Tests Are Set for Adult Drugs Children Take

Tests Are Set for Adult Drugs Children Take

Tue, 21 Jan 2003

American children who cannot say no, will be exposed to the risks involved in drug tests thanks to the influence of special interest groups: the pharmaceutical industry and the physicians they fund.

Whose children will be recruited as human guinea pigs? What cash incentives will lead parents to volunteer their children for experiments the neither the CEOs, government officials, or drug researchers would expose their own children.

So much for family values!

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http://www.nytimes.com/2003/01/21/politics/21DRUG.html?pagewanted=print&position=top

January 21, 2003

Tests Are Set for Adult Drugs Children Take

By THE ASSOCIATED PRESS

WASHINGTON, Jan. 20 (AP) – The government announced plans today to begin clinical tests this year on 12 drugs commonly prescribed for children even though their safety and effectiveness has been tested only in adults.

“Children often react differently to drugs than adults do,” Tommy G. Thompson, the health and human services secretary, said. “We need to conduct testing now to fully understand the effects of these medications in children.”

The drugs include azithromycin, an antibiotic used to treat bacterial infections, and lithium, used to treat bipolar mood disorders. The others are baclofen, bumetanide, dobutamine, dopamine, furosemide, heparin, lorazepam, rifampin, sodium nitroprusside and spironolactone.

Dr. Jane M. Orient, executive director of the Association of Physicians and Surgeons, questioned whether most of the drugs on the list should be tested in children because of potential risks.

“Safety testing needs to be done, but adults should bear the risks,” Dr. Orient said.

The National Institute of Child Health and Human Development developed the list of drugs to be tested in consultation with the Food and Drug Administration and experts in pediatric research.

Congress passed legislation last year giving drug makers financial incentives for conducting the tests. Congress also set up grants to finance pediatric studies. Mr. Thompson said tests would be the first sponsored by the government under the new law. The National Institutes of Health, which will oversee the tests, has set aside $25 million from its budget, and the drug administration, which will review the test results, has set aside $6.6 million.

Mr. Thompson said President Bush’s budget request for the fiscal year that begins in October would include another $61.5 million for the testing program.

The 12 drugs are no longer under patent.

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