More About the Zyprexa Marketing Memos

We previously posted (here, here, here, and here) about allegations in a New York Times series that Eli Lilly and Company had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported, and then how the company tried to restrict publication of the internal memos on which these allegations were based.

More keeps coming out about this topic. The Times (UK) added some information about the internal memos.

Eli Lilly, the American pharmaceutical giant that has consistently denied any link between Zyprexa, its antipsychotic drug, and diabetes, was concerned about the side-effects of the drug as early as 1998, according to documents seen by The Times.

A series of leaked court documents seen by The Times suggested that the company was aware of the risks of weight gain, hyperglycemia (high blood sugar) and diabetes associated with the drug but presented them as common problems across the whole class of schizophrenia drugs and not restricted to Zyprexa.

In one document dated October 9, 2000, Robert Baker, a senior Lilly clinical research physician, e-mailed colleagues about a meeting of an academic advisory board he had attended in Atlanta. It had 'reinforced my impression that hyperglycemia remains quite a threat for olanzapine and may merit increasing even further medical attention and marketing focus on this topic'. Dr Baker added: '[The board was] quite impressed by the magnitude of weight gain on olanzapine and implications for glucose.'

Another internal document dated October 14-15, 1998, described the risk of weight gain as a 'top threat' to Zyprexa.

A statement from Lilly said that the documents represented 'a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly’s conduct nor represent an accurate view of Lilly company strategy or activities.'

It added that the documents were 'selectively and illegally leaked'.

Meanwhile, the New York Times reported on the growing number of investigations of how Eli Lilly marketed Zyprexa.

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.

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.

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.

Sounding like a broken record (if anyone remembers what that means), patients and physicians need the best possible evidence about benefits and harms to decide on treatments. Any attempts to hide such evidence in support of vested financial interests may hurt patients. A pharmaceutical (or biotechnology or device) company that seeks to quiet the discussion of the benefits and harms of their products should not inspire trust.

See also related comments here on the Clinical Psychology and Psychiatry blog and here and here on the PharmaGossip blog.