Concerns about the rise in childhood ADHD and its treatment with psychotropic medication go beyond worried parents and questioning educators. Some say ADHD is a myth -- not a brain-based disorder, but a reflection of what's wrong with our society and education. Others worry about the financial relationships between drug companies and academic researchers who study treatments. Education World looks at some controversial issues surrounding ADHD. Included: Comments from leading researchers and experts!
Almost a century after the symptoms of attention deficit hyperactivity disorder first were recognized, its diagnosis, treatment -- and very existence -- continue to be debated.
The debate focuses on the dramatic rise in the number of children diagnosed with ADHD over the past ten years along with the significant increase in the number of children, including preschool-aged children, being prescribed psychotropic medication to treat the disorder. Some say that this explosion of childhood ADHD is indicative of what's wrong with our society and education system; they blame parents and educators for choosing quick fixes for what they say is a behavioral problem, not a brain-based disorder.
Along with those government investigations, Waters and Kraus, a Texas law firm known for litigating cases involving asbestos and tobacco-related lung cancers, filed three ADHD-related class action lawsuits in 2000. One suit claimed Novartis Pharmaceutical Corporation and its predecessor, Ciba-Gigy Corporation, "planned, conspired and colluded to create, develop and promote the diagnosis of Deficit Disorder to increase the market for its product Ritalin." Ritalin, the brand name for methylphenidate, is the most commonly prescribed psychotropic stimulant medication for treating ADHD.
The lawsuit also contends that Children and Adults With Attention Deficit/Hyperactivity Disorder, a nonprofit organization comprising primarily parents of children with ADHD, conspired with the drug company. The organization accepted nearly $750,000 from Ciba-Gigy between 1991 and 1994, according to the lawsuit. The suit claims that Novartis and Ciba-Gigy worked with the American Psychiatric Association to broaden the symptoms of ADHD to create a large market for Ritalin.
Those accused all deny the conspiracy claims made by Waters and Kraus.
Although the lawsuit raises the issue of financial conflicts of interest between drug companies and nonprofit organizations, specifically regarding ADHD, the growing role of drug companies in medical pharmaceutical research in all areas is also troubling to many people, including Marcia Angell, a senior lecturer at the division of medical ethics at Harvard School of Medicine. Angell is a former editor-in-chief of The New England Journal of Medicine.
At the 2000 Health and Human Services Conference on Financial Conflicts of Interest, Angell called for new, stricter rules and restrictions regarding financial conflicts of interest that could threaten the safety of research subjects or the objectivity of the research itself. Any financial association that would cause an investigator to prefer one outcome of his research constitutes a financial conflict of interest, she stated at the conference. "Thus, there is nothing potential about a conflict of interest. Either it exists or it doesn't."
The relationship between drug companies and academic institutions is no longer at arm's length, as was the practice in the past, she said. "Companies now design studies to be carried out by investigators in academic medical centers who are little more than hired hands supplying the human subjects and collecting data.
"The academic medical institutions are increasingly dependent on pharmaceutical companies," Angell told Education World. "I saw this myself as an editor of The New England Journal of Medicine for over 21 years. The mission of the academic institutions has been corrupted by the investor-owned businesses, mainly the drug companies.
"I think there is fairly good evidence that the research has been tainted because of the financial relationships between academic researchers and drug companies. Researchers who have a financial relationship with a drug company write papers more favorable to the company's product than other researchers."
Disclosure by the researcher of a financial interest in the drug company merely passes the buck to the subjects of the study, Angell maintains. "Researchers have good jobs, and they don't have to supplement their income in a way that strikes at the heart of what they are doing -- objective research," Angell said. "The standards should be: No equity in the drug company whose product you are testing and no consulting for the drug company whose product you are testing."
Angell states she is not aware of financial conflicts of interest with researchers of medication to treat ADHD, however she is aware of the financial ties between researchers and manufacturers of other psychotropic medications. In an editorial, Is Academic Medicine for Sale? published in The New England Journal of Medicine (May 18, 2000), Angell states that a researcher's ties with drug companies that make antidepressant drugs were so extensive that it would have used too much space to disclose them fully in the journal.
Angell said feedback from her article varied; some researchers agreed with her stance, some completely disagreed, and others were in the middle.
Howard Abikoff -- the Pevaroff Cohn professor of child and adolescent psychiatry, director of research at the New York University Child Study Center, and a lead researcher of a National Institute of Mental Health (NIMH) study -- hasn't seen any examples of academic researchers slanting their findings because of financial interests.
"The work we are doing is based on sound science," Abikoff said. "Steps are taken to ensure the research is valid." There are many examples of researchers failing to find benefits in clinical trials, and those findings are reported to the drug company; consequently, the drug company stops production of that particular medication, he said.
According to the National Institutes of Health (NIH), financial interest isn't always a bad thing. In announcing the Health and Human Services Forum on Financial Conflicts of Interest, the agency stated: "The opportunity for investigators' personal financial gain or reward is not intrinsically unacceptable. However, the recent highly publicized instances of apparent financial conflicts of interest have generated concern within the research and lay communities."
The Food and Drug Administration (FDA) also does not prohibit researchers from having financial interests with the drug companies whose products they are testing. However, they do require disclosure under certain circumstances, according to Crystal Rice, a spokesperson for the FDA Center for Drug Evaluation and Research. "With regards to financial disclosure by researchers, to summarize, I have been told that if the manufacturing company is a publicly traded company and the clinical investigator/researcher has financial ties of $50,000 or more, then [the relationship] must be disclosed to the FDA. If it is a non-publicly traded company, [the researcher] must disclose any amount of financial ties to the FDA."
It is common practice for researchers to take money from drug companies in order to conduct drug studies, including those studying ADHD medications, said Lawrence Diller, who practices behavioral pediatrics in California and is author of Running on Ritalin: A Physician Reflects on Children, Society and Performance in a Pill.
"Does drug money influence the researcher?" Diller asks. "There is evidence, there is influence, and there is a perception there is influence.
"You don't need to have an active conspiracy to account for the huge increases in children using medication for ADHD," Diller told Education World. "There are very powerful market forces operating on the system to promote drugs. And there are no market forces to promote special education and counseling."
Diller cites as an example of market forces at work in a national advertising campaign by Alza Corporation, the manufacturer of Concerta. Concerta is a long-acting stimulant medication approved by the FDA for use with children who have ADHD. Alza's one- and two-page advertisements appear in national parent and family magazines. The ads promise that this latest treatment for ADHD can help make homework a more relaxing time. Diller said the ads remind him of the Stepford children; the children, with schoolbooks placed in front of them, are smiling, and so are the parents. "It had a spooky effect on me," he said. (The Stepford Wives is a 1975 movie in which all the wives in the suburb of Stepford happily shop, clean, and cook for their husbands, but the wives turn out to be robots, not people.)
The high rate of stimulant use by children is a concern to Diller. He doesn't dispute that ADHD exists and prescribes Ritalin and other stimulant medications to his own patients. But he does question the large number of children being diagnosed with ADHD and advises all parents and schools to first conduct comprehensive examinations of a child before considering medication.
The NIMH is exploring alternatives to pharmaceutical treatments for ADHD, according to Kimberly Hoagwood, the NIMH associate director for child and adolescent mental health research. The institute is funding a range of studies about intervention and service approaches for children with ADHD, including five nonpharmaceutical studies, Hoagwood told Education World. In particular, the NIMH is most interested in the assessment and treatment practices in schools and pediatric settings, she said.
However, those studies do not include an in-depth study of neurofeedback, a method in which a person learns to modify a behavior or a physiological function by monitoring brain waves. M. Barry Sterman, professor emeritus in the departments of neurobiology and biobehavioral psychiatry at the School of Medicine of the University of California (Los Angeles), maintains one of the most promising alternative treatments for ADHD is neurofeedback, commonly referred to as biofeedback. Sterman said alternative treatments are very much needed because medication is "merely palliative" and not a cure.
Sterman is responsible for discovering biofeedback nearly 40 years ago. He said neurofeedback is a well-established scientific method. Sterman cites several studies that have proved neurofeedback's effectiveness in treating ADHD.
"It is unfortunate that some so-called experts in the field of ADHD have been critical of this literature because of the relatively small number of subjects and the lack of robust controls," Sterman states in a paper. Research has been conducted in clinical settings with large numbers of homogeneous subjects that have documented physiological changes as a result of neurofeedback, according to Sterman.
Diagnosis of ADHD is subjective and based on a child's behavior at home, school, and in other social settings. Sterman said there is a need for physicians to rely on biological markers instead of behavioral markers.
This is especially important because most children at one time or another exhibit some of the symptoms of ADHD. "Diagnosis is complicated further by the fact that these symptoms frequently appear in other disorders as well," he writes.
Brain scanning research, as well as quantitative EEG (electroencephalogram) assessments, has established ADHD as a physiological disorder, Sterman said. An instrument called an electroencephalograph measures and records the electric activity of the brain through electrodes to a patient's scalp pick up low-voltage signals. The QEEG is a more advanced measurement of the brain's electrical activities. Sterman says studies have found that the brains of children with ADHD have different electrical activities compared with the brains of children who do not have the disorder.
Sterman suggests that QEEG "can serve as a reliable biological marker for ADHD and suggests that the disorder actually includes several different neurophysiological subtypes."
A reliable, physiological test would go a long way in refuting the contention that ADHD is a myth. But so far, brain scanning and QEEG technology is still used as a research tool rather than as diagnostic instrument.
Without a reliable tool to diagnose ADHD as a physical disorder, some believe ADHD is not a brain-based disorder, but rather a reflection of societal and family problems in the U.S. culture. But the dispute about whether ADHD is a real disorder gets personal for some whose children have been diagnosed with the disorder.
"I am appalled at those who feel ADHD doesn't exist," said Beth Kaplanek, volunteer president of the National Board of Directors of CHADD, whose 18-year old son, Chris, was diagnosed with ADHD.
"ADHD is a valid, diagnosable disorder, and clearly these authors don't know what they are talking about," Kaplanek said. "I'm offended by their words. They are out there to make money, and they are not living in my home."
Diane Weaver Dunne
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