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sex, sex myths

Flibanserin (Addyi) is more likely to make you sick than horny. What do you think about that?

There has been a lot of talk lately about Addyi, the drug designed to “boost libido” for women.

A lot of the talk has been about creating a false “disorder” (sort of like a real live version of a Cosmo magazine). Not only are our breasts not big enough, but we don’t want to initiate sex enough either! Just more fodder for their ways to “pleasure him” articles.

Snark aside, many people are using the wrong construct when it comes to female sexuality. Women naturally go through phases where they have more or less spontaneous libido, but that doesn’t matter if you have medication to get approved (and hopefully a company) to sell. To put pressure on the FDA and get in some solid marketing a campaign was launched to raise awareness about this “disorder,” called Even The Score.  Because telling women that 43% of them are affected by a lack of spontaneous libido when many question whether this “disorder” even exists being the hallmark of paternalism feminism.

Yesterday I focused on one aspect of the drug that hasn’t been emphasized enough, the fact that it can never, ever be taken with alcohol (and also the fact that the interaction with alcohol was largely studied in men – how’s that for feminism?! If your goal is to ‘even the score” shouldn’t your wonder drug be properly tested on the very people for whom you are trying to even the score?).

Today I want to focus on the discontinuation rate for adverse events – 15%.

flibaserin side effects

But the drug works for 8-13% of women.

So yes, the chance that you will feel sick is greater than the chance it will help. In one study 9.6% of women discontinued the drug due to adverse events (versus 3.7% on placebo), but the summary from the FDA has 15%. Whether it is truly 9% or 15% is probably immaterial given an efficacy rate of 8-13%. And that was sold as feminism.

What do you think about that?

If you want to read two amazing pieces on female sexual response read this interview with Dr. Lori Brotto and this piece in the LA Times by Emily Nagoski.  

Note* the post has been updated to include a range of discontinuation rates.

 

 

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Discussion

25 thoughts on “Flibanserin (Addyi) is more likely to make you sick than horny. What do you think about that?

  1. As a physician, I was intrigued – initially – about reading your article until I read the opening paragraph. If you want some degree of legit acceptance, you can “deep six” the snarky, feminist approach and keep it based on science.
    Raymond Brewer, MD

    Posted by Raymond Brewer, MD | August 25, 2015, 7:03 am
    • I can only assume then you are a first time reader here because my posts have a range of writing styles.

      I don’t think the approval of a drug for a disorder that may not exist that spawned a campaign funded by the manufacturer to get women to believe that 43% of them have something wrong with them when they don’t that has a high side side effect rate and low efficacy and has not been fully safety tested in women deserves more than indignation.

      Posted by Dr. Jen Gunter | August 25, 2015, 8:24 am
      • Some women used to have a sex drive and for whatever reason feel the “lost” it. Many of those women want it back. So it’s not about convincing someone something is wrong with them. Women who “lost” it and want it back want options similar to what men have.

        Posted by Dennis Robinson | September 20, 2015, 1:47 am
    • Disagree, Raymond! Don’t be so medical! Loosen that starched coat and laugh a little.

      Posted by Doug | August 25, 2015, 8:48 am
  2. I’m confused, rate of discontinuation, which appears to be more or less the same as placebo, is around 1-2%,(placebo 0.7%) not 10%. Am I missing something? That being said they’re still offering a very small effect here, one wonders if it will even hold up on post approval analysis.

    Posted by markhoofnagle | August 25, 2015, 7:50 am
    • I’m using the adverse events rate not the discontinuation rate. Not everyone who feels sick will stop it but the side effects vs efficacy is 1 big reason it failed thrice with FDA

      Posted by Dr. Jen Gunter | August 25, 2015, 7:56 am
    • Thanks for catching that. The discontinuation rate is around 9% vs the adverse event rate of 15%. Corrected and thanks again.

      Posted by Dr. Jen Gunter | August 25, 2015, 8:15 am
    • OK one more reply. The FDA data I found quoted the discontinuation rate from adverse events of 15%, a study quoted 9.6%. I;m not sure if the FDA had unpublished data or not. Regardless, 9 or 15% is pretty poor if you consider the efficacy. And again, thanks for pointing out.

      Posted by Dr. Jen Gunter | August 25, 2015, 8:20 am
      • My reading of the data indicates that the side-effect risk (not d/cing risk) is approximately 20% & the benefit effect is about 10% (if not zero) then the risk ratio is 2x the benefit. There is no other drug on the market with a worse risk:benefit ratio. The FDA is theoretically supposed to be above politics & political pressure. How many other useless medications get onto the formulary because of similar pressure from self-interested groups & companies?

        Posted by Victor G Ettinger, MD, MBA, FACE, FACP | August 25, 2015, 10:12 pm
  3. And you might want to work on grammar and sentence structure too.

    Posted by W Ray | August 25, 2015, 7:55 am
  4. It is also important to recognize one of the potential adverse events which may be associated with the medication which is hypotension and Orthostatic BP changes (Syncope was also highlighted). The compound on its own, and with the addition of alcohol may create a risk for specific women and age groups. When looking at therapeutic compounds the focus should always be on the Benefit-Risk ratio. As a reference when assesssing an Oncology agent, if the treatment is effective in treating the cancer but raised blood pressure, and the risk is well defined and can be addressed proactively than clearly the benefit outweighs the risk even in patients who are already hypertensive. Now I recognize that this is a dramatic comparison to Flibanserin, but I believe the FDA briefing document (you can find it online, public document) did provide a good overview and suggestion for additional studies. I think the previous comments and perspective are important, I cannot speak to the therapeutic indication, I don’t know enough about it, but if as researchers and consumers we keep a focus on benefit (efficacy)-risk(safety) it provides a solid foundation. With this specific therapeutic indication it is also important to focus on the misuse of the drug and off-label use. Looking briefly at some of the data tables on compliance, it appeared that this is something to re-address as the phase III data presented a miniumu of 4 week treatment prior to efficacy. Would also be interesting to take a closer look to the study population breakout which is included in the briefing.

    Posted by Jeff Heilbraun | August 25, 2015, 9:17 am
  5. @DrJenGunter – I had seen Flibanserin the news but hadn’t read anything yet; now I probably don’t need to. As an aside, I was going to make a joke about the first comment being tone policing and the bonus grammar/spelling comment. But then I realized that it’s probably not very funny for you, sorry.

    Posted by EpiPete | August 25, 2015, 10:59 am
  6. It’s really hard to respond to this when you don’t provide a primary source for this figure: “given an efficacy rate of 8-13%.” Having read some of the original research myself, I can only assume (which I hate) that the efficacy rate you quote comes from evidence indicating that placebo has ~30% response rate, and 50mg Flibanserin has ~40% response rate, for an overall efficacy of ~10% — the difference between placebo response rate and drug response rate [1].

    If that’s where you’re getting the numbers from, then isn’t it only appropriate to do an apples to apples comparison — and describe the difference between placebo discontinuation vs drug discontinuation?

    Otherwise, aren’t you cherrypicking the data to make your point?

    Can I make some more fruit metaphors? This whole argument drives me bananas. Flibanserin has been shown to have a statistically significant effect. It’s not huge, it’s not going to revolutionize sex, but it could benefit literally millions of people. I really cannot figure out why the whole internet has decided that, because it doesn’t cure ALL female sexual dysfunction, it doesn’t have utility to cure ANY female sexual dysfunction.

    [1] http://onlinelibrary.wiley.com/doi/10.1111/j.1743-6109.2011.02626.x/abstract;jsessionid=6ED8D67B60E2EB3C9DEB5CECCAD83DBD.f03t04?userIsAuthenticated=false&deniedAccessCustomisedMessage

    Posted by Cranky drunk scientist | August 25, 2015, 10:05 pm
  7. This is the biggest load of crap ive ever encountered. Wanna see me horny!! give me an hour to myself where I can pee without being watched, have a glass of wine without answering a question or leave my phone wherever the hell I want without being afraid of missing an important phone call There is nothing wrong with any woman. If you don’t feel like “doing it” just don’t do it and for God’s sake stop making excuses for why you don’t want to do it.

    Posted by Lorraine Peters | August 27, 2015, 4:33 pm
    • What you are disrespecting is there are some people whose drive has “dried up” and they are not happy about it. Some women enjoy sex and others enjoy sex and pleasing their man too. Just cause you cant relate doesn’t mean others don’t care.

      Posted by Dennis Robinson | September 20, 2015, 1:43 am
  8. I’m one of those women! For most of my life I had an almost overactive sex life….always thought about it, always wanted it. Then one day, POOF! It was gone. I had medical tests done, went to counseling….not just once, but for years. I just couldn’t figure out what had happened to this side of me. There isn’t an explanation; not menopause, not relationship issues…nada. So, I’m trying Addyi as a last ditch attempt. Even if the success rate was .01%, I’d take that chance. I just want to be “me” again and not feel like a numbed out lump of clay anymore!

    Posted by Lee Ilyes | January 5, 2016, 11:39 am

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