WSJ Investigative Article Revealed Faulty Data And Improper Record-keeping For Key Drug Study
As reported in a May 2, 2006 article by Wall Street Journal reporter Anna Wilde Mathews, Senator Charles Grassley (R-Ill.) as well as Congressmen Edward Markey (D-Mass.) and Henry Waxman (D-Calf.) are asking the FDA for some explanation about the agency's decision to approve the antibiotic Ketek (telithromycin) in 2004. This scrutiny follows in the wake of Ms. Wilde's May 1, 2006 investigative piece in the Wall Street Journal about how the FDA approved Ketek despite knowing about some problems with a key study -- known as trial 3014 -- which was submitted to the FDA by Ketek's manufacturer, Sanofi-Aventis.
Senator Grassley wrote one letter to the FDA expressing his concerns about the Ketek situation, while Congressmen Markey and Waxman co-wrote a second letter. In her May 2 article, Ms. Wilde reported the reactions to these letters from the FDA and Sanofi-Aventis:
In a statement, an FDA spokeswoman said the agency will "welcome this opportunity to continue talking about the scientifically rigorous work" of the FDA. She also said agency officials are assessing reports of liver damage in people who took the drug but "still believe when used as directed, Ketek is safe and effective." Sanofi-Aventis said in a statement it is "committed to patient safety" and will address questions from the FDA and Congress. It said it "remains confident that Ketek is a safe and effective therapy when used as directed."
More generally, the two Congressmen's letter also pointed out, and questioned, how the efficacy of antibiotics -- unlike most other prescription drugs seeking approval by the FDA -- is tested. In summary, instead of being compared to a placebo as is usually done, new antibiotics are typically compared with older antibiotics that have already been approved by the FDA. For the new antibiotic to gain approval, the drug company needs to prove, only, that its new antibiotic is about as effective as the older drug. In fact, under the current scheme, the new antibiotic can perform a bit worse than the older antibiotic and still be approvable as for its efficacy.
(Posted by: Tom Lamb)