-Caveat Lector- <A HREF="http://www.ctrl.org/"> </A> -Cui Bono?- .............................................................. >From the New Paradigms Project [Not Necessarily Endorsed]: Conspiracy Shopping Cart: http://a-albionic.com/shopping.htmlFrom: Ian Goddard <[EMAIL PROTECTED]> To: <[EMAIL PROTECTED]> Subject: Drugging Kids: MTA Study Critique Date: Saturday, January 22, 2000 5:31 PM The "MTA study" funded by the National Institute of Mental Health is being touted as the long-awaited research confirming that long-term (14 month) drugging of children with stimulants to control misbehavior is more effective than drug-free behavioral therapy. In the following report, however, Peter Breggin, MD, gives us a second opinion about the findings of this study. The first objection Breggin raises constitutes the complete elimination of the study: the study was not a placebo-controlled, double-blind clinical trial. Amazing! Both the study subjects and those evaluating the performance of the subjects knew which subjects were on drugs and which were not, which is known as an "open label" study. The reasons why double-blind placebo-controlled studies are essential for valid drug research are basic to established standards for scientific research -- standards that the much- touted MTA study fails to satisfy. Based on that fact alone, the MTA study is essentially junk science that amounts to a taxpayer-funded advertisement for drugs, yet that's just the beginning of Breggin's critique: ========================================================= A Critical Analysis of the Multimodal Treatment Study for Attention-Deficit/Hyperactivity Disorder (The MTA Study) by Peter R. Breggin, M.D. January 12, 2000 After many months of positive publicity in the psychiatric and the general media, the results of the Multimodal Treatment Study for Attention-Deficit Hyperactivity Disorder (The MTA Study) were finally published in December 1999 (MTA Cooperative Group, 1999a&b). The study was sponsored by the National Institute of Mental Health (NIMH) at six separate sites in the United States. At each site, the study compared four treatment conditions: (1) medication management alone, (2) combined medication management and behavioral therapy, (3) behavioral treatment, and (4) community care. The average age of the children was eight and 80% were boys. The aim of the study was to "resolve controversies and clinical quandaries about the relative value of medication and behavioral treatments" (National Institute of Mental Health, undated). The proponents of the study claim that it demonstrated the superiority of stimulant treatment over behavioral treatments and routine community treatment. However, an examination of the MTA study reveals that it was so grossly flawed methodologically that it lacks scientific validity. The following is a general critique of the MTA study. I. The MTA was not a placebo-controlled, double-blind clinical trial. The MTA study fails to meet the commonly accepted criteria for a scientific study of medication efficacy or effectiveness. It was not a placebo-controlled double-blind clinical trial (MTA Cooperative Group, 1999a). First, there was no placebo control group and no non-treatment control group. Second, to reach their conclusions, the investigators relied upon evaluations made by teachers and parents who were not blind to the treatment. That is, the raters whom the investigators relied upon knew whether or not the children were taking medication. In short, the MTA was an "open label" study--the kind that does not qualify as scientifically valid. It could not be used, for example, for FDA approval of a drug. Rater, researcher, and subject biases, unconscious or conscious, influence the outcome of "open label" studies. Researchers commonly want to prove that the treatment under investigation is effective, and in the case of the MTA studies, all the principal investigators were staunch advocates of medication. Evaluators of efficacy are often unconsciously influenced to perceive what they anticipate perceiving, such as improvement in subjects treated with drugs. Also, the subjects themselves often respond positively to please their doctors or as a result of their belief that the drug will help them. Therefore, open label studies have been discredited for purposes of studying efficacy. As Nies and Spielberg (1996, p. 45) observe, "Placebo effects, which occur in a large percentage of patients, can confound many studies--particularly those that involve subject responses; controls must take this into account" (for additional discussions of placebo, double-blind procedures, and research standards, see Fisher and Greenberg, 1989). II. The blind classroom raters found no difference in any of the treatment groups, i.e., behavioral interventions were equal to medication interventions. The MTA used one group of "blinded ratings of school-based ADHD and oppositional/aggressive symptoms..." (MTA Cooperative Group, 1999a, p. 1074). The blind raters observed the children in the classroom only. The data from these raters are produced in Table 5 (pp. 1082-3) of the study. The blind raters found no difference between any of the treatment groups on any of the variables involving ADHD or oppositional behavior. However, this extremely important finding, that the only potentially objective raters found no drug effect, was given no importance in the study conclusions. Nonetheless, the finding of the blind classroom raters is one of the most important findings of the study, confirming that stimulant drugs have no long-term positive effect. III. There was no control group of untreated children. There was no non-treatment control group. The MTA compared various treatments, not treatment versus no treatment. Two-thirds of the community-treated group received a variety of medications, as well as other interventions, and therefore it cannot be considered a non-treatment control group. Basically, the studied up compared three drug conditions to behavioral interventions, without comparing the drug treatment to placebo. IV. Thirty-two percent of the Medication Management group was already on medication for ADHD at the start of the MTA. Table 3 (p. 1079) shows that of 144 medication management subjects, 46 (32%) were on medication for ADHD at the start of the selection process. This is generally not acceptable in a study of medication effects and corrupted the study. Since the children were already receiving medication, it is highly probably that their parents had already determined to their own satisfaction that the drugs were helpful. Therefore they could not participate objectively in a "random" drug study. V. The Medication Management group was highly selective (in ways that are not fully described) and probably not typical of children who seek services for "ADHD." The study initially screened 4,541 children. These children were referred from a variety of sources, such as public advertisements, clinics, and schools. The aim was to draw from a broad spectrum of the kind of children whose parents bring them for services for "ADHD." But of these 4,541 children, only 579 subjects (12.8%) were selected to enter the trials. The authors do not clarify why so many children were rejected from the study. The small number of subjects actually selected for the trials leaves a suspicion that the children in the trials do not reflect a representative community group. As already noted, many of the children were already taking stimulant medications. Overall, the group that entered the trials may have little relevance to range of children who seek help in clinical practice. VI. The Medication Management group was relatively small. The actual medical management group is much smaller than might be suspected from the seemingly large scale of the study. Of the 579 who entered the trials, only 144 entered medication management, i.e., received medication alone. Thirteen of these dropped out before starting, limiting the actual start group to 131. Eight more dropped out during the study for a total of only 123 finishers in medication management. Thus, of the 4,541 children originally screened, only 2.7 percent (123) completed the medication management trial. In addition, many of the children were comorbid for other psychiatric diagnoses, so that the group of children diagnosed solely with ADHD was much smaller than the total of 123 finishers. In my experience reviewing scientific studies, it is unusual for the trial cohort to be such a small sample of the original screened group. Furthermore, the study was not nearly so large as touted, with only 124 finishers in medication management and even fewer children diagnosed solely with ADHD in the medication management group. VII. The children did not rate themselves improved. The children self-rated themselves on an anxiety scale (the MASC, Table 5 in the study). They did not rate themselves differently in any treatment category at any time. Furthermore, I received inside information that the children also rated themselves on a depression scale. This is confirmed by a handout provided by the Columbia project (New York State Psychiatric Institute and Columbia University Division of Child & Adolescent Psychiatry, 1994). However, no data are reported in the study concerning the depression scale. Stimulants commonly cause depression in children. This raises the question, "Were the depression self-rating scales dropped because they indicated a worsening of the children's condition?" VIII. Most of the subjects were boys. Boys represent a disproportional number of the children who are medicated with stimulants. One reason is the demonstrated usefulness of stimulants in suppressing overall normal spontaneous behavior, thus making boys easier to manage under highly controlled circumstances (Breggin, 1999a&b). In part to counter the argument that stimulants are used for behavioral control of boys who are being over-controlled in school, attempts have been made to include more girls in studies. Despite efforts to recruit more girls, 80% of the subjects were boys, reconfirming that stimulants are used to suppress the relatively higher activity rates of boys compared to girls. IX. Use of the Placebo Washout Although it is not clear how it was conducted, a placebo washout was used, and subjects who responded to placebo were dropped from the study. This technique skewed the study to favor drug effects. X. Drug treatment was continuous for fourteen months; behavioral treatments were stopped earlier. The MTA is not a comparison study of drugs and behavioral treatments at 14 months, since in the last few months, behavioral treatments were spaced out to once a month or stopped. Continuing the drug treatment while discontinuing the behavioral treatment gives the drug treatment an unfair advantage. XI. The behavioral treatments were flawed. The study utilized behavioral treatments developed by Russell A. Barkley. Barkley has used these techniques for decades to try to show that drugs are better than behavioral treatments. He does this by comparing drug treatment to his own type of behavioral treatments. Barkley's behavioral approach is doomed to failure because it treats the child as a defective object suitable for control by parents and teachers rather than as a sentient being in conflict with adults at home and/or at school. It ignores everything that is known about family systems and the necessity of changing the overall patterns of relationship in the family, starting with the parents. Nonetheless, these limited behavioral approaches did as well as all the other treatments, according to the only "blind" observers (see above). XII. Most children suffered from adverse drug reactions (ADRs). Sixty-four percent of children were reported to have some ADRs, 11.4% moderate, 2.9% severe. The authors of the study dismiss the severe reactions because 6 of 11 were in the category of "depression, worrying, irritability." They explain these "could have been due to nonmedication factors." In reality, placebo-controlled double-blind clinical trials show depression, worrying, and irritability are common stimulant ADRs (trials reviewed in Breggin 1999a&b). XIII. There were no trained observers for ADRS. ADRs were recorded on a two page check list by teachers and parents. There was no apparent training for this process. In addition, parents and teachers were reassured in writing that the drug was safe and that ADRs were not serious, thus creating a bias. Furthermore, many ADRs--such as behavioral suppression, loss of spontaneity, apathy, and increased obsessive behavior-- are seen as improvements by parents and teachers. The use of aware, experienced professionals, rather than parents and teachers, is absolutely necessary in order to determine the frequency and severity of ADRs (Borcherding, Keysor, Rapoport, Elia, and Amass, 1990; studies reviewed in Breggin, 1999a&b). In clinical practice, I have found that asking children if they are having adverse drug effects is a very important part of the assessment. Often the child is having drug-related problems, such as headaches or "blah" feelings, without realizing their source and without telling anyone. The MTA study made no specific effort to ask the children what drug effects they might be experiencing. Overall, from the opening statement in the paper to its conclusion, it is obvious that the investigators do not intend to evaluate the single most important issue surrounding the long- term use of stimulant drugs--the risks they pose to the children. XIV. There was no improvement in academic performance. In a note to Table 4 (MTA Cooperative Group, 1999a,) the authors of the MTA study admit there was no improvement or difference in academic performance in spelling or math. The table itself seems to indicate no improvement in reading as well. Overall, no academic improvement was found as a result of any treatment. XV. There was very little effect on social skills. Social skill differences among the groups were limited to a significant difference favoring combined treatment over standard community care. Neither was better than behavioral or medical management treatment (MTA Cooperative Group, 1999a). XVI. All the principal investigators were well-known drug advocates. How could so many experienced professionals produce such an unscientific study? The framer of the studies, Peter Jensen (then at NIMH), and all the principal investigators are avid drug advocates who have been touting the positive results of the study even before the study was completed or published. The six principal investigators included Laurence Greenhill, C. K. Conners, William Pelham, Howard Abikoff, James Swanson, and Stephen Hinshaw (MTA Cooperative Group, 1999am, p. 1077). They have devoted their lives to encouraging the concept of ADHD and the drugging of children. Some, like Conners, have been doing so for four decades. Laurence Greenhill of the New York State Psychiatric Institute and Columbia University represents the kind of conflict of interest that exists among MTA researchers. Although it was later removed amid controversy over research on children at the institute, the New York State Psychiatric Institute and Columbia University website listed the funding of its researchers as of December 21, 1998 (NYSPI Sponsored Research, 1998). Greenhill had research funds or other financial support from six drug companies: Richwood, Bristol-Myers, Solvay, Wyeth-Ayerst, Glaxo, and Eli Lilly. XVII. The parents and teachers were exposed to prodrug propaganda. The families and teachers were exposed to the pro-drug biases of these investigators in the materials given to them before they enrolled in the study. The "Teacher Information" for the MTA study presents the usual claims about how much harm ADHD causes children (NIMH MTA Study, undated, a). It states the children will be treated with a "safe and effective dose of medication..." [bold in original]. This kind of built-in bias has no place in a study that used the teachers to rate safety and efficacy. The "Information for Parents" handout had similar built-in biases, including a reference to biochemical imbalances and genetic factors in "ADHD" (NIMH MTA Study, undated, a). In fact, based on the information handouts given out by Columbia and the NYSPI for the MTA, the parents in this study were not given informed consent for the risks posed to their children by the drugs. XVIII. Use of Intent-to-treat Analyses In order to achieve an apparent superiority of for medication management over behavioral treatment and community care, the study employed "intent-to-treat analyses" (MTA Cooperative Group, 1999b). This method uses data from patients who have dropped out of the study. For example, a patient who drops out because of adverse drug reactions could be counted as successful if, on his or her last visit, a positive evaluation was reported. This misleading method is used when an analysis of the actual finishers of a study fails to obtain the result that is sought after by the investigators. Discussion The MTA study has been highly promoted by advocates of drug therapy as a demonstration of the superiority of stimulant treatment for ADHD. In fact, the study failed to meet the basic scientific criteria for a drug trial. It was not placebo-controlled and in fact had no non-treatment control group. It was not double blind. Teachers and parents provided the ratings relied upon by the study, but both groups knew whether or not the children were taking medications. The MTA study was "open label" and would not have qualified, for example, as a study for the FDA-approval process. As research, it is scientifically unsound. Furthermore, the blind raters in the study who observed behavior in the classroom found no differences over fourteen months in any of the treatment conditions. In other words, the observations generated by the most objective observers confirms that there was the medicated children did not better than the other children in the study. Unfortunately, the MTA study also failed to examine the kind of interventions that, in actual clinical practice, prove very effective in helping children labeled with ADHD. These interventions include individualized family counseling aimed at improving relationships in the family and individualized educational approaches that inspire children to engage themselves in school (Breggin, 1998, 2000). In summary, the MTA study failed to adhere to basic standards for scientific studies of medication efficacy and cannot be used to draw any valid conclusions. Furthermore, the data it generated tends to indicate that stimulant medication produced no different results than any of the other intervention. The MTA study does not demonstrate the superiority, or even the usefulness, of stimulant medication in the treatment of children labeled with ADHD or any other presumed psychiatric disorder. Bibliography Borcherding, B.V., Keysor, C.S., Rapoport, J.L., Elia, J., and Amass, J. (1990). Motor/vocal tics and compulsive behaviors on stimulant drugs: Is there a common vulnerability? Psychiatric Research, 33, 83-94. Breggin, P.R. (1998). Talking back to Ritalin. Monroe, Maine: Common Courage Press. Breggin, P.R. (1999a). Psychostimulants in the treatment of children diagnosed with ADHD: Risks and mechanism of action." International Journal of Risk and Safety in Medicine, 12 (1), 3-35, 1999. Breggin, P.R. (1999b). Psychostimulants in the treatment of children diagnosed with ADHD: Part I: Acute risks and psychological effects. Ethical Human Sciences and Services, 1, 13-33. Breggin, P.R. (2000). Reclaiming our children: A healing solution for a nation in crisis. Cambridge, MA: Perseus Books. Fisher, S., and Greenberg, R. P. (Eds.) (1989). The limits of biological treatments for psychological distress: Comparisons with psychotherapy and placebo. Hillsdale, New Jersey: Lawrence Erlbaum Associates. MTA Cooperative Group. (1999a). A 14-Month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1073-1086. MTA Cooperative Group. (1999b). Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder: the multimodal treatment study of children with attention- deficit hyperactivity disorder. Archives of General Psychiatry, 56, 1088-1096. MTA side effects rating scale--parent. (undated). Obtained from http://pioria.cpmc.columbia.edu/mta/SIDE_P.html on March 1, 1999. MTA side effects rating scale--teacher. (undated). Obtained from http://pioria.cpmc.columbia.edu/mta/SIDE_P.html on March 1, 1999. National Institute of Mental Health. (undated). Multimodal treatment study for attention-deficit hyperactivity disorder (the MTA study). Obtained from http://pioria.cpmc.columbia.edu/mta/basicq.html on March 1, 1999. New York State Psychiatric Institute and Columbia University Division of Child & Adolescent Psychiatry. (1994). Grand Rounds: The multimodal treatment study of attention deficit hyperactivity disorder (MTA Study)--An NIMH cooperative agreement grant. (unpublished; distributed on March 9, 1994). Nies, A.S., and Spielberg, S. P. (1996). Principles of therapeutics. In Hardman, J.G., and L. E. Limbird (Eds.), Goodman & Gilman’s the pharmacological basis of therapeutics, ninth edition, pp. 43-62. New York: McGraw-Hill. NIMH MTA Study. (undated, a). Information for parents. Obtained from http://pioria.cpmc.columbia.edu/mta/parent.html. on March 1, 1999. NIMH MTA Study. (undated, b). Teacher information. Obtained from http://pioria.cpmc.columbia.edu/mta/teacher.html. on March 1, 1999. NYSPI Sponsored Research. (last update, 1998, December 21). Research foundation for Mental Hygiene, Inc., Psychiatric Institute Division. Obtained at http://www.nyspi.cpmc.columbia.educ/nyspi/rfinhgmt.Rf_spon.htm on March 1, 1999. 1. Peter R. Breggin, M.D., Director, International Center for the Study of Psychiatry and Psychology, 4628 Chestnut Street, Bethesda, MD 20814. A version of the report will be made available at www.breggin.com. 2. I wish to thank members of the International Center for the Study of Psychiatry and Psychology (ICSPP) who took the time to share their views with me. Ginger Breggin provided critical background research. My assistant, Ian Goddard, made many trenchant observations. Author's Note: In the public interest, this paper may be reproduced, provided attribution to the author is given. ============================================================ Peter Breggin's report posted: http://breggin.com/hta.html ============================================================ Amphetamine Use Linked To Cognitive Impairment: http://users.erols.com/igoddard/atrophy1.htm Ritalin Induces Schizophrenic Psychopathology: http://users.erols.com/igoddard/polyrisk.htm http://users.erols.com/igoddard/conyers.htm Peter Breggin's Letter To JAMA On Ritalin: http://users.erols.com/igoddard/breggin.htm Can Child-Ritalin-Use Violate Anti-Nazi Law?: http://users.erols.com/igoddard/nazi-rit.htm Excerpts From Breggin's Book on Ritalin: http://breggin.com/ritalinbkexcerpt.html ------------------------------------------------------------ GODDARD'S JOURNAL: http://www.erols.com/igoddard/journal.htm ____________________________________________________________ Shop for Cars On-Line: http://a-albionic.com/ads/srch.html Forwarded for info and discussion from the New Paradigms Discussion List, not necessarily endorsed by: *********************************** Lloyd Miller, Research Director for A-albionic Research (POB 20273, Ferndale, MI 48220), a ruling class/conspiracy research resource for the entire political-ideological spectrum. 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