A series of posts in both Pharmalot and from former Pfizer top executive-turned-whistleblower Peter Rost illustrate another CME scandal in the making. But it's so complicated, even I, one of the more CME-obsessed bloggers on the web, can barely sort it all out.
The major culprit is Pfizer's HIV/AIDS marketing division, which has been desperately trying to market an aging protease inhibitor called Viracept, which has steadily lost market share over the years to competing drugs. The marketing division at Pfizer came up with a "POA", or plan of action, relying heavily on using various forms of company sponsored education to convince prescribers that Viracept, while no more effective than its competitors, is at least safer. In the old days, before company-sponsored CME became the preferred marketing tool for changing physician behavior, Pfizer's pathway to corruption would have been straightforward. Simply create a series of promotional slides that present studies with suspect data and methodology, and make exhuberant pro-Viracept claims. This runs afoul of FDA regulations, which stipulate that any advertising content has to be accurate. Well, Pfizer apparently did make these false claims, and an internal whistle-blower is now telling all.
What's so complicated about this? It's just false advertising, a shady marketing practice which occurs occasionally in all industries. So far, Pfizer's response has been appropriate: They've fired three top sales directors in the HIV/AIDS sales division, and they will be investigating what went wrong.
But another layer of corruption involves a second type of industry education: accredited CME courses. As documented in this Pharmalot posting, and as I've written about in an earlier posting here, the Pfizer sales force had frequently hired the Connecticut cardiologist Dr. Sandip Mukherjee to talk up Viracept in promotional programs. According to an anonymous Pfizer regional manager, Dr. Mukherjee's talks "provides a very positive supportive message on the use of Viracept as part of a viable and safe component of HAART therapy." Basically, Dr. Mukherjee could be counted on to say that Viracept had a relatively benign lipid side effect profile. Fine. There's nothing illegal about hiring a speaker to do advertising for you.
But they screwed up, because the regulations propping up industry-CME activities are so complicated, and change so frequently, that various Pfizer employees just couldn't keep track of all the paper work, and tripped on it.
The first screw up involved confusion about whether Boston Medical Center could use Dr. Mukherjee for a CME certified program. A trail of redacted e-mails shows complete confusion and disarray in the Pfizer camp, which led to an odd scenario in which Mukherjee apparently gave a pro-Viracept lecture at BMC, which was advertised as a CME activity, but which was actually a standard promotional talk.
The second screw-up has something to do with how Dr. Mukherjee was paid. Pfizer, responding to criticism that high payments to hired-gun physicians may tempt them to bias their presentations, recently capped such payments at a maximum of $50,000 per year. The problem is that some physicians are so good at increasing prescriptions of Pfizer products that drug reps all over the country want to use them, and their "cap" gets reached too quickly. This is exactly what happened with Dr. Mukherjee, whose cap was reached in October, meaning that he could not be hired again until January of the next year. But Peter Rost posted internal emails showing that Mukherjee's cap was mysteriously "lifted," allowing him to give extra talks: "They have just adjusted Dr. MacArthur's cap so I am holding great hope that Dr. Mukherjee will be next. Please hold on through the week and hopefully we will have good news soon." The next email presents that news: "Good news, Dr. Mukherjee's cap should be lifted next week, so [name redacted] keep the Nov. 15 talks scheduled with him. We may need to reach out to Tom to see if he can cover the honoraria for one of the talks. I will letyo u know when it is official."
We don't know who "Tom" is or which bucket of money he is in charge of, but this smoking gun does not reflect well on the integrity of Pfizer's honorarium policy.
The bottom line: When your marketing plan is always teetering on the edge of corruption, you're gonna get burned. It's only a matter of time.