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TESTING DRUGS ON KIDS; CLINTON PROPOSAL DRAWS FIRE FROM PHARMACEUTICAL COMPANIES.

Byline: Robert Pear The New York Times

Fierce disputes have erupted over a proposal by President Clinton that would require drug companies to test their products' effects on children before putting new medicines on the market.

Clinton says such studies will improve health care for children by helping doctors assess the safety and determine the proper doses of drugs that are used to treat children.

But drug companies say the president's proposal will needlessly put thousands of children at risk. And these companies contend that the government has no legal authority to make them conduct such studies.

When Clinton announced his proposal on Aug. 13, it seemed politically irresistible. But it is proving much more complicated than expected, and federal officials now acknowledge that the testing of drugs on children raises ethical questions not found in clinical trials with adults.

Since many important drugs are not tested on children, Clinton said, doctors must often guess at the appropriate doses, and youngsters may be deprived of ``the very best treatment available.''

Doctors have generally supported the proposal. Dr. Susan P. Etheridge, a pediatric cardiologist at the University of Utah, said it could be ``the biggest step forward for drug treatment of children in three decades.''

Lawrence A. McAndrews, president of the National Association of Children's Hospitals, said, ``Only about 20 percent of drugs marketed in the United States have been tested and labeled specifically for children.''

Under the president's proposal, drug makers would have to test their products on children if the drugs were used, or were likely to be used, in ``a substantial number of pediatric patients'' or if they offered ``a meaningful therapeutic benefit over existing treatments'' for children.

Dr. Michael A. Friedman, deputy commissioner of the Food and Drug Administration, said, ``Many drugs labeled only for adult use are, in fact, widely used in pediatric patients'' for the same illnesses.

Indeed, doctors say, drugs are routinely prescribed for children even when the labels carry a disclaimer saying, ``Safety and effectiveness in pediatric patients have not been established.''

Clinton's proposal would authorize the Food and Drug Administration to seek court orders requiring drug companies to study how their products affect children. Violators would be subject to fines and other penalties.

In proposing the requirements, the FDA said, ``History is replete with examples of children who have died or suffered other serious adverse effects as a result of the use of drugs that have not been tested in children.''

Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers of America, a lobby for drug companies, said Clinton's proposals were well-intentioned but could harm children because they would require testing of new chemical compounds in children before the drugs' safety in adults had been adequately studied.

The proposals would impose ``new risks on children who might be recruited for clinical trials,'' Holmer said. Companies worry that children injured in drug tests might file lawsuits years later, after they grow up, even though parents gave consent for the tests. The tests raise the ethical question of how researchers can obtain informed consent from children as they do from adults.

Drug makers - including Merck, Glaxo Wellcome, Novartis and Wyeth-Ayerst - said they shared Clinton's goal of discovering better medicines for children but found the details of his proposal extremely impractical and burdensome.

Holmer said that a prescription drug should ordinarily not be tested on children until scientists had clear evidence that it was safe and effective for adult patients. Requiring that drugs be studied simultaneously in children and adults could delay the approval of life-saving medications for adults, he said. Drug company executives said that Clinton, in his zeal to protect children, was exceeding his authority under federal law. The job of the FDA, they said, is to review drugs for the uses proposed by manufacturers.

The Clinton administration assumed that the new drug trials would cost an average of $5,000 to $9,000 for each child included in a study. Overall, it said, the proposed rule would impose costs of $13 million to $21 million a year on the drug industry.

But drug companies said the costs would be much higher. Holmer said the proposal would set ``a dangerous precedent,'' diverting money and other resources away from ``drug research that is more beneficial to the general public.''

Janne Wissel, vice president of the Alza Corp., a maker of drug-delivery technology in Palo Alto, Calif., said, ``The cost of performing pediatric studies, especially for small companies, may be prohibitive.''

Young children often have difficulty swallowing pills, tablets and capsules. So drug companies often need to devise liquid, chewable or injectable forms of their products. Companies say it may cost millions of dollars to develop a formulation specifically for children.

In the absence of such products, parents make their own arrangements, cutting up tablets, crushing them with a mortar and pestle or mixing them with liquid so children can swallow them. But, Dr. Etheridge said, that is ``not the most accurate way'' to measure out drugs.

Drug companies said that under Clinton's proposal they would have to conduct separate tests in newborn infants, young children and teen-agers, because children of different ages often react differently, requiring different amounts of drug per pound of body weight.

Chris Jennings, a White House aide, said the drug companies' objections were not surprising. ``We tried it their way, and it didn't seem to work particularly well,'' he said, noting prior efforts by the government to encourage voluntary testing of drugs in children.
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Publication:Daily News (Los Angeles, CA)
Date:Nov 30, 1997
Words:915
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