I ran across something that may be of interest to some folks. I was reading up about the doctor Dingo interviewed and came across a chapter from an online book which mentions one of his colleagues. The book is “Money Driven Medicine” and the Chapter posted on the web is Chapter 8: Device Makers, Drug Makers and the FDA. (The book received very good reviews from most Amazon reviewers)
I have not read the whole thing, but the first 15 or so pages of this chapter discuss issues related to the FDA and spinal device manufacturers, specifically a certain disc replacement device. The fellow from UC Irvine looks to me like the “good guy” in this controversy.
The chapter offers an interesting perspective, almost from the “inside” about the world of orthopedic surgery and the ethical challenges these folks face.
Searching further, I found a paper written by both the doctor Dingo interviewed and his colleague discussed in the Money Driven Medicine chapter. It too is very interesting but should be read second (after the first 15 pages of the Chapter). I don’t pretend to understand much of what is covered in the paper, but expect some of the folks who are more familiar with spine surgery may better comprehend it. I did understand the last part of the conclusions where they say:
The regulatory function of the FDA to provide for the safety and efficacy of devices has been breached in this case. The authors believe this may be due to the inappropriate influence of industry on both the researchers and the approval process.
Previously, I posted an abstract to a paper in Spine Journal “Is the Spine Field a Mine Field”. This sort of relates to that.
I offer this for discussion hoping that it is not controversial.
I have not read the whole thing, but the first 15 or so pages of this chapter discuss issues related to the FDA and spinal device manufacturers, specifically a certain disc replacement device. The fellow from UC Irvine looks to me like the “good guy” in this controversy.
The chapter offers an interesting perspective, almost from the “inside” about the world of orthopedic surgery and the ethical challenges these folks face.
Searching further, I found a paper written by both the doctor Dingo interviewed and his colleague discussed in the Money Driven Medicine chapter. It too is very interesting but should be read second (after the first 15 pages of the Chapter). I don’t pretend to understand much of what is covered in the paper, but expect some of the folks who are more familiar with spine surgery may better comprehend it. I did understand the last part of the conclusions where they say:
The regulatory function of the FDA to provide for the safety and efficacy of devices has been breached in this case. The authors believe this may be due to the inappropriate influence of industry on both the researchers and the approval process.
Previously, I posted an abstract to a paper in Spine Journal “Is the Spine Field a Mine Field”. This sort of relates to that.
I offer this for discussion hoping that it is not controversial.
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