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FDA admits mistake in approving knee device

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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Oct-16-10 05:42 PM
Original message
FDA admits mistake in approving knee device
http://www.msnbc.msn.com/id/39673492/ns/health/

A
Almost two years ago, the Food and Drug Administration ignored the advice of its scientists and approved a knee implant after being lobbied by members of Congress. On Thursday, the agency issued an unprecedented "mea culpa," saying the device should not have been approved.

The agency said it is taking steps to revoke approval of the Menaflex implant, made by ReGen Biologics. The announcement comes a year after the agency first acknowledged that its decision to approve the device was influenced by outside pressure, including lobbying by four lawmakers from the company's home state of New Jersey.

The 2008 decision to approve the implant was made despite protests by FDA scientists that Menaflex — which reinforces damaged knee tissue — provides little, if any, benefit to patients.


From the full article.........

1. Approved under the Bush regime. The officials responsible are now gone.

2. It was Democrats that had lobbied for approval.
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no_hypocrisy Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Oct-16-10 05:47 PM
Response to Original message
1. Head slap! Steve Rothman!
Bad enough Frank Pallone, Frank Lautenberg, and Bob Menendez.
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angstlessk Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Oct-16-10 05:48 PM
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2. I will bet you one million dollars that every senator...representative lobbies for approval
of a drug/device from their district...this seems to be a set up by the former bushites who were assigned as political operatives to do as much harm as possible to the democrats...bet repukes lobbied for far worse drugs/devices?
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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Oct-16-10 07:13 PM
Response to Reply #2
3. agree with you that they lobby for approval
But the FDA should not succumb......

I highly doubt that the FDA would rescind an approval for an effective device in order to make Democrats look bad. :silly:
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angstlessk Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Oct-16-10 07:26 PM
Response to Reply #3
4. the FDA succumed because of bushbots...political operatives
they scrammed outta there ...and now it is just the democrats who lobbied who are left with egg on their faces
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