Healthy Skepticism Library item: 7603

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Berenson A.
States Study Marketing of Lilly Pill
The New York Times 2007 Jan 20
http://www.nytimes.com/2007/01/20/business/20drug.html

Abstract:

Stepping up government investigations into Eli Lilly’s marketing of its
best-selling drug Zyprexa, state prosecutors in Illinois and Vermont have
demanded that the company turn over information about the way it promoted
the medication.

On Thursday, lawyers from the consumer protection division of the Illinois
attorney general’s office demanded that Lilly hand over marketing materials,
e-mail messages, and other documents with information about promotion of
Zyprexa. Vermont investigators issued a similar order yesterday morning.

The orders are the civil equivalents of criminal subpoenas, according to
Deborah Hagan, the chief of the Illinois consumer protection division.

Illinois and Vermont are now part of a coordinated five-state civil
investigation into the way Lilly promoted Zyprexa, a treatment for
schizophrenia and bipolar disorder. The states are investigating whether
Lilly tried to hide Zyprexa’s risk of causing weight gain and other risks
associated with diabetes and whether the company promoted Zyprexa for use in
patients who do not have schizophrenia or bipolar disorder.

Federal laws prohibit such so-called “off label” marketing, although doctors
may prescribe any drug for any disease that they believe the drug will help.

The orders on Thursday and yesterday are the first formal demands for Lilly
documents from state attorneys and they indicate an escalation of the
investigation, according to Ms. Hagan and Julie Brill, who is an assistant
attorney general in Vermont.

“We can ask for documents; we can ask for answers to questions; and we can
ask for people to come in and testify under oath,” Ms. Hagan said. Federal
prosecutors in Philadelphia have also recently accelerated their own
investigation into Lilly’s marketing of Zyprexa.

In a statement yesterday, Lilly said it would cooperate with the
investigations and had done nothing wrong. “We intend to cooperate with the
Illinois attorney general’s civil investigative demand relating to Zyprexa,”
the company said. “We cannot comment further about this or other ongoing
investigations.”

While the investigation being led by Illinois is civil, other investigations
into Lilly’s conduct are both civil and criminal. Attorneys general in
California and Florida may seek to recover Medicaid payments that the states
made for Zyprexa. Medicaid represents a sizable percentage of the drug’s
overall sales because many people who take the medicine are disabled and do
not work.

Any fine or cost recovery could be sizable, because Zyprexa has been a
commercial success. The drug is by far Eli Lilly’s largest-selling product,
with sales of $4.2 billion last year and about $30 billion since its
introduction in 1996. More than 20 million people have taken Zyprexa since
Lilly began selling the drug.

The investigations could continue for months or possibly years, people
involved in the cases say, as investigators sift through tens of thousands
of documents from the company and talk to current and former employees.

Zyprexa, whose generic name is olanzapine, is a potent chemical that binds
with receptors in the brain to reduce the symptoms of schizophrenia and
bipolar disorder. But Zyprexa also causes severe weight gain and changes in
blood sugar and cholesterol in many patients who take it.

Internal Lilly documents provided to The New York Times last month by a
lawyer in Alaska who represents people with mental illness indicate that
Lilly has engaged in a decade-long campaign to play down the seriousness of
the side effects of Zyprexa.

Lilly did not disclose to doctors that its own data showed that 16 percent
of people taking Zyprexa for a year gained more than 66 pounds, according to
the documents.

The documents also indicate that the company told its drug representatives
to promote Zyprexa to doctors for the treatment of conditions other than
bipolar disorder or schizophrenia.

Lilly has said it did not market Zyprexa off-label and said so again in its
statement yesterday.

“Lilly is committed to the highest ethical standards and to promoting our
medications only for approved uses,” the company said.

But its marketing materials have repeated references to promoting the drug
for other uses. And some sales representatives and doctors have also said
they believed that the company was marketing off-label.

Still, any criminal prosecution of the company could face a high burden.
While settlements of off-label marketing cases have led to large fines, such
cases so far have fizzled if they reach juries.

And as long as drug makers comply with federal requirements to provide data
about their products to the Food and Drug Administration, companies have a
relatively strong defense against criminal prosecution, according to lawyers
who are experts in drug marketing.