Stronger Warning Labels?

            There are some environmental extremists who believe devoutly in NPG, Negative Population Growth (npg.org/whatis.html) as the only hope for Planet Earth. Some of the more enthusiastic of them in England have even suggested a “perfect Terrestrial population of four hundred seventy-eight thousand humans. Since the present population of our world is estimated at six and a half billion . . . their best of all possible worlds would require the death of 93.5% of all those presently living. It’s comforting to find out that the NPG group has found a productive outlet for their energies working for the Food and Drug Administration (FDA) in Washington, D.C. The sheer gall of the FDA is only surpassed by its sheer incompetence and they are definitely NPG’s favorite friend doing their part to trim the unnecessary human population right where it stands . . . .

In early August, 2007, in a classic example of stupidity and by a 22-1 vote the FDA refused to ban the dangerous diabetes drug Avandia, despite 80,000 known deaths, a suspected 205,000 heart attacks and strokes, and knowing it would continue to kill thousands more in the future. Today almost two years later, congratulations NPG advocates, you hitched your wagon to the right horse:  the FDA.  Avandia, Actos and the now defunct Rezulin are a class of drugs called TZD’s, oral anti-diabetes drugs developed in the 1990’s.  Rezulin was dropped early on for causing liver damage in a small but significant percentage of the user population.  Avandia and Actos were said to be free of liver damage . . . however, recent data shows that both significantly increase the risk for liver problems and Avandia is on top of that:  a cardio-vascular system nightmare -- dramatically increasing risk for both heart attacks and stroke.

The New England Journal of Medicine came to that conclusion from one of its studies in 2006, but the FDA had already been told that by the drug’s English manufacturer, Glaxo eighteen months earlier. Then, in a greedy reversal of form, Glaxo said, "To hell with decency and honor" and arrived at the 2007 hearing with thousands of pages of studies and information and received the OK for continuation from the FDA despite its horrific record over the ten years it's been sold, “Let’s not throw the baby out with the wash water!” said one Glaxo enthusiast.    Perhaps he should have said, ” “Let’s not throw Rosemary’s Baby out with the wash water?” Since without any medicine at all . . . one of the more common dangerous side effects of diabetes is increased risk of cardio-vascular problems like heart attacks and strokes, Rajjpuut doesn’t think that giving Avandia (with its notorious record of inflicting cardiovascular damage) to diabetics is a good idea unless you’re an NPGer and euthanasia is your contribution to the movement’s goals.  

The FDA's actions in 2007 with Avandia are part and parcel of the agency's absolute unwillingness over the last decade to reverse even the most atrocious decisions. Much like George Armstrong Custer who has been accurately protrayed as totally unwilling to reverse a "Custer decision," the front-line troops (in this case diabetic patients) are the ones who suffer in large numbers. The case against Ritalin and Celebrex is every bit as strong but in all three of these incidents the FDA seemingly is willing to risk more live and more problems by just making a stronger warning label rather than taking dangerous products off the market.   These are just three of roughly a hundred reasons why Rajjpuut says that since health care is very likely going to change this fall, the very first change needs to be the elimination or complete revamping of the FDA, easily the most corrupt and incompetent agency in the federal government. 

Besides its other sins the FDA did not pass on the Glaxco 2005 warning to American Avandia users, at that time over one million strong. What exactly must the FDA do to receive some sort of sanctions from the GAO or other agencies?

Rajjpuut