Revelations of Wyeth's alleged pay-to-play, ghostwritten articles in medical journals brought by Sen. Charles Grassley (R- Iowa) this week could not come at a worse time for the company.
The hormone-maker's bellwether case, Wyeth vs. Levine, is before the Supreme Court testing whether approval of a drug by a federal agency pre-empts the right of injured consumers to sue.
Wyeth was outed as spending $801,000 in just three months this year lobbying Congress, the White House, the FDA, and the Justice Department against the "generic menace."
And its signature product line, the hormone drugs Prempro and Premarin, still kills.
Since 70 percent of hormone replacement therapy (HRT) patients quit when the Women's Health Initiative (WHI) found the hormones caused a 26 percent increased risk of breast cancer, 29 percent increased risk of heart attack, 41 percent increased risk of stroke, and double the risk of blood clots in 2002, Wyeth has been trying to resuscitate the $3 billion year HRT gravy train.
But the condemning studies won't cease.
Two years ago researchers reported that breast cancer cases fell seven percent and estrogen positive breast cancer 15 percent--sparing 14, 000 women--in the first year women turned their backs on HRT.
Not only could breast cancer from HRT not develop or regress in that short a period of time the New York Times reported, it can also grow that quickly according to new evidence.
New findings from the WHI presented at the San Antonio Breast Cancer Symposium in December reveal that HRT doubles the risk for breast cancer in just five years and increases the risk in just two years.
"It's an excellent message for women: You can still diminish risk (by quitting), even if you've been on hormones for a long time," Dr. Claudine Isaacs of Georgetown University's Lombardi Comprehensive Cancer Center told the Associated Press about the new WHI interpretations. "It's not like smoking where you have to wait 10 or 15 years for the risk to come down."
When the Prempro/Premarin deception blew up in 2002, Wyeth sent out 550,000 letters "educating" doctors about the study findings. It ceased all advertising, "to make sure it was consistent with new data," Wyeth spokesperson Natalie DeVane told PR Week, not that it wasn't in compliance anyway.
Then it sicced its ghostwriters and subsidized docs on the medical press.
Women in the WHI study were too old, too menopausal, took HRT too long, shouldn't have had heart disease and shouldn't have had uteruses said the spin machine even as 4,500 cancer suits were brought against Wyeth.
One arm of the misinformation brigade was the "Council on Hormone Education" at the University of Wisconsin School of Medicine and Public Health, "designed to provide OB/GYNs and primary care physicians access to the most up-to-date and fair balanced scientific and educational information about postmenopausal hormone therapy," according to its website and funded by guess who? Wyeth.
In fact the 64 physician council members named 44 financial ties to Wyeth.
The council offered continuing medical education credit (ACCME) for a course called Quality of Life, Menopausal Changes, and Hormone Therapy--educating physicians about the "physiological effects of estrogen loss"--not in 1998, not in 2001--but in 2006!
P.S. Credit for the course is no longer available.
The course in pharma funded medicine was co-sponsored by the very company Sen. Grassley has accused of planting pay-to-play Wyeth articles in medical journals: DesignWrite of a Princeton, N.J.
And there's more.
Dr. Lila E. Nachtigall, the New York University professor and Women's Wellness Center director whom Grassley documents suggest was recruited by Wyeth for ghostwritten articles was on the distinguished faculty of the 2006: Quality of Life, Menopausal Changes, and Hormone Therapy course.
In addition to taking money from Wyeth, the University of Wisconsin reports she was funded by Eli Lilly, Merck, Pfizer, Proctor & Gamble and Novaritis AG.
While many doctors rode the HRT gravy train, Dr. Nachtigall was an early and zealous promoter.
Way back in 1985 she wrote in the Journal of Reproductive Medicine in an article cryptically titled Is Estrogen Replacement Therapy Necessary? that "Despite continuing controversy, the risks of ERT [HRT] are now considered minimal. With individualized therapy and appropriate monitoring, ERT with progestin supplements appears to be safe and effective for the great majority of postmenopausal women."
Not only was HRT indicated for women during and after menopause--from "menopause to death" as former Wyeth CEO Robert Essner used to tell his reps--"it may even reduce the risk of atherosclerosis," she wrote in the same article adding in the journal Geriatrics in 1990, most "studies have shown that replacing estrogen in the menopausal woman reduces cardiovascular disease."
Dr. Nachtigall was also an early worrier about HRT drop outs and wrote that a physician explanation of risks, "enhances compliance and discourages patients from discontinuing therapy because of fears of cancer or misconceptions about hormone replacement therapy," in Obstetrics & Gynecology in 1990.
So much for "no one knew" until WHI.
Dr. Nachtigall even took the cancer "problem" head on in Obstetrics & Gynecology in 1993 finding that, "22-year year administration of estrogen-progestin hormone replacement therapy did not increase the incidence of breast cancer in a small group of continuously hospitalized postmenopausal women."
Dr. Nachtigall also helped to widen the HRT revenue window with "The Symptoms Of Perimenopause," in Clinical Obstetrics & Gynecology in 1998.
Start 'em young!
Asked by the New York Times if she had rubber stamped pharma written articles as Sen. Grassley's disclosures suggest, Dr. Nachtigall was annoyed.
"It kind of makes me laugh that with what goes on in the Senate, the senator's worried that something's ghostwritten. I mean, give me a break."