If there is a violation, the FDA classifies it in one of two ways: Voluntary action indicated (VAI) means the inspectors have found violations, but the problems aren’t serious enough to require sanction. Official action indicated (OAI) means that the inspectors have found violations significant enough to warrant official action.
Siefe and his assistants used the Freedom of Information Act to request information from the FDA, and supplemented that data with Google searches of the FDA database. They found 57 clinical trials that were directly linked to an OAI inspection.
The misconduct identified by the FDA in these cases included:
- Falsification or submission of false information
- Underreporting of adverse events
- Failure to follow the investigational plan or other violations of protocol
- Inadequate record keeping
- Failure to protect the rights, safety, and welfare of patients
- Use of experimental compounds in patients not enrolled in trials
- Failure to supervise clinical investigations properlyThe 57 trials Seife identified were in turn linked to 78 research articles published in the peer-reviewed scientific literature. 96 percent of these articles failed to mention the violations identified by the FDA inspection—despite the fact that in the majority of cases the inspection was completed at least 6 months before the article was published.