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Writing May Be on Wall for Ritalin
10/16/2000
From Insight Magazine, The Washington Times
By Kelly Patricia O’Meara
omeara@insightmag.com
A lawsuit challenging the validity of the science behind mental illness and
psychotropic drugs will have repercussions for drug makers as well as for the
mental-health establishment.
Hardly a mention was made in the national media concerning the class-action
lawsuit filed in May by the Dallas law firm of Waters and Kraus. It named the
Novartis Pharmaceutical Co. (the maker of the drug Ritalin), the American
Psychiatric Association (APA) and Children and Adults with Attention
Deficit/Hyperactivity Disorder as defendants for conspiring, colluding and
cooperating in promoting the diagnosis of attention-deficit disorder (ADD)
and attention-deficit/hyperactivity disorder (ADHD).
Last week, however, a second lawsuit made a bang when even bigger guns
were rolled out in California and New Jersey to take aim at an industry that
has enjoyed a special relationship with the Clinton/Gore administration.
Indeed it is a relationship which, based on numerous speeches by the vice
president and his wife — who has been the president’s White House
mental-health guru — would continue if Al and Tipper Gore are allowed to make
the White House their new residence on Inauguration Day.
And if the beating the tobacco industry took at the hands of these
attorneys is any indication of what the defendants should anticipate, the
psychiatric community, pharmaceutical industry and mental-health advocacy
groups finally may be called upon to put their science where their mouths
are. Putting aside the legal jargon, what appears to be in question is the
ever-increasing influence of pharmaceutical companies over public and private
mental-health organizations and, ultimately, whether that influence is
responsible for the growing number of “mental illnesses” and the subsequent
increased use of psychotropic drugs.
The class-action lawsuit that was filed last week in California and
New Jersey names Novartis and the APA as defendants for conspiring to create
a market for Ritalin by targeting millions of children and misdiagnosing them
with ADD/ADHD for the strategic purpose of expanding use of the drug.
Both the APA and Novartis have a great deal at stake professionally
and financially. To fight the claim that children have been and still are
being misdiagnosed with ADD/ADHD, the APA — the nation’s leading psychiatric
professional group — will be required to cough up its medical and scientific
data to support the ADD/ADHD diagnosis. This may be difficult given the
growing number of physicians, scientists and even psychiatrists who long have
argued that the diagnosis of ADD/ADHD is not based in science — that the
diagnosis is a fraud based on subjective assessments.
Furthermore, should the APA fail to provide the necessary scientific
data, Novartis could be forced by the courts to return to consumers hundreds
of millions, if not billions, of dollars made from the sale of Ritalin. Even
more devastating to Novartis, should it be exposed that the diagnosis of ADD/
ADHD is scientifically baseless, would be an end to the prescribing of the
drug. This type of judgment could open the industry to additional lawsuits
requiring proof of thousands of alleged mental illnesses. The reverberations
through the pharmaceutical industry could be devastating.
Considering that Ritalin has been in use since the mid-1950s, one has
to wonder how tens of millions of children and adults could be prescribed a
highly addictive drug for more than 40 years without concrete scientific data
to support the diagnosis. According to psychiatrist Loren Mosher, it isn’t
that tough. Mosher is the former chief of the Center for Studies for
Schizophrenia at the National Institute of Mental Health (NIMH) and author of
the definitive book Community Mental Health, A Practical Guide. Mosher
explains that the Ritalin phenomenon comes down to a very simple theory: “If
you tell a lie long enough, it becomes the truth.” Long aware of infiltration
by the pharmaceutical companies into professional psychiatric organizations,
Mosher resigned his membership in the APA with a stinging 1998 letter in
which he wrote:
“The major reason for this action is my belief that I am actually
resigning from the American Psychopharmacological Association. Luckily, the
organization’s true identity requires no change in the acronym. … At this
point in history, in my view, psychiatry has been almost completely bought
out by the drug companies.”
According to Mosher, “The APA receives a huge amount of money from the
pharmaceutical companies through grants, but the most obvious and obnoxious
examples are the two meetings the APA has each year. At both, the drug houses
basically lease 90 percent of the exhibition space and spend huge sums in
giveaway items. They have nearly completely squeezed out the little guys, and
the symposiums that once were dedicated to scientific reports now have been
replaced by the pharmaceutical-industry-sponsored speakers.”
The National Alliance for the Mentally Ill (NAMI), explains Mosher,
“gets the pharmaceutical money and then says they spend it on their
‘anti-stigma’ campaign. They say that mental illness is a brain disease. And
it works well for the people who suffer from this to use their drugs. This is
why NAMI is pushing for forced medication. It is an amazing selling job on
the part of NAMI.”
A nonprofit, grass-roots, self-help support and advocacy organization
for people with severe mental illness, NAMI was featured in a November/
December 1999 Mother Jones article, “An Influential Mental Health Nonprofit
Finds Its ‘Grassroots’ Watered by Pharmaceutical Millions,” by Ken
Silverstein. The article focused on the enormous amount of funding which NAMI
receives from pharmaceutical companies, with Eli Lilly and Co. taking the
lead by donating nearly $3 million to NAMI between 1996 and 1999. In fact,
according to Silverstein, NAMI took in a little more than $11 million from 18
drug companies for that period. Nonetheless, NAMI, Eli Lilly and the others
deny any conflict of interest.
While Eli Lilly, manufacturer of Prozac, admits making substantial
contributions to NAMI and the National Mental Health Association (NMHA), it
claims that for “proprietary reasons” it is unable to provide a list of
specific contributions. According to Jeff Newton and Blair Austin, spokesmen
for the company, “The key issue here is that these are unrestricted grants.
The groups can use the money any way they want. Lilly’s support of these
initiatives presents no conflict of interest since they represent efforts to
raise public awareness around issues that Lilly publicly supports.”
According to Bob Carolla, director of Media Relations for NAMI, “We
represent a constituency that uses their [pharmaceutical] products. Why
shouldn’t they give us money? They’re making money off of our members and
some of it has to go back into the community to help us get better
mental-health programs to help people. Much of what we do has nothing to do
with the pharmaceutical industry. We do not advocate or endorse any specific
medications or products, but we also are not going to back off from saying
that millions of Americans lead productive lives because of the medications
they are prescribed.”
Meanwhile, NAMI has no problem stating that “mental illnesses are
disorders of the brain.” In fact, according to Carolla, NAMI “has been
trying to educate people that mental illnesses are a result of brain
disorders and they are treatable. Stigmas still exist and stigmas need to be
overcome.” Asked to provide scientific data that mental illness is a disease
of the brain, Carolla deferred to a higher authority explaining that “this
[question] reminds me that one small interest group denies that mental
illness even exists.”
Carolla added, “Mental illnesses are biological brain disorders. Go
read the dominant body of medical information out there. It is a function of
biochemistry. I encourage you and recommend you talk to the surgeon-general’s
office.”
Carolla was referring to the Report on Mental Health released by the
U.S. surgeon general in December 1999, which he says “stands as the national
baseline.” This enormous document goes into great detail about mental health
in the United States. But it does not provide a single piece of scientific
data supporting the claim that even one mental illness is caused by a brain
disease. In fact, what it says is “the body of this report is a summary of an
extensive review of the scientific literature, and of consultations with
mental-health-care providers and consumers. Contributors guided by the Office
of the Surgeon General examined more than 3,000 research articles and other
materials. …”
According to the report, “The review of research supports two main
findings: 1) the efficacy of mental-health treatments is well documented, and
2) a range of treatments exists for most mental disorders.”
Voilà! The review of research came up with findings about treatments,
not with scientific causes of mental disorders. And there even appears to be
some question about the validity of the treatments.
The surgeon general nonetheless places Ritalin in a category where the
“efficacy of mental-health treatments is well-documented,” when in Chapter 3
of his report he writes that “because the symptoms of ADHD respond well to
treatment with stimulants,” and because stimulants increase the availability
of the neurotransmitter dopa-mine, the “dopamine hypothesis” has “gained a
wide following.”
The surgeon general may want to review the Drug Enforcement
Administration’s (DEA) 1995 report on methylphenidate, which makes clear that
Ritalin has the same effect on children and adults with ADHD as it does upon
those not diagnosed with ADHD. According to the report:
“There is a considerable body of literature on the short-term efficacy
of stimulant pharmacotherapy on the symptoms of ADHD. From 60 to 90 percent
of children have been judged as positive drug responders to methyl-phenidate
medication. However, contrary to popular belief, stimulants like
methylphenidate will affect normal children and adults in the same manner
they affect ADHD children. Behavioral or attentional improvements with
methylphenidate treatment therefore are not diagnostic criteria of ADHD.”
NAMI, however, is not the only group apparently being misled by the
surgeon general’s report. Take, for instance, the Mental Health Early
Intervention, Treatment, and Prevention Act (S2639), a broad piece of federal
mental-health legislation sponsored by Sens. Pete Domenici, R-N.M., Ted
Kennedy, D-Mass., and Paul Wellstone, D-Minn. According to one staffer
familiar with the legislation, Domenici’s staff took the lead in writing it.
The first of Congress’ “findings” states that “almost 3 percent of the
adult population, or 5 million individuals in the United States, suffer from
a severe and persistent mental illness.” When asked where Domenici got these
figures, the same source explained that “the numbers come from various
federal agencies, various studies that have been conducted and the surgeon
general’s report. The senator takes into consideration that there are those
who argue there is no such thing as a medically diagnosable mental illness
but, when someone like Dr. Steven Hyman [director of NIMH] shows a brain with
schizophrenia and one without, then the senator takes it seriously. Hyman is
well-respected.”
While it appears that Hyman’s “brain” slide show has wowed a great
many people, the fact is that even Hyman has contradicted his own
presentation. For instance, as Hyman explained in a Feb. 28, 1999, New York
Times Magazine article, “indiscriminate use of MRI and PET scans … as a
high-tech form of phrenology … are pretty but inconsequential pictures of the
brain.” While Domenici may place a great deal of trust in the “science”
presented by doctors such as Hyman, he also has a more personal interest much
closer to home: His wife served on NAMI’s board for nearly three years.
Domenici’s office did not respond to inquiries about whether the senator had
received campaign contributions from pharmaceutical companies.
NAMI’s Carolla openly admits that NAMI worked with the sponsors of the
legislation, and one doesn’t have to look too hard to see the similarities
between the Senate bill and NAMI’s proposed Omnibus Mental Illness Recovery
Act, which Eli Lilly paid to print.
NAMI fully supports the Senate bill, which features such programs and
expenditures as Section 581 in which $75 million would be appropriated to
fund an anti-stigma advertising campaign — which many argue is a promotion
for the pharmaceutical industry and should not be funded with taxpayer
dollars. In question also is why taxpayers should be burdened with funding an
anti-stigma campaign which many believe was created by the mental-health
community when it first began labeling individuals as defective.
Section 582 would provide $50 million in training grants for teachers
and emergency-services personnel to recognize (read: diagnose) symptoms of
childhood and adolescent mental disorders. This would allow service personnel
such as firefighters, police officers and teachers to make referrals for
mental-health treatment — a difficult task given that each of these
categories of personnel appears to have its hands full with jobs for which
they already are trained.
Section 583 would provide another $50 million for emergency
mental-health centers within which mobile crisis-intervention teams would be
established. This would allow for the designation of a central receiving
point in the community for individuals who may be cited by, say, a
firefighter, to be in need of emergency mental-health services. And this is
just the beginning of the programs proposed under the Mental Health Early
Intervention, Treatment, and Prevention Act, now pending in Congress.
Larry Sasich, a pharmacologist who handles Food and Drug
Administration drug-safety issues for the Washington-based Public Citizen’s
Health Research Group, tells Insight that “conflicts of interest are kind of
a fact of life in the scientific community. At some point groups like NAMI
are going to have to pay the piper — they’re going to have to answer for
what they are promoting. But it’s hard to tell how much influence the
pharmaceutical companies have. It could be subtle or overt influence
depending on what they want.”
One thing that is certain, concludes Sasich: “The group that is paying
the money wields the big stick.”
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