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Carl Heneghan

Carl Heneghan

Director of the CEBM, GP and clinical lecturer at the University of Oxford.

Ami Banerjee

Ami Banerjee

Cardiology trainee and clinical research fellow at the University of Oxford

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    FDA

    Serious conflicts of interest of Avandia panel member

    Carl Heneghan
    Posted 20th July 2010 @ 06:51pm

    If you weren’t aware last week, Rosglitazone or Avandia as it is known in the trade, was in front of the Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee at the FDA to see if it should remain on the market.

    Overall the panel voted 20-12 to keep it on the market. That means 1/3rd of the panel wanted the drug removed from sale as they considered the harms so bad they outweigh any potential benefits. 17 of the panellists in favour wanted either tighter prescribing restrictions or more warnings about cardiovascular risks. Based on the evidence I'd have voted for its removal.

    This is where it gets bad. Endocrinologist David Capuzzi, who was on the panel confirmed he has been a Glaxo's speakers for several years. Get this ‘he doesn't see the relationship as a conflict,’ of course not. Capuzzi defended the drug during the meeting. Oh, by the way he was one of three members who wanted the drug to remain on the market with no additional earnings or restrictions.

    Dr Capuzzi received $3,750 from GSK between April 2009 and March 2010. He has also received $8,000 in speaking fees form GSK before that period and $3,000 in the 2nd quarter of this year, total $14,750.
    One member who voted to keep Avandia on the market, Arthur Moss , said "I'm surprised we weren't told.” Do you know what, I’m not surprised, are you? It seems the information was never given to the committee or to the public, and the FDA is investigating.

    Because they didn’t get 32 individuals without conflicts they should hold the panel meeting and vote again. Outrageous!

    FDA goes up in smoke

    Carl Heneghan
    Posted 22nd June 2009 @ 02:37pm

    Over a cup of coffee, in one of those shabby railway cafes you get round England, I came across this story in the New Scientist. I couldn’t quite believe what I was reading and therefore decided to buy my first ever issue of the New Scientist - which is quite expensive at £3.25 – to lighten the train journey.

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