Pharma and the Gumshoes, Revisited

This post might best fit in the You Can't Make This Sort of Stuff Up category, but I'll try at the end to draw a meaningful lesson from it.

Eamon Javers at Politico recently revealed:
http://www.politico.com/news/stories/0310/35212.html
--that Amphastar Pharmaceuticals, Inc. paid more than $100,000 to a private investigation agency, Kroll, to snoop on Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research, and on Moheb Nasr, director of the FDA's Office of New Drug Quality Assessment. Turns out that Amphastar was suspicious because the FDA seemed to be dragging its feet in approving its generic-drug application for a low-molecular-weight heparin (anti-clotting drug). The company decided that maybe the FDA was favoring its rival company, Momenta Pharmaceuticals, and so set out to see whether Woodcock and Nasr had any ties to Momenta. They were especially suspicious because Woodcock and one of the co-founders of Momenta had appeared together on a program in Thailand in 2007.

In the end nothing suggestive of inappropriate ties or influence surfaced. One has to wonder about just what Amphastar got for its $100K. According to Javers's article, among the facts Kroll unearthed about Woodcock were her birthdate, the state in which her Social Security number had been issued, who her husband was, and the value of their home. Brilliant detective work, that.

Amphastar's general counsel protested "there was no impropriety" in its hiring Kroll and going after Woodcock and Nasr in this way. Sen. Max Baucus denounced the matter as "an outrage" and added, “Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science rather than wasting their resources hiring private investigators to snoop around the lives of FDA regulators and their families.”

Much as I approve of Sen. Baucus's additional sentiments, I find his denunciation of Amphastar somewhat naive. After all, drug companies have observed how easy it is to wave around a wad of cash, and have academic physicians swarming around like flies on garbage, eager to grab their share in exchange for doing whatever the company wants. The companies figure that if it works for them, their competitors must be doing it too. From those observations it's a short jump to conclude that if people as high up on and social-respect ladder as academic physicians act like that, then FDA officials must, too. So this is simply a matter of rational calculation on Amphastar's part--except, perhaps, for the detective firm they hired. (Just kidding, Kroll folks; please don't start going through my trash.)

PS: If anyone wonders what the history is of drug firms hiring private eyes, read HOOKED on the Betty Dong case in which the pharmaceutical company used private investigators to try to discredit an academic investigator who got results the company didn't like. Or for a more colorful read, go to John Le Carre's novel, The Constant Gardener.