FDA, Medical Journals Rarely Report Violations in Clinical Trials, Which Can Lead to Defective Drugs or Devices
A new study found that US health regulators often find serious problems in how clinical trials are conducted as research facilities, but their final, published reports almost never mention these issues. This can lead not only to misleading information for doctors, but to the introduction of dangerous and defective drugs and medical devices on the market.
Charles Siefe, a professor of journalism and the study’s author, found that out of 78 published research papers reporting on clinical trials, which all featured “very serious issues” with the scientific method, only three mentioned any violations which could indicate unsafe or defective drugs or devices.
“Your physician makes decisions based upon what he knows from the peer-reviewed literature,” Seife said. “If that literature is tainted in some way without the physician knowing, then the physician is making treatment decisions based upon bad data.
“No one really knows unless you go through these documents that anyone is questioning the integrity of the trials,” he added.
The research team examined documents from the FDA dating between 1998 and 2013. The number of problems with clinical trials was low – 2% out of 650, or about 57 of the trials – but Seife said that the real problem was clinical trial fraud occurring at all. The other problem the team ran into was heavy censorship in the studies, with much of the information, including which drug was involved, being redacted.
“In some cases, you can’t even tell which drug is being tested,” he said. Lack of transparency regarding dangers, side effects, or omissions during clinical trial can quickly lead to dangerous and defective drugs or devices being released onto the market.
One or more of the falsified clinical trials involved:
- 22 trials with falsified information.
- 14 trials where researchers failed to report adverse events.
- 42 trials with violations of the trial’s protocols.
- 35 trials with record-keeping errors.
- 30 trials in which researchers failed to protect patient safety or acquire informed consent.
“When the agency does an inspection at a clinical trial site and issues an inspection report with serious findings, it should be easier to identify the specific trial and the specific publication, if there was a publication,” he said. “We think the fact there is a database is a good step, and we suggest that the agency can now move beyond that and do some other things.”
“This study highlights some disturbing examples where articles were published and information was lacking and this would be a concern to readers,” said Dr. Robert Steinbrook, who co-authored an editorial published with Seife’s report. Steinbrook is an editor at large at JAMA Internal Medicine, and is also affiliated with the Yale School of Medicine in New Haven, Connecticut.
In fact, one of the examples found by Siefe’s team was the original Xarelto study – the FDA found the entire study on the blood thinner, which now faces personal injury and wrongful deal lawsuits all over the US, to be completely unreliable. The FDA approved the drug and released it anyway, and the published report on the clinical study had no mention of the FDA’s findings.
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