May 12

Tots Used as Guinea Pigs? ABC News

The drugs being tested on very young, defenseless children are the most toxic, harm producing psychotropic prescription drugs marketed.

The indisputable evidence of these drugs’ severe adverse effects in adults with schizophrenia is now being acknowledged by leading psychiatrists:

In an editorial in the American Journal of Psychiatry, Dr. Carol Tamminga, acknowledged: “the side effect outcomes are staggering in their magnitude and extent and demonstrate the significant medication burden for persons with schizophrenia.…"
See: Dr. Carol Tamminga, "Practical Treatment Information for Schizophrenia" Editorial, AJP, April, 2006, vol. 163:563-565.

How can anyone justify the use of four-year old children as human drug testing guinea pigs?
The experiments described by ABC News expose small children to drugs so toxic they disrupt normal biological and mental function, damage major organs, produce debilitating, chronic diseases such as diabetes, leading to premature death?

According to its website, MassGeneral Hospital for Children, is the largest of the Harvard Medical School teaching facilities, the hospital."

 "the oldest provider of pediatric services in Boston, has provided comprehensive care for children since 1821. It is consistently ranked by U.S. News and World Report, Annual Guide to America’s Best Hospitals, and was ranked number 16 in the 2003 edition. Through its growing network of community-based facilities and pediatricians, the hospital’s excellent care is conveniently accessible to families throughout the region."

If these experiments were approved by the FDA, and passed the institutional review boards (IRBs) of Harvard and MassGeneral, what does it say about the debasement of academic medicine?  

Clearly the system for safeguarding the children’s right to be free from the risks of medical experiments that are not in their best interest, is broken and must be replaced.

Join AHRP’s efforts to stop the putting children in harm’s way in medical experiments.

Help AHRP –we need a hosting a website for a petition to stop experimental exploitation of children.

Add your voice to public comments following ABC story at:

Contact: Vera Hassner Sharav
Tots Used as Human Guinea Pigs?
May 12, 2006 10:56 AM
Joseph Rhee Reports:

ABC News has learned that a Massachusetts hospital is currently recruiting pre-schoolers to test the safety and effectiveness of a powerful antipsychotic drug called Quetiapine.

The study, conducted by the Department of Pediatric Psychopharmacology at Massachusetts General Hospital, is testing subjects from four to six years of age with Bipolar Disorder. An earlier Massachusetts General study of the antipsychotic drugs Risperidone and Olanzapine recruited children as young as three years old.

These antipsychotic drugs are only approved for use by adults and are so toxic they carry a "black box warning." The drugs have been found to cause diabetes; a life-threatening nervous system problem called Neuroleptic Malignant Syndrome; low blood pressure; and have also led to higher death rates in the elderly. Despite these serious potential side-effects, a patient recruitment video obtained by ABC News contains no mention of any of these risks.

Vera Hassner Sharav of the Alliance for Human Research Protection said, "Antipsychotics were never approved for use in children whose developing brains and central nervous system may be irreversibly harmed. We believe that physicians who subject children to the toxic effects of these drugs…are practicing outside medically accepted standards."

A previous clinical trial of Olanzapine was conducted by UCLA in 1998 on five children, aged 6 to 11. The authors of the study said treatment was discontinued within the first six weeks "because of adverse effects or lack of clinically significant therapeutic response."

Sharav also said it’s questionable whether or not three or four year-olds can be accurately diagnosed for Bipolar Disorder. According to a 1999 Surgeon General report, "The signs and symptoms of mental disorders are often also the characteristics of normal development." The National Institute for Mental Health has concluded that "diagnostic uncertainty…surrounds most manifestations of psychopathology at such an early age."

Neither the hospital nor the lead investigator for the trials, Dr. Joseph Biederman, responded to our requests for a comment on the trials.  

Click here for information on the Massachusetts General clinical trial.

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