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Doctors prescribe drugs off label every day. This does not mean they are being irresponsible. You need to understand what off label means. Before a drug can be offered to the public, pharmaceutical companies have to conduct clinical trials showing the efficacy (if it works or not) and safety of the drug. They usually study it in a specific condition. In Neurontin's case, it was extensively studied in seizure patients and found to be effective and safe if taken under a doctor's supervision. The pharmaceutical company then presents this info to the FDA to get approval to offer the drug in the US. The FDA will approve or deny the drug based on this data. The condition studied will be the indication the company gets. In Neurontin's case it got an indication for siezures.

Often with drugs, in the trials or in general use, there is some info showing effectiveness for other conditions. Some companies investigate these other conditions with additional clinical trials so they can show the info to the FDA and get an indication for the other condition. A clinical trial can be very expensive however and some companies do not persue the additional data. If a doctor knows the drug will work for other conditions even if it is not indicated for that condition, he can prescribe it. Most doctors know their behind is on the line so they would not prescribe it for you unless they felt it was safe enough to use.

Parke Davis got in trouble because they actually marketed Neurontin to doctors for conditions other than siezures even though Neurontin was not indicated for the other conditions. The question is not whether it worked or not. Parke Davis sales representatives acted unethically in discussing off label use with doctors. I work as a drug rep for another company and this is a HUGE no no.

Hopefully some of this makes sense. I do not know all about Parke Davis' situation and I may have some of the specifics of the Neurontin deal a little off but I am just trying to give you an idea how some of it works. An interesting side note is that Viagra was first studied for high blood pressure. The "other effects" were actually a reported side effect. That is why you cannot take it with certain Alpha blockers, because it will cause a possibly dangerous drop in blood pressure.

If I do have any of this wrong and you know I do, please correct me.

Alan