Serafem by drug3k
I have written at length about the "corporatization" of health care in the US and the campaign by pharmaceutical companies to "medicalize" depression, menopause and other common conditions to market drugs that supposedly treat them. Thanks to skillful marketing, Eli Lilly has also turned premenstrual syndrome (PMS) into a profit-making commodity almost as lucrative as childhood bipolar disorder (a condition only recognized in the US).
In 1994, the American Psychiatric Association (APA) included premenstrual dysphoric disorder (PMDD) in their diagnostic manual as a "possible mental disorder requiring more research." Although DSM IV lists PMDD as a strictly "research" diagnosis, Eli Lilly immediately seized on it as a genuine disorder and devised a marketing strategy to profit from it.
The Difference Between PMS and PMDD
Approximately 80-90% of women worldwide report physical and emotional changes in the 7-10 days prior to the onset of menstruation. For the majority of women, these consist of minor physical changes similar to those of early pregnancy (water retention, breast swelling and tenderness and abdominal bloating). Approximately 1/3 of women note mental and emotional changes (aka PMS) - depression, anxiety, fatigue, irritability, insomnia, difficulty concentrating - that have a minor impact on their daily functioning. Although the APA has yet to agree PMDD even exists as a disorder, there are numerous claims in psychiatric and women's health literature that approximately 3-8% of women suffer from it. By definition, a woman can only qualify for a PMDD diagnosis if they experience a "marked" decrease in normal functioning due to premenstrual mood changes. A rigorous Swedish study recently ascertained that the true percentage of women experiencing a "marked" decrease in functioning before their period closer to 1.3% (http://www.nytimes.com/ref/health/healthguide/esn-pms-ess.html)
A Golden Marketing Opportunity for Eli Lilly
Once the patent on a drug expires, other manufacturers are free to produce much cheaper generic versions, resulting in plummeting sales of the original brand name drug. Lilly, who was facing the expiration of its patent (in 1999) on Prozac, exploited the inclusion of PMDD in the 1994 DSM IV by re-branding Prozac as a feminine pink and purple tablet called Sarafem. In 2001, the FDA approved Sarafem for "PMDD," on the basis of double blind studies involving several hundred women. Lilly reported a 60% response rate in women who took it for five cycles, with greater effectiveness in women who took it continuously throughout the month (as opposed to 7-10 days before their period).
I found this high response rate really puzzling, given that 30 years of double blind studies using fluoxetine to treat depression have an average response rate of 38-40%. In fact statistical analysis of all randomized controlled reveal that the average response rate of all SSRI antidepressants (i.e. Prozac, Zoloft, Paxil, citalopram, etc) is only slightly higher than the placebo rate (33-37%). In fact as I have written previously (see "Marketing Serotonin Deficiency" http://www.opednews.com/articles/Marketing-Serotonin-Defici-by-Dr-Stuart-Jeanne-B-100713-513.html), there is no scientific evidence that serotonin deficiency (the alleged condition SSRI's are prescribed for) actually causes depression.
Skillful Marketing: Adding Billions to the US Health Care Bill
Charging $3 per dose for their pink and purple Sarafem tablets (in contrast to 41 cents a pill per dose for generic fluoxetine), Lilly launched a massive marketing campaign to convince women they suffered from PMDD. In 2001, the year it came out, nearly 100,000 prescriptions were sold, reaping Lilly $85 million in profits. The high number of prescriptions suggests that doctors have been giving it out indiscriminately for premenstrual complaints, rather than limiting treatment to women with the severe symptoms allegedly associated with PMDD. Moreover given the soaring cost of health care in the US (the main reason millions of Americans do without medical care), it seems cynically immoral to trick doctors and women into wasting nearly a billion dollars on pink and purple pills with a fancy name, when generic fluoxetine would have been equally effective at 1/9 the cost.
After Lilly's phenomenal success, psychiatrists and drug researchers seized on a handful of studies to claim that serotonin deficiency was the cause of both PMDD and PMS. This, in turn, led other SSRI manufacturers to jump on the bandwagon to get their drugs approved.
"Natural" and "Alternative" Treatments for Premenstrual Syndrome
What I find really fascinating about the PMS/PMDD controversy is that it's one of the few women's health "conditions" in which there are more double blind placebo trials of "alternative" or "natural" treatments than medication trials. The three "alternative" treatments that have shown clear effectiveness in randomized controlled trials are omega 3 supplements, megadose Vitamin D and the chaste tree berry.
Omega 3 oil is the most studied in PMS-related mood changes, largely owing to its proven efficacy in depression and large cross cultural studies revealing that populations (for example Asians and Norwegians) consuming large amounts of fish (a primary source of omega 3) in their diets have an extremely low incidence of depression.
Vitamin D, though less well studied in PMS, has also proved helpful for depression in double blind studies, especially in elderly depressives, many of whom suffer from documented Vitamin D deficiency. There are a handful of studies showing that 1,000 -- 2,000 international units of Vitamin D (with or without calcium) is also helpful in alleviating premenstrual symptoms. I don't believe this is a coincidence, given Asian women's extremely low incidence of mood-related PMS. The same oily fish that are a rich source of omega 3 are the only natural food source of Vitamin D (the majority of us derive Vitamin D from a skin reaction triggered by exposure to sunlight).
Three double blind studies in the British Medical Journal, the Archives of Gynecology and Obstetrics and the Journal of Women's Health and Gender-based Medicine reveal that chaste berry helps approximately 52% of women with PMS. Chaste berry is an herbal remedy used by Hippocrates in ancient Greece for premenstrual symptoms. It's believed to work by lowering prolactin (a pituitary hormone influencing milk production). High prolactin levels are a recognized, but infrequent, cause of depression.