Fake drugs, pharmaceutical fake package.

by Paul Fassa
Health Impact News

The largest, most expensive antidepressant efficacy study involving over 4,000 initial participants ended in 2006. The purported intention of the study was to provide real-life results instead of the shorter clinical trial results that are done to get antidepressant drugs approved. 

But the results were not clear regarding antidepressants’ true efficacy compared to clinical trials. Safety was not a consideration, just efficacy at reducing depression.

A new study has recently re-analyzed this massive STAR*D (Sequenced Treatment Alternatives to Relieve Depression) study funded by the National Institute of Mental Health (NIMH) and found evidence that there was obfuscation, intended or unintended, that made antidepressant efficacy look better than it actually is.  

The Latest Review of the STAR*D Study Shows Lower Efficacy of Antidepressants

Earlier this year, 2018, a published paper, Do outcomes of clinical trials resemble those “real world” patients? A reanalysis of the STAR*D antidepressant data set, demystified this study and provided a clearer picture of real-world antidepressant efficacy. 

As one psychiatrist skeptical of antidepressants, Dr. Joanna Moncrieff, reported after reviewing the 2018 reanalysis of the STAR*D paper:

[The 2018 reanalysis was done] 14 years after the [STAR*D] study was finished. What in the world were the main findings of the world’s largest ever antidepressant trial doing being presented now in a little-known journal? The answer may lie in the fact that they show how miserably poor the results of standard medical treatment for depression really are!

… people taking antidepressants do not do very well. In fact, given that for the vast majority of people depression is a naturally remitting condition, it is difficult to believe that people treated with antidepressants do any better than people who are offered no treatment at all. (Source)

The 2018 Reanalysis of the STAR*D Study 

From the abstract published in the September 18, 2018 journal APA PsychNet :

The single-arm first phase of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial was designed to assess the efficacy of a selective serotonin reuptake inhibitor in “real-world” patients. STAR*D improvement scores and response rates based on the Hamilton Rating Scale for Depression (HRSD), which had been designated as the primary outcome measure for the trial, have not previously been reported nor compared to benchmark data. *

Here, for the first time, we report mean improvement and response rates on the STAR*D primary outcome measure. The HRSD improvement in this highly generalizable sample is approximately half that seen in antidepressant comparator trials. Findings suggest that the exclusion criteria in typical clinical trials lead to substantial overestimations of the improvement on antidepressant medication.** [Emphasis added] (Source)

The HRSD or Hamilton Rating Scale for Depression is a questionnaire designed for adults to rate the severity of their depression. The STAR*D study substituted another type of rating system that increased improvement ratings.

Irving Kirsch, Associate Director of the Program in Placebo Studies at Harvard Medical School and his colleagues who submitted their 2018 STAR*D analysis paper explained: 

The actual real-world effectiveness of antidepressants is approximately half that reported in efficacy trials. (Source)

Also, the practice of excluding study participants with co-morbid health, or other issues from short trials for FDA approval, also adds to overestimating efficacy. Kirsch and his colleagues wrote:

These results suggest that the exclusion criteria used in conventional clinical trials inflate remission rates by 89%, response rates by 101%, and continuous improvement scores by 126%. (Source)

Note: The focus with this current study demonstrate was within the realm of efficacy only, not safety. There was no attempt to point out dangers and adverse events. 

But it is helping form opinions among some mental health professionals that perhaps antidepressant drugs are not so effective. By virtue of lowering the benefit, the risk-benefit ratio is increased. So why introduce those risks for little or no benefit?

The Dangers of Antidepressants are Among the Worst of All Pharmaceutical Drugs

Antidepressants are advertised liberally in the media along with other prescription drugs. The TV presentations feature happy customers relieved from their depression and/or anxiety to convince viewers of their effectiveness and safety while rushing through a list of potential adverse side effects.

It’s made it easier for some to whimsically seek psychiatric drug prescriptions from their primary physicians based on their impressions from TV ads.

The psychiatric profession has long since traded notepads used to give lengthy consultations for prescription pads to peddle psychiatric drugs. Also see:

Antidepressants used by 11 percent of Americans 

Many Get Antidepressants for No Psychiatric Reason

As long as the list of some of those adverse side effect warnings may sometimes be, they don’t fill out the total picture. Suicidal and homicidal “ideation” has often led to actualization. Many shooting spree perpetrators are often identified in the media as having undergone psychiatric care.

The mainstream media never mentions what psychiatric drugs these outpatients were on after suicides or shootings, or even if they were on psychiatric drugs at all. But that’s almost completely inevitable among those under psychiatric care as clients or outpatients. See: 

New Evidence that Antidepressants Are Causing an Epidemic of Violence

While most of us have become aware of the reality of pharmaceutical attempts at “curing” depression with their synthetic chemical cocktails, this very recent analysis of pharmaceutical studies points to how the studies submitted to the FDA for approval are skewed.

Perhaps the million dollar+ fees from pharmaceutical companies help the FDA overlook study discrepancies that may exist within the required two most favorable studies a drug company submits while withholding studies that are not favorable.   

In the first video, Dr. Gary Kohls speaks on the dangers of pharmaceutical antidepressants, and in the second video he explains natural antidepressants: