Monday, 27 March 2006

"That thing I'm worried about...where the MedGuide would help, where it might even warrant a black box, if this is common, where somebody hallucinates and then gets put on an anti-psychotic drug. That would really be something worth making sure it doesn't happen,"

One of the positive after effects of FDA advisory hearings is the rippling waves elsewhere on the globe: "Documents obtained by The Australian revealed almost 400 adverse reactions had been reported to the Therapeutic Goods Administration (TGA), some involving children as young as three." Australian Parliamentary Secretary of Health is to meet which Novartis executives to discuss young children suffering strokes and heart attacks from drugs prescribed for ADHD.

From reports in the Pink Sheet (a publication focusing exclusively on FDA issues) following the March 22 Pediatric Advisory Committee meeting devoted to testimony about evidence of ADHD drug induced psychiatric hazards, we learned that committee members were disturbed to learn--from testimony presented by AHRP representatives--that 2.5 million children labeled with ADHD were prescribed antipsychotics in 2002. And from FDA medical officers they learned that children suffered hallucinations from stimulants prescribed for ADHD:

“The committee heard about reports of children experiencing hallucinations - many of which included tactile and visual delusions involving insects, snakes and worms. Some of the children were prescribed anti-psychotics, rather than discontinued from ADHD therapy.”

Furthermore, though the committee did not vote, panel members comments show they were favorably disposed to some of AHRP recommendations for action. Specifically, they agreed that steps were needed to impact on physician prescribing--to stop prescribing antipsychotics for children made psychotic by psychostimulants. Panel members agreed to AHRP recommendations (1) to require physicians to provide families with MedGuides, (2) AND require parental informed consent:

The Pink Sheet reports:
“Several committee members went further and backed a kind of informed consent document that could be signed by patients or parents. Committee member Robert Daum (University of Chicago) cited a vaccine informed consent model that creates "a partnership between parents and children and providers." "Those vaccine information sheets have been very successful, parents have to read them and sign them," Daum noted.”

Warnings should communicate specific actions to be taken by a physician if a child on an ADHD drug experiences an episode of psychosis or mania, a number of committee members said. "We need to communicate to the the face of those kinds of reactions, that discontinuation of the drug would be a reasonable first step," committee consultant Robert Wade (University of Utah) said.

Psychiatric drug-induced adverse effects were the focus of the meeting, not drug-induced suicide. However, when the risk of suicide was raised, FDA’s Thomas Laughren suggested that “suicidality is common in the pediatric population. "[The Centers for Disease Control] sample 20,000 high school students and they find anywhere from 15% to 20% of normal kids who admit to having suicidal ideas."

That CDC data is clearly at odds with claims made by Dr. David Shaffer and the promoters of TeenScreen. Mass mental screening of America’s school children is being promoted as a suicide prevention strategy. Dr. Shaffer’s rationale for mental screening rests on his (unproven) claim that 90% of adolescents who are suicidal are mentally ill—and (again the unsubstantiated claim) that suicide can be prevented by screening and treating children who screen “positive” for mental illness.

The evidence shows that the treatment being offered for children who screen “positive” for mental health problems is overwhelmingly drugs—the drugs prescribed put children’s lives at risk.