How drug companies are pushing ADHD drugs for children by funding researchers and advocacy groups – and ignoring the studies which question their claims.

by Kelly Hearn

(Nov. 29, 2004) -- For Gene Haislip, a former official of the U.S. Drug Enforcement Agency, the perennial debate over Ritalin, the stimulant commonly prescribed for children with "attention deficit hyperactivity disorder (ADHD)," is an aching reminder of a moral battle he fought – and lost – to big drug companies.

For 17 years, the now retired director of the DEA´s Office of Diversion Control set production quotas for controlled substances like methylphenidate (MPH), the federally restricted stimulant commonly known as Ritalin. During that time, he fought hard to raise public awareness about over-prescribing of stimulants to children, about the drug's high rate of street diversion, and about its long-term health impact on young patients.

"This affects the most sensitive part of our population," says Haislip, now a consultant for drug companies on issues of compliance to federal law. "When I was at the DEA, we created awareness about this issue. But the bottom line is we didn't succeed in changing the situation because this – prescribing methylphenidate, for example – is spiraling.

"A few individuals in government expressing concern can't equal the marketing power of large companies," he adds. "I have doubts that the truth is driving this issue. It seems that market forces and money is behind it."

As public scrutiny of drug companies grows, so do questions about what critics say is a vast over-prescribing of MPH, especially as more adults are taking other MPH-based medicines such as Concerta. According to the DEA, production of the central nervous system stimulant, which is pharmacologically similar to amphetamines, grew from 5,000 kilograms in 1993 to 20,967 kilograms in 2002 – probably the largest ever prescribing explosion for a controlled substance, says Haislip.

Echoing the sentiments of many in and outside the scientific community, Haislip says he suspects the dubious marketing tactics of big drug money have fueled the spiraled use of MPH. Specifically, he suspects the compromise of a small group of prolific ADHD researchers whose work is funded by corporate producers of ADHD drugs. He also suspects that one or more ADHD patient advocacy groups that receive drug company donations have essentially become fronts to push the prescribing of stimulants to children.

And evidence suggests Haislip may be right.

"It Was Like A Whitewash"

Enter Dr. William Pelham, director of the Center for Children and Families at State University of New York at Buffalo (SUNY).

A leading ADHD researcher for 30 years, Pelham is a former member of the scientific advisory board for McNeil Pharmaceuticals, which produces Tylenol and markets Concerta, a popular stimulant medication trademarked by Alza Corp. of Mountain View, Calif. Over his career, Pelham has penned over 250 research papers on ADHD, many with industry grants. In 2002, he was given a lifetime achievement award by the world's largest ADHD patient advocacy group, Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD).

In interviews with AlterNet, Pelham provided glimpses into the dubious methods drug maker McNeil-Alza uses to ensure that studies it funds produce favorable results for its ADHD medications.

Between 1997 and 1999, he was paid by McNeil to conduct one of three studies used to get FDA approval. The company currently uses the three studies to claim that 96 percent of children taking Concerta experience no problems in appetite, growth, or sleep. But Pelham says the studies were flawed. The original intent of the studies was to measure both side effects and main effects of the drug. But two of the three studies, including Pelham's, required that the subjects had to already be taking MPH and responding well to it in order to enter the study. In other words, by stacking the studies with patients already successfully taking stimulants, McNeil ensured the subjects would be unlikely to register side effects, Pelham says.

"It's really misleading and I'm surprised the FDA is letting them use the studies to advertise no side effects," he says. "They had no side effects because they took only people with only a positive history of medication. This is really pushing meds without telling the full picture."

There was also pressure from the company to tweak the findings, he says. Part of Pelham's study involved "providing parent training to parents, having a simple behavioral program in place on Saturday lab days, and establishing simple behavioral programs in the children's regular school classrooms." When his paper was in the galley proof stage at the medical journal Pediatrics, Pelham says he joined a conference call with a number of senior people from the corporation who lobbied him to change what he had written in the paper.

McNeil offered no direct response to the allegations.

"We cannot comment on unsubstantiated allegations," says Gary Esterow, a spokesman for McNeil Consumer & Specialty Pharmaceuticals, in a written statement. "The protocols and full study reports for these clinical trials were reviewed by the FDA, and provided the basis for FDA approval. Prior to publication, there was ample opportunity for full discussion of the data among the investigators. Publication of the findings reflect the prevailing opinion of the authors and is further supported by the peer review process of the scientific journals in which these studies appear."

Pelham says McNeil didn't stop there. The company commissioned a follow-up study on the conversion study mentioned above. This time McNeil did the data analysis and coordinated the paper writing. "I insisted on seeing the analyses and having major inputs into the manuscript and it was like pulling teeth to get wording and analyses changed," he says. "It was like a whitewash, a praise to Concerta."

Pelham says the company submitted the paper twice to the Journal of the American Academy of Child and Adolescent Psychiatry. Drafts were sent to Pelham several times but he says he never returned anything with his signature. In the end, however, he says the paper was accepted without his knowledge and published with his name on it.

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Reviewed: 02/2006