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8 Responses

  1. tmana
    tmana January 5, 2009 at 8:39 am | | Reply

    One of the interesting and well-known observations regarding the FDA boondoggles (and they go well beyond “cardiovascular effect testing”) is that under today’s regulations, aspirin — which has been GRAS (Generally Regarded As Safe) for many, many years — could not pass the FDA approval process.

    Another observation, made several places by Dr. Mary Ruwart (research pharmacologist turned political activist) is that — again, even before the cardiovascular-improvement requirement — the FDA’s approval process more than doubles (almost trebles) the amount of time it takes to get a drug from development to market, ignores anything that does not come out of Big Pharma (with Big Graft attached to it!), and kills many, many more people than it saves.

  2. Lawrence I gottlieb MD
    Lawrence I gottlieb MD January 6, 2009 at 7:36 am | | Reply

    Diabetes, unlike many other diseases, has a strong association with cardiovascular disease. Why shouldn’t drugs intended for treatment of diabetes be given the added scrutiny to help protect patients from risk.
    I suspect that the “mainstream corporate driven Media” and the altruistic pharmaceutical industry may cancel each other.

  3. Anne
    Anne January 6, 2009 at 8:46 am | | Reply

    I am in support of patient needs awareness by the FDA as described by the petition, but it is unclear to me why we wouldn’t support more scrutiny, as the above commenter also states, into the association between type 2 drugs and cardiovascular events. The letter that I read seemed to be specific to type 2 drugs and the patient population those will serve do have a much increased risk of cardiovascular events. I haven’t been able to find a clear explanation on what makes these new requirements over the top, other than that they will be costly & take time. With the large & increasing number of type 2 patients out there, there will be a market that will attract new drugs, it seems, even if it is pricey getting the testing done. Personally, I have some loved ones with type 2 diabetes and I have worried about the side-effects–in particular, cardiovascular effects–they may be experiencing from the drugs they are taking. Because past drugs slipped through the cracks, it doesn’t seem to me like they shouldn’t be more careful in the future.

    On the more general issue of patient advocacy and the FDA, I am all for it. But I’d rather (or in the specific case of type 2 drugs, I’d rather my loved ones) wait a year or two than be the guinea pig for the FDA. If there is a clear explanation of exactly why the requirements are so unreasonable, I’d like to see it, since I am not an expert in that!

    Thanks,
    Anne

  4. Anne Findlay
    Anne Findlay January 6, 2009 at 12:00 pm | | Reply

    Maybe someone could explain how these drugs are checked for cardiac safety in phase 1?

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