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

Published 20 January 2009, doi:10.1136/bmj.b217
Cite
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 (£1bn; 1.1bn) in settlement
for the marketing of its antipsychotic drug olanzapine (Zyprexa) for
off-label uses. It is the largest individual corporate fine in
history.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cite this as: BMJ 2009;338:b217

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Santhana K Gunasekaran
bmj.com, 23 Jan 2009 [Full text]

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