October 26

Medscape Cites AHRP Concerns Re: New Law Mandates More Testing of Drugs in Children

Medscape Cites AHRP Concerns Re: New Law Mandates More Testing of Drugs in Children

Wed, 17 Dec 2003

Medscape Medical News reports about passage of the Pediatric Research Equity Act (PREA) which replaces FDA’s Pediatric Rule. The Pediatric Rule was struck down by a Federal court in Oct. 2002 because FDA overstepped its authority. [See: https://ahrp.org/infomail/1002/18a.php ]

The combined lobbying of the medical establishment, whose interests are intertwined with the pharmaceutical industry, and patient “advocacy” groups that are supported by the same industry, resulted in legislation that attempts to lend legitimacy to the enrollment of children to serve as drug testing subjects. None of these special interest groups recommended safeguards to protect the welfare of vulnerable child-subjects ant to prevent their exploitation.

Indeed, the law’s business value is obliquely acknowledged in the Medscape report by child psychiatrist, Adelaide Robb, MD, who notes that as a result of this law, physicians may be “more likely to look at newer medicines rather than only existing ones…”

The concerns expressed by The Alliance for Human Research Protection are noted by Medscape (below). We are concerned about the law’s impact and unintended adverse consequences. An increased number of children will be exposed to unjustifiable risks, will be made to endure pain and discomfort in the process of testing drugs that may have little, if any benefit for them.

AHRP’s concerns about children’s safety and best interest have been validated by recent revelations: some children who served as test subjects in antidepressant drug trials were driven to acts of self-harm and suicide.


New Law Mandates More Testing of Drug Safety in Children
Cathy Tokarski

Medscape Medical News 2003. © 2003 Medscape

Dec. 15, 2003 – Lost in the front-page headlines earlier this month about creation of a new drug benefit for the Medicare population was passage of a law that advocates say will enhance the quality and safety of drugs that are prescribed for use in children.

The Pediatric Research Equity Act of 2003, signed into law by President Bush on Dec. 3, requires pharmaceutical companies seeking approval from the U. S. Food and Drug Administration (FDA) for their new drugs and biological products to assess a drug’s safety and effectiveness, including dosages, in pediatric patients. Companies could be granted partial waivers from such assessments if such studies are “highly impractical or impossible” or if there is “no meaningful therapeutic advantage” in the pediatric population or is not likely to be used in a substantial number of patients.

In addition, according to the law, the federal government could require that labels indicate cases in which a waiver has been granted based on evidence that the drug would be unsafe or ineffective in treating children. The label can also specify a date by which an assessment should be submitted if the drug would provide a “meaningful therapeutic benefit” for one or more claimed indications and if it is used for a number of patients for the labeled indications and the absence of labeling could pose risk to the patients.

The law replaces the Pediatric Rule, a regulation that took effect in 1998 granting the FDA the authority to require pediatric drug studies. It was struck down in October 2002 by the U.S. District Court for the District of Columbia on the grounds that the agency did not have the statutory authority to require such studies.

Enactment of the Pediatric Research Equity Act into law is more than a procedural victory, according to physicians. Supported by the American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatry, “it says [to drug manufacturers] right from the get-go, ‘You need to put safety and efficacy data in as part of the development’ when you’re submitting a new drug application,” said Adelaide Robb, MD, a child and adolescent psychiatrist at Children’s National Medical Center in Washington, D.C. As a result, she added, physicians may be “more likely to look at newer medicines rather than only existing ones because they’ve only been tested in adults.”

The law “is in place of doctors doing unregulated experiments,” said Richard Gorman, MD, a pediatrician in private practice in Ellicott City, Maryland. “The reality is that children are not adults – they are physiologically different. Testing drugs in immature biological systems has taught us a lot,” he added. For example, a pharmacology committee conducting clinical trials on a pediatric population were surprised to learn that dosing ranges for children were off by a factor of 50% to two times the appropriate amount, Dr. Gorman said. “It came as a huge surprise…we were giving either half of an appropriate dosage to two times as much.”

Not everyone is enthusiastic about the FDA’s new legal authority to require evidence of drug safety for children.

Vera Hassner Sharav, who heads the Alliance for Human Research Protection, a New York based advocacy group, said children enrolled in clinical trials do not receive the protection they need and parents often are not adequately informed of potential downsides. “When children are recruited for studies that are not for a life-threatening condition, there is greater need to justify exposing children to pain risk and discomfort,” she said.

Since the 1997 law creating the Best Pharmaceuticals for Children Act, which provided financial incentives for conducting pediatric studies, “children are being harmed,” Ms. Sharav said. “The big one you have is SSRIs [selective serotonin reuptake inhibitors],” she said.

The use of antidepressants to treat child and adolescent depression is “raising lots of controversy,” said Dr. Robb, noting that the FDA will convene a meeting on Feb. 2 examining the link between suicide and use of various antidepressants by pediatric patients. But more, not less, research on drugs is needed to help physicians learn which medications work best in children, she said. “Even if all [SSRIs] work in grown-ups, we learned [from previous studies] they don’t all work in kids. That helped us as pediatric psychiatrists determine which group of medicines to work from. That was an important finding.”

Reviewed by Gary D. Vogin, MD

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