ALLIANCE FOR HUMAN RESEARCH PROTECTIO

ALLIANCE FOR HUMAN RESEARCH PROTECTION
A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and
Accountability
http://www.ahrp.org

FYI

In 1997 Congress passed a law--FDA Modernization Act (FDAMA)--encouraging
the use of children as human subjects in drug trials. The law awards drug
manufacturers who test their patented drugs in children with an addition
6-months of patent exclusivity--regardless, whether the drugs prove harmful
or beneficial for children.

The consequences of that ill-advised law are documented in tales of horror.
The Miami Herald reports about a psychiatrist who repeatedly put children's
lives at risk in commercial psychotropic drug trials.

One 7-year old child, Gabriel Myers, a child in foster care, who was
"treated" by Dr. Sohail Punjwani, committed suicide by hanging himself with
a shower cord.

"Before Gabriel's death, Punjwani had prescribed several powerful mental
health drugs -- some of which had not been approved by the FDA for use on
children and had been linked to dangerous side effects, including an
increased risk of suicide among children."

This boy's death prompted a yearlong investigation by a Department of
Children & Families task force, as well as proposed legislation before the
Florida Senate.

Dr. Punjwani who enrolled numerous children into drug trials, violated
medical ethics, research protocols by overdosing the children, resulting in
serious harm to the children.

The FDA sent a warning letter to Dr. Punjwani, describing inhumane
maltreatment of children in the trials:

Punjwani gave one child doses ``in excess of... specified limits.'' The girl
was ``overdosed'' on the drug for more than two weeks.
The child was discontinued from the trial before it was completed, ``due to
worsening auditory hallucinations that apparently caused the subject to
lacerate her wrists.''

Another child, "Subject 1001" weighed 103 pounds: the child ``was overdosed
on study medication for 20 consecutive days while participating in the
study,'' the letter states.

A child identified as ``Subject 1003,'' who was 15 at the time of the
trials, ``was overdosed on study medication for 21 consecutive days while
participating in the study.''

``Subject 1004,'' a 16-year-old, ``received doses in excess of the maximum
target dose for 3 consecutive days while participating.''

A 10-year-old, identified as ``Subject 1007,'' was ``overdosed'' for nearly
two weeks while on the study...

According to the FDA letter, in one trial, six of seven children -- chosen
at random -- who received one of the tested drugs in Punjwani's study, the
dosage exceeded what was spelled out in the protocol.

The FDA letter does not specify the names or types of drugs the doctor was
testing, and a spokeswoman for the FDA, Sandy Walsh, said "such details are
kept confidential to protect drug companies."

The Department of Children & Families Secretary George Sheldon, who
appointed a task force last year to study Gabriel's death, said Monday he is
asking the FDA to compare a list of Florida foster children with lists of
children enrolled in Punjwani's clinical trials. Sheldon said he was acting
on concerns that children in state care may have been involved in clinical
trials, which is against state law.

FDA spokespersons say the agency considers breaches of its regulations to be
``very serious.'' Yet, even as the FDA warning letter to Dr. Punjwani
notes, ``we are concerned that the response is not adequate to prevent
future recurrence of the violation,'' the agency did not disbar him from
conducting further pediatric clinical trials.

Who is accountable for the chemical torture of children who were subjected
to medical maltreatment that borders on criminal negligence?
How many child casualties, and what level of professional negligence must be
documented before a medical doctor's license to practice is revoked?


Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974