The response to our Dollars for Docs project has been tremendous. Mostly positive, with some negative comments sprinkled in that we focused excessively on a relatively small number of problem cases.
Today, I wanted to touch a bit more on a key issue that lies behind all of our reporting on pharmaceutical payments to doctors: Off-label prescribing.
This is a complicated subject, but the gist of it is this: To get FDA approval, a new drug must be proven safe and effective. If the FDA gives the OK, a drug is given a label that spells out the specific disease or condition it may be used to treat.
But let's say a doctor figures out that a drug used to treat one disease has a benefit in treating another condition. That doctor is allowed to prescribe the drug for an "off-label" use, that is to treat a medical condition not indicated in the FDA-approved label. Some off-label uses are quite similar to the approved use for a drug, for example an asthma drug might be used to treat asthma-like symptoms.
Here is how the FDA describes the issue:
Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product's approved labeling. . . . These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care.
Critics of off-label marketing worry it's an easy way for drug companies to get around the FDA approval process.
I was surprised to learn that off-label prescribing may account for 20% of overall use. An 2006 article in the Archives of Internal Medicine found no more than 30% of off-label uses observed were supported by strong scientific evidence.
Among the drugs that were scientifically supported for off-label use, hypertension drugs were the most common. Though, the most common off-label uses were cardiac medications and anti-asthmatics.
How does this relate to drug company payments to speakers? It is illegal for a drug company to market a product for an off-label use. So if Company X hires a doctor knowing he or she will tout a drug for an off-label use, that is against the law. Indeed, there have been many legal settlements based on just this kind of marketing.
Much of the data in the database ProPublica put together on doctor payments actually came to light, because drug companies were ordered to release that information to settle federal lawsuits charging off-label marketing. More transparency on payments, regulators hope, will make it harder for drug companies to market drugs for off-label use.
If the article in the Archives of Internal Medicine is correct, patients could be paying more than $40 billion a year for drugs that are not scientifically proven to be effective.
Source: http://www.pbs.org/nbr/blog/2010/10/dollars_for_docs_a_word_about.html
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