Download Big Pharma`s Troubling History of Pushing Drugs on Foster Kids

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April 09, 2013
Big Pharma's Troubling History of
Pushing Drugs on Foster Kids
By Michael Barajas
Child protection workers found Jo Angel Rodriguez and her siblings living in a
roach-infested home that reeked of urine and spoiled food. The kids, often plagued
with lice, slept on soiled, squalid mattresses, according to documents filed in a local
court. Rodriguez’s mother lost custody of her children in 2006 when complaints
surfaced she and her boyfriends shot heroin in front of them. Child protection
workers later discovered Rodriguez had been sexually abused by a family member.
The system bounced Rodriguez and her five siblings from one foster home to another
over the next two years. But by 2009, things were getting better. The 11-year-old girl
finished a stint at a North Texas counseling center, where doctors taught her how to
deal with the emotional baggage that comes with abuse and years of neglect. By fall
of that year, she rejoined a sister and brother in a San Antonio foster home.
Rodriguez’s foster parents soon complained she was too much to handle, however. In
September 2009, they tried unsuccessfully to commit her to Laurel Ridge Treatment
Center. Officials with the Texas Department of Family Protective Services were leery,
according to one report, suspecting the foster parents had a pattern of dumping kids
into psychiatric treatment centers whenever they acted out. Rodriguez had, in fact,
already come away from numerous psychiatric evaluations without a clear diagnosis;
doctors seemed to agree, though, that she suffered from some mix of anxiety,
depression, and post-traumatic stress.
A week later, Rodriguez’s foster parents persisted, claiming she had been aggressive
at home and, during time-out one day, said she might harm herself. This time Laurel
Ridge jumped into action, admitting the girl and diagnosing her with bipolar
disorder.
Staff at the facility gave Rodriguez glowing behavior reports, lauding her for
participation in group therapy sessions and for having good manners. One nurse’s
report says Rodriguez became protective of the younger girls in her unit.
Two days after her commitment, doctors put Rodriguez on nightly doses of Abilify,
an antipsychotic. She began to sleep through the day, becoming withdrawn and
refusing to eat. She suffered frequent vomiting and diarrhea.
On September 26, 2009, nurses complained Rodriguez became aggressive when they
tried to bathe her.
Dr. Lindy Bankes, a University of Texas Health Science Center resident moonlighting
on a weekend shift, prescribed Rodriguez a 1-milligram dose of Risperdal, another
antipsychotic. When Rodriguez refused to take the pill, Bankes gave her a 20milligram shot of Geodon instead.
Three hours later, nurses found Rodriguez in her bed, unable to speak or move, with
“shallow and labored” breathing. Due to a stunning breakdown in communication, as
evidenced by facility records detailed in court, it took nearly two hours for an
ambulance to show. When paramedics arrived, Rodriguez couldn’t move her limbs
and had cold, clammy skin. She gasped for air. Her lips were pale, and her blood
pressure had tanked so low the paramedic couldn’t get a reading.
Emergency room doctors later determined Rodriguez suffered from a cardiac
arrhythmia that triggered a full-blown heart attack. She slipped into a coma and died
the next day.
A barrage of errors killed Rodriguez, according to a lawsuit her court-appointed
attorneys filed on her behalf in 2010 targeting Laurel Ridge, Bankes, and the
ambulance company. They also sued Pfizer, Geodon’s manufacturer, alleging the
drug set in motion the deadly chain of events.
Even though the Food and Drug Administration has denied Pfizer’s multiple
attempts to approve Geodon for use in children, meaning the company can’t legally
market it for pediatric uses, Geodon still made its way into Rodriguez’s room that
night.
It wasn’t by accident. The Bexar County lawsuit and several others filed in federal
court with the backing of the Texas Attorney General’s Office claim that Pfizer
schemed for years to illegally market Geodon to child psychiatrists. In the process,
court documents say, Pfizer manipulated information about the drug’s side-effects,
paid off doctors to tout the drug’s use in kids, and purchased ghost-written studies
that essentially amounted to paid advertising posing as science.
Geodon, a drug known to cause dangerous heartbeat irregularities, is among a new
generation of antipsychotics that, while FDA-approved for narrow treatment, have
become some of Big Pharma’s signature off-label moneymakers. While the FDA
approved Geodon to treat adults diagnosed with schizophrenia and bipolar disorder,
Pfizer worked for years to recast the drug for broader use, court records indicate.
Pfizer isn’t alone. The company and its Big Pharma competitors have become the
single largest target of the federal False Claims Act, paying out millions in recent
settlements over allegations of illegal marketing of drugs, many of them atypical
antipsychotics.
“This case is a perfect example, unfortunately, of what can happen” with off-label
marketing of pharmaceuticals, contends Brant Mittler, a cardiologist-turned
malpractice lawyer who handled the Jo Angel Rodriguez case.
“This child didn’t need to die.”
The 1990s were the Manifest Destiny days for drug manufacturers, and Texas
became the first promising frontier. Developed over a half century ago, neuroleptic
drugs, now commonly referred to as antipsychotics, were initially seen as little more
than powerful sedatives, used sparingly for patients diagnosed with schizophrenia or
severe psychotic disorders. Patients often quit the drugs, like Thorazine and Haldol,
because they caused involuntary tics, movements, and restlessness.
By the ’90s, however, drug companies began developing new, second-generation
antipsychotics, often called atypicals, telling regulators they were safer than the old
ones, a dubious claim according to some (non-industry funded) research.
The FDA approved these drugs for treating schizophrenia, but companies dreamed
bigger, pushing for the drugs to treat anything from bipolar disorder to dementia,
attention-deficit disorder or even stuttering, in all age groups, including children and
adolescents.
Texas proved a fertile testing ground. Johnson & Johnson, the first to gain FDA
approval for its atypical Risperdal, blazed a trail most of its competitors would soon
follow. Through subsidiary Janssen Pharmaceuticals, it trolled for experts hungry for
industry cash. Records unearthed in a whistleblower suit that Janssen settled with
the State of Texas last year reveal the company paid prominent psychiatrists at Duke,
Cornell, and Columbia universities half a million dollars to draft the so-called
Schizophrenic Practice Guidelines, draft reports of which were tweaked by Janssen
itself.
By 1997, those guidelines became the Texas Medication Algorithm Project, outlining
which psychiatric meds doctors should use to treat people in the state’s publicly
funded health care system. On the heels of TMAP, the same experts pioneered a
spin-off project that touted similar guidelines for prescribing drugs to foster kids.
Court records from the whistleblower suit show drug-industry cash flooded TMAP.
All told, Big Pharma subsidized TMAP to the tune of $1.3 million, more than half of
which was paid by heavyweights Johnson & Johnson and Pfizer. The TMAP
architects — “key opinion leaders” Dr. Steven Shon, then director of the Texas
Department of Mental Health and Mental Retardation, Dr. Lynn Crismon of
University of Texas’ College of Pharmacy, and Drs. Alexander Miller and John Chiles
of San Antonio’s UT Health Science Center — received speaking fees, travel
expenses, and honoraria. Shon got more than $30,000, Miller $82,000, and Chiles
$151,000 during the TMAP days, according to an expert report filed in Texas’
Medicaid fraud lawsuit against Janssen.
Before the guidelines, the state’s doctors prescribed conventional antipsychotics
first, and only reached for the more expensive atypicals after two or three
conventionals failed. Under TMAP, atypicals became first-choice treatment options,
while conventionals moved down the ladder. In 2002, Texas experts added Geodon
as a first-choice medication.
At least 16 states eventually incorporated these guidelines until 2004, when Allen
Jones, an investigator with Pennsylvania’s Office of Inspector General, blew the
whistle, calling TMAP “a Trojan horse embedded with the pharmaceutical industry’s
newest and most expensive mental health drugs.”
The allegations triggered an investigation by the Texas Comptroller’s Office, which
delivered a scathing report on overuse of antipsychotics in state foster care. The
Comptroller highlighted nightmare cases like the three-year-old foster child taken to
the emergency room for psychotropic poisoning, or that of the six-year-old kid given
60 prescriptions, including mood stabilizers and antipsychotics.
By 2004, Texas foster kids got 23,812 prescriptions for Risperdal, which had yet to
be approved by the FDA for use in children, according to the Comptroller’s report.
Doctors wrote foster kids some 3,330 prescriptions for Geodon that same year.
In 2005, in reaction to the whistleblower lawsuit, Texas drafted the Psychotropic
Medication Utilization Parameters for Foster Children, which were last updated in
late 2010, authored by some of the same industry-friendly doctors outed by the
Texas AG’s lawsuit. The current parameters cite a 2007 article that appeared in the
European Journal of Child and Adolescent Psychiatry boosting the pediatric profile
for atypicals, ghost-written by Excerpta Medica and overseen by Janssen, according
to an investigation report filed in the state’s lawsuit. The report cites a litany of
emails that show Janssen helped craft the article.
Dr. Howard Brody, who heads the Institute for Medical Humanities at the University
of Texas Medical Branch, asserts such ghost-writing has “poisoned the medical
literature” in recent years, particularly when it comes to atypical antipsychotics.
According to Brody, federal and state governments have sued Pfizer more than a
dozen times over the past decade, resulting in millions of dollars in settlement
payouts to quell allegations of illegal marketing of drugs, including Geodon.
Pfizer declined to comment on the allegations contained in any of the lawsuits
against the company, saying through a spokesperson, “Pfizer remains committed to
conducting its business with the highest degree of ethics and integrity, and providing
patients, physicians, and the public with accurate, science-based information
regarding our medicines.”
“Each time, they swear on a stack of Bibles, ‘Oh we’ll never do that again,’ and they
just do it over and over again,” Brody said. “Industry treats this as nothing more than
a cost of doing business.”
The FDA rejected Geodon in 1998, just five months after Jo Angel Rodriguez was
born, fearing the drug’s tendency to cause cardiac arrhythmia was too great. While
the effect is a common one in antipsychotics — known as QT prolongation — the
FDA’s disapproval letter to Pfizer expressed concern that Geodon’s impact was worse
than that of other antipsychotics on the market.
Pfizer quickly started more clinical trials. The manufacturer wanted to ensure good
results, the feds have alleged, so, along with comparing the drug to other leading
atypicals, Pfizer put Geodon up against Thioridazine, a highly potent antipsychotic
that’s rarely used because of a strong risk of cardiac complications; the FDA had, in
fact, already made Thioridazine a second-line treatment because of those concerns.
Some of the data from Pfizer’s clinical trials came from unsavory characters,
according to federal court records. Early participants included Drs. Richard Borison
and Bruce Diamons, former psychiatrists with the Medical College of Georgia who
were later convicted and sentenced to prison for stealing more than $10 million in
clinical research funds from their school. Another trial participant was Louis Fabre,
founder of Houston’s Fabre Research Clinic, which the FDA blamed for a patient
death during a 2002 clinical trial on another antipsychotic.
Over strong objections from staffers, in 2001 the FDA approved Geodon for treating
adults with schizophrenia and bipolar disorder. But federal whistleblower lawsuits,
in which Texas has been a plaintiff, filed before and after Jo Angel Rodriguez’s death
allege that in order to boost Geodon sales, Pfizer followed Johnson & Johnson’s lead,
launching a full-court press to market Geodon for off-label use, particularly in
children and adolescents.
At least twice the FDA chided Pfizer for providing doctors misleading information.
One September 2002 warning letter scolded the company for misrepresenting
clinical and safety studies related to the drug, and for promoting Geodon “in a
manner that is misleading and lacking fair balance” by minimizing the risk of cardiac
arrhythmia. The FDA again warned Pfizer in 2007 for similar problems.
Meanwhile, Pfizer sought to seed the medical literature with studies praising offlabel use of Geodon, some of which the federal government described as little more
than a marketing gimmick in their lawsuit.
According to another whistleblower suit, Pfizer began to contract with Dr. Neil Kaye,
a prominent psychiatrist with Jefferson Medical College in Philadelphia, to promote
off-label prescribing of Geodon in medical journals, at speaking gigs, and in
continuing medical education seminars for psychiatrists.
Pfizer, according to court records, paid Kaye as much as $4,000 a day on top of
expenses, and even flew him around the country in his own private helicopter.
In one court case, the feds called the practice “information laundering.” Apparently it
paid off. According to court records, doctors wrote 89,000 Geodon prescriptions for
children in the U.S. in 2003. By 2005, prescriptions for children jumped to 251,000.
Three weeks before Jo Angel Rodriguez died at Laurel Ridge, Pfizer paid $2.3 billion
to settle claims that it fraudulently marketed Geodon and two other medications. It
was the Justice Department’s largest ever health care fraud settlement, and as part of
the deal Pfizer agreed to comply with a more rigorous corporate compliance
regimen.
But according to another whistleblower’s suit filed a year after Rodriguez’s death, the
illegal marketing never stopped.
In 2009, Pfizer again sought approval to market Geodon for use in children; the FDA
rejected the application late that year. Further, the FDA issued a report after looking
into Pfizer’s data on clinical trials in kids and adolescents, detailing some 24 cases
where children experienced serious complications, including cardiac arrhythmia.
While Pfizer told the FDA cardiac concerns were no different in children than in
adults, the FDA did its own analysis that showed otherwise. The FDA in 2010
scolded three doctors who participated in Geodon’s children trials, saying they
improperly dosed patients, and in a few instances overdosed patients.
Emails from executives in Pfizer’s Missouri-based southern district, which also
covers Texas, Oklahoma, Colorado, and Louisiana, warned sales teams to shy away
from the issue while pitching the drug to child psychiatrists. “[I]nformation related
to Geodon’s pediatric filing status should NOT be discussed,” read one such
exchange.
Meanwhile, Pfizer continued to pay doctors to market Geodon beyond its FDAapproved uses.
Alex Booker, a sales representative out of Pfizer’s Missouri office, blew the whistle
after he was fired for complaining about the pervasive off-label marketing. In court
documents, he claimed Pfizer told sales teams to target child psychiatrists with a
high number of Medicaid patients — one document filed in court shows Pfizer’s
“Medicaid Pull-Through” strategy, listing some two dozen child psychiatrists in the
St. Louis area Pfizer hoped would someday write Geodon prescriptions.
Other court filings show that sales reps encouraged Texas Medicaid doctors to boost
Geodon doses to up to 360 milligrams per day; the drug was only approved for doses
of 160 milligrams, therefore prescriptions over that amount would count as two
prescriptions, a quick, easy way for sales reps to exceed quotas and start earning
bonuses.
Pfizer, according to the lawsuit, would even go so far as to put undercover sales reps
in continuing education seminars. The “plant” would ensure that the group got
Pfizer-paid speakers to discuss off-label prescriptions for children.
Booker complained to Pfizer’s compliance hotline in October 2009, claiming, among
other problems, that Pfizer urged sales reps to manipulate or conceal Geodon’s safety
profile. Hearing nothing back, on January 5, 2010, he followed up with an email to
corporate compliance.
Pfizer fired him the next day.
Brant Mittler sought similar records in the local lawsuit against Pfizer. By early this
year, all defendants had settled except for the drug manufacturer. For months, Pfizer
fought the release of those records, including marketing materials and internal
communications between regional and local sales staff.
When earlier this year it appeared Bexar County Probate Court Judge Polly Jackson
Spencer might force Pfizer to produce, the company started to talk settlement.
Dr. Joseph Hernandez, Jo Angel’s Rodriguez’s admitting doctor at Laurel Ridge, said
the use of Geodon became a bright red flag almost immediately after Rodriguez died,
according to deposition testimony lawyers filed in court.
Hernandez said he spoke to Dr. Benigno Fernandez, Laurel Ridge’s medical director,
wanting to know why the Geodon was given, why he was never called when the girl’s
condition worsened, and why it took so long to transfer Rodriguez to the emergency
room when she crashed.
When he spoke to Dr. Lindy Bankes, who ordered the drug, “she was obviously
upset,” Hernandez recalled. “She was asking me questions about Geodon.”
According to Bankes’ deposition, the Texas Medical Board notified her someone
lodged a complaint against her due to the incident — such complaints are
confidential, so there’s no telling who filed it. Despite Hernandez’s obvious concerns
with the handling of the case, Fernandez and one of Bankes’ trainers from UTHSC
wrote letters to the TMB trying to absolve her of any blame, Bankes testified.
Hernandez found it hard to believe Rodriguez would have been aggressive with staff.
“That represented a departure” for the girl, he said. Hernandez had spoken with staff
over the phone before the girl died, he said. “I was told that she was actually up and
active and laughing, which is not consistent with what was documented” in staff
notes, he testified. “I’m having a difficult time trying to figure out what happened
here … I can’t figure this out from the documentation.”
Bankes, now in private practice in San Angelo, did not respond to calls for comment.
Laurel Ridge’s chief operations officer would not comment, except to say, “Laurel
Ridge takes the care, safety, and privacy of all clients very seriously.”
In depositions, both Hernandez and Bankes recalled an email Fernandez sent out
months before Rodriguez’s death regarding Geodon. It told staff to use Geodon
instead of Zyprexa, an atypical antipsychotic that is FDA-approved for treating
bipolar disorder and schizophrenia in adolescents, for cost reasons.
“It (Geodon) was on the pediatric unit and readily available,” Bankes testified. “And,
in the email that we got from Dr. Fernandez about using Geodon, it didn’t say
anything about not on pediatric patients. I mean, if it was there and on the unit and
doctors were using it, then I assume it had been approved by Laurel Ridge.”
While Bankes denied that complications from Geodon had anything to do with
Rodriguez’s death, Hernandez admitted that the Geodon “led to a cardiac arrhythmia
and a subsequent cardiac arrest and the subsequent death.”
Discussing the case last month, Brant Mittler said “nearly every check and balance in
the system failed Jo Angel.” The lawsuit blamed the most blatant lapses on Laurel
Ridge.
According to a survey of local court filings, no other psychiatric treatment center in
town has the history of serious litigation Laurel Ridge has seen in recent years.
On the night of Rodriguez’s death, a nurse’s entry says the girl was ordered to be
transferred to the emergency room at 11 p.m. Hospital records show another transfer
order a half hour later. At 12:50 a.m., a nurse starting her shift found Rodriguez
barely responsive in her bed, struggling to breathe. An ambulance showed up two
minutes later and spent 14 minutes on the scene. The ambulance left Laurel Ridge
with Rodriguez at 1:06 a.m., arriving at Methodist Stone Oak Hospital, about 3 miles
away, at 1:25 a.m.
Jose Rebolledo, a local pediatric cardiologist who submitted an expert report for the
plaintiffs in Rodriguez’s case, wrote, “So, according to their own records, paramedics
spent 14 minutes on the scene and then took 19 minutes to travel by ambulance at
night 3.2 miles.”
Rodriguez’s death occurred during a particularly troubling period for Laurel Ridge.
Two years earlier, state investigators cited the facility for personnel shortages that
led to patient neglect. On the heels of that, a Dallas Morning News investigation
turned up complaints of teenage patients assaulting each other, of repeated mistakes
in medication delivery, and squalid conditions. Texas Department of Family
Protective Services records from the past two years include an incident in late 2012
when “staff used excessive force while escorting a child into seclusion room which
resulted in bruising.” Another incident report stems from when investigators found
unauthorized meds in one child’s bedroom. Other deficiencies noted in the past two
years include failure to maintain child/caregiver staffing ratios, and lapses in records
keeping.
Nurse Loretta Ramos sued Laurel Ridge in 2008, claiming she was fired because she
reported numerous violations, including unsafe staffing levels, and “was a witness to
the cover-up of facts surrounding [a] patient’s suicide,” concerning the death of a
woman placed on suicide watch at the facility. In another instance, in 2010, a male
patient on suicide watch stormed out of a group therapy session and was found dead
three hours later, having hung himself with a bed sheet. His Laurel Ridge doctor,
Allan Lloyd, had his license revoked by the Texas Medical Review Board a year later
over unrelated charges.
Months before Jo Angel Rodriguez entered Laurel Ridge, 24-year-old Lauren Green
was admitted for mood disorder, bipolar disorder, depression, and suicidal ideation.
According to father Tim Green, Lauren became addicted to Demerol at age 19 when
doctors prescribed the pain medication to alleviate her cellulitis. In 2009, the family,
from the Dallas-Fort Worth area, scoured the country for a treatment center and
settled on Laurel Ridge.
Records show that the day Dr. Malathi Koli discharged Lauren from Laurel Ridge;
she gave Lauren 13 different prescription medications, including painkillers and
antipsychotics. Koli gave Lauren prescriptions for 10 more medications when she
left, according to court records. The day after leaving Laurel Ridge, Lauren headed to
Austin to stay with an ex-boyfriend, filled the prescriptions and took them that
evening. On the phone that night, “she was completely out of it, just a zombie,” Tim
said. The ex-boyfriend found her dead the next morning.
The Travis County Medical Examiner wrote that Lauren died from “acute multiple
drug toxicity,” explicitly stating that there was no evidence of an overdose. Lauren
had taken the medicine as prescribed by Laurel Ridge.
When the family sued, Laurel Ridge settled with the Greens for an undisclosed
amount. The malpractice case against Koli went to trial in a Bexar County court last
December. The Greens lost, and the court awarded Koli more than $5,000 in court
costs, which the Greens now have to pay.
Jason Cruz, Jo Angel Rodriguez’s court appointed attorney and guardian, recalled
rushing to the hospital to visit Rodriguez as soon as he heard she’d been taken to the
emergency room. “When I saw her, she was basically comatose.”
DFPS conducted its own death review, writing, “It is of concern that it appears that
Jo Angel’s physical illness was not being followed closely, nor was any possible
reaction to the emergency medication being monitored.” DFPS also criticized the
hospital for taking so long to call an ambulance.
Cruz, for his part, is still troubled Rodriguez was committed to Laurel Ridge in the
first place
“Bottom line, it was one of those situations where they (the foster parents) were
looking for an excuse to get rid of her,” he claimed. “They had tried to get her
admitted before. … I spent more time with those kids than arguably any other case
I’ve ever had, and that kind of behavior was just not an issue with her.”
The years-long court battle ended with a whimper last week when attorneys met with
Judge Spencer to approve a confidential settlement with Pfizer.
“I guess that was the whole point in filing the lawsuit,” Cruz said, “to try to honor Jo
Angel and get her siblings some money.”
For Cruz, the outcome is bittersweet. “As attorneys, we feel great that we succeeded,”
he said. “But from knowing that little girl, knowing how bright she was, it just feels
kind of empty.”
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