is acting U.S. attorney for Pennsylvania's Eastern District
Martha is a widow who lives near her family and is sometimes confused or agitated. Many of us have a Martha in our lives - a mother, grandmother or older friend who surely does not suffer from schizophrenia or bipolar disorder, but who may, at times, have behavioral issues or symptoms of anxiety, depression or dementia.
"Martha" was one of the fictitious patients highlighted in the sales brochures of pharmaceutical giant Eli Lilly & Co. as a model patient for its drug Zyprexa. From 1999 to 2005, as part of a calculated, aggressive marketing campaign, Lilly deployed an army of sales representatives across the country to market Zyprexa for uses that the Food and Drug Administration never approved as safe and effective.
The FDA had approved Zyprexa to treat schizophrenia and certain types of bipolar disorder. Drug companies such as Eli Lilly are barred by law from "off-label marketing" of drugs, meaning marketing for uses not approved by the FDA.
But Lilly ignored that federal law and undertook a massive campaign to persuade doctors to prescribe Zyprexa not only for the relatively rare problems for which it was approved, but also for common ailments such as dementia, Alzheimer's disease, depression and anxiety. The company's management instructed sales reps, who were not medically trained, to urge primary- and long-term-care physicians to prescribe the drug to people of all ages, but particularly to elderly patients showing signs of dementia.
The company's strategy made sense if market share and profit were all that mattered. Less than 1 percent of the elderly in long-term-care facilities suffer from schizophrenia, but 60 percent to 80 percent suffer from dementia.
Zyprexa can be dangerous - even deadly - for the elderly and other patients. It can increase the risk of stroke and cause significant weight gain leading to diabetes. The FDA warned Lilly by letter about its false and misleading marketing, especially its targeting of the elderly. Later, the agency issued its most serious kind of public warning - a "black-box warning" - about the drug.
But Lilly deliberately declined to have the drug thoroughly tested and to seek FDA approval for additional uses. Instead, it launched the "Viva Zyprexa" campaign, gave sales representatives glossy brochures about fictitious patients such as Martha, and had them use the slogan "Five at five" - that is, 5 milligrams of Zyprexa at 5 p.m. would keep elderly patients quiet all night, not bothering the doctors or nursing staff in a long-term-care facility.
This month, the U.S. Attorney's Office for the Eastern District of Pennsylvania announced the largest financial settlement of a case against a single company in the history of the Department of Justice. Eli Lilly agreed to pay $1.4 billion and plead guilty to a criminal misdemeanor charge for its reprehensible conduct.
Sadly, Lilly is not the only pharmaceutical company risking the health and lives of thousands of patients. Just a few months ago, this office announced that the drug company Cephalon would pay $425 million and plead guilty to a criminal misdemeanor because it engaged in off-label marketing of three drugs.
One of those drugs, Actiq, is a potent painkiller intended only for cancer patients who are already tolerant of other painkillers and still suffering pain. Yet, with the slogan "Pain is pain," Cephalon marketed the drug to primary-care physicians for common ailments such as back pain and migraine headaches.
These cases should send a clear message to the entire pharmaceutical industry: This conduct must stop. Doctors may on a patient-by-patient basis decide that, in a particular case, an off-label prescription is the best option. But drug reps with glossy brochures, catchy slogans, and no medical training should not be misleading doctors into thinking that the FDA has approved an off-label use.
Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer.
Off-label-marketing cases are not easy to bring. They can take years and involve the review of millions of documents by an alphabet soup of federal agencies, state regulators, and law-enforcement officers. But we will keep bringing them until this practice stops.