Sickening Incompetence--FDA -FLU vaccine

[rodeodance]

FLU VACCINE

"http://www.americanprogressaction.org/site/pp.asp?c=klLWJcP7H&b=253514"


Sickening Incompetence

The Bush administration's cronyism and incompetence will cost millions of Americans dearly this flu season. More than 1,000 pages of documents obtained by Rep. Henry Waxman (D-CA) reveal, in striking detail, "that despite being aware of major problems at the vaccine manufacturing facility as early as June 2003, missed repeated opportunities to correct them." (The Chiron facility was located in Liverpool, England, but Chiron is a California company whose operations are regulated by the FDA.) Sixteen months later, British regulators shuttered the facility because of contamination problems and the United States was left with a massive flu vaccine shortage. The incident draws focus to bipartisan concerns about the impact of the Bush administration's personal and financial ties to the drug industry. Sen. Charles Grassley (R-IA) said, "The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny. One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must the FDA's first and only concern."

FDA VISITED PLANT IN JUNE 2003, FOUND HIGH LEVELS OF CONTAMINATION: In June 2003, the FDA inspected the plant and "found high levels of overall bacterial contamination." FDA inspectors, in some instances, "found records of bacteria concentrations that were more than a thousand times higher than inspected." The inspectors also "identified poor sanitary practices that could contaminate sterile parts of the production process." Significantly, the FDA found the company was not doing enough to correct the problems.

TOP OFFICIALS REJECT INSPECTORS' RECOMMENDATION FOR MANDATORY ACTION: The FDA team that visited the facility recommended official enforcement action against the facility. That means issuing a warning letter to Chiron outlining the problems that must be fixed. If Chiron failed to fix the problems, the FDA could have initiated legal action against the company. Instead, FDA officials overruled the recommendation of inspectors and instead submitted a request for voluntary action by Chiron.

FDA DELIVERS REPORT TO CHIRON NINE MONTHS LATE: Even when it recommends voluntary action, the FDA is "supposed to send the manufacturer the full inspection report to help the manufacturer understand what corrective actions are needed." The report wasn't sent to Chiron until a year later – June 2004 – nine months after it was supposed to have been sent. The biggest problem: by that time "manufacture of the 2004 vaccine supply was already well underway." Chiron requested a meeting with the FDA after the 2003 inspection, but the agency never granted the request. lots more (outline formt)

[Hoping4Change]

1. We know enthic cleansing exists, is this another cleansing?

The elderly and infirm are drains on medicare so how convenient that thousands may succumb. <<sarcasm off>>