There’s another wrinkle in the Ketek story. The Wall Street Journal reports on the Congressional testimony of Ann Marie Cisneros. She’s a former employee of Pharmaceutical Product Development (PPD), a leading contract research organization with $1.26 billion in revenues in 2006.

The back story is that Sanofi-Aventis was using PPD in trials of Ketek. Cisneros says both PPD and Aventis knew of fraud at one clinical site.

Without minimizing the seriousness of fraud, that misconduct seems to have been identified and dealt with. (Bloomberg reports the physician in question enrolled his entire office staff in the study.) At least as far as what the WSJ reported, such misconduct is unrelated to the larger questions swirling around the approval of Ketek, an antibiotic used in respiratory infections, or the degree to which the FDA is or is not asleep on the issue of drug safety.

Missing Logic

The WSJ doesn’t quote Cisneros. Nor does it make an explicit connection between the antibiotic’s recent labeling change and the troubled clinical site. The WSJ does allow the members of Congress to repeat their usual criticisms of the industry and the FDA. Example: “Committee Chairman John Dingell, a Democrat from Michigan, called the FDA ‘badly broken.‘“ Transcripts of the testimony provided at the hearing are not yet posted on the relevant Congressional web site.

At the hearing in Washington, there was no one from Sanofi or PPD. Once again, the critic gets a lot of attention, the attacked party is on the defensive. This story reinforces the degree to which minor, routine lapses can be amplified by politicians craving the spotlight. The story also highlights the degree to which disgruntled employees from any quarter of the industry—not just at FDA, but in the sponsor and CRO communities—may be able to settle old grievances using tactics unfamiliar to the life sciences. It’s a brand new world.

Abuse Continues

As frustrating as this situation is, the industry and FDA response both seem timid, hesitant and weak. Inexplicably so.

It’s late in the game. But not too late. The failure of FDA and industry to explain how clinical trials actually work will cost the industry dearly. In the long run, it appears that the industry will let itself be defined by its enemies. This is a perilous situation.

Inexplicably Intimidated

In pharmaceutical research, dependent upon the good will of patients and physicians, it is potentially life-threatening for the industry to let itself be caricatured, and to allow thousands of well-managed trials to become lost in the shuffle of a bleating Congressman’s megaphone. We’re stumped. Why would the industry take this lying down? Why would otherwise sophisticated individuals hold fast to the antiquated notion that misconceptions about the industry can be cleared up in some private, sensible forum later? That did work in the 1970s and 1980s. It ain’t working now.

Mark Senak’s “Eye On FDA” blog has some bracing thoughts on this today. Anyone thinking about the rehabilitation of the image of pharma should check out his site.