MAJOR PROBLEMS EXIST IN FDA APPROVAL PROCESS – (10-20-05)



FDA Standards Good Enough for Government Work?

Unfortunately, many people here in the US have an image of the FDA as a governmental agency that is constantly on the vigil to protect an unsuspecting public from the pharmaceutical companies. Not quite so romantic.

This editorial does a nice job of outlining one of the major problems with the FDA approval process. It’s not that the FDA has lax standards, it’s just that their approval process does not have much application in the real world. Many times, in initial clinical trials of a pharmaceutical, the drug is compared to placebo in a patient that is at an extreme of a condition (the article illustrates this with Redux, which was tested in patients with severe obesity).

But in the real world, the drug reps convince physicians to prescribe for much milder conditions, thus skewing the risk benefit ratio.

Read entire article here

James Bogash

For more than a decade, Dr. Bogash has stayed current with the medical literature as it relates to physiology, disease prevention and disease management. He uses his knowledge to educate patients, the community and cyberspace on the best way to avoid and / or manage chronic diseases using lifestyle and targeted supplementation.







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Category: Drug Research
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