Jury Trials In 2008 Expected To Expose SSRI Maker's Dirty Secrets

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By Evelyn Pringle (about the author) Page 2 of 6 page(s)

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Chemical Imbalance - Selling Sickness in the Absence of Efficacy

The standard line used to sell SSRI's is that mental illnesses are caused by a chemical imbalance in the brain and that SSRI's correct the imbalance. The Lexapro website even states: "Antidepressant medicines relieve the symptoms of depression by restoring chemical imbalances in the brain."

However, "Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature," in the November 8, 2005, PLoS Journal, by Jeffrey Lacasse, a visiting lecturer at the Florida State University, and Jonathan Leo, an Associate Professor of Neuroanatomy at Lincoln Memorial University, reports that, "there is not a single peer-reviewed article that can be accurately cited to directly support claims of serotonin deficiency in any mental disorder, while there are many articles that present counterevidence."

In their most recent paper titled, "The Media and the Chemical Imbalance Theory of Depression," appearing in the February 2008 issue of Society, Mr Lacasse and Mr Leo report that, "In spite of the enormous amount of money and time that has been spent in the quest to confirm the chemical imbalance theory, direct proof has never materialized."

In fact, they advise that the Diagnostic and Statistical Manual of Mental Disorders, which almost all psychiatrists use to diagnose and treat their patients, clearly states that the cause of depression and anxiety is unknown.

Even when prescribed for their intended purpose in treating depression, many experts say SSRI's are ineffective. One of the world's most famous psychopharmacologists, Dr David Healy, author of "The Antidepressant Era," and "Let Them Eat Prozac," says that an overall review of the published clinical trial data on the new antidepressants reveals a 10% difference in the way people respond to the drugs verses a placebo.

He reports that 50% of patients taking the antidepressants showed some improvement and 40% of people taking a placebo showed improvement. And when the data from the unpublished clinical trials are added in, 45% of patients taking a placebo showed improvement.

The author of "Surviving America's Depression Epidemic," Dr Bruce Levine also says "legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all."

However, most prescribing doctors have never heard about this 5% or 10% efficacy statistic, which researchers have referred to as the "dirty little secret," because many of the studies that revealed the "secret" remained hidden for years.

In fact, much of the information is still not in the public domain. A new study in the January 18, 2008 New England Journal of Medicine reports that the makers of the new antidepressants failed to publish many of the clinical trials that were submitted to the FDA for market approval that did not show positive outcomes in patients taking the drugs.

The researchers found that a total of 37 studies were viewed by the FDA as having positive results and all but one were published. But 22 studies that were viewed as having negative or questionable results were not published and 11 were published in a way that conveyed a positive outcome.

The study compared drug efficacy inferred from the published literature with efficacy determined in the FDA reviews and found that in the published medical literature, it appeared that 94% of the trials were positive when the FDA analysis showed that only 51% were positive.

The clinical trials analyzed included the drugs, Wellbutrin, Celexa, Cymbalta, Lexapro, Prozac, Remeron, Serzone, Paxil, Paxil CR, Zoloft, Effexor, and Effexor XR.

"For each of the 12 drugs," the researchers wrote, "the results of at least one study either were unpublished or were reported in the literature as positive despite a conflicting judgment by the FDA."

A total of 12,564 patients participated in these trials and data from 3,449 patients were not published. Data from an additional 1,843 patients were reported in journal articles that highlighted findings that conflicted with the FDA-defined primary outcome.

For each of the 12 drugs, the researchers also found that the effect size derived from the journal articles exceeded the effect size in the FDA reviews, with the increases in effect size in the published reports ranging from 11% to 69%, with an average increase of 32%.

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