Rense: Most Drugs Never Tested for Safety in Children

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Most drugs never tested for safety in children

Children seen facing risks from medicines

By Christopher Rowland, Globe Staff, 8/20/2003

 

Pediatricians are forced to engage in risky " trial-and-error "

medicine when they give drugs to children because two-thirds of all

drugs they routinely prescribe have never been adequately studied on

kids, according to a study by Food and Drug Administration

researchers to be published today in the Journal of the American

Medical Association.

 

 

 

What's more, when certain drugs developed for adults were

methodically tested in children, researchers found previously

unknown safety risks, including higher incidences of death,

seizures, and suicidal thoughts, according to new data contained in

the study.

 

" Most people don't have any idea that such a low proportion of

prescription medicines have never been approved as safe and

effective for kids, " said Dr. Peter P. Budetti, a professor at the

University of Oklahoma College of Public Health who wrote an

editorial accompanying the study.

 

" You can't treat children merely as small adults, " he said. " Just

because a child weighs one-tenth the amount of an adult, it doesn't

mean they can take one-tenth of that drug. They may not be able to

take that drug at all. "

 

The lack of trials is a growing concern in Washington, where the

Senate last month unanimously approved a bill that would give the

FDA authority to require drug companies to test new drugs for

safety, efficacy, and dosing information in children. The measure is

pending in the House.

 

It's both legal and common for doctors to prescribe drugs for

children that haven't been fully tested on them, as long as the

drugs have shown to be effective in limited studies. But with major

differences in physiology between adults and children, doctors have

long worried that relying on these so-called " off-label " indications

is inadequate.

 

The study bolstered those concerns with drugs doctors had been using

for years. After full trials were performed on children given an

anesthesia drug called Diprivan in intensive care units, for

example, researchers found a statistically higher risk of deaths

than for children given different forms of anesthesia. Another

anesthetic, Ultane, triggered rare cases of seizures in young adults

and children with no history of seizures. An antiviral therapy

called Rebetron was associated with suicidal thoughts in 2.4 percent

of children, compared with 1 percent for adults given the drug,

according to the FDA.

 

In an interview, Dr. Richard Gorman, a Baltimore pediatrician and

chairman of the American Academy of Pediatrics' committee on drugs,

said an epilepsy medication called Neurontin prescribed to control

pain in some children was ineffective because the dose was too

small. Once clinical trials were performed, it turned out that the

dosing schedule had been improperly recalculated for children. The

original dosing was based on children's weight alone, without taking

into account their faster metabolism.

 

" We were giving it to kids in good faith to help their pain, and it

didn't work, " he said. " You have kids who suffered needlessly

because the data wasn't there. "

 

Dr. Richard Parad, a specialist in neonatal intensive care at

Brigham and Women's Hospital in Boston, said none of the drugs he

uses to treat premature infants for potentially deadly pulmonary

disorders has FDA approval for pediatric uses. He said he has picked

up expertise in off-label dosing for these drugs by reading medical

journals.

 

" Most of the tools we use as pediatricians are kind of hand-me-downs

that have been tested and tried in adults, " he said.

 

The pace of trials did not pick up significantly until Congress

approved the Food and Drug Administration Modernization Act of 1997.

That gave drug companies an additional six months of market

exclusivity, with no generic competition, if they voluntarily

performed pediatric clinical trials. There have been risks

associated with the accelerated trials, including deaths and

lawsuits relating to alleged ethical lapses.

 

The FDA researchers who wrote the study published today did not

discuss those concerns. They pointed to the benefits of the

government's incentive: 53 drugs have won the exclusivity provision

and 49 drugs have new labels updated with pediatric information.

Thirteen of the findings or labeling changes were

considered " significant " by the FDA, meaning they revealed improper

recommendations for dosage that affected safety or effectiveness.

 

In 1998, the FDA imposed a requirement that all drugs with possible

pediatric indications be tested on children, but that was thrown out

by a US District Court judge in Washington last year after a legal

challenge by several groups that lobby for fewer regulations,

including the Competitive Enterprise Institute and the Association

of American Physicians and Surgeons. The bill passed by the Senate

in July would restore the rule legislatively.

 

Opponents say requiring pediatric clinical trials will slow down new

drug approvals and make it more difficult for companies to bring

drugs to market. Sam Kazman, general counsel of the Competitive

Enterprise Institute, said the measure would discourage drug

companies from researching new uses for drugs if they believed off-

label pediatric uses might trigger FDA requirements for expensive,

full-blown clinical trials.

 

The drug-industry trade group, the Pharmaceutical Research and

Manufacturers of America, backs the voluntary provisions of the 1997

law.

 

Budetti, who wrote the journal editorial, said the FDA needs to

wield a regulatory stick because drug companies on their own aren't

performing enough trials, in part because there are fewer child

patients than adults. " Just in terms of the financial incentive,

there is not the same kind of gain for pharmaceutical companies to

be spending the money that it costs to run the tests in children,

because the market isn't going to be there, " he said. Until the

climate improves for pediatric clinical trials, he added, parents

must be advocates for their children.

 

" It is fair to ask questions like, `How widely is this drug used in

children,' and `Is it approved or not by the FDA,' " he said.

 

Christopher Rowland can be reached at crowland.

 

© Copyright 2003 Globe Newspaper Company.