From: "Saved by Windows Internet Explorer 7" Subject: Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine -- Kmietowicz 338: b217 -- BMJ Date: Tue, 27 Jan 2009 22:56:16 -0000 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C980D2.75A561B0" X-MimeOLE: Produced By Microsoft MimeOLE V6.0.6001.18049 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C980D2.75A561B0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.bmj.com/cgi/content/full/338/jan20_1/b217 Eli Lilly pays record $1.4bn for promoting off-label = use of olanzapine -- Kmietowicz 338: b217 -- BMJ

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Home > News > BMJ = 2009;338:b217,=20 doi: 10.1136/bmj.b217 (Published 20 January 2009)


Published 20 January 2009, = doi:10.1136/bmj.b217
Cite=20 this as: BMJ 2009;338:b217

News

Eli Lilly pays record $1.4bn for promoting off-label use of = olanzapine

Zosia Kmietowicz

1 London

The drug giant Eli Lilly has agreed to pay $1.4bn (=A31bn; = 1.1bn) = in settlement=20 for the marketing of its antipsychotic drug olanzapine = (Zyprexa) for=20 off-label uses. It is the largest individual corporate fine = in=20 history.

The drug, which is licensed for the treatment of schizophrenia = and=20 bipolar disorder, was widely promoted by Eli Lilly between = September=20 1999 and November 2003 to treat more common disorders, such = as=20 dementia, agitation, aggression, depression, and sleep = problems, said=20 the US Department of Justice in a statement.

The company began its promotion by encouraging doctors who = treated=20 people in nursing homes and assisted care facilities to = prescribe=20 olanzapine, because one of the drug=92s side effects is = sedation.=20 It claimed that "this side effect was a therapeutic benefit, = not an=20 adverse event." The sales force used the slogan "5 at 5," = meaning=20 that 5 mg of olanzapine at 5 pm would help patients sleep, = said the=20 department=92s statement.

Eli Lilly expanded its "illegal" marketing strategy to primary=20 care doctors in 2000 with the "Viva Zyprexa" campaign, whose=20 goal, the statement said, was to make the drug "an everyday=20 agent in primary care, even though the company recognized = that=20 schizophrenia and bipolar disorder were not viewed as = conditions=20 typically treated by primary care physicians."

The department said that the off-label marketing campaign = "raised=20 safety issues and posed potential risk to patients."

Eli Lilly knew that olanzapine could cause significant weight = gain=20 and obesity and increase the risk of hyperglycaemia and = diabetes,=20 "yet despite written caution from the FDA [US Food and Drug=20 Administration], Eli Lilly continued to promote these adverse = events=20 as therapeutic benefits of Zyprexa use, particularly in the=20 elderly."

The statement added, "Eli Lilly=92s management created marketing = materials promoting Zyprexa for off-label uses, trained its=20 sales force to disregard the law, and directed its sales = personnel=20 to promote Zyprexa for off-label uses. When promoting Zyprexa = to health care providers, Lilly emphasised that the weight = gain=20 of the drug was a therapeutic benefit for patients who had = trouble=20 maintaining their weight."

Eli Lilly pleaded guilty to one misdemeanour violation of the=20 Food, Drug, and Cosmetic Act and agreed to pay a total of = $615m.=20

Gregory G Katsas, assistant attorney general for the civil = division=20 of the Department of Justice said, "Off-label promotion of=20 pharmaceutical drugs is a serious crime because it undermines = the=20 FDA=92s role in protecting the American public by determining = a=20 drug is safe and effective for a particular use before it is=20 marketed."

In a separate civil settlement agreement Eli Lilly agreed to = pay=20 nearly $800m to the US government and to state Medicaid = programmes=20 for payment for unapproved off-label uses of olanzapine.

Four former sales representatives who blew the whistle on Eli=20 Lilly for the off-label practices and who were either fired = or=20 resigned filed lawsuits against the company, said the Department = of=20 Justice statement. They will share $80m of the civil settlement, = in a=20 bid to encourage whistleblowers. Federal law permits whistleblowers = to share in the money recovered.

Kim Rice, special agent in charge at the FDA=92s Office of = Criminal=20 Investigations, said, "The unprecedented terms of this = settlement=20 demonstrate the government=92s increasing efforts aimed at=20 pharmaceutical companies that choose to put profits ahead of = the=20 public=92s health.

"The FDA will continue to devote resources to criminal = investigations=20 targeting pharmaceutical companies that disregard the = safeguards=20 of the drug approval process and recklessly promote drugs for = uses for which they have not been proven to be safe and = effective."=20

Eli Lilly has agreed to cease off-label marketing and must send=20 doctors letters advising them of the settlement, give them a=20 way to report questionable conduct of sales representatives,=20 list payment to doctors on its website, and ensure that the=20 company complies with the law.

John C Lechleiter, chairman, president and chief executive = officer=20 of Eli Lilly, said in a statement, "We deeply regret the past = actions covered by the misdemeanor plea. At Lilly we take = seriously=20 our responsibilities to abide by all the laws governing our=20 business practices, and we realize that we have a tremendous=20 responsibility to the patients and healthcare professionals = we=20 serve. Every day and with every interaction we strive to = operate in a=20 responsible and compliant manner. Doing the right thing is=20 non-negotiable at Lilly, and I remain personally committed to = all of=20 us at Lilly maintaining the highest standards of conduct."

Cite this as: BMJ 2009;338:b217

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