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Speculation does not constitute scientific evidence

Posted by plosmedicine on 31 Mar 2009 at 00:00 GMT

Author: Vera Hassner Sharav
Position: Information Specialist / Public Advocate
Institution: President, Alliance for Human Research Protection
Submitted Date: October 18, 2006
Published Date: October 18, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Dr Licinio dismisses the long list of behavioral adverse effects that occurred in excess in patients exposed to the drugs compared to placebo patients in randomized controlled trials - as reflected in the Warnings of FDA approved labels - by claiming the information is "not convincing."

Instead, Dr. Licinio seeks to assuage safety concerns with uncontrolled observational ecologic studies - such as his own - showing that in some places in the US, at some times suicide rates are inversely correlated with antidepressant sales. In some other places, however the correlation is reversed. For example, in Ireland the suicide rate has consistently increased since 1970. In young men the suicide rate increased fourfold between 1990 and 1996 and continues to increase. [1]

Further underscoring the fallacy of attributing suicide rates to antidepressant use: The authors of a Columbia University ecologic study [2] compared 1990 and 2000 SSRI sales rates with suicide rates in 10-19 year old youths. When they compared the rates by region, they found, the higher the prescription rates of antidepressants, the higher the suicide rate: "In 1990 and in 2000, there was a significant positive relationship between regional antidepressant medication treatment and suicide, indicating that regions with high rates of antidepressant medication treatment also tend to have high suicide rates. Significant associations were observed for most sex, age, race, and income strata." [p. 979]

Manufacturers acknowledge - in a black box label warning - that antidepressants pose a twofold increased suicide risk for pediatric patients. Furthermore, based on their analysis of controlled clinical trial data and physician reports, manufacturers acknowledge on the FDA-approved antidepressant label, the following serious adverse effects: "anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric."

A responsibility of physicians who prescribe a drug is to warn their patients about the serious risks of harm that are disclosed in the FDA-approved label. Does Dr. Licinio warn patients about these risks or does he mislead them with false reassurances unsupported by controlled trials that antidepressants reduce suicide risks?

Finally, Dr. Licinio's insinuation that I and/or AHRP have an undeclared questionable source of revenue is but another unsubstantiated speculation on his part. We rely entirely on public support and donations from individuals


1. Suicide In Ireland:A Global Perspective and A National Strategy.
2. Olfson M, Shaffer D, Marcus SC, Greenberg T. Relationship between antidepressant medication treatment and suicide in adolescents. Arch Gen Psychiatry. 2003 Oct;60(10):978-82.

Competing interests declared: As president of AHRP I am committed to openness, full disclosrue and accountability. We have taken outspoken positions upholding human rights that are critical of unethical human experimentation.
I have given testimony before national advisory panels, congressional committees, and AHRP has filed complaints with government agencies objecting to the use of non-consensual human beings as subjects in research. We oppose the use of trauma patients in artificial blood experiments; pesticide experiments targeting toddlers; psychotropic drug experiments on children; the use of prisoners in drug experiments; psychiatrists' use of patients with schizophrenia in chemical "challenge" experiments that induce psychosis in order to study the pathophysiology of schizophrenia. We have submitted an amicus brief against exposure of toddlers to lead paint to study the rising lead levl in their blood.
All of these cases and others are documented on the AHRP website at:
AHRP has, so far, relied upon contributions from the public. We do not take money from the pharmaceutical industry or government--thus, we maintain absolute independence. However, we would be most grateful if a private foundation or individual "angel" were to provide us with a substantial grant so that we can expand our operation.
We do not and have never received financial or other assistance from Scientology --the suggestion is a red herring aimed at discrediting the authors' inability to explain thier undisclosed conflicts of interest.