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The FDA requested the Institute of Medicine conduct a yearlong review of the U.S. drug safety system in the wake of the Vioxx controversy, but agency officials supposedly are unhappy with reports of the committee’s deliberations. The final report is expected to be released in July, which could impact congressional action on an important funding bill for the FDA or spark calls for widespread reforms that could hurt the drug industry.
Assessment of the U. S. Drug Safety System - Institute of Medicine
Can the Institute of Medicine review the FDA? - Nature Medicine
Keep an eye out for this report in about a month.
Technorati Tags: drug safety, FDA
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I’ve posted previously about the US plan to deal with a potential bird flu pandemic and how it seems inadequate in many ways. It is interesting to note the level of detail and thought that went into the World Health Organization (WHO) plan.
WHO issues plan to limit bird flu outbreak in humans - Bird Flu - MSNBC.com
If WHO can come up with a plan such as this and give out such a level of detail to re-enforce the view that they are prepared, why doesn’t the United Stated do like-wise?. They’ve done mathematical modeling and have in place a process to communicate with Roche about deliveries of drug if needed and the process appears to work since Roche was put on alert recently to be prepared to ship part of the stockpile if needed to Indonesia. It just seems that emergency preparedness in the US has fallen off dramatically in recent years (just look at the response to hurricane Katrina) and it gives me cause for concern.
Now, I definitely don’t expect the government to take care of me in case of some emergency, but it would be nice to know they cared enough to give out good advice on how to be prepared. I think the US has blown a lot of citizen trust by making some recommendations that appear pitiful to the person on the street. These include such advice as staying three feet from all people to avoid sneezes (ignoring the fact that viruses can survive for quite some time on some surfaces) and stockpiling duct tape and plastic in case of a terrorist attack. I’d really like to see a plan that shows elected officials and the folks working in government have at least thought through various scenarios and have consulted recognized experts and then effectively communicate how they arrived at the recommendations without stirring up fear. Now I realize this isn’t easy, but it I think it could be accomplished without undue expense and effort. Right now, parts of the plan looks pretty pathetic. I will say that in general, the government Pandemic Flu site especially the page on Individuals & Families Planning has some good advice. The individual and families page has advice that applies to any natural disaster and something anyone in an area where such event occur should definitely plan for.
Technorati Tags: bird flu, flu pandemic, H5N1
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