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IV of X. Sense and Consequence - FDA
This entry was posted on 3/4/2008 9:23 AM and is filed under uncategorized.
2 March 2008
IV of X. Sense and Consequence - FDA
Once upon a time actions came with consequences. With every decision made today, s/he will be held accountable tomorrow. As a sort of Taoist equalization, with every one there exists its other.
A beautiful tale of karmic justice, cosmic balance, and natural harmony...shattered in disarray today...
Outside the beautiful tale, everyone is held accountable except those with money, power, and connections. Never has 'greasepalming' been such a blatant slap in the face than with recent reportings surrounding the FDA:
1) In one of the areas most crucial to all humans - rich and poor - the medical sphere (the supposed great equalizer) is now becoming 'immune' from retribution, as if above all accountability. Unfortunately, this is a legal statute in the United States, as with a recent report that makers of medical devices "are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency's specifications" (Linda Greenhouse, "Justices Shield Medical Devices From Lawsuits," The New York Times, 21 February 2008). Now this would not bear too great a consequence if we knew we could effectively rely on the FDA to qualify these medical devices.
Anyone alive and in tune to 'reality', (should) already knows s/he can not rely on the FDA. Even the FDA itself concedes "that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices and food" (Gardiner Harris, "Justices Add Legal Complications to Debate on F.D.A.'s Competence," The New York Times, 21 February 2008).
In summation then, the public is barred from holding medical companies liable for faulty products and the federal agency in charge of regulating and ensuring quality controls of medical companies is incompetent and unable to do so. Or is it?
2) It seems rather that 'greasepalming' rather than incompetence is at the heart of the issue, as with the case of Bayer's Trasylol fiasco (by the way, shame on you, Bayer!).
Here is a general timeline of events:
1998 - FDA approves Trasylol to reduce bleeding. It is given to patients before they undergo heart surgery (FDA News).
26 January 2006 - the New England Journal of Medicine publishes a study of over 4,300 patients finding that heart bypass surgery patients administered with Trasylol doubled their risk of kidney failure requiring dialysis in contrast to those who did not take medicines to reduce blood loss (New England Journal of Medicine, 2006 January 26; 354(4):353-65).
February 2006 - the FDA issues a health advisory about Trasylol but does NOT strengthen the safety warnings on Trasylol's label.
March 2006 - another report finds the same conclusion as the NEJM study - that patients had higher rates of kidney problems thatn those taking alternative drugs before heart surgery to decrease bleeding (Transfusion, 2006 March; 46(3):327-38).
21 September 2006 - FDA advisory panel meets to reconsider the safety profile of Trasylol and makes label changes.
One week later, 2006 - Bayer releases its study on its drug involving 67K patients undergoing coronary artery bypass graft surgery. Those receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure, and stroke.
25 October 2007 - Bayer issues a news release announcing new guidance to physicians and health care providers regarding the use of Trasylol after being notified that the BART Executive Committee halted the Canadian-based trial of cardiac surgery patients.
January 2008 - Bayer suspends marketing Trasylol until the FDA can gain a better understanding of the risks and benefits of the drug.
19 February 2008 - It is announced that the lives of 22K patients could have been saved if US regulators had been quicker to remove Trasylol (Ransdell Pierson, "22,000 Died Amid Delayed Bayer Drug Recall: Doctor," Reuters News Service).
29 February 2008 - Bayer announces its third quarter profit nearly quadrupled with help from a massive tax gain. As a result, it lifts its sales outlook for the year (Matt Moore, "Bayer's 3Q Profit Nearly Quadruples," The Associated Press).
Interjecting a bit of common sense here:
Bayer, what good is it if you kill off all your consumers just to turn a profit?
Eventually, if you kill us all, there will be no one to buy your products of death. You are supposed to help the medical industry, so what's up with the Dr. Kevorkian shenanigans?
Oh by the way, congrats on your 3Q profits, great to know you have no conscience!
3) In another sling at the FDA and the Agriculture Department is the case of the tainted meat being fed to federal nutrition programs including schools (Andrew Martin, "Some Tainted Meat Used in School Lunches, U.S. Says," The New York Times, 22 February 2008).
Just plain common sense here:
What kind of crazy 'nutrition program' is it that feeds children and the public tainted meat!?! Is this the message of our federal government - 'we will poison you' - do they really not care about us to such an alarming degree?
Democracy: the right to be poisoned by your own government.
So great, not only is the level of education severely diminished in the United States that we are an embarrassment to the rest of the world as we churn out incompetents unable to compete in the current marketplace, we have to add insult to injury by poisoning off these same children - our supposed 'future'.
With this future, really, we should just turn back...retreat!
Finland, just ignore us, please...
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