It started when a doctor I had never met or heard of before sent me a message on Twitter wanting to partner up efforts to get the word out about Addyi (the drug flibanserin for women’s libido that essentially doesn’t work and is selling like a lead balloon).
First of all I was like, huh? You clearly have never researched me before because I have written extensively about Addyi, for example it seems like it is more likely to make you sick than horny and was basically brought to market because a questionnaire was designed to make the drug look like it had some kind of benefit. This is about monetizing fears and medicalizing the sexual response cycle and relationship issues.
Then I looked the doctor up and saw he has previously taken a lot of pharma money (2013-2015 money shown here), so I was even more intrigued.
Was he getting calls from reps detailing him on some new “benefit” (cough) of Addyi? Was he on some “Addyi expert panel?” This is the kind of thing drug companies do when they want to hear from experts about new angles for old or failing drugs. These panels often convene on glamorous weekends and the reimbursement for your time is generous. In the 1990s I was flown to corporate lodges on private jets and to private islands for these kinds of retreats. As an academic physician your salary is generally much lower than you can make in private practice and so the universities sort of expect you to make up the slack this way. I reallly thought I wasn’t being bought until I realized I was. I haven’t taken pharma money for anything, not even a meal, for over 12 years.
And then a reporter contacted me to tell me Addyi is being given back to Sprout. The reporter, who covers pharma, said this is usually done when the company thinks they can breathe new life back into the drug.
So now this follow-up tweet from Dr. Krychman made sense…
A weight loss publication. Oh do tell.
So of course I looked it up, and dear readers and this is what I found.
There is no “new” study. There is a recently published “ad hoc” analysis, meaning they retrospectively looked at the original data from the “Addyi development program” and tortured the statistics to try to find something statistically significant. The findings are not remotely interesting or clinically relevant, at least not until you get a doctor telling women it is because what sells as well or even better than a sex drug? Yes, a weight loss drug.
This is what this not-new study found. For women who were barely overweight (mean baseline BMI was 27) after 24 weeks of Addyi (flibanserin) premenopausal women lost an average of 1.4 kg versus 0.1 kg for placebo. Menopausal women lost 1.8 kg versus 0.2 kg for placebo. Over 18 months a mean weight change for premenopausal women was 1.2 kg.
The summary? After 18 months of treatment 12.9% lost 7% or more of their body weight and 8.4% of patients lost 10% or more. Put another way 91.6% of women who took the drug did not lose any significant amount of weight.
Oh and one more thing. Some women gained weight, 6.3% gained 7% or more of their body weight.
So yeah 1.2 kg (less than 4 lbs) is not a weight loss drug. Not by any meaningful clinical metric in my opinion. And when three of the authors on the study work for the drug company and the lead author has taken a lot of pharma money ( > $100,00 over 3 years) as well as the second author (> $600,000 over 3 years), well, I have to look at this study and say, uh no. Honestly, I have no idea how this was even accepted for publication.
So no Addyi is not effective for weight loss in any meaningful way. However, I bet that doesn’t stop doctors from getting detailed on this “amazing new side effect” or receiving a copy of this “study” in the near future.
The old owners of this drug are way down the list of clinical trial transparency – marked 0! Sprout is not on the list …
http://policyaudit.alltrials.net/
I really enjoyed your article. I am surprised and interested to see that you can look up your doctor to see what pharma money they have received. And then also see for which drugs and companies. Fascinating.
Have you written much at all about Hashimotos? My doctor is trying to rule that out for me. Having some symptoms and been working with a Registered Dietician on my weight but still not having any success. Dietician suggested trying Metformin to get my body chemistry back in balance. Doc doesn’t think that will work and has a feeling I am dealing with early stages of Hashimotos. About to do some bloodwork, would like to be informed. I trust what you write.
Thank you for this post. Another example of drug companies producing a product in search of a condition. Do they still market it as a “female Viagra?” That really griped my patootie. More man’splaining what women should or shouldn’t be feeling. Keep wielding the lasso of truth!
It’s cause those women stopped drinking. Stop drinking and you’ll lose weight! Shocking
Lol!!! I never thought of that!
I would find otherwise inexplicable weight loss to be quite a worrying side effect.
I like your sentence, “There is a recently published “ad hoc” analysis, meaning they retrospectively looked at the original data from the ‘Addyi development program’ and tortured the statistics to try to find something statistically significant.”
It’s true that if you torture data, it’ll confess to anything you want.
I enjoy your blog posts and your recent article in the New York Times My Vagina Is Terrific. Your Opinion About It Is Not.
I am glad you are keeping others honest.