The way I learned that motto (back in the late 80’s early 90’s PhRMA days): “(Sometimes) It is better to ask forgivness than permission.”

Obviously the “sometimes” was considered optional, but there is a more than semantic difference between the two versions (Better vs. Easier).

Atlex, if you are lucky enough to work for one of the few PhRMA companies that has not engaged in some outrageously unethical if not frankly illegal promotional scheme, then more power to you. However, if you work with the marketing team, then you know that the PR process as Hack described is not only plausible, but also probable.

I could never prove it, but I believed with all my heart that Pfizer’s brand teams must have included at least one lawyer each. The purpose of the lawyer was to rapidly bring suit against any competitor for any possible complaint which might distract the competitor from actually getting out and selling against them. It never seemed to matter if the complaint was valid, just so long as it involved Federal Court.

In my current job, I see a lot of stuff that wouldn’t pass the smell test. How about drug reps calling to obtain prior authorizations for medications with patient information? How about a rep telling a patient and their physician in the doctor’s office how to defraud their own company’s “free trial” program? How about companies targeting physicians who treat only children for detailing on a drug which has no studies or approval for children? How about comparative effectiveness and safety claims when the only published information is placebo comparisons? How about corportate-sponsored “patient protection” state level legislation written explicitly to dimish the ability of public and private payors to implement utilization controls which would actually help to ensure safe and effective use consistent with labeling?

Ethical lapses in pursuit of using meds for “unapproved uses” are not only an industry problem either. HCat would appreciate that there are significant numbers of doctor’s office personnel who will flat out lie to get a PA. This has a name - insurance fraud, and where I am, it is a class D felony.

My preference for PAs involves no forms, but rather, a real time review of medication claims/use history with or without a diagnosis and procedure history. Makes it very hard to lie, and can provide useful information on other medication use and adherence to the clinician. By the way, Hcat, the PA reviewers I work with are all PharmDs - typically more qualified and knowledgeable about the meds than the people making the requests.

“These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan. At the same time, Warner-Lambert decided not to seek FDA approval for any of the new uses because it was concerned that approval for any of the non-epilepsy uses would allow generic competitors of Neurontin, which was expected to go off-patent soon, to compete with a “son of Neurontin” drug that Warner-Lambert hoped to have approved by the FDA for both epilepsy and non-epilepsy uses.”

“Son of Neurontin” = Lyrica.

Why doesn’t this happen? Every day I think of Syd Taurel in chains.

I do appreciate you taking the time, HC.

I have no idea if fibro was one of the indications then anticipated for Lyrica and “by-passed” for Neurontin.

I know all this because I keep in touch with my old partners at Pfe, having a particular interest in fibro, because one of my friends had fibro way back in the 1980’s,when no one was admitting it existed.