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ADHD Drug Studies Questioned

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Sins of Omission

Besides pressuring researchers they fund, companies also seem to pepper their direct-to-consumer marketing materials with only the science that favors their products.

Makers of stimulant medications fight hard to downplay several longstanding theories.

One theory is that consistent use of stimulants suppresses a child's growth. Concerns increased in April when the journal Pediatrics published a federally-funded study, the largest yet investigating the long-term health impact stimulants have on children. That study, funded by the National Institutes of Mental Health and known as the MTA Follow Up Study, found that consistent use of the stimulants stunts growth in children at a rate of about one inch every two years. The study also questioned a theory, apparently one still promoted by drug companies, that children make up lost growth over time.

Yet some seven months after the study was published, neither Novartis, the maker of Ritalin, nor McNeil mention the study in their web-based marketing materials.

An information document for prescribing physicians found on the Concerta web site tells doctors that Concerta causes "no clinically significant impact on growth with long-term use."

Likewise, the Ritalin website says stimulants may cause "initial, mild slowing of growth," but tells consumers the effect is temporary, that children will make up the lost growth and eventually reach their normal height.

"We used large, well-designed studies to provide factual easy-to-understand information to readers," says Denise Brashear, a spokeswoman for Novartis. "There are hundreds of studies conducted regarding methylphenidate treatment making it difficult to include every study on each topic."

In their written statement to AlterNet addressing questions for this article, McNeil officials did not respond to a question regarding the MTA Follow Up Study.

Potentially most damaging to stimulant sales is that medications like Ritalin may not work over the long run and that behavioral modifications may serve just as well.

According to Pelham, who is on the steering committee for the MTA studies, much of his research, as well as data gleaned from the MTA studies, shows the efficacy of medication declines over time.

"No drug company in its literature mentions the fact that 40 years of research says there is no long-term benefit of medications," he says. "That is something parents need to know."

Front Groups?

The pharmaceutical industry has long donated money to patient advocacy groups that critics say become conduits for spreading industry-friendly information.

In the world of ADHD advocacy, CHADD, based in Landover, MD, is an 800-pound gorilla, claiming 20,000 members and 200 affiliates, even offering members a CHADD Visa Card. Though the organization, which also engages in lobbying, claims to provide "science-based, evidence-based information about ADHD" to parents and the public, critics say CHADD basically promotes stimulant medications manufactured by its corporate donors. Pharmaceutical companies – including Novartis and McNeil – donated a total of $674,000 in fiscal year 2002-2003, making up 17 percent of the group's budget, according to CHADD financial documents posted on its website.

Pelham, who is currently listed by CHADD as a member of its professional advisory board, came face to face with what he says are the group's glaring conflicts of interest.

In 2002, after he received the CHADD Hall of Fame Award, he was subsequently interviewed for Attention!, the organization's magazine. In the interview, Pelham said, among other things, that stimulant drugs have serious limitations when employed alone and at high doses. He also pointed out that psychosocial treatments should be the treatment of first choice in ADHD, with adjunctive medication when necessary.

But eight months later, after CHADD's board of directors tried to quash the article, CHADD published Pelham's interview – but with large swaths cut out, particularly his comments about the limitations of the stimulants.

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"In recent years, I have come to believe that the individuals who advocate most strongly in favor of medication – both those from the professional community, including the National Institutes of Mental Health, and those from advocacy groups, including CHADD – have major and undisclosed conflicts of interest with the pharmaceutical companies that deal with ADHD products," Pelham wrote in a foreword to the unedited version of the article he provided AlterNet. "I believe that parents of ADHD children and the public at large should be made aware of this situation. That is one of the points that I was attempting to make in my interview. As I think is clear from examining the edited sections, the CHADD CEO and board of directors did not share my concerns."

Chadd officials say their board is not involved in any aspects of the magazine and that some of Pelham's claims "were not scientifically supported."

"CHADD did not withhold information because of pressure from pharmaceutical companies," says Phyllis Anne Teeter Ellison, who chairs the editorial advisory board for the magazine. "After extensive review and consultation with the scientific community, CHADD took a responsible position by not publishing some of Dr. Pelham's unsubstantiated claims that were not supported by available data and were not supported by his colleagues on the MTA group."

But some drug makers no doubt find the magazine interesting: Peg Nichols, CHADD's director of communications and executive editor of Attention!, confirmed that Shire Pharmaceuticals, makers of the stimulant medication Adderall, buys 65,000 of the 100,000 copies each print run. Shire sales representatives, in turn, place them in doctors' offices.

Pelhams suspects his comments in the article, while edited heavily, were still "conservative" enough to cause problems with his pharmaceutical industry contacts. For several years, Pelham has hosted a conference on treatment for childhood mental health disorders for which drug companies, including McNeil and Shire, have provided educational grants. Since the article ran, he says his former contacts have not underwritten the conference.

Other types of organizations are also targets for pharmaceutical industry contributions. Concerta.net, for example, references guidelines issued by the American Academy of Pediatrics and the American Academy of Child & Adolescent Psychiatry that recommend stimulant medications like Concerta as the first choice of treatment for children with ADHD.

Those prominent trade groups also have links to Big Pharma. McNeil, according to a document from The American Academy of Pediatrics, has given at least $25,000 in donations to the academy. It could not be confirmed if AACAP receives direct donations but links do exist. Dr. Graham J. Emslie, a professor at the University of Texas Southwestern Medical Center and a consultant for McNeil, serves on the corporate contributions and research committee for the AACAP, according to the Center for Science in the Public Interest (CSPI).

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Reviewed: 02/2006



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