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Bob Carroll
Bob Carroll
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FDA Asks Right Question Regarding Stents But To Wrong Experts

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Let’s see if this makes sense. Six physicians with financial ties to Johnson & Johnson and other heart-device makers will be advising U.S. regulators whether to restrict the use of some products because of potentially lethal side effects.

FDA waives rules for expert panel on stents

The doctors will serve this week on a FDA panel of experts in Washington reviewing blood clots linked to stents. The panel members, listed on an FDA Web site Nov. 22, will include Robert Harrington, who runs a Duke University research institute funded by stent makers J&J and Boston Scientific Corp.

To allow the doctors to participate in the review, the FDA is waiving rules that bar panelists from serving in matters affecting companies in which the experts have stock ownership or consulting contracts.

In an Administration which allows the trucking industry to set trucking regulations, I suppose having device manufacturers guide the FDA is to be expected.