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.