Prescribed and Abandoned--Another Drug Settlement
It was supposed to replace the millions Wyeth lost when its hormone drugs Prempro and Premarin tanked in 2002 thanks to links to breast cancer, heart disease, blood clots and strokes. So many women quit the Wyeth menopause drugs when the risks surfaced, the company announced it would close its Rouses Point, NY plant where it manufactured them and eliminate 1,200 jobs. No wonder Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) looked like the way to retain the lucrative menopause market. It wasn't a hormone.
But the FDA had other plans. Though it approved Pristiq in 2008 for the treatment of adults with major depressive disorder, it gave no such green light to Pristiq for hot flashes associated with menopause. There were too many safety signals.
Why did two women in the study group taking Pristiq have heart attacks and three need procedures to repair clogged arteries compared with none taking placebo, asked the FDA? Why did trials disclose serious liver complications? How could Wyeth assure the long term safety of Pristiq when 604 of the 2,158 test subjects took it for only six months? Seventeen suicides were also reported in Pristiq’s post-marketing data.
This week Pfizer, who acquired Wyeth in 2009, agreed to settle a class-action lawsuit by former Wyeth shareholders claiming they were misled about Pristiq's risks, for $67.5 million. Pristiq has already cost the company severely, losing it $7.6 billion in market value when the FDA refused the menopause indication, reports Reuters.
Even before this week's settlement, Pristiq had few friends in the Pharma community. “Pristiq is not a good drug by any standard,” wrote an anonymous poster on the industry chatroom cafepharma when the FDA declined the menopause indication.
“We tried to get 100 mg approved as the standard dose. But our patients got so sick that they care less about the efﬁcacy," wrote another poster. "They just couldn’t tolerate the drug long enough to see any improvement."
Smelling blood in the water at Wyeth’s setback other posters piled on. “No study exists showing any antidepressant including Pristiq works any better than a placebo for reducing hot ﬂashes, which are subjective anyway and only last a few minutes long at worst,” wrote another industry insider. “That is a heavy price to pay to take a heavy duty drug 24/7 for a few minutes of daily relief that a sugar pill also provides. FDA is crazy (or bought) if they allow this unproven drug travesty on the market.”
Would women want to trade “hot ﬂashes for decreased libido, nausea, increased blood pressure and incredible withdrawal issues” found with Pristiq asked another poster? “Women and their physicians are not as gullible as they were back in the Premarin days.”
Psychiatrist Daniel Carlat, who wrote a 2007 New York Times Magazine exposé about working as a Wyeth-paid spokesman selling Effexor to other doctors, also weighed in on Pristiq. “Every patient who takes Effexor produces Pristiq in their own body, at no additional charge,” he wrote in a blog article titled “Top 5 Reasons to Forget about Pristiq.” Pristiq is a metabolite of Wyeth's antidepressant Effexor XR which netted $3.7 billion in 2006 and was viewed as an unabashed patent extender for when Effexor XR went off patent in 2010.
The hormone drugs made by Pfizer, formerly Wyeth, proved so harmful to women, many said the "H" in HRT stood for hoax. This week's Pristiq settlement suggests there are more drugs in the hoax category. END