Annals of Internal Medicine: Off label use common among practicing physicians
If you had a chance to read my BLOG last week then you are well aware of the NY Times articles targeting Lilly's marketing practice for off label use of Zyprexa. Forget that this was leaked by an attorney who is in litigation with Lilly and has a vested interest in releasing this information what really strikes me, once again, is the lack of research by the NY Times and the reporter who wrote the articles. Two medical journals have stated that off label use is common among practicing physicians.
According to an article in August of 2006, the Annals of Internal Medicine stated the following:
Off-label use is the common practice of prescribing a drug for an indication other than those approved by the FDA. The physician rationale for prescribing off-label is often based on the lack of FDA-approved effective treatments, reports of clinical effectiveness for the off-label use, or both. A recent study confirms that off-label prescribing continues in earnest, with 21% of drugs listed in a data set being prescribed for off-label uses, most with little scientific evidence of efficacy. Although the responsibility for seeking FDA approval for adding new uses to the product label resides solely with the manufacturer, companies are reluctant to invest the resources necessary to develop the evidence required for FDA review, particularly when the off-label uses are already profitable.
In addition another article in the Archives of Internal Medicine in May of this year found:
Off-label medication use is common in outpatient care, and most occurs without scientific support.
So what does this mean? It means that physicians are doing what they feel is in the best interests of their patients. They don't have a lot of confidence in the FDA or pharmaceutical representatives to give them the information they need to make decisions based upon what is best for patients. Pharma companies, for the most part, do not promote off label use of their products and anyone who engages in such behavior is subject to immediate termination. It also means that once again a reporter did not present a balanced news story that was researched in depth.
Next time I read a story like this I am going to check my drivers license to ensure that I was not born yesterday...