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
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.
Go here for information on the Massachusetts General clinical trial
Joseph Rhee Reports
Merck Targets Children for Sex Disease Vaccine
In the hallowed New Jersey tradition of "Pass a law; Make a business"
drug company giant Merck & Co. is pressuring Congress to mandate a vaccine
that will target 32 million children in the U.S. for a sexually transmitted
virus that allegedly causes cervical cancer, reports Bloomberg. (http://quote.bloomberg.com/apps/news?
Mandated vaccines like Merck's Gardasil which is billed as a preventative measure
against HPV (Human Papilloma Virus) will ensure a steady revenue stream for
the giant pharmaceutical company, which evidently requires government guarantees
and mandates to retain their egregious profits.
According to Bloomberg, Merck claims Gardasil is "the most important product
Merck is developing and analysts say it may generate $3 billion in annual sales...
"Merck will present evidence to a government committee that the vaccine
works best in youngsters before they become sexually active. The drugmaker's
pitch for universal immunization as early as age nine may be a tough sell with
parents worried about adding another routine childhood vaccine.
Bloomberg also reports that the FDA (Food and Drug Administration) will decide
to approve Gardasil by June 8 under a priority-review process.
The so-called revolving door between government regulators and drug companies
has been well-documented, and, sure enough, Bloomberg also reports that "an
FDA staff report yesterday said Gardasil appears safe and effective."
"Safe and effective"? At least until the Vioxx-style class action
Sounds like the FDA staffer that wrote that "drug promotion" can
move right into Merck after "retiring" from government.
Since the FDA is just the marketing and publicity arm of Big Pharma, it should
be a very smooth transition into the "private sector."