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Re: You are the problem.
by MarylandMD

Max Duley:
There are several medications in the news today that were all thought to be harmless and beneficial and have been prescribed to thousands of patients by smart Doctors in the name of medical progress and the greater good. Here is a link to the FDA RECALL list. <link>

I had trouble cutting and pasting your link. Here is a link to the associated page with more detailed information about the recent MedWatch bulletin on RotaTeq you referred to:

<link>

First a correction. You did not provide a link to the FDA "RECALL list". You linked to website of MedWatch, the FDA's Safety Information and Adverse Event Reporting Program. This is how the FDA keeps all citizens, doctors and patients alike, informed about actual and potential safety issues regarding a wide range of medical products, including vaccines and prescription medications. You do us all a service by pointing out this source of drug safety information. Anyone with an interest in medicine would do well to refer to this website periodically.

The specific bulletin you refer to shows how the FDA is monitoring for adverse events from vaccines. They are pointing out that a few cases of Kawasaki's disease have been temporally associated with administration of RotaTeq. This is not a recall of RotaTeq. As the bulletin makes clear, the FDA is monitoring the situation, but the few cases of Kawasaki's seen are not any more than would be expected due to chance. At this time, there is no evidence of a link between Kawasaki's and RotaTeq. If new data come to light, the FDA will issue a new bulletin and possibly further recommendations. Right now, they are asking doctors and patients to keep a sharp eye out for Kawasaki's and any possible relationship with RotaTeq.

How this MedWatch bulletin supports the argument that the FDA, the CDC, and other heath authorities are in the thrall of the vaccine manufacturers is beyond me. This suggests instead that the public health institutions are trying to protect the public by keeping watch for problems caused by vaccines and other medications. Sure, the system isn't perfect, and some medications like Vioxx have been pulled much later than some of us wanted. But the system does function to identify problems and warn everyone about them.

I have no problem with parents who have concerns and are considering holding off on brand new vaccines such as RotaTeq. I usually avoid using new prescription medications for at least the first 2 years after they go out on the market, especially when there are older, better-known alternatives. But when I explain what a Rotavirus infection is like to the poor child and the rest of the family, the parents always elect to get the vaccine. Given what we know right now, the risks of RotaTeq appear to be very very small, and when balanced against the risks of a Rotavirus infection, the risk/benefit analysis tips heavily in favor of giving the vaccine, as new as it is. We will never know everything, but that is no excuse for inaction.

Physicians are generally not upset or threatened by patients educating themselves with responsible, scientifically based information (like MedWatch!) about medications and their health.

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