Fred A. Baughman Jr., MD
Representative Cornelius E. Gallagher of New Jersey, presiding, opened the September 29, 1970 Hearing on Federal Involvement in the Use of Behavior Modification Drugs on Grammar School Children: “I want to welcome you here today to ou7r hearing into Federal responsibility in promoting the use of amphetamines to modify the behavior of grammar school children.”… “ One of our witnesses today has been quoted as saying that the use of this type of therapy will “zoom” from its current usage in approximately 200,000 to 300,000 American children today.”… “From the time of puberty onward, each and every child is told that “speed kills” and that amphetamines are to be avoided. Yet this same child has learned that Ritalin, for example, is the only thing which makes him a functioning member of the school environment and both his family and his doctor have urged the pills on him.”
Dr. Ronald Lipman, Chief of the Clinical Studies Section, FDA, testified: “All I am saying is that hyperkinesis is frequently something that brings the child into conflict with his parents, peers, and teachers, and that the teacher observes behavior and has a referral role to play, but, as you know, hyperkinesis is a medical syndrome. It should be properly diagnosed by a medical doctor.”
Here, Lipman, speaking for the FDA, claims that “hyperkinesis”/ “minimal brain dysfunction” (forerunners of ADD, ADHD) is a medical syndrome/a disease/an abnormality within the child, and he does so with no scientific-medical proof whatsoever.
Mr. Gallagher (to Lipman): Then further you state, “I think the results of the last few years of research will soon reach the Nation’s doctors. The pediatricians will begin using them. In effect, what will happen is it will zoom as word of its success spreads throughout the Nation’s medical community.”
Dr. Lipman: “I didn’t use the term ‘zoom.’ I said it would probably increase.”
Mr. Gallagher: “I think your enthusiasm led to the word ‘zoom.’”
In a letter to Chairman Gallagher of November 3, 1970, the Honorable Elliot L. Richardson, Secretary, Department of Health Education and Welfare (HEW) wrote: “As you notice stimulant drug treatment of children with this disorder began in the late 1930’s and has been widely accepted as safe and effective by the medical community.”
Here we have the Secretary of HEW, touting for the pharmaceutical industry, assuring one and all: “We have no vested interest in the use of any one treatment modality and are continuing to look for the most effective treatments and treatment combinations for this disorder.”
Dr. John D. Griffith, Assistant Professor of Psychiatry, Vanderbilt University School of Medicine, testified: “I would like to point out that every drug, however innocuous, has some degree of toxicity. A drug, therefore, is a type of poison and its poisonous qualities must be carefully weighed against its therapeutic usefulness. A problem, now being considered in most of the Capitols of the Free World, is whether the benefits derived from Amphetamines outweigh their toxicity. It is the consensus of the World Scientific Literature that the Amphetamines are of very little benefit to mankind. They are, however, quite toxic…after many years of clinical trials it is now evident that this antidepressant effect of Amphetamines is very brief- on the order of days. If a patient attempts to overcome this tolerance to the drug, he runs the risk of becoming addicted and even more depressed.”
INVENT CHEMICAL IMBALANCES TO RX. WITH CHEMICAL BALANCERS–PILLS
In 1980 the terms “hyperactivity”/ “minimal brain damage” and “minimal brain dysfunction” were replaced by attention deficit disorder—ADD. None, contrary to the testimony of Lipman were ever proved to be an objective abnormality/abnormal phenotype/medical syndrome/disorder/disease or “chemical imbalance. Incidence in 1980: 250 to 500 thousand.
In 1986 Nasrallah, et al [1], reported brain atrophy (CT scans) in young adult males treated with amphetamines as children, and suggested that the amphetamines caused it. Nasrallah, et al (1986) did structural-anatomic computerized tomographic (CT) brain scans on twenty-four adult males with a childhood history of hyperkinesis/minimal brain dysfunction (HK/MBD—forerunner of ADHD), all treated with stimulant drugs during childhood. Fifty-eight percent (58%), fourteen of twenty-four, had brain atrophy, compared to one of twenty-seven, controls (3.8 percent). They concluded: “… since all of the HK/MBD patients had been treated with psychostimulants, cortical atrophy may be a long-term adverse effect of this treatment.”
In the 1987 DSM-III-R [2], ADD became attention-deficit hyperactivity disorder–ADHD. 8 of 14 behaviors were diagnostic! The epidemic: 500,000-750,000.
In 1994 DSM-IV [3], ADHD was re-conceptualized; now, six of the nine behaviors diagnosed 3 subtypes. Still no “chemical imbalance,” no proof the children were abnormal/diseased. Epidemic: approximately 2 million.
1994: Paul Leber, MD, Director, Division of Neuropharmacological Drug Products,
FDA, writes me, December 22, 1994, stating: “that as yet no distinct pathophysiology for the disorder (ADHD) has been delineated.” This is a plain and simple confession from the FDA that no such disease as ADD/ADHD is known to exist. And yet they remain a party—a main player—in the labeling and drugging of disease-free, normal American children called “ADHD.”
In 1996, Schiller, of the Department of Education, and Jensen and Swanson of the NIMH & CHADD [4], wrote: “Once parents and teachers…recognize that children with ADD are not lazy or ‘bad’, but have a biological disorder, they can stop blaming themselves…”
On October 8, 1996, ADHD expert, Lawrence Diller wrote to Mrs. Sue Parry (to testify February 9, 2006 at the FDA): “The reason you have been unable to obtain any articles presenting clear … evidence of a physical or chemical abnormality… is.. there are none… the search for a biological marker is doomed from the outset because of the contradictions and ambiguities of the diagnostic construct of ADHD…
In 1993, I testified at the NIH: “If, as I am convinced, these entities are not diseases, it would be unethical to initiate research to evaluate biological interventions—unethical and fatally flawed scientifically.” I neglected to say “contrary to the Hippocratic oath, “criminal.”
On May, 13, 1998, F. Xavier Castellanos of the NIMH confessed by letter to me: “… we have not yet met the burden of demonstrating the specific pathophysiology that we believe underlies this condition.”
Opening the November 16-18, 1998, NIH, Consensus Conference on ADHD, Steven E. Hyman, Director of the NIMH, posited: “ADHD affects from 0-3% in some school districts up to 40% in others… this cannot be right.”
William B Carey, MD, [5], reporting on “Is ADHD a Valid Disorder?” concluded: “What is…described as ADHD in the United States appears to be a set of normal behavioral variations…”
Richard Degrandpre [6], author of Ritalin Nation, commenting on the Report of the Panel, observed: “… 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.” Failing to prove that ADHD is a disease, they seek to re-define the word ‘disease’.
I testified at the Consensus Conference [7]: “Without an iota of proof … the NIMH proclaims the … children “brain-diseased,” “abnormal.” CHADD, funded by Ciba-Geigy, … has spread the “neuro-biological” lie. The US Department of Education, absolving itself of controlling the children and rendering them literate, coerces the labeling and drugging…ADHD is a total, 100% fraud.”
SWANSON & CASTELLANOS WEAVE ILLUSIONS OF ADHD AS A DISEASE
Now, let us look at the structural-anatomic, CT and MRI brain scan research from Nasrallah et al in 1986 through the ADHD Consensus Conference, held at the National Institutes of Health, November 16-18, 1998, and to the present.
At the Consensus Conference, Swanson and Castellanos [8] reviewed the structural-anatomic MRI literature–the only line of evidence, they claimed, suggesting that ADHD was an actual disease, a brain disease. They concluded: “Recent investigations provide converging evidence that a refined phenotype of ADHD/HKD is characterized by reduced size in specific neuroanatomical regions of the frontal lobes and basal ganglia.” Nor did they (Swanson presenting) leave any doubt that they were claiming that the brain atrophy was due to ADHD, the biological basis of ADHD.
The 14 such studies Swanson and Castellanos reviewed at the Consensus Conference [Hynd et al, (1990)[9], Hynd et al (1991)[10], Hynd et al, (1993)[11], Giedd et al, (1994) [12], Castellanos et al, ( 1994)[13] Semrud-Clikeman et al, (1994)[14], Baumgardner et al, (1996)[15], Aylward et al, (1996)[16], Castellanos et al, (1996)[17], Filipek et al,(1997)[18], Casey et al, (1997)[19], Mataro et al, (1997)[20], Berquin et al, (1998)[21], and Mostofsky et al, (1998)[22] all scanned ADHD-treated subjects—never an ADHD untreated group,proving, time and again, that the treatment/drugs, not the never-validated “disease” ADHD, was the cause of the brain atrophy. Two of these studies did not report whether the ADHD subjects were medicated or not and one did not report clearly. Leo and Cohen [23] estimate that 247 of the 259 total ADHD subjects in these studies–95%–had been medicated (“ADHD-medicated”).
Nonetheless, in virtually all of these studies, the journal titles, abstracts, conclusions, and their attendant press releases, crow the finding of brain atrophy/shrinkage and insisted, time and again, they were the proof that ADHD is a brain disease, never saying a word–except in the fine print of the full manuscript–that virtually all of the subjects were treated (ADHD-treated) and, of course that their treatment with the poisons–Ritalin and the amphetamines–not the never validated “disease” ADHD was surely the cause of their brain atrophy.
When Swanson had finished his Consensus Conference presentation, not saying a word about the “treated” status of virtually all of the ADHD subjects in the studies reviewed, I took a floor microphone and asked: “Dr. Swanson, why didn’t you mention that virtually all of the ADHD subjects in the neuroimaging studies have been on chronic stimulant therapy and that this is the likely cause of their brain atrophy?” Swanson: “…this is a critical issue and in fact I am planning a study to investigate that.” (See the official, NIH video of the Consensus Conference or the video I have produced: ADHD—Total, 100% Fraud)
With no proof of a biological basis for ADHD, the final statement of the Consensus Conference Panel, November 18, 1998, was a necessary confession: “ …we do not have an independent, valid test for ADHD, and there are no data to indicate that ADHD is due to a brain malfunction.” [24]
The discovery that this or that real disease no longer exists would be the end of most epidemics, but not so with ADHD. The phenomenal ADHD epidemic stood at 4-4.5 million at the time the 1998, Consensus Conference came to the conclusion “there are no data to indicate that ADHD is due to a brain malfunction.” Not so with polio and its eradication by the vaccine of Dr. Jonas Salk. But here we speak of a real disease, of which there are none in psychiatry
A January, 2000, Readers Digest article [25] “Castellanos and his group found three areas of the brain to be significantly smaller in ADHD kids than in normal children…Some critics claim that such brain differences in ADHD children might actually be caused by Ritalin…To address this, Castellanos has now embarked on another study, imaging the brains of ADHD youngsters who have not been treated with drugs.” From Nasrallah in 1986 to 2000, and finally, Castellanos and the NIMH were going to do a valid study, they would scan children not drugged, not poisoned. They might, at long last, learn whether or not ADHD children were different than normal children—something they had never proved. Might they prove it now?
STILL REFUSING TO DO VALID RESEARCH
On October 9, 2002, Castellanos et al [26] reported: “…the first neuroimaging study ( the first in all of the MRI literature, 1986-2002) to our knowledge to include a substantial number (n = 49) of previously unmedicated children and adolescents with ADHD.” Here we have a confession there has never in 16 years of brain scanning been a study of an ADHD-unmedicated group of patients. The 49 ADHD-unmedicated subjects had a mean age of 8.3 years vs. the 139 controls with whom they were compared, with a mean age of 10.5 years; 2.2 years younger! How could the ADHD-unmedicated subjects not be smaller, overall? How could they not have smaller bodies, heads, brains? Next, they compared ADHD-medicated (n = 103) to ADHD-unmedicated (n = 49) subjects. The ADHD-unmedicated subjects, mean age 8.3 years, were 2.6 years younger than the ADHD-medicated subjects, mean age 10.9, years. Nor were these two groups suitable for comparison. But this did not stop Castellanos, et al from concluding, as it was predetermined that they should, that: (1) “…the cerebrum as a whole and the cerebellum (essentially, the whole brain) are smaller in children and adolescents with predominantly combined type ADHD,” or, (2) “Conversely, we have no evidence that stimulant drugs cause abnormal brain development,” neither conclusion justified given that none of the comparisons were valid.
Once again, as throughout 16 years of MRI brain scanning research (1996-98), Castellanos, and the NIMH refused to do a valid study, the comparison of a group of ADHD- untreated to a truly matched group of normal controls. A truly matched control group could have been constituted, but was not. Rather, since the 1986, Nasrallah study, they have known that Ritalin-amphetamine treatment induces brain atrophy and they have proven this time-after-time, obscuring however possible their “treated”/“drugged” status while consistently representing that the atrophy produced is, instead, due to ADHD, the abnormality of the brain confirming it is a disease, a brain disease.
Starting with an always-subjective behavioral-emotional, DSM construct, their biological-medical research is destined never to prove a thing. Instead, in this study and in all such studies in “biological psychiatry” the only abnormalities found—and they are real—are those induced by the brain-damaging drugs they are invariably put on.
In fact the entire ADHD-MRI literature, all of it showing atrophy of the brain and brain parts, all of it performed on stimulant-treated subjects is proof, replicated time and again, that these methylphenidate and amphetamines, not the never-validated “brain disease” ADHD, are the cause of the brain atrophy.
The 2003 study of Sowell et al, [27] showed brain atrophy but once again failed to include an ADHD-untreated group. Can there be any doubt that the their market plan is to scan ADHD-treated subjects, knowing they will find brain atrophy, say little or nothing about the fact of their treatment and then represent, in all but the finest print, the brain atrophy to be the “proof “ that ADHD is a “disease.”
The 2003 review of Leo and Cohen [23] lead them to conclude: “We found that most subjects diagnosed with ADD or ADHD had prior medication use, often for several months or years. This substantial confound invalidates any suggestion of ADHD-specific neuropathology. Moreover, the few recent studies using unmedicated subjects have inexplicably avoided making straightforward comparisons of these subjects with controls.”
In other words they have purposely avoided doing valid scientific research. Why? When will they be made to answer? What is the bounty for illusions of ADHD the “disease”?
A CONFESSION: NO SUCH THING AS A PSYCHIATRIC DISEASE
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Actually, the answer to the psychiatric disease/no disease question was delivered by Swanson himself on March 7, 1998, in an address to the American Society of Adolescent Psychiatry, in San Diego (I was there). He confessed, “I would like to have an objective diagnosis for the disorder (ADHD). Right now psychiatric diagnosis is completely subjective…We would like to have biological tests—a dream of psychiatry for many years.” Swanson’s saying this means there is no such thing as an actual disease or physical abnormality in all of psychiatry; it means the brain atrophy in all of the studies, from that of Nasrallah, et al [1], in 1986, up to and including that of Castellanos, et al [26], in JAMA, October, 9, 2002 could only be due to their Ritalin/amphetamine therapy; it means that every physical consequence or side effect of every psychiatric “disease” can only be due to the drug treatments themselves, there being no such thing as an actual, real, genuine, bona fide, psychiatric disease.
Swanson’s saying this also means that the 6 million children in the US with ADHD were entirely normal until the moment their Ritalin/amphetamine “treatment” was begun.
LYING TO PATIENTS–STANDARD OF PRACTICE IN MENTAL HEALTH
On May 28, 2002, I wrote to Bernard Alpert, MD, President of the Medical Board of California (MBC): “Every time parents or a patient is lead to believe that their child’s emotional/behavioral problem is a “disease” due to an abnormality within their body or brain, they have been lied to, their informed consent rights wholly violated…”
On June 14, 2002, Dr. Alpert, responded: “As you outline in your letter, there is tremendous professional support for categorizing emotional and psychological conditions as diseases of the brain. In published materials, some quoted in your letter, you will find that support from chairs of psychiatry departments, the American Psychiatric Association and professors of major medical schools. It is clear that the psychiatric community has set their standard, and while one might disagree with it, that standard becomes the legal standard upon which the Board (CMB) must base its actions.”
Unbelievably, what Alpert, speaking for the Medical Board of the State of California is saying here, is that whatever the majority do, even lie, knowingly violating the informed consent rights of all patients, that that becomes the unassailable, legal “standard of practice. ” Consider, if you will that, conversely, to tell patients the truth—specifically, that ADHD and all psychiatric diseases are not diseases at all, or to fail to prescribe “chemical balancers”- drugs for each and every “chemical imbalance of the brain” would be contrary to the “standard of practice” putting the physician who is the purveyor of truth and science, in legal jeopardy.
ADHD FRAUD: MAKING “PATIENTS” OF NORMAL CHILDREN
The reasons for the forthcoming FDA Hearing, February 9-10, 2006, are set forth in the February 2, 2006, CNNMoney.com by staff writer Aaron Smith in his story (http://money.cnn.com/2006/02/01/news/companies/adhd/index.htm?section=money_latest ) FDA eyes heart risks of ADHD drugs. Agency wants know if medication for attention deficit hyperactivity causes heart attacks in children.
(Smith’s text in quotes, my responses are not)
Writing: “there’s no proof that these drugs cause fatal heart attacks,” Smith ignores the extensive history of cardiac side effects of all Schedule II psychostimulants, those routinely used to treat so-called ADHD (see below).
We know these drugs are poisons and we know they are highly addictive, dangerous and sometimes deadly. The main question the FDA needs to answer concerns ADHD, the “disorder” these addictive, dangerous, sometimes deadly drugs are used to treat. The shocking fact of the matter is that it is not a disorder/disease at all; children said to have it are entirely normal meaning they bear no objective, demonstrable, diagnosable, abnormality, meaning there is no justification for prescribing these or any other drugs for so-called ADHD–a wholly fictitious, wholly subjective entity.
“Following a temporary suspension of Adderall XR in Canada last year, the Food and Drug Administration wants to find ways to study the long-term heart risks of drugs for Attention Deficit Hyperactivity Disorder.”
“Although this sort of news can cause parental panic, there’s no proof that these drugs cause fatal heart attacks.”
This is a failure to acknowledge the world’s scientific literature, an outright lie, or both. To what extent are members of the media bought and paid for by the pharmaceutical industry?
“And Ritalin, the most recognizable name in ADHD treatments, has been FDA-approved and on the market for half a century. The first kids who took Ritalin are now old enough to be concerned about the new Medicare bill. So Ritalin, a Novartis (up $0.44 to $55.60,Research)-produced drug that lost patent protection decades ago, is not a new drug with unseen long-term side effects.”
Ritalin is an old drug with well-known potential to damage the heart and kill. 160 methylphenidate/Ritalin-related deaths were reported to FDA Medwatch voluntary reporting system from 1990-97. See the DEA, October, 1995 Background Paper on Methylphenidate.
“The FDA will be taking a close look at ADHD drugs at an advisory committee on Feb. 9. It is responding to reports of sudden death, heart attack, stroke and hypertension in children and adults taking ADHD drugs, the agency said.”
“The committee will try to find the best way to test the drugs for cardiovascular risks in long-term use.”
“Although it won’t get specific about ADHD products or drug makers, the agency appears to be talking primarily about Adderall XR, the market leader produced by the British companyShire (Research). The FDA issued an alert in 2005 that a Canadian health care agency had pulled Adderall XR off the market because of reports of sudden unexplained death in children taking the drug. It was returned to shelves six months later.”
That it was returned to market by Health Canada (counterpart of the FDA) says nothing of true evidence of risks or benefits. Health Canada refused to answer my letter requesting proofs/references within the medical literature that ADHD is a proven disorder/disease/objective abnormality demonstrable in any patient population.
“ADHD is a mental disorder that impairs concentration and the ability to control behavior in four percent of U.S. adults and three percent to seven percent of children, according to the American Psychiatric Association.”
Saying “disorder” they mean disease, meaning an objective, demonstrable abnormality within the brain or body. None such has ever been proved, children said to have ADHD have never been proved to be other than normal.
“The three drugs are based on separate compounds: methylphenidate hydrochloride for Ritalin; atomoxetine hydrochloride for Strattera, produced by Eli Lilly & Co (up $0.27 to $56.89, Research).; and Adderall XR is an amphetamine. Sold as a generic by various companies, methylphenidate sales totaled $60 million in 2004, according to the most recent figures from Verispan/Drug Topics. This pales in comparison to revenue from its branded competitors: $552 million in 2005 sales for Lilly’s Strattera, and $607 million in 2004 sales for Shire’s Adderall XR, in the most recent figures available.”
“On its label, Adderall XR warns that amphetamine misuse may ‘cause sudden death and serious cardiovascular adverse events.’”
If there are no such risks, as written by reporter Smith , where has this warning come from?
“Since 2005, Strattera has carried an FDA warning label that the drug could increase the risk of suicidal thinking in children and teens, which is the type of warning generally applied to antidepressants. Strattera and Ritalin do not carry warnings of potentially fatal heart problems — although Ritalin’s label urges caution in use with patients with hypertension.”
All drugs, including all drugs used in the treatment of so-called ADHD have some acknowledged risks, that is, all are foreign (to the body) compounds = poisons. What are the risks of having ADHD? Are there any? It is not a disorder = disease = abnormality. There is nothing to treat and make normal or more nearly normal, thus, no justification to give any of these drugs for so-called ADHD.
“Adderall XR, a longer-acting version of Adderall, was yanked off the Canadian market for six months in 2005 because of reports of 20 sudden deaths and 12 strokes in adults and children using the drug.”
Where are results of autopsies kept, in the US, UK, and Canada in ADHD/stimulant, ADHD deaths? Knowing of the findings of Fischer and Fischer and Henderson (see below) have they mandated electron-microscopic studies which would corroborate the pathological findings due to this group of drugs, case by case. If not why not ?
“In February, 2005, the FDA sent out an alert that Health Canada, a government health care agency, had suspended marketing of Adderall XR products ‘due to concern about reports of sudden unexplained death in children taking Adderall and Adderall XR.’ “
“But the FDA alert also said there was “a very small number of cases” and that the agency “cannot conclude that recommended doses of Adderall can cause [sudden unexplained death."”
How could the FDA say this without autopsy results exonerating the drugs. The cardiac consequences of amphetamines are substantial, are known, and should be made public. How could the FDA exonerate Adderall not having provided these particulars to the public?
The FDA did not pull Adderall XR from the market.
In fact, at the time the FDA contacted Health Canada and urged them not to take Adderall XR off the market. Where was the exonerating evidence from the autopsies of the 20 cases of sudden deaths and from the clinical records assessments of the 12 cases of stroke.
‘Health Canada allowed Adderall XR to return to the market in August 2005, with a warning about misuse of the drug and the fact that it should not be used in patients with "structural cardiac abnormalities."’
This infers that the structural abnormalities preexisted Adderall treatment in this ADHD population, a contention never before heard, quite as if these "structural abnormalities" of the heart were co-morbid with, part of ADHD, a contention never before heard. What are these "structural abnormalities"? Were they first found at autopsy? How many persons/children having them were known to have had them prior to Adderall exposure? In how many were they first discovered at autopsy leaving the distinct possibility, even likelihood that they were due to the stimulant treatment. In fact, with ADHD, not in the least proven to be a disorder/disease effecting any system of the body, with their stimulant treatment, the only physical variable, the only plausible explanation for the "structural abnormalities" of the heart is that they were due to the cardiac pathogens--the psychostimulants. The case of Matthew Smith all by itself is powerful evidence of just this. Matthew Smith is dead today not because of ADHD, but, as carefully delineated by the medical examiner, his chronic Ritalin/methylphenidate exposure. Nor is there any other plausible explanation for the death of Stephanie Hall, 11 years old of Canton, OH. No physical predisposing factor other than Ritalin was present leading up to her death, in bed, by cardiac arrhythmia.
“Matt Cabrey, a spokesman for Shire, said there is no proven link between Adderall and sudden deaths in any patients, and that there have been more than 50 million prescriptions for Adderall products since their FDA approval in 1996.”
With his salary paid by Shire, he cannot be expected to say anything negative about the drug. An independent, scientific source(s) is needed.
‘Referring to the upcoming FDA meeting, Cabrey said it's "an important process and Shire is supportive of the committee evaluation."’
“Dr. Andrew Adesman, chief of Developmental and Behavioral Pediatrics at Schneider Children's Hospital in Lake Success, N.Y. and an ADHD expert, believes that Adderall XR did not likely cause the pediatric deaths.”
From MSNBC 2/01: Saying that ADHD is a developmental disorder, also, that it is ‘life-impairing’, Dr. Adesman, implies that it is an actual disease having a detectable, diagnosable, physical or chemical abnormality within the patient. As an MD, responsible for distinguishing those with ‘disease’/abnormality, from those who are normal, Dr. Adesman knows that ADHD is not a disease, and that children said to have it are not demonstrably other than normal. This is the lynch-pin of the ADHD controversy, and it cannot be glossed over. Diagnosis comes first and the first element of ‘diagnosis’ is to determine whether or not a disease/abnormality is present. If an abnormality is present but the exact disease, is not clear, the second part of diagnosis, ‘differential diagnosis’ commences to determine ‘which disease.’ Where no abnormality can be found—and this is the case in 1/3rd to ½ of persons who see physicians (and in 100% of psychiatric, ‘mental’ patients) it is concluded that no disease is present, and no medical treatment is necessary.
“Sudden death from heart attacks does occur in children, but it is rare, and no link to ADHD drugs has been proven.”
It has been absolutely proved in the case of Matthew Smith of Detroit, Michigan. The pathologist/medical examiner in this case concluded that chronic methylphenidate exposure was the cause of Matthew’s lethal cardiac abnormalities. Further, this case has been reported in the national media.
"Adderall XR is back on the market in Canada, because after review it was not clear that Adderall XR was contributing to these risks," said Adesman. "
With ADHD never proved to be a disorder/disease/abnormality, the risk/benefit analysis cannot possibly be positive, in any way justifying administration to what would be a normal/disease-free subject.
“As rare and horrible as these cases are, there's no clear link to medication.”
This is an absolute lie. See here a discussion of the cardiac risks:
RITALIN, PSYCHIATRIC DRUGS & THE HEART
By Fred A. Baughman, Jr., MD
What of Ritalin’s toxicity for the heart? Did the coroner consider that Ritalin might have caused Stephanie Hall’s sudden death, her cardiac arrhythmia? That it might have contributed? Did he look at the extensive literature on Ritalin and other drugs in the amphetamine family and their commonplace cardiovascular effect? After all, the day prior to her death the dose of Ritalin had been increased. That morning seemed real weird, out of it. Her mother kept asking, that morning ‘Steph’ are you OK?’” “She kept saying ‘I’m OK Mom,’ ‘I’m OK.’ Did poor, drugged Stephanie, that last day of her life know what OK really was…what normal was…what it felt like.
As of 1993, there had been 4 sudden deaths associated with Norpramin (desipramine), a member of the family of tricyclic antidepressants (TCAs) and a common alternative to Ritalin, in the treatment of ADHD. In 1995, Werry, of New Zealand, called for an embargo of desipramine in children, but was shouted down by Biederman, et al, of the Harvard-Massachusetts General Hospital, Pediatric Psychopharmacology Group. To date, desipramine- and other TCA-related, sudden, cardiac deaths have risen to16, most of them in normal children said by school teachers, to have ADHD.
As of May, 1996, there were 13 cases of liver failure leading to death or liver transplant from Cylert (pemoline), touted to be the “safest,” of the stimulants.
Of 2,993 adverse reaction (AR) reports concerning “Ritalin” or “methylpenidate” listed by the FDA’s Division of Pharmacovigilance and Epidemiology (DPE), from 1990 to 1997, there were 160 deaths and 569 hospitalizations--36 of them life-threatening. One hundred twentysix (126) were cardiovascular occurrences, and 949 central or peripheral nervous system occurrences. There were 6 cases of “cardiomyopathy,” 12 of “arrhythmia,” 7 of “bradycardia,” (slow pulse), 5 of “bundle branch block,” (impairment of conduction apparatus of the heart), 4 of “EKG abnormality,” 5 “extrasystole,” (heart rhythm abnormalities), 3 “heart arrest,” 2 heart failure, right,” 10 “hypotension,” (low BP), 1 “myocardial infarction,” 15 “tachycardia” (rapid pulse).
While many of Ritalin’s cardiac side effects might be due to its action on the sympathetic nervous system, it may bind to and alter cellular architecture, leading to symptoms and signs that are secondary to actual structural damage.
Ritalin is known to cause cardiac arrhythmia, tachycardia and hypertension. Ritalin and other amphetamines can interfere with the body phospholipid (complex fat) chemistry causing the accumulation of abnormal membranes visible with an electron microscope. Such abnormalities were seen in an adult treated with Ritalin for 4 ½ years. A heart muscle biopsy was obtained during coronary bypass surgery. Fischer (1972) concluded: “Although the patient was exposed to a variety of different drugs, we feel the methylphenindate (Ritalin) should be considered as the incriminating factor since this agent is amphetamine-related.”
Henderson & Fischer (1994) next exposed experimental mice and rats to MP (Ritalin), and found identical membrane proliferation to that in the patient described by Fischer (1972). Moreover, they found that “The MP (Ritalin) doses used in the experimental rodents fell within the range of therapeutic dosage prescribed for patients with attention deficit disorders (ADD/ADHD).”
Other such molecules include fenfluramine (Pondimin)—the ‘fen’ of ‘fen-phen’—the weight reduction compound found to cause heart valve defects, leading to it’s being withdrawn from the market. There have been reports of reversible cardiomyopathy with methamphetamine (Desoxyn, Gradumet); of cardiomyopathy with dextro-amphetamine (Dexedrine) ); of left ventricular failure following a single, i.v. dose of amphetamine, and of sudden reversible cardiomyopathy with fenfluramine (Pondimin) and mazindol (a weight loss drug).
In The Pathology of Drug Abuse, Karch writes: “Amphetamine’s adverse effects on the heart are well established …(sharing) common mechanisms with cocaine toxicity…cardiomyopathy seems to be a complication of amphetamine abuse more often than cocaine abuse…The clinical history in most of these cases is consistent with arrhythmic sudden death (as in Stephanie Hall). Reports of amphetamine-related sudden death were first published shortly after amphetamine became commercially available” (late 1930’s, about the same time Bradley discovered the paradoxical, calming effect of amphetamines that has lead to todays Ritalin epidemic).…Stimulant-related cardiomyopathy has occurred in association with amphetamine, methamphetamine…and methylphenidate (Ritalin)…In all cases there was acute onset of heart failure associated with decreased cardiac output…”
Adesman, continuing: “So the issue [for the FDA] is teasing out whether there’s a risk specific to medication, or whether this is an expected outcome given the numbers of children treated.”
But if the risk of death seems slim or nonexistent, why is the FDA scrutinizing ADHD drugs?
Adesman said the FDA was “put in an awkward light” by the Adderall XR’s temporary suspension in Canada last year and “is obligated to make sure it has the information it needs to be sure that the medicines are as safe as they believe they are.”
It was established above that Matt Cabrey, taken as a spokeman on the subject, is an employee of Shire Pharmaceuticals, manufacturer of Adderall. What about Andrew Adesman, MD? Dr.Adesman is chief of developmental and behavioral pediatrics at Schneider Children's Hospital in New Hyde Park, New York, and associate professor of pediatrics at the Albert Einstein College of Medicine. Dr. Adesman has served on the Board of Directors of CHADD and as a consultant for and advisor to, and on the speaker’s bureau for Eli Lilly, McNeil, Novartis, and Shire.
It seems clear to me that while Dr. Adesman is a medical doctor (MD), he is also a defacto employee of pharmaceutical corporations and is not free to advocate, primarily, for patients. I would add here that I know no ADHD experts, surely none with ties to CHADD, who are any less conflicted by ties to industry than is Dr. Adesman. Notable, Peter S. Jensen, sometimes called “Mr. ADHD,” forbade the use of drugs to treat his ADHD-diagnosed son while advocating such drug treatment for all ADHD-diagnosed children nation-wide, if necessary, by court order. And this for ADHD—made up of subjective symptoms, not a bona fide disease, destined never to be a disease.
NO DOUBT THE FDA IS CALLING IT A DISEASE
In your study, “Effect of Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disroder: A functional magnetic resonance study (NIH study 2514-1 (4-97) PA 09-25-0099),” you write:
“Your child is invited to volunteer in an outpatient research study examining the effects of a single dose of dextroamphetamine on brain activation patterns in healthy children and children with ADHD.”
Saying, “in healthy children and children with ADHD” you infer that those with ADHD are other than healthy, i.e.,diseased, abnormal.
Saying, “Dextroamphetamine is a psychostimulant that has been approved by the FDA for the treatment of ADHD in both children and adolescents,” you infer ADHD is something that needs a treatment, i.e., a disease/abnormality. This has never been proved.
Saying: “Your child has been asked to participate because he/she has been diagnosed with ADHD,” you infer ADHD is a disease/abnormality.
Saying: “The purpose of this study is to compare brain activity between healthy children and children with ADHD,” you infer that children with ADHD are unhealthy/diseased and that their brain activity (as seen on f-MRI scanning) is abnormal.
Saying: “Compare the effects of a single dose of dextroamphetamine on brain activity in healthy children and children with ADHD” once again infers children with ADHD are unhealthy, diseased.
The facts remain:
ADHD is not a disorder/disease; saying it is is a lie and abrogation of informed consent
ADHD is not a disorder/disease meaning children/adults thus diagnosed are physically/medically normal.
The Schedule II stimulants cause brain atrophy.
The Schedule II stimulants cause growth retardation generally
The Schedule II stimulants cause cardiac abnormalities of many types.
The Schedule II stimulants cause chromosomal abnormalities, potential for cancer.
The Schedule II stimulants are highly addictive.
In that ADHD is not a disease, there can be no justification for it’s drug treatment, much less a claim that the risk/benefit ratio for such treatment is “positive.”
In that ADHD is not a disease all drugs for it’s treatment should be removed from the market for human consumption. The fact of the matter is that narcolepsy, is the only real disease for which this group of stimulants is indicated and may have a positive risk/benefit ratio.
References:
1 Nasrallah et al Cortical atrophy in young adults with a history of hyperactivity in childhood. Psychiatric Research, 1986;17:241-246.
2 DSM-III-R, APA, 1987.
3 DSM-IV, APA, 1994
4 Schiller E, Jensen PS, Swanson JM. 1996, in the journal of the Parent Teachers Association (PTA).
5 Carey, WB. NIH Consensus Conference on ADHD, November 16-18, 1998.
6 DeGrandpre, R. NIH Consensus Conference on ADHD, November 16-18, 1998.
7 Baughman, F.A. Jr. NIH Consensus Conference on ADHD, November 16-18, 1998.
8 Swanson J, Castellanos FX. Biological Bases of Attention Deficit Hyperactivity Disorder. NIH Consensus Development Conference on ADHD (p 37-42, program and abstracts), November 16-18, 1998, National Institutes of Health, Bethesda, MD
9 Hynd GW, Semrud-Clikeman M, Lorys AR, et al.
Brain morphology in developmental dyslexia and attention deficit disorder/hyperactivity.
Arch Neurol.
1990;47:919-926.
10 Hynd GW, Semrud-Clikeman M, Lorys AR, et al.
Corpus callosum morphology in attention-deficit hyperactivity disorder: morphometric analysis of MRI.
J Learn Disabil.
1991;24:141-146.
11 Hynd GW, Hern KL, Novey ES, et al.
Attention deficit hyperactivity disorder and asymmetry of the caudate nucleus.
J Child Neurol.
1993;8:339-347.
12 Giedd JN, Castellanos FX, Casey BJ, et al.
Quantitative morphology of the corpus callosum in attention deficit hyperactivity disorder.
Am J Psychiatry.
1994;151:665-669.
13 Castellanos FX, Giedd JN, Eckburg P, et al.
Quantitative morphology of the caudate nucleus in attention deficit hyperactivity disorder.
Am J Psychiatry.
1994;151:1791-1796.
14 Semrud-Clikeman M, Filipek PA, Biederman J, et al.
Attention-deficit hyperactivity disorder: magnetic resonance imaging morphometric analysis of the corpus callosum.
J Am Acad Child Adolesc Psychiatry.
1994;33:875-881.
15 Baumgardner TL, Singer HS, Denckla MB, et al.
Corpus callosum morphology in children with Tourette syndrome and attention deficit hyperactivity disorder.
Neurology.
1996;47:477-482.
.
16 Aylward EH, Reiss AL, Reader MJ, et al.
Basal ganglia volumes in children with attention-deficit hyperactivity disorder.
J Child Neurol.
1996;11:112-115.
295.
17 Castellanos FX, Giedd JN, Marsh WL, et al.
Quantitative brain magnetic resonance imaging in attention-deficit/hyperactivity disorder.
Arch Gen Psychiatry.
1996;53:607-616
18 Filipek PA, Semrud-Clikeman M, Steingard RJ, et al.
Volumetric MRI analysis comparing attention-deficit hyperactivity disorder and normal controls.
Neurology.
1997;48:589-601.
19 Casey BJ, Castellanos FX, Giedd JN, et al.
Implication of right frontostriatal circuitry in response inhibition and attention-deficit/hyperactivity disorder.
J Am Acad Child Adolesc Psychiatry.
1997;36:374-383.
20 Mataro M, et al. Archives of Neurology 54 (1997):963-68
22 Berquin PC, Giedd JN, Jacobsen LK, et al.
The cerebellum in attention-deficit/hyperactivity disorder: a morphometric study.
Neurology.
1998;50:1087-1093.
22 Mostofsky SH, Reiss AL, Lockhart P, Denckla MB.
Evaluation of cerebellar size in attention-deficit hyperactivity disorder.
J Child Neurol.
1998;13:434-439.
23 The 2003 review of Leo and Cohen 2. Leo JL, Cohen DA. Broken brains or flawed studies? A critical review of ADHD neuroimaging studies.The Journal of Mind and Behavior 2003;24(1):29-56.
24 Final statement of the Panel of the Consensus Panel, November 18, 1998.
25 Endnote A January, 2000, Readers Digest article [Pekkanen J. Making Sense of Ritalin(interview of F.X. Castellanos). Readers Digest, January, 2000:159-168.] reported: “Castellanos and his group found three areas of the brain to be significantly smaller in ADHD kids than in normal children…Some critics claim that such brain differences in ADHD children might actually be caused by Ritalin…To address this, Castellanos has now embarked on another study, imaging the brains of ADHD youngsters who have not been treated with drugs.”
26 Developmental Trajectories of Brain Volume Abnormalities in Children and Adolescents With Attention- Deficit/Hyperactivity Disorder F. Xavier Castellanos, Patti P. Lee, MD; Wendy Sharp, MSW; Neal O. Jeffries, PhD; Deanna K. Greenstein, PhD; Liv S. Clasen, PhD; Jonathan D. Blumenthal, MA; Regina S. James, MD; Christen L. Ebens, BA; James M. Walter, MA; Alex Zijdenbos, PhD; Alan C. Evans, PhD; Jay N. Giedd, MD; Judith L. Rapoport, MD JAMA. 2002;288:1740-1748 .
27 The 2003 study of Sowell et al, [34] showed brain atrophy but once again Sowell R, Thompson PM, Welcome SE, Henkenius AL, Toga AW, Peterson BS. Cortical abnormalities in children and adolescents with attention-deficit hyperactivity disorder. The Lancet 2003;362:1699-1707.