[Dr. Baughman-
Commentary on So-Called 'Biological'
Psychiatry, 8/2/00]
Drug OK Could Be a Boon for Alza
FDA approves firm's pill for hyperactivity
Tom Abate, Chronicle Staff Writer
Wednesday, August 2, 2000
------------------------------------------------------------
The U.S. Food and Drug Administration yesterday approved
a one-a-day pill for attention-deficit disorder that is
easier to take and possibly more effective than current
three-a- day versions of the commonly prescribed drug
Ritalin.
The FDA decision is a commercial boost for Mountain
View's Alza Corp., which can now enter the $700
million-a-year market for drugs that treat attention-deficit
and hyperactivity disorder.
ADHD makes it difficult for children to concentrate in
class and in many instances makes them hyperactive and
unruly.
"This is the time of year when parents are making the
decision to use or not use ADHD medications," said Alza
chief executive Dr. Ernest Mario.
Mario said the company will immediately start promoting
its one-a-day capsule to pediatricians. He said Alza could
ship the first pills out of its Vacaville factory "in a
matter of days."
[Dr. Baughman-
what will become of the 'epidemiology' of ADHD now? How frequent
will it become now the the advent of a once-a-day pill? Let us not be
decieved that ADHD is a bona fide disease, that there is an abnormality,
a chemical imbalance within the child. Mother, Father, in providing
'informed consent' wherever the acronym ADHD appears, strike it and put
'NORMAL CHILD.' Wasn't it a 'NORMAL CHILD' you wanted, a 'NORMAL CHILD'
you praised God you got. Who is a teacher, a psychologist, a
psychiatrist with interviews and pencil-paper tests and behavior scales
to tell you your child is not NORMAL. There is no ethical or moral
justification for drugging a NORMAL CHILD.
]
The Alza pill is based on the drug methylphenidate, the
generic version of Ritalin, which has been used since the
1950s to control ADHD.
For the 3 to 5 percent of schoolchildren, mainly boys, who
are believed to have ADHD, pediatricians routinely prescribe
Ritalin or generic alternatives two or three times a day,
generally around mealtimes.
Although Novartis, the Swiss drug firm that invented
Ritalin, brought out a sustained-release version in 1984,
that single- dose pill has not been widely used by
physicians. Dr. Ami Goodman, a pediatrician with Kaiser
Permanente in San Francisco, said doctors typically
prescribe the multiple- dose versions because they think
they work better.
Goodman said doctors have been hoping for an effective
one-a-day version because fewer children will forget to take
the drug. He said a one-a-day pill would remove the stigma
that attaches to kids who must slip off to the school
nurse's office for a noon booster.
"It's a matter of trying to keep ADHD a more private
affair," said Goodman, who had no opinion about whether the
new Alza formula would be any more effective than Novartis'
little-used sustained-release pill.
[Dr. Baughman-
I would point out to Dr. Goodman, to Kaiser-Permanente, her employer
and to Alza, that they owe 'informed consent' to every child/patient
which means a full disclosure of all that is material about the
condition to be treated as well as all that is material about the
available treatments (their drug included). If they leave unclear the
fact that ADHD has never been proved to be a disease, meaning the
child/patient is not abnormal, but NORMAL, they will have violated the
informed consent rights of their patient/family which is tantamout to
medical malpractice.
]
But Dr. Glen Elliot, a psychiatrist at the University of
California at San Francisco and an Alza consultant, said the
clinical studies leading up to the FDA's approval suggest
that Alza has found the time-release technology that works.
Alza's secret is the pill itself, which is about the size
of a Tic Tac candy. The pill's outer coating is actually a
dose of the drug, which dissolves quickly and begins
circulating through the child's bloodstream when the pill is
taken before or after breakfast.
But it is what is inside the pill that counts. The outer
shell dissolves to reveal a tiny plastic pump filled with a
12-hour dose. The pump works by osmosis. It absorbs water
from the body. The water liquifies tiny amounts of drug and
pushes the liquified drug out a microscopic hole in the pump
at a rate calculated to exhaust the medicine just as the
child is finishing homework.
The availability of an easy-to-use pill is sure to fuel
the debate about whether ADHD is overdiagnosed -- and
whether Ritalin or its generic alternatives are
overprescribed.
Stephen Hinshaw, a psychiatrist at the University of
California at Berkeley and an ADHD specialist, was part of a
recent National Institutes of Health study that endorsed the
effectiveness of Ritalin for controlling ADHD.
But, said Hinshaw, who is also an Alza consultant, the
problem is that ADHD can be misdiagnosed in two ways:
labeling boys with the condition simply because they are
rambunctious, while missing girls who may have a form of
ADHD that shortens their attention span without making them
unruly in class.
[Dr. Baughman-
to understand why Hinshaw or any 'expert' organization, university
or medical school department says what it says on such issues, one must
have full knowledge of their ties to the manufacturer and the industry.
We have entered a tragic era in which universities, especially medical
school faculties are largely behold to industry and are constrained from
performing science for science's sake or for the public good, even
though the public through tax money still pay for a major part of what
they do. Make no mistake, 'industry' not you and I, John and Jane Q.
Public, has control of the purse strings, our elected representative
included--and calls the shots. Our federal government, including the
White House, the First and Second Ladies the Senate, Congress, the NIH,
DHSS, Surgeon General and the CDC all know that psychiatry's claims that
they treat bon fide diseases are fraudulent claimes. They, know they
the children/patients they call DISEASED, are not, that they are
NORMAL.
]
"The problem is that you can't evaluate ADHD in 10
minutes, but in some places that's all the time you get with
your physician," Hinshaw said. For information about ADHD,
contact the nonprofit group Children and Adults With
Attention-Deficit/Hyperactivity Disorder in Landover, Md.
Its Web site (www.chadd.org ) posts
links to local chapters.
For information about ADHD, contact the nonprofit group
Children and Adults With Attention-Deficit/Hyperactivity
Disorder in Landover, Md. Its Web site (www.chadd.org) posts
links to local chapters. E-mail Tom Abate at
abate@sfgate.com.