So many allegations, so little time. As Pfizer investigates charges made by sales reps that its HIV sales team was encouraged to improperly promote two drugs - maraviroc, which isn’t yet approved by the FDA - and the aging Viracept pill, there are numerous examples to share. This latest batch of slide printouts were allegedly given to sales reps to show to docs and nurse practitioners, according to a sales rep who has complained to the drugmaker and was questioned as part of the internal probe.

The issue with these materials? The sales rep alleges the slides were never approved by Pfizer’s own Review Committee and they violate company policy due to the content. Specifically, the rep says the slides must must have ‘fair balance’ and also be able to back up scientific claims, such as with head-to-head comparisons. You can read more about those rules, which begin on page C1 of Pfizer’s Health Compliance Manual. Before we get to the slides, this is what the sales rep has to say:

“Viracept is an HIV drug and you can’t use it for anything else. There’s no other disease to talk about, so you can’t promote it for anything else. You want to make claims of superiority, but if you lose the potency argument, which we did with Viracept, then you make claims of safety. And these handouts were used to show other HIV drugs were unsafe, which is another way of saying, by default, that Viracept must be safer. But there were problems with them. None of this data is accurate as far as a promotion of Viracept is concerned. It only says Kaletra is bad, Reyataz is bad, so Viracept must be safer. But there’s no proof offered.”

This first slide discusses the influence of HIV drugs on on lipid levels in hepatitis C patients, and raises issues with Abbott’s Kaletra, a widely used AIDS med. But the sales rep alleges that “there is no balance. There is no mention of what risks Viracept may have. It has no package labeling. It is clearly designed to make a false safety claim by saying Kaletra is unsafe with patients who have hepatitis C. It makes mention of a study that is not comparative with other studies, or Viracept compared to Kaletra.”

The second slide discusses outcomes of various HIV meds in an outpatient study that began in 1993, although there are limitations - it’s a retrospective analysis and only a minority of patients had viral load data to review. Meanwhile, the slide claims the data “shows the importance of starting patients early on (HIV) therapy. Viracept has been shown to be extremely safe and effective. It is ideal for first-line therapy because it can preserve other PI options and help providers effectively strategize their patients long-term regimens.”

However, the sales rep charges that “there’s really no data, because this study is very outdated. The viral load test wasn’t even being done then. It’s comparing apples to oranges as far as patients are concerned. And where was Viracept shown to be extremely safe? Where does it say Viracept preserves future options? There is no proof.”

And finally, there’s a third slide set, which is really all about atazanavir, a Bristol-Myers Squibb HIV med that’s better known as Reyataz. This is a curious handout. For one thing, there’s a Pfizer logo, even though this discusses another company’s drug. The slides highlight issues with Reyataz, such as increases in cholesterol and triglycerides, and liver abnormalities. There’s also a claim that beginning therapy with Viracept is a safer choice.

One slide indicates a limitation: Viral load stratification data was not shown. “This is kind of important to know before you make a comparison of your drug against another. This uses incomplete data, and says Bristol was faulty. In other words, we’re criticizing their data and putting our logo on their slides. Since this is a Bristol study, it’s inapropriate to use. It’s not allowed. It has no packaging information and we make an assertion that Viracept is safer. Why? Because (Reyataz) had some patients with jaundice. Where is the head to head? Where is the fair balance?

“This is bad science, where you make your drug the safer one by tearing apart the competition. If you look at all three slide sets, the HIV division is making claims of superior safety based on no proof….They make assertions based on incomplete information and by default, we become safer…And if we didn’t use it, we were roundly criticized. But as I told the lawyers, somebody has to tell us to do this. We didn’t dream this up on our own.”

This is third installment in a series we have run this week concerning the Viracept allegations. You can read the first one here, and the second one here.