In 1998, Lilly, one of the world's largest pharmaceutical companies, was on the verge of losing its patent on fluoxetine (more commonly known as Prozac) worth over $2 billion annually. However, if Lilly could find a new use for the drug, the patent could be extended. That year, Lilly helped fund a "roundtable" of researchers to gather in Washington D.C., along with staff from the Food and Drug Administration to discuss a scientifically controversial condition called "premenstrual dysphoric disorder" (PMDD), which had only recently, and after much controversy, been included in the appendix of the Diagnostic and Statistical Manual—the bible of psychiatric disorders—as a disorder "under evaluation." But the Lilly-funded researchers soon published an article in a small medical journal suggesting, falsely, that the debate was over and that PMDD could now be considered a "distinct clinical entity," distinct from the stress and tension that can accompany ordinary PMS.
Lilly has not said what role it played in turning the "roundtable" into a journal article, but by 1999, the article helped convince the FDA to approve the use of fluoxetine to treat PMDD—and extended the patent until 2007. Lilly simply repackaged the drug in lavender pill-form, renamed it Serafem, and began marketing it to women. Never mind that independent researchers questioned whether PMDD even existed as a condition. Never mind that Europe's drug regulators raised serious questions about PMDD and criticized Lilly's clinical trials that purported to show the benefits of Serafem. Never mind that even the industry-friendly FDA was appalled at Lilly's television ads, with their too-vague tagline: "Think it's PMS? It could be PMDD."
• Marcia Angell's The Truth About Drug Companies