Study Shows FDA Approvals are Not Backed with Thorough Research

Published By : 17 Aug 2015 | Published By : QYRESEARCH

A new study conducted by Yale School of Medicine the medical devices used by medical practitioners are thoroughly studied by the FDA. The study thus raises the question about the credibility of regulators and safety of millions of patients who depend on these medical devices for survival.

Over the years, the FDA has also drawn flak from associations such as Government Accountability Office and Consumer Reports for taking lives of several patients with mediocre approvals. These groups have always maintained that 99% approvals given by the FDA for devices are not supported by thorough research or study. 

In addition the nonchalance by the FDA, the Yale School of Medicine stated that barely 1% of medical devices are studied prior to this approval. These 1% of the medical devices are “high-risk” devices which are used for implantation in order to support normal functioning of the human body. The researchers at Yale noted, these devices are only tested with one big study per piece before getting the FDA approval. Thus, doctors are implanting devices such as intraocular lenses, replacement hips, and coronary stents in thousands of patients with only a few hundred tests. 

Professor at Yale School of Medicine, Dr. Joseph Ross stated this situation is due to a federal legislation that allows FDA to grant approvals so long as manufacturers have done the bare minimum research to prove the efficiency and safety of the device. He further added, the law has been structured in this manner to facilitate faster move toward a therapy, as lawmakers believe therapy is above everything else. However, the poor research on devices and its efficacy is resulting in an inability to make the correct decisions for the patients.
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