January 12, 2007
Public Has Right To Know Secrets Revealed In Zyprexa Documents
By Evelyn Pringle
deciding whether to allow Eli Lilly to continue to use court orders to
hide documents that show the company illegally marketed Zyprexa for
unapproved uses and failed to warn the public about the serious health
risks associated with the drug for a decade, the court needs to
consider the harm done to the public by Lilly's conduct.
public has a right to know everything about the drugging for profit
scheme revealed in the documents since the majority of profits made off
Zyprexa came from the public trough. The court needs to recognize the
harm done to tax payers in billing public health care programs like
Medicaid for the massive off-label sale of the drug. According to the
October 23, 2005, San Francisco Chronicle, nationwide, Medicaid
programs purchase an estimated 60 to 75% of antipsychotic drugs.
California for instance, in the year ending June 2005, Zyprexa was the
highest expenditure at close to $250 million. On November 28, 2005, the
Indianapolis Business Journal listed Zyprexa as the most costly
antipsychotic covered by South Carolina's Medicaid program with a
month's supply of 20-milligram tablets costing South Carolina $700.52
at the time.
On September 29, 2005, Bloomberg News stated that
Medicaid could reduce the "$5.5 billion it spends annually on
schizophrenia drugs for the poor" because a study found the cheaper
generic, perphenazine, about as effective as new drugs, including
"The 40-year-old drug perphenazine costs less than
$1.50 a day," Bloomberg wrote, "while the newer medicines can cost 10
times as much."
When buying a 3-month supply, at
drugstore,com, the retail price for Zyprexa in September, 2005 was
$1,500, and a 3-month supply of perphenazine, was only $135.
has even found ways to convince doctors within the Veteran
Administration's hospital system to prescribe Zyprexa rather than the
older, cheaper and equally effective drugs. Dr Robert Rosenheck, a
Director with the Department of Veterans Affairs, reviewed the
prescribing records for schizophrenic patients in the VA system for
2003 and found that more than 80% were on the new antipsychotics. He
calculated that the VA spent more than $208 million on antipsychotics
that year, with over $106 million, or more than half, spent on Zyprexa.
to the New York Times, the company documents at issue show that Lilly
knew full well about Zyprexa's association with diabetes and weight
gain that often leads to diabetes. The public's right to know about
this charge can not be easily dismissed considering the costs to the
public of paying for the care of the tens of thousands of Zyprexa
victims who developed diabetes.
By using fraud, kickback and
antitrust statutes, state attorneys general all over the US are filed
lawsuits against Lilly to recover the money paid for Zyprexa, and the
medical costs for patients harmed by Zyprexa, whose health care is
covered by public programs.
In February 2006, West Virginia
and Alaska filed lawsuits against Lilly alleging the company marketed
Zyprexa for unapproved uses in those states and as a result it has cost
millions of dollars to care for patients who developed diabetes and
West Virginia is seeking payment for all
medical costs related to Zyprexa, in addition to the more than $70
million the state paid for the drug. The lawsuit says studies have
linked Zyprexa to diabetes since 1998, and that sales representatives
misled doctors about the safety and the efficacy of Zyprexa and that
Lilly's advertisements deceptively understated its risks and overstated
The complaint alleges that Lilly promoted "off
label" prescriptions for a host of conditions including anxiety, sleep
disruption, mood swings, attention deficit hyperactivity and dementia.
"Lilly benefited from its misrepresentations and fraudulent conduct by
gaining sales of Zyprexa at the expense of other, safe, effective
drugs," the complaint states.
A lawsuit was filed by the
attorney general of Mississippi, JimHood, in July 2006, to recoup the
ill-gotten gains that Lilly enjoyed by promoting the off-label use of
Zyprexa in that state, and alleges that Lilly knew Zyprexa increased
the risk of diabetes, because in April, 2002, nearly a year and a half
before Lilly first warned doctors and consumers in the US, the company
changed Zyprexa's labeling in the UK and Japan to include warnings
about the drug's association with diabetes related injuries.
Balducci, Mississippi special assistant attorney general, says Lilly
targeted Mississippi because the state's Medicaid program is not set up
to signal when a doctor prescribes a drug off-label.
to Mr Hood, about 10% of Zyprexa patients have developed diabetes, some
of whom are children, even though Zyprexa "has never been approved for,
nor found to be effective, in the treatment of children."
fact is, Lilly has doctors prescribing Zyprexa off-label to children
and billing state Medicaid programs all over the country. For instance,
a study in the August 3, 2004, Archives of Pediatric Adolescent
Medicine, found the number of Tennessee children covered by TennCare,
who were prescribed antipsychotics nearly doubled in six years. The
largest increases were among children aged 13 to 18 at 116%, followed
by a 93% increase in children aged 6 to 12, and a 61% increase in use
with preschool children.
In Texas, a review of prescription
records for the months of July and August 2004, found that more than
19,400 teenagers were prescribed antipsychotics billed to a publicly
funded program, according to ACS-Heritage, a medical consulting firm
hired by the state to investigate the use of psychotropic drugs on
With nearly 98% of the teens, ACS reported, the
antipsychotics were prescribed off-label and in more than half of the
cases, the dosage appeared to be inappropriately high. The study also
said that almost half of the children did not appear to have a valid
diagnosis warranting the use of the drugs, and one-third were on 2 or
Research published in the March/April 2006 Journal
of Ambulatory Pediatrics, led by Dr William Cooper at Vanderbilt
University, analyzed data drawn from the National Ambulatory Medical
Care Survey and the National Hospital Ambulatory Medical Care Survey,
which are national samples of health care services rendered to the US
population and conducted by the National Center for Health Statistics.
1995–2002, the study found that there were nearly 6 million outpatient
visits to health care providers by children between the ages of 2 and
18, during which an antipsychotic was prescribed. Nearly 80% of the
visits occurred in physician's offices, 14% in outpatient clinics, and
9% in emergency departments.
The authors of the research
pointed out that there had been no increase in mental health disorders
that could account for the increases "as recent studies do not suggest
significant increases in the incidence of schizophrenia," they stated.
addition," the researchers noted, "schizophrenia and psychosis
accounted for only 13.5% of the total antipsychotic visits during the
study period, so this diagnosis alone could not explain the increase."
they said, "the most likely explanation for the study results is that
similar to our findings in the Tennessee Medicaid population, there was
a substantial increase in physician prescribing of antipsychotics
during the study period."
Experts say the side effects of
Zyprexa are more common and severe in children than in adults. The
Children's Hospital of Philadelphia recently found that 19% of children
who were newly diagnosed with Type 2 diabetes were being treated with
the new antipsychotics.
Zyprexa is not only dangerous when used
by children, it is less effective than the older cheaper
antipsychotics. A study published in August 2006, by the New York
Psychiatric Institute, found that the older antipsychotics worked much
better, with the average response rate in children using the new
antipsychotics at only 55.7%, compared to a 72.3% response rate among
children who were given the older drugs.
The study also found
that the average weight gain in patients treated with the older drugs
was much lowers and the sedation side effect was less common. The
authors of this study also pointed out that the FDA "has not approved
any antipsychotic drugs for treating childhood schizophrenia; yet,
clinicians routinely use medications for this disorder."
is no doubt that Lilly knew about these serious health risks long
before it issued warnings in the US in 2003. In a study published in
the July 2002, journal Pharmacotherapy, P Murali Doraiswamy, the chief
of biological psychiatry at Duke University, reviewed the FDA adverse
event reports submitted on Zyprexa and found 289 cases of diabetes
reported, with 225 patients being newly diagnosed.
addition, the review showed that 100 patients developed ketosis, a
serious complication of diabetes, and 22 people developed pancreatitis
or inflammation of the pancreas that is life-threatening. The review
identified 23 deaths, including a 15-year-old who died of necrotizing
Last month, the New York Times reported details
from the documents that Lilly wants to keep hidden, and revealed that
Lilly sales representatives were promoting Zyprexa with primary care
physicians specifically for the off-label treatment of dementia.
allowing Lilly to keep this information secret, the court needs to
consider the harm being done to elderly citizens. On April 11, 2005,
the FDA announced that elderly patients with dementia who were given
antipsychotics were far more likely to die prematurely than those given
placebos and also announced the addition of black box warnings about
the increased risk of death on the labels of Zyprexa and the other
A June 13, 2005, study in the
Archives of Internal Medicine, reviewed antipsychotic use in nursing
home for approximately 2.5 million Medicaid beneficiaries and found
that "over half (58.2%)," received drugs that exceeded the maximum
recommended dosage, received duplicate therapy, or had inappropriate
conditions for the drugs to begin with. The study determined that more
than 200,000 residents received antipsychotic therapy but had "no
appropriate indications for use."
In October 2005, the Journal
of the American Medical Association published a meta-analysis of trials
of more than 5,000 elderly patients treated with atypical
antipsychotics that found that patients had a 54% increased chance of
dying within 3 months, compared to patients taking a placebo.
has also been actively promoting the off-label sale of Zypexa in other
countries. In August 2006, Janet Currie, the director of the
Victoria-based Psychiatric Medication Awareness Group in Canada, called
for a public inquiry into the use of atypical antipsychotic because
they are being prescribed to children and the elderly for sedation and
According to Ms Currie, Zyprexa is a
special authority drug that may only be prescribed under special
criteria and the patient must have been diagnosed with schizophrenia or
other non-dementia-related psychosis and other antipsychotic drugs must
have failed, or not been tolerated by the patient.
payment for Zyprexa comes from the government funded PharmaCare program
and according to BC health ministry data, the program paid $26,493,119
for Zyprexa in 2005.
Lilly is also facing numerous lawsuits in
Canada alleging the exact same conduct revealed in the documents that
Lilly is trying so desperately to suppress. According to Lilly's SEC
filings, in 2005 the company was served with four lawsuits seeking
class action status in Canada on behalf of patients who took Zyprexa,
and one of the lawsuits has been certified for residents of Quebec.
allegations in the Canadian actions," Lilly states in the filing, "are
similar to those in the litigation pending in the United States."
lawsuit filed in New York in August 2004, on behalf of private health
insurers accuses Lilly of violating racketeering laws, in part, by
bankrolling nonprofit groups to promote Zyprexa for unapproved uses and
to downplay the medicine's side effects.
Evidence to support
these allegations can be found in Kentucky. When Kentucky held public
hearings to try to exclude Zyprexa from Medicaid's list of covered
drugs, the most notorious Big Pharma backed front group in the US, the
National Alliance for the Mentally Ill, bused in protesters for the
hearings, placed full-page ads in newspapers, and sent faxes to state
officials. However, a little known fact is that by funneling money
through NAMI, Lilly paid for the buses, ads, and faxes, according to
the December 18, 2003 New York Times.
Should the court continue
to allow Lilly to hide the documents with the incriminating
information, it will not be surprising to many experts. For as
pediatrician, Dr Lawrence Diller, author of the book, "Should I
Medicate My Child," stated in language relevant here, while testifying
before an FDA advisory committee in September 2004, regarding the
conduct of companies concealing the adverse effects of drugs and
promoting off-label prescribing:
"The blame is clear: The money,
power and influence of the pharmaceutical industry corrupt all. The
pervasive control that the drug companies have over medial research,
publications, professional organizations, doctors' practices, Congress,
and yes, even agencies like the FDA, is the American equivalent of a
And it is clear in this instance, that the
thousands of lawsuits filed against Lilly have done nothing to deter it
from promoting the off-label sale of Zyprexa. According to Lilly's SEC
filings, sales worldwide in the second quarter of 2006, were $1.12
billion, a 2% increase over the second quarter of 2005.
filing, Lilly noted that US sales of Zyprexa were down 1%, but said the
company simply charged a higher price for the drug to make up for the
To date, Lilly has agreed to pay about $1.2
billion to settle claims with roughly 26,000 litigants who alleged
among other things, that the company promoted the sale of Zyprexa for
off-label uses and concealed the health risks associated with the drug.
legal experts say to look for more settlements soon as Lilly tries to
avoid public trials in the Medicaid fraud cases, where it will be easy
to prove that Zyprexa sales would have spiraled downward long ago, had
Lilly quit promoting the drug for off-label use.
Authors Bio: Evelyn Pringle is a columnist for OpEd News and
investigative journalist focused on exposing corruption in government
and corporate America.