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

A class-action lawsuit on behalf of women who say they developed breast cancer after taking hormone replacement therapy (HRT), was certified by the British Columbia Supreme Court this week. The lawsuit alleges the makers of the HRTs Premarin and Premplus failed to warn patients about studies that showed a link between HRT and breast cancer. The lawsuit also claims that the company went to extraordinary measures to sway doctors and downplay any publicized risks associated with the drugs.

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The U.S. Supreme Court has rejected an appeal from Pfizer over its hormone replacement therapy (HRT) Prempro, which means the pharmaceutical company will have to pay three Nevada women nearly $58 million. Pfizer claimed that plaintiffs attorneys biased the jury during closing arguments, which led to the jury awarding $134.1 to the three women. That award was later reduced to $57.6 million.

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“I am writing this letter only after a tremendous amount of contemplation and reflection,” writes Carl Whatley, Jr., Professional Territory Manager with Wyeth-Ayerst Laboratories. “I have been struggling with and agonizing over this for months, and I feel I must bring it to your attention.”

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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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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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Drug companies’ advertisements touting the benefits of hormone replacement therapy (HRT) sold Delores Ann Spann Whatley of Tyler, Texas on the idea that her mood swings and hot flashes could be wiped away with just a daily pill. The estrogen-and-progestin cocktail was touted as a miracle drug, able to squash menopause symptoms while warding against osteoporosis, heart disease and cancer. But the pharmaceutical companies soon realized that the HRT that was making them rich was actually making consumers sick. But instead of notifying the public and pulling their product, the drug companies attempted to cover up the mounting statistics and continued to advertise to women about the benefits of HRT.

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Women who reported new-onset breast tenderness following use of estrogen-plus-progestin hormone replacement therapy (HRT) were at a much greater risk of developing breast cancer than women on the same HRT who did not report tenderness in their breasts, according to a study by researchers from the David Geffen School of Medicine at the University of California – Los Angeles.

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