Sanofi-Aventis, the maker of antibiotic Ketek, received a stern warning letter from the FDA which cited numerous serious violations in the drugmaker's safety study. Referring to the study known as "Study 3014," the FDA wrote, ". . . we conclude that Aventis did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations."
Although the problems with Study 3014 were numerous and serious, the FDA's letter focuses on the study site run by Dr. Maria Anne Kirkman Campbell, "a solo practitioner in rural Alabama who had never previously conducted an FDA-regulated study, but randomized 407 subjects into Study 3014 over a 3 months time period (i.e., November 2001-January 2002.)" When the FDA reviewed Dr. Kirkman Campbell's records, they "found that she falsified Case Report Forms (CRFs) that were submitted to the sponsor and falsified documentation to support the existence of a fictitious subject. Dr. Kirkman subsequently pled guilty to one count of mail fraud in connection with this fictitious subject and was sentenced to 57 months in federal prison."
In addition to fictitious patients, other problems cited by the FDA include: 1) lack of valid informed consent by patients enrolled in the study; 2) failure to properly diagnose the condition being studied, i.e. bronchitis, before enrolling the patient and dispensing the drug; 3) failure to inquire whether the patient had sensitivities to certain substances which would have disqualified them from taking the drug being studied; 4) enrolling large numbers of patients in a short period of time during which, in fact, the doctor's office was "closed for lunch and not seeing patients" . . . and the list goes on.
The focus of the FDA's ire is that Aventis, via reports from its agent, PPD Development, was fully aware of the violations, yet "failed to promptly secure compliance from Dr. Kirkman." Since Study 3014 was designed to provide safety data relied upon by the FDA in approving the drug, fraudulent reporting is particularly egregious. Sanofi-Aventis has 15 days to tell the FDA its plan for ensuring that such violations do not happen in future studies, and its response will be followed up by a meeting between the FDA and the drug maker.