Drugs in Search of a Disease—Pharma Targets Women—Premenstrual Dysphoric ‘Disorder’

Last week I focused on drug advertisement for “Low T” catching up with all the attention given to menopausal women with declining hormones. But women still are the primary targets for pharmaceutical advertising, in part because they can be captured for multiple products—if not quite from the cradle, at least from puberty, through pregnancy, to menopause and to grave.

Scientific American—October 2, 2012
by Judy Stone

We have a new “illness,” Premenstrual Dysphoric Disorder…PMDD is no longer a disease in search of its own drug. Eli Lilly has taken care of that problem, initially rebranding Prozac as Sarafem, “the first and only FDA – approved prescription drug to treat PMDD and ‘help you feel more in control.’

Last week I focused on drug advertisement for “Low T” catching up with all the attention given to menopausal women with declining hormones. But women still are the primary targets for pharmaceutical advertising, in part because they can be captured for multiple products—if not quite from the cradle, at least from puberty, through pregnancy, to menopause and to grave.

What are some of the consequences of this relentless focus on women’s hormones and common symptoms? For one, it seems to promote a nation of hypochondriacs. It is extremely profitable for pharmaceutical companies, but it is not so good for the target of this attention, women.

For example, for the younger set, we have a new “illness,” Premenstrual Dysphoric Disorder (PMDD). In my day, it was moodiness at “that time of the month,” more typically known as bitchiness. We didn’t have an ICD-9 or DSM code. We had uncomfortable days but knew that this, too, would pass. Now cyclical hormones are a disease. The Diagnostic and Statistical Manual of Mental Disorders, revision four, made the diagnosis official, although “an example of a depressive disorder not otherwise specified.” It is said to affect 3-8% of reproductive age women. Not everyone agrees that PMDD warrants a distinct psychiatric diagnosis. In 1999, the FDA adopted PMDD as a distinct disorder for treatment.

But PMDD is no longer a disease in search of its own drug. Eli Lilly has taken care of that problem, initially rebranding Prozac as Sarafem, “the first and only FDA – approved prescription drug to treat PMDD and ‘help you feel more in control.’ ” Other pharmaceutical companies have followed suit, and now several selective serotonin reuptake inhibitors (SSRIs) have approval for this indication. Sometimes these drugs are prescribed to be taken intermittently, only during the luteal phase of the menstrual cycle (the two weeks before menstruation). Some have raised concern that the intermittent administration of SSRIs for PMDD might contribute to increased suicides. Another concern is that of drug interactions, as many of these women are also on oral contraceptives. Who knows what unintended consequences there might be with this combination (as well as the myriad of other drugs taken for symptomatic relief)?

Click image to read all studies and warnings issued on antidepressant drugs

Anti-depressants, like SSRIs, have many side effects, including decreased libido. So, just as we have the tragedy of “Low T” and the blockbuster sales of erectile dysfunction drugs (e.g., Viagra, Cialis), we now have pharma working feverishly to develop drugs to boost women’s libidos, such as the “female Viagra,” which is even thoughtfully a pink, rather than blue pill. Flibanserin (Boehringer Ingelheim) was another such drug, developed for the newly described syndrome of hypoactive sexual desire disorder (HSDD) or lack of libido. It failed, however to achieve FDA approval. Other companies are in hot pursuit.

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