THE TRUTH WILL OUT

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, FullDisclosure, and Accountability http://www.ahrp.org/cms/

In the wake of the extraordinary acknowledgement this month by Glaxo SmithKline that the clinical trial evidence shows that not only children and adolescents are at increased risk of suicidal behavior if they take its antidepressant, Paroxetine/Paxil (or any other "new generation"antidepressant). Adults too are at increased risk of suicide if they take Paxil and that risk is six-fold compared to those given a placebo.

Our colleague in the UK, Charles Medawar, of Social Audit, has been closely monitoring British public officials, drug company executives and leading academic psychiatrists, almost all of who have a financial/professional stake in protecting the reputation of SSRI antidepressants. His primary focus has centered on the British cast of characters in this tedious and insidious shadow play. GSK's acknowledgement confirms that the"authorities"- academic, government regulators and industry - have denied, deceived, and concealed evidence of drug harm. GSK's acknowledgement refutes the recent claims made in the official organ of the American Psychiatric Association, The American Journal of Psychiatry.

The claimed findings reported by Dr. Gregory Simon and colleagues about their epidemiological study, Suicide Risk During Antidepressant Treatment, in The American Journal of Psychiatry 163:41-47, January 2006, vol.163.1.41 are unsupported by the data. Dr. Simon reported that there was no increased suicide risk during the first week of treatment with an SSRI. This claimed finding from a methodologically flawed, uncontrolled study was widely disseminated in the major press. "Depression Drugs Safe, Beneficial, Studies Say" (Washington Post). Uncritical reporters transcribed the investigators' claims without understanding that these were scientifically invalid. However, Charles Medawar found egregious inconsistencies in that published report. He inquired, ever so politely, of Dr. Simon, the lead author to explain the inconsistencies. The one sided correspondence reveals that academic psychiatrists have misrepresented what the data actually shows. "In agreement with Jick and colleagues (15), we found a significantly higher risk of suicide attempts in the first week of antidepressant treatment than in subsequent weeks". In Dr. Simon's initial response, he conceded: "Risk in week 1 was not higher than in weeks 2, 3, and 4. But risk in week 1 was higher than in subsequentweeks (from week 5 onward)." Uncorrected, inconsistent statements of findings confuse many readers: they serve to deflect from the very troubling evidence that these widely prescribed drugs pose a serious threat to those who take them, especially throughout the first month. Such misleading reports served industry's interests. http://www.socialaudit.org.uk/6060521.htm#ANTIDEPRESSANTS

The release simultaneously of two "positive" SSRI studies, both financed by the National Institute of Mental Health, seems suspiciously calculated. Our suspicions are validated by the accompanying editorial in the Amer. J of Psychiatry which questioned the need for the black box label warnings! It is especially troubling that that most of the uncritical media had accepted the claimed "positive" results on faith. But the report, like most of the scientific literature about SSRI antidepressant safety and efficacy provides false and misleading information tailored to conceal that these drugs induce suicides. Since SSRIs have failed to demonstrate an antidepressant effect, given that in controlled clinical trials placebo has matched and even outperformed SSRIs, critics are beginning to wonder on what basis the FDA approved these drugs as "antidepressants"? This may be a case of misbranding. Simon G, et al http://ajp.psychiatryonline.org/cgi/content/abstract/163/1/41

See also: http://www.ahrp.org/cms/content/view/94/94/;http://www.ahrp.org/cms/content/view/23/28/ Contact: Vera Hassner Sharav212-595-8974
veracare@ahrp.org