Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Charles H. Payne was told he was being insubordinate to his manager when the Wyeth-Ayerst Territory Manager first raised concerns about promoting the drug company’s hormone replacement therapies (HRT) Premarin and Prempro to physicians for indications that were not approved by the Food and Drug Administration (FDA). The 22-year veteran of the company decided to take the issue to Wyeth-Ayerst’s Office of Ethics and Business Conduct.

In a letter dated July 18, 2000, Payne wrote that he had been given written presentations from company management to promote the drugs for conditions such as the prevention of Alzheimer’s disease and of cardiovascular disease. The drugs are only approved for the treatment of menopausal symptoms such as hot flashes and vaginal dryness.

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For years, Mrs. Smith* chose not to take hormone replacement therapy (HRT) to treat bothersome symptoms of menopause. During menopause, some women become “estrogen deficient” – their estrogen level drops so low that they experience symptoms such as hot flashes, night sweats and vaginal dryness that can be so severe it interferes with a woman’s quality of life.

Mrs. Smith talked to her doctor, who recommended Prempro, a pill made by Wyeth that contains a mixture of estrogen and synthetic progestin hormones. The pills were also marketed to doctors and women as a miracle drug that tamed not only menopausal symptoms but also had the added benefit of protecting women against heart disease and osteoporosis. HRT became widely prescribed, and Wyeth racked in billions in profits.

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In July 2000, Cynthia L. Waldrep was a territory specialist with Wyeth-Ayerst’s female healthcare division, promoting the company’s pharmaceuticals to doctors throughout Alabama and Georgia, when her conscience led her to write a letter to Wyeth’s executives and to the company’s Office of Ethics and Business Conduct.

“Instruction from my management for promotion of products … has included information outside of labeling. In other words, core presentations for promotion contain information that the FDA has not granted approval for use with these drugs. Specifically, the use of Premarin for the prevention/treatment of cardiovascular disease, Alzheimer’s disease, and colorectal cancer. Additionally, the issue of potential side effects has been minimized, such as the risk of breast cancer,” she wrote.

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“Not every woman requires (nor should every woman take) hormones,” writes Dr. K. Flood-Shaffer, associate professor in the department of obstetrics and gynecology at the University of Cincinnati in Ohio, in MyHealthNewsDaily. “For the average woman in the perimenopausal or menopausal period, the reason to start a hormone regimen is very specific. Hormones are used to ease the symptoms of hot flushes (flashes), to control irregular bleeding or to treat vaginal dryness. There may be, in some women, an improvement in her overall sense of well being, improvement in sleep patterns or quality of sleep, or improvement in libido – but none of these are indications to start hormone therapy.”

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Thousands of women who claim their hormone replacement therapy (HRT) caused them to develop breast cancer and other deadly diseases and conditions may finally have some resolution, now that Pfizer Inc. has announced it expects to shell out an additional $300 million to settle the last of more than 10,000 product liability lawsuits. The drug giant has already paid $472 million to settle with plaintiffs.

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Hormone replacement therapy (HRT) is blamed for increasing a woman’s risk of breast and ovarian cancer, heart attacks and strokes. Now, a new research study shows the pills also increase women’s risk of developing painful kidney stones.

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The reports of health problems associated with hormone replacement therapy (HRT) keep coming. First, the Women’s Health Initiative identified women who took the combined estrogen-plus-progestin therapy were at a much greater risk of developing breast cancer. It later showed these women were at an increased risk of heart disease and other serious health problems. Now, an article published online in the Journal of Clinical Oncology suggests that women who took combined HRT are at an increased risk of lung cancer by as much as 50 percent.

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William T. Creasman was listed as the author of an article written by a freelance writer for the December 1998 Journal of Women’s Health. The title: “Is there an association between hormone replacement therapy and breast cancer?” The article points out that there is no “definitive evidence” that HRT is linked to breast cancer. But the dirty little secret behind that article in the medical journal is that Creasman didn’t actually write the article. It was authored by a writer for DesignWrite, a marketing firm that represented HRT-maker Wyeth, now owned by Pfizer. As the story was going to press, Wyeth was covering up evidence that proved otherwise. The drug company’s estrogen-plus-progestin HRT was, in fact, increasing a woman’s risk for breast cancer as well as heart disease and Alzheimer’s.

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A study involving nearly 58,000 women in France over a 12-year period suggests that hormone replacement therapy (HRT) may increase a woman’s risk of developing asthma after menopause. Researchers from the Gustave Roussy Institute in France and the Instituto Nacional de Salud Publica in Mexico published the findings in the British medical journal, Thorax. The study suggested that women who took HRT were 21 percent more likely to develop asthma than women who did not take HRT. The risk was even greater for women who took estrogen-only HRT compared to the combined estrogen-plus-progestin therapy, with the estrogen-only group at 54 percent greater risk of developing asthma compared to women who did not take HRT. This is the first long-term, large-scale study to suggest that estrogen-only HRT puts women at much greater risk of asthma than the combined therapy.

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There is plenty of bad press about hormone replacement therapy (HRT), a striking reversal of just a decade or two ago, when drug makers were touting the many benefits of HRT for menopausal women. Those drug makers spent millions of dollars developing advertising campaigns and paying doctors to write articles in medical journals claiming the pills that combined estrogen and progestin were the fountain of youth. They put an end to nasty menopause symptoms such as mood swings and hot flashes, and offered the added benefit of strengthening bones and protecting women against cancer and heart disease.

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