The Zyprexa Chronicles: "Good Selling!!!"

I know there's been a lot of noise again about Zyprexa what with five states investigating Eli Lilly and an article in the Times of London, based upon the leaked Zyprexa documents, which alleges that Eli Lilly was concerned about diabetes in patients using Zyprexa as far back as 1998. Both of these items are very interesting. So, too, is the following.

On July 27, 2003, Bradley Hawkins emailed a group of 10 fellow Lilly employees "re: Zyprexa Best Practices," as reads the subject line of the email, according to a copy of the document that I reviewed. It is unclear what Hawkins' position was in Lilly at the time, although the email is, to my eyes at least, a marketing communique. Hawkins begins the email by declaring "Producers!!!"

In the email, Hawkins summarizes highlights from a meeting he'd attended the week before. "There are definitely some pearls," he writes. From the text of his email, it is apparent that he was mostly concerned with sales strategies for Zyprexa Zydis, a quick-dissolving formulation of Zyprexa approved in 2000 for use in schizophrenia. Quick-dissolving formulations of tablets are typically given to chronic schizophrenics who are not med compliant and have a history of tucking away tablets in the corner of their mouth and, then, spitting them out later when medical personnel are not around. If the quick-dissolving route doesn't work (and such formulations are not available for every pill), then patients are typically given injectable drugs such as Haldol, Risperdal and Zyprexa.

Two weeks before Hawkins' email went out, Zyprexa had received further approval from the FDA for use in acute mania in combination with Lithium or Depakote. Zyprexa had been approved in 2000 for use in acute mania. Hawkins had something else in mind, according to the documents.

"With the new indication, we should be mentioning that when a drug goes before the FDA for a new indication, they open up the entire label," writes Hawkins. "If they wanted to change anything with Zyprexa's labeling, they could at that time. The FDA left our label exactly the same. So if they had concern with diabetes or glycemic conditions, they would have put it in there."

At the time, the FDA and Lilly officials were going back and forth over proposed label changes to Zyprexa and other atypical antipsychotics over concerns about diabetes and hyperglycemia attributed to use of the drugs. The next year, the FDA ordered that a black box warning be placed on the entire class of drugs.

In his email, Hawkins makes it clear that he's trying to develop tactics to sell Zyprexa Zydis "as a great option for the patient with symptomatic problems." He states that sales efforts should be focused on "shot clinics" (translation: large clinics, typically serving low-income chronically-ill patients who often have med adherence problems) with each member of the sales force to focus on one community mental health clinic per quarter. Sales efforts should "focus on treatment teams" with "lunches and/or programs designed for treatment team members." Treatment teams are commonly comprised of social workers, counselors, nurses and so on. These are the mental health workers to whom often falls the task of working with chronically-ill patients to get them to take their meds as prescribed.

"Zydis should be used as a create action tool, not a different patient type," writes Hawkins in the email. "If they use it GREAT--but as long as they use Zyprexa."

In one section of the email entitled "diabetes," Hawkins stresses: "Don't fight the war alone. If the issue is there, bring in a speaker to challenge the customer on the issue." One approach, according to the email, would be for sales reps to ask customers raising the diabetes issue, "What is the mechanism for Zyprexa causing diabetes. Ask doctors/treatment teams to ask other reps [from competing companies such as Janssen and AstraZeneca] why when they say Zyprexa causes diabetes." In addition, Hawkins writes that sales reps should utilize diabetes nurse educators (either Lilly employees or nurses on contract) and Solutions for Wellness. The latter is an education program Lilly undertook to counteract concerns of weight gain amongst patients and their doctors to educate patients on how to manage their weight through food and nutrition. In October 2005, actress Linda Hamilton famously appeared on "Larry King Live" to discuss her experience with bipolar disorder and to raise awareness of the Solutions for Wellness program. I've written about her appearance here.

The email concludes with Hawkins recommending "possible speakers to bring to NYC," although for what event is unclear. He lists Terry Bellnier (Assistant Clinical Professor, The State University of NY at Buffalo, Department of Pharmacy Practice), Mark Fry (Hawkins identifies Fry as the director of bipolar research at UCLA, but I cannot find a listing for him), Evan Zimmer (a clinician in the Miami area) and James Oberwetter (an endocrinologist in Boulder, Colo.). Hawkins notes that the "Miami district has used [Zimmer] to challenge doctors on diabetes, great sense of humor."

"Good selling!!!" is how Hawkins concludes his email.

Two Lilly colleagues responded to his email, according to the document I reviewed. "Thanks, Brad," writes Eileen Sidaros on July 28, 2003. "To the stage!!!"

"Thanks, Brad, for sharing--let it rip!" replies Daniel Williams on the same day. It is unclear what positions Sidaros and Williams held at the time with Eli Lilly.