Prior to September 27, 2007, there was no requirement that drug companies publish the results of the clinical trials of their drugs. Since drug companies are interested in making a profit, they were not publishing the results of clinical trials that question the effectiveness or safety of their drugs and imperil their profits.

Dr. Grace Jackson, a psychiatrist, in her book RETHINKING PSYCHIATRIC DRUGS, summarizes the findings of a study entitled “The Emperor’s New Drugs:  An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration.” Dr. Jackson states,

“In conducting their meta-analysis (meta-analysis is a method designed to increase the reliability of research by combining and analyzing the results of all known trials of the same product or experiments on the same subject), the research team reviewed findings of 47 short-term RCTs (Randomized Controlled Trials) (5 Prozac, 16 Paxil, 7 Zoloft, 6 Effexor, 8 Serzone and 5 Celexa). All of these trials lasted four to eight weeks in duration. Findings were remarkable for the following:
•    80-90% of the antidepressant response was consistently duplicated by a placebo;
•    Two dose-response studies for Prozac were submitted to the FDA; one trial (mild depression) found no difference in treatment response between low and high doses; the second trial (moderate to severe depression) found lower doses to be significantly more effective than higher doses.
•    Three trials were conducted among severely depressed, hospitalized inpatients; two of these studies failed to detect a significant difference between active medication and placebo.”

Dr. Jackson continued,

“While antidepressant enthusiasts maintain that drugs are indispensable in the treatment of severe depression, the FDA database contradicts their assertion. Two-thirds of the trials conducted among hospitalized patients revealed a placebo response equal to active drug treatments. Similarly, the FDA database fails to support the argument that higher doses produce superior outcomes.”

A May 7, 2002, an article by Shankar Vedantam appeared in the Washington Post entitled “Against Depression, a Sugar Pill is Hard to Beat.”  Vedantam refers to a study done by Dr. Arif Khan, an anesthesiologist and pain specialist. 

“His analysis of 96 antidepressant trials between 1979 and 1996 showed that in 52 percent of them, the effect of the antidepressant could not be distinguished from that of the placebo (sugar pill).”
“Khan said the makers of Prozac had to run five trials to obtain two that were positive, and the makers of Paxil and Cymbalta had to run even more.”

The article then referred to another study just released comparing the effectiveness of Cymbalta to St. John’s wort.

“…a trial last month that compared the herbal remedy St. John’s wort against Cymbalta. St.John’s wort fully cured 24 percent of the depressed people who received it, and Cymbalta cured 25 percent–but the placebo fully cured 32 percent.”

When Dr. Erick Turner, a psychiatrist, was working for the FDA, he would talk about how some of the clinical trials he examined showed that antidepressants were ineffective and his colleagues were surprised.  The clinical trials that they had reviewed showed the effectiveness of antidepressants.

This led to a study published in the NEW ENGLAND JOURNAL OF MEDICINE by a team led by Dr. Turner, now a professor. The study concluded that there were many studies showing that antidepressants were ineffective that were not published, and this caused more antidepressants to be prescribed which otherwise would have been were the true results shown to doctors.

Dr. Turner found:
•    A total of 74 studies of a dozen antidepressants involving 12,564 patients were registered with the FDA from 1987 through 2004.
•    The FDA considered 38 of the studies to be positive. All but one of those studies were published, the researchers said.
•    The other 36 were found to have negative or questionable results by the FDA.
•    Most of those studies — 22 out of 36 — weren’t published, the researchers found.
•    Of the 14 that were published, the researchers said at least 11 of those studies mischaracterized the results and presented a negative study as positive.
•    Pfizer submitted five trials on its drug Zoloft to the FDA. In three of the five trials, the placebo did just as well at reducing indications of depression.
•    Only the two favorable trials were published, researchers found.
With the passage of the Food and Drug Administration Revitalization Act (“Revitalization Act”), the drug companies now have an obligation to publish the results of all their clinical trials.  The only problem is that it will take a number of years for this to be implemented.