Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval.

The biggest Big Pharma success story last week was described in the headline “FDA panel backs Pfizer HIV drug.”

The drug is maraviroc, and it will be the first CCR5 receptor antagonist on the market. This group of drugs blocks a secondary but crucial doorway typically used by the human immunodeficiency virus to enter white blood cells. Barbara Ryan, analyst for Deutsche Bank North America, projects that annual sales will peak at $500 million by 2011.

But now there’s a fly in Pfizer’s ointment; an internal whistleblower, whom we’ll call Jane Roe. She claims that Pfizer used the HIV sales force to illegally promote the drug to doctors before approval.

Roe says that the illegal conduct started already in November 2006, when Pfizer was trying to set up “expanded access sites” throughout the country for a maraviroc experience trial. The sales reps were used as liaisons to help medical affairs enroll new research sites and the sales reps were allegedly asked to promote the “trial,” in which doctors were paid $1200 per patient for one year, along with free drug.

Evidence of this, Roe says, is an “unapproved slide set” for maraviroc, which was given to some HIV sales reps in November 2006. The reps were then asked to give these slides to key doctors (download the-smoking-gun presentation here) The slides were allegedly used to “goose the skids” as well as in verbal discussions which included data outside what was published. Roe claims she was asked to slip the slide presentation on a memory stick to physicians whom the company trusted.

Roe points out that the actual paying of a fee to institutions is not generally wrong but using sales reps to promote a drug before approval violates FDA rules. Normally drug companies avoid using the sales force in any prelaunch activity, because it looks by definition like, well, selling . . . . and they need FDA approval to do that.

Roe says that some reps expressed concern to her, but were unwilling to rock the boat and went along with this unusual task. She says many physicians were also concerned that she and her colleagues were putting themselves in a difficult situation by participating in this program and some were upset.

Roe goes on to say that, "a researcher told the medical director she wasn't interested and said very loudly she did not know we were coming in to strong-arm her. It was during a lunch meeting at her office and very uncomfortable. I think as a result of these actions at the very least people thought we were inept running around with sales reps and a medical director who had never worked in a clinic or had no HIV experience. "

Roe claims this effort was directed by senior sales management and medical affairs, and she has shown me an e-mail from a Pfizer medical director for the HIV team, with an MS, PhD degree after the name, which supports the allegation that there was an ongoing coordination between medical affairs and the sales force to enroll physicians in the trial. Roe also says she was part of several meetings the medical director had with doctors.

In fact, Roe and some others in the sales force were so disturbed by this program that they not only objected to the company, but also recently reported this to the HHS Office of the Inspector General. (Pfizer has been forced to sign a Corporate Integrity Agreement, and any violation of this agreement is handled by the OIG.)

The sales force promotion of the “trial” went on until January 2007, when the sales force involvement was abruptly stopped. Also noteworthy, is that Roe says the sales reps were recently asked to delete all materials related to maraviroc.

A closer scrutiny of the slide presentation reveals that the author name electronically embedded in the presentation is not the doctor on the first slide, but “Peter Pinkowish.”

His name can be found on another HIV related slide presentation, for Bristol-Myers Squibb (available for download here), in which his title is “Medical Editor.” So here we have the first clue that this was a slide show written by someone who appears to be a hired gun. That smells marketing. In yet another medical paper, related to hormone therapy Pinkowish's title is “Medical Writer,” and it wouldn’t be far-fetched to assume that this is a person working for a medical education agency, churning out advertising disguised as semi-scientific papers and presentations for drug companies.

So why would Pfizer risk its reputation, using the sales force to premarket doctors?

Roe responds, "It is my understanding the enrollment has hit several obstacles because as I mentioned the complexity of miraviroc as well as the test that need to accompany it. 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."