Letters reveal Wyeth downplayed breast cancer risks, promoted dangerous off-label use of HRT medications

posted on:
September 30, 2010

author:
STAFF

Formerly classified letters from Wyeth sales representatives express serious concerns about drug maker’s promotion of Hormone Replacement Therapy drugs

MONTGOMERY, ALA. (September 30, 2010)  – Letters written in July 2000 by sales representatives of Wyeth-Ayerst Laboratories, a division of Pfizer pharmaceutical company, have recently been made public. The letters, addressed to Wyeth executives and to their Office of Ethics and Business Conduct, express serious concerns by Wyeth employees that the company encouraged and even required its drug sales reps to minimize any risk of breast cancer and promote dangerous off-label usage of its hormone replacement therapy (HRT) drugs, Premarin and Prempro. These off label uses were never approved by the U.S. Food & Drug Administration (FDA).

Premarin, Prempro and other HRT therapies are traditionally used to treat symptoms of menopause in women. Off-label uses promoted to physicians by Wyeth representatives included prevention/treatment of cardiovascular disease, Alzheimer’s disease and colorectal cancer. Premarin and Prempro have since been shown to cause breast cancer.

The letter writers sold medications to physicians in Alabama and Georgia in their work for Wyeth. In one of the letters, Territory Specialist Cynthia L. Waldrep writes, “I fear that [patients'] lives may be placed in serious potential danger.” She goes on to say, “It appears the only thing that matters now is increasing market share.” Charles H. Payne, a Wyeth-Ayerst Territory Manager, writes, “This is a potentially life threatening situation for the women in Alabama and Georgia and I will not be intimated [sic] or coerced to relent in my actions to correct this problem.”  Carl Whatley, yet another Territory Manager, expressed concern that such off-label promotion could lead to well intentioned physicians prescribing the drugs inappropriately and causing injury.

The letters were kept confidential as part of ongoing litigation against Wyeth, but recently became public as a result of a trial. Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., is representing numerous clients who were injured or died as a result of using Premarin and Prempro.

“The employees of this company took a bold step in speaking out against its unethical practices,” said the firm’s founding shareholder Jere L. Beasley. “By marketing these drugs for uses that were never approved and downplaying the risk of breast cancer, Wyeth put the lives of thousands of women at serious risk. Now, these letters can finally come to light, and more people can learn that all too often Big Pharma is only concerned about its own bottom line, not the health and well-being of the public.”

Read the Whatley letter.

Read the Payne letter.

Read the Waldrep letter.

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