The osteoporosis drug EvistaÂ® (raloxifene) was recently approved for use to reduce the risk of invasive breast cancers in postmenopausal women who also have osteoporosis or are at high risk for developing breast cancer http://www.fda.gov/bbs/topics/NEWS/2007/NEW01698.html. The FDA reports that EvistaÂ® is only the second drug ever approved to reduce the risk of breast cancer. TamoxifenÂ® was the first such drug that was approved and has been marketed by Astra-Zeneca under the brand names NolvadexÂ®, IstubalÂ®, and ValodexÂ® and is also available as a generic.
The EvistaÂ® story is particularly relevant to Alley, Clark, Greiwe & Fulmer’s involvement in the HRT litigation for the last several years. Currently, we are pursuing nearly 100 lawsuits filed by post-menopausal women from the Tampa Bay area and throughout Florida who developed invasive breast cancers after ingesting Prempro, Premarin taken in combination with Provera or MPA, and other combination hormone replacement therapy drugs. For years, Wyeth and other HRT manufacturers engaged in aggressive campaigns to discourage gynecologists from prescribing EvistaÂ® for the prevention of osteoporosis – one of the very few benefits of HRT drugs. Evidence in the HRT litigation, which involves more than 5,200 women nationally, has shown that physicians were told that HRT drugs did not promote the development of breast cancers and that EvistaÂ® did not provide the “bundle of benefits” that Wyeth and others claimed had been proven with regard to Prempro and other combination hormone replacement therapies. This “bundle of benefits” was at the heart of the controversial Wyeth marketing campaign known as “Body of Evidence” that touted the alleged proven benefits of HRT drugs for a number of conditions, including prevention of Alzheimer’s disease, heart disease, strokes, and heart attacks while falsely reassuring patients and physicians that HRT drugs were not associated with a risk of breast cancer. We now know, especially after the WHI and Million Women studies, that the “bundle of benefits” that lured so many women and their physicians into accepting HRT therapy were never there, and, in fact, HRT drugs appear to cause heart attacks, strokes, and worsen Alzheimer’s disease in addition to the very significant risks of breast cancer. One can only wonder how different our client’s lives might have been if their doctors had accurate information back then about the substantial risks and limited benefits of HRT versus EvistaÂ®, bioidentical hormone therapies, or the now accepted (but previous maligned) notion that many women don’t need drugs at all once they enter menopause.
For more information on this subject matter, please refer to the section on Drugs, Medical Devices and Implants.