That’s the allegation in an item posted late last night by Question Authority, the blog run by former Pfizer exec-cum-whistleblower Peter Rost, who writes that an unnamed Pfizer sales rep told him she was forced to participate in efforts to promote a new AIDS drug to docs prior to FDA approval. And the HHS Office of Inspector General has supposedly been alerted.

The drug in question is maraviroc, which is the first in a new class of AIDS drugs. An FDA advisory committee earlier this month recommended the agency approve the med and Wall Street believes annual sales will reach a few hundred million dollars. Maraviroc also represents an opportunity for Pfizer to expand its reach in the AIDS market.

And this may explain the push, according to ‘Jane Roe,’ the nom de drug given the Pfizer rep by Rost, who writes that the alleged illegal marketing began in November 2006, when the drugmaker was attempting to establish so-called expanded access sites for a trial. The reps were used as liaisons to help medical affairs enroll new sites, and reps were allegedly asked to promote the trial, in which docs were paid $1200 per patient for one year, plus free quantities.

The sales rep provided a slide set, which allegedly was given in November 2006 to sales reps, who were then asked to give the slides to key docs. The slides were allegedly used to “goose the skids” as well as in discussions that included data beyond what was published. Roe claims she was asked to slip the slide presentation on a memory stick to trusted docs.

The allegations also suggest the effort was directed by senior sales managers and medical affairs, in particular an unnamed medical director, who supposedly attended meetings with both reps and docs. The slides may also have been written, in part, by a hired medical writer, something that smacks of marketing, writes Rost.

Supposedly, Roe complained internally and the involvement of the sales force ended abruptly in January. Around the same time, sales reps were asked to delete all maraviroc materials. By then, however, it appears the HHS OIG was contacted. Pfizer, by the way, already has a Corporate Integrity Agreement with that office.

The allegations remain to be proven. The sales rep, after all, remains anonymous and other than the slides, there isn’t much evidence to review. On the other hand, why does a sales rep have this material prior to product approval? Rost, by the way, appears confident that Roe is, indeed, a real Pfizer rep.

The larger issue, of course, is the ongoing angst over marketing efforts and the lines that some may cross. The past month has seen a scandal unfold at AstraZeneca over off-label marketing allegations and the subsequent buzz is serving as a reminder that inappropriate marketing may become a liability rather than a cost of doing business. Will these latest accusations, if true, take on similar proportions? That remains to be seen.

This is what Jane Roe says: “The research shows half of all people or thereabouts cannot safely take this product. It has become a very difficult issue which is why in my opinion they enlisted the sales force to get buy-in prior to approval. It has become clear that Pfizer’s commitment to HIV may depend on the approval and success of this product. Maraviroc provides a needed benefit to HIV patients and even though it may never be a Pfizer blockbuster it fills a gap since the current Pfizer HIV product Viracept is almost 9 years old and not considered first line very often. It seems this was a desperate attempt to impact futures sales; I guess some call this premarketing I call it bullshit and against the law.”

Read more at Peter Rost’s Question Authority.[tags]Maraviroc, Off-Label Marketing, Pfizer[/tags]