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Issues - Chemical abuse -
More drug abuse of child behaviour
Deepening the controversy over psychotropic medicine for children,
a drug marketer is taking the rare step of asking federal
officials to loosen controls over a popular stimulant medication
used to treat attention deficit/hyperactivity disorder, or
ADHD.
Ignoring critics who say such drugs are already overprescribed,
especially for children, the US marketer of Concerta apparently
aims to gain a marketing advantage over its main competitor,
Ritalin, and, according to some observers, make the medicine
more widely available than ever.
The move by McNeil Consumer & Specialty Pharmaceuticals
is further evidence that drug companies are going to ever
bolder lengths to compete, observers say. Concerta contains
a stimulant that the Drug Enforcement Administration (DEA)
considers to have an addiction potential similar to cocaine
if misused.
Pressure to curtail the use of psychotropic drugs, especially
antidepressants, in children grew after New York's attorney
general on June 2 accused British pharmaceutical giant GlaxoSmithKline
of burying research showing its antidepressant, Paxil, may
trigger suicidal thoughts in children and teenagers. In April,
a National Institute of Mental Health study published by the
journal Pediatrics showed that consistent use of stimulants
causes mild growth suppression in children.
Other studies, however, suggest that children eventually regain
lost growth. And medical studies have linked the use of such
stimulant medications to dramatic reductions in such ADHD
symptoms as restlessness and hyperactivity. Many patients
and a large swath of the nation's medical community credit
the drugs for bringing clarity to once-chaotic lives.
The DEA tightly controls Concerta because, like the controversial
ADHD medication Ritalin, it contains the stimulant methylphenidate
- a Schedule II substance that, along with cocaine, is often
used illegally. The DEA places all regulated substances into
one of five schedules, depending on their medicinal value,
harmfulness, and potential for addiction or abuse. Highly
addictive drugs with no therapeutic value are classified as
Schedule I, while the least dangerous drugs are placed in
Schedule V.
In February, McNeil filed a petition with the DEA to reclassify
Concerta as a less-restrictive Schedule III substance, a spokesman
for the Fort Washington, Pa., company confirmed last week.
McNeil, which also makes Tylenol, markets Concerta, a trademark
of ALZA Corp. of Mountain View, Calif.
McNeil is not asking officials to reschedule bulk manufacturing
of methylphenidate, a move that could help their competitor
too. Instead, it wants the Concerta dosage formula moved to
Schedule III. The upshot is that Concerta's makers would still
be bound to annual production quotas and other DEA requirements
for Schedule II substances. But now it would be able to tout
the less restrictive Schedule III classification in its marketing
efforts.
Such petitions are rare, observers say, because drugmakers
try to avoid unfavorable publicity that might come from such
a sensitive move. "Actions like this by outside parties
are uncommon," says Gene Haislip, who for 17 years headed
DEA's Office of Diversion Control and is now a consultant.
"That doesn't mean it is good or bad. It's just uncommon."
In the early '90s, advocacy group Children and Adults with
Attention Deficit/Hyperactivity Disorder asked the DEA to
reschedule methylphenidate to Schedule III. But critics say
the group withdrew its request after news surfaced that it
received money from Ciba-Geigy, then the manufacturer of Ritalin.
Novartis, the successor to Ciba-Geigy, now manufactures Ritalin.
The current petition doesn't stand much chance of approval
either, observers say.
"I don't think the DEA would ever do it, but if it did
it would open even further the floodgates for stimulant use
in this country," says Lawrence Diller, behavioral pediatrician
and author of "Running on Ritalin." "This is
an issue of convenience for drug companies. By making it a
Schedule III, you essentially have a huge removal of impediments
to prescribe."
Not everyone agrees. "Physicians don't care how a drug
is scheduled," says Russell Barkley, a leading research
psychologist working on ADHD who lobbied in support of the
petition to reclassify methylphenidate in the 1990s. "If
a drug is effective and safe, they will prescribe.... What
this is all about is allowing [McNeil] to go head to head
with Eli Lilly."
Drugmaker Eli Lilly is heavily marketing Strattera, the only
nonstimulant ADHD medication on the market.
If the DEA approves McNeil's request, other countries that
disagree with the direct-to- consumer marketing tactics of
some US pharmaceutical firms might retaliate, Dr. Diller says,
possibly limiting or even banning imports of the drug.
The DEA doesn't classify methylphenidate as Schedule II because
Concerta or other prescription drugs cause addiction concerns,
Dr. Barkley adds. "The problems arise when the drugs
are diverted to street use."
Methylphenidate production has skyrocketed over the past decade
from 5,000 kilograms in 1993 to 20,967 kilograms in 2002,
the DEA says. Behind that rise lies a constellation of social,
economic, cultural, and medical factors that is causing doctors
to prescribe such drugs, almost always for young, white, relatively
affluent boys.
Whether that's good medicine or aggressive marketing depends
on one's point of view.
Drug controversies prompt call for clinical trial registry
Advocates hope to build on existing databases to create one
mega-source, including published and unpublished research.
By Victoria Stagg Elliott, AMNews staff. July 5, 2004.
When David Fassler, MD, a child and adolescent psychiatrist
from Burlington, Vt., was called to review data -- much of
it unpublished -- about antidepressant use by kids and teenagers
for a February Food and Drug Administration hearing, he was
stunned.
The information suggested that several of these drugs were
not effective for depression in this age group and could actually
lead to an increased risk of suicidal behavior.
With this article
AMA calls for more federal funding for medical research
See related content "This data clearly had an impact
on our own analyses, our comments and our recommendations
and on the subsequent public debate," said Dr. Fassler.
The fact that the findings had not previously been accessible
has focused new attention on efforts to open up the clinical
trial process. Adding to this momentum are other related events,
including the FDA's initial June 2003 caution regarding the
antidepressant paroxetine, its expanded advisory issued in
March, and a New York State lawsuit that charged the drug's
manufacturer, GlaxoSmithKline, with concealing information.
Registries are one of the mechanisms currently gaining favor.
Delegates to the AMA's Annual Meeting in Chicago last month
endorsed a policy that would urge the Dept. of Health and
Human Services to establish a comprehensive registry for all
clinical trials and require every trial to have a unique identifier.
More than 300 clinical trial registries currently exist.
Similarly, a proposal being considered by the International
Committee of Medical Journal Editors would require all clinical
trials to be listed in a registry as a requirement for publication.
Meanwhile, the AMA has recommended that all trial data be
made available through publication or an electronic data repository.
The Association also will study methods to enhance public
access to data considered by the FDA as part of the drug approval
process.
"What we want to do is eliminate the problem of information
just disappearing," said John Schneider, MD, MPH, a member
of the AMA Council on Scientific Affairs.
Clinical trial registries are not a new concept. More than
300 exist. The largest, run by the National Institutes of
Health, is available online (www.clinicaltrials.gov). GSK,
which has posted on its Web site all its paroxetine research
findings, announced in June that it would create a public
registry listing protocols and results of GSK-sponsored trials.
But physicians and others pressing for more transparency say
that while these kinds of registries are a step in the right
direction, much more progress is necessary.
Many clinical trials are not listed in any registry.
"There are lots of registers," said Kay Dickersin,
PhD, a professor of epidemiology at Brown University and director
of the U.S. Cochrane Center, an independent nonprofit organization
based in Providence, R.I., that produces systematic reviews
of health care interventions. "They're hard to use, and
they're not comprehensive." Advocates say the sheer number
of registries makes the process of finding trials too cumbersome
for patients and scientists alike. And many trials aren't
registered anywhere.
Also, no repositories include unpublished data resulting from
trials. The AMA policy attempts to address this point by calling
for findings to be published or put into a database -- but
not simply left to perish. Experts estimate as much as 50%
of clinical trial results never see the light of day, and
supporters argue that the result is unethical because it leads
to buried data that could otherwise have had an impact on
patient care. It can also slow the progress of science because
researchers unknowingly repeat lines of inquiry that may have
already been proven unsuccessful.
"Studies that do not make it into journals should be
available to clinicians and physician researchers," said
Samuel Blackman, MD, PhD, an AMA Council on Scientific Affairs
member. "A comprehensive clinical trial registry is crucial.
In addition to reducing publication bias, a comprehensive
registry will allow physician researchers to know what research
questions have already been asked and potentially will allow
researchers to refine their research questions and improve
study design."
Those who run clinical trial registers agree that what the
AMA and others have in mind is feasible. The NIH collection,
for instance, which only lists studies related to severe and
life-threatening diseases and links to published findings,
could be expanded.
There is significant concern, however, about making unpublished
data, which have not yet gone through the peer-review process,
more publicly available.
"From a technical point of view, the infrastructure is
in place," said Alexa McCray, PhD, director of biomedical
communications at the National Library of Medicine and of
the NIH's registry, ClinicalTrials.gov. "But there is
the whole question of quality control. We don't want people
putting data into ClinicalTrials.gov that has not been validated
or peer-reviewed in one way or another. But as a community
we need to have a discussion about what counts as validated
data."
While scientists are worried about how lay people would interpret
such information, pharmaceutical companies are worried about
another angle -- trade secrets.
"It's very important that proprietary data be protected,"
said Jeff Trewhitt, a spokesman for the Pharmaceutical Research
and Manufacturers of America. "And there is strong potential
for confusion with a registry unless it's done right."
Still, advocates say that much of the information companies
are seeking to protect is already out there. A universal trial
registry would simply make it easier to find. Such a repository
would also make companies less likely to be accused of hiding
things.
"As a scientist, I feel that, if there's scientific data,
there's no reason to hide it," Dr. Schneider said. "That
information is valuable, and it needs to be available. I don't
think the drug companies are interested in hiding information
either. By [creating registries], it probably protects them."
AMA calls for more federal funding for medical research
The American Medical Association called for increased funding
to the National Institutes of Health and the Agency for Health
Care Research and Quality, according to policy approved at
the Association's Annual Meeting last month in Chicago.
The AMA has long advocated for more money for a wide array
of medical research but felt the need to take this action
because signals indicate that the 2005 federal budget might
not be increasing science investment as it has in the past.
Funding for AHRQ is expected to be the same in 2005 as in
2004. The NIH expects a 2.7% increase in 2005 but received
3.1% more than in the previous year in 2004. The agency has
also enjoyed some years with double-digit increases.
"Increases in NIH funding over the past five years have
resulted in a wide range of advances that we're now on the
cusp of bringing to the bedside," said, Robert Vigersky,
MD, AMA alternate delegate from the Endocrine Society. "We
want to continue this expansion."
Weblink
Information about clinical trials from the National Institutes
of Health (clinicaltrials.gov)
Transcript of the Food and Drug Administration's Feb. 2 hearings
on antidepressant use by children (www.fda.gov/ohrms/dockets/ac/04/transcripts/4006t1.htm)
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