PMS Times 10

What's pink and purple and just might make you feel good all over? A little pill called Sarafem. It's the first drug treatment approved in the U.S. for women suffering from Premenstrual Dysphoric Disorder (PMDD).

You've heard of PMS.

No? Well, PMDD is PMS times 10. According to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), "the essential features are symptoms such as markedly depressed mood, marked anxiety and decreased interest in activities."

There are also physical symptoms such as breast tenderness and swelling. The severity is such that it causes "an obvious and marked impairment in the ability to function socially or occupationally in the week prior to menses." And in its most severe form, "The symptoms may be accompanied by suicidal thoughts."

What's interesting about Sarafem's new arrival is that it's not really new at all.

Eli Lilly and Co., the pharmaceutical giant that gave us Prozac, is now giving us Sarafem. Prozac's active ingredient is fluoxetine hydrochloride. Sarafem's active ingredient is fluoxetine hydrochloride. It's been done before. Take a drug, repackage it, rename it, and give it a new purpose. Wellbutrin, an anti-depressant, was renamed Zyban and is now prescribed for smoking cessation.

Yet this particular re-birth comes at a time when a U.S. federal appeals court reversed a decision that had given Eli Lilly Prozac patent protection through 2003, opening the door for generic competition earlier than Lilly had anticipated. So while Lilly's Prozac sales might go down, their Sarafem sales are safe.

According to Lilly, the name change was simply a way to avoid the stigma of depression associated with the name Prozac that might make women reluctant to take the drug. "Lilly's primary goal is to help provide relief for the millions of American women who suffer from this disorder," said Gary Tollefson, M.D., Ph.D., president, neuroscience products, for Lilly.

Lilly's web site, www.sarafem.com, opens with the line "Think it's PMS? Think Again... It could be PMDD." The smiling face of a different attractive, successful-looking and PMD-free woman greets you as you navigate through the pages of the site. Answers to questions all lead to the same obvious conclusion -- buy Sarafem. The first question addressed is "What is PMDD?"

Answer: "PMDD is a medically recognized condition that affects millions of women everywhere... But PMDD won't go away with aspirin. And left untreated, it can get worse with age." The next question is: "What causes PMDD?... While PMDD is not fully understood, many doctors believe it is caused by an imbalance of a chemical in the body... The good news is your doctor can now treat PMDD symptoms with a new treatment called Sarafem."

It's true that no one is 100 percent sure what causes PMDD and why fluoxetine might alleviate its symptoms, but according to clinical studies, it does. Meanwhile, PMDD sits not in the body of the book, but in the appendix of DSM-IV, awaiting further research to justify its place in the world of mental disorders.

A 1999 article in The New Republic, "Selling Shyness," spoke of the medical and pharmaceutical industries' creation of shyness as a mental disorder, under the name of "social phobia." Michelle Cottle, the author, describes social phobia as a "hot diagnosis -- this year's version of the attention deficit disorder (ADD) boom that took off a few years ago." She goes on to say: "Disorders don't just happen. Definitions of illness do not belong solely to the white-coated realm of pure science. They are social, cultural and economic phenomena as well."

In the U.S. after World War I, evidence was used to show that women should not work outside of the home because of the debilitating effects of menstruation. Yet, when World War II came along and women were needed once again to work outside of the home, sentiment shifted.

According to the authors of a 1994 study published in the Psychology of Women Quarterly, "Menstrual Joy, The Construct and Its Consequences," "the 'facts' about the menstrual cycle may have changed, but the tendency to focus on describing its negative, unpleasant, and 'unhealthy' aspects remains the same."

It's common to hear about a woman being moody, irritable or overly sensitive during her "time of the month." These are all possible symptoms for a PMDD diagnosis. Yet, one rarely hears about a woman being more vibrant, more self-confident or more creative during the time of her menses. These are not possible symptoms for a PMDD diagnosis. Most references to "the little visitor" are negative.

Susan Golub's 1992 book Periods from Menarche to Menopause notes that "many Americans still accept the taboo against sexual activity during menstruation," although some women report increased sexual desire during menstruation. There are various possible side-effects associated with fluoxetine -- nausea, headaches, anxiety, insomnia, and last, but certainly not least, loss of sexual appetite.

Whether or not PMDD is just another "hot diagnosis" and whether or not millions of women are indeed suffering from it, and whether or not Sarafem sells, millions of people will continue to "buy" the notion that the days prior to the onset of menses are a problem that needs fixing.

I have always loved sensing the cyclical changes in my body. Nothing makes me feel more like a woman that the breast tenderness and swelling I experience right before my period. I love telling my partner, "Be gentle. They're extra sensitive now. I'm getting my period." I say it with an air of authority I take on during those days. Only I can sense what my body is doing. I used to predict when my period would arrive by the waterfall of tears that would come the night before. I thought of it as the emotional catharsis before the physical cleansing. I think of the painful cramps as a reminder that my body is doing one of the things it's supposed to do -- prepare me to give birth. I have never perceived my symptoms as severe.

According to DSM-IV criteria, I might have a bit of PMS, but nothing that would require treatment. I think of a friend of mine, who says she suffers terribly, both emotionally and physically, the week before her periods. She might call it a disorder and gladly swallow a little pink and purple pill just to get through that week. But me, I'd rather call it one of the joys of being female and swell and cry and cramp up and bleed without pharmacological intervention.

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