The HIV sales force scandal just exploded in Pfizer's face.

Those of you following Question Authority know that I've spent a lot of time on Pfizer's maraviroc scandal and allegations about illegal premarketing and how the FDA suddenly delayed approval of this novel HIV drug for "unknown reasons . . . " in spite of recommendations by an advisory committee to approve the drug.

Ed Silverman over at Pharmalot just followed up with his own Pfizer HIV sales force whistleblower story, complete with e-mail and power point presentation, focusing on Viracept, which is the drug this HIV sales force is actually selling.

This well researched story is a must read and I'm simply reproducing Ed's outstanding work below. I can't wait for his next installment!

At Pfizer, Improper Marketing Is An Infectious Disease; Drugmaker Probes Another AIDS Med

June 26th, 2007 8:58 am By Ed Silverman

Over the past few weeks, Pfizer has had nothing but trouble with its new AIDS drug, maraviroc. The FDA unexpectedly delayed approval and the reasons aren’t clear. Meanwhile, the drugmaker quietly began investigating allegations that its sales team was instructed to promote maraviroc to physicians. This is a big no-no, because the drug still isn’t approved and this would violate a Corporate Integrity Agreement with the feds.

As it turns out, Pfizer is also investigating charges that the same HIV sales force was encouraged to improperly promote Viracept, an aging AIDS drug. Sales reps were given unapproved training and detailing materials (see below). The allegations, which also involve unapproved funding of CME programs, were made by a sales rep who now complains of retaliation. A Pfizer spokesman confirms the investigation is under way, adding that “we take any concerns about any appropriateness of activities involving the company very seriously.”

Why did this happen? A mix of panic and frustration. Pfizer got into the AIDS business in 2000 by acquiring Warner-Lambert, which itself had bought Agouron Pharma and its Viracept, or nelfinivir, a new AIDS med that generated about $420 million in sales in 1998. But Viracept was soon eclipsed by other drugs, such as Kaletra, Sustiva and Reyataz, and by last year, annual sales dwindled. Underscoring the point, Viracept is no longer listed separately in Pfizer financial reports. (Look here for the decline. On the far left, Viracept is the green line that begins at 20 percent and later plummets).

“We call it has-been-avir, not nelfinivir” says the sales rep. “They had to do something. And so we were given all sorts of materials to boost business. You know, a sales rep just doesn’t wake up one morning and say ‘I’ll use these unapproved studies or slides or whatever.’ It has to come from somewhere. And we were told that our performance was based on whether we were able to use that material in the field. But it violates Pfizer’s own policy. That’s why I reported these things.”

Here’s one example. This e-mail was written by a Pfizer professional science liasion, a position more commonly called medical science liasion at other big drugmakers. The note encourages HIV sales reps to show doctors a set of slides entitled ‘Treatment Considerations for HIV Today and Tomorrow.’ But the sales rep points out that the slides disclose a problem.

From: REDACTED

> > Sent: Thursday, November 09, 2006 11:09 AM
> > To: Wilson, Blythe Ashley; Weiss, Lawrence; Wynn, Jeffrey S;
> > Bilawsky, Leslie J; Miller, Vanessa Z; Raymond, James; Fazzina,
> > Douglas; DeRamus, Lisa A; Turner, Edward; Shimp, Christine Lynn
> > Cc: Zaleski, Carolyn
> > Subject: Slides - Today’s HIV Patient
> >
> > New York/New England Team,
> >
> > Attached are the slides that we discussed at the POA. This is an
> > excellent slide deck to present to your providers to provide value,
> > and sell Viracept. This is for your information, and to be shared
> > only with your providers. Please let me know if you have any
> > questions on utilizing these slides in your territory.
> >

POA is plan of action, a scheduled meeting for a sales force to discuss strategy. You can either flip through the slide set or go right to page 19, and there’s a chart that compares Viracept with other protease inhibitors and their affect on lipid levels. However, this is a prospective, observational study, not a head-to-head trial. In other words, it’s an inappropriate comparison.

This would appear to violate Pfizer’s own policy, which is described in The Field Guide, a manual given sales reps: “A comparative claim generally must be backed up by at least two adequate, well-controlled studies in which the drugs were compared head-to-head using comparable dosage regiments or a single, large, well-controlled study.” See pgs. 21 and 22.

The sales rep also alleges the slides and other materials were never approved by the Pfizer Review Committee, a mandatory step. This is the sort of activity that Pfizer is required to report to the HHS Office of Inspector General as part of its CIA, which Pfizer signed as a result of its settlement over improper marketing of Neurontin. “…Our obligations under these settlements include…disclosing activities by Pfizer colleagues that are non-compliant with the health care laws,” according to the drugmaker’s own rules on page 9 in The Field Guide.

The Viracept investigation is occuring at the same time as the maravoric investigation, since the same marketing and sales teams were involved and many of the same sales reps are being questioned. The probe is being handled by the same outside lawyer, Ropes & Gray’s Josh Levy, who spoke with the sales rep who provided this information. The maravoric investigation was first disclosed in April by Peter Rost, who has subsequently posted numerous updates on the way Pfizer has handled the problem.

The slide set was just one of many materials and documents the sales rep tells us were part of a so-called road map designed to make it possible for the HIV sales force to ultimately convince doctors to write Viracept scrips. Internally, this effort was known as ‘promotional mapping,’ which the sales rep says contained various clinical arguments that also came in the form of obscure studies.

“This was a way to put all of these unapproved materials into one place and then train us. But it didn’t just appear – the sales rep didn’t get together one Sunday afternoon by themselves and decide to use these materials. We weren’t renegade reps. We went to a POA and it was represented to us as a way to do business.”

Two notes to Pharmalot viewers:

1 – There will be a few additional installments in coming days.
2 – The sales rep was granted anonymity due to this person’s role as a whistleblower.