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Molecules to Medicine

Molecules to Medicine

Demystifying drug development, clinical research, medicine, and the role ethics plays

Drugs in Search of a Disease Pharma Targets Women

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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)?

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.

As women mature, we come to the premenopausal years and the hormone replacement therapies to save women from the “decay” of menopause, discussed in my last post. Approaching menopause, women also have to worry about osteoporosis.

Dexa Scan

But pharma hasn’t wanted to wait for us to develop osteoporosis. Instead, they created a new disease, osteopenia, well described by NPR’s “How A Bone Disease Grew To Fit The Prescription.” Not only was there a new need for a drug for this manufactured illness, but an entire industry rose up around special new x-ray machines, called densitometers, to diagnose osteopenia, and repeated diagnostic tests to monitor therapy. Then the “Bone Measurement Institute”, created by Merck, successfully lobbied Congress to pass the Bone Mass Measurement Act, which required Medicare to cover the costs of the scans. This biography of osteopenia and its multi-billion dollar industry is a must-read.

Note, however, that clinical research has shown that drugs for osteoporosis are effective are valuable and may be life saving. Drugs for early osteopenia have not shown such benefit, and have many serious side effects. In fact, long-term use of bisphosphonate drugs (e.g., Fosamax, Boniva) for osteoporosis may actually weaken bones, leading to increases in fractures. Limiting use of such drugs to less than 5 years was recommended after finding unusual hip (subtrochanteric) fractures and osteonecrosis of the jaw in drug users. (Osteonecrosis is bone death, explained here).

Rather than have ads specifically targeting certain patient groups, last year Ian Spatz, a healthcare industry advisor and former Merck executive, wrote a seductive New York Times op-ed, “Better Drug Ads, Fewer Side Effects.” In this piece, Spatz raised the reasonable sounding idea of “legislation that would allow drug companies to cooperate with one another, and with physician and patient organizations, to develop joint ad campaigns that are specific to certain diseases and conditions but not to any particular drug.” While this may be an improvement over the current plethora of erectile dysfunction drug ads, the proposal skirts an important issue. Spatz pitches this innocently, suggesting, “we’d get unbiased information about the medical conditions we care about, and encouragement to seek out the medicines and vaccines that can help us maintain and improve our health.”

Elixir of Youth

Two problems are immediately evident. The first is that the emphasis remains on medicines. While I certainly value drug therapies, we would have a far healthier population if there were a more holistic approach and emphasis on nutrition, exercise, preventive care, and personal responsibility. Instead, patients are again encouraged to seek instant gratification for any minor complaint, rather than taking any—let alone difficult—steps to alter their behavior or be an active, responsible participant in their well-being.

Spatz’s pitch also makes me wary of the claim that this new model of patient education won’t just be a repeat of the same successful—for pharma—approach of direct-to-consumer (DTC) advertising. I’ll have more about that in an upcoming post. Until then, be wary of innocent sounding offers of drugs to relieve all of your discomforts.

Note: The latter part of this post is adapted from an earlier post of mine on "Politics, Science & Other Assorted Musings," February, 2011.

Credits

Dr. Coderre's Pills - H Michael Karshis/Flickr

Bowl of antidepressants - Carsten Schertzer/Flickr

Dexa Scan - ActiveSteve/Flickr

Elixir of Youth - *Kid*O*Cone* - Flickr

The views expressed are those of the author and are not necessarily those of Scientific American.

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