Shadowproof

Over Easy: A Small Price to Pay for The Molecule

How Big Pharm profited by mismarketing a drug.

In January of 2009, Eli Lilly settled a case with the Department of Justice (DOJ) for 1.415 billion dollars, for improper off-label promotion of Zyprexa, a drug approved for treatment of schizophrenia and bipolar disorder. This is the fourth largest pharmaceutical company settlement with the DOJ in US history. The criminal charge notes, in part:

In September 1999, Eli Lilly began encouraging doctors to prescribe the drug for the treatment of dementia, Alzheimer’s, agitation, aggression, hostility, depression, and generalized sleep disorder. Zyprexa was not approved for use for any of these disorders, which, unlike schizophrenia, are prevalent in the elderly population. Nevertheless, Eli Lilly’s long-term care sales force promoted the use of Zyprexa in elderly populations for these symptoms.

While Eli Lilly had little choice but to pay up for its fraudulent marketing practices, lest it lose its Medicare/Medicaid business, Forbes reports just last month that nursing home patients are still receiving “dangerous antipsychotic drugs.” The manufacturer’s package insert for Zyprexa contains a black box warning that states, “Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.”

Lilly was aware from the beginning that its schizophrenia ‘molecule’ was not going to generate the revenue of Prozac, which would soon come off-patent. Rather than marketing Zyprexa honestly, it played to the drug’s side effect of chemical restraint. When chemical restraint meets the free market, the result is an Eighth amendment violation that, although rationalized or otherwise couched in other terms is no different than chaining a person.

At the same time the company improperly encouraged off-label uses, it willfully downplayed voiced physician concern and study findings indicating side effects of weight gain and diabetes in patients receiving olanzapine (Zyprexa) therapy for approved use. As a whistleblower summed, “If you torture the data long enough, it’ll tell you anything you want to hear.” This practice is, to use Eli Lilly’s own internal email communication-come-court-document, “a small price to pay for the molecule.”

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