FRED
A. BAUGHMAN, JR. M.D.
NEUROLOGY AND CHILD NEUROLOGY (Board Certified)
FELLOW, AMERICAN ACADEMY OF NEUROLOGY
1303 HIDDEN MOUNTAIN DRIVE
EL CAJON, CA 92019
Tele:(619) 440-8236 Fax:
(619) 442-1932
Re:
FDA AS A KNOWING, WILLFUL PARTY TO
THE ADHD FRAUD
(6163 words)
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
.
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 company Shire
(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
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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.
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12 Giedd
JN, Castellanos FX, Casey BJ, et al.
Quantitative morphology of the corpus callosum in attention deficit
hyperactivity disorder.
Am J Psychiatry.
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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.
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15 Baumgardner TL, Singer HS, Denckla MB, et
al.
Corpus callosum morphology in children with Tourette syndrome and attention
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Neurology.
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16 Aylward EH, Reiss AL, Reader MJ,
et al.
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disorder.
J Child Neurol.
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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.
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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.
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22 Mostofsky SH, Reiss AL, Lockhart P, Denckla
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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.