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When drug makers' profits outweigh penalties
The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.
"It's an unbearable cost to a system that's going broke," Avorn says. "We can't even afford to pay for effective, safe therapies."
About 15 percent of all U.S. drug sales are for unapproved uses without adequate evidence the medicines work, according to a study by Randall Stafford, a medical professor at Stanford University.
As large as the penalties are for drug companies caught breaking the off-label law, the fines are tiny compared with the firms' annual revenue.
The $2.3 billion in fines and penalties Pfizer paid for marketing Bextra and three other drugs cited in the Sept. 2 plea agreement for off-label uses amount to just 14 percent of its $16.8 billion in revenue from selling those medicines from 2001 to 2008.
The total of $2.75 billion Pfizer has paid in off-label penalties since 2004 is a little more than 1 percent of the company's revenue of $245 billion from 2004 to 2008.
Lilly already had a criminal conviction for misbranding a drug when it broke the law again in promoting schizophrenia drug Zyprexa for off-label uses beginning in 1999. The medication provided Lilly with $36 billion in revenue from 2000 to 2008. That's more than 25 times as much as the total penalties Lilly paid in January.
Companies regard the risk of multimillion-dollar penalties as just another cost of doing business, says Lon Schneider, a professor at the University of Southern California's Keck School of Medicine in Los Angeles. In 2006, he led a study for the National Institute of Mental Health of off-label use of drugs, including Zyprexa.
"There's an unwritten business plan," he says. "They're drivers that knowingly speed. If stopped, they pay the fine, and then they do it again."
Paying the doctors
In pushing off-label use of drugs, companies find ready and willing partners in physicians. Under the fragmented system of U.S. medical regulation, it's legal for doctors to prescribe FDA-approved drugs for any use. The FDA has no authority over doctors, only over drug companies, regarding off-label practices. It's up to the states to oversee physicians.
"I think the physician community has to take some ownership responsibility and do their own due diligence beyond the sales and marketing person," says Boston's former U.S. Attorney Michael Sullivan.
Doctors generally don't tell people they're prescribing drugs pitched to them by pharmaceutical salespeople for unapproved treatments, says Peter Lurie, former deputy medical director of Public Citizen, a Washington-based public interest group. Most doctors don't keep track of FDA-approved uses of drugs, he says.