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Issues - Chemical abuse -
More drug abuse of child behaviour

USA > Society & Culture
from the June 28, 2004 edition

A firm's bold bid to win market for its ADHD drug
By Kelly Hearn | Correspondent of The Christian Science Monitor

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.
Let the sun shine in
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."

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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