Duty to Warn

new-logo25kohlsGary G. Kohls, MD

 

 

 

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Myth # 1:

“The FDA (US Food and Drug Administration) tests all new psychiatric drugs”

False. Actually the FDA only reviews studies that were designed, administered, secretly performed and paid for by the multinational profit-driven drug companies. The studies are frequently farmed out by the pharmaceutical companies by well-paid research firms, in whose interest it is to find positive results for their corporate employers. Unsurprisingly, such research policies virtually guarantee fraudulent results.

Myth # 2:

“FDA approval means that a psychotropic drug is effective long-term”

False. Actually, FDA approval doesn’t even mean that psychiatric drugs have been proven to be safe – either short-term or long-term! The notion that FDA approval means that a psych drug has been proven to be effective is also a false one, for most such drugs are never tested – prior to marketing – for longer than a few months (and most psych patients take their drugs for years). The pharmaceutical industry pays many psychiatric “researchers” – often academic psychiatrists (with east access to compliant, chronic, already drugged-up patients) who have financial or professional conflicts of interest – some of them even sitting on FDA advisory committees who attempt to “fast track” psych drugs through the approval process. For each new drug application, the FDA only receives 1 or 2 of the “best” studies (out of many) that purport to show short-term effectiveness. The negative studies are shelved and not revealed to the FDA. In the case of the SSRI drugs, animal lab studies typically lasted only hours, days or weeks and the human clinical studies only lasted, on average, 4- 6 weeks, far too short to draw any valid conclusions about long-term effectiveness or safety!

Hence the FDA, prescribing physicians and patient-victims should not have been “surprised” by the resulting epidemic of SSRI drug-induced adverse reactions that are silently plaguing the nation. Indeed, many SSRI trials have shown that those drugs are barely more effective than placebo (albeit statistically significant!) with unaffordable economic costs and serious health risks, some of which are life-threatening and known to be capable of causing brain damage.

Myth # 3:

 “FDA approval means that a psychotropic drug is safe long-term”

False. Actually, the SSRIs and the “anti-psychotic” drugs are usually tested in human trials for only a couple of months before being granted marketing approval by the FDA. And the drug companies are only required to report 1 or 2 studies (even if many other studies on the same drug showed negative, even disastrous,  results). Drug companies obviously prefer that the black box and fine print warnings associated with their drugs are ignored by both consumers and prescribers. One only has to note how small the print is on the commercials.

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