Letters to the Editor
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Don't quit your dayjob, Ralph.
This is why he should stick to consumer protection. I had never heard this, and I appreciate him raising awareness.
And he should stay the hell away from running for POTUS. *daydreams about the alternate universe in which Gore won* Me, bitter? Nahhh.
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Reminds me of DES
If you visit www.notmypill.org website, it asks the questions: Why would doctors prescribe a dangerous hormone to women, and why would the FDA let this happen? The same thing happened with DES from 1938-1971 in the US. The FDA never banned that drug. For more info, visit www.desaction.org.
Truly pathetic. As someone who was exposed to DES in utero, you'd think it wouldn't surprise me that dangerous hormones are being prescribed to women. But I am blown away by the lack of mainstream press coverage re: this issue.
Thank you Salon.com for running this item. You've just saved some lives!
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don't be so quick to abandon your pill
This is not the no brainer it seems to be.
While it is true the risk of blood clot from this particular progesterone is twice that of older pills, that is not necessarily a deal breaker. If the risk of blood clot from an older pill is 1/100,000, the risk with the newer pill is only 1/50,000. Certainly a difference, but remember there are some benefits to the newer progestins. Many of my patients report less nausea, less weight gain, and less decreased libido with these pills.
The big pharma issue is not huge here, as these "newer" progestins are not that new, and almost all are available as generics, so no 1 drug company is making a fortune on these pills. I think doctors should tend to use the older pills for the most part, but these pills clearly have a niche in providing options for birth control in women.
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I'm not sure I trust the source
I'd really like to get more information about this. What are the risks of this pill compared to other pills? What is the effectiveness of this pill compared to other pills? We live in an information age, where I can look up pretty much anything on the internet, but I have no idea where to even begin. Is this just another way for Nader to get his and his organizations names in the headlights, or is it a real threat?
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This isn't news...
Back in 1996, my doctor had me switch from Desogen to a different pill because she had read studies showing the elevated risk of clots. Why on earth are these pills still on the market eleven years later?
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Not news
Although I know nothing about this hormone, blood clots have been a side-effect risk of the Pill since the beginning of time. This does not shock me. And I'm on the Pill.
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let's talk informed consent, shall we?
I appreciate lay people becoming informed about their own bodies and health, but this is a short-sighted campaign (and blog post), and ultimately does women a disservice.
Desogestrel is the progestin (synthetic progesterone) of choice for:
women with polycystic ovarian syndrome (6% of the reproductive-age female population, so not exactly obscure),
women with hirsutism (which, if you are the sufferer, can seem quite major indeed, so shouldn't be discounted), and
women who experience breakthrough bleeding on hormonal contraceptives (i.e., bleeding not in the placebo week, which is a very annoying side effect).
An individual woman can evaluate what a 1/50K risk means to her, incorporating knowledge about her personal smoking history, her weight, her cholesterol and other blood lipids, her blood pressure, her age, and so on. And especially and of course, an individual woman can weigh those risks against the much more significant risks of pregnancy.
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the site seems inadequately vetted...
since it recommends Trivora, which during the 2nd week of active pills contains 40 micrograms of ethinyl estradiol (synthetic estrogen), in lieu of Kariva or Mircette, which contain 20 micrograms of EE. Although levonorgestrel is the progestin in Trivora, estrogen is a more significant culprit in blood clotting risk than progesterone.
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I was curious about this, so I checked with Planned Parenthood. Here's what they said.
Perhaps some actual facts are in order. Below is a Bloomberg News interview on this subject with Planned Parenthood Federation of America’s vice president for medical affairs, Dr. Vanessa Cullins. I’ve included the URL at the end.
Consumer Group Asks FDA to Ban a Birth Control Pill (Update4)
By Rob Waters and Duncan Moore
Feb. 6 (Bloomberg) -- Some birth control pills, made by Barr Pharmaceuticals Inc., Watson Pharmaceuticals Inc. and others, should be banned by U.S. regulators to reduce the risk of life-threatening blood clots, a consumer group said.
Women who take pills containing the hormone desogestrel face twice the risk of developing clots, usually in the legs, as users of other drugs to control conception, Public Citizen said in a petition to be filed today with the U.S. Food and Drug Administration. Another group, Planned Parenthood, said it opposed the petition.
Most birth control pills contain a combination of estrogen and progestin and work by blocking the release of eggs from a woman's ovaries. Desogestrel avoids side effects of earlier combination pills, such as acne and unwanted hair growth. The hormone also causes roughly three of every 10,000 women to develop clots, Public Citizen said.
“There's no unique benefit over safer, older-generation oral contraceptives,” said Sidney Wolfe, the director of Public Citizen's health division, in a phone interview yesterday. The calculus of U.S. drug regulators should be: “unique risk, no unique benefit -- off the market.”
The Planned Parenthood Federation of America, the women's reproductive health organization, said the Public Citizen petition was “unwarranted and extremely misleading.”
`Very Effective'
“Desogestrel pills should not be taken off the market; they are safe and very effective,” said Vanessa Cullins, Planned Parenthood's vice president for medical affairs, in a telephone interview today. She said Public Citizen was “dredging up old information from 1995.”
Barr shares fell 51 cents to $53.22, at 4 p.m. in New York Stock Exchange composite trading. Watson stock rose 29 cents, or 1 percent, to $27.85.
Barr, the biggest supplier of birth control pills in the U.S., makes five brand-name and 24 generic oral contraceptives, said Carol Cox, a spokeswoman for the Woodcliff Lake, New Jersey-based company, in an e-mailed statement.
The company's desogestrel-containing pills carry warnings in their labels, approved by the FDA, that alert doctors and customers to the risks of blood clots, she said. The pills also “provide significant benefits to the women who use them,” she said.
About 7.5 million prescriptions were filled for birth control pills containing desogestrel in 2006, Public Citizen said in its petition. Contraceptives that contain desogestrel include Barr's Mircette, Kariva, Velivet and Apri-28 products; Watson's Reclipsen; Organon Biosciences' Desogen and Cyclessa; and Johnson & Johnson's Ortho-Cept.
Science Studies
Several studies dating to the mid-1990s have shown an increased risk of blood clots among women taking contraceptives with desogestrel, the petition said.
Public Citizen said the FDA has been aware of the risk for more than 10 years, since the agency issued a statement in 1995 noting a “two-fold increase in the risk of venous blood clots associated with products containing desogestrel.”
It is true that birth-control pills raise the incidence of blood clots over not using them, said Cullins of Planned Parenthood.
“You have to put it into context,” she said. For women who aren't using any form of hormonal birth control and who aren't pregnant, the risk is four out of 100,000, she said. For all birth-control pills, the risk is 10 to 30 in 100,000, she said, while in pregnancy the risk of blood clots is 60 in 100,000.
“What we are talking about is a slight rate of increase in a very rare event,” Cullins said. “For some women desogestrel is a better choice than other drugs.”
In 1995 the British Committee on Safety of Medicines published a warning about blood clots and birth-control pills. It led many women to stop taking oral contraceptives and resulted in “a marked actual increase in pregnancies and the abortion rate in 1996 and 1997 in that country,” Cullins said.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net; Duncan Moore in Chicago at Dmoore35@bloomberg.net.
-- http://www.bloomberg.com/apps/news?pid=20601103&sid=auA3TH5.nQco&refer=us&cid=1113383924&ei=BwHKRYKTCa2esQHfyvyIBw