One way a drug company can increase sales is by promoting medicines for purposes that haven't been approved by the Food and Drug Administration. The practice, called off-label marketing, is illegal. But, as a slew of settlements with the government have shown, it's been commonplace.
How common? Just ask Dr. Aaron Kesselheim, a doctor at in Boston. He has pored over dozens of complaints from whistle-blowers and compiled a comprehensive picture of off-label marketing practices. And his findings appear in the latest PLoS Medicine.
We caught up with Kesselheim, who tells Shots that some of the most common problems, including companies ambitious sales quotas for reps, are also the hardest to regulate.
The details in his analysis won't shock anyone familiar with the industry. Off-label marketing has become ubiquitous and persistent. Take a look at Pfizer, for instance. In 2004, Pfizer was taken to court over off-label promotion of an epilepsy drug called Neurontin, and promised to change its practices. Years later it was revealed that at the exact same time, it was pushing unapproved uses of the painkiller Bextra, since withdrawn from the market.
"In the Neurontin case, the ultimate settlement was 450 million dollars, whereas the sales of that drug were over a billion dollars in just one year," Kesselheim says. "In general, these payments are a drop in the bucket — there is a concern that they are seen as the cost of doing business."
So what will it take to curb off-label marketing? "It takes the industry's willingness to change, and it also takes regulation and better attention by the FDA," Kesselheim says.
While many in the industry have pledged to do better, the Department of Justice is trying new enforcement tactics, inlcuding pursuing individuals within drug companies for violations.
Kesselheim is skeptical. "Attempts to try and stop this practice with government regulation is never going to reach all the kinds of crevices and cracks this system has entered," he says. "Ultimately, the only thing that is really going to make this change is if physicians themselves become aware of the risks of off-label promotion."
Kesselheim thinks there should be independent organizations that can provide unbiased information about prescription drugs to doctors. He consults for , an nonprofit outfit that's been trying that. "If physicians decide to reject the education that is coming to them from pharmaceutical companies, they need credible unbiased alternative education sources," he says.
Kesselheim adds that a doctor's willingness to prescribe off-label might be linked to the desire to quickly and easily deal with a patient's needs. "If someone comes in with acid reflux it's easier to write a prescription for a proton pump inhibitor than to go over their diet and excercise," he explains.
But there are times when prescribing a drug, even an off-label one, is the best approach. In some cases, data shows that off-label prescription of cancer drugs can be effective. In other cases, the rarity of a disease makes studies to approve drugs extremely difficult, and off-label medicine has to be used.
In the end, the decision to go off label is difficult and must be based on the body of evidence, Kesselheim says. "That's one of the reasons why the FDA review process is important — then you have a set of highly trained experts reviewing the data," he explains. "Making these kind of decisions is very, very important."
In any case, he says, that decision about when to use medicine shouldn't be influenced by drug companies.
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