Recently unsealed internal company documents from Eli Lilly & Co. show it urged doctors to prescribe the house drug, Zyprexa, to elderly patients suffering from dementia when fully aware that it had absolutely no beneficial effect against the disease. Zyprexa was developed and intended for use as an antipsychotic (a drug for the treatment of diseases such as bipolar disorder and schizophrenia that works by blocking receptors in the brain's dopaminergic pathways).
At best, "antipsychotic medication is not generally regarded as a good treatment, just the best available."
In 1999, four years after Lilly sent study results to the U.S. Food and Drug Administration showing Zyprexa didn’t alleviate dementia symptoms in older patients, it began marketing the drug to those very people. . .Bloomberg
Eli Lilly knew in 1995 that Zyprexa was ineffective for treating Alzheimer’s and dementia in the elderly. But it figured it could find a bigger market share by targeting Alzheimer's patients with its off-label promotions. Less than 1 percent of Americans suffer from schizophrenia but Lilly nonetheless makes $3 billion a year on sales of the drug, largely due to, highly successful -- you got it -- off-label promotion.
"Off-label means there is no clear evidence that the benefits of a drug outweigh the risks,"
Sidney Wolfe, head of the health research group at Public Citizen in Washington, said.
"The reason why off-label promotion is illegal is that you can greatly magnify the number of people who will be harmed." Bloomberg
Plaintiffs in a lawsuit against Lily are claiming 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. B-Net
The cynicism and downright criminal behavior that the drug company engaged in to satisfy greed is palpable, especially in light of these revelations. But as you will see later in this story, theirs was not the only greed that needed to be satisfied by such attitudes and actions.
In 1998, Lilly went back to the FDA seeking approval to market Zyprexa to those battling Alzheimer’s, the most common form of dementia, the company said in its 2003 request for a meeting on a proposed label change. Lilly withdrew its bid to promote Zyprexa for Alzheimer’s cases in 1999, according to the document.
In a November 2000 memo to Lilly salespeople, company executives said the dementia marketing initiative was abandoned because the FDA questioned Zyprexa’s effectiveness in treating the ailment. Corante
But that's not the case, nothing of the kind was abandoned.
Lilly’s long-term care unit also saw Zyprexa sales rise 2.9 percent in the second quarter of 2002. . .
(snip)
At that time, long-term care sales made up about 20 percent of Zyprexa prescriptions, according to the summary. Of that number, 65 percent were written for nursing-home patients.
Overall, prescriptions for older patients were the "2nd biggest money-producing segment" for Zyprexa in the U.S., according to a Feb. 15, 2002, e-mail from Lilly researcher Peter Feldman to Denice Torres, the company’s global marketing director.
In short, Eli Lilly struck a goldmine when it eagerly and criminally exploited a population incapable of questioning its medical caregiver, and -- at first glance -- it exploited another population apparently incapable of exercising its own ethical duty to "first do no harm." The reality apparent from a second glance is that the drug company and the prescribing physicians engaged in a conspiracy to defraud a group of people unable to detect such fraud. Further, physicians endangered the health of dementia patients in their care to whom they prescribed the drug as its side effects can be serious, especially in the absence of blood testing that would be part of the blood monitoring given to psychotic patients, but not necessarily to dementia patients.
Side effects of the drug include, neurological problems, weight gain, diabetes, and CV complications (hypotension) and seizures. . .
The drug box indications can be read inthis pdf file, of which the following is excerpted:
RECENT MAJOR CHANGES --------------------------
Boxed Warning, Increased Mortality in Elderly Patients with
Dementia-Related Psychosis
Reprehensible doesn't adequately characterize Lily's and the prescribing physicians' collusion.