Govt pays for deadly, unapproved drugs (Update)
November 23rd, 2008 By RICARDO ALONSO-ZALDIVAR and FRANK BASS , Associated Press Writers
Graphic shows some deadly drugs banned by the FDA.
(AP) -- Dozens of deaths have been linked to medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found.
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This story lacks perspective. There are many drugs that predate any FDA approval process or FDA for that matter. Just as some herbal medicines used for thousands of years, may have real theraputic value, so do some of these unapproved drugs. Unapproved does not mean obsolete or bad. Furthermore, valuable patents are the only incentive for a drug manufacturer to spend hundreds of millions or billions on a drug approval process. Requiring one simply amounts to banning the drug. Who would pay $2 billion to try to get some niche drug, used by a few thousand eighty year olds, for 60 years, approved by the FDA?
Should we be deprived of our own Western heritage of folk medicines?
The fact is that the FDA drug approval process, sometimes better and sometimes worse, over the decades, is now more or less broken. Getting a drug approved is now prohibitively expensive, even for Pharm giants with expectations of lucrative patents. Little drugs like these, in the public domain, don't have a prayer of approval, regardless of efficacy.
Welcome to the world. Human trials start with the poorest, not the most affluent. When the drug is proven to work well and is valuable, the haves can afford the "safer" version, while the have-nots cannot afford it whatsoever.