Monday, January 21, 2002
Incentives boost child-drug testing
But critics say drug makers reap millions more in profits
By Derrick DePledge
Enquirer Washington Bureau
WASHINGTON A few years ago, doctors prescribing ibuprofen to treat infants had little idea of the proper dosage. As with many other common drugs, the popular pain reliever was not widely tested on children before being released on the market.
The federal government sought to close these medical gaps in 1997 by offering brand-name drug companies an opportunity: Conduct drug studies on children in return for an additional six months of market exclusivity for patented drugs.
Today, doctors and parents know the right dose of ibuprofen for children 6 months to 2 years old. In the short life of the law, new studies have been performed on drugs that help doctors treat children with anxiety disorder, epilepsy, obsessive-compulsive disorder, diabetes, hyperten sion, juvenile rheumatoid arthritis and AIDS.
President Bush this month signed a six-year extension of the law after Congress made several changes, including new incentives for drug companies to study older drugs on which patents have expired.
We live in a world where incentives work, said Philip Walson, a professor of pediatrics and director of the clinical pharmacology division at the University of Cincinnati. Our kids benefit.
The Food and Drug Administration and the General Accounting Office, in separate reviews of the law, found that the market incentive has been effective in prompting important new drug studies, and in providing useful information for doctors and parents on drug labels.
But the reviews have also shown that drug companies, which had been reluctant to conduct drug studies on children without a financial incentive, profit from the law. An extra six months of market exclusivity can mean millions in revenues for brand-name drug companies because it delays competition from lower-priced drugs from generic drug manufacturers.
The FDA estimates that brand-name drug companies will gain $29.6 billion in added sales and $592 million in annual profits under the law in the next two decades.
Meanwhile, the market incentive will cost consumers $13.9 billion in higher drug costs. The expense, according to the FDA, will fall disproportionately on low-income families that lack health insurance and pay cash for prescription drugs.
In some cases, drug companies have done studies on drugs with marginal uses for children to obtain additional market exclusivity and ward off competition from generic drug makers. Some drug companies also have been slow to update drug labels after studies found unfavorable results in children, according to the GAO.
Sen. Mike DeWine, R-Ohio, one of the law's sponsors, said the market incentive adds less than one-half of 1 percent to total drug costs in exchange for valuable medical information for doctors and parents. He recalled how one of his eight children was once prescribed an inhaler for asthma that had never been adequately tested on young people.
Pediatricians were making guesses, Mr. DeWine said. They may have been educated guesses, but they were guesses.
Only about 25 percent of drugs on the market have been tested and labeled for children. The American Academy of Pediatrics has warned that the absence of information could cause medical errors and pose substantial health risks.
Children are frequently prescribed the same drugs as adults. But without detailed labels, doctors in some cases have to estimate the proper dose based on age or weight or experience, exposing children to adverse reactions or poor treatment if the prescription is off.
Before the federal incentive, drug companies were hesitant to conduct drug studies on children because of concerns about potential liability, as well as a lack of available patients for certain diseases. Drug companies also would rarely perform tests on children when adults were the target audience for particular drugs.
Drug companies resisted doing studies even after specific requests from the FDA. For example, the companies promised to conduct 71 drug studies on children between 1991 and 1996 but completed only 11 of the studies, according to the FDA.
The FDA, attempting to screen important drugs that were not being studied, began requiring drug companies to test certain drugs on children in December 2000. The Competitive Enterprise Institute, a nonprofit group that favors limited government, and other groups are challenging the rule in federal court.
Congress, in updating the law last year, also agreed to provide $200 million for pediatric research on drugs with no patent life and no obvious financial incentive for drug companies.
Meredith Art, a spokeswoman for the Pharmaceutical Research and Manufacturers of America representing brand-name drug companies, said the government's marketing incentive has revolutionized pediatric drug development.
The underlying issue here is that it is benefiting our children, she said.
Generic drug makers, who tried, and failed, to block the marketing incentive in court, argue that brand-name drug companies have used the law to undermine competition in the lucrative prescription-drug market.
It's our position that the brand-name companies should be doing this research anyway because it's important to know which drugs are safe for children, said Clay O'Dell, director of public affairs for the industry group Generic Pharmaceutical Association.
Consumer advocates like Public Citizen have dismissed the market incentive as a windfall for brand-name drug companies. The nonprofit group believes drug studies on children should be required as part of the FDA's evaluation of new drugs without a financial incentive for drug companies.
Mr. Walson, who serves on the American Academy of Pediatrics' committee on drugs, said the complaints from generic drug makers are hollow because they have done little to research drugs themselves. He said the cost to consumers is offset by the potential for new and improved treatment for children.
The FDA had recognized 212 new drug studies on children as of Dec. 1, had granted market exclusivity to 55 drugs and had approved updated labels on 27 drugs.
Mr. Walson said new studies will help doctors avoid uncertainty in dosing.
We have doctors who say, "We don't know if this works. We don't know how much to give. We don't know if it's better than anything else. But we want you to take it.'
We've said that it's OK to have physicians use their best judgment.
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