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FDA Hiding Serious Problems with Clinical Trials?

The US Food and Drug Administration has hidden from the public problems with clinical trials, including instances of scientific fraud, according to an article published in JAMA Internal Medicine.

In the article, Charles Seife, who teaches journalism at New York University, looked at 78 publications on trials in which the FDA found serious issues, and determined that only three of the publications had any mention of the problems uncovered by the agency.

Seife writes that typically the FDA will not notify a journal when it finds violations during a trial site inspection, even if the agency classifies the violation as official action indicated, the agency's most serious classification of violations.

The agency also does not typically make any announcement to alert the public about the misconduct it finds. "The documents the agency discloses tend to be heavily redacted," Seife writes. "As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct."

He adds that the FDA has "legal as well as ethical responsibilities regarding the scientific misconduct it finds during its inspections. When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect."

Seife unleashes his most pointed criticism at the FDA in an article in Slate.

"[O]ver 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," he continues. "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." 

In an editorial in JAMA Internal Medicine accompanying Seife's article, the authors note that the FDA is making efforts at being more transparent, but finding information about specific trials remains a challenge.

For example, many FDA documents on clinical trials do not include the Identifier, also known as the National Clinical Trial, or NCT, number. "It would be a great advance if the FDA included the NCT number of trials within all agency documents and reviews that refer to specific trials," Robert Steinbrook and Rita Redberg say in the editorial. 

Steinbrook is with the Yale School of Medicine, while Redberg is at the University of California, San Francisco. 

"For inspections with findings classified as Official Action Indicated, it would be advantageous for the FDA to promptly notify so that the trial registration listing can link directly to the inspection report, as Seife suggests," they add. "Links in searchable public databases are also an efficient and effective approach to informing medical journals and the medical and research communities."