July 18, 2005

FOR IMMEDIATE RELEASE

Contact

Sheila Matthews

National Vice President

203-966-8419

American Medical Association Endorses Drug Experiments on Children

The American Medical Association has issued a report advocating the training of investigators to study the effects of psychotropic drugs on children, adolescents, and young adults. According to the AMA, “SSRIs should remain available for use in children and adolescents, including for unlabeled uses.” SSRIs were a popular class of antidepressants that have been the subject of widespread controversy, banned in Great Britain in 2003 for use in children and adolescents due to their propensity to induce suicidal thoughts and ideations, and more recently given black box labels in 2004 by the Food and Drug Administration.

The AMA’s statements indicate that it views both the FDA Black Box Suicide Warning on these drugs, and the issue of full informed consent as a restriction. This comes despite their conclusions that “The use of antidepressants is associated with a doubling in the number of reports indicative of suicidal thinking and behavior in children and adolescents with Major Depressive Disorder and other psychiatric disorders.”

Ablechild contacted the FDA to obtain a comment regarding the AMA’s report which promotes the experimental use of drugs that are known to increase suicidal tendencies.  According to FDA Spokesperson, Susan Cruzan, “The FDA has reviewed all the scientific data and incorporated two advisory boards’ recommendations on the link to suicide ideation, resulting in a Black Box Warning recommending close oversight for all that use antidepressants to look for increased suicide ideation.  The FDA worked with the manufacturers on the Black Box warning mandated on all antidepressants.”

According to Bill Hall, Health & Human Services Spokesman, "HHS regulates all human subjects research carried out by those institutions and organizations that have signed assurances with the HHS Office for Human Research Protections (OHRP).”   Unfortunately, OHRP is not funded to track all unlabeled usage of psychotropic drugs as promoted by the AMA in their recent report.

Based on the statements of both organizations we have concluded that there is insufficient oversight of experimental use of psychotropic drugs on children.

OHRP must protect all citizens from becoming unknowing victims of experimental research.

The promotion of unlabeled SSRI use on children by the AMA, when the dangers and risks associated with the usage is well documented, is unethical and irresponsible. It undermines the FDA’s role, its recommendations, and jeopardizes overall public health.

The AMA needs to be reminded that disclosing drug risks to the public and promoting full disclosure should not be seen as a barrier, but as requisite to public health and safety.

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