Pharma’s Cutting Edge

I’d like to make my opinion known to those of you who will read the attached article about Dr. Pearlman’s head lice cure and think: “Gee…it doesn’t seem so ethically troubling to me.” It does to me. No, not troubling, disgraceful. I read the 2004 Pediatrics article in which Dr. Pearlman described his clinical trial results. He provides the ingredient list of “Nuvo” (aka Cetaphil Cleanser) but never mentions that the compound is already available over the counter nor the trade name of the formulation. And he had the gall to charge clinical-trial subjects to participate in the testing of his regimen. I don’t care what his motivations were, this is not the way to conduct clinical trials. It is against all tenets of proper clinical research to fool trial participants, journal editors and the general public in this way.

And while I’m on my soapbox, perhaps I’ll reach the ears of other wily entrepreneurial clinical researchers with this admonition: Don’t think for a second that you personally know how to secure patent rights for, test or market your own proprietary new molecular entity, formulation or therapeutic method of use. In all likelihood, you don’t, just as Dr. Pearlman did not. I don’t care how many trials you have participated in as an investigator, how many CME talks you’ve given or how much of your annual compensation derives from the industry. Unless you have broad inner-industry experience yourself or you have secured the services of someone who has to guide you through process, you will almost certainly not succeed.

Anyone in need of a contentious pharma exec? There’s one looking for a job. I’ve written about Rost at least twice in these pages, as I recall, both times denouncing his self-aggrandizing, ill-conceived posturing against his employer, Pfizer. I called for Pfizer to fire him long ago and have never understood why they didn’t–until now. Now, it has been revealed that Rost was trying to get the U.S. feds to back him in a whistle-blower lawsuit over his former employer’s (Pharmacia) handling of Genotropin marketing in Europe. That is why Pfizer couldn’t can his ass; he was protected by U.S. federal law and could have sued Pfizer for wrongful termination had they fired him. Now that the feds have decided not to back Rost in a whistle-blower suit, Pfizer was free to fire him, which is precisely what they did. It’s a shame Pfizer deemed it necessary to offer the overpaid exec the post-merger Pharmacia golden umbrella severance package, but I’m sure they consider it a small price to pay to have Rost off their payroll. My career advice to Dr. Rost…give Public Citizen a call. You and Dr. Wolfe seem to have much in common.

FDA issued a presolicitation for pharma sales and promotion data that is kind of interesting (link expired). Wonder if it’s being requested by the new Office of Drug Safety in collaboration with DDMAC. Anyway, make of it what you will for now. Not sure myself.