Two of the allegations brought to the attention of the Senate Finance Committee relate to an FDA advisory committee meeting, specifically the Anti-Infective Drugs Advisory Committee (AIDAC or Advisory Committee) meeting held January 8, 2003. (According to the FDA, the value of an Advisory Committee is to provide independent expert advice, to lend credibility to the FDA's review process, and to allow for public discussion of controversial issues, among others.)The two allegations are: 1-FDA management instructing FDA officials to present fraudulent data to the Advisory Committee because discussing issues regarding data integrity and the conduct of a safety study would not be productive; and, 2-the FDA actually presenting fraudulent study data to the Advisory Committee.
In 2001, the Advisory Committee requested that a phase III safety study of patients in a usual care setting to examine the potential toxicities of Ketek with regard to cardiac, hepatic (liver), visual, and vascular safety.
In response, the manufacturer submitted an amendment on July 24, 2002, containing the large safety study requested by the FDA to evaluate adverse events in the usual care setting.
Doctors were paid well for subjects to enroll which led to fake subjects, family members and staff, and people who did not suffer from the indications (community acquired pneumonia, bronchitis, and bacterial sinusitis). In one study site, an entire weight loss group was enrolled. Of the top 30 enrollers, eight enrolled 1 percent or more of the adult population of their city; plus there was failure to maintain completed informed consents and case report forms for study subjects and failure to sign the return shipment form for investigational product. Several doctors are now under criminal fraud investigation.
The FDA official charged with presenting Study 3014 at the Advisory Committee stated that he was not satisfied with what he knew about the integrity of Study 3014 and was against presenting it at all. When asked why he did indeed present a study he knew to have data integrity problems, the official replied that he was asked directly by the FDA Division Director to present Study 3014 during a team meeting. He said he viewed this as a verbal instruction.
Source: http://content.nejm.org/cgi/content/full/356/16/1601
