http://www.naplesnews.com/npdn/news/article/0,2071,NPDN_14940_4289779,00.html

Naples woman is part of drug lawsuit

By LIZ FREEMAN, epfreeman@naplesnews.com
December 5, 2005

A Naples woman is fighting some of the biggest names in the pharmaceutical industry, joining ranks with thousands of woman nationwide, contending hormone replacement therapy caused her breast cancer.

Roberta Kay Lamar filed a lawsuit last month in federal court in Fort Myers against Wyeth and its subdivisions, Pfizer Inc., and Pharmacia and Upjohn Co. for negligence, product liability, fraud and failure to warn menopausal women that hormone replacement therapy significantly increases the risk of developing breast cancer and other serious health problems.

Lamar took three hormone drugs from 1992 through 1998, as prescribed by her doctors, and regularly had cancer-screening mammograms, according to her lawsuit.

In 1998, a mammogram and biopsy revealed she had breast cancer and she underwent a left mastectomy. At the time of her diagnosis, she was instructed by her doctor to stop her hormone therapy.

Four years later, she and millions of other women nationwide learned of significant risks of developing breast cancer, heart disease and blood clots after long-term use of combination hormone therapy.

"(Her) ingestion of Premarin, Provera and Prempro was a substantial factor in causing her to develop breast cancer," according to the 68-page complaint.

"In the alternative, (her) ingestion of said hormone therapy drugs increased her risk of developing breast cancer and/or accelerated the growth of a pre-existing breast tumor."

Lamar declined to comment. She is seeking in excess of $75,000 in damages.

About 3,600 lawsuits nationwide have been filed against Wyeth, Pfizer and other makers of hormone replacement drugs. The bulk of the lawsuits have been consolidated, by multidistrict litigation, before U.S. District Judge William Wilson Jr., in Little Rock, Ark.

That's the case with Lamar's lawsuit, and the judge some time ago issued a gag order against attorneys speaking publicly about the cases, said Lamar's attorney, R. Deryl Edwards Jr., of Joplin, Mo.,

The first hormone replacement therapy lawsuit could get under way next summer in federal court, according to Drug Injury Watch, a Web site sponsored by plaintiff's attorney Thomas Lamb, of Wilmington, N.C.

"Through a massive and decades-long marketing and advertising campaign, Wyeth convinced doctors and the public that menopause is a disease requiring drug treatment rather than the natural process of aging," according to Lamar's lawsuit.

By the mid-1970s, more than 30 million prescriptions for Premarin were being written annually, making the estrogen product the fifth most prescribed drug in the United States, according to the lawsuit.

Studies linked estrogen therapy to endometrial cancer and sales of Premarin nose-dived. Wyeth and the other drug manufacturers switched gears and pitched adding a progesterone component, or combination hormone therapy. Pfizer developed a synthetic progesterone hormone, named Provera, and marketed it for prescribing with Premarin or a generic estrogen for combination theory, disregarding known risks.

"Despite having sufficient information to know such combination therapy exposed patients to even greater risks than either prescription drug alone, the (drug manufacturers) avoided fully studying the risks and therefore never had enough information to tell doctors or the public the truth about these risks," according to the lawsuit.

In 1994, Wyeth began marketing its hormone therapy drugs in a single pill, called Prempro, and downplayed studies coming out of Europe of the risks of breast cancer in women with bone-density problems, fractures or osteoporosis. On the contrary, the company promoted Prempro as preventing osteoporosis and heart disease. That's even after a company-funded study that was launched to prove Prempro prevented heart disease found the opposite was true and actually increases the risk of heart disease. Wyeth downplayed or ignored the findings.

"Defendants' sales representatives encouraged doctors to prescribe hormone therapy even if a woman was not having menopausal symptoms because of the therapy's purported cardiac benefits," according to Lamar's lawsuit.

But doom was turning the corner when Wyeth a few years earlier supported a massive study, the Women's Health Initiative, WHI, conducted by the National Institutes of Health and undertaken to confirm that Prempro was beneficial to the heart and helped prevent osteoporosis.

The study was abruptly halted in July 2002, three years early, by federal officials when the investigators found the risks of taking Prempro substantially outweighed the benefits. The findings contradicted decades of claims made by the drug manufacturers of the benefits of combination hormone therapy and spawned further studies of the heightened risks of breast cancer, strokes and heart attacks. At the time, 6 million Americans were on the therapy.

The findings from the WHI study were deemed so important they were released immediately to the public and doctors were advised to stop prescribing combination therapy for long-term use. Subsequent studies raised questions about the safety of even short-term hormone therapy.