February 5, 2010
With drug giant GlaxoSmithKline (GSK) now stating it will abandon future antidepressant research, one can only wonder if the U.S. Food and Drug Administration (FDA) noted GSK’s CEO Andrew Witty’s admission that it is “hard to prove that a depression drug is working” because “patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.”
To put this in perspective, the head of GSK is pointing out an obvious flaw in the psycho/pharmaceutical cash cow of psychiatric drugs. There is no way to prove if a drug is working because there are no lab tests to prove anyone has a mental disorder in the first place—unlike medical diseases where blood and lab tests can show the effect of any drug upon the disease.
Given this statement, the next logical question is how did the FDA ever approve any psychiatric drug as safe and effective when the drug makers admit there is no proof of efficacy, only “subjective mood surveys.”
It seems the drug companies are catching on while the FDA is still promoting junk science in order to grant drug approval.
And that’s on top of the Journal of the American Medical Association (JAMA) landmark study published last month that found antidepressants no more effective than placebo. Add to that, 40% of antidepressant clinical trials have not been published because of negative results—they failed to show any significant benefit. So, even with a “subjective mood survey,” they can’t get the drug to make the mark. And the studies that did “prove” it did so, as Newsweek put it, for “the same reason why Disney’s Dumbo could initially fly only with a feather clutched in his trunk—believing makes it so.”
The FDA says: “Drugs must undergo a rigorous evaluation of safety, quality, and effectiveness before they can be sold.” Clearly, there is nothing rigorous about testing efficacy in antidepressants. GSK’s confession is on par with former American Psychiatric Association president, Steven Sharfstein admitting that there is no lab test to confirm a chemical imbalance in the brain. Reiterating this was his APA cohort Mark Graff, who told CBS Studio 2 that this theory was “probably drug industry derived”—in other words, a marketing ploy in the same vein as antidepressants are “effective.”
John Swann, Ph.D., historian at the FDA, once said: “To establish fraud, the bureau had to show that the manufacturer knew the product was worthless, and this proved difficult in many cases.”[i]
Well, FDA, if a drug company can admit what the FDA has known all along—that the efficacy of an antidepressant or any psychiatric drug is entirely subjective and, therefore, not based on science, how can the FDA continue to approve and condone the use of these drugs as “safe and effective?”
Instead of the potential fraud of a manufacturer, a more pertinent question we should be asking is this:
What if the government agency in charge of approving drugs, the FDA, knew a product was worthless and approved its use anyway? What happens then?