InfoMail for April 8, 2002



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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

April 8, 2002

Testing Drugs On Children: A Collision ofInterests


The New York Times editorial (below) berates the Bush administration forabandoning (what they call) "a farsighted regulation designed to ensurethat all medicines used in children undergo proper testing for safety andefficacy." The 1998 FDA "Pediatric Regulation" REQUIRED thetesting of new drugs on children–before they were found to be safe inadults.

The Times editorial and those who lobbied forthe Pediatric Regulation claim the rule would "protect children"by providing physicians with pediatric dosage information. They fail to address theprofound moral issue:

Who has the moral authority to"volunteer" a human being — i.e., a child — for invasive, risky, andpainful medical experiments  for the good of others?

As Dr.Henry Miller, a former FDA official, who supported a lawsuit filed by threeorganizations challenging the FDA, charged that the Pediatric Rule"raises serious ethical problems about testing drugs on children beforethey have been fully tested on adults."  And , Dr. Russell C. Libby, apracticing pediatrician, noted there are many drugs "approved in thiscountry for adults, which are safe and effective for my patients."Currently, responsible physicians prescribing drugs "off label" forchildren, assume full professional responsibility.  They are guided bythe guidelines, recommended tests, and drug dosage schedules provided inthe highly regarded, Harriet Lane Handbook (now in its 15th edition). 

The Alliance for Human ResearchProtection calls for a public debate addressing the moralissue of consigning children to serve as experimental subjects, and calls for animpact evaluation by the Office of Inspector General, based on analysisof existing FDA and NIH research data.

Whose children are to be selected to bear theburden for society?
Whose children will be exposed to risks and discomfort to test the safety andefficacy of drugs?

Will the doctors conducting the trialsvolunteer their own children to become test subjects?
Will the drug company CEO’s volunteer their children to become test subjects?
Will the NYT editors volunteer their children or grandchildren to become testsubjects?

Or, will the burden of risk and discomfort be relegated to nonconsenting children of poor families–as has been the history of pediatricmedical experiments?

Indeed, Health and Human Services officials in the previous administrationreferred to such children as "risk bearing children." 

None of the stakeholders in biomedical research have voiced concern about themorality of offering cash payment incentives to parents tovolunteer their children for drug tests. The Alliance for Human ResearchProtection regard such cash payments as undermining parental responsibility toprotect the best interests of their children.

The Maryland Court of Appeals unequivocally ruled that no one has the right toexpose children to potential harm for the good of others:
"whatever the interests of a parent, and whatever the interests of thegeneral public in fostering research that might, according to a researcher’shypothesis, be for the good of all children, this court’s concern for theparticular child over-arches all other interests."
[See, Grimes v Kennedy-Krieger Institute and Higgins v Kennedy-KriegerInstitute. Maryland Court of Appeals. August 16, 2001, p.80.]  Online at:



April 7, 2002
The Need to Test Drugs on Children

The Bush administration senselessly plans to abandon a farsighted regulationdesigned to ensure that all medicines used in children undergo proper testingfor safety and efficacy. This is a bizarre abdication of responsibility forguaranteeing that society’s youngest and most vulnerable members are providedwith the same safeguards that protect adults from unsafe or ineffectivemedicines. It is time for saner heads in both parties in Congress to press theadministration to retain the rule it is trying to disown.

The need for the rule stems from injuries and ineffective treatments suffered bychildren taking medicines that have not been tested for safety and efficacy inyoung people. Drug companies generally test prospective products on adults andseek approval from the F.D.A. to market them for adults. But once a drug is onthe market, doctors are free to prescribe it for anyone they please. When theywant to give a drug to children, they typically cut the dose and assume that itwill work well and safely. But the doctors, alas, may guess wrong. They mayprescribe too small a dose to be effective or too large a dose, causing harm.There also may be unexpected side effects in children. In 1999, seven newbornsbecame seriously ill and required surgery after taking erythromycin, which hadnot been tested in their age group.

In 1997, Congress established an incentive program to coax manufacturers intoconducting the desired tests by offering to extend patent protection on theproducts involved by six months. That voluntary program has spurred a flood oftests. The chief complaint is that it has given a windfall to some companies,yielding them hundreds of millions of dollars in added profits from the patentextensions and slowing the introduction of cheaper generics. The incentive hasnot worked for drugs that lack patent protection or have small markets.

In 1998, the Food and Drug Administration issued a Pediatric Rule that allowedit to require manufacturers to test their medicines in children, if the productswere likely to be used by substantial numbers of pediatric patients. Thismandatory approach seems to have been used less often than the incentives, butchildren’s advocacy groups believe that it is imperative for the F.D.A. toretain the ability to require tests where needed.

Unfortunately, three conservative groups – the Association of AmericanPhysicians and Surgeons, the Competitive Enterprise Institute, and ConsumerAlert – have filed suit challenging the F.D.A.’s legal authority to require thepediatric tests. Rather than fight, the F.D.A. seems to be caving in. It hastold the court that it may suspend all or part of the mandatory rule whiledetermining whether it is still needed.

The F.D.A. should not lightly abandon this potentially vital tool. The voluntaryapproach will leave unstudied many medicines and age groups that themanufacturers see no profit in testing. Congress has recently plugged part ofthis gap by authorizing payment for some pediatric studies through a new privatefoundation or through government contracts, but there is no guarantee thatenough money will be available. At any rate, there will surely be circumstanceswhere pediatric tests are needed and will not be conducted unless the F.D.A. canorder a company to do them. It makes no sense to abandon any weapon in the longuphill fight to obtain safe and effective medicines for the nation’s youngpeople.

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