Migraine

Many meds used for migraine prevention are prescribed "off label." The med was originally approved for another condition but has sometimes been successful in migraine prevention.

An article in today's Wall Street Journal said that the FDA is recommending that drug companies be allowed to distribute copies of articles in peer-reviewed medical journals that discuss studies into off-label uses of a particular medication. Currently, marketing off-label uses to doctors is extremely limited.

Of course, the recommendation is controversial. I think, however, it will be a step forward for us migraine sufferers, who often depend on off-label uses for our preventives. I'm currently taking 3 meds off-label.

Gretchen in Mississippi

We just had this discussion at work. Here was our general take on the matter. Knowledgeable doctors will already know about off label uses b/c they are reading their journals and keeping up on the studies and educating themselves. Personally, I'm not a big fan of small studies b/c they can be skewed to say whatever the researcher wants them to say. I can make the statistic work in my favor any day. Give me a big _____________ (Dain bramage moment here for the big collective type of lots of studies - where lots of different researchers have shown the same results) any day.

Drug companies on the other hand have one goal in mind - to make money. They are going to use that one study with 10 people and 6 of them got positive results - so what. The drug company is making money off someone else's work and advertising. I don't agree with 90% of the advertising they do already. They shouldn't be allowed advertise something they didn't prove. This happened recently with Risperdal and advertising it for use in the nursing home patients with dementia. Big problem. Sure it makes sense and doctors are going to try it, but it's not a labeled use and the company got in trouble for advertising it that way. As they should have b/c it's also risky for the elderly to be using in the first place for many reasons and they aren't warning of that at the same time.

There are already other people out there writing articles and sending letters to the editors of the respective medical journals of their specialty and using the drugs off label for things that make sense. Word of mouth is a grand thing in the world of medicine. Like our list of other headache meds. I personally don't have ANY problem with a list like this. You know why? Because there is no value attached to it. No one is out to make money off it. So print it off and take it to all your doctors. Mail it anonymously.

Don't get me wrong. I spent a whole summer working at a Pharmaceutical company. I KNOW that it takes time and money to bring a drug on the market. I KNOW that for every drug breakthru there are hundreds of failures. I also know there are lots of me-toos (same drug different company) on the market and that WAY, WAY, WAY too much is spent on direct to consumer advertising of medications that have no business being advertised. Like how stupid is it to advertise chemotherapy drugs in Women's Day or Sports Illustrated? You can Educate, but don't specify the drug.

OK, I've given my soapbox reply. I have friends who are drug reps and they are great people! I don't have a problem with the job as it is, just don't let it get any further out of hand than it is....

Diane

I think it may indeed be a step forward. Granted, many doctors are going to learn about off-label uses for any given med from journal articles and research study findings. But...there are also many cases where the off-label use is learned through anecdotal patient accounts, too. And off-label usage prescribing based on the latter is more apt to end up in denied coverage of the med by insurance companies. So...in a way, easing up the restrictions on off-label usage data could add more legitimacy to the practice of establishing off-label usage in the first place, which could be beneficial to patients in the long run.

I too think this could be a step forward. MAYBE doctor will read journal articles and the like, but too often, we're seeing doctors who don't know as much as they should know. I see too many people here who are trying to educate their doctors. I had to drive 8 hours each direction to get to a doctor who could help me with my Migraines. It would certainly be nice to have gotten that care closer to home.

This is an interesting dilemma. I think Diane makes some great points - and though I teach people marketing, and think there's nothing wrong with ethical marketing (how else would anyone know what someone/some company has to offer) - I am uncomfortable that so much of our doctors' continuing education seems to be in the hands of marketing departments!

On the other hand, just as Teri and Droolie say, it would be great to get the information more widely and reliably disseminated. While we can certainly push for better (publicly funded, even!) health research and education, do we want to wait until an entirely new system is in place to get the word out?

I really don't know where to come down on this one, but am interested to see how it comes out.

- Megs