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In
this issue:
F.D.A Looking at Stricter Approval Standards
The Food and Drug Administration is considering stricter guidelines and standards for clinical data and human trials from companies that are seeking approval for their medical devices. A recent report found deficiencies in clinical trials accepted by the F.D.A. over the past ten years, and the agency has been criticized for the standards it uses in approving medical devices. The F.D.A. reported that they will urge companies to more closely follow patients in clinical trials and sharpen their criteria for success in those trials. Barry Meier, LA Times 12/29/2009
Window Blind Recall Largest in U.S. History
The Consumer Product Safety Commission on Tuesday recalled all Roman-style shades and roll-up blinds with cords – around 50 million – due to the risk of child strangulation and death. The Chicago Tribune reports that eight child deaths and 16 near-strangulations from these types of shades have occurred since 2001. A nonprofit group called Parents for Window Blind Safety was founded earlier this decade by a parent whose child was strangled by shades in 2002 and has been lobbying the federal government for action. Several major retailers, including Wal-Mart and JCPenney, also are participating in the recall, the Tribune reports. Dan Simmons and Oscar Avila, Chicago Tribune 12/16/2009
Menopause Drugs Allegedly Cause Breast Cancer (No Direct Link)
Tens of thousands of women have filed suit against drug maker Wyeth this decade, claiming its menopause drug Prempro causes breast cancer and that warnings were not made clear to consumers. In October, Connie Barton of Peoria, Ill., was awarded $78 million by a Pennsylvania court. According to the New York Times, documents recently released hints that doctors across the country jumped on the belief of “protective benefits” of Prempro in its early stages, although later studies dispute those benefits. Court documents revealed that doctors failed to realize the negative effects of the drug. Natasha Singer and Duff Wilson , New York Times 12/12/2009
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