ALLIANCE FOR HUMAN RESEARCH PROTECTION: Lilly - Settlement Talks With .
A c a t a l y s t f o r p u b l i c d e b a t e
Lilly - Settlement Talks With U.S - But what about the death toll?
the settlement is reached, the Times reports, Lilly would pay the
In a recent study in The Lancet, compared Risperdal an
antipsychotic in the same class as Zyprexa, to placebo in
calming aggression--which is the primary reason that Zyprexa
and Risperdal are prescribed. They found the harmless placebo
The authors concluded: "Antipsychotic drugs should no longer
be regarded as an acceptable routine treatment for aggressive
challenging behaviour in people with intellectual disability."
Underscoring the total failure by the US government to take
meaningful action to protect the public health as well as the
The Lobotomist - When Medicine Goes Awry (PBS Jan .
public wealth, The Times reports: "But the company would be
allowed to keep selling Zyprexa to Medicare and Medicaid, the
government programs that are the biggest customers of the
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ALLIANCE FOR HUMAN RESEARCH PROTECTION: Lilly - Settlement Talks With .
drug. Zyprexa is Lilly's most profitable product and among the
Baseball Challenged on Rise in Stimulant (Amphetam.
worlds best-selling medicines, with 2007 sales of $4.8 billion,
about half in the United States." Indeed, Medicaid pays for
Antidepressant Claimed "Efficacy" : 31% of Trials .
about 70% go 80% of the antipsychotic drug prescriptions.
All anyone involved cares about is money--as they lend their
government seal of approval that leads the lambs to slaughter
Lack of Evidence for "Early Intervention.early o.
January 30, 2008 Lilly in Settlement Talks With U.S.
Eli Lilly and federal prosecutors are discussing a settlement
of a civil and criminal investigation into the company's
marketing of the antipsychotic drug Zyprexa that could
result in Lilly's paying more than $1 billion to federal and
If a deal is reached, the fine would be the largest ever paid
by a drug company for breaking the federal laws that govern
how drug makers can promote their medicines.
Honest Medicine Clinical Psychiatry: A closer look
Several people involved in the investigation confirmed the
settlement discussions. They insisted on anonymity because
they have not been authorized to talk about the
Zyprexa has serious side effects and is approved only to
treat people with schizophrenia and severe bipolar disorder.
But documents from Lilly show that between 2000 and 2003,
Lilly encouraged doctors to prescribe Zyprexa to people with
age-related dementia, as well as people with mild bipolar
disorder who had previously been diagnosed only as
Although doctors can prescribe drugs for any use once they
are on the market, it is illegal for drug makers to promote
their medicines any uses not formally approved by the Food
Lilly may also plead guilty to a misdemeanor criminal charge
as part of the agreement, the people involved with the
investigation said. But the company would be allowed to
keep selling Zyprexa to Medicare and Medicaid, the
government programs that are the biggest customers for the
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ALLIANCE FOR HUMAN RESEARCH PROTECTION: Lilly - Settlement Talks With .
drug. Zyprexa is Lilly's most profitable product and among
the world's best-selling medicines, with 2007 sales of $4.8
billion, about half in the United States.
Lilly would neither confirm nor deny the settlement talks.
"We have been and are continuing to cooperate in state and
federal investigations related to Zyprexa, including providing
a broad range of documents and information," Lilly said in a
statement Wednesday afternoon. "As part of that cooperation
we regularly have discussions with the government. However,
we have no intention of sharing those discussions with the
news media and it would be speculative and irresponsible for
Lilly also said that it had always followed state and federal
The Lilly fine would be distributed among federal and state
governments, which spend about $1.5 billion on Zyprexa
each year through Medicare and Medicaid.
The fine would be in addition to $1.2 billion that Lilly has
already paid to settle 30,000 lawsuits from people who claim
that Zyprexa caused them to suffer diabetes or other
diseases. Zyprexa can cause severe weight gain in many
patients and has been linked to diabetes by the American
Prescriptions for Zyprexa have skidded since 2003 over
concerns about those side effects. But the drug continues to
be widely used, especially among severely mentally ill
patients. Many psychiatrists say that it works better than
other medicines at calming patients who are psychotic and
hallucinating. About four million Zyprexa prescriptions were
Federal prosecutors in Philadelphia are leading the settlement
talks for the government, in consultation with the Department
of Justice headquarters in Washington. State attorneys
general's offices are also involved. Lawyers at Pepper
Hamilton, a firm based in Philadelphia, and Sidley Austin, a
firm based in Chicago, are negotiating for Lilly.
Nina Gussack, who is representing Lilly at Pepper Hamilton,
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ALLIANCE FOR HUMAN RESEARCH PROTECTION: Lilly - Settlement Talks With .
said she could not comment on the case. Joseph Trautwein,
an assistant United States attorney in the Eastern District of
While a settlement has not been concluded and the
negotiations could collapse, both sides want to reach an
agreement, according to the people involved in the
investigation. Besides the escalating pressure of the federal
criminal inquiry, Lilly faces a civil trial scheduled for March in
Anchorage, Alaska, in a lawsuit brought by the state of Alaska
to recover money the state has spent on Zyprexa
prescriptions. A loss in that lawsuit would damage Lilly's
bargaining position in the Philadelphia talks.
While expensive for Lilly, the settlement would end a four-
year federal investigation and remove a cloud over Zyprexa.
While Zyprexa prescriptions are falling, its overall dollar
volume of sales is rising because Lilly has raised Zyprexa's
Federal prosecutors have been investigating Lilly for its
marketing of Zyprexa since 2004, and state attorneys general
since 2005. The people involved in the investigations said the
inquiries gained momentum after December 2006, when The
New York Times published articles describing Lilly's multiyear
efforts to play down Zyprexa's side effects and to promote
the drug for conditions other than schizophrenia and severe
bipolar disorder - a practice called off-label marketing.
Internal Lilly marketing documents and e-mail messages
showed that Lilly wanted to convince doctors to prescribe
Zyprexa for patients with age-related dementia or relatively
In one document, an unidentified Lilly marketing executive
wrote that primary care doctors "do treat dementia" but leave
schizophrenia and bipolar disorder to psychiatrists. As a
result, "dementia should be first message" to primary-care
doctors, according to the document, which appears to be part
of a larger marketing presentation but is not marked more
specifically. Later, the same document says that some
primary care doctors "might prescribe outside of label."
In late 2000, Lilly began a marketing campaign called Viva
Zyprexa and told its sales representatives to suggest that
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ALLIANCE FOR HUMAN RESEARCH PROTECTION: Lilly - Settlement Talks With .
doctors prescribe Zyprexa to older patients with symptoms of
The documents were under federal court seal when The
Times published the articles, and Judge Jack B. Weinstein of
Federal District Court in Brooklyn rebuked The Times for
The settlement negotiations in Philadelphia began several
months ago, according to the people involved in the
Last fall, the two sides were close to a deal in which Lilly
would have paid less than $1 billion to settle the case, which
at the time consisted only of a civil complaint.
Then Justice Department lawyers in Washington pressed for a
grand jury investigation to examine whether Lilly should be
charged criminally for its promotional activities, according to
the people involved in the negotiations. A few days ago,
facing the possibility of both civil and criminal charges, Lilly
opened new discussions with the prosecutors in Philadelphia.
Labels: Government collusion, Lilly, Zyprexa
Posted by Vera Hassner Sharav 2/02/2008 04:42:00 PM | Permalink
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