Public
Has Right To Know Secrets Revealed In Zyprexa Documents
By Evelyn Pringle
13 January, 2007
Countercurrents.org
In 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.
The 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.
In 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 Zyprexa.
"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.
Lilly 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.
According 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 other diseases.
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
its benefits.
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.
Tim 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.
According 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."
The 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 children.
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 more drugs.
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.
Between 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.
"In 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."
"Therefore," 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."
There 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.
In 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 pancreatitis.
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.
Before 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 atypical antipsychotics.
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.
Lilly 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 behavioral control.
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.
In Canada, 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.
"The allegations in the Canadian actions," Lilly states in
the filing, "are similar to those in the litigation pending in
the United States."
A 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 drug cartel."
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.
In the 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 lower sales.
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.
But 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.
(Evelyn Pringle [email protected]
is a columnist for OpEd News and an investigative journalist focused
on exposing corruption in government and corporate America)
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