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This article comes from the May/June 2005 issue
of Mother Jones Magazine.
Medicating Aliah
When state mental health officials fall under the
influence of Big Pharma, the burden falls on captive
patients. Like this 13-year-old girl.
by Rob Waters
May/June 2005 Issue
ALIAH GLEASON IS A BIG, lively girl with a round face, a
quick wit, and a sharp tongue. She's 13 and in eighth grade
at Dessau Middle School in Pflugerville, Texas, an Austin
suburb, but could pass for several years older. She is the
second of four daughters of Calvin and Anaka Gleason, an
African American couple who run a struggling business taking
people on casino bus trips.
In the early part of seventh grade, Aliah was a B and C
student who "got in trouble for running my mouth." Sometimes
her antics went overboard -- like the time she barked at a
teacher she thought was ugly. "I was calling this teacher a
man because she had a mustache," Aliah recalled over
breakfast with her parents at an Austin restaurant.
School officials considered Aliah disruptive, deemed her
to have an "oppositional disorder," and placed her in a
special education track. Her parents viewed her as a
spirited child who was bright but had a tendency to argue
and clown. Then one day, psychologists from the University
of Texas (UT) visited the school to conduct a mental health
screening for sixth- and seventh-grade girls, and Aliah's
life took a dramatic turn.
A few weeks later, the Gleasons got a "Dear parents" form
letter from the head of the screening program. "You will be
glad to know your daughter did not report experiencing a
significant level of distress," it said. Not long after,
they got a very different phone call from a UT psychologist,
who told them Aliah had scored high on a suicide rating and
needed further evaluation. The Gleasons reluctantly agreed
to have Aliah see a UT consulting psychiatrist. She
concluded Aliah was suicidal but did not hospitalize her,
referring her instead to an emergency clinic for further
evaluation. Six weeks later, in January 2004, a
child-protection worker went to Aliah's school, interviewed
her, then summoned Calvin Gleason to the school and told him
to take Aliah to Austin State Hospital, a state mental
facility. He refused, and after a heated conversation, she
placed Aliah in emergency custody and had a police officer
drive her to the hospital.
The Gleasons would not be allowed to see or even speak to
their daughter for the next five months, and Aliah would
spend a total of nine months in a state psychiatric hospital
and residential treatment facilities. While in the
hospital, she was placed in restraints more than 26 times
and medicated -- against her will and without her parents'
consent -- with at least 12 different psychiatric drugs,
many of them simultaneously.
On her second day at the state hospital, Aliah says she
was told to take a pill to "help my mood swings." She
refused and hid under her bed. She says staff members
pulled her out by her legs, then told her if she took her
medication, she'd be able to go home sooner. She took it.
On another occasion, she "cheeked" a pill and later tossed
it into the garbage. She says that after staff members
found it, five of them came to her room, one holding a
needle. "I started struggling, and they held my head down
and shot me in the butt," she says. "Then they left and I
lay in my bed crying."
What, if anything, was wrong with Aliah remains cloudy.
Court documents and medical records indicate that she would
say she was suicidal or that her father beat her, and then
she would recant. (Her attorney attributes such statements
to the high dosages of psychotropic drugs she was forcibly
put on.) Her clinical diagnosis was just as changeable.
During two months at Austin State Hospital, Aliah was
diagnosed with "depressive disorder not otherwise
specified," "mood disorder not otherwise specified with
psychotic features," and "major depression with psychotic
features."
In addition to the antidepressants Zoloft, Celexa,
Lexapro, and Desyrel, as well as Ativan, an antianxiety
drug, Aliah was given two newer drugs known as "atypical
antipsychotics" -- Geodon and Abilify -- plus an older
antipsychotic, Haldol. She was also given the
anticonvulsants Trileptal and Depakote -- though she was not
suffering from a seizure disorder -- and Cogentin, an
anti-Parkinson's drug also used to control the side effects
of antipsychotic drugs. At the time of her transfer to a
residential facility, she was on five different medications,
and once there, she was put on still another atypical --
Risperdal.
The case of Aliah Gleason raises troubling -- and
long-standing -- questions about the coercive uses of
psychiatric medications in Texas and elsewhere. But
especially because Aliah lives in Texas, and because her
commitment was involuntary, she became vulnerable to an even
further hazard: aggressive drug regimens that feature new
and controversial drugs -- regimens that are promoted by
drug companies, mandated by state governments, and imposed
on captive patient populations with no say over what's
prescribed to them.
In the past, drug companies sold their new products to
doctors through ads and articles in medical journals or, in
recent years, by wooing consumers directly through
television and magazine advertising. Starting in the
mid-1990s, though, the companies also began to focus on a
powerful market force: the handful of state officials who
govern prescribing for large public systems like state
mental hospitals, prisons, and government-funded
clinics.
One way drug companies have worked to influence
prescribing practices of these public institutions is by
funding the implementation of guidelines, or algorithms,
that spell out which drugs should be used for different
psychiatric conditions, much as other algorithms guide the
treatment of diabetes or heart disease. The effort began in
the mid-1990s with the creation of TMAP -- the Texas
Medication Algorithm Project.
Put simply, the algorithm called for the newest, most
expensive medications to be used first in the treatment of
schizophrenia, bipolar disorder, and major depression in
adults. Subsequently, the state began developing CMAP, a
children's algorithm that is not yet codified by the state
legislature. At least nine states have since adopted
guidelines similar to TMAP. One such state, Pennsylvania,
has been sued by two of its own investigators who claim they
were fired after exposing industry's undue influence over
state prescribing practices and the resulting inappropriate
medicating of patients, particularly children.
Thanks in part to such marketing strategies, sales of the
new atypical antipsychotics have soared. Unlike
antidepressants -- which have been marketed to huge
audiences almost as lifestyle drugs -- antipsychotics are
aimed at a small but growing market: schizophrenics and
people with bipolar disorder. Atypicals are profitable
because they are as much as 10 times more expensive than the
old antipsychotics, such as Haldol. In 2004, atypical
antipsychotics were the fourth-highest-grossing class of
drugs in the United States, with sales totaling $8.8 billion
-- $2.4 billion of which was paid for by state Medicaid
funds.
At a time when ethical questions are dogging the
pharmaceutical industry and algorithm programs in Texas and
Pennsylvania, President Bush's New Freedom Commission on
Mental Health has lauded TMAP as a "model program" and
called for the expanded use of screening programs like the
one at Aliah Gleason's middle school. The question now is
whose interests do these programs really serve --
THE TEXAS MEDICATION ALGORITHM PROJECT got under way in
the mid-1990s just as the new generation of antipsychotic
drugs was coming on the market. For some 40 years before,
medications like Thorazine, Haldol, and Mellaril were given
to patients with schizophrenia or psychosis to silence their
voices and calm their agitation. But they caused terrible
side effects, including sedation, social withdrawal, and
tardive dyskinesia, which causes muscle and facial tics and
strange jerking movements like those in people with
Parkinson's disease. Many patients would refuse to take
them -- when they had a choice. Some sued drug companies
and doctors for failing to warn them about the side effects
and won large awards.
Into that environment, drug companies brought out the new
atypical antipsychotics and began describing them in almost
miraculous terms. The drugs -- including Janssen
Pharmaceutica's Risperdal, Eli Lilly's Zyprexa, Pfizer's
Geodon, AstraZeneca's Seroquel, and Bristol-Myers Squibb's
Abilify, as well as a slightly older drug, Clozapine by
Sandoz -- were said to be more effective than the
first-generation antipsychotics and less likely to cause
motor problems and other side effects. "A potential
breakthrough of tremendous magnitude," Stanford University
psychiatrist Alan Schatzberg gushed to the New York Times.
Laurie Flynn, executive director of the National Alliance
for the Mentally Ill, added that now "the long-term
disability of schizophrenia can come to an end."
Despite the hoopla, not all doctors immediately embraced
the new drugs, and many patients bounced haphazardly between
the old and new antipsychotics. "They complained that
whenever they got new doctors, their whole medication
regimen usually changed," says Dr. Steven Shon, the medical
director for behavioral health for the Texas Department of
State Health Services (DSHS).
In 1995, Shon began talking with researchers at the
UT-Southwestern Medical Center in Dallas about the use of
algorithms to address these random prescribing practices.
From the start, the process of creating the algorithms
reflected the extensive ties between academic psychiatrists
and the pharmaceutical industry. UT-Southwestern was a
major research center stocked with investigators conducting
drug trials paid for by pharmaceutical companies.
One of Shon's key collaborators was Dr. John Rush, a
nationally known psychopharmacologist who has extensive ties
to industry. Rush declined to speak for this article, but
according to a disclosure statement appended to one of his
published articles, he has received grant and research
support from 14 pharmaceutical companies, has served as a
consultant to 11, and has been a member of 10 drug company
speakers' bureaus.
Together, Shon, Rush, and the then-chair of
UT-Southwestern's psychiatry department convened panels of
experts who drew up "consensus guidelines" for
schizophrenia, bipolar disorder, and major depression --
blueprints on which drugs to give patients in what order and
combination. Of the 46 members of the three panels, 27 have
conducted research on behalf of pharmaceutical companies,
served on drug company speakers' bureaus, or served as
consultants to a drug company, according to a review
conducted for Mother Jones by the Center for Science in the
Public Interest, a watchdog group that maintains a database
on the financial links of researchers.
For the drug companies, TMAP represented an opportunity.
Their products were given a high priority in the algorithm,
and if the algorithm was widely followed, it could mean
thousands of prescriptions and millions of dollars in
revenue. The industry didn't miss the chance. "We went to
the pharmaceutical companies or, actually, they approached
us because they are always dropping by," Shon told Mother
Jones. "Once we created the algorithms, they said, 'Could
you use any financial help for any materials?' And we said,
'Yeah,' because we have to publish manuals. We have to
create training videotapes."
Shon says the initial creation of the TMAP guidelines was
underwritten by state funds, along with $3 million in grants
from foundations, including $2.4 million from the Robert
Wood Johnson Foundation, a charity set up by the estate of a
former chief executive of Johnson & Johnson, the parent
of Janssen. Shon insists that no industry money went into
the creation of the guidelines, though a 1999 paper he
coauthored outlining the "development and implementation" of
TMAP acknowledged grant support from seven pharmaceutical
companies.
Shon also told Mother Jones that his department received
only $285,000 from drug companies for TMAP's training
materials in the program's "feasibility testing stage." But
Nanci Wilson, an investigative reporter for KEYE-TV in
Austin, reviewed the DSHS accounts, and her analysis
indicates that gifts from pharmaceutical companies totaled
$1.3 million from 1997 to July 2004, at least $834,000 of
which was earmarked for TMAP. For example:
- Janssen Pharmaceutica, the maker of Risperdal, gave
$191,183 "to help support further developmental
activities of TMAP" or in general support of TMAP.
- Eli Lilly, the maker of Prozac and Zyprexa, gave $47,000
to "help fund the collaborative effort to develop
medication best practices for the treatment of major
depression, schizophrenia and bipolar disorders." All
together Lilly contributed $103,000 to support
TMAP.
- Pfizer, the maker of the antidepressant Zoloft and the
new antipsychotic Geodon, contributed at least $146,500
for TMAP.
While not refuting Shon's statement, DSHS spokesman Doug
McBride says he is "aware" that industry donated $1.3
million. Representatives of pharmaceutical companies
contacted by Mother Jones denied that their contributions
were intended to shape TMAP. "We didn't participate in the
development or influence the content," said Janssen
spokesman Doug Arbesfeld. "It was an arm's-length
contribution." Heather Lusk, an Eli Lilly representative,
said contributions to TMAP were "educational" grants made by
a company grants office that "is completely independent of
any kind of sales and marketing function."
Pfizer's Jack Cox pointed out that nonprofit mental
health advocacy groups also raise and spend money to
influence policy. "There's an assumption that our money is
dirty and corrupt," he said. "I beg to differ."
AS THE TMAP PANEL MEMBERS worked on the protocols, drug
companies aggressively promoted the new antipsychotics
across the psychiatric landscape. Their key selling point:
that they were more effective and caused fewer serious side
effects than the older antipsychotics, especially Haldol,
the most widely used. Though it did approve six atypicals,
the FDA was dubious of some of these claims. "We would
consider any advertisement or promotional labeling for
Risperdal false, misleading or lacking fair balance if there
is a presentation of data that conveys the impression that
[Risperdal] is superior to [Haldol] or any other marketed
antipsychotic drug product with regard to safety or
effectiveness," an FDA official wrote in a 1993 letter to
Janssen Pharmaceutica. But the letter was only made public
53years later, when journalist Robert Whitaker quoted it in
his 2002 book, Mad in America. Most prescribing doctors
were left in the dark. (For more on how drug companies
manipulated clinical trials for atypicals see
motherjones.com/spinningdoctors.)
The largest study to date, a review of 52 clinical trials
including more than 12,000 patients published in the British
Medical Journal in 2000, found "no clear evidence that
atypical antipsychotics are more effective or better
tolerated than conventional antipsychotics." A 2003 study
comparing Zyprexa, the top-selling atypical antipsychotic,
and Haldol, published in the Journal of the American Medical
Association, found the new drug "does not demonstrate
advantages compared with [Haldol] in compliance, symptoms or
overall quality of life."
The new drugs now appear to be associated with higher
suicide rates and to cause tardive dyskinesia, too, though
perhaps at lower rates than the first-generation drugs.
They can cause rapid weight gain and thus an increased risk
of diabetes. In September 2003, the FDA required the makers
of all atypicals to add to their labels a warning that the
drugs can cause hyperglycemia, diabetes, and even death.
Janssen was also made to send doctors a letter conceding it
had misled them when it said that Risperdal does not
increase the risk of diabetes. In fact, the company had to
admit, it probably does.
When TMAP's schizophrenia algorithm was finalized in
1997, however, it did exactly what industry representatives
must have hoped for: It called for the newest, most
expensive drugs -- five atypicals -- to be used first. If a
patient does not respond well to one of those drugs, a
second member of this group should be tried. If that drug
also fails, a third drug should be tried, this time either
another atypical or an older antipsychotic. The guidelines
for major depression and bipolar disorder similarly favor
new drugs.
"When [the drug companies] saw the newer medications were
there, they liked that, of course," says Shon. "I know that
has raised questions in people's minds: 'Why are the
newest, most expensive first?' Well, the newest, most
expensive are either the most efficacious and/or the
safest."
But that assertion is increasingly disputed. "When
atypicals came out, they looked a little better in
effectiveness and a lot better in terms of side effects,"
says Mike Hogan, Ohio's mental health director and former
chairman of President Bush's New Freedom Commission on
Mental Health. "These days, they look perhaps a tiny bit
better in terms of effectiveness, but increasingly it's not
clear whether the side-effect profile is better or just
different."
Ohio adopted a TMAP-like algorithm in 2001 but with a
critical difference. According to Hogan, it's merely a
guideline for prescribing doctors to consider. But in
Texas, state officials put far more pressure on its
physicians to follow the protocols. Under regulations
codified by the legislature in 1999, doctors in state-owned
and state-funded mental health entities must follow the
algorithm, or justify a different course with a note in a
patient's file -- a hurdle that sends the message that such
deviation should be the rare exception.
As the TMAP guidelines began to be adopted in 1997, Texas
Medicaid spending on the five atypical antipsychotics
skyrocketed from $28 million to $177 million in 2004.
MANY DOSES OF THESE DRUGS went to patients like Aliah
Gleason. She was one of 19,404 Texas teenagers prescribed
an antipsychotic in July or August of 2004 through a
publicly funded program, according to ACS-Heritage, a
medical consulting firm hired by Texas to investigate the
use of psychotropic drugs on children. Nearly 98 percent
were atypical antipsychotics -- unapproved for children and
prescribed "off-label," a controversial practice in which
doctors legally prescribe FDA-cleared drugs to patients,
such as children, or for conditions, such as depression, for
which they are not approved. The report found that more
than half of the doses for antipsychotics appeared
inappropriately high, that almost half did not appear to
have valid diagnoses warranting their use, and that
one-third of child patients were on two or more
medications.
When she was transferred from Austin State Hospital to a
residential facility on March 18, 2004, Aliah was on five
different medications, putting her on the extreme end of a
growing practice known as polypharmacy that worries many
doctors. "This is a complicated regimen using powerful
psychotropic medications in a barely adolescent girl, so I
would be quite concerned about it," says Dr. Joseph
Woolston, a Yale University professor and chief of child
psychiatry at Yale-New Haven Hospital. "It isn't grossly,
acutely dangerous, but it is sedating and would make it
difficult for a child to experience the world in a normal
way. If you or I were on that regimen we would have a lot
of trouble attending to work or school. We don't have any
idea what that combination of medications does to a
developing child. It may have a number of long-term side
effects." He also suspects that the drugs may have been used
as much to control the angry reactions of a girl who was
hospitalized against her will as to treat any mental and
emotional problems.
Dr. Clifford Moy, clinical director of Austin State
Hospital, says that while the hospital's philosophy is to
avoid using more than one member of any particular class of
psychiatric medication, using multiple drugs from different
classes is often the best way to treat a patient with
multiple symptoms. While declining, for privacy reasons, to
discuss Aliah's treatment, he said medication and restraint
would never be used for punitive purposes or merely to
promote compliance with hospital rules, but only in the case
of a "significant emergency behavioral situation." He added
that forced injection of an antipsychotic -- which happened
to Aliah several times -- might be used "if there were a
legal consent for an oral antipsychotic medication, which
the patient refused." Such consent was apparently provided,
in Aliah's case, by the Department of Protective and
Regulatory Services.
The 46-bed child and adolescent wing where Aliah stayed
was not, like the rest of Austin State Hospital, obligated
to follow TMAP. Its treatment regimens were influenced more
by CMAP, the children's algorithm not yet mandated by the
legislature. CMAP steers clear of providing protocols for
schizophrenia and bipolar disorder -- the disorders that
atypicals were designed to address -- in part, says DSHS's
Doug McBride, because there's "little scientific evidence"
as to what the appropriate regimen for kids would be. CMAP
does, however, call for combining atypicals with
antidepressants for children diagnosed -- as Aliah was -- as
suffering from depression "with psychotic features." McBride
defends such off-label use of prescription drugs, saying
that the FDA approval process "is not the end of clinical
and other scientific evidence on the use of that
medication."
Beyond their technical dictates, the algorithms
established a culture that affected which medications were
prescribed. Steven Shon, who, along with his colleagues,
had led training sessions for the staff of Austin State
Hospital, argues that the algorithms were designed to
prevent irrational and excessive medication. Yale's
Woolston agrees with the goal, though not necessarily the
reality. "Algorithms are supposed to cut down on people
using medications inappropriately and to take into account
medication interaction," he says. "Where they become a
problem is when people use them as a mandate, forget their
own clinical judgment, and believe that when you're in
doubt, you're supposed to move forward in the algorithm and
add more medication."
Medications can be invaluable, and some patients say
their lives have been transformed by atypicals. But
algorithms reinforce the perception in both psychiatry and
popular culture that mental problems always require drug
treatment. "An algorithm may put blinders on a psychiatrist
and create the presumption that the only clinical approach
to problems is to use medications," Woolston says. If a
patient doesn't respond to a particular medication, a doctor
relying on an algorithm may think they need to use or add a
different medication, he says. "But sometimes, the best
approach is to say, 'Medication isn't working; let's try
something else.'"
ONCE THE DEVELOPMENT of the algorithms was largely
complete, Shon began hitting the road, making about one trip
a month -- often at the expense of drug companies -- to
spread the TMAP gospel to officials in other states. This
close relationship between TMAP and the pharmaceutical
industry raises disturbing questions about whether the drug
companies were wielding undue influence or profiting at the
expense of patients. But no one raised these questions
until 2002, when Allen Jones, an investigator for the state
of Pennsylvania's Office of Inspector General (OIG) began to
look into a complaint that mental health officials had set
up an unorthodox bank account to collect money from drug
companies.
Jones, a lanky, 50-year-old chain-smoker, had spent
several years with the OIG in the late '80s and early '90s,
but left to pursue real estate investing to pay for his
daughters' college tuition. He had only just rejoined the
agency in the summer of 2002 when he began investigating
this case. Over several months, he interviewed state
officials, traveled to New York and New Jersey to question
pharmaceutical company executives, and learned all he could
about TMAP. He soon felt that something inappropriate, and
possibly illegal, was going on. "It just did not pass the
smell test," he says.
Jones learned that in early 2000, Dr. Steven Karp, who
was then medical director of the state's Office of Mental
Health, had become interested in implementing a Pennsylvania
version of TMAP. Karp discussed his interest with
executives of Janssen Pharmaceutica, Jones found, and the
company paid for Shon to come to Pennsylvania in late 2000
to meet with Karp and Steven Fiorello, the state's chief
pharmacist. Shon returned in March 2001 to train state
medical personnel, according to records Jones obtained and
provided to Mother Jones. To cover Shon's travel expenses,
Janssen made an "educational grant" of $1,765.75. A Janssen
funding request form notes that the grant was to support the
"TMAP initiative to expand atypical usage and drive Steve
Shon's expenses." A box marked "Risperdal" is checked on the
form. Janssen's check was sent to Fiorello and placed in
the account where other donations from pharmaceutical
companies were deposited.
Two months later, Janssen provided $4,000 for Fiorello
and a state psychiatrist to travel to New Orleans for
meetings with Dr. Madhukar Trivedi, a UT-Southwestern
psychiatrist and TMAP project team director. The funding
request form for this payment listed the "deliverable" as
the "successful implementation of PennMAP." A Janssen
representative also attended and paid for $80-per-person
dinners for the Pennsylvania and Texas officials. Fiorello
and the psychiatrist made another trip to New Orleans later
that year, also paid for by Janssen, according to Jones.
Such perks, while of no great consequence to a company the
size of Janssen, did forge a friendly relationship with
Pennsylvania officials whose decisions carried enormous
financial stakes for the company.
Fiorello told Jones he was the state's "point man" for
selecting drugs for the state formulary -- those used in
state hospitals -- and that industry representatives visit
him often "to ensure access of their drugs to the state
system," Jones wrote in a file memo as he pursued his
investigation. In April 2002, Fiorello and Dr. Frederick
Maue, clinical director for the state's Department of
Corrections, spoke at a Janssen-sponsored symposium for
prison doctors and nurses on treating mentally ill
offenders. They were paid $2,000 by Comprehensive
NeuroScience, a marketing firm working for Janssen that
helped shape their presentation. Another marketing company
hired by Janssen appointed Karp to its advisory board,
flying him to meetings in Seattle and Tampa. Pfizer put
Fiorello on an advisory council and twice paid his expenses
to come to New York.
Jones became convinced that, as he puts it, "the
pharmaceutical companies were buying influence with key
decision makers in state government, trying to turn their
drugs into blockbusters." But as he brought these findings
to his boss, Daniel Sattele, he was told to stop pushing so
hard. After he was barred from investigating whether state
officials had received inappropriate payments from drug
companies, Jones sued in federal court, alleging that "major
public corruption investigations were being delayed,
obstructed, or otherwise hindered by officials in the OIG."
Sattele subsequently conceded in a deposition taken in 2003
that he asked Jones if he were "a salmon," telling him, "go
with the flow, don't swim against the current." Sattele also
said that after Jones came to him with his concerns for the
fourth or fifth time, he reminded Jones of the industry's
power and influence. "I said, 'Allen, pharmaceutical
companies are very aggressive in their marketing. They
probably donate to both sides of the aisle,'" he recalled in
the deposition.
When Jones continued to pursue the case he was removed as
lead investigator, then pulled off altogether, he says.
Nonetheless, over the coming months, he quietly copied
documents and, on his own time, gathered more
information.
In February 2004, Jones laid out his charges for the New
York Times and the British Medical Journal. In April he was
suspended. In May he again sued in federal court, charging
that his superiors were harassing him to "cover up,
discourage, and limit any investigations or oversight into
the corrupt practices of large drug companies and corrupt
public officials who have acted with them." He was then
fired. He is now working as a bricklayer; both his actions
are pending.
A spokeswoman for the Pennsylvania Office of Inspector
General declined to comment on Jones' allegations or his
termination. A representative of the Department of
Corrections told Mother Jones that Maue donated the
honorarium he was given by Comprehensive NeuroScience to the
state's general fund. And Stacey Ward, a spokeswoman for
the Department of Public Welfare, said that the state "did
not receive contributions of any kind from any
pharmaceutical company to study or support the
implementation of PennMAP." [Ed note: After the print
edition of this story went to press, the Pennsylvania State
Ethics Commission fined Steven Fiorello, the state's chief
pharmacist, $27,000 for using his position to earn extra
income from sources that included Pfizer.]
Meanwhile, another Pennsylvania official was becoming
increasingly alarmed with how drugs being pushed by the
pharmaceutical industry were actually affecting patients.
Dr. Stefan Kruszewski, a Harvard-trained psychiatrist
working for the state's Department of Public Welfare, was
charged with reviewing psychiatric care provided by
state-funded agencies to identify cases of waste, fraud, and
abuse. In the summer of 2001, he began documenting examples
of what he calls "insane polypharmacy" and widespread use of
drugs for reasons not approved by the FDA. Most shocking to
him were the cases of children placed in state-funded
residential treatment facilities, sometimes for years, and
heavily drugged on the new antipsychotics and
anticonvulsants, including some of the same medications
given, off-label, to Aliah Gleason.
"These kids were on multiple medications without the
clinical diagnoses to support the medications," Kruszewski
says. One drug, Neurontin, approved for controlling
seizures, "was being massively prescribed for anxiety,
social phobia, PTSD, social anxiety, mood instability,
sleep, oppositional defiant behavior, attention deficit
disorder. Yet there's almost no evidence to support these
uses in adults and no evidence for kids whatsoever."
Last year a Pfizer subsidiary pleaded guilty to criminal
fraud and agreed to pay $430 million in fines for promoting
off-label prescribing of Neurontin, which racked up $2.8
billion in U.S. sales in 2004. Officials estimate that
off-label uses account for some 90 percent of its sales.
New York attorney Andrew Finkelstein says he's been enlisted
by the relatives of 425 people who committed suicide while
on Neurontin, and thus far has filed 46 lawsuits against
Pfizer.
Kruszewski sent memos to his bosses about dangerous
off-label uses of these medications but says they were
ignored. He also looked into the deaths of four children in
residential programs and submitted a report on an Oklahoma
facility, where Pennsylvania children were sometimes sent.
He found that many of the kids "were severely overmedicated"
with atypical antipsychotics, antidepressants, and
anticonvulsants, and he theorized that the death of at least
one child could be attributed to a culture that combined
polypharmacy and neglect.
His report earned him no plaudits. The day after
submitting it, he says, he was yelled at for "trying to dig
up dirt." The next day he was fired and escorted to the
street. He has since filed suit in federal court against
the state officials who fired him, along with several drug
companies that, he charges, have "distorted statistics,
violated regulations and misrepresented the effects of the
use of their psychotropic drugs simply to make money." (The
Pennsylvania Department of Public Welfare declined to
comment on Kruszewski's charges because of his pending
lawsuit.) Months after he was fired, Kruszewski alternates
between anger and sorrow as he thumbs through documents
piled in the dining room of his Harrisburg home. "I get
very emotional about these reports," he says. "The people
who were paid to protect consumers did exactly the wrong
thing."
UNLIKE SOME OTHER HEAVILY medicated children, Aliah
Gleason survived. In June 2004, more than five months after
she was taken from school, Calvin and Anaka Gleason saw
their daughter for the first time -- in a courtroom. "I was
so excited," Aliah recalls. "I hid under the table so I
could surprise them. I started crying when I saw them. I
thought I would never see them again."
It would take another four months of legal wrangling with
the state before a district court judge ordered Aliah
released into her parents' custody. Finally, the Gleasons
were allowed to choose the people who would treat their
daughter. They selected Austin psychologist John Breeding,
a well-known critic of the overuse of psychiatric
medications, and soon the whole family began meeting with
him.
The first priority, Breeding said, "was to get her off
the medication." Working with the family's doctor, he helped
design a program for tapering her off her final drugs,
Risperdal and Depakote, a process that was completed by the
end of last year. He says the goal now is to help her
recover from the emotional wounds she suffered as a result
of her time under the state's care. She also needs to lose
all the weight she gained while on the atypicals.
The good news, he says, is that "the family is reunited,
she's doing well in school, and is even participating in
extracurricular activities." Like her sisters, Aliah plays
in the school band and also takes part in a drill team.
"She's coming back, starting to get that gleam in her eye,"
Breeding says.
Aliah found herself at the intersection of a capricious
child-protection system and a health care system that's all
too ready to medicate. As doctors dispense ever-greater
quantities of potent psychiatric drugs, and the industry
spends ever-greater amounts of money promoting them, how can
consumers be confident that decisions about their care are
truly informed and in their interest? Whatever the stakes
for the drug companies, the stakes for patients are
infinitely higher.
Rob Waters has written extensively on the use of
psychiatric medication by children. Last year he revealed
in the San Francisco Chronicle that the FDA suppressed an
internal report linking antidepressants to an increased risk
of suicide among children, a story that led to congressional
hearings and warnings being issued for the drugs.
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