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Warning On Athletes' Use Of Prescription Drugs
Athletes could be putting their lives at risk by doping themselves with powerful prescription drugs, a leading academic has warned.

Pledges To Reduce Health Care Costs, Spending Growth Could Violate Antitrust Laws, Lawyers Say
U.S. antitrust laws could affect health care industry groups" efforts to work together to rein in health care costs, the New York Times reports (Pear, New York Times, 5/27). In a letter sent to President Obama on May 10, a coalition of groups -- the American Medical Association, the American Hospital Association, Pharmaceutical Research and Manufacturers of America, the Advanced Medical Technology Association, America"s Health Insurance Plans and the Service Employees International Union -- pledged to reduce the annual health care spending growth rate by 1.5%. The groups did not elaborate on what specific measures they would use to achieve such reductions, but the Obama administration has requested specific plans from the groups by June 1 (Kaiser Daily Health Policy Report, 5/26). According to the Times, many of the plans being considered by the health care industry would require greater cooperation across health care providers. Robert Leibenluft, a former Federal Trade Commission official, said, "Any agreement among competitors with regard to prices or price increases -- even if they set a maximum -- would raise legal concerns." In addition, while Obama is asking for specific plans from the health care industry, the administration has not offered any relief from antitrust laws, the Times reports. Furthermore, during his campaign Obama pledged to increase enforcement of antitrust laws, according to the Times.Antitrust laws have had a negative effect on previous health reform efforts, the Times reports. In 1993, the drug industry established a voluntary cost control plan that limited each drug company"s annual increase in the average price of prescription drugs to the increase in the Consumer Price Index, but the Department of Justice ruled that the proposal would violate antitrust laws. DOJ officials said that the U.S. Supreme Court made it clear that setting price maximums was akin to setting price minimums, which is illegal. In a letter to the Senate Finance Committee, AHA wrote that uncertainty regarding the enforcement of antitrust laws "makes it difficult for a hospital and doctors to collaborate to improve care" and reduce costs. AMA has asked Congress to amend antitrust laws to allow physicians to collectively negotiate with insurers over fees and other concerns, but FTC repeatedly has designated the practice illegal price-fixing, according to the Times. FTC officials said that consumers could benefit from cooperation among health care industry groups but that cooperation also could lead to increased bargaining power for physicians and hospitals, making it easier for them to set prices and eliminate competition (New York Times, 5/27). Reform Developments
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Public Health

GTx's Toremifene 80 Mg Increased Bone Mineral Density In Multiple Clinically Relevant Subpopulations Of Prostate Cancer Patients

GTx, Inc. (Nasdaq: GTXI) announced the presentation of data demonstrating that toremifene 80 mg treatment compared to placebo increased bone mineral density (BMD) in multiple clinically relevant subpopulations of men with prostate cancer on androgen deprivation therapy (ADT). The data, an analysis of results of the recent Phase III clinical trial evaluating toremifene 80 mg for the prevention of bone fractures and treatment of other estrogen deficiency side effects of androgen deprivation therapy in men with prostate cancer, were presented yesterday at the 2009 Annual Meeting of the American Society of Clinical Oncology. Toremifene 80 mg treatment compared to placebo showed higher BMD at the spine and the hip in an analysis of specific subgroups defined by baseline characteristics such as time on ADT (above/below the median 2.3 years), age (above/below 70 years), baseline BMD (normal or low), prevalent fracture, country of origin (United States or Mexico), or use of calcium/vitamin D (Abstract # 5055: "The effect of toremifene citrate on BMD in men on ADT: A phase III clinical trial"). "Estrogen is the principal hormone responsible for maintaining bone integrity, and loss of estrogen due to androgen deprivation therapy can lead to increased risk of fracture in men with prostate cancer," said Daniel W. Lin, MD, Associate Professor and Chief of Urologic Oncology, Department of Urology, University of Washington School of Medicine, and a Principal Investigator in the study. "In the Phase III clinical trial, treatment with toremifene 80 mg, a selective estrogen receptor modulator, resulted in increased bone mineral density compared to placebo in men with prostate cancer on ADT and, most importantly, toremifene 80 mg treatment significantly reduced the risk of fracture." Additional data from the clinical trial presented yesterday at ASCO demonstrated that in a univariate analysis, age greater than 70 years and degree of bone loss are independent predictors of fracture risk in men with prostate cancer on androgen deprivation therapy (Abstract # 9517: "Use of age and BMD to predict fracture risk in men on androgen deprivation therapy"). About the Study The two year, double blind, placebo controlled, randomized study of 1,389 ADT patients was conducted at approximately 150 clinical sites in the United States and Mexico. The primary endpoint was new morphometric vertebral fractures measured by dual X-ray absorptiometry (DEXA). Key secondary endpoints included bone mineral density, lipid changes, hot flashes, and gynecomastia. In the study, toremifene 80 mg treatment demonstrated statistically significant reductions compared to placebo in new morphometric vertebral fractures (the primary endpoint), in all nontraumatic fractures, and in first of either a nontraumatic fracture or greater than 7% bone loss. Toremifene 80 mg treatment compared to placebo also resulted in statistically significant increases in bone mineral density at the lumbar spine, hip, and femur; improvements in lipid profiles including a reduction in LDL, triglycerides and total cholesterol and an increase in HDL; and improvements in breast pain and tenderness. Toremifene 80 mg was well tolerated. Among the most common adverse events that occurred in over 2 percent of study subjects were joint pain (treated 7.2 percent, placebo 11.5 percent), back pain (treated 5.9 percent, placebo 5.0 percent), dizziness (treated 5.9 percent, placebo 4.8 percent), and constipation (treated 4.2 percent, placebo 5.0 percent). About ADT for Prostate Cancer ADT, primary treatment for advanced prostate cancer, has improved survival in men with prostate cancer. Approximately 700,000 men with prostate cancer are being treated with ADT and an estimated 100,000 initiate ADT each year. ADT is accomplished either surgically by removal of the testes, or more commonly by injection with LH releasing hormone (LHRH) agents. ADT works by reducing testosterone to castrate levels. The reduction in testosterone from ADT also results in very low estrogen levels, because estrogen is derived from testosterone in men. Estrogen deficiency side effects associated with ADT include high risk of skeletal fractures, adverse lipid changes, hot flashes, gynecomastia, depression, and memory loss. Of patients on ADT, up to 77% develop significant bone loss, making them susceptible to fracture. Recent studies indicate that the annual risk of fracture in men on ADT is 5% to 8%. Fractures are serious and can reduce survival in men on ADT by more than three years. GTx


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