Research on kids needs tighter rein, panel says

Rules for medical studies sound but not consistently applied, experts report

March 26, 2004|By David Kohn | David Kohn,SUN STAFF

To avoid putting children at unnecessary risk, pediatric medical research must be more stringently supervised, a panel of experts said yesterday.

The report by the Institute of Medicine uncovered no abuses but said there was not enough information to get a full picture of the state of pediatric research, which has grown rapidly in recent years.

"We found nothing alarming, but we found very little information to tell us what is happening," said Stanford University pediatrics professor Richard Behrman, chairman of the committee that wrote the report.

The field is now supervised in a disorganized and sometimes contradictory way, which could increase hazards for some pediatric subjects, the report said. While federal regulations are generally sound, they are applied in widely divergent ways.

Medical research on children has increased sharply in recent years. This growth has been driven largely by a 1997 federal law giving drug companies incentives to conduct drug tests on children. A law passed last year also authorizes the Food and Drug Administration to require pediatric tests for many older drugs that weren't previously tested.

Over the past seven years, the number of children in industry-sponsored studies has likely more than tripled, said Marilyn Field, the study's director. In 1997-2003, more than 37,000 children participated in drug tests, according to the FDA.

Researchers and pediatricians have long argued that such tests are necessary because drugs act differently on children than on adults. Children might require higher or lower doses per weight than adults and might experience a range of different effects. In some cases, drugs that are safe for adults might be hazardous, or even lethal, for children.

"Research on children is very important. Children are not small adults," said Dr. Francis Sessions Cole, a pediatric researcher at Washington University in St. Louis, as well as a member of the institute panel. The nonprofit institute, an arm of the National Academy of Sciences, advises the government on health.

The panel also called for federal regulations to be extended to all privately funded pediatric research.

Rules governing human studies - on adults or children - largely apply only to federally funded research or to studies of drugs that require FDA approval. While many academic medical centers voluntarily apply these rules to other research, they are not obligated to do so.

Most studies, including those involving children, are examined by an Institutional Review Board (IRB), an expert panel set up by a university, hospital, federal agency or other private organization to decide whether a proposed project is ethical.

The report found wide variation in how these boards treat proposed pediatric studies. In one study of cystic fibrosis that involved at least nine medical centers, some OK'd including children, some asked for more information, and others refused to allow children to participate because the risks were too high.

Part of the problem, Cole said, is that those serving on the review panels might not know enough about children's health.

The institute report recommends that at least three pediatric experts review all studies involving children.

The report also calls for more communication among review boards and urged more federal guidance.

Field said in particular that the Office for Human Research Protections, a part of the Department of Health and Human Services, needs to be more aggressive about supervising pediatric studies.

"It isn't doing as much as it should," Behrman said of the agency.

An agency spokeswoman declined to comment until officials had seen the report.

Some experts say the problems extend beyond pediatric research. More than 20 million people volunteer for research studies in the United States each year, but no more than 60 percent are in studies that fall under federal ethics rules, estimated Adil E. Shamoo, a University of Maryland biochemist and editor of the journal, Accountability in Research.

"If you do research with animals - paid out of private funds, federal funds or out of your own pocket - there are federal regulations that cover it," he said. "That is not true with humans, whether it's children or adults."

Sun staff writer Julie Bell contributed to this article.

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