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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.
- GlaxoSmithKline had studies hidden that showed serious safety and efficacy concerns for Paxil.
- Merck did not publish trials and did not bring the data to the attention of the FDA showing increased risk of developing cardiovascular problem with their drug Vioxx.
- Avandia, an diabetes drug, was shown to be potentially harmful to its users but that data went unpublished.
- Only after media attention and Congressional inquiry did the ENHANCE study get released showing a negative outcome for the drug Zetia, a non-statin drug to lower cholesterol.
- The antibiotic Ketek, which is an antibiotic, was killing children in a trial in Zaire and there was data fraud in the trial as well to hide the problems.
- Bayer had problems with Baycol and knew it but that was only released as a result of a lawsuit (Want to know why they want tort reform? So they can avoid telling the truth).
- Bayer further knew their clotting drug Tasylol caused an increased risk for cardiovascular and renal disease but didn’t release it until after a meeting with the FDA.
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, Healthcare, Research | No Comments »