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Ped Med: ADHD treatments raise questions

By LIDIA WASOWICZ, UPI Senior Science Writer

SAN FRANCISCO, March 24 (UPI) -- While no causative connection has been proven, reports of a small number of children medicated for attention-deficit/hyperactivity disorder seeing snakes or suffering strokes have prompted two federal advisory panels to recommend that parents and physicians be alerted to the potential risks.

In the latest non-binding move, a Food and Drug Administration pediatric committee Wednesday urged a beefed-up warning on the drugs' labels, though not the direst type referred to as a "black box." That's the kind an FDA-commissioned group of experts focusing on safety had favored in February after reviewing cases of sudden death, heart attacks, strokes and other cardiac problems experienced by a tiny fraction of ADHD patients who were taking the medicines and who apparently had underlying cardiac irregularities.

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The specialists meeting Wednesday took the softer approach in part because of testimony by psychiatrists and mental health officials concerned about frightening families away from needed treatment. They said stimulant drugs like Ritalin, Adderall and Concerta are effective against hyperactivity, lack of focus and impulsivity that form the hallmarks of ADHD. However, others have raised red flags about overuse of the drugs -- which rack up close to $3 billion in annual sales.

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Both panels agreed patients, parents and physicians should receive clearer information about potential side effects, including heart problems, psychotic symptoms like hallucinations of snakes, worms, spiders, roaches, bugs, jellyfish and other creepy crawlies, manic episodes or aggressive behavior -- effects the drug companies say are no more prevalent among medicated patients than among the general population.

The FDA is now free to follow the prescription of either or neither of the panels.

In discussing ADHD treatments, consider some straight talk about the disorder:

-- Diagnosis is in the eyes of the beholder, there being no biological diagnostic test.

-- There are compelling clues but no patented proofs of the basis for the disorder.

-- There is no cure.

-- Treatment can control behavior, but there is little evidence it can increase knowledge or improve academic skills or achievement.

-- The condition is chronic, likely to last years, perhaps decades, with the majority of children affected to some degree into adolescence and even adulthood.

-- Most children improve with age, showing fewer symptoms and problems by their early 20s, whether or not they receive treatment.

-- There is a dearth of sound scientific evidence of the effects of psychotropic drugs on growing brains and bodies over the long haul.

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-- Every chemical treatment, even when properly prescribed, can have unwanted and oftentimes unforeseen effects.

-- Inappropriate administration of medication, either for the wrong child or at the wrong dose, can have additional, devastating, even deadly, consequences.

-- All treatments come with caveats.

-- Most psychiatric drugs are not approved by the Food and Drug Administration for younger age groups, and, like the majority of medicines for minors, are used "off-label," or at the doctor's discretion.

"Medication will help reduce some symptoms, but taking medication over time won't eliminate them," said pediatric neurologist Donna Palumbo of the University of Rochester in New York. "We can't say if you take this drug for five years, (the problem) will go away. We can't predict what will happen."

In a change of medical mind, increasing numbers of youngsters are taking the drugs for prolonged periods.

"Part of the reason for (the) overall increase in prescriptions is that kids are now being treated throughout the day and during adolescence, unlike the former pattern of stopping with puberty," said Stephen Hinshaw, professor and chair of psychology at the University of California, Berkeley, and author of "The Years of Silence are Past: My Father's Life with Bipolar Disorder" (Cambridge University Press, 2002).

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"If ADHD is validly diagnosed and is present in about 5 percent of children, current rates are more understandable, despite the concerned reactions of some critics."

Those concerns arise in part from some spectacular spikes in the growth charts of pharmaceutical sales in recent years.

Drug Enforcement Agency records show between 1991 and 2000, annual production of methylphenidate -- a central nervous system stimulant like Ritalin or Concerta -- shot up by 847 percent, to 14,957 kilograms, or more than 16 tons. Domestic sales for the period ballooned by nearly 500 percent.

During the same nine years, the annual production quota for the other half of the stimulant treatment equation, amphetamines -- the active ingredient in the anti-ADHD drugs Adderall and Dexedrine -- rocketed more than 2,000 percent, to 9,007 kilograms, or nearly 10 tons.

Against this backdrop, the annual number of prescriptions written for ADHD over the nine years mushroomed by a factor of 5, capping at 11 million for methylphenidate and 6 million and counting for amphetamines.

An estimated 80 percent of the total, or some 14 million, were for children, with 40 percent of these for youngsters 3 to 9. In addition, doctors made out 4,000 orders for stimulants for tykes 2 and under.

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Critical of such trends, the DEA has made a point of noting most of these drugs are not approved for use in children under 6 and none for toddlers under 3 because their safety and effectiveness have not been established in those age groups.

In line with the DEA figures, an analysis by Medco Health Solutions, a prescription management company, found drug spending for behavioral conditions ran up 77 percent between 2000 and 2003, due to hikes in both costs and use.

Medications prescribed primarily to treat ADHD were a standout during the period. Spending jumped 183 percent for children overall and 369 percent for tots under 5, nearly one in 10 of whom was taking one or more of the drugs, noted the report, aptly dubbed, "Managing Generation Rx."

Central nervous system pediatric medicines, which encompass those for behavioral and neurological conditions, outran even cardiovascular medications to reach the top spot in spending for all prescription drugs for all ages in 2003.

"This analysis provides a striking commentary on the state of pediatric treatment in this country, as well as the costs shouldered by parents whose children live with these conditions," Dr. Robert Epstein, Medco's chief medical officer, said in a statement accompanying the release of the analysis of prescription data for 300,000 minors under 20.

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"It goes without saying that early detection and appropriate treatment of these conditions is extremely important, but the emphasis is on 'appropriate' with an eye on cost-effective therapy, as well."

With Americans producing, and popping, 80 percent to 85 percent of the world's supply of the pills, it is little wonder the U.S. ADHD market -- which brought in more than $2.5 billion in revenues, or 97 percent of the total, in 2004 -- dwarfs all others, according to a report from Datamonitor, a London-based independent market analyst.

It is, however, more than slightly startling to note the estimated 2.5 million medicated American children ages 4 to 17 -- or some 56 percent of those diagnosed with ADHD -- comprise but a tiny fraction of the more than 20 million youngsters identified with the disorder worldwide.

"There is definitely both a higher willingness to prescribe drugs and acceptance by families to have their children on drugs in the U.S., whereas parents in the EU (European Union) generally prefer to try other non-drug interventions first," said Alistair Sinclair, Datamonitor central nervous system analyst.

Even more than the Europeans, the Japanese -- whose national insurance does not cover such medications -- lag behind the Americans in their awareness and drug treatment of ADHD.

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As other Asian countries, Japan leans toward a conservative corner of culture where conditions like ADHD often come with stigma attached and where parents and patients tend either not to be aware of a problem or prefer to manage it on their own, without outside medical assistance, the report observes.

It does not address the question of why Japanese and, for the most part, European children consistently outscore their American counterparts on standardized measures of academic achievement.

In one recent international comparison, for example, U.S. fourth graders came in 12th in math scores, behind Singapore, Korea, Japan, Hong Kong, Netherlands, Czech Republic, Austria, Slovenia, Ireland, Hungary, and Australia.

They came in third in science, following Korea and Japan. By the eighth grade, the American students slipped to the 28th and 17th slots, out of 41 countries, respectively. By 12th grade, they were close to the bottom, besting only Cyprus and South Africa in math and coming in 16th out of 21 nations in science.

The preponderance of mainstream research suggests psychiatric drugs, if properly administered and monitored, are safe, at least in the short term, and effective, at least for clamping down on the core symptoms of ADHD, but there is little hard-core evidence they upgrade a child's scholastic skills.

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Where the United States does have an unshakable lead is in the global ADHD drug market, which is forecast to swell from $2.7 billion in 2005 to an anticipated $3.3 billion by 2015.

Next: Taking a backward glance at ADHD treatments

(Editors' Note: This series on ADHD is based on a review of hundreds of reports and a survey of more than 200 specialists.)

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UPI Health News welcomes comments on this column. E-mail: [email protected]

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