Page 73 - Bioterrorism

72

risks chilling the open exchange of views that is essential to the effective conduct of agency
business.” A more skeptical outsider like myself would interpret this to mean “that when people
are killed the FDA is above the law and doesn’t need to disclose relevant information.”

Dingell is not taking the matter lying down: “What is in those briefing books that he does not
want either my Republican colleagues or our side to see? Is there evidence of perjury? Are there
statements embarrassing to the administration?” He went on to say that “Neither Chairman Stupak
nor I will tolerate such a perversion of Congressional powers to investigate and probe.” His next
step to get the von Eschenbach records may be to hold Michael Leavitt, the HHS Secretary, in
contempt of Congress – setting up a major showdown with the Bush Administration.

FDA Whistleblower

Dr. David Ross served as the FDA’s primary safety reviewer on Ketek. He was concerned about
liver damage as early as 2000 and was stunned by the fact that the U.S. clinical trial contained
blatant fraud. Back in 2003 he wanted to give this information to the FDA advisory panel that
was deciding if Ketek was safe to use for the public. FDA management prevented him from doing
so and purposefully withheld information from the advisory panel about the ongoing criminal
investigation.

Ross buckled to FDA management pressure and omitted the safety risks and his concerns about
Ketek from his final report. This all happened prior to von Eschenbach coming to the FDA.
Under von Eschenbach’s tenure as temporary head of the FDA the Ketek problems began to hit
the fan. Congress started actively looking into the matter and von Eschenbach went into damage
control mode. He called a meeting of 40 FDA employees regarding Ketek issues and
mysteriously Ross was invited to this meeting (he no longer worked on the Ketek issue).

Ross has reported that during the meeting von Eschenbach likened the workings of the FDA to a
football locker room, where differing views can be vented but that once on the field the team
speaks with one voice and any FDA staff who speaks differently will be warned the first time,
benched the second time, and traded the third time.

In the face of such a blatant effort to suppress the truth of the situation Ross turned whistleblower.
He has told Congress that the FDA approved Ketek “despite knowing that it could kill people
from liver damage and that tens of millions of people would be exposed to it.”

Grassley Predicted the Unethical Behavior of von Eschenbach

Back in February of 2007 Senator Grassley informed the House committee of the extensive nature
of the FDA cover-up on Ketek as well as other issues, including FDA disregard for Congressional
investigation.

Von Eschenbach is a cancer-industry insider who took the job at the FDA so he could get quick
approval of new biotech drugs while using humans for cruel experiments in the name of
“progress.” His nomination as permanent head of the FDA took place during the 2006 lame duck
session of Congress and was rubber stamped by Big Pharma friendly Senators. Senator Grassley
knew better, as he stated on the floor of the Senate during the confirmation hearings:

“People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the
position he is currently occupying [acting head of the FDA].…That is an insult….In my
interactions with the Department of Health and Human Services and the FDA these last 8 months,
I have seen a complete and utter disrespect for congressional authority and hence the law.… This