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Steven E. Hyman, MD October 14, 2000 Director, National Institute of Mental Health 6001 Executive Blvd. Bethesda, Maryland 20892 Dear Dr. Hyman, Unfortunately, I did not get your letter, stamped September 28, 2000, in time to consider it in my prepared statement delivered to Committee on Education and the Workforce, hearing entitled "Behavioral Drugs in Schools: Questions and Concerns," held September 29, 2000, 9:00 a.m., in Room 2175, Rayburn House Office Building, Washington, DC, 20515-6100. Psychiatrists, like neurologists, and all other medical specialists, are physicians first and specialists second. All of us are responsible for knowing that the demonstrable physical abnormality in the patient is the disease. All of us are responsible, by the time we get our MD degree, for being able to distinguish those who have disease from those who do not. You did not respond to question #1 in my letter of September 19, 2000 (with cc to Representative Robert Schaffer, R-CO): "Is ADHD a bona fide disease with a confirmatory physical or chemical abnormality demonstrable within the patient? Circle yes or no?" You are aware, I suspect, that no physical or chemical abnormality has ever been confirmed in children meeting any of the ever-changing criteria, either for ADD ( DSM-III, 1980) or for ADHD ( DSM-III-R, 1987, or DSM-IV, 1994), and that the answer to question #1, quite simply, is no. As you and I both know, a yes or no answer is always possible. Moreover, regardless of what proofs may exist (none do) in the scientific literature, or in some remote institute, if a physical abnormality has not been demonstrated in the child/person, by their own physicians, they cannot be said to be abnormal-diseased. No child said to have ADD/ADHD can legitimately be said to be other than normal. You have said so yourself in paragraph 3 of your letter: " there are currently no biological markers that can be used for diagnostic purposes." For this reason, no child with ADD/ADHD is demonstrably abnormal until their drugging commences. You persist, nonetheless, in speaking of the valid diagnosis of ADHD and of manic-depressive disorder, and major depression, and of all psychiatric disorders--by which you mean diseases. It would be legitimate of you to refer to such diagnoses as valid if your only claim or inference was that they were behavioral problems in physically normal individuals, but that is not your/psychiatrys claim or inference. Rather, without physical evidence, you make the blanket claim, and broadcast to patients and the populace alike that these are diseases with validating, physical abnormalities within the patients--the only kind of validity that applies when claiming disease is present. As you and I were taught in medical school, the physical abnormality is the disease. In diabetes, the elevated blood sugar and all of its attendant physical complications, is the disease. Diabetes is the name it is given. In diabetes and in all bona fide medical/surgical diseases, treatment is not begun until the diagnostic physical abnormality is found. In ADHD, 6 million are being treated with addictive, dangerous, at time deadly drugs, without prior demonstration of an abnormalitya disease. Getting back to ADHD and your letter, you state (paragraph 3): "Scientific studies have shown that there are identifiable differences in the brains of children with ADHD as compared to normal." You give two references (your references #4 and #5). Let us look at these reports. The first (#4 in your bibliography), authored by Castellanos, et al. (like yourself, from the NIMH) was entitled: Quantitative brain magnetic resonance imaging in attention deficit-deficit hyperactivity disorder. It appeared in the Archives of General Psychiatry. 1996;53:607-616. Castellanos et al, took magnetic resonance images (scans) of the brains of 57 boys, 5-18 years of age, said to have ADHD, and of 55 "healthy" age-matched controls. Those in the ADHD group were found to have smaller, atrophic brains than the " healthy" controls. They concluded that the brain atrophy was due to ADHD, tending to prove, as you accept, that ADHD, diagnosed with pencil-paper behavior rating scales (mostly by teachers), is a "brain disease" with the brain atrophy, its confirming abnormality. However, under "Subjects with ADHD," it was explained that "Fifty-three of them (53 of the 57 with ADHD) had been previously treated with psychostimulants, and 56 had participated in a 12-week, double-blind trial of methylphenindate, dextoamphetamine and placebo " (and may also have been on medication) as had been described in a 1991 article. Under "Comment," is found the brief acknowledgment: "Because almost all (93%) subjects with ADHD had been exposed to stimulants, we cannot be certain that our results are not drug related." This did not, deter Castellanos, et al, from concluding that the brain atrophy was due to ADHD, not to the brain damaging (encephalopathic) drugs that 93% to 98% of their ADHD subjects had been on. That was 1996. In 1986, Nasrallah, et al, reported "Cortical atrophy in young adults with a history of hyperactivity in childhood," in Psychiatric Research, 1986;17:241-246. This was a computerized tomography (CT) brain scan study (comparable, but not quite as refined as MRI, which came along 5-10 years after CT). Scans of 24 hyperactive subjects showed brain atrophy (shrinkage) in more than 50% leading the authors to conclude: "cortical atrophy may be a long-term adverse effect of this treatment." Has the NIMH considered this possibility? Have they explored it? Castellanos, still at the NIMH, was interviewed for an article entitled Making Sense of Ritalin by John Pekkanen, which appeared in the January, 2000, Readers Digest. Therein it is stated: "Some critics claim that such brain differences in ADHD Children might actually be caused by Ritalinmeaning these smaller areas of the brain could be the result of the stimulant treatment. To address this , Castellanos has now embarked on another study, imaging the brains of ADHD youngsters who have not been treated with drugs." With the rate of stimulant prescriptions for ADD/ADHD rising so rapidly (from approximately 500,000 in 1985, to 1.0 million in 1990 and 6 million today), why didnt the NIMH long ago conduct the one experiment necessary to determine whether the brain atrophy that was being found on the brain scans was due to so-called ADHD or to the Ritalin/amphetamine treatment. Three patient groups would have been sufficient: (1) a normal control group; (2) ADD/ADHD, treated; and (3) ADD/ADHD, not treated. Nasrallah et al suggested the need for such a study in 1986 and it could well have been initiated, getting an answer to this all-important question, even with the then-existing, CT technology. There were, for that matter, MRI scanners becoming available by that time as well. Far from confirming that ADHD is a disease, the brain scanning research (CT and MRI) from 1986 to the present, showing, on-average, 10% brain atrophy (shrinkage) in ADHD subjects (most all of them on Ritalin or amphetamine treatment) as compared to normal control subjects, allows no conclusion other than that the Ritalin/amphetamine exposure, itself, is the only plausible cause of the brain atrophy. So much for your reference # 4. Let us turn now to the second article (your reference # 5, Dopamine transporter density in patients with attention deficit hyperactivity disorder. Dougherty DD, Bonab AA, Spencer TJ Rauch SL, et. al. Lancet. 1999;354:2132-2133, December 18, 1999) which you claim shows "identifiable difference in the brains of children with ADHD as compared to normals." Here, I will be referring not just to the article of Dougherty, et al, but to my own (Baughman FA Jr. The Lancet, 2000;355:1460; April 22, 2000) letter to the editor critiquing the article of Dougherty, et al. I wrote: "Dougherty, et. al., state that patients were excluded from "therapy with drugs which affect the dopamine system within 1 month before participation". Saying "drugs which affect the dopamine system" they likely refer to the amphetaminesmethylphenidate (Ritalin), d-, l- amphetamine (Adderall), an d-amphetamine (Dexedrine). Brown, et.al. [Brown WD, Taylor MD, Roberts AD, et al. FluoroDOPA PET shows the nondopaminergic as well as dopaminergic destinations of levodopa. Neurology. 1999;53:1212-1218.] have shown such theory to be simplistic and invalid, accentuating that it cannot be said of any drug, or class of drugs, that they are known to act exclusively on any one set of chemical transmitters, or, that it is known exactly how they act. Assuming they are speaking, if not of stimulants, of other types of psychotropic drugs it cannot be assumed, with no mention of what they might have been or how long the subjects had been on them, that there would be no drug affect capable of altering the SPECT testing, after just one month off of whatever drug it was they were on. Observing that these were 6 adult subjects with ADHD , it is likely that they had been on chronic, long-term psychotropic therapy, more likely with stimulant therapy than with other psychotropic drugs. But again, none of these things are stated in methods. Surely, the authors make no claim that their ADHD patients were wholly drug-naïve, that is, that they had used no drugs at all, any time in their lives, and that their ADHD (behaviors) were the sole variable. The fact that they were apparently on some psychotropic medications until one month or more prior to SPECT scanning means that theythe 6 ADHD subjects--were not drug-naïve, and that the scan differences between the subjects and controls were likely drug-induced. Certainly, it cannot be concluded that the study defines an ADHD phenotype, pathology, pathological physiology or pathological chemistry. Reviewing the neuro-imaging literature at the National Institutes of Health, Consensus Conference on ADHD, November 16-18,1998, Swanson [Swanson J, Castellanos FX. Biological Bases of ADHD: Neuroanatomy, Genetics, and Pathophysiology. Program and Abstracts, NIH Consensus Conference on the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder, November 16-18,1998: pages 37-42] showed that the brains of ADHD subjects were, on average, 10% atrophic compared to normal controls. He stated there were no such studies in which the ADHD subjects were drug-naïve; i.e., virtually all such ADHD subjects had been on stimulant therapy. This being the case, stimulant therapy, not ADHD, is the likely cause of the brain atrophy. There can be no contention that having persons off of stimulants, or off of any psychotropic medication, for a period of 1 month, a few months, or for any period at all, entirely rules out the possibility of drug affect. ADHD has yet to be validated as a disease (with a confirmatory physical or chemical abnormality), a syndrome, or a phenotype (with a confirmatory physical or chemical marker)." To the best of my knowledge, as of today, October 14, 2000: "ADHD has yet to be validated as a disease (with a confirmatory physical or chemical abnormality), a syndrome, or a phenotype (with a confirmatory physical or chemical marker)." None of the articles that you have cited in your letter of September 28, 2000, and no article or articles in the peer-reviewed literature, to date, constitute proof of a physical or chemical abnormality validating ADD/ADHD as a disease, a syndrome, or as anything whatsoever, physical or organic. At the November 16-18, 998, ADHD Consensus Conference, Richard Degrandpre, author of Ritalin Nation [15], commented on the Report of the Panel, as follows: " it appears that you define disease as a maladaptive cluster of characteristics. In the history of science and medicine, this would not be a valid definition of disease." Having failed to prove that ADHD is a disease, it appears that the Panel sought to re-define the word disease. It occurs to me, Dr. Hyman, that you would not be seeking so intently to represent that you have found physical differences in ADHD and in all psychiatric diseases were you not convinced of the need to demonstrate abnormalities to validate them as diseases. There can be no claim in the US today, or anywhere else in the world, that children said to have ADD/ADHD are anything but normal. There is no justification to make patients of normal children/persons and to diagnose and label them (in itself invariably damaging) or to, in any way, treat them, as if there were a legitimate need to do so. There is not. For lack of proof in every article (including the ones you have just offered as proof) and in every press release, ADHD is a fraud. Every normal child thus labeled and drugged is inevitably injured. Those who do this, knowing that the children are normal, must be identified and held accountable. Sincerely, Fred A. Baughman Jr., MD 1303 Hidden Mountain Drive El Cajon, CA 92019 phone 619 440 8236 fax 619 442 1932 cc Congressman Bob Schaffer cc Congressman Pete Hoekstra cc Congressman Henry Hyde Senator Teddy Kennedy Senator Paul Wellstone Senator Pete Domenici Senator Harkin Tipper Gore Enclosures: 1. Letter to Dr. Hyman of September 19, 2000 2. My oral testimony to Committee on Education and the Workforce, hearing entitled "Behavioral Drugs in Schools: Questions and Concerns," held September 29, 2000, 9:00 a.m., in Room 2175, Rayburn House Office Building, Washington, DC, 20515-6100.