The New York Times on Sunday examined recently unsealed court documents from lawsuits arguing that drugmaker Wyeth oversold the benefits of its menopausal hormone drugs while failing to warn of their risks. Lawyers released some of the documents earlier this year, and the New York Times and the Public Library of Science successfully filed motions to unseal thousands more. According to the Times, the documents paint Wyeth as company that "over several decades, spent tens of millions of dollars on influential physicians, professional medical societies, scientific publications, courses and celebrity ads, inundating doctors and patients with a sea of positive preventive health messages that plaintiffs' lawyers say deflected users' attention from cancer concerns.
Postmenopausal women who take antidepressants face a small but statistically significant increased risk for stroke and death compared with those who do not take the drugs. The new findings are from the federally-funded, multi-institution, Women's Health Initiative Study sponsored by the National Institutes of Health, and the results are published in the December 14 online edition of Archives of Internal Medicine. Senior author Sylvia Wassertheil-Smoller, Ph.D., is a principal investigator in the Women's Health Initiative and is division head of epidemiology and professor of epidemiology & population health at Albert Einstein College of Medicine of Yeshiva University.
In connection with the New York Times' recent coverage of hormone therapy1, Pfizer Inc. released important facts and context to respond to the newspaper's account. Pfizer believes the coverage is based on a misleading and selective reading of both the science and history of hormone therapy (HT) medicines. Premarin (conjugated estrogens tablets USP) and Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), which are approved by the Food and Drug Administration (FDA), have brought relief to tens of millions of women for decades. The FDA has stated that HT has a well-established safety profile and is among the most studied classes of medicines.
Osteologix Inc. Announces Plans To File For European Marketing Authorization For Proprietary Osteoporosis Drug
Osteologix Inc. (OLGX.OB) announced that the company anticipates that it will be prepared to file a marketing application in 2011 in the European Union for its proprietary second-generation strontium therapy, NB S101 (strontium malonate). If successful, this will be Osteologix' first marketing approval of NB S101 for the treatment of postmenopausal osteoporosis. Following the successful completion of the company's initial Phase 2 study comparing NB S101 (strontium malonate) to Protelos® (strontium ranelate), which is marketed by Les Laboratoires Servier (Servier), Osteologix sought feedback on its development program from various regulatory authorities.
Special issue focuses on cardiovascular disease prevention and outcomes Emerging research on cardiovascular risk factors and treatment effects are helping clinicians gain a better understanding of which patients are most likely to benefit from close monitoring, lifestyle changes and/or additional therapeutic interventions. New findings published in the December 15/22, 2009, Prevention and Outcomes Focus Issue of the Journal of the American College of Cardiology aim to disentangle the influence of menopause versus chronological aging in upping women's post-menopausal risk for heart disease, evaluate the role of smoking status, physical activity and diet-induced weight loss in certain patient populations, and more fully describe the effects of intensive lipid-lowering therapy on subsequent cardiovascular events.
New research from the US has discovered that women who used bisphosphonates, commonly-prescribed bone-strengthening drugs, had significantly fewer invasive breast cancers than women who did not use them. The study is the work of lead investigator Dr Rowan Chlebowski, medical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed), and colleagues, and the findings are being presented at the 32nd San Antonio Breast Cancer Symposium in Texas this week from 9 - 13 December. The symposium is presented by the CTRC (Cancer Therapy & Research Center), AARC (American Association for Cancer Research), and the Baylor College of Medicine.