June 15, 1988 EXTENSIONS OF REMARKS 14745 EXTENSIONS OF REMARKS RITALIN activity being present in many, but by no icit Disorder (314.00). Copies of these two ci­ means all such children. Second, we need to tations are enclosed. clarify that the FDA does not, in most cases, Clearly, additional work needs to be done HON. CASS BALLENGER conduct its own studies or even fund studies, in operationalizing and empirically validat­ OF NORTH CAROLINA and we have not conducted or funded any ing the constructs suggested by this diag­ IN THE HOUSE OF REPRESENTATIVES studies of ADD. However, we have surveyed nostic entity. However, from the standpoint Wednesday, June 15, 1988 the literature published since 1975, and we of selecting individuals for treatment, the have focused on approximately 50 papers re­ diagnostic category of ADD is adequately Mr. BALLENGER. Mr. Speaker, Ritalin­ porting on adequate and well-controlled reliable and valid, and is widely accepted in methylphenidate hydrochloride-is a drug pre­ studies of children with this diagnosis, or the medical community (both pyschiatric scribed for children who suffer the symptoms some equivalent diagnosis <see our response and non-psychiatric). Furthermore, the cur­ of attention deficit disorder [ADD]. ADD is to question No. 2.) rently approved labeling for Ritalin recom­ most commonly known as hyperactivity in chil­ These were all double-blind, placebo con­ mends that the diagnosis of ADD be "based trolled studies. We reviewed a large sub­ upon a complete history and evaluation of a dren. group of these studies that involved school child and not solely on the presence of one Earlier this year, several of our colleagues age children with ADD, uncomplicated by or more of the characteristics identified joined me in contacting the Food and Drug mental retardation or specific learning dis­ with the Attention Deficit Disorder syn­ Administration and three other executive abilities. For the most part, these studies fo­ drome." The labeling further notes that "di­ agencies regarding Ritalin. We asked specific cused on impaired attention, impulsivity agnosis requires the use not only of medical questions about the safety, efficacy, and use and hyperactivity as principal outcome vari­ but of special psychological, educational and of Ritalin. ables. All but two of these studies showed a social resources." Listed below are the responses we received statistically significant effect favoring Rita­ Question 3: Has usage of this drug in­ from the Food and Drug Administration and lin over placebo. One of the failed studies creased over the years? If so, what has led the National Institutes of Health. The re­ did not assess patients until one week after to this increase and how many children do Ritalin was discontinued, and the other you estimate take the drug? sponses from the Drug Enforcement Agency failed study focused on learning, rather and the Department of Education will appear than the core features of ADD noted above. RESPONSE in the CONGRESSIONAL RECORD of Thursday, The clear conclusion from these numerous According to the National Prescription June 16, 1988. studies is that school age children with Audit, the use of Ritalin peaked in the early FOOD AND DRUG ADMINISTRATION, ADD treated with Ritalin can be expected 1970's with an estimated 4.3 million pre­ Rockville, MD, May 31, 1988. to have improved attention, a decrease in scriptions per year. Subsequently, its use de­ Hon. CASS BALLENGER, impulsivity, and somewhat less consistently, clined rather dramatically throughout the House of Representatives, a decrease in hyperactivity. 1970's, reaching a low of approximately 1.2 Washington, DC. Several of the more recent studies have, in million prescriptions per year in 1981. Since DEAR MR. BALLENGER: This is in further re­ addition, looked more specifically at the ef­ then its use has gradually increased to ap­ sponse to your inquiry of February 18, 1988, fects of Ritalin on learning per se. Some of proximately 1.8 million prescriptions per on behalf of yourself and several other Con­ these studies have demonstrated beneficial year in 1986. gressmen in which you pose questions relat­ effects of Ritalin on laboratory learning There are several possible explanations ing to the drug Ritalin. tasks and/ or on actual academic achieve­ for the approximately 50 percent increase in The Agency has received a number of in­ ment. However, the results are not consist­ use since the early 1980's: quiries in recent months regarding the use ently positive, and there is still no consensus a. It has become increasingly apparent of Ritalin in the treatment of attention def­ regarding the direct effects of Ritalin on that ADD does not end in childhood, and icit disorder <ADD>. Consequently, we have learning. It should be noted that the cur­ indeed, often extends into adolescence and reexamined the available data regarding the rent labeling for Ritalin makes no claim for early adulthood <ADD, residual type.) There safety and effectiveness of this drug as it is its effectiveness in improving learning, or are data supporting the effectiveness of Ri­ used in treating this specific disorder. We for its effectiveness in specific learning dis­ talin in treating ADD of the residual type. have reviewed spontaneously Feported ad­ abilities. Indeed, the labeling emphasizes b. Narcolepsy has been added as a second verse events associated with the use of Rita­ the need for a comprehensive treatment ap­ approved indication for treatment with Ri­ lin, and current data on its safety and effec­ proach, often including "psychological, edu­ talin, and this disorder has received in­ tiveness. Ciba Geigy has provided us with cational and social" treatment approaches creased attention in recent years, resulting data on the safety and effectiveness of Rita­ along with Ritalin in children with ADD. in the greater likelihood of individuals with lin obtained subsequent to its approval in Question 2: Are there any problems with this disorder being diagnosed and treated. 1956, as well as other information pertain­ the diagnostic criteria used to determine if a c. Finally, ADD itself has received a resur­ ing to the use of Ritalin in ADD. They have child is hyperactive and should be placed on gence of interest in recent years, leading to informed us that they have also provided Ritalin? If so, should the criteria be greater recognition and treatment of chil­ you with a selected subset of these materi­ changed? dren with this disorder, especially of the als. RESPONSE type without overt hyperactivity. Based on data from the National Disease The Food and Drug Administration's As with any other psychiatric and medical <FDA> Center for Drug Evaluation and Re­ and Therapeutic Index data base, it has disorders, diagnostic terms and practices been estimated that approximately 600,000 search has prepared the following answers have changed over time with regard to the to your specific questions. to 700,000 individuals are being treated with entity now identified as ADD. From the Ritralin as of 1987. An estimated 70 percent Question 1: Reports and studies indicate somewhat diffuse category of minimal brain that Ritalin is very useful in calming hyper­ of these prescriptions are for children or damage the hyperactivity syndrome was de­ adolescents. active children. Do your studies of this drug rived, and in more recent years the predomi­ indicate that this is true? Question 4: Have you received any com­ nantly used term has been attention deficit plaints about Ritalin? RESPONSE disorder. This term is used to identify a First, we need to clarify the disorder in group of children who are characterized by RESPONSE children for which Ritalin is indicated, i.e., impaired attention, impulsivity and often, The vast majority of adverse clinical attention deficit disorder. We will elaborate but not always, hyperactivity. The current events occurring in association with the use on the issue of diagnosis at greater length in edition of the Diagnostic and Statistical of Ritalin are reported to the sponsor, Ciba our response to your question No 2, but here Manual of the American Psychiatric Asso­ Geigy. Ciba Geigy is required by law to we simply state that the most prominent ciation <DSM-III-R> distinguishes between transmit these reports periodically to FDA, features of this disorder are impaired atten­ Attention Deficit Hyperactivity Disorder and to our knowledge, they have fully com­ tion and impulsivity, with behavioral hyper- (314.01) and Undiffereniated Attention Def- plied with this requirement. e This "bullet" symbol identifies statements or insertions which are not spoken by a Member of the Senate on the floor. Matter set in this typeface indicates words inserted or appended, rather than spoken, by a Member of the House on the floor. 14746 EXTENSIONS OF REMARKS June 15, 1988 Question 5: Are there any side effects as­ pirical data. Thus clinicians' attempts to sociated with the use of Ritalin? If so, how place children into diagnostic categories of [In percent] many complaints have you recevived and ADD with hyperactivity ADD, without hy­ what should be done? No peractivity, or an ADD residual type may Yes No re- RESPONSE not be reliable. Therefore, prescription of sponse As is true of all effective pharmacological pharmacological treatment for ADD with agents, Ritalin has a number of adverse hyperactivity may not be made solely upon l. Would you support an increase in your Social diagnostic category. A discussion of the dif­ Security taxes to pay for a new long-term health events associated with its use. These events care program? .......... .... .. .............................................. 38 61 are listed in the currently approved labeling ficulty in making the diagnosis of hyperac­ 2. Some are proposing a federal public works program <enclosed) for Ritalin, under the sections, tivity is included in the Interagency Com­ even though our recent unemployment figure was 5.7% and 15 million new jobs have been created Warnings, Precautions, or Adverse Reac­ mittee's publication "Learning Disabilities: in the private sector since 1981.