The decision to medicate a child with a behavioral disorder is a complex one that involves many discussions between the child’s parents, teachers, and physicians. In the case of children suffering from Attention Deficit Hyperactivity Disorder (ADHD), parents are placing increasing trust in a drug called Ritalin. Much of this trust is based on the fact that the company that manufactures Ritalin, Novartis Pharmaceuticals, has performed the government-required studies to determine the safety of the drug. Further validation comes from the American Psychiatric Association and government agencies such as the Food and Drug Administration and the U.S. Surgeon General’s Office, all of whom have officially endorsed the use of Ritalin as a treatment for ADHD. But the medication of children is a weighty issue, and the claims made in a recent Texas lawsuit suggests that we take a closer look at where we have placed our trust.

Manuals for the treatment of ADHD do caution that medication should not be an automatic step, and that extensive interviews with both parents and teachers should be conducted to diagnose the severity of the illness.

The law firm of Waters & Kauff has filed a class action lawsuit against Novartis in Texas as “Hernandez, Plaintiff, Individually and on Behalf of all others Similarly Situated v. Ciba Geigy Corporation, U.S.A., Novartis Pharmaceuticals Corporation, Children and Adults with Attention- Deficit/Hyperactivity Disorder, and the American Psychiatric Association.”

The lawsuit claims that the Novartis Corporation improperly promoted the use of Ritalin in order to increase its sales. In addition, the lawsuit lists a series of neurological and cardiovascular side effects that the plaintiffs claim Novartis does not accurately relay to its customers.

The Debate Over Ritalin ADHD is a condition that often affects grade school children. It has many symptoms, but three of the main bases for diagnosis of the illness are: difficulty paying attention, impulsive talking and behavior, and hyperactivity that often manifests as excessive fidgeting and squirming.

The Texas lawsuit is the latest voice in an ongoing debate over ADHD and Ritalin. Many educators and clinicians believe that ADHD is over-diagnosed, and that Ritalin is increasingly over-prescribed. A study in February 23 issue of the Journal of the American Medical Association (JAMA) has added to these concerns by reporting that the prescription of Ritalin to children under the age of three increased two to three-fold between the years 1991 to 1995. Soon after the JAMA article was published, Hillary Clinton announced a federally sponsored study of the use of psychiatric drugs for children.

On the other side of the debate are the numerous studies showing the positive effects of Ritalin for children who suffer from ADHD. Many of these studies indicate that while alternative treatments such as therapy can be of some help, the most effective treatment for ADHD is with pharmacology. Ritalin is the pharmacological treatment of choice because other drugs such as tricyclic antidepressants and monoamine oxidase inhibitors can have serious side effects and often sedate the hyperactivity without treating the children’s problems with attention and concentration. Manuals for the treatment of ADHD do caution that medication should not be an automatic step, and that extensive interviews with both parents and teachers should be conducted to diagnose the severity of the illness. However, once it is determined that the child is suffering from ADHD, Ritalin has been the standard and most effective method of controlling the more debilitating symptoms of the illness.

The Texas lawsuit claims that the Novartis Corporation has actively promoted the diagnosis of ADHD and the subsequent prescription of its product Ritalin. The suit also claims that Novartis distributed misleading sales and promotional literature to parents and schools in order to increase the number of ADHD diagnoses and thus the number of Ritalin prescriptions.

Did Novartis Influence ADHD Diagnoses? When asked about Novartis’s distribution practices, Regina Moran, a spokesperson for the Novartis Corporation, stated that “Ritalin is a 40 year old product and Novartis has not detailed the product to physicians for over 15 years, nor have we had any field presence or sales representatives. We do not advertise the product nor have we for many years.” In an official statement, Novartis says that it plans to “vigorously” defend itself against the lawsuit.

Scott Magee, an associate of the law firm filing the claim, said that the decision to sue Novartis at this time was made simply because the number of parents angry with the pharmaceutical company had reached a “critical mass”.

“A Ritalin epidemic has taken over,” Magee says. He asserts that Novartis was able to influence the diagnostic rules for ADHD listed in the mental health manual DSM-IV by giving donations of hundreds of thousands of dollars to the American Psychiatric Association (APA). He also claims that Novartis influenced the patient support group CHADD (Children and Adults with Attention Deficit Disorder), again with substantial financial donations, to lobby the government to reduce restrictions on Ritalin use.

In response to the allegations made by Scott Magee, Regina Moran of Novartis stated that, “The notion that Novartis improperly influenced either the American Psychiatric Association (APA) or the National Institutes of Health or the Food and Drug Administration has no merit.”

The DSM-IV manual is a review of the psychiatric literature that is compiled by a task force and the APA to aid physicians in making their diagnoses. Moran stated that Novartis did provide funds to support educational programs sponsored by the American Psychiatric Association, but that these were unrestricted funds that were not meant to influence the mental health manual. She also pointed out that this type of donation is standard industry practice, and that many other pharmaceutical companies associated with the psychiatric field have participated in similar ways. In addition, the DSM-IV manual does list other psychiatric drugs for the treatment of ADHD in addition to Ritalin (see the American Psychiatric Association website: www.psych.org for more information on the DSM-IV manual). Novartis also denies influencing CHADD to convince the government to reduce restrictions on Ritalin, stating: “Novartis rejects the notion that these unrestricted educational grants to credible third parties creates improper influence upon them.”

What Cautions Should Be Taken? The amount of damages sought by the plaintiffs in the suit has not been disclosed, but in addition to damages, they are asking that Novartis be compelled to state all the side effects that the plaintiffs claim Ritalin can provoke (see www.ritalinfraud.com for the list of side effects). It bears mentioning that many of the cardiovascular and neurological side effects that the plaintiffs list are not extensively noted in the medical literature surrounding Ritalin. This does not mean that the side effects do not occur, but it does indicate that many of the listed side effects may not be that common.

In the end, punishing Novartis for the prevalence of ADHD diagnoses may not be the most appropriate response to a legitimate concern. The growing number of children being given Ritalin is an alarming trend. However, Novartis is not the only causal link in this chain– prescriptions for Ritalin are offered by family physicians and are accepted by parents. Although Ritalin is the most effective treatment for ADHD, most experts caution against resorting to medication too quickly. There is as yet no standard way to diagnose ADHD, although many brain imaging specialists are hoping to use their technology to create a test for the illness that is based on biological standards. Right now, the best diagnosis for ADHD involves extensive interviews conducted by a physician of the child, the parents, and the child’s teachers. Parents should be aware that some experts suggest attempting to solve the problem through counseling and support groups before resorting to medication. Parents should also be aware that Novartis does not recommend that Ritalin be used for children under the age of 6 years, since no studies have been done on the safety of this drug for such young children.

Anyone interested in joining the class action suit or obtaining more information about its legal basis should visit the attorney’s website at www.ritalinfraud.com.