Page 72 - Bioterrorism

71

not involved. Will the Bush administration offer protection for a situation that involves needless
deaths to Americans? The Chinese sentenced to death the head of their FDA for far lesser
misdoings.

The issue revolves around the fraud-riddled antibiotic Ketek which is made by Aventis, now
Paris-based Sanofi-Aventis. Sen. Charles Grassley, R-IA, has been holding the FDA’s feet to the
coals on the Ketek issue for the past several years ever since an 18 year old boy from Iowa was
killed by the antibiotic when being treated for a routine infection. There are other deaths and
many cases of liver failure. The House Oversight and Investigations Subcommittee has been
looking into the matter since early last year, shortly after von Eschenbach’s permanent
appointment to head the FDA.

The available evidence paints a picture of the FDA turning this deadly drug loose on children even
though it knew of safety problems, a trail of evidence von Eschenbach has actively covered up. In
the face of Congressional scrutiny the FDA has since scaled back it’s approved use of Ketek, but
has left it on the market to treat pneumonia. The FDA blames Aventis for the problems, who is
also in hot water with Congress. The FDA is refusing to hand over records showing what it knew
and when. Insider information indicates significant FDA wrongdoing.

We already know that a clinical trial involving the drug was forged by a weight loss clinic in
Gadsden, Alabama. The physician in charge, Dr. Maria Anne Kirkman-Campbell, is now serving
five years in prison. Congress has been trying to get to the bottom of the matter, seeking to
establish what Sanofi-Aventis and the FDA knew. Congress has hit a stone wall. It appears they
both knew plenty – and covered their tracks.

The House Subpoenas FDA Records

Congress finally had enough. On January 25, 2008 John Dingell and Bart Stupak of the House
Oversight and Investigations Subcommittee sent a memorandum stating they intended to
subpoena FDA investigators, a private contractor, and various FDA records, which they followed
through on several days later.

On February 12, 2008 the House committee held hearings on the matter. Douglas Loveland, a
special agent at the FDA’s criminal-investigation office, told the committee that Aventis should
have known there was fraud and there was a “catastrophic failure” of their clinical trial systems.
They ignored “red flags” about the bogus data, “they were loud signals…they were bright
signals.”

The FDA even admits that it knew there were “serious protocol violations and regulatory
noncompliance by multiple clinical investigators” and that it had no knowledge these problems
were ever fixed before approving the drug. However, the FDA is not forthcoming about
information that may indicate a von Eschenbach cover-up.

Last March von Eschenbach provided written testimony to the committee on events surrounding
the Ketek drug approval. The committee subsequently learned from an FDA insider and those
familiar with the approval that the testimony was not truthful. The committee had recently
subpoenaed the FDA records regarding the preparation of this testimony to learn why it was lied
to.

On February 12, 2008 the committee was told by the parent of the FDA, the Health and Human
Services Department, that these documents would not be provided because “The department has
serious concerns about providing the kind of materials the committee has subpoenaed…such
highly confidential and deliberative materials used to prepare witnesses testifying before Congress