America’s Overmedicated Children, Presentation by Vera Sharav, Sweden

“Forgotten Children” is an investigative report by Carole Keeton Strayhorn,[1] the Texas Comptroller (2004) who uncovered evidence that 60% of children in the Texas foster care system are being drugged with powerful psychotropic drugs, most of which have not been tested in or approved for use by children. The Food and Drug Administration (FDA) acknowledges that many of these drugs have serious adverse side effects, both physical and psychological. The Comptroller said she was alarmed that in her review of a single month (November 2003), two powerful antipsychotic drugs — Risperdal and Zyprexa — made up half of the drugs prescribed to foster children in Texas. These two drugs have been approved only for adults for the treatment of psychosis – primarily schizophrenia – yet, she found that children as young as four, were receiving these powerful, mind-altering drugs.

The Power of $4 bill Drug Ads: Doctors Respond with Diagnosis & Prescription – WashPost

The Power of $4 bill Drug Ads: Doctors Respond with Diagnosis & Prescription – WashPost Thu, 28 Apr 2005 What does $4 billion dollars in drug advertising buy? The Washington Post reports that a University of Washington study published in the Journal of the American Medical Association confirms the insidious…

Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Proposed Changes to Subpart D Regulations Increase Risks to Children in Non-Therapeutic Research Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations April 18, 2005 The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What…

Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations

The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What is the Best Way to Protect Children?”

Our recommendation – which is backed up by evidence that children have suffered harm in medical research – is to significantly limit the discretion of IRBs to approve greater than minimal risk research without direct benefit for the child-subjects under 46.406.

We recommend staying the course in requiring that any such proposed experiment undergo a transparent open evaluation with ample opportunity for public oversight and comment – as required under the provisions of 46.407.

Depressing news for GSK

Depressing news for GSK Thu, 14 Apr 2005 A class lawsuit by US investors has been filed against GlaxoSmithKline in the US federal District Court in New York, alleging violation of securities laws. The suit charges GSK issued “false or misleading public statements” about the antidepressant, Paxil (Seroxat). The law…

Texas Foster Care Investigation – Children as young as 3 are drugged with antipsychotics

Texas Foster Care Investigation – Children as young as 3 are drugged with antipsychotics Sat, 13 Nov 2004 The Dallas Morning News reports that Texas comptroller, Carole Keeton Strayhorn, who hade conducted an investigation of the foster care system, concluded that up to $4 million a year might be wasted…

Unlawful drug marketing: GlaxoSmithKline & 4,000 doctors Face Criminal Charges in Italy

Unlawful drug marketing: GlaxoSmithKline & 4,000 doctors Face Criminal Charges in Italy Mon, 7 Jun 2004 On March 25, 2004, the US Attorney in Pennsylvania commenced an investigation of Eli Lilly’s marketing promotion of Zyprexa (olanzapine), Prozac (fluoxetine) and Evista (raloxifene). On April 19, a class action lawsuit was filed…

TeenScreen – Angel of Mercy or Pill-Pusher for Drug Industry

TeenScreen – Angel of Mercy or Pill-Pusher for Drug Industry Thu, 14 Apr 2005 An investigative reporter has dug up the facts behind TeenScreen, the aggressive marketing scheme that targets America’s school children who are being “screened” for undetected mental problems – even though no accurate diagnostic screening tool for…

NAMI & Eli Lilly partners in bankrupting state Medicaid budgets – NYT

NAMI & Eli Lilly partners in bankrupting state Medicaid budgets – NYT Sat, 20 Dec 2003 The New York Times reports that Medicaid expenditure for prescription drugs has escalated to $27.5 billion. These costs are up 19% from last year. Antipsychotic drugs, such as Eli Lilly’s Zyprexa, eat up more…

AHRP Comments Re: Best Pharmaceuticals for Children’s Act of 2002

Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…

Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.