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Under Scrutiny in the Courts and Elsewhere
The popular drug Ritalin has been coming under increasing fire
lately, from many different perspectives. This week we will take
a look at some of the recent activity surrounding this controversial
medication that is being given to increasing numbers of our children.
Lawsuits Allege Conspiracy to "Create" Broadly-Defined
ADHD
The debate over whether kids are placed unnecessarily on Ritalin
is headed to the courts. Charges
that Swiss drug-maker Novartis conspired with the American Psychiatric
Association to create an overly broad definition of Attention Deficit
Disorder, have been leveled in class action lawsuits filed in California
and New Jersey.
A Novartis spokesman dismissed the allegation that they conspired
to invent the disorder. In a statement, Novartis says the charges
are ''unfounded and preposterous.''
''I am not saying it doesn't exist,'' said Richard Scruggs, one
of the lawyers bringing the suit. ''I am saying the definition
is inappropriately broad. Under (those) criteria, there's not a
child in America that's not ADHD. And everybody makes money on the
diagnosis: the shrinks, the drug company and the schools.''
The lawsuits have caused a furor in the medical community, where
ADHD is considered a major childhood health issue. They also have
created a buzz in the legal world because some
of the lawyers involved in this are veterans of the successful litigation
against tobacco companies.
The lawsuits have also generated a furor within the community of
families of children already diagnosed with ADD/ADHD. Bob Seay,
the ADD "guide" at About.com is one of the most vociferous
critics of the action. On his site, which is an online community
revolving around the ADD/ADHD issue, he has been an outspoken critic
of the lawsuits.
Another lawyer involved in the action, Donald Hildre, states that
''The turning point in the tobacco litigation was when we showed
the tobacco companies were targeting children," which he thinks
will be the turning point in this case as well.
Jules Asher, a spokesman for the National Institute of Mental Health,
says that although Ritalin is an effective treatment for ADD, no
one knows what effect the stimulant has on children who take it
for many years, or on very young children.
Peter Jensen, director of the Center for the Advancement of Children's
Mental Health at Columbia University, says studies are underway
to find answers to both questions. Last year, Jensen reported his
findings in the largest-ever study on ADHD children ages 7 and older.
He concluded the condition is under-diagnosed, contrary to the lawsuits'
premise. ''It's flabbergasting that someone could concoct this argument
and keep a straight face,'' he says.
Ritalin has been manufactured since the mid-1950s. Attention deficit
disorder (ADD) became an accepted medical diagnosis in 1980. The
diagnosis was modified and ADHD became official in 1987.
In 1995, physicians wrote 6 million Ritalin
prescriptions for children and adolescents.
Although some kids might fidget and talk too much, Scruggs says,
that doesn't mean they have ADHD. ''It's a real injustice to have
these kids think they are diseased.''
Methylphenidate, the active ingredient in Ritalin, is also available
in generic form through Celltech Group Plc's Medeva unit. Shire
Pharmaceuticals Group Plc has a rival product to treat ADHD called
Adderall.
Is it a "Lazy" Diagnosis?
In an article on WebMD, Neil Osterweil asks the question "ADHD:
Real Deal or Lazy Diagnosis?"
"ADHD is a catchphrase in search of a
syndrome in search of a disorder in search of a cause," writes
neurologist Jeff Victoroff, MD, in a provocative article
published in a recent issue of Psychiatric Times.
Dr. Victoroff doesn't dispute that the symptoms and problems associated
with what we call ADHD are real. Rather, he suggests the art
of psychiatric diagnosis has gotten itself ahead of the science
of the mind -- to the detriment of children who may be misdiagnosed
by primary care physicians or pediatricians and overmedicated at
the urging of parents or school systems looking for a quick fix
to complex behavioral problems.
"To look at a kid and say if they meet six of the nine
[DSM-IV] criteria -- if they're distractible or contentious or inattentive
then they have this disease -- is kind of a Luddite approach to
the science," Dr. Victoroff said in an interview with WebMD.
He states that "we should look forward to a better psychiatry
in the future where we're looking at this very real population of
kids who suffer, and whose families suffer, but identify them in
a scientific way rather than a theoretical, observational way."
His argument is supported by a recent study published in Biological
Psychiatry in which researchers from Massachusetts General Hospital
and Harvard Medical School in Boston reviewed a variety of outcome
studies to assess the validity of an ADHD diagnosis in adults.
"Although ... converging lines of evidence support the validity
of ADHD in adults, follow-up studies of ADHD
children have yielded ambiguous results," write
the authors.
"The question is whether, among the children who meet the
current ADHD criteria, there might be a subgroup suffering from
a neuropsychiatrically specific disorder with a unitary neuropsychopathology,"
Dr. Victoroff writes. "There is emerging evidence that such
a disorder, in fact, does exist, and that it involves frontal-subcortical
circuits."
He points to studies suggesting a clinical similarity between
ADHD and other conditions such as obsessive-compulsive disorder
and Tourette's syndrome that are thought to involve the basal ganglia.
Also, MRI studies of the brain have shown
that children diagnosed with ADHD have abnormalities in the basal
ganglia and/or prefrontal cortex, and that low frontal and striatal
volumes correlate with failure to inhibit inappropriate behaviors.
He also cites evidence of focally increased dopamine synthesis
in the brains of children diagnosed with the disorder.
In the future, Victoroff told WebMD that diagnostic criteria might
include functional MRI measures of response inhibition or PET scanning
studies of dopamine synthesis and storage in the midbrain.
Victoroff says his intention was not to cast doubt on the existence
of a hyperactivity disorder, but to raise questions about the validity
of ADHD, primarily out of concern for the safety of children.
"I think it's one thing once the brain is fully formed to
expose it to a drug that alters dopamine transmission," he
tells WebMD. "I think it's scarier
when the brain is somewhat unformed and when the kid is learning
those early lessons of life about reward and punishment and pleasure
and pain. If you alter the chemistry of rewards during that extremely
early phase, we have no way to test the safety of that in the conventional
drug development format that the FDA would require. ... My question
is, if you have a thousand kids exposed to a drug that alters the
chemistry of reward at age 3, what will those kids' relationships
be like at age 40?"
New UK Prescribing Guidelines
The UK National Institute of Clinical Excellence (NICE) is set
to release strict guidelines for the use of the widely used hyperactivity
drug, methylphenidate (Ritalin).
There are growing concerns by some doctors and the public that
it causes depression and lethargy in children and is over-prescribed.
The drug could be banned for children under the age of five, according
to a recent report in The Guardian.
"Right now, Ritalin has had no universal prescriptive guidelines
throughout Britain," a NICE spokesperson told Reuters Health.
"Some doctors are currently prescribing it for very young children,
while others will only give it to children over five."
According to a 1998 National Health Service Executive Report by
Dr. Anna Gilmore, Ritalin Seems to only be
effective in children for six months. After this period
of treatment, the benefits of the drug are uncertain, she said.
Department of Health figures show 157,900 prescriptions were issued
in the UK last year compared to 126,000 prescriptions for Ritalin
in 1998, which is about a 25% increase in just 1 year.
US Congressional Probe and Pending Legislation
The chairman of the US House Judiciary Committee has asked for
a government probe of Ritalin abuse in the nation's schools.
Rep. Henry J. Hyde also expressed support for legislation requiring
states to certify that they have guidelines in place for ensuring
against prescription drug abuse on school premises.
In a letter to US Comptroller General David Walker, Reps. Hyde
and Bill McCollum (R-FL) ask the General Accounting Office to investigate
the prevalence of psychostimulant abuse in the elementary and secondary
schools.
ADHD diagnoses have swelled in recent years, fueling a heated debate
over the controversial use of stimulants such as Ritalin. In
1996, 10% to 12% of all American school-age boys were prescribed
Ritalin, according to Hyde.
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