U prof: Tests on humans won't ensure device safety

  • Article by: JANET MOORE , Star Tribune
  • Updated: August 10, 2010 - 9:33 PM

A study of FDA product recalls shows that more clinical testing wouldn't prevent most problems.

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jasonkiddAug. 11, 10 1:42 AM

The Author forgot to disclose that (1) he worked as a Big Pharma litigator his entire career, (2) still does, and (3) is a registered CEO of a small device company.

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meegwichAug. 11, 10 5:16 AM

Could not agree more with 'Diligence,' Except to add that it appears he's not only the CEO, it's his company, run from North Oaks where he lives. Once again, it's another small piece of the puzzle that never seems to get finished over at the 'U'. As a consumer, I am really questioning everything I now read regarding any research activity or "authored" publication coming out from the University of Minnesota. They have shown no remorse for their failures to clean up their act regarding doctors, pharmaceutical ties, non-disclosed conflict of interest, the list goes on and on. They just want to hand out backpacks at the fair and pretend all is well.

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woodyagAug. 11, 10 8:47 AM

They only looked at studies from 2005 to 2009???????? Can you remember how completely Bush gutted the regulatory agencies? They still haven't recovered. If such a study is to have any validity, it needs to start around 1960, at least.

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togunnerAug. 11, 1010:08 AM

You need to go back to 1995 for review of data. Prior to 1995 there was no such thing as the 510(k) process as it is practiced. Published studies are a double edged sword: someone has to pay for them (studies cost MONEY), so there is bound to be some bias - intended or not. The hard part is buffering the bias out of the study by identifying the true purpose of the study.

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woodyagAug. 11, 1010:43 AM

100% yes. The blankety bias is always there. I know the info won't be uniform way back; but I do think it's still worth looking at. We can learn, I hope.

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cityguyusaAug. 11, 10 3:44 PM

Once again the capitalism paradigm fails to produce good results and instead shows how cutting corners and bad choices made to speed-up time to market are at fault. The very incentive that capitalism provides.

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HyperionAug. 11, 10 9:48 PM

Not that I expect anything written in an internet comments section to change a person's mind, ever, but I want to let you know that Prof. Hall did disclose to the IOM panel his work in the industry as well as his involvement as CEO of a the small start-up device company.

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explanthisOct. 20, 10 9:27 PM

There are no warranties on joint replacements and the medical device industry has had a "get out of jail free" card since 2/2008 when the Supreme Court decided on Riegel v. Medtronic. The only advisory panel within the FDA that does NOT allow the Consumer Representative and Patient Representative to vote is-? guess what ?-the Medical Device panel. In addition, implant surgeons are not legally required to report a device failure. How can failed devices be detected and removed-they can't? Misleading direct-to-consumer ads fuel the pipeline for this unsustainable system. All implant patients should be followed for a minimum of 10 years in a non-industry administered database.

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