Share This PageBayer disciplined over Yasmin birth control pill claims
By Erica Johnson
Tuesday, May 31, 2011, 11:28 AM
A story in the news makes me think that every once in a while drug companies must have a good chuckle to themselves. Yesterday, the maker of one of Canada's top-selling birth control pills was sharply reprimanded for misleading promotion -- again. But the disciplinary action carries no fine or penalty other than public criticism.
German-based Bayer manufactures Yasmin, a birth control pill for which Canadian doctors wrote almost 2-million prescriptions last year.
In our Marketplace story earlier this year, Spinning A Pill, we outlined how the maker of Yasmin made false claims about its pill to promote it to American women. Health authorities forced the company to withdraw the ads, and spend 20-million dollars correcting the misleading information. But the message was out there -- supposedly, Yasmin wasn't just good for birth control, it helped with ailments like acne, and premenstrual symptoms. Those "extra benefits" are claims the company's not licensed to make.
Now, Bayer has made similar claims in the British medical journal, Pulse. Bayer's advertisement carried the headline, "Contraception and more" and claimed the drug has been "...shown to have a beneficial effect vs. baseline on acne, fluid retention, hirsutism and premenstrual symptoms." Remember, Bayer's not licensed to do that. And was disciplined two years ago in the UK for claiming Yasmin helped with fluid retention.
On Marketplace, I interviewed Canadian women whose doctors had given them the same information. They said these perceived added benefits made the pill more attractive to them than other oral contraceptives.
The concern? New research has found that women on Yasmin have up to three times the risk of developing a blood clot, compared to the safest pills on the market. That risk is still small, but women we spoke to said they would have chosen a different pill, had they known the risk of a serious side effect was greater on Yasmin. Jennifer Wright of Montreal told us, "I think people should be aware that this has an increased risk. And if there's an equally effective alternative that they can ask for, and get that instead."
The controversy surrounds the new chemical used in Yasmin, called drospirenone. Class action lawsuits in Canada and the US allege that drospirenone leads to an increased risk of blood clots.
As for the misleading advertising in the British medical journal, the Prescription Medicines Code of Practice Authority ruled that Bayer's advertisement was misleading, and that "to apply possible clinical uses that were not licensed was a serious matter." For its part, Bayer says it has "provided an undertaking to comply with these rulings."
So Bayer gets a public wrist slap, but that's it. And how many medical professionals read the misleading advertising? Sort of makes you wonder why more drug companies don't make unsubstantiated claims.
German-based Bayer manufactures Yasmin, a birth control pill for which Canadian doctors wrote almost 2-million prescriptions last year.
In our Marketplace story earlier this year, Spinning A Pill, we outlined how the maker of Yasmin made false claims about its pill to promote it to American women. Health authorities forced the company to withdraw the ads, and spend 20-million dollars correcting the misleading information. But the message was out there -- supposedly, Yasmin wasn't just good for birth control, it helped with ailments like acne, and premenstrual symptoms. Those "extra benefits" are claims the company's not licensed to make.
Now, Bayer has made similar claims in the British medical journal, Pulse. Bayer's advertisement carried the headline, "Contraception and more" and claimed the drug has been "...shown to have a beneficial effect vs. baseline on acne, fluid retention, hirsutism and premenstrual symptoms." Remember, Bayer's not licensed to do that. And was disciplined two years ago in the UK for claiming Yasmin helped with fluid retention.
On Marketplace, I interviewed Canadian women whose doctors had given them the same information. They said these perceived added benefits made the pill more attractive to them than other oral contraceptives.
The concern? New research has found that women on Yasmin have up to three times the risk of developing a blood clot, compared to the safest pills on the market. That risk is still small, but women we spoke to said they would have chosen a different pill, had they known the risk of a serious side effect was greater on Yasmin. Jennifer Wright of Montreal told us, "I think people should be aware that this has an increased risk. And if there's an equally effective alternative that they can ask for, and get that instead."
The controversy surrounds the new chemical used in Yasmin, called drospirenone. Class action lawsuits in Canada and the US allege that drospirenone leads to an increased risk of blood clots.
As for the misleading advertising in the British medical journal, the Prescription Medicines Code of Practice Authority ruled that Bayer's advertisement was misleading, and that "to apply possible clinical uses that were not licensed was a serious matter." For its part, Bayer says it has "provided an undertaking to comply with these rulings."
So Bayer gets a public wrist slap, but that's it. And how many medical professionals read the misleading advertising? Sort of makes you wonder why more drug companies don't make unsubstantiated claims.
