Senator Chuck Grassley (R-IA) says he suspects the FDA is involved in a cover-up of its activities involving the controversial antibiotic Ketek, citing the agency's refusal to make one of its investigators available for questioning. Grassley showed up at the Department of Health and Human Services to make his demands known and quickly filled in reporters after he left with nothing. HHS says that they aren't involved in a cover-up, claiming that they've already turned over more than 400 boxes of information on Ketek and wouldn't offer up the investigator in the middle of an agency inquiry. One point of contention is the use of data from a clinical trial for Ketek that was riddled with fraud. Safety data from that trial was presented to an FDA committee, which wasn't told about the problems that surrounded the study.
- read the article [1] from The Washington Post on Ketek
Links:
[1] http://www.washingtonpost.com/wp-dyn/content/article/2006/06/14/AR2006061402091.html