Pubdate: Tue, 16 May 2000 Source: San Jose Mercury News (CA) Copyright: 2000 San Jose Mercury News Contact: 750 Ridder Park Drive, San Jose, CA 95190 Fax: (408) 271-3792 Website: http://www.sjmercury.com/ Author: Sara Solovitch, RITALIN FACES COURT CHALLENGES Scrutiny Intensifies After Children's Deaths RITALIN, the most commonly prescribed medication for children, is coming under a flurry of legal attacks and medical scrutiny in the wake of two adolescent deaths that have been attributed to the drug. The lawsuits -- filed within the last month -- go after the maker of the stimulant drug on different grounds. The real spotlight, however, is on a case that hasn't yet sparked any legal action. Doctors and psychiatrists around the country are talking about a recent autopsy that links the death of a 14-year-old Michigan boy to his long-term use of Ritalin for attention deficit hyperactivity disorder. Matthew Smith died in March while skateboarding. At first, it was assumed that he'd suffered a head trauma. That notion was immediately ruled out during the autopsy, when pathologists found that the small blood vessels leading to his heart were so scarred that not enough oxygen was getting through. Same Signs As Drug Abuse ``The finding was comparable to what you'd see in an adult who has abused amphetamines or cocaine for years,'' says Dr. Ljubisa Dragovic, forensic pathologist and chief medical examiner for Oakland County in Michigan. ``If you continuously and repetitively bring in this kind of drug -- not only for days and weeks, but for months and years -- the body will show changes. And these are the changes we saw in the heart of this kid. ``There was no other underlying condition, no other illness or disease, no other drug. Only a background of 10 years of continued use of methylphenidate (Ritalin).'' Psychiatrists say the finding puzzles them. ``This has been a drug that's been around in heavy use since the 1950s, and to suddenly discover that it's got serious cardiovascular effects would be very surprising,'' says Dr. Glen R. Elliott, director of child and adolescent psychiatry at University of California-San Francisco. ``We're talking about millions of kids who've been on this drug. And with this kind of finding -- one would expect to have it been noted before.'' Michael Mosher, a Texas lawyer, contends that several cases have been reported to the Food and Drug Administration. He has filed a case in U.S. District Court against Novartis, the drug manufacturer, for the wrongful death of Stephanie Hall, a 10-year-old Ohio girl who died in her sleep from cardiac arrest in 1996 -- the very day her Ritalin dosage was increased. No evidence of congenital heart problems was found. Psychiatrists' Nemesis Mosher's expert witness is Dr. Peter Breggin, author of ``Reclaiming Our Children,'' a book that examines the over-medication of children in the U.S. Breggin has long been a thorn in the side of the U.S. psychiatric establishment -- largely due to his vociferous public criticism of medicating practices. He is also a consulting witness in a class-action lawsuit filed two weeks ago in the Texas Supreme Court. That suit alleges fraud and conspiracy against three defendants: Novartis, a parents organization called Children and Adults with ADHD, and the American Psychiatric Association, for over-promoting Ritalin. The suit claims, among other things, that the APA ``conspired, colluded and cooperated'' with Novartis and CHADD, while taking financial contributions from the pharmaceutical industry. In a 1999 article published in the International Journal of Risk & Safety in Medicine, Breggin referred to many reports filed over a 12-year period with the FDA's Spontaneous Reporting System, of 121 cardiovascular problems associated with Ritalin use. Most of these reports involved arrhythmias , but nine cardiac arrests and four heart failures were also mentioned. Since filing his own report with the FDA, Dragovic says he has received hundreds of inquiries from worried parents whose children have complained of chest pains, palpitations and irregular heartbeats. He advises them to contact their doctors, but warns that the long-term cardiovascular effects of stimulant use are asymptomatic and difficult to diagnose -- even when using the most sophisticated testing. - --- MAP posted-by: Doc-Hawk