Backlash on bipolar diagnoses in children

Please note that this is a year old and before the disclosures of the
previous post.

http://www.boston.com/yourlife/health/diseases/articles/2007/06/17/bac
klash_on_bipolar_diagnoses_in_children/

Boston Globe
Backlash on bipolar diagnoses in children
MGH psychiatrist's work stirs debate
By Scott Allen
June 17, 2007

No one has done more to convince Americans that even small children
can suffer the dangerous mood swings of bipolar disorder than Dr.
Joseph Biederman of Massachusetts General Hospital.

From his perch as one of the world's most influential child
psychiatrists, Biederman has spread far and wide his conviction that
the emotional roller coaster of bipolar disorder can start "from the
moment the child opened his eyes" at birth. Psychiatrists used to
regard bipolar disorder as a disease that begins in young adulthood,
but now some diagnose it in children scarcely out of diapers,
treating them with powerful antipsychotic medications based on
Biederman's work.

"We need to treat these children. They are in a desperate state,"
Biederman said in an interview, producing a video clip of a tearful
mother describing the way her preschool daughter assaulted her before
the child began treatment for bipolar disorder. The chief of pediatric
psychopharmacology at Mass. General, he compares his work to
scientific break throughs of the past such as the first vaccinations
against disease.

But the death in December of a 4-year-old Hull girl from an overdose
of drugs prescribed to treat bipolar disorder and attention deficit
hyperactivity disorder has triggered a growing backlash against
Biederman and his followers. Rebecca Riley's parents have been charged
with deliberately giving the child overdoses of Clonidine, a
medication sometimes used to calm aggressive children. Still, many
wondered why a girl so young was being treated in the first place
with Clonidine and two other psychiatric drugs, including one not
approved for children's use. Riley's psychiatrist has said she was
influenced by the work of Biederman and his protege, Dr. Janet
Wozniak.

"They are by far the leading lights in terms of providing leadership
in the treatment of children who have disorders such as bipolar,"
said J.W. Carney Jr., lawyer for Dr. Kayoko Kifuji, a Tufts-New
England Medical Center psychiatrist who temporarily gave up her
medical license after Riley died on Dec. 13, 2006. "Dr. Kifuji
subscribes to the views of the Mass. General team."

Part of the criticism of Biederman speaks to a deeper issue in
psychiatry: the extensive financial ties between the drug industry and
researchers. Biederman has received research funding from 15 drug
companies and serves as a paid speaker or adviser to seven of them,
including Eli Lilly & Co. and Janssen Pharmaceuticals, which make the
multi billion-dollar antipsychotic drugs Zyprexa and Risperdal,
respectively. Though not much money was earmarked for bipolar
research, critics say the resources help him advance his aggressive
drug treatment philosophy.

Numerous psychiatrists say Riley's overdose suggests that bipolar
disorder is becoming a psychiatric fad, leaving thousands of children
on risky medications based on symptoms such as chronic irritability
and aggressiveness that could have other causes. Riley's father, for
example, had only recently returned to the home after being accused of
child abuse, according to police. Since the girl's death, state
officials have stepped up a review of the 8,343 children taking the
latest antipsychotic medications under the Medicaid program for
conditions including bipolar disorder, to be sure the treatment is
appropriate.

Psychiatrists too often prescribe these medications, which carry side
effects such as weight gain and heart disease risk, without addressing
problems in the children's lives, said Dr. Gordon Harper, director of
child and adolescent services at the state Department of Mental
Health. He likened the approach to "tuning the piano while the subway
is going by."

Aggressive treatment
Biederman's critics chide him for not speaking out against misuses of
a diagnosis that he has helped inspire. Among leading authorities on
bipolar disorder, the Mass. General team has proposed the most
aggressive treatment for the broadest group of children, they say, and
Biederman should take responsibility when treatment goes wrong. At a
conference on bipolar disorder at Pittsburgh's Point Park University
last weekend, one speaker, Dr. Lawrence Diller, a California
behavioral pediatrician, contended that Biederman bears some blame
for Riley's death.

"I find Biederman and his group to be morally responsible in part,"
said Diller, whose popular book, "Running on Ritalin," accused
psychiatrists of over treating another childhood condition, attention
deficit hyperactivity disorder. "He didn't write the prescription,
but he provided all the, quote, scientific justification to address a
public health issue by drugging little kids."

Biederman rejects the idea that Riley's death is a cautionary tale,
accusing critics of exploiting a tragedy to fan fears about
psychiatry, a profession that has long faced prejudice. "The fact
that she had XY drug or XY treatment is irrelevant to what
happened. . . . If this child had the same outcome from treatment for
asthma or seizures, we wouldn't have this frenzy," said Biederman in
an interview at Mass. General's Cambridge mental health clinic.

Though Biederman acknowledges that distinguishing bipolar disorder
from ordinary crankiness and flights of fancy in young children is
challenging, he insists there is no ambiguity in the patients at his
practice. "People have to wait a long time to see me or my
colleagues. . . . It's not that somebody comes to me after their
child has a temper tantrum. They do things for years that are
dangerous. These are things that profoundly affect the child," said
Biederman, putting them at risk of academic failure or even suicide.

Biederman dismisses most critics, saying that they cannot match his
scientific credentials as co author of 30 scientific papers a year and
director of a major research program at the psychiatry department that
is top-ranked in the "US News & World Report" ratings.

The critics "are not on the same level. We are not debating as to
whether [a critic] likes brownies and I like hot dogs. In medicine and
science, not all opinions are created equal," said Biederman, a native
of Czechoslovakia who came to Mass. General in 1979 after medical
training in Argentina and Israel. He now lives in Brookline

Struggle for research funds
Biederman's thinking on bipolar disorder grew out of his work in the
early 1990s, when he observed that many children referred to Mass.
General's psychiatric clinic seemed to have periods where they were
extremely aggressive, deeply depressed, or angry. And they were not
getting better from taking medications such as Ritalin, which is
prescribed for attention deficit hyperactivity disorder.

At the time, psychiatrists considered bipolar disorder a condition
that typically revealed itself around age 20, and rarely in children
under 12, but Biederman believed that many of his patients met the
definition normally applied to adults. Working with Wozniak, he
published an influential paper in 1995 reporting that one out of six
children at his clinic might be bipolar and that the rate was even
higher among children with ADHD.

Biederman was already quite successful as an ADHD researcher,
establishing close ties with companies that manufactured drugs such as
Ritalin to fund research projects that the federal government would
not pay for. He also received payments for giving speeches about
mental health issues and serving on scientific advisory boards that
typically meet a few times annually to discuss research. He declined
to say how much he receives, but said that all of the income was
approved by both Harvard Medical School and the hospital.

Biederman's boss said he does not believe the money affects
Biederman's judgment. "I think a pharma person would not dare to tell
Joe what to say," wrote Dr. Jerrold Rosenbaum , chief of psychiatry
at Mass. General, in an e-mail. "And if they made that mistake, it
would be only once. . . . For Joe, it is his ideas and mission that
drive him, not the fees."

Biederman said he quickly discovered that drug companies were less
interested in bipolar disorder than the more established ADHD. He and
Wozniak, who did not respond to a request for an interview, struggled
to get funding for research on bipolar children. "The more
controversial a diagnosis is, the harder it is to get funding from
conventional sources," he explained.

Contrasting viewpoints
Occasionally, they received small grants from drug companies or
private philanthropies to test drugs on children, but Biederman
admits these studies are not enough to prove the drugs are safe and
effective. Nonetheless, the Mass. General studies were enormously
influential: their 2001 study, in which 23 children diagnosed as
bipolar received the drug Zyprexa for eight weeks, became one of the
most frequently quoted articles in the history of the Journal of
Child and Adolescent Psychopharmacology. The study showed that the
drug eased outbreaks of aggression, though children typically gained
more than 10 pounds.

Biederman was disappointed that he could not do more comprehensive
studies, but he saw no reason to delay treatment. "At least the line
of drugs I'm talking about gives some relief," he said. "The only way
to understand the side effects is in the context of the seriousness
of the illness."

As bipolar disorder received increasing media attention, Biederman and
Wozniak's research was often cited as the scientific rationale for
diagnosing and treating the disease (disease? huh?) aggressively.
Another leading researcher, Dr. Barbara Geller of Washington
University in St. Louis, adopted a more restrictive view, requiring
that children have a series of specific symptoms such as reduced need
for sleep before she would diagnose the disorder. But the Mass.
General team used broader categories, saying that children who are
extremely irritable or aggressive might be bipolar. Skeptics said
those symptoms were too common, leaving too much room for dispute
over who is really sick.

Dr. Biederman's staff "can do the same diagnostic interview on 100
children and come up with five or 20 bipolar disorders, and I might do
the same thing and find only one or none," said Dr. Jon McClellan , a
psychiatrist at the University of Washington who chaired a panel of
the American Academy of Child and Adolescent Psychiatry that recently
concluded there is no proof that children under 6 can be diagnosed
with the disorder. He says he has received no money from the
pharmaceutical industry for years.

A surge in diagnoses
Biederman's work helped fuel a surge in the number of children
diagnosed with bipolar disorder over the past 15 years. A national
study of community hospitals found that the percentage of mentally
ill children diagnosed as bipolar quadrupled from 1990 to 2000.

The rapid rise raised concerns at the National Institute of Mental
Health, prompting its top officials to convene leading specialists,
including Biederman, to urge them to come up with diagnosis and
treatment standards. The resulting guidelines, released in 2001,
acknowledged that Biederman was right: Bipolar disorder can strike
before puberty. However, the guidelines also stated that identifying
the disease among children is challenging because normal children are
prone to be irritable, aggressive, or giddy.

Dr. Steven Hyman, who was then director of the mental health institute
and is now provost at Harvard University, said he remains very
concerned about the growing use of "big gun" antipsychotic drugs such
as Zyprexa, Risperdal, and Seroquel on children. In the Massachusetts
Medicaid program, the number of people under 18 receiving at least
one of the "atypical antipsychotic" drugs rose from 6,943 in 2002 to
9,123 in 2005, a 31 percent jump, before declining to 8,343 in 2006.
Hyman says that none of the drugs has the approval of the Food and
Drug Administration for use in bipolar children, and doctors
prescribe them based on their individual judgment.

"We don't know the first thing about safety and efficacy of these
drugs even by themselves in these young ages, let alone when they are
mixed together," said Hyman.

Rebecca Riley's treatment
Kifuji was careful in treating Rebecca Riley, meeting the child six
times before diagnosing bipolar disorder, according to Carney. Based
on the child's behavior and family history, Kifuji prescribed three
drugs to the 3-year-old child, including the antipsychotic medication
Seroquel and Clonidine, a high blood pressure medicine that is often
prescribed to calm aggressive children. Last year, Clonidine was
prescribed to 1,195 children under age 7 served by the Massachusetts
Medicaid program, including Riley.

Police charge that her parents, Carolyn and Michael Riley , repeatedly
convinced Kifuji to give them extra Clonidine, ultimately accumulating
dozens of extra pills that they used to control the little girl. Long
before the child finally died on the floor beside her parents' bed,
the police report said, teachers and school nurses noticed that she
had become lethargic like a "floppy doll" on a nurse's lap.

Carney said his client, who is not practicing while the investigation
continues, did nothing wrong in writing the prescriptions for the
girl. Although some were shocked that the child was taking so much
medication, Carney said Kifuji was practicing mainstream psychiatry
for a very troubled child. He observed that Biederman's "research and
teaching validates Dr. Kifuji's work with patients."