Pfizer has been developing a potential blockbuster of an HIV treatment: Miraviroc, the first three syllables of whose name suggest (Mirabile) nothing short of miraculous. Resistance to HIV treatments is becoming a serious problem and news of the drug was extremely welcome to HIV patients, their families and the rest of the world. Back in March, the buzz from Los Angeles at the 14th Conference on Retroviruses and Opportunistic Infections was all good. (Click here to read an old post on that subject, with video on resistant viral strains---oops link to Pfizer clinical results news in that post is already dead...click here for another)
If the science behind the drug is sound, there may be serious problems on the marketing compliance side, more evidence of the blockbuster model gone wrong and the pressure that this model puts on all segments of the drug industry. If we are to believe an insider who sent evidence to Web 2.0 uber blogger/journalist Peter Rost, the company had sales people indirectly "promote" the drug, which hasn't yet been approved, to physicians, starting last November. As Rost has reported, someone from the HHS's OIG has expressed an interest in speaking with the insider and in investigating these allegations.
Just about everyone has blogged or written about this. If you missed the story, as I did during a self-imposed'blogging rehab', go straight to the source. Here is the initial post, but read successive posts for more on the story, including an email from an investor who noted the fact that Rost had an axe to grind with Pfizer and accused him of using National Inquirer tactics.
AstraZeneca's top management responded almost immediately to "Zube-Gate" and the "buckets of money" scandal. Even the company's CEO issued public statements that were reported in numerous newspapers. And now, according to Pharmalot, Democratic Representative Pete Stark has called for an investigation into unsound marketing practices. His letter to the HHS OIG used the telling phrase "tip of the iceburg" to describe the AstraZeneca story in relation to industry practice.
Will Pfizer's management overlook the messenger and who has publicized this "insider's" message, and respond to the message and avert a P.R. disaster? Even a "we're looking into this seriously" would at least be something.
One can't help but feel sympathy for the insider, who, Rost reports, wrote recently,
"Once I told them, they iced me out and have made my life pretty stressful. I am looking at it now and thinking its kind of comical in weird way. I just wanted to do my job and be treated fairly and trust me if you ever complain that will not happen. I hope you're listening Mr H., you told me no one would leak, no one would retaliate if I came forward and told HR the truth. I trusted these people now they won't even talk to me. That's it in a nutshell I apologize if anyone gets hurt by this but I didn't do anything wrong. I only reported it."
On the cGMP and manufacturing side, we don't have too many examples of pharma whistleblowers except Mark Livingston, who lost his case against Wyeth over Prevnar manufacturing practices last year. He's likely carrying on with his own consulting practice, but the experience must have been alienating and difficult.
But insiders can take courage from Rost, who shows that one can reinvent oneself and, in the process, find roads not taken.
Perhaps in a few years---or more likely, decades---companies will investigate insiders' charge of illegalities in the spirit of "continuous improvement", without exacting revenge, alienating or firing employees. Top FDA officials already say they're moving in that direction. But there's clearly a very long way to go.
