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Archive for February, 2007

Study: Seniors Face Risks with All Antipsychotic Drugs

Tuesday, February 27th, 2007

For the last couple of years, there have been a lot of questions raised about the cost, effectiveness, and safety of second-generation (or atypical) antipsychotic drugs such as Zyprexa, Seroquel, and Risperdal. However, a new Canadian study has found that older, conventional antipsychotic medications pose a similar risk of death to elderly patients perhaps an even greater risk than the atypical class.

A new report published in the current issue of the Canadian Medical Association Journal (CMAJ) claims that, among elderly patients, “the risk of death associated with conventional antipsychotic medications is comparable to and possibly greater than the risk of death associated with atypical antipsychotic medications. Until further evidence is available, physicians should consider all antipsychotic medications to be equally risky in elderly patients.”
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FDA Questions Efficacy of Sanofi’s Bird-Flu Vaccine

Monday, February 26th, 2007

This week, the U.S. Food and Drug Administration (FDA) has scheduled a two-day meeting of its Vaccines and Related Biological Products Advisory Committee, and among the agenda items will be a discussion of the safety and effectiveness of Sanofi Aventis’ H5N1 inactivated influenza (bird flu) vaccine. In advance of the meeting, the FDA has released several briefing documents that have called into question the effectiveness of the vaccine.

FDA researchers determined that “there were no significant safety signals that would preclude administration of this vaccine to additional persons.” However, they also found that the vaccine was not as effective as previously thought. Last year, a New England Journal of Medicine study found that only 54 percent of trial patients had developed an effective immune response. The FDA’s analysis of the same study, put forth in the new briefing documents, found that only 45 percent of patients who’d received the highest dosage (a series of two shots, 90 micrograms each) developed an effective immune response to the virus.
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Study: Big Pharma Influences Breast Cancer Research Results

Monday, February 26th, 2007

In an enlightening and alarming new study, researchers led by Dr. Jeffrey Peppercorn of the University of North Carolina report that clinical breast-cancer trials that are funded by drug companies tend to produce more favorable results than independently funded studies. According to the authors, “Pharmaceutical involvement in published clinical breast-cancer research may affect study design, focus, and results.” The findings of the report, already available online, will be published in the April 1 edition of Cancer, the journal of the American Cancer Society (ACS).

“Breast cancer treatment trials supported by the pharmaceutical industry are more likely to report positive results than non-sponsored studies,” notes the ACS. “In addition, there are significant differences in the design of trials and types of questions addressed by pharmaceutical industry sponsored trials compared to non-sponsored trials. The study is the first to examine the impact of the pharmaceutical industry on breast cancer research.”
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