January 14, 2007
Attorney Asks Eli Lilly to Issue Warning on Zyprexa
By Evelyn Pringle
Jim Gottstein, is calling for Eli Lilly to issue a Dr Doctor letter to
warn prescribing physicians about the serious health risks associated
with Zyprexa, which has become Lilly's top selling drug even though it
is only approved to treat adults with schizophrenia or bipolar disorder.
a letter to Lilly's attorneys, Mr Gottstein wrote, "it is formally
requested that your client, Eli Lilly, issue what is sometimes referred
to as a "Dear doctor" letter to all health care providers in the United
States advising them Zyprexa should not be prescribed to anyone who is
not already taking it."
Mr Gottstein explains that Zyprexa
should not be withheld from current users because abrupt withdrawal can
cause Neuroleptic Induced Discontinuation Syndrome.
"It is now
clear," he wrote, "that Zyprexa has no benefits over other
neuroleptics, while causing far more cases of diabetes than do other
drugs in its class."
"This represents a massive health
disaster including at least thousands of past and inevitable future
deaths," the letter states.
Other experts agree that doctors and
consumers alike need to be warned about the health risks of Zyprexa and
its atypical cousins. "Millions of unsuspecting patients and their
unsuspecting physicians are using and prescribing these brain-altering
drugs without full information as to their safety, an issue that has
serious medico-legal implications for the doctors who are being
influenced by the Psycho-pharmaceutical Complex to prescribe them so
widely, often for off-label uses," Dr Gary G Kohls, warns in the paper,
"Significant Dissociation of Brain and Plasma Kinetics With
Antipsychotics," Preventive Psychiatry E-Newsletter #93.
Gottstein's request for a Dear doctor letter is based in part on
internal company documents he obtained last month in litigation that
show Lilly was aware that psychiatrists were reporting that many of
their Zyprexa patients were developing high blood sugar or diabetes,
but company officials decided not to reveal the information to
consumers and doctors because they knew the disclosure would have a
negative impact on Zyprexa sales.
The Lilly documents span
from 1995 to 2004, and show that Lilly engaged its sales force in
off-label marketing schemes, one called "Viva Zyprexa," to convince
doctors to prescribe Zyprexa for conditions other than those approved
resulting in many more injuries and deaths then would normally be
expected if the drug was used only for its approved indications.
information about Lilly's illegal conduct was actually discovered
several years ago in litigation. However, Lilly has been successful in
keeping it from public view by obtaining protective court orders to
keep the documents under seal and silencing thousands of plaintiffs by
requiring them to sign confidentiality agreements when settling their
cases out of court.
Last month, when Mr Gottstein realized the
magnitude of Lilly's off-label marketing of the drug, he took the
information to the New York Times, which published several articles
quoting the documents and setting off a coast-to-coast firestorm in the
Mr Gottstein obtained the documents from a doctor
who served as an expert witness in a previous Zyprexa case and learned
about the concealment of risks and off-labeling marketing scheme when
he reviewed the documents several years ago.
As soon as the
articles began to appear in the Times, Lilly's legal team began pursing
legal action against the doctor and Mr Gottstein for disclosing the
company's misdeeds to the media giant, and has been frantically trying
to get the incriminating information back under seal with court orders
In addition to injunctions against Mr Gottstein and
the expert witness doctor, Lilly has thus far been successful in
getting a court in New York to issue injunctions against specific
advocacy groups, journalists, authors, doctors, and web sites on the
internet, to bar them from disseminating or communicating any
information contained in the Lilly documents .
The out of court
settlement in the earlier litigation, in which Lilly was able to keep
the documents sealed, cost Lilly just under $700 million to settle with
roughly 8,000 Zyprexa victims In re: Zyprexa Products Liability
litigation, MDL No 1596, United States District Court, Eastern District
of New York (MDL 1596).
Lilly recently announced that it had
reached out of court settlements with about 18,000 more Zyprexa
plaintiffs for around $500 million, which will bring the total for
settlements so far to approximately $1.2 billion.
The fact that
this new settlement was underway is probably what led to Lilly's
over-the-top proclamations of outrage last month when the secret
documents became public. But then again, Lilly is also probably worried
about the information's impact in future cases because the company's
legal troubles are far from over. According to the Indy Star on January
5, 2007, about 1,200 claims remain unsettled, and Lilly also faces
lawsuits from several states, including Alaska, Mississippi, Louisiana
and West Virginia, to recoup money paid out by Medicaid.
more states could still sue, H Blair Hahn, an attorney who has been
involved in the Zyprexa cases, told the Star. "That litigation is many
times larger than what Lilly has dealt with to date," Mr Hahn said.
"Their liability could be in billions in those cases."
Gottstein is not alone in his attempts to stop the Zyprexa drugging for
profit schemes. Other people who have been injured by the drug, or
their family members, have been writing letters to law enforcement
officials calling for a criminal investigation of Lilly for concealing
the adverse effects of the drug and marketing it for unintended uses.
Bleecker, whose nephew died unexpectedly at age 39 of hyperglycemia,
wrote to the attorney general in his state and said in part:
your capacity as New Jersey's Attorney General, I ask that you launch
an investigation into Eli Lilly's violation of the public interest by
its concealment of the risks of Zyprexa."
"I appeal to you," Mr
Bleeker wrote, "to investigate Eli Lilly's willingness to see patients
suffer and die to enhance its profits."
He informed the AG
that New Jersey itself has an interest in this matter "since government
programs like Medicare and Medicaid purchase over 70% of the Zyprexa
sold in the USA, taxpayers in our State as well as across the nation
are footing most of the bill."
"Despite the FDA restrictions on
use and warning labels," he told the AG, "the drug continues to be
vigorously promoted by Lilly and prescribed for patients in record
numbers, including children."
According to a Medicaid fraud
lawsuit filed in West Virginia, Lilly illegally promoted the sale of
Zyprexa in that state to patients of all ages for the off-label
treatment of dementia, anxiety, sleep disruption, mood swings, and
attention deficit hyperactivity.
On July 24, 2006, Mississippi
filed a lawsuit alleging that Lilly engaged in a calculated marketing
plan to defraud the state Medicaid program out of millions of dollars
for off-label uses of Zyprexa and "Mississippi is spending millions of
dollars on Zyprexa® for patients who are not indicated for the drug;
and further, who are being harmed by it."
Even though the drug
is not approved for any use with children, Lilly's off-label marketing
efforts have led doctors to prescribe Zyprexa to many children
including infants and toddlers. On April 25, 2005, the Columbus
Dispatch reported a review of Ohio Medicaid records that found 18
newborn to 3 years-old babies had been prescribed antipsychotic drugs
in the month of July 2004.
A study directed by Oregon Health
& Science University professor David Pollack, found 246 preschool
children covered by the Oregon Health Plan receiving antipsychotic or
antidepressant drugs, with 41% prescribed for attention deficit
In February 2006, Florida's public health officials
ordered an independent investigation into why the number of children on
Medicaid in that state taking antipsychotics has nearly doubled over
the past five years from 9,500 to almost 18,000.
prescribing is killing children. A USA Today report on May 1, 2006,
based on an analysis of FDA data, determined that at least 45 children
had died with an atypical listed as the "primary suspect," between 2000
Zyprexa is also being fed to elderly patients with
grave consequences. In April 2005, the FDA warned that the new
antipsychotics had been linked to deaths from heart failure and
pneumonia in elderly dementia patients and instructed drug makers to
revise their drug labels to include strong warnings about the increased
risk of death.
Any Zyprexa death count would have to include
suicides because investigative journalist, Robert Whitaker, reports
that "researchers in Ireland reported in 2003 that since the
introduction of the atypical antipsychotics, the death rate among
people with schizophrenia has doubled."
In addition, according
to the June 12, 2006, New York Times, more mentally ill patients are
dying from diabetes and complications like heart disease. "Uncontrolled
diabetes can ruin a person's life as much as uncontrolled
schizophrenia," Dr Newcomer, a professor of psychiatry at Washington
University in St Louis, told the Times.
A 2003 survey by the
City's health department, found that about 17% of adults who reported
symptoms of a mental illness, or about 52,000, also had diabetes and
the cost of atypical-induced conditions is taking a toll on public
programs. "Mental illness is itself a money sponge," the Times notes,
"an expense borne largely by tax dollars."
"But that cost may be
dwarfed," the Times points out, "by the bill to manage the heart
attacks and amputations that diabetes bestows."
its impossible to estimate how much Zyprexa injuries will end up
costing tax payers in the future, a class actions filed in New York, on
February 28, 2006, requested payment for monitoring all people who have
taken Zyprexa but have not yet been diagnosed with pancreatitis,
diabetes or high blood sugar.
There is no telling how many
people have actually died while Lilly concealed the risks and raked in
billions of dollars each year. Former federal fraud investigator turned
whistleblower, Allen Jones states that correlating dollars spent with
deaths from side effects suggests that people may be dying at the rate
of at least one death for each one million dollars spent.
Authors Bio: Evelyn Pringle is a columnist for OpEd News and
investigative journalist focused on exposing corruption in government
and corporate America.