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.