Here you will find important information not often known or acknowledged within the mental health community. Attached is Dr. Watson's ongoing detailed summary of research related to this topic.
Information contained herein is designed to support, not replace, the therapeutic relationship between doctor and patient. All information is kept in strict confidence, and no information, written or verbal is given out to any party what so ever without explicit written permission by our clients and patients. Dr. Watson works under the Corporation: Associated Psychological Health Services, as a private corporation, and insured personally for his work. He has no clinical financial ties or funding resources other than from client income.
PLEASE NOTE: Starting, adjusting or tapering and stopping psychiatric medications can be very dangerous and even life threatening. You should not stop taking a medication without medical supervision. Talk to your doctor about all information you may have about your mental and physical health before adjusting any medications you may be taking. Type your paragraph here.
Coming soon, being updated...
What is ADD/ADHD?
Lydia Furman, MD , J Child Neurol. 2005;20(12):994-1003. ©2005 BC Decker, Inc., Posted 02/02/2006
Department of Pediatrics, Case Western Reserve University School of Medicine, Rainbow Babies and Children's Hospital, Cleveland, OH.
Attention-deficit hyperactivity disorder (ADHD) is described as the most common "neurobehavioral condition" of childhood, and Dr. Furman raises the concern that ADHD is not a disease per se but rather a group of symptoms (thoughts, feelings and behaviors) representing a final common behavioral pathway for a gamut of emotional, psychological, and/or learning problems. A methodical review of the literature raises concerns, and "Core" ADHD symptoms of inattentiveness, hyperactivity and impulsivity are not unique to ADHD. Rates of "comorbid" psychiatric (labels) and learning problems, including depression and anxiety, range from 12 to 60%, with significant symptom overlap with ADHD...thus, making it very difficult to diagnosis or label a child with any sort of validity. No neuropsychologic test result is pathognomic for ADHD, and structural and functional neuroimaging studies have not identified a unique etiology for ADHD. No genetic marker has ever been consistently identified, and heritability studies are confounded by familial environmental factors.
Taken together, ADD/ADHD, the label that was simply made up of a list of thoughts feelings and behaviors, has no validity nor can really be accurately labeled given the overlap with so many other psychiatric labels. (Dr. Watson).
So, what about treatment though for those kids who do struggle so much?
The MTA STUDY:
A Critical Analysis of the NIMH Multimodal Treatment Study for ADHD (The MTA Study). This is one of the, if not the largest study ever conducted on the effectiveness of medications with children meeting the label ADHD. Period. Don't by the National Institute of Health, over several years. The best...
Full study can be found here: Jensen et al: Findings from the NIMH Multimodal Treatment Study of ADHD (MTA): Implications and Applications for Primary Care ProvidersDevelopmental and Behavioral Pediatrics, Vol. 22, No. 1, February 2001.
by Peter R. Breggin, M.D.
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. 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 several gross methodological flaws that undermine its scientific validity and limit any conclusions that may be drawn from it. 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. It could not be used, for example, for FDA approval of a drug.
Bias on the part of researchers, observers or evaluators, and research subjects?whether conscious or unconscious?often influence the outcome of "open label" studies. Researchers commonly want to prove that the treatment under investigation is effective. In the MTA studies, the sponsors and all the principal investigators were staunch advocates of medication. Evaluators of efficacy often make observations that confirm what they anticipate finding, such as improvement in subjects treated with drugs. The research subjects themselves often give responses that they know will please their doctors. They also tend to respond to their own belief that the drug is safe and effective, and that it will help them or their children. Therefore, open label studies have been discredited for purposes of evaluating effectiveness. 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).
I have been informed that the principal investigators in the MTA study have claimed that it would have been unethical to use a placebo group because stimulants have been proven effective as a treatment for ADHD. In reality, placebo groups are commonly used in ADHD and stimulant research. For example, I recently reviewed eight double-blind placebo controlled studies of stimulants for ADHD that were conducted from 1990-98 (Breggin, 1999a&b), including clinical trials carried out by the National Institute of Mental Health (Borcherding, Keysor, Rapoport, Elia, and Amass, 1990; Castellanos, Giedd, Elia, Marsh, Ritchie, Hamburger, & Rapoport, 1997). A well-known double-blind placebo-controlled study of stimulants for children diagnosed with ADHD lasted over fifteen months (Gillberg, Melander, von Knorring, Janols, Thernlund, Hagglof, Eidevall-Wallin, Gustafsson, & Kopp, 1997). It was not criticized for withholding medication from some of the children. Furthermore, placebo-controlled trials are routinely carried out in psychiatry for far more dangerous ?disorders? than ADHD, including ?major depression? and ?mania.?
Furthermore, a number of the children in the MTA study went without medication while they were in the community and behavior treatment groups. It would have been no more ?unethical? to add an actual placebo group.
Ultimately, the lack of a placebo control group marred the study regardless of the motivation behind omitting the group. If the study could not be done in a manner that generated useful data and valid conclusions, it should not have been done at all.
Finally, there can be no ethical problem surrounding the use of double-blind procedures. Yet this basic methodology was also omitted.
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 not considered in the study conclusions. Nonetheless, the findings of the blind classroom raters are the most important in the study, confirming that stimulant drugs offer no observable advantages over other interventions, including behavioral therapy and non-specific community treatments.
III. There was no control group of untreated children.
There was no non-treatment control group. The MTA compared various treatments, but did not compare treatment to no treatment. Two-thirds of the community-treated group received a variety of medications, as well as other interventions, and cannot be considered a non-treatment control group. Basically, the study compared three drug conditions to behavioral interventions, but failed to compare 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 would be expected to corrupt 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 small percentage of applicants actually selected for the study suggests that the children in the trials do not reflect a representative community group of children routinely treated for ?ADHD.? As already noted, many of the children were already taking stimulant medications. As a result, many of the children who entered the trials probably had parents who were already favorable toward medication.
VI. The Medication Management group was relatively small.
The actual medical management group is much smaller than might be suspected based on the seemingly large scale of the study. Of the 579 who entered the clinical trials, only 144 entered medication management, i.e., received medication alone (others received medication in combination with other treatments or behavioral therapy 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. Overall, of the 4,541 children originally screened, only 12.8 percent entered the study and 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.
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. That is, the children did not rate themselves as doing better on the drugs than on any other treatment. This result supports the use of the safer non-drug treatment.
Furthermore, I received inside information that the children also rated themselves on a depression scale. This information was 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.
Because stimulants commonly cause depression in children, the authors of the MTA study should publish any data they posses on this issue. If the children did rate themselves on a depression scale, one might raise 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. Stimulants are known to be temporarily effective in suppressing overall normal spontaneous behavior in children and animals. This drug-induced suppression of socialization, play, autonomy, and spontaneity makes normal boys easier to manage under certain circumstances, such as a home or classroom setting that does not meet their needs for spontaneous activity or provide them adequate discipline and engaging education (Breggin, 1999a&b). In part to counter the argument that stimulants are used for the behavioral or social control of normal boys , attempts were made to include more girls in the MTA studies. Despite efforts to recruit more girls, 80% of the subjects were boys. This focus on treating boys reconfirms that stimulants are used to suppress the relatively higher activity rates of normal boys compared to girls.
IX. Drug treatment was continuous for fourteen months; behavioral treatments were stopped earlier.
The MTA claims to have compared behavioral and medication treatments. However, it did not compare drugs and behavioral treatments for the same length of time. Only the drug treatment persisted for 14 months. In the last few months, behavioral treatments were spaced out to once a month or stopped. Furthermore, parental attendance was inconsistent. Continuing the drug treatment while discontinuing the behavioral treatment gives the drug treatment an unfair advantage.
X. 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 inadequate programs of behavioral treatment. 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. Barkley?s behavioral approach 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 (Breggin, 2000). Nonetheless, these limited behavioral approaches did as well as all the other treatments, according to the only "blind" observers (see above). Once again, the study shows no advantage to drugs , thus favoring non-toxic behavioral interventions, and perhaps no treatment at all.
XI. 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). Their dismissal of known stimulant-induced ADRs also points to the strong biases of the investigators.
XII. There were no trained observers for ADRS.
ADRs were recorded by teachers and parents on a two-page check list . 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, creating a bias in favor of the drug?s safety. Furthermore, many ADRs--such as behavioral suppression, loss of spontaneity, apathy, and increased obsessive behavior--are mistakenly interpreted 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 about any potential adverse drug reactions is central to the assessment. Often the child is having drug-related problems, such as headaches or ?blah? feelings, but does not understand their source or tell anyone about them until questioned by the doctor. The MTA study made no effort to ask the children what drug effects they might be experiencing.
The study failed to carry out an objective evaluation of long-term adverse effects that have already been demonstrated in short-term studies. For example, the study should have gathered data on physical parameters such as height and weight (growth), blood pressure, cardiac status, and abnormal movements, as well as on psychological parameters such as cognitive and affective functioning, including over-focusing (perseveration) and depression. None of this was done.
Overall, from the opening statement in the paper to its conclusion, it is obvious that the investigators did not intend to evaluate the single most important issue surrounding the long-term use of stimulant drugs--the risks they pose to the children.
XIII. 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 marginal improvement in reading. However, according to Bertram Karon (personal communication, January 24, 2000), the statistical analysis was flawed (due to the use of a Bonferroni correction of 6 that was too small). Overall, no academic improvement was found as a result of any treatment and no differences were found among the treatments.
XIV. 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).
Of great importance, the peer group sociometrics analysis yielded no advantage to any of the treatment groups. The other children did not rate the medicated children as improved.
XV. All the principal investigators were well-known drug advocates.
How could so many experienced professionals produce a study with so many flaws? The framer of the MTA studies, Peter Jensen (then at NIMH), and all the principal investigators are drug advocates who touted the positive results of the study even before it 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. 10077). They have devoted their careers 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. Before the data were later removed from the web site during controversy over dangerous research on children at the institute and the university, the New York State Psychiatric Institute and Columbia University web site originally 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.
XVI. 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 invalidated the observations made by the teachers concerning safety and efficacy, especially in an open label study.
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 the opportunity for informed consent for the risks posed to their children by the drugs.
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 criteria for a drug trial. It was not placebo-controlled and lacked a 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 purporting to demonstrate the effectiveness of stimulant drugs, it is scientifically unsound.
Furthermore, the blind raters in the study who observed behavior in the classroom found no difference over fourteen months between any of the treatment conditions. In other words, the observations generated by the most objective observers showed that the medicated children did no better than the other children in the study. Similarly, the peers of the subjects did not rate the children as improved in any of the treatment groups.
Positive ratings for the medication groups came from the parents and teachers who were heavily propagandized in favor of the drugs and who knew which children were receiving them. In many cases, the children were already on the drugs, indicating teacher and parent biases in favor of medication.
The study also failed to evaluate adverse drug effects in a scientific manner. Lacking observations by trained professionals, while relying upon potentially biased and untrained parents and teachers, the study is not a valid source of data concerning stimulant-induced adverse effects.
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 scientific standards for clinical trials of medication efficacy and cannot be used to draw valid conclusions about stimulant efficacy. 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.
How did these kids do 3 years later?
"...despite treatment, the children with ADHD showed significantly higher-than-normal rates of delinquency (27.1 percent vs. 7.4 percent) and substance use (17.4 percent vs. 7.8 percent) after three years. Earlier evidence of lower substance use rates among children who had received intensive behavioral therapy had lessened by the third year." http://www.nimh.nih.gov/press/mtafollowup.cfm
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.
Castellanos, F.X., Giedd, J.N., Elia, J., Marsh, W.L., Ritchie, G.F., Hamburger, S.D., & Rapoport, J.L. (1997). Controlled stimulant treatment of ADHD and Comorbid Tourette?s syndrome: Effects of stimulant and dose. Journal of the American Academy of Child and Adolescent Psychiatry, 36, 589-596.
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.
Gillberg, C., Melander, H., von Knorring, A-L., Janols, L-O., Thernlund, G., Hagglof, B., Eidevall-Wallin, L., Gustafsson, P., & Kopp S. (1997). Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms: A randomized, double-blind, placebo-controlled trial. Archives of General Psychiatry 54, 857-864.
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.