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Science Forum Index » Medicine - Nursing Forum » NYTIMES: Psychiatrists, Children and Drug Industry’s Role
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| Ilena Rose |
 Posted: Tue Apr 08, 2008 11:23 am |
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EXCERPTS: Anya Bailey is among a growing number of children given
antipsychotic drugs by doctors who are paid by the makers of those
drugs.
.... and doctors may prescribe drugs as they see fit.
.... 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.
.... 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.
Note from Ilena Rosenthal, Director of the Humantics Foundation
www.BreastImplantAwareness.org/blog.htm
BRAVO BRAVO BRAVO
In my 12 years of struggles for speaking out on the dangers of breast
implants ... this difficult road was shared by those speaking out on
the dangers of overuse of pharmaceutical drugs ... especially for
children.
The same propaganda teams use the same Smear Tactics against those of
us attempting to raise awareness ... and even the same internet usenet
flacks.
www.BreastImplantAwareness.org/QuackWatchWatch.htm
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``
http://www.nytimes.com/2007/05/10/health/10psyche.html?_r=1&th=&oref=slogin&emc=th&pagewanted=all
By GARDINER HARRIS, BENEDICT CAREY and JANET ROBERTS
Published: May 10, 2007
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.
Anya Bailey has a painful nerve condition called dystonia, in which
the muscles in her back clench as a result of taking an antipsychotic
drug.
Anya Bailey with her younger sister, Melanie, and her mother,
Isabella.
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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