Guest guest Posted January 17, 2005 Report Share Posted January 17, 2005 Hello List members, Drug safety- Saturn on Rahu..Scandals and drugs, Cancer chart.. Aloha, Sally Senator Chuck Grassley, an Iowa Republican who held hearings on recent F.D.A. actions, said, "At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us." The Celebrex disclosure came on the heels of a decision by Merck to withdraw its arthritis drug Vioxx from the market after a study showed a link between long-term use of the drug and an increased risk of heart attacks and strokes. Two weeks ago, an article in The British Medical Journal suggested that Eli Lilly & Company had long concealed evidence that the antidepressant Prozac could cause violent and suicidal behavior. The company denies the accusation, which the journal forwarded to the F.D.A. Connie Gipple, President HealthQuest International A Gift for Drug Makers By Bob Herbert Published: January 14, 2005 Vioxx, Celebrex, Prozac. ... With all the problems and the bad publicity that drug companies have been facing recently, you might think that this would not be a good time for the Bush administration to toss yet another bonanza their way. But the administration is like an ardent lover in its zeal to shower the rich and powerful with every imaginable benefit. So tucked like a gleaming diamond in proposed legislation to curb malpractice lawsuits is a provision that would give an unconscionable degree of protection to firms responsible for drugs or medical devices that turn out to be harmful. The provision would go beyond caps on certain damages. It would actually prohibit punitive damages in cases in which the drug or medical device had received Food and Drug Administration approval. We know the F.D.A. has failed time and again to ensure that unsafe drugs are kept off the market. To provide blanket legal protection against punitive damages in such cases is both unwarranted and dangerous. We learned just last month that Celebrex, the phenomenally popular painkiller from Pfizer, more than tripled the risk of heart attacks, strokes and death among those taking high doses in a national trial. Those findings, "raised new questions about how well federal drug regulators protect the public and worsened drug makers' already dismal image." Senator Chuck Grassley, an Iowa Republican who held hearings on recent F.D.A. actions, said, "At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us." The Celebrex disclosure came on the heels of a decision by Merck to withdraw its arthritis drug Vioxx from the market after a study showed a link between long-term use of the drug and an increased risk of heart attacks and strokes. Two weeks ago, an article in The British Medical Journal suggested that Eli Lilly & Company had long concealed evidence that the antidepressant Prozac could cause violent and suicidal behavior. The company denies the accusation, which the journal forwarded to the F.D.A. If the malpractice legislation so relentlessly touted by President Bush became law, Pfizer, Merck and Eli Lilly would be immunized against even the possibility of punitive damages arising from any harm to patients that resulted from use of these drugs - as long as the companies followed F.D.A. rules. All three drugs were approved by the F.D.A. The whole idea behind punitive damages is to severely punish the most egregious offenders. Huge punitive damage awards are supposed to serve as a deterrent to extremely bad behavior. "It's an important system to have in place," said Joanne Doroshow, executive director of the Center for Justice and Democracy, a nonprofit consumer advocacy group. "The F.D.A. is certainly not doing its job. The legal system is a very important backup. It's really the last line of defense to ensure that the marketplace only has safe products." If Mr. Bush has his way, that line of defense will be substantially weakened. With the possibility of punitive damages eliminated, drug companies will be even less vigilant than they are now about problems with products that pose a serious - even fatal - threat to patients. The Democratic leader in the Senate, Harry Reid of Nevada, was blunt on the matter. He said, "Congress should not be giving a free pass to big drug companies at a time when millions of Americans may have had their health put at risk by pharmaceutical giants." The drug companies have an incredible racket going, as Marcia Angell, the former editor in chief of The New England Journal of Medicine, documents in her book "The Truth About the Drug Companies." "Now primarily a marketing machine to sell drugs of dubious benefit," she wrote, "this industry uses its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the Food and Drug Administration, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)" Among those co-opted is the president himself. Nothing's too good for the drug companies. If ordinary Americans got the same sweet treatment from this administration as the great pharmaceutical houses, we'd all be in a much better place. FDA is "Virtually Incapable of Protecting You From Unsafe Drugs" Most people are familiar with the scrupulous claims against the FDA's inability to protect Americans from unsafe drugs. It has been an issue flooding the headlines of newspapers and the nightly news for the past few months. Accusations against the FDA started when Merck was pulled Vioxx from the market in 2004. Apparently the FDA had been aware of the drug's adverse side effects as early as 1999. Since Vioxx's removal, other drugs have been placed under the microscope and the agency's credibility has been questioned. One FDA drug safety reviewer, Dr. David Graham, told a Congressional panel that federal drug regulators were "virtually incapable of protecting America." Previously "Approved" Drugs in Question a.. Crestor (cholesterol-lowering drug): Causes acute kidney failure b.. Bextra (painkiller): Increases risk of heart attack in those undergoing cardiac surgery and may also cause a fatal skin reaction c.. Meridia (weight-loss pill): Causes substantial increases in blood pressure and has been associated with 124 reports of serious cardiovascular problems d.. Serevent (asthma medication): Increases risk of asthma-related deaths and life-threatening episodes e.. Accutane (acne drug): Causes birth defects The director of the FDA's Center for Drug Evaluation and Research opposed Graham's accusations; arguing Graham's findings and numbers "constitute junk science" and were nonetheless "irresponsible." The director continued on by stating that all of the agency's decisions and drugs are not only safe but also effective. New York Times - November 19, 2004 ********************* Important Announcements OPC Plus An Exceptional Antioxidant Boost We are pleased to announce a product improvement… HQI OPC PLUS Now Features Grape Seed Extract Standardized to 95% Polyphenols - The Highest Guaranteed Amount Available! Also Includes: a.. Milk Thistle - Antioxidant that assists in protecting the liver. a.. Bilberry - Antioxidant that assists in protecting the eyes. a.. CoQ10 - Antioxidant that assists in protecting the heart. Oligomeric proanthocyanidins (OPC's) featured in HQI OPC Plus are some of the strongest antioxidants known today. These bioflavonoid complexes are 50 times stronger than vitamin E and 20 times stronger than vitamin C. Questions: HQI Distributor Services – 847-836-3010 – Mon thru Fri 9-5 cst *********** Did You Know? Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an estimated 7600 deaths and 76,000 hospitalizations in the U.S. each year. Alternative Medicine, March 2003 See our new health facts: http://www.hqintl.net/didyouknow.cfm Submit your health facts to info Quote Link to comment Share on other sites More sharing options...
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