News & Politics

Sarafem: The Pimping of Prozac for PMS

Sarafem, a new FDA-approved treatment from Eli Lilly, promises to make you "more like the woman you are."
Most of the time it's discussed, it's passed off as a joke. An office comment about cranky female staffers. A stand-up's punch line about his emotionally-unstable wife. The stereotypical, hyper-sensitive, chocolate-seeking bitch: PMS is cliché.

But for many women, it's also a lot more. From extreme irratibility to emotional breakdowns, premenstrual symptoms aren't always so funny. I would know. Pre-period, I will weep over a parking place. I snap in a Safeway line. Everything can provoke me: traffic, a broken dish, an unenthusiastic hello. There are times when I have hidden in employee bathrooms, humiliated by my inability to control myself. Once I get my period, I feel fine, but during those days I wonder if the mental illness in my family gene pool has finally claimed me.

When I first saw an ad for a pill to treat something called Premenstrual Dysphoric Disorder, or PMDD, I felt validated. Having a new clinical acronym to name my monthly mood swings made me feel less responsible, more normal. The commercial's snappy, bloated, irritated women reminded me of the bitch I don't want to be. The pill, spiraling across the screen like the bone in Kubrick's 2001: The Space Odyssey, looked like the next major evolution for woman-kind. I thought: At last our symptoms were considered seriously! At last, like the other great pill of the '60s, we could be liberated from the biological drawbacks of our sex!

That was my introduction to Sarafem, a new FDA-approved prescription treatment from the pharmaceutical mega-company Eli Lilly. With the active ingredient fluoxetine hydrochloride, Sarafem promises to make you "more like the woman you are." Such a lovely gesture. But it also turns out Eli Lilly wants to treat the women we aren't. Much more than a drug to relieve monthly moodiness, Sarafem is a wolf in sheep's clothing.

Snuggly Sarafem

And what a soft wool they've weaved. Intrigued by Sarafem's ad and interested in ways to rectify my monthly Jekyl and Hide complex, I visited Sarafem's heavily promoted website. Images of women seemingly plucked from Oprah's audience flashed across the screen, while nebulous phrases like "bloating" and "mood swings" flickered to and fro. Even in my entirely composed post-menstrual state, the site provoked the high levels of irritability Sarafem purports to solve. Yet after the annoying intro, the site's information was as fuzzy as their soft-lit television spots.

It says PMDD is "a distinctive medical condition" that is not "yet fully understood," but does little to distinguish it from most women's normal premenstrual syndromes. According to Eli Lilly, a woman must experience at least five of the following 11 symptoms for a diagnosis to be made: mood swings, irritability, tension, depressed mood, decreased interest in usual activities, difficulty concentrating, lack of energy, marked change in appetite, insomnia/ hypersomnia, feeling overwhelmed and bloating and breast tenderness. Eli Lilly goes on to claim that only 3 to 5 percent of women experience PMDD, but based on this vague diagnosis, almost every woman I know suffers from this mental disorder.

Eli Lilly qualifies its diagnosis by explaining PMDD's symptoms must occur about a week before one's period, remit on its onset and "interfere with daily life." But what "interfere" means is never explained. What's more, the company contradicts its own diagnosis by including a testimonial from a woman who "felt (her)self only one week of the month" before taking Sarafem.

Perhaps the only viable service the website offers is "Serene Screens" (pictures of flowers and natural scenes), "Soothing Sounds" (of crickets, cicadas and croaking toads) and "Inspirations." They'll even email you a "Daily Affirmation" that special time of the month. All in all, such ploys were good for a laugh -- a treatment I've always found to be an excellent antidote to PMS -- but I'm not sure this was Eli Lilly's intent. What they've actually adopted is a "Remembering Your Spirit" version of therapy, as if spinning sunflowers and babbling brooks are really going to calm those times when the computer looks like the enemy.

The Dubious Diagnosis of PMDD

So the site is annoying. But it's also alarming, if you pay attention. There's a bit hid deep in the website (and slipped in at the end of the TV ad) that reads: "Sarafem contains the same active ingredient as Prozac." When I first heard this statement, sitting in my living room wiping the tears away after some sappy-ass mini-series, it didn't sound so bad. I figured Sarafem must be diluted with a milder medicine, made in a lesser dose and/or taken less frequently. Certainly they wouldn't prescribe Prozac for PMS.

But it turns out that's exactly what Eli Lilly has done. The company changed the color of the pill from green to girly pink and turned the depression-stigmatized lable Prozac to the oh-so-feminine name Sarafem. Yet Sarafem/Prozac both require daily 20 mg. doses of fluoxetine hydrochloride. You don't take Sarafem any less often. You don't take it any smaller doses.

When pushed, Eli Lilly won't admit to this. Asked if Prozac and Sarafem are the same drug, Laura Miller, a marketing associate at Eli Lilly, explained the difference not in terms of the drug but the diagnosis. "PMDD is a distinct medical condition different from depression. PMDD is not depression," she said.

Which begs the question, if PMDD is a distinct condition, then what exactly is it? The American Psychiatric Association's (APA) list of mental disorders doesn't provide an answer. Neither PMS or PMDD can be found in it. However, PMDD is listed in the APA appendix of mental disorders, characterized by the same premenstrual symptoms on Sarafem's website: moodiness, irratibility, depressed mood, bloating, etc. The APA also states it will not consider PMDD an official disorder until further research is conducted.

Depression is another story. The APA's symptoms for depression include diminished interest in normal activities, change in appetite, insomnia, fatigue and depressed mood -- the very symptoms Eli Lilly uses to describe PMDD. Yet the APA is also very clear that these symptoms must be present most days for a minimum of two weeks -- not just 4 or 5 days a month. Which raises a second question. If PMDD is not depression, then why is it being treated with the same drug?

Patents and Dangers

The answer has to do with money, with commerce, with, basically, sly marketing. Sarafem's appearance on the market comes just before Eli Lilly looses its exclusive patent to Prozac. Come August, generic versions of fluoxetine hydrochloride will be available. Sarafem's patent, however, does not expire until spring of 2007. So by giving Prozac a new name and a new consumer base of potentially half the human population and increasing its price 13 cents a dose, Eli Lilly has effectively extended its lucrative ownership of that little green pill.

Yet that little green pill also has some not-so-little side effects. Besides the ones we have grown numb hearing about with prescription medicines -- stomach upset, rashes, dizziness and difficulty concentrating -- Prozac also affects sexual desire. Most patients on Prozac experience a considerable loss of sexual function and complain about its effect on their romantic relationships.

Another lesser known danger of fluoxetine hydrochloride is its connection to agitation and suicide. Because Prozac is prescribed to the depressed, Eli Lilly has been able to wave off accusations based on their patient's mental state. But that doesn't negate the fact that between 1978 and October 1993, the FDA recorded over 20,000 complaints of adverse side effects, including 1,885 suicide attempts and 1,249 deaths. There have been hundreds of wrongful death suits against Lilly, but all but two were settled out of court or dismissed. One of these suits, Forsyth vs. Eli Lilly (filed after Bill Forsyth, who had been on Prozac for one week, stabbed his wife to death and killed himself) introduced internal documents that proved Eli Lilly's knowledge of Prozac's suicidal side effects.

The Other Side Effect

Given that Sarafem is a different color Prozac, it's possible some women who suffer from PMS and take fluoxetine hydrochloride will experience these harmful side effects. But Sarafem's dangers are more than just physical. It's pharmaceutical truth also suggests a social side effect. By prescribing Prozac for PMS, Eli Lilly essentially has diagnosed those who suffer from premenstrual symptoms as mentally ill.

I hark back to when I first saw that Sarafem commercial and felt validated. I thought that my monthly emotional crisis was being taken seriously. That the male-centered medical industry had finally accepted PMS as something more than an irrational episode. In truth, they have done the opposite. They have classified my monthly syndromes as a mental sickness needing treatment. They have taken advantage of my worst premenstrual fears by stating that I am crazy.

So, despite Eli Lilly's women's pop-psychology marketing -- its touchy-feely commercials and Oprah-esque website -- Sarafem really has little to do with women's physiology. Instead it's about a looming patent loss wrapped up in a vague diagnosis -- a diagnosis most women can relate to. And while some women's premenstrual syndromes might "feel better" with Prozac as Eli Lilly claims, so would many things when one is on a mood-altering drug.

Sarafem is not about PMS, it's about profits, hushed side effects and deceptive advertising. It's about using women's emotional cycles -- fluctuations we already are made to feel self conscious and embarrassed about -- as a market for a dangerous drug. It's about peddling Prozac to those who don't need it. No amount of floral screen savers and croaking frogs can disguise that.
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