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AD/HD DRUG RITALIN FACES COURT, CAPITOL HILL, MARKETPLACE SKIRMISHES
September 26, 2000
** updated October 9, 2000 **
WASHINGTON -- Ritalin manufacturer Novartis AG is under fire from several directions this month as the longstanding debate over medicating children with Attention-Deficit/Hyperactivity Disorder rages on. In the wake of two new class-action lawsuits filed Sept. 13 against Novartis and the American Psychiatric Association, the House Education and Workforce Subcommittee on Oversight and Investigations has scheduled a hearing for Friday on the use of Ritalin in schools. Meanwhile, two Novartis competitors have stepped up their efforts to unseat the top-selling attention medication.
The lawsuits, led by Washington, D.C., attorney John Coale and Pascagoula, Miss., attorney Richard Scruggs, who won fame for leading similar suits against the tobacco industry in the late 1990s, allege Novartis and the APA conspired to create a bloated market for Ritalin, the most prescribed drug for AD/HD. The suits were filed in a federal court in California and a state court in New Jersey; they mirror a suit filed last spring in a state court in Texas by Dallas law firm Waters & Kraus. That suit also names the national advocacy group, Children and Adults with AD/HD, as a defendant.
Novartis called any allegations that it has conspired with the APA, CHADD or any other organization "unfounded and preposterous." A company spokeswoman said Wednesday Novartis had not yet seen the lawsuits filed in New Jersey and California. However, the company said, "any charge that ADHD is not a medically valid disorder is contrary to medical evidence and scientific consensus." Forty years of research, documented in the New England Journal of Medicine and the Journal of the American Medical Association, as well as acknowledgements by the National Institutes of Health and the U.S. Food and Drug Administration that ADHD "is a commonly diagnosed behavioral disorder of childhood," validate Novartis' development of Ritalin to treat it, the company added.
The APA did not respond to a request for comment.
Ritalin is Novartis' brand name for methylphenidate, a stimulant that is also available from ALZA Corp. Despite the increasing scrutiny on AD/HD drugs in general and Ritalin in particular, ALZA has seen notable success with its Concerta 12-hour AD/HD medication, according to market analysts. The pill, prescribed for patients age 6 and older, hit the market in late August and is "performing better than expected, with prescriptions rising," SG Cowen analyst Ian Sanderson said in a research note Monday.
Concerta is the only methylphenidate pill available in 12-hour form. Such a pill could eliminate the need to dispense medication for children at school, which some observers say presents a logistical challenge for schools and increases the chance of a child being stigmatized for having the disorder.
Shire Richwood Inc., a subsidiary of Shire Pharmaceuticals Group, may also stand to benefit from the negative attention Novartis is attracting. Shortly after Concerta hit the market and just before the two new class-action lawsuits were filed against Novartis, Shire Richwood announced the impending release of a new version of Adderall, an amphetamine that is challenging Ritalin as the most prescribed medication for children with AD/HD. Similar to Concerta, the new version of Adderall would reduce the amount of medication children must take each day to combat AD/HD. The new pill is slated to be submitted for FDA approval in the fourth quarter and could reach the market next year.
Shire Richwood appears to be trying to capitalize on the heightened attention AD/HD has generated recently. In announcing several new versions of Adderall are nearing market-readiness, Shire Richwood specifically noted it typically does not discuss publicly drugs that are still in development. "For commercial reasons, Shire has in the past disclosed few details of this project to the market," the company said. "However, the Company is now pleased to announce that it has developed SLI 381, a novel once-a-day formulation of Adderall for AD/HD, and that pivotal efficacy studies designed to support the approval of SLI 381 have been completed approximately six months ahead of schedule."
The new pills and lawsuits are only the latest reasons AD/HD continues to attract attention from parents, educators and medical professionals. A national debate has been raging for years over the benefits and side effects of drugs used to treat the disorder. As reported, the House Education and Workforce Committee's Subcommittee on Early Childhood, Youth and Families examined the issue in May, shortly after First Lady and U.S. Senate candidate Hillary Rodham Clinton announced a White House plan to study the use of psychotropic medication in preschoolers. The Clinton Administration also began a campaign to educate families on treatment choices for children with emotional and behavioral problems and asked the FDA to clarify prescription guidelines for children's medications.
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Friday's House hearing is slated to feature testimony from Dr. Fred Baughman, a pediatric neurologist in El Cajon, Calif., Patricia Weathers, a parent from Millbrook, N.Y., and Patti Johnson, a member of the Colorado State School Board. In addition, House Judiciary Committee Chairman Henry Hyde (R-Ill.) and Rep. Bill McCollum (R-Fla.) have asked Congress' nonpartisan General Accounting Office to conduct a study of the use and abuse of Ritalin and other psychotropic drugs in schools.
"Corresponding to the increase in diagnosis and prescriptions, virtually every data source available indicates that some children are diverting and abusing psychostimulants, and that this illicit use is increasing," Hyde said in announcing the request. "We need to know whether or not proper safeguards exist to curb its illegal use. In a growing number of communities, the answer is no. In too many schools, there may be too few safeguards to halt the growing diversion, theft, sale and abuse of this powerful drug."8
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