The good, the bad, and the ugly of the pharmaceutical industry have all converged into an embarrassing controversy; one that will doubtlessly boost the case for health care reform.
Two pharmaceutical behemoths, CVS Caremark and Eli Lilly, a leading drug manufacturer, have been linked together in a marketing scheme involving Zyprexa, a controversial antipsychotic approved by the FDA to treat schizophrenia. Lilly used CVS to help “encourage” physicians to endorse the medication, not for what it was approved for, but for the treatment of dementia in elderly patients.
As a result, a group of healthcare insurance providers and pension plans is suing Lilly for continuing the push for a drug they knew was ineffective; Lilly is fighting the plaintiffs’ claims in a U.S. District Court in New York.
The term used for promoting an unapproved use of a drug is called off label promotion, which Lilly began doing with Zyprexa in earnest beginning in 1999. The problems related to their “due diligence” in this regard are myriad:
· The intense endorsement campaign began after studies documented that Zyprexa was ineffective in treating dementia patients, yet Lilly began targeting the elderly AFTER said evidence, which was derived from no less than seven studies.
· Lilly engaged in a practice called “ghostwriting;” they hired writers to compose medical journal studies, then asked doctors to sign off on them. Indeed, according to the Boston Globe, Lilly had a “guide” to hiring scientists with the express purpose of having them write favorable reviews.
· Not only was Lilly aware of the ineffectiveness of the drug, they also had documentation which revealed that elderly patients who took Zyprexa were at a greater risk of death than those who took placebo pills.
· Lilly entered into an “arrangement” with CVS Caremark in an effort to promote the drug for dementia, despite the fact that CVS contracts with insurers and pension plans. In a blatant instance of interest conflict, CVS offered to send out 120,000 letters promoting the drug at a $5.00 apiece. As Richard Beck, executive director of the Texas Pharmacy Business Council eloquently stated, “There is no question that these folks are all in bed together.”
CVS Caremark, the largest pharmaceutical retailer and pharmacy benefit manager (PBM), has not been without its own controversy, even before the current Lilly scandal. In 2008, the company agreed to pay nearly $37 billion to 12 states and the federal government; they billed Medicaid for a more expensive form of generic Zantac in order to improve their bottom line. The capsules they gave allowed them to charge 4 times as much as they could have gotten for generic tablets.
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