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 CLINICAL TRIALS: "Planned Ritalin Trial for Tots Heads Into Uncharted
 Waters."  Science, November 17, 2000; 1280-1282, by Eliot Marshall

[Fred A. Baughman Jr., MD:
Here we have an august, scientific, journal/publication - SCIENCE
magazine - commenting upon a research proposal authored by the National
Institute of Mental Health to recruit and drug 2 - 5 year old children
with no objectively demonstrable abnormality or disease.

SCIENCE, like other peer-reviewed, scientific and medical journals over
the past 20-25 years, speaks of this research as 'controversial'.
However, SCIENCE does not identify the primary source of controversy:
this disease has been contrived. The ADHD diagnosis is not and has
never been verified or confirmed through an abnormality within their
brain or body.

In other words, the main source of controversy, just as in drug
treatment throughout child/adolescent psychiatric research and practice,
is that none of these disorders/diseases are proven as diseases. Not a
single one of the children they drug has been demonstrated to be other
than normal at the time their 'treatment'/drugging began. However, once
these foreign chemicals and compounds circulate daily, monthly, yearly
through their brains and bodies, they become clearly diagnosable as
abnormal, and increasingly so over time.

W.B. Carey testified at the November 16-18, 1998, NIH, Consensus
Conference: " .What is now most often described as ADHD in the United
States appears to be a set of normal behavioral variations. This
discrepancy leaves the validity of the construct in doubt." Carey's
statement was not an expression of his own belief or of that of some
group - it was an expression of the fact that nowhere in the scientific
literature of the world has there been proof of a confirmatory,
characteristic, physical or chemical abnormality to validate ADHD as a

Carey went on: "The ADHD behaviors are assumed to be largely or entirely
due to abnormal brain function. The DSM-IV does not say so, but
textbooks and journals do." With no proof, how can leaders of
medical/scientific academia, those who author the textbooks and
journals, go on saying such things, knowing that their statements are
unproved and untrue; knowing that the children being made into
'patients', then 'treated'/drugged, are normal?

Carey also told the Consensus Conference that most text books and
journals state, overtly, that ADHD is a disease. Others regularly imply
it, as if there were no doubt, as if it has been proven that children
labeled by pencil-and-paper behavior checklists are diseased/abnormal,
and as it it were negligent, even criminal to leave them untreated

Virtually every US journal in psychiatry, neurology, pediatrics, and
general and family practice including all of the most august - The New
England Journal of Medicine, JAMA, PEDIATRICS, and NEUROLOGY, as well as
the THE LANCET (from the U.K.- not immune to the influence) - have
written of ADHD as if it were a legitimate, proven, neurological,
biological disease and epidemic, fostering its feverish 'diagnosis' and

All the while ADHD has never been proved. It has never been a disease.
And all the while those millions upon millions of children - labeled and
drugged, made fodder for medicine-- in economic disarray, and for the
pharmaceutical industry - were nothing other than normal.

And now they would victimize normal 2 - 5 year olds. Although they
cannot diagnose this "disease" by any objective standard in individuals
above the age of 6, now, they tell us, they will ‘diagnose’ ADHD from
cradle to kindergarten. Diagnosis leads directly to administration of
drugs. We already know they can drug!

Finally, discussing the Consensus Conference Panel statement, Carey
implored the professors of ADHD - those who write of ADHD in the
textbooks and journals: " . we see the statement that there is no
diagnostic test for ADHD and that the causes of these behaviors called
ADHD are entirely speculative. And yet, out there in the real world,
parents and children are being told that these behaviors are due to a
brain malfunction. Can you not please strengthen the statement to
discourage practitioners from making this statement when there is not
adequate proof to support that at this time?"

Would that his peers would heed Carey's words.]

 A new study of whether a popular but controversial drug is safe and
 effective for preschool children also raises ethical concerns about
 using young subjects in clinical trials.  Doctors like to say that
 medicine is an art as well as a science. But the science seems a bit
 thin when it comes to giving drugs to young children.

[Fred A. Baughman Jr., MD:
The above is especially true when those young children have no
discernible disease, i.e., are normal. When there is no science - and no
actual disease - no amount of art justifies giving normal children,
especially not such young innocents, drugs that are addictive, dangerous
and even deadly. Here we have the journal SCIENCE scrutinizing the
diagnosis and treatment of so-called ADHD. Is it to much ask that
SCIENCE would illuminate and explain the "Is it a disease or isn’t it"
controversy: ADD/ADHD, regardless of its several conceptualizations,
has never been validated as a diagnosable disease. Without such
consideration, there can be no final statement made as to the
risk/benefit ratio of treatment thereof with the usual drugs, Ritalin
and amphetamines.]

 Physicians write millions of prescriptions for children each year
 without solid  evidence that the therapy they're offering is safe or
 effective. To fill in that knowledge gap, U.S. scientists are gearing up
 for a major clinical trial intended to measure the effects of a popular
 stimulant on a previously untested population -- children aged 3 to 6.
 But in doing so, they are also running up against one of the hottest
 ethical issues in research.

[Fred A. Baughman Jr., MD:
The knowledge gap that supersedes all others is that the subjects
said to have ADHD in the PATS study proposed by the NIMH have not been
shown to have any disease, i.e., have not been shown to be other than
normal. The true ethical issue is the labeling of normal children as
diseased/abnormal, and making them 'patients' for purposes of for-profit
medical practice or 'subjects' for medical or surgical experimentation.
Such was the prevailing ethic in the Third Reich. Tell me it has not
become acceptable in the U.S.?]

 The study, funded by the National Institute of Mental Health (NIMH) in
 Bethesda, Maryland, and set to begin in December, will recruit about 300
 preschoolers  diagnosed with attention deficit hyperactivity disorder

[Fred A. Baughman Jr., MD:
None of the versions of ADHD in the DSM (ADD in DSM III, 1980; ADHD
in DSM III R, 1987 and in DSM IV, 1994) nor any other psychiatric
'disorder' have been proven to be a disease due to an abnormality within
the brain or body of the 'patient'. This being the case, the subjects
are physically normal, and, regardless of age, it is not justifiable to
'treat' them with drugs that are known to be addictive, dangerous, and
even deadly.

It is truly amazing, and inexcusable, that the fundamental disease vs.
no disease distinction is lost upon a publication such as SCIENCE. If no
physical or chemical abnormality, i.e., disease, is demonstrable in the
patient it cannot be said that a physical or chemical abnormality, i.e.,
disease, is a variable, i.e., determinant of the behavior of the
child/adult in question. This being the case, it can only be said that
situational/circumstantial factors are at work, as in all normal

 Almost half will receive Ritalin, or methylphenidate (MPH), a drug used
 to help older children get along with playmates and fit into school
 routines. The scientists involved in the study admit that they are
 concerned about the drug's effect on the children's still-developing
 personalities and brains, as well as their inability to give informed

[Fred A. Baughman Jr., MD:
In this study, informed consent will be sought from the parents.
However, parents cannot give informed consent so long as they are have
been persuaded that ADHD is a disease caused by an abnormality within
the child. Nor can they give informed consent when they are not told of
the 14 years of brain scanning research that leaves no doubt that
treatment with these drugs in older children and adolescents causes 'on
average 10% brain atrophy' (J Swanson & FX Castellanos in "Biological
Bases pf ADHD" NIH Consensus Conference on ADHD, November 16-18, 1999;
FX Castellanos interview in "Making Sense of Ritalin," Reader’s Digest,
January, 2000.]

 But they believe that such trials are the only way to answer concerns
 about rising use of the drug among this population. "We've put the study
 through an ethical wringer" to win approval, says NIMH director Steven

[Fred A. Baughman Jr., MD:
The foxes are guarding the hen house. Drs. Hyman, Castellanos, and
Jensen of the NIMH, and virtually all in the hierarchy of ADHD research
know as well as I that none of the subjects in their proposed ADHD
research are other than normal. They know this to be true for the simple
reason that ADHD has never been proven to be a disease.]

 However, the demand for better scientific data runs counter to growing
 concern about human subjects research. "There is a big clash between the
 pressure to include children in clinical trials [and] discomfort about
 enrolling young children" in studies, says Norman Fost, a pediatric
 researcher and bioethicist at the University of Wisconsin, Madison. The
 ethical problems are reduced if the child volunteers have a chance of
 benefiting from experimental therapy, says Fost, who also notes that
 NIMH can be trusted to provide rigorous oversight.

[Fred A. Baughman Jr., MD:
Dr. Fost is a bioethicist, who, like most bioethicists, are from
the world of medical academia, which, like psychiatry in general, is
largely bought and paid for by industry -- primarily by the
pharmaceutical industry. It is no wonder that they find a friendly,
'ethical' interpretation for such a wholly un-ethical research
undertaking. See "The Kept University" by E. Press and J. Washburn, The
Atlantic Monthly, March, 2000.]

 Drugs without data
 The idea for undertaking a trial like this arose 3 years ago, when
 psychiatrist Laurence Greenhill of the New York State Psychiatric
 Institute met with other academic researchers and NIMH to discuss the
 lack of safety and dose information for treating children under 6 with

[Fred A. Baughman Jr., MD:
Where, Dr. Greenhill, are the abnormalities/diseases you propose to
treat? This is where all therapy begins. If there is no disease, no
abnormality, then there is no place for medical intervention, i.e., for
treatment. The fact, disclosed by Zito, et al, in JAMA early this year,
that thousands of infants are already being 'treated' with
psycho-stimulants, does not constitute proof that this is justifiable
medical undertaking. I have written condemning this as 'criminal' and
see no reason whatever to change that assessment. The bigger the
endeavor and the more it obtains officialdom's imprimatur, the wider and
more heinous the crime. To understand Dr. Greenhill's or anyone's
motives for proposing such medical treatment in children having no
diagnosable disease, one would have to see their complete financial
statements - as complete as those required for your home mortgage.]

 He proposed a large multicenter study that would enlist preschoolers in
 a test that would establish the best dose for very young children--a
 group rarely tested for any type of drug use. Peer reviewers at the
 National Institutes of Health (NIH) gave the proposal, called the
 Preschool ADHD Treatment Study (PATS), a favorable score in 1998. It
 then wended its way slowly through a series of ethics and policy review

[Fred A. Baughman Jr., MD:
Again, a detailed financial statement for each and every peer
reviewer involved in the process should be required and would be
necessary to understand how it has come to pass that normal
children/persons of any age are made subjects in drug experiments such
as this.]

 Its importance seemed to grow, as people became increasingly aware of
 the need for better scientific data for some popular prescription drugs.
 Companies have run very few drug trials that include young children, but
 this hasn't stopped doctors from writing prescriptions. By one estimate,
 94% of drugs given to children are prescribed "off label" in this way.

[Fred A. Baughman Jr., MD:
Nor does this or any level of "off label" prescribing justify such
a practice or the research proposal to give psycho-stimulants,
experimentally, to 3-5 year olds who have no disease, who are normal.
All this proves is that vast numbers of physicians have incorporated the
psychiatric labeling and drugging of normal children into their

 In 1997, the Food and Drug Administration (FDA) drew up a "short list"
 of the 10 most widely prescribed products used for children without FDA
 approval. They ranged from the anti-asthma drug Albuterol, approved only
 for children aged 12 and older, to the antidepressant Zoloft, approved
 for those 16 and older. Ritalin is on the list, prescribed 226,000 times
 in 1994 for off-label uses.

[Fred A. Baughman Jr., MD:
Albuterol for asthma differs from the proposed Ritalin/stimulant
therapy for 3 to 5 year olds in that asthma is an actual disease with
diagnosable physical abnormalities.]

 Early this year, epidemiologist Julie Zito of the University of
 Maryland, Baltimore, reported in the Journal of the American Medical
 Association (JAMA) that the off-label use of psychoactive drugs by
 youngsters has increased steadily. Using Medicaid and insurance data,
 she traced a tripling from 1991 to 1995 in the use of psychoactive
 medicines among children 2 to 4 years old.  MPH topped the list, and
 Zito estimates that there may now be 150,000 to 200,000 U.S. children in
 this age group taking it.

[Fred A. Baughman Jr., MD:
This drugging of 2-4 year olds with no demonstrable disease, i.e.,
who are normal, is in no way justifiable. The perpetrators know there is
no disease but, in virtually all cases, represent that there is, for
purposes of gaining 'informed consent' to begin drugging. There is no
legitimacy here. It is criminal to allege to all concerned that a
disease being treated, while knowing that the disease does not exist and
never has.]

 Commenting on Zito's findings in the same issue of JAMA, Harvard
 University psychiatrist Joseph Coyle asked whether psychoactive drugs
 might affect the development of visual processing, language, motor
 skills, and memory of young children. The "disturbing prescription
 practices" documented by Zito, he said, deserve "more thorough

[Fred A. Baughman Jr., MD:
Coyle's expression of concern is rare from among the ranks of
academic psychiatry. One wonders if his concern springs from the known
dangers of these drugs, or from the fact that these are normal toddlers
and preschoolers with vulnerable, rapidly growing, developing brains, or
both. He should be quizzed as to the legitimacy and advisability of
going forth with the NIMH, PATS research.]

 Hillary Clinton and White House health policy staffers picked up the
 message in March, urging officials to warn the public of the risks of
 off-label use of psychoactive drugs. With such encouragement, NIMH moved
 ahead and on 30 September awarded $6 million to Greenhill and colleagues
 at five other psychiatric centers.

 PATS is part of a broader effort to get better information on how
 prescription drugs affect children. Since the mid-1990s, advocates for
 children's health have been lobbying to get clinical researchers to
 include young volunteers in their studies, just as others campaigned to
 increase the representation of women and minorities in research.

[Fred A. Baughman Jr., MD:
What advocates, financed by whom? ]

 Now they've succeeded, and both FDA and NIH are taking steps to enroll
 thousands of children in clinical trials.

[Fred A. Baughman Jr., MD:
These are like the thousands of children all over the country who
are physically normal until the day that psychiatric drugs begin
circulating through their bodies and brains. The diagnostic labels they
will be given, although defining no disease or abnormality, will stick,
will stigmatize, and will lead both to their ongoing participation in
psychiatric drug trials, and to their continued role as psychiatric
patients. There are no cures and no 'discharges'. The only way to
normalcy, or what remains of it, is to leave 'against medical advice,'
'against psychiatric advice.']

 A 1997 law giving FDA new authority for such trials allows it to reward
 companies with exclusive marketing rights to a drug for 6 months if they
 agree to study the safety and efficacy of treating children. An April
 1999 FDA rule requires companies seeking approval of a new drug to run
 tests that include children, if children are suitable candidates for
 therapy. In the psychiatric area, an FDA official said recently, the
 agency has already requested pediatric studies of drugs for
 posttraumatic stress, mania, social anxiety, and "premenstrual dysphoric
 disorder." Soon, it may ask companies to study pediatric drugs for
 "conduct disorder" (a type of aggressiveness), panic disorder, and

 In parallel, the National Institute of Child Health and Human
 Development has created a 13-site network to provide technical support
 for more than 50 industry-sponsored trials of nonpsychiatric drugs. A
 recent announcement boasts of access to a pediatric population with
 160,000 inpatient admissions and 2.3 million outpatient visits annually.
 NIMH has set up a seven-site clinical network to support similar work
 called the Research Units on Pediatric Psychopharmacology. All of these
 changes, a recent NIH announcement notes, have produced "an
 unprecedented surge in the number of pediatric drug trials."

 But PATS is the first major trial for preschoolers. "We are breaking new
 ground with this study; there was no prototype," said Benedetto
 Vitiello, chief of NIMH's branch of child and adolescent treatment and
 preventive intervention, who spoke last month at a public forum on the
 PATS trial in New York City. *

[Fred A. Baughman Jr., MD:
Dr. Vitiello also knows that ADHD has never been validated as a
disease having a confirmatory, diagnostic, physical or chemical

 Trials and tribulations
 Designers of the PATS trial have faced some novel challenges. One of the
 first was to develop a definition of ADHD for 3-year-olds. A child may
 be included only if an experienced clinician using an agreed-on set of
 behavioral criteria makes the ADHD diagnosis, a parent and a teacher
 both rate the child as troubled, and the child has exhibited symptoms
 for 9 months. Another hurdle is overcoming skepticism about the
 diagnosis, which has been controversial for decades.

[Fred A. Baughman Jr., MD:
The 1980 DSM III version (ADD) was never validated as a disease
before it was reconceptualized as ADHD in 1987. The 1987 DSM III R
version of ADHD was never validated as a disease before it was
reconceptualized into the 1994 DSM IV version of ADHD. The DSM IV
version of ADHD has not, to this day, regardless of age, been validated
as a disease due to a physical abnormality within the subject. And now
they plan to develop a definition of ADHD in 3 year olds?]

 Today, ADHD is said to be a common disorder, affecting as much as 5% of
 the school-age population.

 But critics question whether it makes sense to rely so heavily on
 chemicals,  because ADHD isn't defined by a biochemical or even physical

[Fred A. Baughman Jr., MD:
Having acknowledged that ADHD isn't defined by a biochemical or
even a physical abnormality, what medical, moral or ethical standard
could possibly view administering drugs (poisons) as acceptable?]

 These doubters range from the die-hard variety, like the Bethesda,
 Maryland, psychiatrist Peter Breggin, to moderate skeptics like
 pediatrician William Carey of the Philadelphia Children's Hospital.
 Carey has written that the "assumption that ADHD symptoms arise from
 cerebral malfunction has not been supported, even after extensive

[Fred A. Baughman Jr., MD:
This is medical science speaking clearly. Support of ADHD as a bona
fide disease is not a matter of belief or consensus, but of science and,
as in all diseases, whether or not a confirmatory, diagnosable physical
or chemical abnormality can be found in the patient, and found

 The "very fuzzy" diagnosis of ADHD for school-age children includes a
 broad range of normal behaviors, he says.

 Breggin, meanwhile, has signed up as an expert witness for parents of
 ADHD children who this year filed lawsuits against the manufacturer of
 Ritalin and psychiatric organizations in several states, alleging that
 they conspired to promote the drug. Breggin and California neurologist
 Fred Baughman Jr. blasted the use of Ritalin in congressional testimony
 on 29 September. Baughman called the ADHD diagnosis "a total fraud."
 Enrolling young children in a trial of MPH, he adds, is
 "outrageous" and "immoral."

 Robert Findling, a psychiatrist at Case Western Reserve University in
 Cleveland, Ohio, who conducts research in this field, dismisses such
 views as "nihilist" and says that they don't carry much weight among the

[Fred A. Baughman Jr., MD:
Such views don't carry much weight among the credentialed,
industry-sponsored ADHD experts - experts in a disease that doesn't
exist, that was created/invented/conceptualized as a reason to
administer Ritalin.]

 Greenhill acknowledges that ADHD is "not a well-defined psychiatric
 disorder in this age group." Findling agrees but says that ambiguity
 should not be an excuse for inaction.

[Fred A. Baughman Jr., MD:
Is Findling saying 'whether it actually exists or not shouldn't get
in their way'?]

 "Just because we don't know what causes it doesn't mean it's not a
 problem," he argues.

[Fred A. Baughman Jr., MD:
Is Findling saying that if something is a problem, regardless of
the cause of the problem, potent and dangerous drugs are a justified

 "This is not just benign fidgetiness. ... Parents will tell you how
 awful it is that these kids can't be taken out in public because they're
 so impaired. We know they suffer for years and years."

 Hyman agrees that researchers have not identified any distinguishing
 biological hallmarks of ADHD. But he says that the disorder is well
 defined in behavioral terms, that ADHD children who fail to receive
 treatment often suffer life-changing harm, that older ADHD kids appear
 to benefit from drug therapy, and that no "really gross side effects"
 have been documented. All this adds up to a strong argument for the
 trial, he believes. "Without good clinical data, every child who
 receives this
 medication represents an uncontrolled experiment," says Hyman. "That is
 entirely unacceptable."

[Fred A. Baughman Jr., MD:
Hyman, and all at the NIMH, have kept from the public the results
of 14 years of brain scan research which shows conclusively, not that
ADHD is due to brain atrophy, but that the brain atrophy was caused by
the Ritalin/stimulant therapy administered to virtually all ADHD
subjects. The younger the infant/child, the more vulnerable their brain.
This is among the more compelling reasons to cancel the PATS research.]

 Assessment of efficacy is another major issue. How will researchers know
 whether a 3-year-old is functioning "on-task" during therapy -- one of
 the goals of giving MPH? Greenhill explains: "We're going to set up a
 laboratory classroom, and we'll observe common tasks done in nursery
 school," such as stacking blocks and stringing beads on a thread.
 Children will be asked to sit in a circle and take part in group events.
 The test will be whether the child is "compliant" and participates or
 "attends for a few seconds before drifting away and doing everything
 else in the room."

[Fred A. Baughman Jr., MD:
Does this not sound hopelessly subjective? Based on whether or not
the infant/toddler is "on-task", "compliant" or "attends for a few
seconds," they will be given dangerous, addictive, sometimes deadly,
always brain-altering drugs.]

 The PATS researchers have taken other steps to allay qualms about the
 effects of MPH therapy itself and the difficult issue of getting
 informed consent. Each family will begin the trial with a 10-session
 "training" period in which researchers will attempt to treat ADHD with
 nonchemical therapy.

[Fred A. Baughman Jr., MD:
What are the researchers' biases? How many will be, directly or
indirectly, financed by drug companies ?]

 Only if this fails will a child be assigned randomly to drug therapy or
 a placebo group. To address concerns about the effect of MPH on young
 children, only very low doses of MPH will be used in the initial
 stage--so low that a planning memo calls the level "homeopathic."

 In fact, Greenhill anticipates that this initial dose may have no
 effect. Once safety has been demonstrated, children will receive
 gradually higher doses until they reach a "best dose," which they will
 receive for 40 weeks.  No child will be enrolled who lacks the language
 skills to "indicate that he or she is in distress," and parents will be
 given information and asked to give fresh consent on behalf of their
 child at each of the five stages of the trial.

 After what Vitiello calls "zillions" of safety and ethics reviews and
 funding approval, the trial received a final green light from the data
 safety monitoring board. Greenhill says the clinics will begin
 recruiting the first subjects in a few weeks.
 * Research Forum on Optimal Strategies for Developing and Implementing
 Psychopharmacologic Studies in Preschool Children, Annual Meeting of the
 American Academy of Child and Adolescent Psychiatry, 25 October, New
 York City.

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