TEST DRUGS ON CHILDREN? SPARKS FLY

HEALTH

Doctors generally support Clinton's proposal,but drug companies say it
will needlessly put thousands of kids at risk.

WASHINGTON Fierce disputes have erupted over a proposal by President
Clinton that would require drug companies to test their products 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 Aug. 13, it seemed politically
irresistible. But it is probing much more complicated than expected, and
federal officials now acknowledge that the testing of drugs in 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 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
wellintentioned 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 WyethAyerst 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 a prescription drug should ordinarily not be tested in 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 lifesaving medications for adults,
he said.

Drug company executives said 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 form "drug research that is more beneficial to the general
public."

Janne Wissel, vice president of the Alza Corp., a maker of drugdelivery
technology in Palo Alto, said, "The cost of performing pediatric studies,
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 million 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.

Drug companies said that under Clinton's proposal they would have to
conduct separate tests in newborn infants, young children and teenagers,
because children of different ages often react differently, White House
aide Chris Jennings 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 previous efforts by the government to encourage voluntary
testing of drugs in children.