Nexus - 0806 - New Times Magazine-pages

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US parents sue Novartis and APA for promoting Ritalin ‘wo lawsuits have been filed in California and New Jersey, asserting that Novartis, makers of Ritalin, and the American Psychiatric Association (APA) conspired to create a market for methylphenidate. These follow a class action launched in Texas in May 2000 by the Dallas law firm Waters and Kraus, alleging that since 1955 and through 1996 when it merged with Sandoz to become Novartis: "Ciba/Novartis planned, conspired and colluded to cre- ate, develop and promote the diagnosis of Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder in a highly successful effort to increase the market for its prod- uct Ritalin... It has repeatedly violated Article 10 of the United Nations Convention on Psychotropic Substances, 1019 UNTS 175 (1971)." It continued: "The American Psychiatric Association (APA) conspired, colluded and cooperated with the other Defendants while taking financial contributions from Ciba as well as other members of the pharmaceutical industry..." Specifically, the company is accused of: = actively promoting and supporting the concept that a significant percentage of children suffer from a "disease" which required narcotic treatment/therapy; = actively promoting Ritalin as the "drug of choice" to treat children diagnosed with ADD and ADHD: = actively supporting groups such as Defendant CHADD, both financially and with other means, so that such organi- sations would promote and support (as a supposed neutral party) the ever-increasing implementation of ADD/ADHD diagnoses as well as directly increasing Ritalin sales; distributing misleading sales and promotional literature to parents, schools and other interested persons in a suc- cessful effort to further increase the number of diagnoses and the number of persons prescribed Ritalin." Mr Richard Scruggs, one of the lawyers in the class actions, is quoted as saying that the Defendants "manufac- tured a disease. It has been grossly over-prescribed. It is a huge risk." (BMJ, 23 Sept 2000, p. 723) The APA issued a statement last July, saying: "Allegations that the [APA] conspired with others to cre- ate the diagnoses of [ADD and ADHD] as part of its Diagnostic and Statistical Manual so that medication could be used to treat these disorders are ludicrous and totally false. The APA will defend itself vigorously by presenting a mountain of scientific evidence to refute these meritless allegations, and we are confident that we will prevail." The US support group CHADD (Children and Adults with Attention Deficit Disorder/Hyperactivity Disorder), which strongly advocates the use of Ritalin and is mainly funded by drug firms (it received $748,000 from Ciba/Novartis in the period 1991-94 alone), is accused of deliberately work- ing to promote and increase the use of Ritalin, which has resulted in a huge increase in its use by children across the US, to the enormous profit of Ciba/Novartis. It is also accused of working to reduce or eliminate laws controlling the use of Ritalin in the US. For further details, see the website www.ritalinfraud.com. [Also see "Class Action Lawsuit on Ritalin Fraud" in DeBriefings, NEXUS 7/06.] for children and young people with epilepsy, psychotic disorders or a history of drug or alcohol dependence. Proponents assert that MPH works by correcting a "brain disor- der", "biochemical imbalance" or "biological dysfunction", but critics (Baldwin, 2000, op. cit.) assert that no scientific rationale for MPH prescription has ever been made explicit by its adherents (Jensen, P.S. et al., unpublished paper, Walter Reed Army Inst., Washington, 1989; Barkley, R.A. et al., Pediatrics 1989;86:184- 92; Kewley, G., BMJ 1998;314:1594-5). In November 1998, the US National Institutes of Health held a Consensus Development Conference on the diagnosis and treat- ment of ADHD. The 31 expert panel members (including Dr Breggin; see below) noted that no valid, reliable, independent test of ADHD exists and that there are "no data to indicate that ADHD is due to a brain malfunction" or that it might be a disease state or brain pathology (NIH, Rockville, 1998; see www.odp.od.nih.gov/consensus). Despite this, supporters cite a large multimodal treatment study of ADHD, known as the MTA Study, which was sponsored by the National Institute of Mental Health at six separate sites (MTA Cooperative Group, Arch. Gen. Psychiat. 1999;56:1073-86). It compared four treatments, and proponents claim that it showed the superiority of stimulant treatment over behavioural and other treatments (although no nutritional alternative was tested). However, one of America's fiercest critics of MPH, psychiatrist Dr Peter Breggin, of Johns Hopkins University's Education Faculty and author of Talking Back to Ritalin (Common Courage Press, 1998), has produced a 16-point critical rebuttal of the study that severely undermines its credibility and results (see www.breggin.com). Chief among his criticisms is that it was not a placebo-controlled, double-blind trial; the blind sroom raters found no difference in any of the treatment groups; there was no control group of untreated children; the children themselves did not rate themselves as improved; and out of 4,541 children origi- nally screened, only 2.7% (123) completed the medication man- agement trial. His demolishing of the MTA Study is important. While the study lacks any evidence for MPH's efficacy, in Britain the National Institute for Clinical Excellence, which issued its Guidance on the use of MPH last October (NICE, 2000, "Technology Guidance No. 13"; see www.nice.org.uk), accepts in its sment of any evidence the official MTA results with little critical analysis. It refers to the study as "well conducted", when only one of the 125 listed references refers to a nutritional trial. It basically endorses the use of MPH, while acknowledging that "if improve- ment of symptoms is not observed after appropriate dose adjust- ment over one month, the drug should be discontinued". However, it does not mention that about 30% of children show no response to MPH or that up to 50% show side-effects. Baldwin (2000, op. cit.) states: "Adverse drug reactions and side effects (more accurately described as 'main effects') from MPH include: CNS [central nervous system] sequelae, gastro-intestinal effects, cardiovascular effects, liver abnormalities, convulsions (including grand mal), drug dependency and addiction, drug withdrawal reaction, hair loss, low white blood cell count, agitation, hostility, depression, psychotic depression, abnormal thinking, hallucinations, psychoses, emotional lability, overdose and suicide [Breggin, Ethical Hum. Sci. Services 1999;1(1):13-33]. Paradoxically, the supposed desirable behavioural effects (including passivity, attention, reduced spontaneity) are the primary toxic effects of psychostimulants." [His italics] see 20 = NEXUS US parents sue Novartis and APA www.nexusmagazine.com OCTOBER — NOVEMBER 2001