The FDA found that the alleged “antidepressants” are neither safe nor effective for an unknown percentage of the adolescent population and, based on the evidence that twice as many children in clinical trials showed a greater risk of suicidality taking the antidepressants, coupled with the evidence that the antidepressants in the majority of the clinical trials were no more effective than sugar pills, the FDA had little choice but to “request” the pharmaceutical companies add the black-box warnings. The initial version of the warning is as follows.
Suicidality in Children and Adolescents:
“Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.”
Based on the data reviewed by the committee, this seemed like appropriate language. But, when all was said and done, the FDA’s final black-box warning was a skeleton of the initial language:
Suicidality in Children and Adolescents:
“Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.” (italics added)
Talk about shoving the knife in a little deeper! The original draft of the warning intimated that the risk was serious and ongoing within the pediatric and adolescent population. But in the final version, the FDA appears to suggest that the risk posed by the antidepressants is limited to the clinical trials or “short-term studies” that occurred in the past—as if what happens during the clinical trials doesn’t carry over into the general population.
The FDA clearly took the low road on this language and the point can well be made by the simple fact that the word “increase” has been replaced to reflect the past tense in the final version and that “short-term studies” has been inserted. In what can only be described as what many believe as the standard operating procedure of putting the public’s best interest behind that of the psychiatric community and pharmaceutical industry, the FDA’s language changed from advising the public that “antidepressants increase the risk of suicidal thinking,” to “antidepressants increased the risk of suicidal thinking and behavior in short-term studies.”
This pathetic compromise looks as if the FDA is taking a bold step in advising the public that there were problems just in those darn short-term studies. If it wasn’t for the explanation provided by a mouthpiece of the APA, one might rightfully conclude that the FDA committee had itself suffered from some weird collective mental deficit.
David Fassler, M.D., a child and adolescent psychiatrist and clinical associate professor of psychiatry at the University of Vermont School of Medicine and a trustee of the APA made it clear which group was responsible for the language change when, during an interview with Jim Rosack of Clinical and Research News, the APA spokesman said “the change in wording brings the FDA warning closer to the actual science. I’m glad they responded to the extensive and detailed input from both practicing psychiatrists and the research community. Hopefully, the FDA will consider further revisions in the future, as more long-term and follow-up data become available.”
One has to wonder, though: If the APA’s spokesman is right and the language is closer to the actual science, that the threat is only in the short-term clinical trials, what exactly was the reason for the FDA to warn the public about the possibility of violent behavior and self-harm? Furthermore, referring back to Graham Aldred’s accounting of just the top three antidepressants, Prozac, Paxil and Zoloft, if the FDA’s conclusions are accurate and the 4% greater risk of suicidality is carried over into the general public, at a minimum the number of people susceptible to the adverse reactions to the drugs could be in the millions. But, hey, the FDA’s “warning” intimates that it was only those people who participated in short-term studies that experienced violent and even suicidal thoughts. Those other 68 million people taking just three of the top-selling antidepressants shouldn’t have a problem. But, if the reverse logic is applied to the FDA’s and APA’s language, this psycho-pharma yah yah is the equivalent of saying that the percentage of the people who reportedly benefited from taking the mind-altering drug also doesn’t carry over into the general population—that the benefits are limited just to the short-term studies.
Mental-health officialdom doesn’t want to go down that road because the FDA’s data reveal that sugar pills were as effective as the drugs in a majority of the clinical trials, but this astounding fact didn’t prompt the drug approval agency to pull the mind-altering drugs from the market. This is no small point when one considers that the agency’s overriding purpose is to ensure that the drugs are safe and effective.
There always are people who want to believe in the “chemical imbalance” theory, regardless of the evidence or, in this case, the lack of evidence. In fact, the APA, governmental bodies, pharmaceutical companies and private mental health organizations have spent billions on advertising campaigns to educate and reassure those afflicted with the reported psychiatric mental illnesses that it isn’t their fault and that they shouldn’t be stigmatized.
So for those skeptics that still believe that the “chemical imbalance” is more than a theory—indeed a hypothesis—there is one sure-fire way to know the truth on a very personal level: Ask your treating physician or psychiatrist for a paper copy of the results of the test that was conducted to measure your brain chemical levels. Something along the lines of: grossly, minimally, or just a smidge out of balance, providing the physician a template to determine the necessary dosage and, more importantly, the duration of treatment. And, one might assume, this test presumably would also be used at the completion of treatment to determine if the chemical “imbalance” had been sufficiently corrected or balanced.
Researchers would be unable to locate a single psychiatric drug user capable of providing such results. It is fair to say that if objective, confirmable proof of a neurological “chemical imbalance” were required prior to filling a prescription for any of the psychiatric mind-altering antidepressants that reportedly “correct” the “chemical imbalance” in the brain, not a single prescription would be written because to date the only known method of determining chemical levels in the brain is during autopsy.
Jonathan Leo, associate professor of anatomy at Western University of Health Sciences and author of Broken Brains or Flawed Studies? A Critical Review of ADHD Neuroimaging Research, hit the nail on the head about the legitimacy of “chemical imbalance” when he explained in his 2004 paper “The Biology of Mental Illness”: “If a psychiatrist says you have a shortage of a chemical, ask for a blood test and watch the psychiatrist’s reaction. The number of people who believe that scientists have proven that depressed people have low serotonin is a glorious testament to the power of marketing.”
Pfizer is not the only pharmaceutical company to link the “chemical imbalance” theory to the cause of the alleged psychiatric mental illness for which a drug has been approved to treat. In fact, virtually all of the antidepressants reviewed by the FDA for “black box” warnings mention the chemical levels in the brain as possible causes of the alleged mental disorders. The following is a list of what some of the other pharmaceutical companies have to say about the chemical imbalance theory and key words to focus on that provide a glimpse into what really is known by the makers of psychiatric drugs about the alleged mental illnesses the drugs reportedly treat and how the particular drug works on the alleged psychiatric disorders.
While the following explanations are heavy in medical/scientific jargon, what is clear is that none of the pharmaceutical companies know exactly how their drugs work on the reported psychiatric mental illnesses.
Eli Lilly and Co., the makers of the first SSRI antidepressant, Prozac (fluoxetine hydrochloride): “Depression is not fully understood, but a growing amount of evidence supports the view that people with depression may have an imbalance of the brain’s neurotransmitters, the chemicals that allow nerve cells in the brain to communicate with each other. Many scientists believe that an imbalance in serotonin, one of these neurotransmitters, may be an important factor in the development and severity of depression. Prozac may help correct this imbalance by increasing the brain’s own supply of serotonin.” [i] Furthermore, how Prozac works—its clinical pharmacology—is explained by the FDA this way: “The antidepressant, antiobsessive-compulsive, and antibulimic actions of Fluoxetine (Prozac) are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin…” Key words: believe, may, presumed.
Organon Pharmaceutical, the makers of the antidepressant Remeron: “Remeron, introduced by Organon in 1994, is a noradrenergic and selective serotonergic antidepressant (NaSSA), the first of a new class of therapy. Its active compound, mirtazapine, has a dual-action effect aimed at rectifying the chemical imbalances in the brain that are understood to cause depression.” [ii] The FDA explains Remeron this way: “The mechanism of action of Remeron (mirtazapine) Tablets, as with other drugs effective in the treatment of major depressive disorder, is unknown. Evidence gathered in preclinical studies suggests that mirtazapine enhances central noradrenergic and serotonergic activity…” Key words: unknown, suggests.
Forest Laboratories, Inc., the makers of the antidepressant Lexapro: “As a selective serotonin reuptake inhibitor (SSRI), Lexapro helps restore the brain’s chemical balance by increasing the available supply of serotonin, a substance in the brain believed to influence mood.” [iii] The FDA: “The mechanism of antidepressant action of escitalopram (Lexapro), the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).” Key words: presumed, believed.
Wyeth Pharmaceuticals, the makers of antidepressant Effexor: “Effexor XR is known as an SNRI (serotonin and norepinephrine reuptake inhibitor) and is believed to help treat depression and the associated symptoms of anxiety by affecting the level of two chemicals in the brain—serotonin and norepinephrine. These two chemicals are thought to play a key role in depression and the associated symptoms of anxiety. Correcting the imbalance of these two chemicals may help relieve depression symptoms and the associated symptoms of anxiety…” [iv] The FDA: “The mechanism of the antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the CNS…” Key words: believed, thought, and may.
GlaxoSmithKline, the manufacturer of the antidepressant Wellbutrin: “Research suggests that depression may be caused by an imbalance of brain chemicals called neurotransmitters. Scientists believe that Wellbutrin XL helps balance the levels of two of these neurotransmitters called dopamine and norepinepherine.”[v] The FDA: “While the mechanism of action of bupropion, as with other antidepressants, is unknown, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms.” Key words: suggests, may, believe, unknown, presumed.
Solvay Pharmaceuticals and Pharmacia & Upjohn jointly market the antidepressant Luvox, GlaxoSmithKline, manufacturer of the antidepressant Paxil, and Forest Laboratories, the manufacturer of the antidepressant Celexa, all report similar “understanding” of their drugs, using similar scientific jargon about how the antidepressants are “presumed” to work on the brain chemicals.
While all of the above pharmaceutical companies claim or suggest the particular mind-altering drug either “helps correct,” “helps restore,” “enhances,” or “mediates” the chemical balance in the brain, nowhere on any of the company Websites is information provided about any objective, confirmable neurological/biological testing conducted to determine the levels of the alleged “chemical imbalance.” All of the above pharmaceutical company Websites except Solvay (Luvox) and GlaxoSmithKline (Wellbutrin) offer a “quiz” “checklist” or “self-test” to help determine if an individual may be suffering from one or several of the alleged mental illnesses that the company’s drug will “treat.”
In other words, the extent of testing for a variety of alleged mental abnormalities, which all of the named pharmaceutical companies either state is due to or suggest may be due to a “chemical imbalance,” is as easy as answering questions on a self-test or quiz. Not one of the pharmaceutical company “quiz” questions ask if the would-be patient has had their brain chemical levels evaluated or measured and, if so, what those chemical levels may be.
The above pharmaceutical companies do not understand “completely” how their mind-altering drugs work on the indicated alleged mental illness(s) for which the drugs have been approved for treatment, nor do they provide any objective confirmable evidence of a “chemical imbalance.” But the pharmaceutical companies are not alone. In fact, the “chemical imbalance” theory is rampant among private mental health organizations and even in the top echelon of the mental-health experts in the federal government.