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Show jatunlay, DAILY September 4. 2004 HERALD A3 FDA committee considers ethics of giving experimental drugs to healthy children Diedtra Henderson fy !' ' t - al ' b. t ; BOWER Associated ROBERT Press Weit Yellowstone, Mont, entrance to Yellowstone National Park on Dec. 1 7. Attorneys implored aiederal judge on Thursday to dump, once and for all, a Clinton-er- a rule banning snowmobiles in Yellowstone and Grand Teton national parks. snowmobilws enter, the d Put-guide- Judge asked to permanently lift snowmobile ban in two parks Robert W. Black -- THE ASSOCIATED PRESS I' 'CHEYENNE, Wyo. Attorneys for snowmobile manufac- turers, winter resorts and othventures er tourism-relatehave asked a federal judge to permanently lift a snowmobile ban in Yellowstone and Grand teton national parks so the Businesses can have peace of mind about their survival U.S. District Judge Clarence Brimmer heard the request Thursday from the businesses, joined by the states of -tana and Wyoming. Their lawyers said action by Brimmer would prevent another federal judge, in Washington, DC, from reinstituting the 2001 ban and creating economic uncertainty for the area. "This thing keeps showing up," Wyoming attorney Jay Jerde told the judge. The ban --has not been struck down by any court or ruled invalid by any court." The Clinton administration ban, to take effect last winter, was set aside in early 2003 by the National Park Service to settle a lawsuit filed by snowmobile makers. Under the agreement, new rules were drafted to allow a limited number of snowmobiles inside the d i ' - ( Attorney Keith Burron, representing Montana, said the state feels strongly about protecting Yellowstone's natural resources but that the effects on businesses were not fuDy considered. There are some extreme gateway community impacts," he said. "That's why Montana is in this case now." Andrew Emrich, an attorney with the US. Department of Justice, argued that the Park Service should be allowed to continue working on the new e, d rules. Brimmer pressed Emrich to make sure all parties have a chance to participate. Emrich said they would. Brimmer criticized Sullivan several times for asserting jurisdiction in a case that began in Wyoming in 2000. "I think this appearance of quarreling or competition between two U.S. district courts is most unseemly," he said. "He shouldn't have done it because this court had jurisdiction in the first place." Brimmer said he would issue a decision later, then told Yellowstone officials in the courtroom that he has "no intention of supplanting your jurisdiction in running the park." noise. If the new regulations are challenged in court, Sullivan might again invoke the ban, said William Horn, representing the International Snowmo OVER 450 STORE LOCATIONS NATIONWIDE 1ii i r r i LOTED TIME ORECK XL VACUUM CLEANER 8-L- B. & Lightweight ; EJtTRA nm o LWnVO 1 Warranty Cord Long 25-f- t. SALE-PRICE- ITy -- W im The'new trial would add magnetic resonance images to map potential differences in brain activation patterns. While Rapoport's trial is little different from the earlier one, review boards that balance risk vs. scientific gain have changed dramatically in 20 years. Indeed, an NIH review panel met twice and was unable to reach a consensus whether risk COATS DISCOUNT ! TCTWAMHOKm. 89V2100S 779-299- 832-950- O SALE-PRICE- 968-782- 1 fpip D WOMEN'S ACCISSORIES, HANDBAGS & &SLEEPWEAR; BRIDGE, FASHION JEWELRY WATCHES, FINE JEWELRY OFF SHOES A INTIMATE FOUNDATIONS DISCOUNT on Superior Vahnt. Rnt Wttcket. 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The Park Service now is planning new regulations to. cover the next three winters, which attorneys for the federal government and environmental groups said should be allowed to continue. Hie merits of that rule need to have their day in court," argued Abigail Dillen of Earthjus-tica Bozeman, Mont.-basefirm representingthe Greater Yellowstone Coalitioa Both sides agreed that if Brimmer strikes down the 2001 rule, the Park Service would probably have to revert to its at least temporarily 1983 rule allowing unregulated snowmobiling. Brimmer was clearly uncomfortable with that option, given the consensus that limits on the snowmobiles are necessary to protect the park's wildlife and reduce would too high in the new study. They kicked the sensitive matter over the FDA's new pediatrics ethics subcommittee. The study would involve 14 children with ADHD, 14 healthy children, 12 pairs of identical twins and 12 pairs of fraternal twins. As the children completed specified tasks, their brain activity would be captured by MRIs. one with Comparing twins ADHD, the other normal helps researchers tease out genetic explanations of differences in response to treatment. In September 2003, an NIMH panel that reviewed the proposal's scientific merit called the program an excellent submission. The panel noted that it Is it ethi-;cin the name of science to 'give a healthy child as young as 9 a controlled substance? That's ? the dilemma facing the Food and Drug Administration's Pedi-- ! atrfc Ethics subcommittee at its first-eve- r meeting on Friday. The research, proposed by the National Institute of Mental Health, includes healthy children who among 9- - to would receive a single 10 mg dose of dextroamphetamine. The hoped-fo- r payoff for research: A better understanding of how healthy brains work differently from those of children diagnosed with attention deficit hyperactivity disorder. ' The payoff for families: $570. Characterized by inattentive-nes- s, overactivity and impulsiveness, ADHD affects up to 5 percent of schoolchildren. The disorder continues in roughly 60 percent of those youths as they age, although experts say the disorder is underdiagnosed in adults. Dextroamphetamine, the active ingredient in such drugs as Dexedrine and Adderafl, is prescribed commonly to increase attention span and calm restlessness. Doses vary with children's needs, with daily doses as little as 5 mg or as much as 30 mg. Judith L Rapoport, chief of child psychology at NIMH, within the National Institutes of Health, conducted a similar trial 20 years ago. The same stimulant was given to children at a higher dose. Researchers B looked only at how the stimulant changed children's behavior as they performed tasks. The stimulant improved attention span in the children, regardless of whether they had WASHINGTON be the first ADHD study to compare twins, which has been useful in past studies on schizophrenia. The panel that considers a safety of human subjects, however, was troubled by the youngest tested children's age and the potential for coercion because each participant would be paid (570 for the study. The major stumbling block was determined to be the risk of giving a class 2 controlled substance to healthy children, which some fretted might breed future substance abuse. Children in the 1980 NIH trial had no increased risk of drug abuse in the five years after the trial ended, researchers say in ; the study protocol. to healthy volunteers would be THE ASSOCIATED PRESS it s l r r-- 1U. Xoriq. prick ; - tipiKS Nit . |