One of the biggest scandals that doesn’t always get the attention it deserves is the literally thousands of medical studies that are fraudulent (1) with the sole intention of fooling the FDA.

There’s big money to be made in medicine, especially where devices and prescription drugs are concerned. Sometimes, the temptation is too great to resist for those motivated by greed. This leads to falsifying studies and placing patients at risks, sometimes in life-threatening situations.

A December 2014 study conducted by Charles Seife (2) of Arthur L. Carter Institute of Journalism at New York University. The university and students examined the FDA inspection files (open to public scrutiny) for clinical trials. The objective of the study aside from applying journalism investigative skills was to ascertain if violations in clinical trials were later mentioned in “peer-reviewed literature”.

The conclusion of the paper was that such violations were rarely included in this literature. This finding is especially disconcerting since some of the violations include data manipulation and complete fabrication and falsifying of documents and records (3).









FDA Files Reveal Fraudulent Medical Studies

These included such things as falsifying lab tests, admitting ineligible participants, fake X-rays, forged signatures and other violations that clearly compromised the integrity of the clinical trials making them invalid.

The students found 68 cases of the investigation results being “published in the peer-reviewed literature, resulting in a total of 95 publications”. However, out of those, 11 cases couldn’t be substantiated that the violations were related to the clinical trial, so these were excluded in the students’ analysis. This left 57 cases that the group examined.

In browsing through these files, Arthur L. Carter Institute of Journalism students uncovered letters sent to companies and/or clinical investigators charging that an FDA investigation discovered doctored reports, clinical trial findings, X-rays and more.

One file case concerns a prescription drug for acute sinus infections. The FDA charged that the company faked X-rays to demonstrate a successful trial for patients suffering from Acute Bacterial Sinusitis (ABS) Infections. According to the FDA investigation, the X-ray reports in truth were lies and the drug was ineffective (4).

The FDA stated that the X-rays used were falsified and the doctor who apparently signed off on the reports swore in an affidavit that the signature on the reports was not hers. So not only were fake X-rays used, the signature on the accompanying documents was forged.

The FDA letter states that their investigation proved that the X-ray assessments were false and that they noted the difference in the doctor’s signature. The letter concludes, “…you have submitted false information and repeatedly or deliberately failed to comply with the cited regulations for investigational new drugs and it proposes that you be disqualified as a clinical investigator.”

This isn’t the only case of falsified records by any means. Other types of fraud are committed when clinical investigators don’t perform their jobs.