Wyeth’s Pay-to-Play

Illinois (Where Our Governors Make Our License Plates)

Revelations of Wyeth’s pay-to-play, ghost-written articles in medical journals made public by Sen. Charles Grassley’s (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 kill.

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 per cent and estrogen positive breast cancer 15 percent– sparing14, 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.

Then it sicced its ghost writers and 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 Heath, “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.

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 is no longer available.

The course was co-sponsored by Designwrite, the Princeton, N.J. medical communications firm that Sen. Grassley has accused of planting pay-to-play articles for Wyeth in medical journals.

Dr. Lila E. Nachtigall, the New York University professor and Women’s Wellness Center director named in Grassley’s charges for rubber stamping Wyeth ghost written 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.

Of course many doctors rode the HRT gravy train but some, like Dr. John Eden, associate professor at the University of New South Wales and director of the Sydney Menopause Center in Australia, were willing to meet the cancer “problem” head on.

There is “no definitive evidence” that progestin causes breast cancer, Dr. Eden wrote in a May 2003 article in The American Journal of Obstetrics and Gynecology cited by Sen. Grassley in December in his charges–adding that  hormone users have a “better chance” of surviving cancer.

While physicians were questioning whether the breast cancers they were seeing were caused by HRT, Dr, Eden was actually recommending HRT as a post cancer treatment.

“HRT use for menopausal symptoms by women treated for primary invasive breast cancer is not associated with an increased risk of breast cancer recurrence or shortened life expectancy,” he wrote in an article titled, Hormone Replacement Therapy After A Diagnosis Of Breast Cancer in the Oct. 7, 2002 issue of the Medical Journal of Australia.

Other like Dr. Nachtigall worked the compliance angle for Wyeth.

“Physicians who prescribe hormone replacement therapy for menopausal women should explain the purpose, risks, and side effects of the treatment,” she wrote in an article titled Enhancing Patient Compliance With Hormone Replacement Therapy At Menopause in Obstetrics & Gynecology in 1990. “This enhances compliance and discourages patients from discontinuing therapy because of fears of cancer or misconceptions about hormone replacement therapy.”

Asked by the New York Times if she had rubber stamped drug-company-written articles, the doctor said that was also a  misconception and she had written her approximately 1,000 articles herself.

Nor did she think the medical pay-to-play Sen. Grassley is charging and the 4,500 HRT cancer victims it helped to create is a biggie.

“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,” said Dr. Nachtigall.

MARTHA ROSENBERG is a columnist/cartoonist who writes about public health. She can be reached at: mrosenberg@evmark.org






Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).