Antipsychotic drugs, once used to treat only the most serious mental illnesses, have emerged as the top-selling class of pharmaceuticals in the U.S., generating annual revenue of about $14.6 billion. Yet much of the sales boom has been achieved with illegal or controversial marketing tactics by major pharmaceutical companies to promote uses of the drugs that have not been approved by the U.S. Food and Drug Administration.
The result, according to an account by The New York Times, is that every major manufacturer of antipsychotic drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has recently settled criminal or civil government cases for hundreds of millions of dollars or is under investigation by the Department of Justice for possible health care fraud. The criminal fines paid by Eli Lilly and Pfizer last year set records last year for the largest criminal fines ever imposed on corporations, although in the case of Pfizer, the case was built only partly on the marketing of an antipsychotic drug.
In their defense, the companies say that they follow tight business ethics guidelines and that all possible side effects of their medicines are fully disclosed. Recently, however, the government has warned that some of the drugs may be fatal for older patients and have unknown effects on children. And critics question how drugs approved by the agency for use by 1 percent of the population, to treat illnesses such as schizophrenia and bipolar mania, could have turned into top sellers, prescribed for everyone from preschoolers to octogenarians.
At least part of the answer lies in the companies’ marketing tactics. The Times reports that civil and criminal lawsuits against big pharmaceutical companies have revealed hundreds of documents showing that some company officials knew they were using questionable tactics when they marketed these powerful, expensive drugs.
According to analysts and court documents, these tactics have included payments, gifts, meals and trips for doctors, biased studies, and ghostwritten medical journal articles. These all are meant, federal investigators say, to promote the benefits and downplay the risks of the drugs, while encouraging off-label uses — that is, uses the FDA has not approved but which doctors, if they choose, can pursue with their patients anyway.
Drug companies skirt restrictions on promoting off-label uses by hiring consultants, researchers and educators to handle the job, delivering the marketing message verbally and through company-sponsored studies. “They can give a small hint, and people will take the bait,” Dr. Robert Rosenheck, a professor of psychiatry and public health at the Yale School of Medicine, told the Times. “Psychiatric disorders are vaguely defined enough that you can stretch definitions.”
The Justice Department claims drug companies trained sales representatives to rebut valid medical concerns about unproved uses of antipsychotic drugs. For example, the department says, Eli Lilly produced a video called “The Myth of Diabetes” to sell Zyprexa, which became its all-time best-selling drug, even though evidence showed that Zyprexa could cause diabetes.
The bottom line for Eli Lilly: Last year it paid a $515 million criminal fine as part of a broader, $1.4 billion settlement with the government over the company’s marketing of Zyprexa.
Pfizer last year paid even more — a $1.3 billion criminal fine as part of a broader, $2.3 billion settlement — to resolve a government case involving its marketing of drugs including the antipsychotic Geodon.
Eli Lilly & Co, the world’s biggest maker of psychiatric drugs,
Psychotropic meds are indicated for true clinical conditions.
Zyprexa was pushed by Lilly Drug Reps.
They called it the “Five at Five” (5 mg at 5 pm to keep nursing home patients subdued and sleepy) and “VIVA ZYPREXA” (Zyprexa for everybody) campaigns to off label market Eli Lilly Zyprexa as a fix for unapproved usage
I was prescribed Eli Lilly Zyprexa by my physician *off-label* for PTSD and it was all wrong,cost me a lot of money and the side effects damaged my pancreas and gave me life-long diabetes.
Daniel Haszard Zyprexa whistle-blower