Posted in Capers, CDC, Evidence-based Medicine, FDA, Government Regulations, Influence peddling, NIH, Patient Safety, Policy Issues, Unsettled Science

Behind the Veil: Conflicts of Interest and Fraud in Medical Research

chris-kresser-about-320x457
Chris Kresser

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.

via Behind the Veil: Conflicts of Interest and Fraud in Medical Research.

Author:

A primary care physician by training, my passion is researching and writing about the importance restoring patient centered care, supporting independent private physicians, promoting free-market solutions and seeking sustainable fiscal policy in healthcare.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s