Pfizer Pays

In my paid work, I address (educate) health care professionals, students and groups of persons interested in the field of tobacco treatment. Because of this, I learned about FDA approval processes and guides for using medications. In my presentations, on some level or another, I explain that a medicine becomes available for use through a process that involves applications to the FDA, lab tests on animals and experiments on humans, phase I, II and III clinical trials, panel recommendations and final FDA approval. The FDA approval will be for a certain indication and whatever that indication is, is what the drug company can market and promote the medicine to treat. You have heard me say this here, but again, this is FDA approved use or first line use.

(As an aside, drug companies do have to create a drug to treat a condition that no other drug treats, or treat a condition more effectively than an existing drug, or do the same as an existing drug, but with less side effects, etc)

Once a drug is approved for a condition, the drug company can do its promotion, its commercials and such, for that FDA approved purpose. IF it turns out that the drug also treats another condition or one of its side effects is something beneficial to people without the disease condition, a physician can CHOOSE to prescribe that drug for an off label use. Legally.

A company cannot blatantly market the drug nor offhandedly promote it for any other use. This includes spending money on doctors and nurses with gifts and meals, handing out samples and mentioning that Geodon(antipsychotic) might also work on children, or Bextra ( NSAID like Vioxx)is good for a sprained ankle, or Lyrica (for epilepsy) helps with pain. Pfizer has just pleaded guilty to illegally marketing Bextra for acute pain and for promoting at least Geodon and Lyrica for off label uses. They have to pay 2.3 billion in settlement costs.

I was witness to these events. Drug reps from Pfizer came to the hospital with gifts and suggestions, they hosted dinners for interns and certain Attendings appeared to be educating others on these off label uses. I know that we prescribed Lyrica to treat pain, which was legit, but I don’t know how we figured out to try it. I myself was given samples of Bextra to take for an acute running injury, which was an off label use.

Pfizer is being watched more closely as this is the third time it has had to settle in court for such behavior. It is on a 5 year special scrutiny list and a reporting system is being set up so that clinicians can report when they feel a Pfizer rep was inappropriate. There were 13 drugs involved in this particular case.