FDA Oversight and the Problem with Trust

Here is the abstract for an article by Charles Seife, MS, published in JAMA in April, 2015. This paper reveals huge ethical breaches found by the FDA when they inspected the sites of clinical drug trials between 2008 and 2013.  The author finds 57 published clinical trials inspected by the FDA during this period had significant evidence of:

  • Falsification or submission of false information  [22 trials, 39%]
  • Problems with adverse events reporting  [14 trials, 25%]
  • Protocol violations [42 trials, 74%]
  • Failure to protect the safety of patients and/or issues with oversight or informed consent [30 trials, 53%]
  • Inadequate or inaccurate record keeping [35 trials, 61%)

The paper notes that when these breaches occur, the FDA “has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.” Actually, this is exactly what happens: Only 4% of the research found to have significant violations mentioned any such problems when the research was published. Seife notes: “No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.”

A few key things to remember when looking at these findings:

  1. These infractions occurred in research that became published clinical trials,
  2. The FDA doesn’t inspect very many clinical trial sites.  A Vanity Fair article from 2010 revealed that in sample year 2008, the FDA inspected about 1.9% of trial sites for research conducted in the US (and less than 1%, when the research takes place outside the country).

A skeptic would be left with a number of additional questions about how much we can trust published vaccine research:

  • How many of all vaccine clinical trial sites are inspected by the FDA?
  • How many of those inspected have ethical breaches or problems with conditions or practices?
  • Did the landmark research ‘proving ‘ vaccines to be safe and effective undergo FDA inspection during the trials? If so, did they have similar breaches?
  • How representative are these findings of all clinical drug trials?
  • If clinical trials are published as valid and reliable, even after the FDA finds major issues with the research, what is the purpose of inspection? 
  • What about the 96% of published clinical trials that didn’t reveal the problems the FDA found with their research?  Is there any body or organization that requires researchers to uphold these standards or are they on the honors system?
  • What do these findings mean for the integrity of the FDA approval system?

Read more at visionlaunch.com

This is Part 1 in the 12 part series: A Comprehensive Review of Vaccines

Part 1: Why Are So Many People Choosing Not To Vaccinate?

Part 2: A Closer Look at Pharmaceutical Companies

Part 3: Vaccine Policymakers and Conflicts of Interest

Part 4: How The CDC, FDA and WHO Lost the Trust of Vaccine Skeptics

Part 5: Are Vaccines Safe & Effective?

Part 6: What Are The Real Risks of Not Vaccinating in the U.S.?

Part 7: Herd Immunity, Shedding and the Questionable Science Behind Vaccines

Part 8: Did Vaccines Really Eradicate Infectious Diseases in the 20th Century?

Part 9: The Conclusive Evidence Linking Vaccines and Autism

Part 10: Why Don’t We Hear The Whole Story About Vaccines?

Part 11: What Are Independent Experts Telling Us About Vaccines?

Part 12: Vaccines: The Greater Good or Greater Greed? – Conclusion