Thursday, May 31, 2007

Pfizer caught in maraviroc whistleblower's web.

Jane Roe, the maraviroc whistleblower just sent another slide set to me.

She says that, "These slides are or were being used by this physician as a paid speaker for Pfizer HIV. Remember we were not supposed to do any promotion of miraviroc prior to approval. Sales rep in NY were paying him to speak off label to promote an unapproved product... unapproved according to the Pfizer/FDA guidelines, wrong, wrong, wrong...."

Download presentation here.

Here's the tricky part:

Of course a doctor can discuss an unapproved drug with other doctors. Otherwise there wouldn't be any clinical trials. But a doctor paid by a drug company cannot promote or premarket an unapproved drug.

So was this promotion?

One test is if the speaking engagements were arranged by the medical department as part of clinical trial work. Then things would appear OK. But if the speaking engagements were arranged by the sales force, it looks like selling. After all, the job of the sales force is not to do clinical trials, but to sell.

Another indication that this is a paid-for, marketing presentation are the speakers notes, clearly written to guide the presenter(s) on what to say. And, of course, the third party which developed the presentation is one of those "medical eduction firms," check under "properties" in the slide presentation and you'll find out more.

So if what Jane says is true, and we certainly have seen many memos corroborating other parts of her story (here), then this presentation may be troublesome.


Anonymous said...

Well, having reviewed the slide deck, if this is supposed to be promotion, it's pretty weak tea. Seems like a garden variety, new-treatment-options-in-development presentation with no particular hype for maraviroc built in.

Anonymous said...

the issue is..the slides are not approved for the use for Viracept promotion so weak tea or not it is sales reps we promote an approved product with approved slides that's it no exceptions. We are only allowed as sales reps to pay for approved promotion of approved products...wake up will ya