Journalist Robert Whitaker, via the Freedom of Information Act gained access to FDA data on the drug trials for the Atypicals Risperdal, Seroqual and Zyprexa. Whitaker found that:
Again: Here's what the FDA has labeled "safe and effective." And once again; Thanks to Allen Jones for his Full Whistle Blower Report. (pg 23)
"1. One in every 145 patients who entered the trials died, and yet those deaths were never mentioned in the scientific literature.
2. The trials were structured to favor the Atypicals and most of the study reports were discounted by the FDA as being biased.
3. One in every thirty-five patients in Risperdal trials experienced a serious adverse event, defined by the FDA as a life threatening event or one that required hospitalization.
4. Twenty-two percent of patients in Zyprexa trials suffered serious adverse events
5. The Atypicals did not demonstrate superior effectiveness or safety over Typical antipsychotics.
It is important to note that a drug company does not have to prove that a new drug is safer or more effective than an old drug to gain FDA approval. Essentially, the manufacturer has to demonstrate that the drug is proved to yield better results than placebo in a statistically significant number of patients in short-term trials (6-8 weeks). "
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