FDA Hides Fraudulent Clinical Trials From Public


Clinical trials performed by scientists, researchers, businesses, and universities do not always hold the truth. Recent evidence uncovered by Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University shows researchers of at least 57 medical and clinical trials secretly amputated limbs, faked X-ray reports, forged retinal scans, and reported phony lab tests.

Moreover, internal documents obtained through the Freedom of Information Act (FOIA) show the U.S. Food and Drug Administration (FDA) was privy to fraudulent clinical trials, did not tell the public, kept the information secret, and allowed clinical trials that were in violation to be published in medical journals.

Clinical Trials Investigated For Fraud 

According to Medical News Today (MNT), the FDA found bad practices ranging from poor record keeping to falsification of results in 57 clinical trials between 1998 and 2013.

Professor Seife and his student’s investigation cross-referenced the FDA’s official actions and uncovered the following serious violations among the 57 clinical trials. Only three of the 78 published reports for these research studies mentioned fraud, misconduct, or violations identified by the FDA.

Fraudulent clinical trials included the following:

  • Failure to protect the safety of patients and/or issues with oversight or informed consent – 53% (30 trials)
  • Inadequate or inaccurate recordkeeping – 61% (35 trials)
  • Protocol violations – 74% (42 trials)
  • Other violations not categorized – 35% (20 trials)
  • Fraudulent (“falsification or submission of false information”) – 39% (22 trials)
  • Problems with the reporting of adverse events – 25% (14 trials)

MNT’s coverage provided the following quote from the investigation cited in the latest online issue of JAMA Internal Medicine.

“One of the studies, published in 2012, gives positive claims about a stem cell treatment for all the 26 patients with severe loss of blood circulation to their legs, stating “major clinical improvements” for all, while making no mention that one of the patients, in fact needed amputation of their leg two weeks after having the treatment for severe limb ischemia.”

An additional editorial article by Dr. Robert Steinbrook and Dr. Rita Redberg cites that these examples of fraud in clinical trials are disturbing. In addition, Steinbrook and Redberg claim that another case of an “entire study deemed unreliable by the FDA but published without mention of the issue.”

Dr. Steinbrook and Redberg commented on inadequate disclosure by medical researchers and a lack of transparency from the FDA, adding that a “central responsibility of medical journals is maintaining and improving trust in the medical literature.”

An excerpt from the editorial is as follows:

“Journals should expect that investigators and sponsors of clinical trials would promptly notify them of substantial findings from FDA and other regulatory agency inspections, and modify their reports of clinical trials as needed, either before or after publication.”

FDA Departs From Good Clinical Practices

Professor Seife offers the following conclusion.

“When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct. In addition to this failure of the people reporting their clinical trial results to reveal serious violations, there is no public disclosure by the FDA either.”

This recent investigation shows that patients and doctors are left uninformed by the agency that’s supposed to protect them.

Here’s a little of what Professor Seife’s wrote in Slate.

“The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.”

Based on this recent investigation on fraudulent clinical trials and how the FDA handles them, it does not look like a safe alternative or sound practice to trust without question, or rely too much on some governmental agencies, including the FDA.

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George Zapo, CPH
George Zapo, CPH is certified in Public Health Promotion & Education. George focuses on writing informative articles promoting healthy behavior and lifestyles. Read more of George's articles at his website: https://georgezapo.com.