E-drug: FDA Evaluation of Telithromycin (Ketek)
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Dear Colleagues:
The FDA's Anti-Infective Drugs Advisory Committee is reviewing the safety
and efficacy of Aventis' antibiotic telithromycin (Ketek) today (April 26,
2001). Aventis filed for U.S. and European approval of the drug in March
2000. The European Medicines Evaluation Agency's Committee for Proprietary
Medicinal Products this week recommended approval of telithromycin for
community-acquired respiratory tract infections.
The FDA has several concerns about the safety and efficacy of
telithromycin: 1) QT interval prolongation; 2) hepatotoxicity; 3)
pharmacokinetic variability and drug-drug interactions; and 4) resistance
claims for S. pneumoniae.
As a result of a lawsuit Public Citizen filed against the FDA in early
1999, the reviews done by agency scientists of data submitted by
manufacturers in support of the approval of new drugs that go before
advisory committees are now available on the Internet 24 hours prior to
meetings. Before the settlement of our lawsuit, FDA reviews were not
disclosable to the public until after a drug was approved.
The FDA's reviews and other materials distributed to members of the
advisory committee for discussion about telithromycin can be found on the
agency's web site at: www.fda.gov/ohrms/dockets/ac/cder01.htm. The
procedure for obtaining reviews for drugs already approved in the U.S. can
be found at www.fda.gov/opacom/backgrounders/foiahand.html.
Unfortunately, the management of drug information, including which
information will be published and where, is now but one step in a corporate
marketing strategy. We believe that it is no longer possible to conduct
independent appraisals of the therapeutic value of new drugs by relying
solely on published clinical trials. Research submitted to the FDA that
shines a less than favorable light on a new drug is, at times, not
published or its publication can be delayed. We urge those who conduct
systematic reviews of new drugs to include these FDA reviews in their work
for completeness.
Warmest regards,
Larry
Larry D. Sasich, Pharm.D., M.P.H., FASHP
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Voice: 202-588-7782
FAX: 202-588-7796
E-Mail: lsasich@citizen.org
Web Site: www.citizen.org/hrg
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