Panel May Issue Subpoenas Related to FDA Approval
on Antibiotic Drug Ketek
By Anna Edney CongressDaily
From CongressDaily
By Anna Edney
January 28, 2008
The House Energy and Commerce Oversight and Investigations Subcommittee will
vote Tuesday on subpoenaing Food and Drug Administration criminal
investigators and documents related to a potentially deadly drug the FDA
approved despite receiving fabricated data, according to a subcommittee memo
obtained by CongressDaily.
The subpoenas may be part of the panel's investigation into whether
pharmaceutical company Sanofi-aventis knew of critical integrity problems in
clinical trial data it submitted to FDA on the antibiotic Ketek.
Sanofi-aventis's lead researcher on the largest Ketek clinical trial, Anne
Kirkman-Campbell, pleaded guilty to mail fraud in 2004 in connection with
accusations she enrolled weight-loss patients and others in the trial who
did not suffer from the respiratory illnesses Ketek treats.
The panel might subpoena FDA investigators Robert West and Douglas Loveland
and former investigator Robert Ekey as well as Ann Marie Cisneros, who was a
contractor who oversaw the Kirkman-Campbell study and said she reported
problems to Sanofi-aventis to no avail, according to the subcommittee memo
sent Friday. The subcommittee also is after a document that is expected to
reveal investigators recommended that Sanofi-aventis deserved prosecution,
not just Kirkman-Campbell, for knowingly submitting false trial data. FDA
handed over the note to the subcommittee but redacted the entire document.
Senate Finance ranking member Charles Grassley, R-Iowa, who first looked
into Ketek as chairman of the committee, and Energy and Commerce Committee
leaders have questioned whether FDA conspired to approve Ketek despite
knowing about the false trial results. FDA has maintained it largely
excluded Kirkman-Campbell's study data and relied mostly on European data.
The subcommittee also wants FDA Commissioner Andrew von Eschenbach's
briefing book from a March 22 subcommittee hearing where he was accused of
making false statements regarding Ketek's approval. Lawmakers want to know
whether the commissioner was deliberately misled in preparation for the
hearing. They have tried requesting the briefing documents, but HHS has
denied the request. FDA approved Ketek in 2004 and just a year ago pulled
approval of the drug for two of the more minor illnesses it treated, chronic
bronchitis and acute bacterial sinusitis.
FDA agreed with its expert advisory panel that determined in December 2006
that Ketek had not proved beneficial to treat the respiratory illnesses in
light of its risk. Ketek remains approved to treat pneumonia. In addition to
the Ketek subpoenas, the subcommittee also will vote whether to subpoena
documents related to its investigations into generous bonuses FDA
distributed, particularly $5,000 bonuses given to its civilian physician
employees.
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