If you're a drug manufacturer. You may have heard that Eli Lilly has agreed to pay a total of $1.42 billion to resolve criminal and civil charges related to its marketing of the antipsychotic drug Zyprexa (generic name olanzapine). Like the other so-called "atypical" antipsychotics, the drug was tested in clinical trials to control symptoms of psychosis. Not a whole lot of people have psychoses, however, so they looked for bigger markets.
The linked article describes their efforts to market the drug in nursing homes and assisted living facilities, to be given to people with dementia; and to primary care doctors, who obviously would have no business prescribing it since psychoses are only appropriately managed by specialists. In fact, like all the atypical antipsychotics, the drug is extremely dangerous. It causes weight gain, diabetes, and heart rhythm irregularities and is therefore associated with both long-term development of cardiovascular disease and increased risk of sudden cardiac death.
The AP article doesn't mention what might be the worst part, but New York Times does: Lilly was heavily promoting the drug for "disruptive" children. The side effects of weight gain and hyperglycemia are particularly pronounced in children, and obviously set them on a lifelong path of ill health and risk for premature death. They got a lot of help from a psychiatrist at Harvard named Joseph Biederman, who has almost singlehandedly created an epidemic of diagnosing bipolar disorder in children and feeding them antipsychotic drugs. According to the NYT:
In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.
Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.
What Biederman wasn't telling us -- what he was in fact actively lying about -- was that during this period he took more than $1.6 million in consulting fees from drug companies, including Lilly; and that his studies of antipsychotic drugs in children, funded by the drug companies, were too small and poorly designed to show the benefits he claimed they showed. In fact, whether such a things as bipolar disorder even exists in children, or could be accurately diagnosed, is questionable. But the harm done by these drugs is unquestioned.
As for elderly people with dementia, Lilly knew for years that Zyprexa increased their risk of death, and the FDA finally issued a "black box" warning to that effect in 2006. But the marketing campaign was so successful that it continued to be effective long afterwards. We discovered that my own father had been given antipsychotics, in an assisted living facility in 2007 and in a nursing home in 2008, without consulting my mother and, in the second case, contrary to her specific orders. The reason? He was wandering around and it was easier for the staff to zonk him out with drugs than to keep an eye on him. And that was indeed the basis for much of the marketing -- that stoning old folks made it easier on the staff.
Now, you may think that $1.42 billion in fines would be a pretty strong deterrent to this sort of behavior, but in fact, Zyprexa brings in $4 billion a year, so Lilly is happy to pay it. As for Biederman, he's in big trouble -- they've made him promise not to do it again. In fact, the executives at Lilly, and Dr. Biederman, are murderers, and their motive is greed. They should be dealt with accordingly.