Saturday, February 16, 2008

The FDA Is Hollow.



Good Reprint Practices of Medical Journal Articles
V. Summary

FDA recognizes that the public health can be served when health care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products. Accordingly, if a manufacturer follows the recommendations described in Section IV of this draft guidance and there is no unlawful promotion of the product, FDA does not intend to use the distribution of such medical and scientific information as evidence of an intent by the manufacturer that the product be used for an unapproved use.
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What does this proposed new rule do? Instead of doing clinical trials, just toss some grant money to a college and presto your NASAL SPRAY is an off label treatment for E.D..

This new guidance would:
1. Allow "Laundered Research" to promote off label drug prescriptions. Laundered research is like laundered money except it's cheaper and easier to do and you don't go to prison for it you get a Ph.D. for it.
2. Allow drug company marketing materials er... FDA approved labels from the product attached to the "research" papers. Look what this means that instead of some chemical compound identification in a research paper, now it's my nasal spray.
3. Seeding trials will occur at 100X their current rate. What's a seeding trial? Well, it's basically a tiny study done that doesn't follow any of the rules. You know, rules like you have to document everything and tell the whole story...
4. No FDA APPROVAL FOR MY DRUG'S OFF LABEL USE! NO CLINICAL TRIALS. NO SAFETY. NO EFFICACY. JUST SEEDED TRIALS AND LAUNDERED RESEARCH... THIS MEANS BILLIONS IN REVENUE FOR DRUG COMPANIES AND PEOPLE WILL DIE BECAUSE OF THIS. WOMEN, CHILDREN, PEOPLE YOU KNOW WILL DIE BECAUSE OF THIS NEW "GUIDANCE".






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