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When the FDA approves a new medication for the market, it has undergone extensive testing to demonstrate it is safe and effective for the intended use. But once it is available, doctors can prescribe it for nearly any purpose that seems reasonable to them. We speak with an expert who has warned his colleagues about the pitfalls of this practice.
Senator Ted Kennedy has begun his treatment for brain cancer. What sorts of treatment are given after surgery, and what is on the horizon for the future?
A listener tantalized others with his testimonial on using a dietary supplement, l-carnosine, to reverse his cataracts. We discuss this approach with the ophthalmologist who suggested it.
Explore the stories behind the health headlines.
Guests: Randall S. Stafford, MD, PhD, Associate Professor of Medicine at the Stanford Prevention Research Center in the program on Prevention Outcomes and Practices at Stanford University in Palo Alto, CA. His article on off-label drugs was published in The New England Journal of Medicine April 3, 2008.
Henry Friedman, MD, James B. Powell, Jr., Professor of Neuro-Oncology; Professor of Pediatrics; Associate Professor of Surgery and Medicine; Assistant Professor of Pathology; Co-Deputy Director of The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center.
Robert Abel, Jr., MD, ophthalmologist and author of The Eye Care Revolution: Prevent and Reverse Common Vision Problems. His Web site is www.eyeadvisory.com
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I listened to your comments on off-label drugs with interest, but find your position condemning the FDA for not regulating in contrast with your position of promoting home remedies or alternative uses of OTC medications.
I am an emergency physician and can recount several instances of off-label use that are essential to our specialty. These are uses commonly for drugs that have been around awhile, and we have lots of experience with that are noted to have unique properties that were not the reason for their existence. There is no economic incentive for drug companies to undergo the expensive testing required to obtain FDA approval, and frequently the use will be so small and generate no income to the company that they are even not interested in pursuing it. The physician usually learns of these uses from case reports or small studies, not from companies seeking to promote their products as you imply in your article.
As an example in emergency medicine, glucogon is commonly used as an off-label adjunct to promote the passage of a food bolus causing esophogeal obstruction. This is not an FDA-approved use. But it saves thousands of surgeries or endoscopies each year. Again, however, only used a few thousand times each year and not capable of generating the dollars needed to perform the FDA mandated testing.
IMHO
PROVIGIL WAS MARKED IN THE MID 1990'S FOR NARCOLEPSY. I HAVE MULTPLE SCLEROSIS WITH INCREASING COGNITIVE PROBLEMS. MY NEUROLOGIST PRESCRIBED THIS MEDICATION FOR ME AS SOON AS IT WAS APPROVED BY THE FDA. I HAVE TAKEN THIS MEDICATION EVERY DAY SINCE. IT HELPS ME STAY ALERT ALL DAY. MY HEALTH ISURANCE COMPANY WOULD NOT PAY FOR ANY PORTION OF THIS EXPENSE SINCE IT WAS APPROVED FOR NARCOLEPSY AND NOT MS. MY COST HAS INCREASED FROM FIVE DOLLARS TO ELEVEN DOLLARS PER DAY JUST TO GET THROUGH EACH DAY.