledging the discrepancy of the research funded by Bayer and giving it equal standing as that performed by other bodies including the FDA itself.

Prior to this decision being announced a number of women’s health groups got together to write a letter to the FDA asking that they look again at the question put to the board of experts. They argued that the correct comparison for the board to consider would be between drospirenone-containing contraceptives and other oral contraceptives, and not between Bayer’s drugs and unwanted pregnancy. In the final sentence, they remarked that they believed that “lives will be saved” if the pills were no longer on the market. They met with the FDA and one representative asked that the FDA strongly reassess its acceptance of Bayer-funded research. Another asked that the drugs no longer be prescribed and that the FDA “get back to the arc of history and progress that protects women while supporting their contraceptive needs.”

The new labeling will state the “conflicting” findings and advise that women speak to their doctor if concerned. The official statement on this decision, relayed through the media coverage, reminded women that when compared to pregnancy the risk of development of a blood clot was insignificant. They also asked that women currently taking the drugs not stop doing so. Despite the FDA studies suggesting the blood clot risk is particularly high for women under 30, the statement compounded the understanding that the issue is only relevant to those over 35,  those overweight, those that smoke, and those with relevant medical history.

Pill-pushers

January 19th, 2011 by Holly Grigg-Spall

yaz

In the LA Times earlier this month, under the banner ‘oddities, musings and news from the health world,’ came a rewritten press release masquerading as one of the above that stated ‘Birth control pills using 24-day regimen may be more effective.’ Firstly, just from the headline, it is clear that this is one of those tell-us-what-we-already-know stories that only serve to reveal the amount of money wasted on research that concludes the obvious. If a woman takes a pill more days a month than she does not, then she’s less likely to forget to take that pill. Plus the more pills you take, the more days of the year, the less likely your body will find an opportunity to ovulate. The article, and the study on which it is based, attempts to suggest that 24-day regimen pills are more effective for other reasons. Other reasons like those pills – or should we say pill, as there’s only one this is referring to, without actually being named as Yaz – contain drospirenone.

Bayer, the pharmaceutical company behind Yaz, has long implemented an aggressive marketing campaign in the promotion of its now number-one selling product. However, it has never before been able to claim that Yaz was more effective as birth control than any other pill on the market. This is one reason why the adverts emphasize other benefits – that Yaz is acne-clearing, reduces bloat. Originally Yaz was also suggested to improve a woman’s mood all-round, and reduce PMS-related anxiety and depression. The FDA had Bayer change that message, so that now Yaz can only be said to improve symptoms of PMDD, although the definition and existence of this syndrome is still in controversy. Birth control pills are hard to market when, until now, they could all only be said to be as effective at their primary objective – preventing pregnancy – as each other. There was no way to differentiate. It’s similar to the way bottled waters must strive to stand out from the crowd. Different pills do use different progestins, and these cause different side effects, and so women are often encouraged to swap from one to the next in avoidance of problems from breakthrough bleeding to depression. The synthetic oestrogen used is the same for all, but at different levels. A study that suggests Yaz is better at doing its actual job – aside from all the other suggested benefits, many of which have been overturned over time – is a boon for Bayer.

And an important boon, considering sales of Yaz have dropped since drospirenone was linked to the deaths and injuries of many young women, and has become the centre of hundreds of court cases against the company. Not to mention the web-based uproar over the negative impact Yaz has had on many women’s emotional and mental well-being.

That the study, or at least its promotion, leans heavily on the drospirenone as the cause of this effectiveness, and not just that the pill is taken for 24 days out of the 28 day cycle, and inactive pills are taken during the break thus producing more of a ritual and habit to pill-taking, than those brands that have a longer break, or no inactive pills, suggests that either this study was funded by Bayer – it was undertaken in Germany, and Bayer is a German company – or that Bayer is manipulating the study and paying off the researchers. That the statistics state that Yaz has a 2.1% failure rate after one year in comparison to a norm of 3.5%, and a 4.7% failure rate after four years in comparison to the 6.7% norm concretes that this difference is down to the method of pill-taking and not the drospirenone. After four years a woman is more likely to forget to take a pill here or there, the drospirenone level and impact remains the same and so cannot be the cause of the change in rate from one to four years. Only the method can be taken into account here.

Don’t Just Take Yaz, Be Yaz

November 17th, 2010 by Holly Grigg-Spall

yaz-tv-commercial-300x168Despite facing ever-rising numbers of lawsuits over their top-selling drug – birth control pill Yaz – the Bayer pharmaceutical company has released a rebranded version, with added vitamin B. Despite, or perhaps as a result of, the mounting claims for compensation made by those who believe Yaz, or more specifically the synthetic progesterone component of Yaz – drospirenone, caused their stroke, blood clot or heart attack or that of their now dead or disabled loved one, the company has seen fit to produce a modified alternative to improve on the risk of other, lesser known side effects.

Bayer suggests that Beyaz, with its added levomefolate calcium – a form of folic acid, which is a B vitamin – will alleviate the possibility of pregnancy complications and birth defects produced by the original Yaz pill. Yaz causes folate deficiency which creates problems if a woman falls pregnant whilst taking the drug, or soon after stopping. In the press release sent out by Bayer last week, the company stated that Beyaz would provide ‘folate supplementation’ – admitting in subtext that Yaz causes this deficiency and that the millions of women taking Yaz as the most popular birth control pill in the US and Europe have therefore experienced deficiency in a type of vitamin B seen as vital enough to necessitate the creation of a new drug.

Just as it seemed possible Yaz might be taken off the market, here is Yaz, new and improved. Except Beyaz still contains drospirenone, the claimed cause of not only serious physical side effects – but also a negative mental and emotional impact documented by women across the Internet.

Bayer is focusing on the effect of folate deficiency on pregnancy and the unborn. This choice suggests Bayer’s marketing department is aware that most women taking the Pill aren’t wanting to get pregnant, aren’t planning on getting pregnant soon and therefore will dismiss folate deficiency as nothing to worry over, yet. Although some women may be alarmed at their suggestion that you can get pregnant when on the Pill. A little research reveals folate supplementation has been linked in studies to a decrease in stroke and thrombosis risk – a subtext Bayer could not print without admitting blame and accepting the law suit claims.

The production of pharmaceuticals is a billion dollar industry and it is, unfortunately, necessary to assume moves are made for money and the market and not in the hope of improving the lives of women. The less sick, or deceased women, the less lawsuits, and the more money to be made for Bayer. The creation of Beyaz suggests Bayer cares, and has the interests of women at heart, but essentially it is a cynical ploy to win back the loyalty of the many women who have become suspicious of Yaz, and consequently the Pill as a whole, due on the controversies and, most importantly, their own experiences.

Bayer has created a product that will solve a problem caused by one of its products, and make money from this. Even more ludicrous than that, it is ‘solving’ a problem by making an addition to a Pill that is causing the problem, in the hope the negative impact on the body will be balanced out. Bayer could have told its customers that they need to take a folic acid supplement when using Yaz, or eat foods rich in folic acid, instead of creating Beyaz.

The Next YAZ?

May 7th, 2010 by Elizabeth Kissling

In the flood of media commemorating the 50th anniversary of FDA approval of the birth control pill, this story from the Washington Post about its newest iteration may just slide under your radar: FDA approves new birth control pill from Bayer.

Bayer, as you may recall, is the manufacturer of Yaz and Yasmin, which is currently facing more than 1100 U.S. lawsuits and two Canadian class action suits. The new drug, Natazia, contains various dosing of estrogen and progestin throughout the cycle, making it the first four-phase hormonal contraceptive. The new pill uses dienogest, rather than drospirenone, the synthetic progestin in Yaz that is the apparent source of its dangerous side effects. The most common side effects of Natazia in clinical trials included irregular bleeding, headaches, nausea, and vomiting.

Yaz and Yasmin are Bayer’s best-selling prescriptions, by the way -  combined sales for 2009 were $1.64 billion.


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Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.