Hormone Replacement Therapy, Mass Torts - Friday, December 10, 2010 12:51 - 0 Comments

Wyeth promoted dangerous off-label use of HRT medications

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 the Alabama Office of Ethics and Business Conduct, express serious concerns by Wyeth employees that the company encouraged and even required its drug sales representatives to 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.

As we have written in prior issues, 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 and treatment of cardiovascular disease, Alzheimer’s disease and colorectal cancer. It’s now widely known that Premarin and Prempro have since been linked to the development of breast cancer.

The sales representatives who wrote these letters marketed medications to physicians in Alabama and Georgia in their work for Wyeth. In one of the letters, Cynthia L. Waldrep, who was a Territory Specialist, wrote, “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.” Also Charles H. Payne, a Wyeth-Ayerst Territory Manager, wrote, “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.”

These letters were kept confidential as part of ongoing litigation against Wyeth, but recently were released as public record. Our firm is representing numerous clients who were either injured or had family members to die as a result of using Premarin and Prempro. The employees of this company took a bold and courageous step in speaking out against their unethical practices. By marketing these drugs for uses that were never approved, Wyeth put the lives of thousands of women at serious risk. Now, since these letters can finally come to light, 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.