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An end run to marketing victory Drug makers find ways to circumvent
an advertising ban and promote psychiatric drugs for children

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By Lawrence H. Diller

Oct. 18, 2001 | In a step that represents an escalation in the influence of
the pharmaceutical industry over parents and children, Alza Corp. has
announced that it will use television commercials in its campaign to promote
Concerta, a drug for the treatment of attention deficit/hyperactivity
disorder (ADHD). Alza, which pioneered direct-to-consumer print ads to
address ADHD last year, becomes the first drug company to promote -- on TV
the use of a medication for a children's psychiatric disorder.

[Fred A. Baughman Jr., MD:
saying psychiatric disorder, means a behavioral-emotional problem,
the response of a normal child to their environment, never a physical or
medical abnormality/disease. Here we give an known substance of
addiction for normal behaviors in normal children, not a justifiable
prescription, not one with any possibility of other than a negative

The groundbreaking TV ads for Concerta will not directly mention the drug --
that would be illegal. Concerta, like most of the medications used to treat
ADHD in children, is a stimulant, which makes it a candidate for potential
abuse. For this reason, its production, like that of Ritalin, is tightly 
controlled by the Drug Enforcement Administration (DEA), and its promotion
is subject to controls set by the 1971 United Nations Convention on
Psychotropic substances. According to these rules, monitored by the U.N. 
Narcotics Control Division, drug companies are not allowed to market
controlled substances directly to consumers.

[Fred A. Baughman Jr., MD:
And what, thinly
veiled is this. Are not the FDA, DEA and INCD party to a deception and
to existing regulations, at least, of the INCB]

But Alza, along with a half-dozen companies marketing stimulants directly to
parents (in magazines like Redbook and Good Housekeeping), neatly sidesteps
the limits on specific product advertising by promoting awareness of ADHD,
not the drug treatment itself. In its print ad from last year, Alza features
a smiling school-age boy holding a pencil who is surrounded by his beaming
parents and sister. The caption beneath the photo reads: "Thanks to new ways
for effectively managing ADHD, homework may be a more relaxing time at the
Wilkin house."

Readers of these prints ads, like those who will view the new TV ads, are
advised to call a toll-free number for the "latest treatment information."

Parents are then sent a video, a copy of a government study on ADHD
treatment and material on Concerta.

This strategy mirrors the one used by Purdue Pharma with OxyContin, a
time-release pain medication that has been so widely abused that the company
has been forced to considered a new plan for its formulation. To adhere to
regulations on the marketing of narcotics while creating a market for its
drug, Purdue didn't specifically promote OxyContin to consumers, but chose
an approach called "nonbranded education," in which the company highlighted
the plight of those who suffer pain and need a drug exactly like OxyContin.
In this way they were able to broaden and prepare the market for their drug,
while staying within the law.

In the fast-growing market of psychotropic drugs for children, only
Celltech, a stimulant manufacturer, has challenged the rules by explicitly
mentioning its product, Metadate CD, in magazine ads aimed at consumers.

Consequently, the DEA has issued a cease and desist order to Celltech; court
actions, as well as international sanctions, could follow. The company also
is taking some heat for using a cartoon superhero to promote Metadate CD in
some of its ads. Comparisons to the much-denounced Joe Camel campaign have
been raised, even though the manufacturer insists that the cartoon is meant
for advertising aimed exclusively at physicians.

The remaining several companies involved in advertising stimulants for kids
by promoting "awareness" of ADHD maintain that they are performing a public
service. However, in the affluent suburban middle-class community where I
work, you'd have to be living in a cave without children for the last 10 
years to be unaware of ADHD. In fact, I regularly hear parents and teachers
describe children's problems of behavior and performance in what sounds like
a learned catechism of ADHD symptoms. "He's distractible in the class.  He
can't focus. He'll only concentrates on the things he likes."

It's almost as if they've read a script. And that's the point. Increasingly
the pharmaceutical industry has come under fire for influencing the way we
think about ourselves, and now, for influencing the way we evaluate our
children. Recently, David Healy, a prominent British psychiatrist, was fired
from his high-profile mental health post at the University of Toronto for
speaking out about his provocative revisionist history of American
psychiatry. He claims that our entire psychiatric diagnosis and treatment
model of the last 50 years has been determined by drugs like Thorazine and
Prozac and by the pervasive influence of the pharmaceutical industry on
research, publications, professional organizations and promotion.

[Fred A. Baughman Jr., MD:
What’s more, Healy is exactly right. Because he is truthful and
correct, and because he cannot be "bought" by the industry, he was
blocked from the appointment promised him at the University of Toronto.
Such things occur precisely because academic departments of psychiatry
and whole medical faculties, from one end of the continent to the other
have been bought and paid for. A renegade like Healy is the last thing
they want or need, especially one with sterling scientific credentials
bent on telling the truth. I suspect that Diller knows full well that
Healy’s provocative revisionist history of American
psychiatry, determined by drugs, authored by Big Pharma and those they
enslave, is entirely correct. Surely Diller knows that the
representation of ADHD as a disease is a total fraud, that children said
to have it are normal, and still he writes hundreds of prescriptions for
addictive stimulant medications each year. His book say so.]

Meanwhile, a consortium of legal firms have filed class action suits in five
states against Novartis, the maker of Ritalin, and the American Psychiatric
Association, claiming a conspiracy between the two to defraud the public 
about ADHD and the need for stimulant medication.

Our right to free speech allows the powerful pharmaceutical industry to
promote a particular point of view on ADHD, a purported brain-based disorder
calling for a medication. And it is true that a child's brain is important;
but common sense tells us that homework completion is a complex
social/developmental undertaking that involves many more factors.

[Fred A. Baughman Jr., MD:
Here, Diller glosses over a point of pivotal
importance, that being, what is ADHD? Does free speech allow the
powerful pharmaceutical industry to promote a particular point of view
on ADHD, a purported brain-based disorder calling for a medication. Are
they allowed, in information they put forth to sell their medical/health
products, to lie to the public for that is exactly what they are doing.
They have invented a disease out of normal if troublesome/annoying
behaviors in normal children for which to sell treatments—their
pharmaceuticals. It is that simple and clearly it is in violation of
the Controlled Substances Act and of California’s Senate Bill 836,
Figueroa. (Advertising: truthfulness: referral services) Under
existing law, it is unlawful for any person licensed in the healing arts
to disseminate or cause to be disseminated any form of public
communication, as defined, containing a false, fraudulent, misleading,
or deceptive statement or claim, for the purpose of inducing the
rendering of professional services or furnishing of products in
connection with the licensed person's professional practice or business,
as specified. Existing law provides that a violation of these provisions
is a misdemeanor.

This bill would extend the applicability of this prohibition to a false,
fraudulent, misleading, or deceptive image and to specified claims. By
expanding the definition of an existing crime, this bill would impose a
state-mandated local program. This bill would
incorporate additional changes in Section 651 of the Business and
Professions Code proposed by SB 450, to be operative if this bill and
SB450 are enacted and become effective on or before January 1, 2000, and
this bill is enacted last. The California
Constitution requires the state to reimburse local agencies and school
districts for certain costs mandated by the state. Statutory provisions
establish procedures for making that
reimbursement. This bill would provide that no reimbursement is required
by this act for a specified reason.]

Unfortunately, there is no equal countervailing influence to rebut the drug
companies' strong suggestion that ADHD is the cause of poor homework
completion. There are no stock dividends or equity for special education 
teachers, no TV commercials for family therapists who might have a
different, more nuanced point of view.

Drug advertising works, and pharmaceutical companies rely on it now more 
than ever as they compete in narrow markets. With nearly a dozen stimulants
now available without too much to distinguish them clinically, manufacturers
will have to advertise heavily to maintain or create their niche in the
legal stimulant market -- worth some $750 million a year. It took just three
years of relentless advertising directed at physicians, for instance, for
Adderall, another stimulant, to surpass Ritalin in 1999 as the most common
brand name drug prescribed for ADHD.

Stimulants do work -- low doses have been shown to improve concentration and
work completion for everyone (child or adult, ADHD or not). But stimulants
are not the moral equivalent of -- or substitute for -- helping parents
parent and teachers teach. Yet I'm afraid in our current environment, this
doctor's opinion is likely to be dwarfed by the next 30-second spot.

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About the writer
Dr. Lawrence H. Diller practices behavioral pediatrics in Walnut Creek,
Calif. He is the author of "Running on Ritalin: A Physician Reflects on
Children, Society, and Performance in a Pill."

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