KETEK PROMPTS LAWMAKERS TO QUESTION FDA CLINICAL TRIAL PROTOCOLS
In the latest step in the fight between the FDA and Congress over the agency's handling of sanofi-aventis' antibiotic Ketek, a bipartisan coalition of lawmakers is asking the Government Accountability Office (GAO) to investigate the agency's use of a type of clinical trial associated with the drug.
Lawmakers, including Sen. Chuck Grassley (R-Iowa) and Reps. John Dingell (D-Mich.), Henry Waxman (D-Calif.), Edward Markey (D-Mass.) and Bart Stupak (D-Mich.), are requesting that the GAO assess the FDA's use of non-inferiority trials. The lawmakers asked the GAO to document how often the agency used this approach to approve products over the past 10 years and evaluate the FDA's oversight over and reliance on this practice. Non-inferiority trials involve comparisons between a new product and a similar one for which efficacy is already known.
This approach is flawed because it lacks a placebo to compare the new product with, the lawmakers said in a Sept. 6 letter. This leads to an incomplete and ineffective study, they wrote. "If careful attention is not given to the design of non-inferiority trials, then the trial may not be able to accurately assess effectiveness and may provide potentially misleading results."
Even worse, according to Waxman, is that the approach is dangerous. "Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans," Waxman said. "An antibiotic that is no better than a placebo can't fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective."
The genesis for this dispute is the FDA's handling of Ketek (telithromycin), a congressional staffer said. Grassley has long been at odds with the agency over its handling of clinical trial fraud regarding the drug. Ketek, which has been associated with liver damage, was approved based on non-inferiority trials.
"These studies -- which were used to approve the antibiotic Ketek -- are dubious because they don't provide any evidence that a particular drug is any better than nothing at all," Grassley said in a Sept. 8 statement.