lillycontinuestoharm

FYI

. . . And the band plays on and the body count continues to mount--

The New York Times reports that Eli Lilly is in negotiation talks with the

US Justice department to settle both civil and criminal investigations of

the company's marketing of its toxic diabetes-inducing antipsychotic,

Zyprexa. If the settlement is reached, the Times reports, Lilly would pay

the biggest fine in history.

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 to be more effective:

http://www.thelancet.com/journals/lancet/article/PIIS0140673608600720/abstract

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 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

drug. Zyprexa is Lilly's most profitable product and among the worlds

best-selling medicines, with 2007 sales of $4.8 billion, about half in the

United States."

Indeed, Medicaid pays for 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

Contact: Vera Hassner Sharav

veracare@ahrp.org

212-595-8974

http://www.nytimes.com/2008/01/30/business/30cnd-drug.html?hp

THE NEW YORK TIMES

January 30, 2008

Lilly in Settlement Talks With U.S.

By ALEX BERENSON

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 state governments.

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.

Several people involved in the investigation confirmed the settlement

discussions. They insisted on anonymity because they have not been

authorized to talk about the negotiations.

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 depressed.

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 and Drug Administration.

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 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 anyone to

do so."

Lilly also said that it had always followed state and federal laws when

promoting Zyprexa.

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 Diabetes

Association.

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 written in the

United States last year.

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, said she could

not comment on the case. Joseph Trautwein, an assistant United States

attorney in the Eastern District of Pennsylvania, also declined to comment.

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 price about 40 percent since 2003.

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 mild bipolar disorder.

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 doctors prescribe Zyprexa to older

patients with symptoms of dementia.

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 publishing them.

The settlement negotiations in Philadelphia began several months ago,

according to the people involved in the investigation.

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.