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    Clinical Trial Transparency – A Long Time In Coming

    By Mark Schauss | March 19, 2008

    Pharmaceutical companies have been under fire recently because data that showed that some of their drugs had significant side-effects or were not as effective as we were told or that they had serious human research protection violations when studied were hidden from the public and even the FDA. The journal Science, recently reviewed a new bill (the FDA Amendments Act – FDAAA) passed by Congress last September that mandates an opening of data to the public on most clinical trials. The section in question is known as 801. Basically what it does is releases the information from the trials within 12 months of its completion or within 30 days of FDA approval for a drug.

    Why do we need this?  Here are some examples of the pharmaceutical companies manipulation of known negative results for their money making drugs.

    The industry is up in arms saying that public access to these trials and the data is wrong because they are not sophisticated enough to properly review the data. Wait a minute, you do think we’re sophisticated enough to listen to your deceptive commercials and make choices about drugs you push? Do you see the hypocracy?

    I don’t hold out a lot of hope that things will change as long as the model of health care in America is one of profit above everything else. As long as Wall Street drives health care, we are doomed to ever increasing costs and lowered performance.  A major overhaul is needed and needed now.

    Topics: Drugs, Health, Research, Healthcare | No Comments »

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