We have been writing for some time about Big Pharma's primary care problem: the industry is built on an incredibly lucrative business model--selling oral medications for use by millions of patients with chronic conditions--that is going away before our eyes.
The primary care market is shrinking. The regulatory system is tilting towards smaller, niche market opportunities. The infrastructure built to support the blockbusters of yore is choking the industry. And the imperative to develop the next Lipitor is surely one reason behind the staggering lack of productivity in Big Pharma R&D.
Well, here's something you might not have realized. Apparently Big Pharma's incredible success in building massive primary care markets can now be painted as criminal conduct. That, at least, seems to be one implication from Lilly's record-setting $1.4 billion settlement agreement to resolve an investigation into its marketing of the antipsychotic Zyprexa. [UPDATE: of course records are meant to be broken, right? Pfizer's $2.3 billion Bextra settlement, astutely camoflaged by the Wyeth takeover, now takes that dubious honor.]
According to the government's memorandum supporting the entry of guilty plea by Lilly, a key element of the off-label promotion at issue was a decision by Lilly to "market Zyprexa to primary care physicians, even though there was almost no on-label use for Zyprexa in this market."
Here are some excerpts from the memo. (NB: These are described in the memo as facts that Lilly agrees would have been proven at trial.)
“Eli Lilly commissioned a report entitled ‘The Primary Care Opportunity’ from a nationally-known consulting firm. This report found that ‘larger competitors [eg. Merck, Pfizer, Bristol Myers] are migrating toward the primary care channel with drugs driven by profile improvements’ as compared to Eli Lilly, which was headed in the direction of providing drugs in specialty markets. The consulting firm advised Eli Lilly that ‘Primary care is a large opportunity that is likely to remain important. Lilly does not outperform its competitors in primary care and is leaving money on the able with current and pipeline products.’ The report identified Eli Lilly products, including Zyprexa, that if sold in the ‘primary care channel’ could significantly increase Eli Lilly's woridwide sales....
"The evidence would show that in October 2000, Eli Lilly began to detail Zyprexa to PCPs even though at least one internal Eli Lilly document acknowledged that there was virtually no on-label use for Zyprexa in the primary care market. The document, ‘ZYPREXA – Primary Care Strategy and Implementation Overview,’ provided that detailing PCPs was a major challenge because ‘Zyprexa's primary indications - schizophrenia and bipolar - are not viewed as PCP [primary care physician]-treated conditions, so there's not a specific indication for Lilly reps to promote in the PCP segment.'
"To get around the impediment that Zyprexa's indications - schizophrenia and bipolar mania - were not viewed as PCP-treated conditions, sales representatives were instructed to tout Zyprexa as a safe option for the treatment of a wide array of mood disorders commonly treated by PCPs....
"According to an internal newsletter, Eli Lilly USA Online, published on July 25, 2001, the launch of Zyprexa into primary care was a huge success."