Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved

The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved | Pharmaguy's Insights Into Drug Industry News | Scoop.it
How do you measure sexual desire?


If you’re a drugmaker trying to win approval for a medication to boost female libido, it might come down to two questions on a medical questionnaire. Those questions made the difference for Sprout Pharmaceuticals, which received federal approval Tuesday for Addyi, the first pill for women who suffer from a loss of sexual appetite.


But the history and development of that questionnaire — funded by drugmakers — underscores how closely the field of sexual medicine is intertwined with the pharmaceutical industry. And lends weight to arguments that low libido is just the latest commonplace sexual problem — like impotence or low testosterone — to be transformed into a medical condition by drugmakers.


Today, the form is widely-used, cited in hundreds of papers on women’s sexual health. But for years it failed to win the support of one critical group of experts: the Food and Drug Administration.


That presented a challenge for Sprout and its drug Addyi, which the FDA rejected twice in 2010 and 2013 due to side effects and minimal benefits. Regulators noted that the original drug studies failed to show an increase in female desire based on daily journal entries by women.


Sprout argued that the FDA should disregard those results and instead look to monthly results from the questionnaire, which showed a small, but statistically significant, boost. Patients taking the drug reported a 34 percent increase in desire, compared with 25 percent for women taking a placebo.


Finally, in its third round reviewing the pill, the FDA conceded that while the form “may not be an optimal assessment, it may provide interpretable findings of efficacy.”


Pharma Guy's insight:

These questionable questionnaires are also used to market drugs to consumers. For example, read "Your Aging Problem: Is It [LowT]? Take this Quiz and Find Out. Or Just Chalk It Up to Clever Marketing. Adriane Fugh-Berman, MD, Explains"; http://bit.ly/1Jfymp4 

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How to Use Shire's Binge Eating Disorder Symptom Checklist to Score a Controlled Substance Rx

How to Use Shire's Binge Eating Disorder Symptom Checklist to Score a Controlled Substance Rx | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After writing yesterday's blog post about Monica Seles helping Shire promote Vyvanse for Binge Eating Disorder (B.E.D.), which is a new indication for the ADHD drug, I wondered if this would make it easier for young people to obtain prescriptions for Vyvanse, which is a Schedule II controlled substance with a high potential for abuse.

Like overweight college students, I too could use a little "pick me up" pill from time to time.

Since there is no lab test to confirm a B.E.D. diagnosis, all I have to do to get a prescription for Vyvanse is convince a doctor that I meet all of the DSM-5® diagnostic criteria for binge eating disorder, which Shire provides here on the BingeEatingDisorder.com website.


Anyone can use Shire's handy "Binge Eating Disorder (B.E.D.) Symptom Checklist," which you can find on the "Talking With Your Doctor" page where "Starting the Conversation Is Key." 

It's easy to use the Checklist and get a printout (pdf file) to bring to your doctor. Here's how I filled in the Checklist and the advice I got from Shire on "starting the conversation" with my doctor - a surefire way of getting a prescription for Vyvanse and the boost I need during my busy day.


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Pharma Guy's insight:


This is not the first time Shire has used a symptom checklist to get people to visit their doctor and get their drug. Key to Shire's "Keep Momming" campaign is to get site visitors to take the "Symptom Checklist" (here) and bring the results to their doctor. "If you’re concerned your daughter might have ADHD [and who wouldn't be after watching the videos?], complete the ADHD Symptom Checklist based on her symptoms for the past 6 months, and share the results with her doctor."

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