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Lilly Receives Zyprexa Greetings From Capitol Hill
Washington, DC: The Chairman and
CEO of Eli Lilly, Sidney Taurel, has become a regular pen pal with
lawmakers on Capitol Hill since the company's ten-year campaign to
increase profits by promoting the off-label use of Zyprexa for patients covered by public health care programs became the focus of investigations in both houses of Congress.
According to the March 23, 2007, New York Times, Zyprexa costs more
than $300 a month and is the single biggest drug expense for state
Medicaid programs, with spending of more than $1.3 billion in 2005.
Although Zyprexa is FDA-approved only for the extremely limited use of
treating schizophrenia and bipolar disorder in adults, SEC filings show
Zyprexa is Lilly's top-selling drug with overall sales of $4.36 billion
Medicaid records show that Lilly promoted Zyprexa off-label to patients
of all ages for unapproved uses in treating anxiety, sleep disruption,
mood swings, attention deficit hyperactivity and dementia.
According to Pennsylvania psychiatrist Dr Stefan Kruszewski, Zyprexa
increases the risk of obesity, diabetes, hypertension, heart attacks
and stroke and taxpayers are now footing the bill to care for patients
injured by the drug.
On June 12, 2006, the New York Times reported that the cost of
atypical-induced medical conditions was taking a toll on
publicly-funded health care programs. "Mental illness is itself a money
sponge," it noted, "an expense borne largely by tax dollars."
"But that cost may be dwarfed," the Times said, "by the bill to manage the heart attacks and amputations that diabetes bestows."
A 2003 survey by the city's health department found that about 17% of
adults surveyed, or 52,000, had diabetes. The Times noted that more
mentally-ill patients were dying from diabetes and complications like
heart disease than from suicide. "Uncontrolled diabetes can ruin a
person's life as much as uncontrolled schizophrenia," Dr Newcomer, a
professor of psychiatry at Washington University School of Medicine in
St Louis, told the Times.
On April 4, 2007, as a ranking member of the Senate Committee on
Finance, Senator Charles Grassley (R-IA), sent a letter to Mr Taurel,
saying, "I have an obligation to ensure that the public's money is
properly spent to provide safe and effective treatments to the
vulnerable populations that are beneficiaries of the Medicare and
"I am aware of several pending product liability actions regarding
Zyprexa," he said, "and questions have been raised regarding safety
information and marketing practices relating to that drug."
Senator Grassley also wrote, "I understand that Eli Lilly produced
certain documents in the course of these litigations that shed light on
issues of interest to the Committee," referring to documents produced
in litigation that were kept under seal with a court order until they
were quoted in the New York Times in December 2006, which showed that
Lilly knew about the serious health risks of Zyprexa for over a decade
and had engaged in an off-label marketing scheme called "Viva Zyprexa."
Senator Grassley told Mr Taurel, "please provide to the Committee all
documents and materials, including, but not limited to, emails,
letters, reports, and memoranda, that were made available ... pursuant
to pretrial discovery in In re Zyprexa Prods. Liab. Litig."
Anchorage attorney Jim Gottstein, director of Law Project for
Psychiatric Rights, provided the documents to the Times after he
subpoenaed them for another case from Dr David Egilman, who was
retained by the plaintiffs as an expert witness in the underlying
Zyprexa litigation and became so alarmed by what he found in the sealed
documents that he went looking for a legal way to warn the public.
According to Mr Gottstein in a February 13, 2007, interview with the
Anchorage Daily News, Lilly's hidden document showed the rate at which
Zyprexa causes diabetes, massive weight gain and other metabolic
problems and that Lilly trained sales staff to mislead doctors about
the drug's association with diabetes and illegally promoted Zyprexa for
off-label use with children and the elderly.
Families of deceased Zyprexa victims want criminal prosecutions. "Lilly
executives should go to prison for knowingly being responsible for
people's deaths, shattered families; ruined and grieving families,"
says Ellen Liversridge, whose 39-year-old son gained nearly 100 pounds
while taking Zyprexa before he lapsed into a coma and died 4 days later
of profound hyperglycemia in October 2002.
"Thanks to the FDA," she says, "there was no warning on the label of
Zyprexa even though two other countries had made Lilly place warnings
about diabetes, hyperglycemia, and death."
For its part, the secret documents show that Lilly was not the least
bit concerned that patients like Ellen's son were developing diabetes.
The company's one and only worry was that sales would fall when the
news about Zyprexa's link to diabetes became made public. A July 7,
2003, "Diabetes Update" memo discussed the company's strategy to
counter the negative impact on doctor's prescribing habits when news of
the FDA's decision to add a black box warning about the diabetes risk
to the label of Zyprexa became public.
"We must embrace the fact that many physicians are curtailing their use
of Zyprexa (particularly in the moderately-ill patient and in the
maintenance phase)," the Update said, "solely on the basis of personal
fear (of being sued)."
To ward off the drop in Zyprexa prescriptions because doctors were
afraid of being sued, the Update said Lilly should offer to indemnify
doctors, in other words, cover any lawsuits filed against doctors as a
result of prescribing Zyprexa. "Indemnification represents the most
meaningful demonstration of confidence in Zyprexa--both with our
customers and with our employees," the Update stated.
This plan was apparently successful with doctors after the risks of
Prozac became public when documents disclosed in litigation that were
also kept hidden under a court order were revealed in a subsequent
lawsuit. "Our experience with Prozac," the Lilly memo states, "confirms
the impact and goodwill of such an initiative."
The Update also describes a plan to pay millions of dollars to the most
notorious industry-funded front group in the US, the National Alliance
on Mental Illness, to organize nationwide campaigns to discount the
claim that diabetes was caused by Zyprexa.
The strategy for NAMI described in the memo was to "mobilize our
allies" and provide "NAMI a multimillion dollar grant to stage a
national screening" to "help educate physicians and patients on the
inherent risks of diabetes--regardless of the antipsychotic."
On February 13, 2007, Dr David Graham, the FDA whistleblower of Vioxx
fame, testified at a hearing before the House Energy and Commerce
subcommittee and recommended that lawmakers also investigate the FDA's
handling of the Zyprexa matter, saying that the agency knew "for a long
time" about the risk of weight gain and diabetes.
About 2 weeks later, on March 1, 2007, Mr Taurel received greetings
from Rep Henry Waxman (D-CA), chairman of the Committee on Oversight
and Government Reform, in a letter that requested information related
to communications between Lilly and the FDA, including a list of
trials, studies, or reports for any New Drug Application or
Investigational New Drug application, including any supplemental
applications submitted to the FDA.
The letter began by stating: "Allegations have been raised that Eli
Lilly misled physicians and inappropriately promoted off-label uses of
"As part of the Committee's ongoing oversight of the pharmaceutical
industry's research and marketing practices," Rep Waxman wrote, "I am
writing to request information relevant to Zyprexa and these
Rep Waxman also asked Lilly for copies of the secret documents obtained
by Mr Gottstein, and a list of all trials, studies, or reports
initiated, supported or sponsored by Lilly relating to Zyprexa,
including any conducted outside the US, along with an exhaustive list
of documents related to the promotion, marketing and sale of Zyprexa.
Federal law prohibits drug companies from promoting drugs for uses
other than those approved by the FDA, and since 1998, FDA records show
companies have been cited over 70 times for promoting drugs off-label.
However, drug makers obviously continue to engage in these illegal
marketing schemes because, in the end, the profits far outweigh any
For example, Lilly continued to market Zyprexa for unapproved uses,
even while the company was under investigation for doing the exact same
thing with another drug. In December 2005, the US Department of Justice
announced that Lilly had agreed to pay a $36 million fine and plead
guilty to illegally marketing Evista for the prevention of breast
cancer and cardiovascular disease although it was only approved for
treating post-menopausal women with osteoporosis.
And just as Lilly concealed the health problems associated with
Zyprexa, at the time that the company was promoting Evista to prevent
cancer, Lilly in fact knew that the drug caused cancer. An October 24,
2002, press release by the Cancer Prevention Coalition reported that
Lilly had suppressed a study in which Evista was "shown to induce
ovarian cancer in rats and, at doses well below the therapeutic, in
The press release noted "the strong scientific consensus that the
induction of cancer in well-designed studies in two species creates the
strong presumption of human risk."
Dr Samuel Epstein, Chairman of the Coalition, cited data showing "an 8
percent increased incidence of ovarian cancer in white females over 65,
those most likely to be treated with Evista, from 1997 to 1999."
A $36 million fine was pocket change for Lilly in a year where the
company reported 3rd-quarter sales for Evista of $770.8 million,
compared to $755.4 million for the same period in 2004.
In the case of Zyprexa, Lilly has so far agreed to pay about $1.2
billion to settle cases out of court with roughly 28,000 victims. But
here again, $1.2 billion for claims spanning a 10-year period amounts
to petty cash for a drug with sales of $4.36 billion in 2006, and a 10%
increase to $1.108 billion reported in the first quarter of 2007, over
the first quarter of 2006.
Allen Jones, a former fraud investigator in the Pennsylvania Office of
Inspector General, Bureau of Special Investigations, has calculated the
death rate in the US for patients taking atypicals in correlation with
the total annual sales and determined that the ratio would be nearly 7
deaths for every million dollars, or about $162,000 per patient death.
In the latest development in the Zyprexa saga, on April 25, 2007, Alex
Berenson reported in the New York Times that the FDA has "questions
about a Lilly document from February 2000 in which the company found
that patients taking Zyprexa in clinical trials were three and a half
times as likely to develop high blood sugar as those who did not take
Alex Berenson is the reporter who broke the story on the secret
documents and reported that doctors were provided information about the
blood-sugar risks of Zyprexa which did not match data circulated inside
the company, in the Times on December 21, 2006.
He quoted documents which showed that Lilly had examined 70 clinical
trials and found that 16% of patients taking Zyprexa for a year had
gained over 66 pounds. But instead of making these findings public,
Lilly used data from a smaller group of trials that showed roughly 30%
of Zyprexa patients gained 22 pounds.
According to SEC filings, about 1,300 Zyprexa lawsuits against Lilly
are still pending, and the company is also facing Medicaid fraud
lawsuits filed by attorneys general in 9 states so far.
Zyprexa Legal Help If you have or a loved on has taken Zyprexa and suffered from diabetes or hyperglycemia, please contact a [Zyprexa] lawyer who will evaluate your claim at no charge.