Premenstrual dysphoric disorder (PMDD) — a severe form of premenstrual syndrome — is the focus of an investigative report published Tuesday by journalists at the Milwaukee Journal Sentinel and MedPage Today.
The article describes the early and troubling role that the pharmaceutical industry played in getting the Food and Drug Administration (FDA) to approve drugs for PMDD, years before the American Psychiatric Association recognized it — with considerable controversy — as a mental disorder in 2013.
Reporters John Fauber, Kristina Fiore and Matthew Wynn also explain how estimates for the number of women affected by PMDD are far greater than the scientific evidence suggests, thus putting millions of women at risk of taking potentially harmful drugs unnecessarily. In other words, the PMDD story is yet another example of disease mongering — widening the diagnostic definition of a medical condition in order to expand the market for its treatment.
A private meeting
The story begins with a 1998 meeting in Washington, D.C., which was funded by the global pharmaceutical giant Eli Lilly and Company, whose lucrative patent on the antidepressant Prozac was about to expire. The company wanted to find a new market for the drug.
At the meeting were six officials from the FDA, four executives from Eli Lilly and 16 researchers, report Fauber, Fiore and Wynn. Here’s their summary of what happened at that gathering:
There was strong disagreement over [PMDD], which the American Psychiatric Association had determined needed more study before it could be included in its manual defining mental disorders and symptoms.
That didn’t stop the meeting participants.
On their own, they determined PMDD was a distinct clinical disorder and declared that a class of antidepressant drugs known as selective serotonin reuptake inhibitors — a group including Prozac — were effective at treating it.
Eight months later, the researchers wrote a paper summing up their findings and describing the process that led to them. It was published in a medical journal [the Journal of Women’s Health] affiliated with an organization that had gotten money from Lilly in the past.
Lilly rebranded Prozac, changing the pill’s colors from green and yellow to pink and purple, and giving it a more feminine-sounding name — Sarafem.
Sarafem won FDA approval [in 2000]. So did three drugs from other companies: the antidepressants Zoloft (2002) and Paxil (2003), and the birth control pill Yaz (2006).
It wouldn’t be until 2013 that the American Psychiatric Association formally recognized PMDD as a distinct psychiatric condition — a determination that was based on the recommendation of a panel on which nearly 70% of the members had drug company ties.
Much less pervasive
As Fauber, Fiore and Wynn point out, the new market for PMDD drugs “was built on a disputed condition, inflated estimates of how many women had it and drugs that carry severe risks and side effects, such as suicidal thinking.”
When Sarafem was being considered for FDA approval, Eli Lilly-affiliated researchers claimed that as many as 8 percent of menstruating women in the United States — or 6 million women in total — had PMDD.
Those numbers are much too high, according to independent (non-drug-company-funded) research. For example, a 2009 study involving more than 1,200 Midwestern women found that only 1.3 percent of premenopausal women may have PMDD in any given year.
Concerns about the drugs
The antidepressants used to treat PMDD — Sarafem, Zoloft and Paxil — are not innocuous. Somewhat common side effects include increased fatigue, daytime sleepiness and decreased libido. In addition, all three carry strong “black box” FDA warnings for increased risk of suicidal thinking. And Yaz has been linked to dangerous blood clots.
Furthermore, as Fauber, Fiore and Wynn note, the drug companies’ own studies show that antidepressants work in only about 60 percent of women with PMDD.
“No rigorous studies have been done that show the long-term effectiveness of the antidepressants,” the reporters add.
Women health advocates have expressed other concerns about the drugs — and about the PMDD diagnosis itself. One of these advocates, psychiatrist Nada Stotland, a former president of the American Psychiatric Association, spoke with the Journal Sentinal/MedPage reporters:
Stotland said she feared that making the condition a mental disorder would lead to women with problems such as stress or depression getting lumped into a diagnosis of PMDD.
What’s more, since Prozac was merely repackaged and renamed as a treatment for PMDD, she felt it would make it easier for family practice doctors and gynecologists to prescribe it without doing the kind of psychological assessment that was needed to rule out other mental problems.
Another concern was that having it in the diagnostic manual could help mask what otherwise might be a woman’s justified reaction to abuse and mistreatment.