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               Lilly says Ritalin alternative
               shows significant promise
               Alternative treats disorder without stimulants
               By Thomas M. Burton

               October 26 (2000)— For decades, it has been a Holy Grail
               of medical research to find a treatment for
               attention-deficit disorder that doesn’t involve the
               use of stimulants. Now, it appears that the goal is
               at hand.

[Fred A. Baughman Jr., MD:
Speaking of Holy Grails, Lawrence Diller, author of Running on Ritalin
and a conferee at the DEA Conference on Stimulant Use in the Treatment
of ADHD, December, 10-12, 1996, wrote, "The reason why you have been
unable to obtain any articles or studies presenting clear and confirming
evidence of a physical or chemical abnormality associated with ADHD is
that there are none. Not that medical science, especially in recent
years, hasn’t tried. However the search for a biological marker is
doomed from the outset because of the contradictions and ambiguities of
the diagnostic construct of ADHD as defined by the DSM. I liken efforts
to discover a marker to the search for the Holy Grail." ]

               Research on an Eli Lilly & Co. drug, to be made public
               in New York Thursday at a child-psychiatry conference,
               suggests the medicine improves concentration to a degree
               similar to that of Ritalin, the primary treatment for
               attention-deficit disorder, or ADD. Unlike Ritalin and other
               treatments, the Lilly drug, tomoxetine, isn’t a stimulant.
               Researchers say it doesn’t trigger sleeplessness and has
               relatively little tendency to suppress appetites.

[Fred A. Baughman Jr., MD:
These are things CHADD says Ritalin never does]

               ADD is often
               characterized by an inability to concentrate and sometimes
               by aggression and hyperactivity.
                      "This will open windows for patients who would
               otherwise not be medicated," says Joseph Biederman, the
               chief of pediatric psychopharmacology at Massachusetts
               General Hospital, in Boston, who ran the recent study on

[Fred A. Baughman Jr., MD:
Pharmacology, clinical: the branch of pharmacology concerned with the
pharmacology of therapeutic agents in the prevention, treatment and
control of diseases in man (Stedman’s, 25th Edition). In that
‘psychopharmacology’ deals not with diseases (disease = abnormality),
but with emotional/behavioral problems in normal (normal = no disease)
persons, it cannot be considered a branch of clinical pharmacology.
They are quite fond of framing everything they do in medical/biological
terms when there is no biology and—there being no diseases—there is
nothing medical. The ‘specialty’ of pediatric psychopharmacology is
that which give brain-altering, brain-damaging drugs to normal infants,
toddlers and children with emotional/behavioral problems. That is, the
infants, toddlers, and children were normal until the foreign
compounds/drugs, targeting no known abnormality, were begun. Yet
another definition I have come across impresses. Pharmacomania:
(Dorland, 21st Edition) abnormal fondness for taking or administering
drugs. This, it would seem is endemic in only the North American mental
health industry at the turn of the century. 96% of Ritalin/amphetamine
use in the world, virtually all of it in children, for the fraudulent
disease—ADHD, is in North America]

               These findings place Lilly, of Indianapolis, at the front
               of the pharmaceutical footrace to treat ADD and 
               closely-related ADHD, attention deficit/hyperactivity
               disorder. Glaxo Wellcome PLC’s U.S. unit is in the race,
               too, and also is presenting research results Friday of its own
               new drug, called GW320659; Glaxo says the drug is also
               being studied for its effectiveness against other illnesses.
               Another entrant is Abbott Laboratories, but Abbott hasn’t
               started testing its ADD drug in humans.
                     For Lilly, tomoxetine could provide a badly needed
               boost. Its leading product, the antidepressant Prozac, will
               lose patent protection next August unless the company
               prevails on appeal of a patent lawsuit.
                      "The market could easily exceed $1 billion for a
               product like tomoxetine," says independent
               medical-industry analyst Hemant K. Shah.  "Ritalin has such
               a bad name that it would not be that difficult to convert
               people to a nonstimulant." Ritalin, a Novartis AG brand
               name for a controlled substance whose use is monitored by
               law enforcement authorities, is one of several drugs that
               critics have said are overprescribed for children. About 11
               million prescriptions for Ritalin and its generic equivalents
               were written in the U.S. last year, for an estimated 1 million
               to 1.5 million patients, mostly children. Since more than
               80% of these were for the generic version, called
               methylphenidate, the 1999 sales in dollars were only $400
               million. The entire category of stimulant drugs to treat ADD,
               including Adderall and Dexedrine, has generated sales of
               more than $900 million during the most recent 12 months.
                      Mr. Shah estimates that a high percentage of Ritalin
               patients would switch to an alternative. Moreover, about
               30% of ADD patients don’t respond to Ritalin or any of the
               stimulant drugs, and about 50% have difficulties with side
               effects, primarily insomnia and appetite suppression.
                      The Lilly clinical studies are considered Phase II,
               meaning one more stage of research is needed for the Food
               and Drug Administration to consider approval. Things could
               still go wrong for Lilly. However, there were already 127
               children involved in the research — a relatively large
               number — and the findings were compelling. Youngsters on
               tomoxetine had nearly three times the improvement of
               children taking a placebo. Their improvement nearly
               matched that with Ritalin.
                      The study’s results regarding insomnia were powerful in
               favor of tomoxetine: Among Ritalin patients, 27% had
               insomnia, as did 9% of patients on a placebo. Only 7% of
               patients on tomoxetine reported insomnia.
                      "I truly think we’re going to be the first company to
               bring a nonstimulant alternative to the market," says John H.
               Heiligenstein, a Lilly research physician who first suggested
               using the drug in attention-deficit children.
                      Joseph DeVeaugh-Geiss, Glaxo vice president of
               neurology and psychiatry-clinical research, agrees, "We’re
               not as advanced in development as they are." He says,
               though, that Glaxo has had "really good response" with its
               new drug and that about 76% of 46 child patients
               responded to the Glaxo medication. (Glaxo’s results to be
               made public Friday don’t include a placebo group for
                      ADD has been the topic of controversy for years.
               Many have debated whether it truly is a medical condition.
               British doctor who identified it in 1902 thought it
               stemmed from what he called a "defect in moral control."
               More recently, many Americans have grown convinced the
               condition is at least overdiagnosed and that many children
               are overmedicated. In May, a Dallas law firm filed a
               would-be class action in state court in Brownsville, Texas,
               alleging Novartis overpromoted Ritalin and failed to disclose
               adequately a range of side effects of the drug. Novartis
               called the suit "without merit."
                      Even so, there is increasing evidence that in perhaps as
               many as 3% to 5% of children and in some adults ADD
               does exist and is triggered by abnormal activity in the brain.
                      It has been known for decades that insufficient amounts
               of the brain chemical dopamine play a role in ADD.

[Fred A. Baughman Jr., MD:
This is an industry-planted piece without a doubt. Here they say—and
you must read this carefully: "It has been known for decades that
insufficient amounts of the brain chemical
dopamine play a role in ADD." No such thing has ever been proven. No
physical or chemical defect has ever been proven validating ADD (by
whatever acronym) as a disease, with objective abnormality = disease]

               Within the
               last decades, evidence has accumulated that deficiency of
               another brain chemical, norepinephrine, also is involved.

[Fred A. Baughman Jr., MD:
If the first lie doesn’t fly, try another. Nor does proof exist of a
defect of norepinephrine.]

               The precise
               role of both is uncertain, but a physiological cause of the
               condition appears more and more likely.

[Fred A. Baughman Jr., MD:
And here we have the caveat: "The precise role of both is uncertain."
As they well know, the role of both is unproven! They as much as
confess this in saying "a physiological cause of the condition appears
more and more likely." Is this not deception?]

                      Stimulants such as amphetamines have been the
               dominant form of treatment since the 1930s, when their
               effects on ADD were discovered by accident. Ritalin,
               introduced in 1955, primarily works by increasing dopamine
               levels. But side effects also have been a problem, and
               efforts to find a drug that avoided them have fallen short
               until now. One drug, desipramine, an antidepressant used to
               treat ADD in the 1980s, worked well, but a handful of
               sudden cardiac deaths occurred in children, and 
               desipramine’s use for the condition almost stopped
               overnight about a decade ago.

[Fred A. Baughman Jr., MD:
Psychiatrist John Werry of New Zealand called for an embargo of
desipramine in 1995 but was shouted down by US psychiatrists, Biederman,
et al, of the Mass General drugging unit. Despite the
no-one-knows-how-many sudden cardiac deaths there were in normal
children with emtional/behavioral problems, due to desipramine, it’s
continued availability was thus assured. The ever-present question
remains: how can physicians (psychiatrists among them) serve their
pharmaceutical masters and their human patients at the same time.
Increasingly, I am of the opinion that they absolutely cannot.]

               An Abbott drug called
               Cylert, introduced in the mid-1970s, showed great promise
               but quickly fell out of favor because of acute liver toxicity.

[Fred A. Baughman Jr., MD:
Liver deaths, and liver transplants as the only way to avoid death.
"acute liver toxicity" doesn’t quite tell the story. Furthermore, the
actual numbers of such deaths and transplants was continually
understated. In Canada, where the government still values human life
more than industry dollars with which to fuel political machinery,
Cylert was removed from the market. But here in the USA, the FDA, a
sham as a protector of the public, has seen to it that Cylert remains
available. After all there is so much ADD/ADHD yet to be treated—every
last one of them normal until the drugging starts.]

               Researchers also tested the new class of antidepressants,
               such as Prozac and Zoloft, in ADD patients, with generally
               unsatisfactory results.
                      Early in the 1990s, Lilly’s Dr. Heiligenstein, a
               pediatrician and child psychiatrist, developed his own ideas
               about ADD and its causes.

[Fred A. Baughman Jr., MD:
Lilly—Dr. Heiligenstein, where exactly (cite the article, articles) is
the proof that ADD/ADHD exists? Where is the proof that the children
being targeted by industry and all of psychiatry for these drugs and
nothing else are other than normal when labeled. (in that no disease =
abnormality is proven, demonstrated, we should be loathe to use the term

               He was convinced that a drug
               that worked just on norepinephrine might treat ADD
               without the stimulants’ side effects. Tomoxetine, originally
               developed to be an antidepressant, was such a drug, so he
               convinced the Mass General researchers to try it.
                      The research group had to move fast: The last batch of
               tomoxetine usable in clinical tests was due to hit its
               expiration date in April 1995. If researchers couldn’t prove
               to company executives tomoxetine’s usefulness by then, it
               would be abandoned. But the first test of the drug, in adults,
               was encouraging. Lilly decided to continue testing it. The
               next stage, testing in children, is the one whose results are
               being made public Thursday.

                         Copyright © 2000 Dow Jones & Company, Inc.
                                  All Rights Reserved.

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