Antidepressants and Placebo: Controversy in Pharmacology

Depression may only be in your head

A 2012 interview performed by Lesley Stahl on 60 Minutes with Harvard Medical School Associate Director Irving Kirsch showcased a report of data analyzed and reported to the FDA. These reports were filed by pharmaceutical houses on the effectiveness of antidepressant medication over the course of 8 weeks. According to Kirsch, those individuals possessing mild or moderate depression will see no better effect on their health from these medications than placebo alternatives.

Famous author Robert Whitaker’s paper on the Anatomy of an Epidemic to New York Review of Books contrasted the long-term treatments of schizophrenia, major depression, and bipolar outcomes before implementing the use of drugs. Whitaker found that outcomes have actually worsened with drug use and the availability of such; with speculation “on psychotropic medications as a contributing factor to the swelling Social Security Disability rolls in the United States”.

Research has proven that the aforementioned social workers compose nearly 65 percent of the mental health industry in America, with a similar 35 specifically designating psychological care as their primary sector of service.

What even is depression?

In general, depression disorder is a neurological affliction that has a dangerous level of prevalence within the human population. As of the last 10 years, nearly 15 percent of people over the age of 12 reported regularly consuming antidepressant drugs.

Of this same group, more than 60 percent have been under this condition for over 2 years, with close to a staggering 15 percent for more than a decade, despite the supposed benefits of the medication.

It becomes clear then, that these “psychological mood fixes” have been purposely designed to treat, but not cure the disastrous disease. Survey statistics have suggested that the very social workers of question are the ones who are directly involved with this particular issue.

Under assessment via the Hamilton 51 point rating scale, more than 50 percent of outcome statistics submitted to the Food and Drug Administration have proven that the application of antidepressants fails to produce effects that are noticeably superior to placebo in the task of reducing depression symptoms.

The false impression that the drugs perform the contrary is due to the rather simple fact that big pharmaceutical corporations only publish successful, positive stories that directly serve to distort any well-researched, peer-reviewed publications.

Antidepressants vs. Placebo

To combat this dilemma, Kirsch compiled a collection of all studies, both good and bad, that were submitted to the Food and Drug Administration by the houses. His analysis specifically noted that the actual mathematical difference between conditions derived from antidepressants and the placebo effect was less than 2 points out of 51 on the rating scale.

Several of the studies included patients that had completed side effect ratings. After revising the results for the sake of perception, the difference between the two became even less significant. This suggests that any reported outcomes of improvement were in sync with the expected effect that was induced by the actual drug’s much stronger side effects.

In the studies in which atropine is selected and implemented for the role of the placebo, the patients were far more likely to believe that they were consuming a real drug. Unfortunately, less than 25 percent of the studies demonstrated any benefits of consuming antidepressants over a placebo alternative.

During the same documented interview on 60 Minutes with Kirsch, it was also reported that for the individuals that are in possession of severe, true depression (officially defined on the 51 point Hamilton scale as scoring a rank above 28), the antidepressants are in fact useful and effective.

This same result was confirmed by critics in later replicated meta-analyses. Yet still, even among the truly sick, there is no more than a 4 point differentiation with respect to the Hamilton scale between the antidepressant group and the drug-treated.

Despite uproars in the population for reasons related to these reports, the establishment present within the psychiatric field has stated that they are well aware of the issues with antidepressant efficiency, with several subsequent counterarguments performed.

While the Hamilton 51 point rating scale has seen much criticism as a measure of outcome, it was in point of fact selected by the target pharmaceutical corporations, and any other information that would be of more significant relevance to recovery have seen compilation but have not seen any major publishing efforts.

Many of the existing clinicians have remarked positive improvements from patients consuming antidepressants, yet these results are difficult to conceive of given the aforementioned empirical data.

Data fails to show the hard facts. But do antidepressants really work?

However, Kirsch has placed some faith in these points; yet only to a certain degree. That degree is that patients see successful treatment for their depression from both placebos and antidepressants.

Even more importantly, it is of no trivial matter for one to receive the treatment of the placebo; in fact, “it includes close monitoring and nonspecific psychosocial helping from a helping professional”. It must be restated that the question is not a matter of whether or not antidepressants have an effect at all, but rather the degree to which they are essential for patient recovery.

In the Information Age complete with evidence-based practices, anyone insisting that these antidepressant drugs work on an anecdotal basis would see immediate challenge to their strange claim.

Similar to the critiques raised over the level of efficiency between the two mental health strategies is that any randomized controlled trials (RCT) with regards to antidepressants specifically fail to reflect any psychiatric procedure applied in the real world. As such, the National Institute of Mental Health’s $35 million depression case study known as STAR*D became even more critical than before.

In particular, this study was not as selective in the different types of patients; instead, the clients were selected through a randomization process in accordance with numerous real-world applications for treating depression.

In addition to augmentation, other strategies not typically allowed within RCTs for psychopharmacological purposes were included. Resulting in a massive publication slew, a synopsis was perfected by the quote “the proportion that responded or remitted and stayed well for a year was estimated to be a disappointing 15%”.

A direct debate in print against Kirsch’s work came via industry-funded psychiatric researcher Michael Thase; a man who also saw an appearance on the same segment for 60 Minutes that spoke in defense of antidepressant efficiency.

While acknowledging that only half of every severely depressed individual that had been prescribed selective serotonin reuptake inhibitors (SSRIs) reported noticing a “substantial benefit”, he claimed that a great many persons are being helped; at least from the perspective of public health. Further acknowledgments were made that barely 2 out of every 3 patients in 8-week long drug trials successfully achieve up to a 50 percent reduction in any documented symptoms.

According to data examined from the National Institute of Mental Health Collaborative Depression Study, rates of remission organized by the severity of disease are as follows: for those with extremely severe depression, a ratio of 32 percent with drug versus 18 percent on placebo; for those with severe depression, a ratio of 34 percent with drug versus 27 percent on placebo; for moderate or mild depression, 45 percent with drug versus 44 percent with placebo.

As stated by Director of the National Institute of Mental Health Tom Insel, “the unfortunate reality is that current medications help too few people to get better and very few people to get well”. Moreover, this same study also found that any depression episode’s duration with remain at a relative constant of approximately 5 months regardless of the number of previous encounters; complete with the fact that the recovery probability rate remains at a consistent rate of anywhere between 88 percent to 92 percent.

This was further proved by a 6-month naturalistic analysis performed by peers that concluded that the rate of recovery for the high dosage group was 70 percent and the group without any medication was 71 percent.

Studies performed by pharmaceutical corporations only examine efficiency response rates for 8 weeks at a time. Unfortunately, the majority of individuals find no consolation in any reprieve of temporary time scale; instead preferring treatments that provide much-needed sustained rates of recovery. In such a case, the duration of positivity or lack of negativity between the 20 week-long episodes is what matters the most.

Publications existing before the regulated implementation of antidepressants will confirm that the majority of depressed individuals saw a remission period lasting up to 2 to 3 years long, with up to 66 percent reported to have not experienced later episodes.

Later studies confirmed this same conclusion and found that any depressed individual, regardless of symptoms, demographics, etc. that did not consume antidepressants found that they were less likely to encounter a relapse after their last successful recovery.