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How Big Pharma Distorts Science for FDA Approval of Dangerous Drugs
In February the Justice Department charged Forest Laboratories with illegally marketing antidepressants Celexa and Lexapro to younger patients and burying a study that showed suicidal side effects in children. But the very next month the FDA approved Lexapro for depression in adolescents 12 to 17.
In March the Justice Department charged AstraZeneca with knowing and hiding the diabetes side effects of Seroquel. But this month the FDA considers expanding the antipsychotic's approvals to depression and anxiety.
And in January, Eli Lilly pled guilty to promoting its antipsychotic Zyprexa for unapproved and dangerous uses in a $1.4 billion settlement. But in March the FDA approved Lilly's Zyprexa/Prozac combo, Symbyax, for treatment resistant depression (TRD). What do you get when you cross Zyprexa with Prozac? Someone who gains 100 pounds and feels great about it!
"TRD" is such a new pharma invention that Googling it brings up Toyota Racing Development and Teacher Recruitment Days. But it will soon move prescriptions like GAD (general anxiety disorder), MDD (major depressive disorder) ADD (attention deficit disorder) RLS (restless legs syndrome) GERD (gastroesophageal reflux disease) and PMDD (Premenstrual dysphoric disorder) -- and for the same reasons.
How do dangerous drugs keep getting approved? Through the best articles and spokesmen money can buy.
Forest paid Massachusetts General Hospital researcher Jeffrey Bostic $750,000 to chat up Celexa and Lexapro, according to US District Court in Boston filings. AstraZeneca paid University of Minnesota researcher Charles Schulz $112,000 to push Seroquel, according to US District Court in Orlando filings. And a decade of pain "studies" conducted by Baystate Medical Center's Scott S. Reuben on Vioxx, Lyrica, Celebrex and Effexor were completely fabricated--including the patients say published reports.
And speaking of "made up," Coast IRB, an institutional review board which oversees some 300 clinical trials and 3,000 researchers, agreed last year to approve a human trial for "Adhesiabloc," a surgical gel that the Government Accountability Office completely made up in a sting operation. Oops.
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