News Policy
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| Moderated by: VT-R, TD, Paula Ticks, mb, Lynne, kC, Jeƒƒro | ||
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Yoda Member 
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BUSH HEALTH CARE The Feckless FDA is in bed with the Drug Companies……..what else would you expect? Yesterday, additional evidence emerged that, in the Bush administration, the Food and Drug Administration is more concerned about its relationship with the drug industry than the safety of the American people. Dr. David Graham, who has worked at the FDA for more than 20 years, told the Senate Finance Committee that the agency had become “feckless and far too likely to surrender to demands of drug makers.” The hearing's primary focus was the recent withdrawal of the pain reliever Vioxx, produced by Merck. Graham estimated that -- based on Merck's own studies -- 139,000 Americans suffered from a heart attack or stroke because of taking the drug. Of that group, "30 percent to 40 percent probably died; for the survivors, their lives were changed forever," according to Graham. He called the Vioxx scandal "the single greatest drug safety catastrophe in the history of this country or the history of the world." (http://www.nytimes.com/2004/11/19/business/19fda.html?hp&ex=1100926800&en=a96b5a1c2a7455a1&ei=5094&partner=homepage) (http://www.latimes.com/news/nationworld/nation/la-na-vioxx19nov19,0,2869038.story?coll=la-home-headlines) (http://www.nytimes.com/2004/11/19/business/19fda.html?hp&ex=1100926800&en=a96b5a1c2a7455a1&ei=5094&partner=homepage) |
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Yoda Member
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TOP ADMINISTRATION OFFICIALS ATTACK THE MESSENGER Let no good deed go unpunished………. Not surprisingly, the Bush administration attacked Dr. Graham for speaking honestly. Before his testimony yesterday, FDA Commissioner Lester Crawford called Dr. Graham "a maverick who did not follow Agency protocols." Nevertheless, Graham's supervisor at the FDA said the paper that formed the basis of his testimony was "an excellent study and analysis of a complex topic." Sen. Charles Grassley (R-IA) said Crawford's comments were “intended [to] intimidate a witness on the eve of a hearing” Grassley recommended Crawford spend time "on the problem rather than going after congressional witnesses who helped identify the problem in the first place." . (http://finance.senate.gov/hearings/statements/111804cg.pdf) |
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Yoda Member
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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 [Chiron] vaccine manufacturing facility as early as June 2003, [the Food and Drug Administration] 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 are too cozy. (That is exactly the opposite of what it should be. The health and safety of the public must the FDA's first and only concern.") (http://democrats.reform.house.gov/Documents/20041117132027-14753.pdf) http://www.washingtonpost.com/ac2/wp-dyn/A58470-2004Nov17?language=printer) |
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Yoda Member
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FDA VISITED FLU PLANT IN JUNE 2003, FOUND HIGH LEVELS OF CONTAMINATION......... and looked the otherway? 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. (http://democrats.reform.house.gov/Documents/20041117132027-14753.pdf) |
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Yoda Member
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THE PRICE OF SAFETY How can the pharmaceutical companies get away with it? Over the past four years, the industry has contributed over $68 million to federal candidates -- including almost $1.5 million to President Bush. Pfizer, the manufacturer of Bextra -- a drug still on the market but singled out by Graham as potentially unsafe -- contributed over $120,000 to President Bush. (http://www.opensecrets.org/industries/indus.asp?Ind=H04) (http://www.opensecrets.org/industries/recips.asp?Ind=H04&Cycle=2000&recipdetail=A&Mem=N&sortorder=U) (http://www.opensecrets.org/indivs/search.asp?NumOfThou=0&txtName=&txtState=%28all+states%29&txtZip=&txtEmploy=Pfizer&txtCand=Bush&txt2004=Y&txt2000=Y&Order=N) . |
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Yoda Member
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"Merck has promptly disclosed the results of Merck-sponsored studies of Vioxx to the FDA, physicians, the scientific community and the media." -- Merck CEO Raymond V. Gilmartin, 11/18/04 (http://finance.senate.gov/hearings/testimony/2004test/111804RGtest.pdf) VERSUS "Long before drug was removed, risks were known to Merck and the FDA, senators are told." -- LA Times headline, 11/19/04 (http://www.latimes.com/news/nationworld/nation/la-na-vioxx19nov19,1,6906905.story?coll=la-headlines-nation) |
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