Did Company Overpromote ADD/ADHD, Ritalin?

Nestor Sosa spent three years and $40,000 fighting to get his son off Ritalin.

Ritalin, an amphetamine-like drug used to treat ADD, or attention deficit disorder, is prescribed to an estimated 4 million American schoolchildren each year.

But Sosa thought his son shouldn’t be among them.

The boy’s mother and school both felt Ritalin, which helps some kids to concentrate, would assist the youngster in overcoming some of his learning difficulties. Sosa, of Chatsworth, Calif., believes his son, now 14, never had ADD. He thinks the boy was a victim of a trend in this country to diagnose normal juvenile behavior as a disease.

“ADD is like a catchall,” says Sosa, who took his ex-wife to court over their son’s Ritalin use. “Nobody could give me a straight answer and nobody could define ADD.”

Sosa’s conflict with well-meaning doctors and educators reflects a growing controversy about whether ADD and its variant, attention deficit (hyperactivity) disorder, are being over-diagnosed — causing children to be drugged for no reason.

Conspiracy to Over-Diagnose?

In fact, a class-action lawsuit against Ritalin manufacturer Novartis, the American Psychiatric Association and the parents’ group Children and Adults with Attention Deficit Disorder alleges the company fraudulently overpromoted the diagnosis of ADD/ADHD in collusion with the two organizations to boost drug sales.

The action, filed in a state court in Brownsville, Texas, in May, seeks unspecified damages against Novartis, charging, among other things, that the Basel, Switzerland-based company failed to adequately warn the public of Ritalin’s impact on children’s cardio-vascular and nervous systems.

Several hundred Texas parents have signed on as plaintiffs, but are not discussing the case with the press. Sosa is not involved in the lawsuit.

The suit alleges that the American Psychiatric Association has expanded the definition of ADD/ADHD in the Diagnostic and Statistical Manual IV, the handbook of psychiatric diseases, over time so that more and more children would fall into this category. Additionally, it claims the drug company encourages the diagnosis of ADD/ADHD and its treatment with Ritalin by economically supporting both CHADD and the psychiatric association.

In a written statement to ABCNEWS.com regarding these allegations, the company said it would defend itself vigorously against the suit, adding: “Novartis has supported educational programs sponsored by the American Psychiatric Association, as is standard industry practice, and as do most pharmaceutical companies with a therapy in the psychiatric area. The notion that Novartis improperly influenced the APA has no merit.”

Number of Cases Increasing

As for CHADD, the company said: “Novartis is proud to help CHADD and other credible third-party organizations that provide valuable information to many people. Novartis rejects the notion that these unrestricted educational grants to credible third parties creates improper influence upon them.”

CHADD declined to comment on the case.

Statistics do show an increase in the number of cases of ADD/ADHD and a rise in drug prescriptions. Attention deficit (hyperactivity) disorder is now the most commonly diagnosed behavioral disorder of childhood, affecting 10 percent of school-age children in the United States, according to the a 1999 Drug Enforcement Administration report. IMS Health, a health information company in Plymouth Meeting, Pa., reports that prescription rates for Ritalin have increased 390 percent in the last five years as of June.

Pointing to “a mountain of scientific evidence” to refute the charges that it helped Novartis manufacture the diagnosis for ADD/ADHD, the APA called the allegations “ludicrous and totally false.”

“The diagnostic criteria in DSM-IV were extensively tested for validity and reliability in field trials funded through a research grant from the National Institute of Mental Health,” the APA said in a statement. It says it develops its diagnostic manual based on the research and input of thousands of experts from around the world. Representatives declined to comment further on the case.

Defining Diagnosis

Psychiatrists say the proper diagnosis of ADD/ADHD takes time and careful evaluation. Dr. David Fassler, chairman of the Council on Children, Adolescents and Their Families for the APA, emphasizes it is important to ensure a child has received a comprehensive professional evaluation, including family, school and medical history, before being diagnosed with a disorder.

Some critics blame the diagnosis’ popularity on the “pencil/paper diagnostic exam,” a form that teachers or other school authorities fill out. Schools routinely base recommendations for further medical evaluation on the test, but critics say it is too subjective and inclusive.

Behaviors listed on it should be considered normal, says psychiatrist Dr. Peter R. Breggin, the author of Talking Back to Ritalin and Reclaiming Our Children. Breggin is a medical consultant to the plaintiffs’s attorneys in the lawsuit.

Behaviors on the diagnostic exam for ADD include:

“Often fails to give close attention to details or makes careless mistakes in school work.”

“Often avoids, dislikes, or is reluctant to engage in tasks that require mental effort (such as schoolwork or homework).”

Symptoms for ADHD on the list include:

“Often fidgets with hands or feet or squirms in seat.”

“Often has difficulty playing or engaging in leisure activities quietly.”

Dr. Fred Baughman, an El Cajon, Calif., neurobiologist, has been following ADD/ADHD research for 20 years and believes the disorders are “a colossal fraud.” He says there is no evidence of a physical or chemical abnormality in people diagnosed with ADD or ADHD.

But many other disorders, including Alzheimer’s, do not have objective markers that show up in a physical examination or a blood or urine sample. “It’s no more subjective than any other medical disease,” says Fassler.

Calls for a Closer Look

The rise in the use of Ritalin has federal agencies worried. In March, the American Academy of Pediatrics announced a plan to further study the issue. The DEA held a conference in 1996 on stimulant use in the treatment of ADD/ADHD. “There is a legitimate place for these drugs,” Gene Haislip, deputy assistant administrator of the DEA’s Office of Diversion Control, concluded in a report about the meeting.

But Haislip warned parents to protect their children by informing themselves.

“Regrettably, much of the literature and promotion of the drug in recent years has ignored or understated the potency and abuse potential of methylphenidate and Ritalin,” he wrote. “This appears to have misled many physicians into prescribing the drug as a quick fix for problems of school and behavior.”

But for parents who say Ritalin has helped their children, the proof is on the report card. Eileen Lee, a pediatric physical therapist in Reading, Mass., says her daughter’s grades went up significantly after she was put on Ritalin.

Now 14, the girl has been on the drug for about two years. In combination with years of counseling, Ritalin has also helped curb her aggressive behavior, allowing the girl to function better in social situations, Lee says.

“Ritalin wasn’t a cure, but it helped to take the edge off,” Lee says.

But Sosa, who eventually won the legal battle with his ex-wife to take their son off Ritalin, the issue goes beyond grades and behavior. “This is almost like a violation of [children’s] human rights,” he says.

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