Lobbyists at the FDA

Over the past 10 years, more and more innovative and expensive drugs have been pushed to market on what's called the "fast track" at the Federal Drug Administration.  What does the fast track achieve?  It allows big pharmaceutical companies such as Pfizer, Merck, Bayer, Wyeth, Bristol-Myers Squibb, Sanofi-Aventis, Hoffman-LaRoche, AstraZeneca, etc. to rush lightly tested and sometimes barely proven drugs to the general public.  Why is this important?  Because people are getting hurt, and even killed by these drugs that are rushed to market before they are proven safe or before sterner "Black Box" warnings can be put on the labels, and in some instances, before their efficacy is proven.

Just recently, Pfizer cut off all clinical trials and development of its newest cholesterol drug, Torcetrapib, citing a high number of "unexpected" deaths and cardiovascular problems. Pfizer had hoped to rush FDA approval of this drug so it could sell it in combination with its cholesterol reducing drug, Lipitor.  Lipitor is scheduled to lose its patent protection in 2010, so Pfizer was looking to replace what could be a loss of up to $14 billion in sales due to patent expirations.  This should concern  all Americans because, for around ten years, the FDA, while staffed with some terrific scientists and administrators, has been effectively run by lobbyists who either worked for, or soon hope to work for, big pharmaceutical companies such as those mentioned above.  While I'll admit that many new drugs have proven to have fantastic health benefits, I'm not naïve enough to think that “Big Pharma” isn't always looking at its bottom line.  How else can you explain the following problems in just the last 10 years?  Can you say Fen-Phen, the drug manufactured first by American Home Products who was then bought out by by Wyeth?

All of the drugs mentioned above have helped thousands of people.  However, they've also proven to have severe and sometimes life-altering side effects on certain population groups.  Because, in my humble opinion, the FDA is more concerned about making drug companies happy and profitable, my concern is that in combination with the Big Pharma lobbyists, the FDA fast tracks drugs that can sometimes cause more harm than good.  Big Pharma likes the fast track approval process because it protects their bottom line - profits.  I'm all for pushing new drugs that can improve the lives of sick Americans.  Heck, our drug industry is tops in the world.  With the advent of some of the biotech offerings that are on the horizon, we're way ahead of the curve of pharmaceutical and biotech medical science.  However, I get worried when drug after drug gets rushed to market and people get hurt.  I'm hopeful that once we get the lobbyists out of the hen house of the FDA, our system will right itself and the FDA will again ensure that all Americans are properly warned about all side effects these new drugs might have on users.


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