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Parkinson's Disease Clinical Trials For posting and discussion of clinical trials related to Parkinson's Disease, and for the Parkinson Pipeline Project. All are welcome. |
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05-08-2008, 02:28 PM | #1 | ||
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In Remembrance
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FDA Scraps Helsinki Declaration on Protecting Human Subjects
In the mid-1990s, the National Institutes of Health ran a clinical trial in Africa testing whether a new antiretroviral drug to combat AIDS worked to prevent mother-child transmission. The trial created an ethical uproar because the control group received a placebo instead of an older anti-AIDS drug called AZT, which had already been proven successful in reducing the number of babies who contracted HIV from their mothers. To critics, failure to provide a proven therapy to participants in this and similar trials was a basic violation of standards outlined in the Helsinki Declaration on protecting human subjects in research, originally adopted by the World Medical Association in 1964. But to the U.S. Food and Drug Administration and the drug industry, to which it had grown increasingly close over the course of the 1990s, it contradicted its longstanding policy of only requiring trials showing that a new drug was "better than nothing," i.e., better than placebo, to win regulatory approval. If the drug industry were to closely adhere to the Helsinki Declaration, it would always have to run comparison trials if an effective drug were already available. Read blog
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paula "Time is not neutral for those who have pd or for those who will get it." |
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05-11-2008, 10:44 AM | #2 | |||
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In Remembrance
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as far as I have seen - we the USA have been a huge clinical trial!
FDA - I have replaced those intials with others that apply more aptly... unfortunatey I must keep them to myself... <~~~~~~~ that is the FDa doing a lil song & dance... never forget the death camps -the ethnic cleansing -eugeneics? never forget the Bushman that funded the NAZI Regime. never forget GDNF trials!!!! never forget the mercury in the babies vaccines never forget they use fetal tissue in makeup! never forget the USA -genocide of the unborn... we only have been spoonfed "ideaology" peace to your heart, tena Quote:
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with much love, lou_lou . . by . , on Flickr pd documentary - part 2 and 3 . . Resolve to be tender with the young, compassionate with the aged, sympathetic with the striving, and tolerant with the weak and the wrong. Sometime in your life you will have been all of these. |
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