Sunday, December 6, 2015

FDA approves drug for sexual condition in women even though it has been found barely effective -- UPDATED

Long time readers of this blog will remember that since back in 2009, I have been following the debate as to whether the so-called Hypoactive Sexual Desire Disorder in women is really a medical condition or something the pharmaceutical industry came up with in order to convince women to buy a product they don't need. See here. The drugmaker (Boehringer Ingelheim) geared up an enormous publicity effort to promote the pill, but the FDA was not impressed and decided the pill was neither safe nor effective. See here.

What appears below is the same story I originally posted in August of this year.  The UPDATE appears at the end. 

At that time, all 11 members of the FDA advisory committee decided the side effects of the drug were unacceptable, and 10 ruled the pill is not effective. For the full story up to that point (including links to more information), go here.

Because of this failed effort, the manufacturer decided to discontinue development entirely. For more on the story go here.

Soon thereafter, however, Sprout Pharmaceuticals picked it up and again submitted it for approval in 2013. Since there was no new evidence to contradict the earlier findings, the FDA rejected it, again.

Somehow, however, with still no new evidence, two years later, the FDA has indeed approved the drug.  How, or why, did this happen?

Sprout smartly enlisted thousands of women’s activists and members of Congress in a campaign about gender double standards and sexual politics, in an attempt to avoid the discussion of the fact that the medical evidence that the drug actually works safely is weak and that the FDA rejected drug twice because its minimal benefits failed to outweigh the safety risks.  

Converting the discussion from one about health and safety into one about gender (based on the argument that it’s time that the agency gave the same priority to drugs to treat women’s sexual problems as it has to drugs for men) apparently provided enough pressure on the FDA to change its ruling, even though the scientific evidence is still the same.

It has been reported that the FDA approval comes with a requirement that the company take steps to ensure doctors prescribe the drug carefully and make women aware of its health risks.  But isn't that true of all drugs?  That statement adds absolutely nothing to current standards of the medical profession.

The FDA is also mandating that the drug will have with a black box warning — the strongest FDA warning language — to highlight the risk of severe blood pressure drops and fainting in patients who drink alcohol or use certain other drugs during treatment.  That is a good thing, but perversely, because of the state of the law regarding preemption in cases based on inadequate warnings, it will make it more difficult for plaintiffs to recover for injuries caused by the drug.

So, as I said in one of my recent posts on the subject, when the drug is shown to cause injuries, and the medical evidence and past history shows it more than likely will, it will inevitably result in litigation. The story is just beginning.

For more on the story you can go here, here and here.

Go here for videos on a documentary about this issue.

UPDATE (12-5-15):   The website VITALS has a very good overview of the debate and controversy over the now approved drug, which is now officially called "Addyi" here.  The article is called "Is the “Female Viagra” Worth It?" and it concludes that for most women, given the risks, costs and uncertainty, the answer is no.  If you are interested in the topic, the article (and the comments) are well worth reading.

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