Not only has it failed to approve three new Wyeth drugs designed to replace Effexor revenues when its patent expires in 2010--Viviant, for osteoporosis, Pristiq, for depression and menopause and bifeprunox for schizophrenia--it dared to compare their benefit/risk profile to drugs already on the market, challenging the Pharma received wisdom that newer equals better.
In the past the FDA compared new drugs to placebo and not existing drugs which is how lemons like Vioxx, Avandia and Ketek happen says former editor-in-chief of the New England Journal of Medicine Marcia Angell in The Truth About the Drug Companies.
Now, the FDA is asking not just if a drug is safe and effective but if it's necessary after a decade of pharma induced carnage courtesy of unforeseen side effects in fast tracked prescription drugs.
And it's anti competitive says Essner!
"If you're the first company to get approved in a certain area and competitors can't get on the market, the FDA is now establishing monopolies. And that's certainly not their mandate."
Of course Essner could just as easily see the glass as half full.
The FDA didn't stop Wyeth from selling Redux-the notorious fenfluramine/phentermine combo-until a 1997 study found 30% of users sustained heart damage.
And it's still marketing Premarin and Prempro with impunity even though hormone replacement therapy (HRT) causes a 26% increased risk of breast cancer, 29% increased risk of heart attack, 41% increased risk of stroke, and 100% increased risk of blood clots according to the federal Women's Heath Initiative. And increases the risk of ovarian and lung cancer, mental decline, hearing loss, urinary incontinence, lupus, non-Hodgkin's lymphoma, scleroderma and asthma according to other studies.
And even though the recent dramatic drops in U.S. breast cancer-up to 15% for estrogen positive cancer -coincide with the millions of women who dropped out of HRT in the early 2000's .
The FDA sent Wyeth no cease and desist letters when it claimed in The Pharmacist's Guide to Women and Menopause, The Good Housekeeping Guide to Women's Health and Take Charge! A Woman's Guide to Fighting Heart Disease that estrogen replacement prevented (sic) coronary heart disease risk.
Or when it told its sales reps to "promote Prempro for Alzheimer's" as came out at the first Premarin/Prempro trial brought by mastectomy survivor Linda Reeves in Little Rock, AR last year. (she lost)
And even though Essner himself was described as staging Enron style Prempro parties in which he called for "no boundaries, no limits to your selling effort" to keep women "on HRT from menopause to death" by Wyeth sales rep Charles Payne at the Arkansas trial he is not in Club Feb like some counterparts.
But Essner evidently sees the glass half empty.
As the 60-year-old leaves the Wyeth helm and prepares to go back to teaching, the company faces $21.1 billion in Redux liabilities and 5,300 more Prempro/Premarin lawsuits.
And this month a jury of five men and two women in Reno, NV awarded $99 million in punitive damages to three breast cancer survivors who had taken Wyeth hormones, after only two hours of deliberation.
The jury didn't seem to think the cancer causing Premarin and Prempro taken by Jeraldine Scofield, 74, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 65, of Yerington were safe, effective or even necessary.