Despite evidence of harm–including the suicide of a 7-year old Gabriel Myers– the FDA, which is charged with ensuring the safety of children in drug trials, fails to maintain a record of children enrolled in commercial drug trials.

By contrast, after the suicide of Gabriel Myers , a seven-year old boy in foster care who had been prescribed three powerful psychotropic drugs in a dubious clinical trial, George Sheldon, Florida’s Secretary of the Department of Children and Families, examined the records of children in State foster care and found a high percentage being drugged with psychotropic drugs:

"Not only was the percentage high, it was not really known. And, in more than a third of known cases, required approval permission documents were missing."

So he wrote to the FDA–which is responsible for ensuring that children’s involvement in drug trials is approved and understood by parents or guardians who give surrogate consent. The FDA is charged with overseeing pediatric trials conducted under the FDAMA law–a law that awards drug manufacturers who test their drugs in children with an extended, highly lucrative, 6-months of market exclusivity.  

Sheldon asked the FDA how many Florida foster children were involved in drug studies as they bounce from foster family to foster family?

The answer encapsulates FDA’s irresponsible approval for the use of children–who are, after all, NON-CONSENTING human beings–without regard for children’s safety.

Drug trials pose known and potential risks of harm, pain, and discomfort. Commercially-driven drug trials rarely offer children a direct benefit.

The Herald Tribune (Florida) reports (below) the response by Jill Hartzler Warner, an associate FDA commissioner, to Sheldon’s question:
"the FDA didn’t have an exact number. Or even an estimate. The FDA, in fact, doesn’t have the slightest idea how many Florida foster kids are or have been involved in its drug studies."

What’s more, Hartzler and the FDA also urged Sheldon "not to bar Florida’s foster kids from drug trials, arguing that benefits can outweigh risks."

Richard Wexler of the National Coalition for Child Protection Reform, says the FDA’s position is absurd.
"I would love to ask Associate Commissioner Hartzler if she’d care to let a total stranger decide if her children should be enrolled in a trial for a potentially dangerous drug."

Does Jill Hartzler Waner’s response represent the official position of FDA and its Commissioner, Dr. Margaret Hamburg?

 *Jill Hartzler Warner, J.D., is Acting Associate Commissioner for Special Medical Programs at FDA.  She oversees FDA’s Office of Pediatric Therapeutics, Office of Orphan Products Development, Office of Good Clinical Practice, Office of Combination Products, and the Advisory Committee Oversight and Management Staff.  In this position, Ms. Warner provides leadership and direction in the coordination of internal and external review of pediatric science, safety, ethics, and international issues.

Vera Hassner Sharav

Herald Tribune
Lyons: Government is daring to keep kids on drugs
By Tom Lyons
Published: Sunday, July 25, 2010

Apparently the U.S. Food and Drug Administration had at least heard about the suicide of Gabriel Myers.

Myers’ death by hanging happened in a Florida foster home last year, but that wasn’t the main reason it triggered a major reaction at Florida’s Department of Children and Families.

The real reason: He was 7 years old.

Whatever else might have helped lead such a young child toward ending his life, one detail was impossible to ignore: The boy was being treated with three different psychotropic medications.

Medications of that sort make some people more depressed or even suicidal, and their effects when combined are harder to predict, especially in children.

So DCF did a quick check on how many foster children were being given such drugs. Troubling facts emerged.

Not only was the percentage high, it was not really known. And, in more than a third of known cases, required approval permission documents were missing.

DCF Secretary George Sheldon quickly acknowledged the problem and started a study group to learn more and give advice. And a year later, the picture is at least more clear. Very few files lack required documentation now. And when I asked for the most current numbers, they were available, and somewhat lower. In the Sarasota-Manatee-

DeSoto county region, 11 percent of foster children are given psychotropic meds. Statewide, it is 13 percent.

Some critics insist too many foster parents, lacking the skill or patience to work with troubled children who arrive as strangers, are still too quick to see medication as the way to curb problem behavior or just keep foster children quiet, no matter the side effects.

But whatever the truth of that, the study group recommended some good changes, and one made sense immediately, I thought: Ban the use of foster kids in drug trials.

Drugs helpful to some adults can react differently in children, who may suffer more extreme and unintended side effects. And so, clinical trials on children are needed, but it is a scary field of study. The most alert and caring parents are key for monitoring the children during such trials, I would think.

So I was surprised at the FDA’s response when Sheldon wrote to ask how many Florida foster children were involved in drug studies as they bounce from foster family to foster family.

Jill Hartzler, an associate FDA commissioner, responded that the FDA — which oversees the studies to make sure children’s involvement is approved and understood by

parents or guardians — didn’t have an exact number. Or even an estimate. The FDA, in fact, doesn’t have the slightest idea how many Florida foster kids are or have been involved in its drug studies.

But that wasn’t the weirdest part. Hartzler and the FDA also urged that Florida not bar foster kids from drug trials, arguing that benefits can outweigh risks.

I’m happy to say Sheldon is not taking that advice. But as he explains his reasoning more tactfully than does Richard Wexler of the National Coalition for Child Protection Reform, I’ll quote Wexler, who says the FDA’s position is absurd.

"I would love to ask Associate Commissioner Hartzler," Wexler said, "if she’d care to let a total stranger decide if her children should be enrolled in a trial for a potentially dangerous drug."

Tom Lyons can be contacted at tom.lyons@heraldtribune.com or (941) 361-4964.

   This story appeared in print on page BN1