High-Risk Medical Devices and Drugs Often Approved After Low-Quality Clinical Trials, Studies Warn

Two new studies join a growing body of evidence that suggests federal regulators are approving both high risk medical devices and new drugs based on flimsy scientific research and low-quality clinical trials. 

The new research was published last week in the Journal of the American Medical Association (JAMA). One study was by researchers from the University of California, looking at clinical studies used for FDA approval of high-risk medical device modifications. The other was by researchers from the U.K. and Boston, looking at studies used for FDA’s approval of new drugs.

The findings of both studies came to almost the exact same conclusion: that the FDA accepts clinical studies as proof of the safety and efficacy of drugs and medical devices, even when the findings have lacking quality and thoroughness.

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The medical device study looked at 83 clinical studies for 78 high-risk products approved between 2006 and 2015. It found that only 45% involved randomized clinical trials and only 30% were blinded. The FDA required post-approval studies for 29 of them, due to open questions about safety issues or potential risks.

“Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points,” the researchers concluded. “These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved.”

The drug approval study looked at accelerated approvals granted by the FDA to 22 drugs for 24 indications from 2009 through 2013. The researchers in that second study also found that the studies had serious problems, including lack of blinding, randomization and comparator groups.

When post-approval studies were required to confirm that drugs already being doled out to U.S. citizens actually worked and were safe, the researchers found it took at least three years to complete half of them, and most of those relied on surrogate measures instead of clinical outcomes.

The new studies come following a number of similar reviews by independent researchers, including a study published in The BMJ in May, which looked at prospective controlled clinical studies for all drugs that were published after the FDA initially approved them between 2005 and 2012. All of the drugs included in the study were approved on the basis of a single pivotal clinical trial.

In June 2015, The BMJ also published an analysis that warned about numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for heart devices. Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer reviewed.

Since drug makers and medical device makers often aggressively market new products after they are approved, espousing the benefits of their new treatment options, large numbers of unsuspecting patients may end up being unwilling test subjects.


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