ADHD, Ritalin and Lawsuits

Some of the lawyers who successfully sued the tobacco industry have now filed class action suits against the American Psychiatric Association (APA) and Novartis, the company that makes a brand of methylphenidate known as Ritalin. The suit claims that APA conspired with Novartis to promote Ritalin sales and the diagnosis of attention deficit hyperactivity disorder (ADHD). These lawyers seem to have forgotten that they won the tobacco suits because the science demonstrating the harmful effects of tobacco was so strong, and the evidence for the tobacco industry’s duplicity so convincing, that the industry had to be punished for concealing and denying these facts for so long.

In these Ritalin/APA suits the science and the history is overwhelmingly against the plaintiffs. Hyperactivity was first described in 1902 and the first report of using a stimulant (amphetamine) to treat it was in 1937. This use is one of the most studied over the longest time period of any drug in medicine. By 1977 there were more than 100 controlled studies demonstrating the short-term efficacy of stimulants for hyperactive impulsive behavior. Twenty years later there were a total of 170 studies covering more than 6,000 school-age children.

The response rate is approximately 70 percent to a single stimulant, and up to 90 percent when an alternative is given. Ritalin is usually the first choice of treatment because it is less likely than other stimulants to be abused. Just one year ago, a major study was published, in which 579 children were followed for 14 months, demonstrating very clearly that stimulants were effective, and more effective than intensive behavioral treatments alone. A combination of these treatments, but not behavioral treatment alone, improved other symptoms, including parent/child relations and reading achievement. Thus the scientific evidence for the safety and effectiveness of Ritalin is very strong.

Likewise, the official description of the diagnosis of ADHD is based on strong, well-tested foundations. It started as “hyperkinetic reaction” in 1968 in the second edition of the APA’s Diagnostic and Statistical Manual (DSM), became attention deficit disorder in DSM III (1980), and is now attention deficit hyperactivity disorder in DSM IV (1994). The diagnoses in the DSM were developed through an open process involving more than a thousand nationally and internationally known clinicians and researchers reviewing literature and data. They were then extensively tested in field trials to make sure the descriptions were valid and that different clinicians using them came to the same conclusion.

The DSM diagnoses are used throughout the world, especially by researchers, because they are accurate and meaningful. The International Classification of Diseases (ICD), which is the official classification in most countries of the world, has largely similar criteria for the diagnosis of ADHD. When properly diagnosed using these criteria, a condition is identified that is similar all over the world, with similar risk factors, groupings in families, and outcomes. Further, similar problems exist with peers, family and school, including injuries, drug abuse, parental divorce and similar responses to treatment.

Thus the evidence is overwhelming that ADHD exists, that it can cause great distress and great costs, and that treatment with stimulants is generally effective, is more effective than any other kind of treatment, and is safe.

Given this, it appears the lawsuits are bound to fail.

ADHD and its symptoms and the long-term use of stimulants must continue to be examined dispassionately and scientifically. We need to better understand the nature, causes and prevention of ADHD, and to ensure that treatments are used in the best and safest way. Everyone — parents, healthcare workers, health administrators and politicians, as well as judges and lawyers — needs the skills to assess the scientific basis of medical conditions and the effectiveness of treatments. In addition we must find ways to counter harassing lawsuits and unscientific, biased publicity.

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