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Psychiatrists, Children and Drug
Industry’s Role
By GARDINER HARRIS, BENEDICT CAREY and JANET ROBERTS
Published: May 10, 2007
http://www.nytimes.com/2007/05/10/health/10psyche.html?_r=1&th&emc=th&oref=slogin
When Anya Bailey developed an eating disorder after
her 12th birthday, her mother took her to a
psychiatrist at the University of Minnesota who
prescribed a powerful antipsychotic drug called
Risperdal.
Created for schizophrenia, Risperdal is not approved
to treat eating disorders, but increased appetite is
a common side effect and doctors may prescribe drugs
as they see fit. Anya gained weight but within two
years developed a crippling knot in her back. She
now receives regular injections of Botox to unclench
her back muscles. She often awakens crying in pain.
Isabella Bailey, Anya’s mother, said she had no idea
that children might be especially susceptible to
Risperdal’s side effects. Nor did she know that
Risperdal and similar medicines were not approved at
the time to treat children, or that medical trials
often cited to justify the use of such drugs had as
few as eight children taking the drug by the end.
Just as surprising, Ms. Bailey said, was learning
that the university psychiatrist who supervised
Anya’s care received more than $7,000 from 2003 to
2004 from Johnson & Johnson, Risperdal’s maker, in
return for lectures about one of the company’s
drugs.
Doctors, including Anya Bailey’s, maintain that
payments from drug companies do not influence what
they prescribe for patients.
But the intersection of money and medicine, and its
effect on the well-being of patients, has become one
of the most contentious issues in health care.
Nowhere is that more true than in psychiatry, where
increasing payments to doctors have coincided with
the growing use in children of a relatively new
class of drugs known as atypical antipsychotics.
These best-selling drugs, including Risperdal,
Seroquel, Zyprexa, Abilify and Geodon, are now being
prescribed to more than half a million children in
the United States to help parents deal with behavior
problems despite profound risks and almost no
approved uses for minors.
A New York Times analysis of records in Minnesota,
the only state that requires public reports of all
drug company marketing payments to doctors, provides
rare documentation of how financial relationships
between doctors and drug makers correspond to the
growing use of atypicals in children.
From 2000 to 2005, drug maker payments to Minnesota
psychiatrists rose more than sixfold, to $1.6
million. During those same years, prescriptions of
antipsychotics for children in Minnesota’s Medicaid
program rose more than ninefold.
Those who took the most money from makers of
atypicals tended to prescribe the drugs to children
the most often, the data suggest. On average,
Minnesota psychiatrists who received at least $5,000
from atypical makers from 2000 to 2005 appear to
have written three times as many atypical
prescriptions for children as psychiatrists who
received less or no money.
The Times analysis focused on prescriptions written
for about one-third of Minnesota’s Medicaid
population, almost all of whom are disabled. Some
doctors were misidentified by pharmacists, but the
information provides a rough guide to prescribing
patterns in the state.
Drug makers underwrite decision makers at every
level of care. They pay doctors who prescribe and
recommend drugs, teach about the underlying
diseases, perform studies and write guidelines that
other doctors often feel bound to follow.
But studies present strong evidence that financial
interests can affect decisions, often without people
knowing it.
In Minnesota, psychiatrists collected more money
from drug makers from 2000 to 2005 than doctors in
any other specialty. Total payments to individual
psychiatrists ranged from $51 to more than $689,000,
with a median of $1,750. Since the records are
incomplete, these figures probably underestimate
doctors’ actual incomes.
Such payments could encourage psychiatrists to use
drugs in ways that endanger patients’ physical
health, said Dr. Steven E. Hyman, the provost of
Harvard University and former director of the
National Institute of Mental Health. The growing use
of atypicals in children is the most troubling
example of this, Dr. Hyman said.
“There’s an irony that psychiatrists ask patients to
have insights into themselves, but we don’t connect
the wires in our own lives about how money is
affecting our profession and putting our patients at
risk,” he said.
The Prescription
Anya Bailey is a 15-year-old high school freshman
from East Grand Forks, Minn., with pictures of the
actor Chad Michael Murray on her bedroom wall. She
has constant discomfort in her neck that leads her
to twist it in a birdlike fashion. Last year, a boy
mimicked her in the lunch room.
“The first time, I laughed it off,” Anya said. “I
said: ‘That’s so funny. I think I’ll laugh with
you.’ Then it got annoying, and I decided to hide
it. I don’t want to be made fun of.”
Now she slumps when seated at school to pressure her
clenched muscles, she said.
It all began in 2003 when Anya became dangerously
thin. “Nothing tasted good to her,” Ms. Bailey said.
Psychiatrists at the University of Minnesota,
overseen by Dr. George M. Realmuto, settled on
Risperdal, not for its calming effects but for its
normally unwelcome side effect of increasing
appetite and weight gain, Ms. Bailey said. Anya had
other issues that may have recommended Risperdal to
doctors, including occasional angry outbursts and
having twice heard voices over the previous five
years, Ms. Bailey said.
Dr. Realmuto said he did not remember Anya’s case,
but speaking generally he defended his unapproved
use of Risperdal to counter an eating disorder
despite the drug’s risks. “When things are
dangerous, you use extraordinary measures,” he said.
Ten years ago, Dr. Realmuto helped conduct a study
of Concerta, an attention deficit hyperactivity
disorder drug marketed by Johnson & Johnson, which
also makes Risperdal. When Concerta was approved,
the company hired him to lecture about it.
He said he gives marketing lectures for several
reasons.
“To the extent that a drug is useful, I want to be
seen as a leader in my specialty and that I was
involved in a scientific study,” he said.
The money is nice, too, he said. Dr. Realmuto’s
university salary is $196,310.
“Academics don’t get paid very much,” he said. “If I
was an entertainer, I think I would certainly do a
lot better.”
In 2003, the year Anya came to his clinic, Dr.
Realmuto earned $5,000 from Johnson & Johnson for
giving three talks about Concerta. Dr. Realmuto said
he could understand someone’s worrying that his
Concerta lecture fees would influence him to
prescribe Concerta but not a different drug from the
same company, like Risperdal.
In general, he conceded, his relationship with a
drug company might prompt him to try a drug. Whether
he continued to use it, though, would depend
entirely on the results.
As the interview continued, Dr. Realmuto said that
upon reflection his payments from drug companies had
probably opened his door to useless visits from a
drug salesman, and he said he would stop giving
sponsored lectures in the future.
Kara Russell, a Johnson & Johnson spokeswoman, said
that the company selects speakers who have used the
drug in patients and have either undertaken research
or are aware of the studies. “Dr. Realmuto met these
criteria,” Ms. Russell said.
When asked whether these payments may influence
doctors’ prescribing habits, Ms. Russell said that
the talks “provide an educational opportunity for
physicians.”
No one has proved that psychiatrists prescribe
atypicals to children because of drug company
payments. Indeed, some who frequently prescribe the
drugs to children earn no drug industry money. And
nearly all psychiatrists who accept payments say
they remain independent. Some say they prescribed
and extolled the benefits of such drugs before ever
receiving payments to speak to other doctors about
them.
“If someone takes the point of view that your doctor
can be bought, why would you go to an E. R. with
your injured child and say, ‘Can you help me?’ ”
said Dr. Suzanne A. Albrecht, a psychiatrist from
Edina, Minn., who earned more than $188,000 from
2002 to 2005 giving drug marketing talks.
The Industry Campaign
It is illegal for drug makers to pay doctors
directly to prescribe specific products. Federal
rules also bar manufacturers from promoting
unapproved, or off-label, uses for drugs.
But doctors are free to prescribe as they see fit,
and drug companies can sidestep marketing
prohibitions by paying doctors to give lectures in
which, if asked, they may discuss unapproved uses.
The drug industry and many doctors say that these
promotional lectures provide the field with
invaluable education. Critics say the payments and
lectures, often at expensive restaurants, are
disguised kickbacks that encourage potentially
dangerous drug uses. The issue is particularly
important in psychiatry, because mental problems are
not well understood, treatment often involves trial
and error, and off-label prescribing is common.
The analysis of Minnesota records shows that from
1997 through 2005, more than a third of Minnesota’s
licensed psychiatrists took money from drug makers,
including the last eight presidents of the Minnesota
Psychiatric Society.
The psychiatrist receiving the most from drug
companies was Dr. Annette M. Smick, who lives
outside Rochester, Minn., and was paid more than
$689,000 by drug makers from 1998 to 2004. At one
point Dr. Smick was doing so many sponsored talks
that “it was hard for me to find time to see
patients in my clinical practice,” she said.
“I was providing an educational benefit, and I like
teaching,” Dr. Smick said.
Dr. Steven S. Sharfstein, immediate past president
of the American Psychiatric Association, said
psychiatrists have become too cozy with drug makers.
One example of this, he said, involves Lexapro, made
by Forest Laboratories, which is now the most widely
used antidepressant in the country even though there
are cheaper alternatives, including generic versions
of Prozac.
“Prozac is just as good if not better, and yet we
are migrating to the expensive drug instead of the
generics,” Dr. Sharfstein said. “I think it’s the
marketing.”
Atypicals have become popular because they can
settle almost any extreme behavior, often in
minutes, and doctors have few other answers for
desperate families.
Their growing use in children is closely tied to the
increasingly common and controversial diagnosis of
pediatric bipolar disorder, a mood problem marked by
aggravation, euphoria, depression and, in some
cases, violent outbursts. The drugs, sometimes
called major tranquilizers, act by numbing brain
cells to surges of dopamine, a chemical that has
been linked to euphoria and psychotic delusions.
Suzette Scheele of Burnsville, Minn., said her
17-year-old son, Matt, was given a diagnosis of
bipolar disorder four years ago because of intense
mood swings, and now takes Seroquel and Abilify,
which have caused substantial weight gain.
“But I don’t have to worry about his rages; he’s
appropriate; he’s pleasant to be around,” Ms.
Scheele said.
The sudden popularity of pediatric bipolar diagnosis
has coincided with a shift from antidepressants like
Prozac to far more expensive atypicals. In 2000,
Minnesota spent more than $521,000 buying
antipsychotic drugs, most of it on atypicals, for
children on Medicaid. In 2005, the cost was more
than $7.1 million, a 14-fold increase.
The drugs, which can cost $1,000 to $8,000 for a
year’s supply, are huge sellers worldwide. In 2006,
Zyprexa, made by Eli Lilly, had $4.36 billion in
sales, Risperdal $4.18 billion and Seroquel, made by
AstraZeneca, $3.42 billion.
Many Minnesota doctors, including the president of
the Minnesota Psychiatric Society, said drug makers
and their intermediaries are now paying them almost
exclusively to talk about bipolar disorder.
The Diagnoses
Yet childhood bipolar disorder is an increasingly
controversial diagnosis. Even doctors who believe it
is common disagree about its telltale symptoms.
Others suspect it is a fad. And the scientific
evidence that atypicals improve these children’s
lives is scarce.
One of the first and perhaps most influential
studies was financed by AstraZeneca and performed by
Dr. Melissa DelBello, a child and adult psychiatrist
at the University of Cincinnati.
Dr. DelBello led a research team that tracked for
six weeks the moods of 30 adolescents who had
received diagnoses of bipolar disorder. Half of the
teenagers took Depakote, an antiseizure drug used to
treat epilepsy and bipolar disorder in adults. The
other half took Seroquel and Depakote.
The two groups did about equally well until the last
few days of the study, when those in the Seroquel
group scored lower on a standard measure of mania.
By then, almost half of the teenagers getting
Seroquel had dropped out because they missed
appointments or the drugs did not work. Just eight
of them completed the trial.
In an interview, Dr. DelBello acknowledged that the
study was not conclusive. In the 2002 published
paper, however, she and her co-authors reported that
Seroquel in combination with Depakote “is more
effective for the treatment of adolescent bipolar
mania” than Depakote alone.
In 2005, a committee of prominent experts from
across the country examined all of the studies of
treatment for pediatric bipolar disorder and decided
that Dr. DelBello’s was the only study involving
atypicals in bipolar children that deserved its
highest rating for scientific rigor. The panel
concluded that doctors should consider atypicals as
a first-line treatment for some children. The
guidelines were published in The Journal of the
American Academy of Child and Adolescent Psychiatry.
Three of the four doctors on the panel served as
speakers or consultants to makers of atypicals,
according to disclosures in the guidelines. In an
interview, Dr. Robert A. Kowatch, a psychiatrist at
Cincinnati Children’s Hospital and the lead author
of the guidelines, said the drug makers’ support had
no influence on the conclusions.
AstraZeneca hired Dr. DelBello and Dr. Kowatch to
give sponsored talks. They later undertook another
study comparing Seroquel and Depakote in bipolar
children and found no difference. Dr. DelBello, who
earns $183,500 annually from the University of
Cincinnati, would not discuss how much she is paid
by AstraZeneca.
“Trust me, I don’t make much,” she said. Drug
company payments did not affect her study or her
talks, she said. In a recent disclosure, Dr.
DelBello said that she received marketing or
consulting income from eight drug companies,
including all five makers of atypicals.
Dr. Realmuto has heard Dr. DelBello speak several
times, and her talks persuaded him to use
combinations of Depakote and atypicals in bipolar
children, he said. “She’s the leader in terms of
doing studies on bipolar,” Dr. Realmuto said.
Some psychiatrists who advocate use of atypicals in
children acknowledge that the evidence supporting
this use is thin. But they say children should not
go untreated simply because scientists have failed
to confirm what clinicians already know.
“We don’t have time to wait for them to prove us
right,” said Dr. Kent G. Brockmann, a psychiatrist
from the Twin Cities who made more than $16,000 from
2003 to 2005 doing drug talks and one-on-one sales
meetings, and last year was a leading prescriber of
atypicals to Medicaid children.
The Reaction
For Anya Bailey, treatment with an atypical helped
her regain her appetite and put on weight, but also
heavily sedated her, her mother said. She developed
the disabling knot in her back, the result of a
nerve condition called dystonia, in 2005.
The reaction was rare but not unknown. Atypicals
have side effects that are not easy to predict in
any one patient. These include rapid weight gain and
blood sugar problems, both risk factors for
diabetes; disfiguring tics, dystonia and in rare
cases heart attacks and sudden death in the elderly.
In 2006, the Food and Drug Administration received
reports of at least 29 children dying and at least
165 more suffering serious side effects in which an
antipsychotic was listed as the “primary suspect.”
That was a substantial jump from 2000, when there
were at least 10 deaths and 85 serious side effects
among children linked to the drugs. Since reporting
of bad drug effects is mostly voluntary, these
numbers likely represent a fraction of the toll.
Jim Minnick, a spokesman for AstraZeneca, said that
the company carefully monitors reported problems
with Seroquel. “AstraZeneca believes that Seroquel
is safe,” Mr. Minnick said.
Other psychiatrists renewed Anya’s prescriptions for
Risperdal until Ms. Bailey took Anya last year to
the Mayo Clinic, where a doctor insisted that Ms.
Bailey stop the drug. Unlike most universities and
hospitals, the Mayo Clinic restricts doctors from
giving drug marketing lectures.
Ms. Bailey said she wished she had waited to see
whether counseling would help Anya before trying
drugs. Anya’s weight is now normal without the help
of drugs, and her counseling ended in March. An
experimental drug, her mother said, has recently
helped the pain in her back.
This article is by Gardiner Harris, Benedict Carey
and Janet Roberts. |
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