Review: “The Bleeding Edge” documentary on unsafe medical devices

November 1, 2018- by Steven E. Greer, MD

The Netflix 2018 documentary “The Bleeding Edge” reviews modern cases of medical devices that were poorly tested by the FDA, which then went on to maim or kill thousands of people. They review the cobalt hip implants, vena cava filters, etc.

I know all about these scandals being a medical device Wall Street analyst and CEO of The Healthcare Channel. The standards of approval at the FDA’s medical device division has been eroded by powerful lobbyists more influential on Capitol Hill than the Big Pharma lobbyists.

However, what caught my attention was the segment on CT-scans. I was literally a pioneer in the field CT-scan radiation safety. Starting in 1997 or so, as a surgery resident forced to order needless CT-scans, I had a hunch that these devices were delivering unsafe levels of radiation. I also knew they they were huge moneymakers for hospitals. 10-years later, papers started to come out in in major journals proving me right.

However, I did not realize that the infamous FDA scandal in the late 2000’s involving the medical device review division leader Jeffrey Shuren installing spyware onto FDA scientists’ computers was related to CT-scan risks. The lead scientist explains that a file crossed his desk about the risks of CT-scans. When he reported it to Dr. Shuren, not only were the concerns swept under the rug, but Shuren then retaliated and fired nine of the scientists.

Dr. Shuren remains at his post to this day. He was never reprimanded.

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