Today's Article
A House panel is
questioning 'the
agency’s ability and
willingness to protect
Americans from
excessive risk from
prescription drugs,' a
press release stated.
questioning 'the
agency’s ability and
willingness to protect
Americans from
excessive risk from
prescription drugs,' a
press release stated.
The American Spark
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Did The FDA Knowingly Approve A Dangerous Drug?
By Cliff Montgomery - Feb. 3rd, 2008
A House panel on Tuesday approved subpoenas for the testimony of Food and Drug Administration (FDA)
criminal investigators involved in the agency's decision to clear for sale a dangerous drug, despite receiving
false clinical data on the product.
The Energy and Commerce Oversight and Investigations Subcommittee unanimously approved subpoenas
"for the testimony of two current and one former criminal investigator of the Food and Drug Administration
(FDA)," as well as one for "documents related to the briefing book and other materials used to prepare FDA
Commissioner Andrew von Eschenbach for his testimony before the Subcommittee on March 22, 2007,"
according to a Tuesday House press release.
"The drug involved is Ketek, an antibiotic produced by Sanofi-Aventis (formerly Aventis)," the press release
continued.
The lead researcher for Sanofi-Aventis' largest clinical trial of the drug was Anne Kirkman-Campbell. In 2004,
Kirkman-Campbell pled guilty to mail fraud in connection with charges that she enrolled numerous individuals
into the trial who did not have the respiratory illnesses that Ketek treats.
The FDA cleared the drug for release in 2004, but apparently pulled its approval of Ketek for use against two
illnesses--chronic bronchitis and acute bacterial sinusitis--"just before the Subcommittee’s first hearing on the
matter last February," according to the House press release.
The FDA still approves Ketek as a treatment for pneumonia, however.
A subpoena also was issued for Ann Marie Cisneros, a contractor who managed the Kirkman-Campbell review.
Cisneros has claimed that she told Sanofi-Aventis of problems with the drug, but that her protests fell on deaf
ears, according to a subcommittee memo obtained by CongressDaily news service.
"Three other document requests were removed from consideration for subpoenas after the FDA delivered the
material" to the House panel, stated the Tuesday press release.
"These requests dealt with records related to the Ketek investigation...and FDA’s lack of oversight over
Institutional Review Boards," the release added.
A hearing is scheduled for February 12th, 2008.
The panel also is looking to obtain a full FDA document which may reveal the advice of investigators that
Sanofi-Aventis deserves prosecution for purposely submitting false trial results to the agency.
FDA leaders did give the document to the House subcommittee--but only after redacting the entire paper.
Much of this mess came to light thanks to Senate Finance ranking member Charles Grassley (R-IA). He
began asking questions about Ketek during his tenure as committee chairman.
Now House Energy and Commerce leaders are beginning to question if the FDA knowingly approved Ketek in
spite of its faked trial results.
"The Subcommittee is seeking testimony regarding the agency’s ability and willingness to protect Americans
from excessive risk from prescription drugs," the House release stated.
“It is important for the Subcommittee to ascertain what the FDA and Aventis knew and when they knew it
regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake,"
added Oversight and Investigations Subcommittee Chairman Bart Stupak (D-MI), in the House press release.
The FDA has claimed that it essentially excluded Kirkman-Campbell's data on Ketek, and primarily relied on
European clinical data to reach its decision on the drug.
Like what you're reading so far? Then why not order a full year (52 issues) of the The American Spark e-
newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!
By Cliff Montgomery - Feb. 3rd, 2008
A House panel on Tuesday approved subpoenas for the testimony of Food and Drug Administration (FDA)
criminal investigators involved in the agency's decision to clear for sale a dangerous drug, despite receiving
false clinical data on the product.
The Energy and Commerce Oversight and Investigations Subcommittee unanimously approved subpoenas
"for the testimony of two current and one former criminal investigator of the Food and Drug Administration
(FDA)," as well as one for "documents related to the briefing book and other materials used to prepare FDA
Commissioner Andrew von Eschenbach for his testimony before the Subcommittee on March 22, 2007,"
according to a Tuesday House press release.
"The drug involved is Ketek, an antibiotic produced by Sanofi-Aventis (formerly Aventis)," the press release
continued.
The lead researcher for Sanofi-Aventis' largest clinical trial of the drug was Anne Kirkman-Campbell. In 2004,
Kirkman-Campbell pled guilty to mail fraud in connection with charges that she enrolled numerous individuals
into the trial who did not have the respiratory illnesses that Ketek treats.
The FDA cleared the drug for release in 2004, but apparently pulled its approval of Ketek for use against two
illnesses--chronic bronchitis and acute bacterial sinusitis--"just before the Subcommittee’s first hearing on the
matter last February," according to the House press release.
The FDA still approves Ketek as a treatment for pneumonia, however.
A subpoena also was issued for Ann Marie Cisneros, a contractor who managed the Kirkman-Campbell review.
Cisneros has claimed that she told Sanofi-Aventis of problems with the drug, but that her protests fell on deaf
ears, according to a subcommittee memo obtained by CongressDaily news service.
"Three other document requests were removed from consideration for subpoenas after the FDA delivered the
material" to the House panel, stated the Tuesday press release.
"These requests dealt with records related to the Ketek investigation...and FDA’s lack of oversight over
Institutional Review Boards," the release added.
A hearing is scheduled for February 12th, 2008.
The panel also is looking to obtain a full FDA document which may reveal the advice of investigators that
Sanofi-Aventis deserves prosecution for purposely submitting false trial results to the agency.
FDA leaders did give the document to the House subcommittee--but only after redacting the entire paper.
Much of this mess came to light thanks to Senate Finance ranking member Charles Grassley (R-IA). He
began asking questions about Ketek during his tenure as committee chairman.
Now House Energy and Commerce leaders are beginning to question if the FDA knowingly approved Ketek in
spite of its faked trial results.
"The Subcommittee is seeking testimony regarding the agency’s ability and willingness to protect Americans
from excessive risk from prescription drugs," the House release stated.
“It is important for the Subcommittee to ascertain what the FDA and Aventis knew and when they knew it
regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake,"
added Oversight and Investigations Subcommittee Chairman Bart Stupak (D-MI), in the House press release.
The FDA has claimed that it essentially excluded Kirkman-Campbell's data on Ketek, and primarily relied on
European clinical data to reach its decision on the drug.
Like what you're reading so far? Then why not order a full year (52 issues) of the The American Spark e-
newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!