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Suit: Lilly Touted Zyprexa for Alzheimer's Knowing It Was Ineffective; Sales Reps Had $10K Off-Label Promo Budgets

By Jim Edwards

Updated on: June 12, 2009 / 12:10 PM EDT / MoneyWatch

Eli Lilly knew in 1995 that Zyprexa was ineffective for treating Alzheimer's and dementia in the elderly but promoted it for that purpose anyway, according to a lawsuit. The suit also claims that each Zyprexa sales rep had a $10,000 budget that it used to pay pharmacies and doctors for talking up off-label uses of Zyprexa.

The news comes from the same case outlined by Bloomberg yesterday:

Lilly employees also compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets...

While much of the Bloomberg article focuses on the issue of ghostwriting, the legal papers on which the article is based are filled with other gems about how Lilly promoted Zyprexa, allegedly off-label, playing down its side effects and throwing money at anyone who might trigger more prescriptions.

(Download your own copy of the Zyprexa complaint here.) Lilly had this statement:

Plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases ... Lilly remains prepared to defend ourselves against all of these allegations in the appropriate venue, a court of law.

According to the suit, less than 1 percent of Americans suffer from schizophrenia but Lilly nonetheless makes $3 billion a year on sales of the drug.

The drug was particularly promoted for off-label use among the elderly, the suit, filed by union benefit funds, claims:

This off-label marketing promotion is particularly sinister given the results of a study performed by Lilly in 1995, before Zyprexa was even approved. Lilly learned that olanzapine was ineffective in treating such conditions as dementia and Alzheimer's. ...
Neverthless, Lilly promoted Zyprexa for symptoms of dementia and Alzheimer's in the elderly from the product's inception.

The suit has been heavily (and, in some parts, bizarrely) redacted, so it is difficult to figure out the specific facts. Nonetheless, Lilly employees will recognize the names of dozens of their colleagues within it.

The suit claims that Lilly's Zyprexa sales reps would get pharmacies to stage an educational program. The Pharmacy would write to the company requesting a check for the program, and then the pharmacy would then in turn cut a check for a doctor to give the presentation. The doctor would be recommended by a Lilly rep:

Since the pharmacy theoretically "controlled" the presentation, Lilly consider it a "REDACTED" event that could contain off-label information without running afoul of FDA regulations.

I'm going to take a wildly speculative guess that "redacted" in this case means "medical education" or "unrestricted grant." Both terms would fit within the blacked out text. The suit further states that each sales rep had a budget of $10,000 for this type of activity.

More broadly, the suit alleges that public officials received "gratuities" or financial payoffs in order to foster Zyprexa usage.

Side effects of the drug include, neurological problems, weight gain, diabetes, and CV complications, the suit claims, but Lilly played those down:

Lilly opted for the bare minima of clinical trials, of limited duration, such that no side effects were likely to be revealed.

When Lilly did want to publish studies, the suit claims, it give tame docs templates from which to write:

Lilly also trained its sales people as to how to "outline" or to even write articles for the doctors and in fact provided templates of articles that the doctors could submit under their own name.

Negative studies were not published or delayed.

Bloomberg notes that at one point, Lilly's journal articles were being written by pr agents at Cohn & Wolfe:

"We 'ghost' wrote this article and then worked with author Dr. Haddad to work up the final copy," [C&W employee Kerrie] Mitchell said in the e-mail.

The Bloomberg story and the suit raise a question: Why have medical journals gone along so quietly with drug companies submitting ghostwritten articles to them? At one point, the legal papers describe an editor at the Journal of Clinical Epidemiology complaining of being emailed by Lilly execs. So medical editors must know what's going on -- and for years have published very little about it.

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