All in all I agree with the fine, but its pretty hard for me to work up a lot of moral outrage over something I ultimately benefited from.

But here’s another scenario. If gabapentin was ever shown actually to be useful for bipolar disorder–rather than the horse manure put out by WL that kept who knows how many pts from getting genuinely efficacious treatment–it would probably be worth some price increase.

I certainly follow the argument. But, yes, I do think it should be illegal for reps to promote unapproved uses. The arguments that this is the only way docs will learn, etc. just don’t counterbalance the downside.

That said, there are obviously degrees of malfeasance in this arena. Paying docs to rx for off-label, creating indications where there is zilch data, suppressing internal studies that actually show harm from such use, etc., add to the heinousness quotient, needless to say.

2. If you were a suffering patient or had a loved one who has tried everything to improve their quality of life (or save their life) and your doctor suggested an off-label use which might work, would you say NO? You would rather wait and hope that in years it would be in black and white in the P.I. (Package Inset)?

3. As a patient, using a drug off-label and you receive a call that the doctor stating to stop using it but you FINALLY found something that works, would you stop?

I am not in favor of out-right promotion of an off-label use, especially when it includes a small trial of 12 patients and a monkey. However, as a person, who is actively involved in my health, I DO want to know all the options for improving and saving lives when it comes to my life and those of loved ones. I EXPECT my doctor to know the latest and greatest on how drugs can make a difference. It does seem self-serving when that information comes from a drug rep, but should that make it illegal? How many doctors spend their free time actually keeping up on the latest medical news or do they rely on others to give it to them. How many doctors even know the specialists they refer to and sit down on their own dime, and personal time learning what is being seen in each others’s practice?

Anyone want to talk about actual examples when approvals followed market usage by years, even a decade? How many patients were thankful they had access to an “off-label” drug during that time.

I think the govenment has found another way to bring in the revenue from those, “greedy drug companies”. God help us all when more money goes into the legal profession and gov’t pockets instead of R&D.

Yes, I am a former drug representative of 12 years. Yes, I have seen abuse in the industry. AND Yes, I do believe there are companies and people, who want to make a difference in the lives of others. Keep an open mind and hope others are open when you are in need.

MB

For the love of [God], $81M NOT ENOUGH.

MB