FW Taking the Wraps Off Drug Safety Data From Clinical Trials

[Guest guest]

Doing so is overdue!!!

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Taking the Wraps Off Drug Safety Data From Clinical Trials

Current Rules Allow Data to be Kept Secret, Hinder Discovery of Dangerous

Side Effects

For Immediate Release.

Boston, MA  For years, pharmaceutical companies have sought to restrict

public access to drug safety data collected in clinical trials on the basis

that it is proprietary information, arguing that competitors could use that

information in the development of their own products. However, a number of

recent cases of drugs found to have dangerous side effects after coming to

market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised

concerns about safety data being treated as confidential. A new analysis by

researchers at the Harvard School of Public Health (HSPH) and Brigham and

Women’s Hospital (BWH) of laws and regulations governing public disclosure

of clinical trial data submitted to the Food and Drug Administration (FDA)

suggests changes should be made to the way the FDA implements its policy

regarding the confidentiality of those data. Allowing greater access to

safety data would enable researchers to independently evaluate risks,

resulting in more timely risk detection. The review and commentary appears

in the March/April 2007 issue of Health Affairs.

Read the entire article at

http://fmsglobalnews.wordpress.com/2007/03/13/taking-the-wraps-off-drug-safety

-data-from-clinical-trials/

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Mit freundlichen Gruessen

Katharina Gutsche

Sincerely,

Katharina

www.Auto-Thera.com

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Katharina Gutsche, M.A. Psycholinguistics, Dipl.-Psych.Clinical Psychology,

State Licensured Naturopath (Psychotherapy)

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