As noted in the story…
The…oversight subcommittee is investigating whether FDA Commissioner Andrew von Eschenbach gave misleading testimony on Sanofi-Aventis SA's antibiotic Ketek during a committee hearing in March. Ketek has been linked to fatal side effects. In a Feb. 11 letter to the House panel, Leavitt didn't comply with a subpoena requesting briefing papers used to prepare von Eschenbach for his testimony.And the reason why Leavitt didn’t provide the briefing papers used by von Eschenbach? He was worried about a “chilling effect.”
``We're going to respond and have discussions over the next few days,'' Leavitt said in an interview during a break in the hearing today. ``I feel optimistic.''
Lawmakers of both parties warned in their letter, dated yesterday, that they would back a contempt citation against Leavitt unless he produced the briefing papers or allowed the lawmakers to see the documents and interview FDA staff.
I can actually understand that. I can see that there would be a “chilling effect” on one’s prospects for future employment and career success in the event of a conviction for obstruction of justice (though I believe this is another matter that could fall into the lap of AG Michael Mukasey, and considering the low view of this administration towards those who don’t give them what they want and their likely demand of Mukasey not to prosecute, I think we know what would happen next, or not happen, more precisely).
The reason the subcommittee wants to investigate von Eschenbach is because Ketek was linked to death and liver failure in 2006, and oversight committee chairman Bart Stupak wants to find out if von Eschenbach was lying when he said he did not use a flawed safety study to approve the drug (Stupak, as noted here, has also said that von Eschenbach should step down because of “a total lack of leadership”).
And as noted here (the more you dig here, the worse it gets)…
Fred Eshelman, chief executive officer of PPD (the firm that monitored the study of Ketek by Sanofi-Aventis), did take some revealing questions concerning how PPD selects investigators and whether it relies on FDA’s debarment list during that process. Committee members were incensed with the FDA that (Anne) Kirkman-Campbell (a former clinical investigator) was not on the list and prevented from doing clinical research even though she was convicted of fraud. Eshelmann said the company does check the FDA list.Oh, and as noted here, von Eschenbach requested a report on his own agency (maybe to find out how to do his job?) and the report found that the FDA was overwhelmed. The culprit?
The report blamed Congress for requiring the FDA to take on more responsibilities without providing enough funds to hire staff.Well, if you want to spread the blame around, go ahead. But this prior post tells us that von Eschenbach has done nothing but propose spending cuts for the FDA, apparently resulting in contracting PPD to conduct the monitoring of the drug instead of his own agency (since, as we all know in Bushco’s demented universe, the private sector always works more efficiently than that dreaded “big government”).
Stupak is right – von Eschenbach should be gone as a result of this, followed closely by Leavitt if he doesn’t come clean also.
O, to be governed by adults again…