BALA CYNWYD, Pa., Oct. 1, 2003 (PRIMEZONE) -- The following statement was issued today by the law firm of Schiffrin & Barroway, LLP:
On July 9, 2002, the Journal of the American Medical Association released an expedited article concerning the WHI Prempro clinical trials. The article, summarizing the wide-ranging harm caused by Prempro, concluded that among Prempro users, there are "increased risks for cardiovascular disease and invasive breast cancer," and the article noted that "there were more harmful than beneficial outcomes in the estrogen plus progestin group vs. the placebo group."
A little over one year later, lawsuits for women injured by hormone therapy continue to mount. Over 30 lawsuits have been filed in Philadelphia, Pennsylvania, where Wyeth is located, according to prescribing information on Wyeth's flagship hormone therapy drugs, Premarin and Prempro. The lawsuits, filed by the Bala Cynwyd, Pennsylvania law firm of Schiffrin & Barroway, LLP, allege injuries from ingestion of hormone therapy drugs, including stroke, blood clots, pulmonary embolism, breast cancer, heart attack, ovarian cancer and death. The WHI study findings for the estrogen plus progestin (Prempro) group compared to the placebo group included a 41% increase in strokes; 29% increase in heart attacks; 22% increase in total cardiovascular disease; and 26% increase in breast cancer. It is expected that hundreds of more cases will be filed in Philadelphia, alleging similar injuries. Defendants in the hormone therapy lawsuits include Wyeth, Pharmacia Upjohn (a division of Pfizer), Barr Laboratories and Greenstone Ltd.
Prempro is a medication that was commonly prescribed as a substitution for hormones lost at menopause and to reduce incidence of post-menopausal symptoms such as hot flashes, night sweats and vaginal dryness. One year ago, approximately 3.4 million women in the United States were taking Prempro daily. Today, 1 million women are still taking Prempro pills. The drug first received FDA approval as a hormone replacement therapy in 1995.
The WHI Prempro clinical trials were cut short in 2002 when researchers determined that participants of the study were at an increased risk for developing serious injury from ingestion of Prempro. In all, the WHI Prempro study enrolled more than 16,000 women in a set of clinic trials to examine, among other things, the effect of estrogen plus progestin on the prevention of heart disease and hip fractures, and any associated change in risk for breast and colon cancer. The specific drug used during the study was Prempro supplied by Wyeth and Wyeth-Ayerst Research.
Shortly after the release of the WHI Prempro findings, a new study was released revealing that Wyeth's Premarin, an estrogen medicine, may be linked to ovarian cancer in women. James V. Lacey of the National Cancer Institute and lead researcher on an estrogen study said that long-term use of estrogen-only drugs can translate to additional cases of ovarian cancer. In the study, released in the July 17, 2002 edition of JAMA, researchers tracked the health of 44,241 women for approximately 20 years. The researchers found women taking estrogen had a 60% increased risk of ovarian cancer compared to those who were not. The risk increased with length of estrogen use.
Today, in the October 1, 2003 issue of JAMA, users of Prempro and estrogen-progestin pills got more bad news on the risk of ovarian cancer. Estrogen-progestin pills do not reduce the risk of ovarian cancer and might even increase it, according to a study that raises more red flags about a once widely accepted treatment for women going through menopause. "It's more bad news" for hormones, said American Cancer Society epidemiologist Dr. Carmen Rodriguez. The findings are further results from the WHI Prempro study. The new analysis found that 32 of the 16,608 participants developed ovarian cancer during about 5-1/2 years of follow-up. There were 20 cases in women who took hormones and 12 in those on placebo pills. In all, there was a 58% increase in ovarian cancer among participants in the study. According to the lead author of the study, Garnet Anderson, of the Fred Hutchinson Cancer Research Center in Seattle, "If women have no menopausal symptoms, they should not be taking" hormone pills.
The newest JAMA study comes at the end of September, which is Ovarian Cancer Awareness month. Every year one in 60 women is diagnosed with ovarian cancer and each year, approximately 14,000 women die from ovarian cancer. It's the fourth leading cancer killer among women. Once ovarian cancer spreads, the 5-year-survival rate is only 29%.
Wyeth continues to deny the link to ovarian cancer: "It does not prove that there's any kind of causal relationship," Wyeth's Dr. Victoria Kusiak said. Nevertheless, Wyeth now recommends that women seeking relief should take the lowest possible dose for the shortest possible duration, contrary to their long-standing advice to stay on hormone therapy drugs.
If you or anyone you know has been prescribed Prempro, Premarin, or other hormone therapy drugs and you have questions concerning your rights following your injuries from use of hormone therapy drugs, contact Schiffrin & Barroway, LLP. Schiffrin & Barroway, LLP has significant experience and expertise prosecuting complex class actions nationwide, including in the area of pharmaceutical litigation. For more information on Schiffrin & Barroway, please visit www.sbclasslaw.com.
More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca