[SecretsNowRevealed] another vioxx?

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At 08:18 AM 5/26/07, you wrote:

>After Vioxx, Avendia. Drugstory repeats itself. Jagannath Chatterjee

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>1. After Vioxx, Avendia. Drugstory repeats itself.

>Posted by: " Jagannath Chatterjee " jagchat01 jagchat01

>Fri May 25, 2007 7:29 am (PST)

>

>

>May 25, 2007

>Editorial

>http://www.nytimes.com/2007/05/25/opinion/25fri1.html?th & emc=th

>Ignoring the Warnings, Again? The latest findings on Avandia, a

>top-selling diabetes drug, raise concerns both about its safety and about

>the way the manufacturer and the Food and Drug Administration have

>responded to signs of danger. It would be rash to make definitive

>judgments until the F.D.A. completes a detailed analysis. But the handling

>of this case bears disturbing resemblances to the Vioxx debacle, in which

>early warning signs were ignored by its manufacturer until the evidence of

>serious harm became inescapable and the drug was pulled from the market.

>Avandia was approved for sale in 1999 based on studies showing that it

>could lower blood glucose levels in patients suffering from Type 2

>diabetes, also known as adult-onset diabetes. The assumption was that the

>drug could alleviate some of the most damaging effects of the disease,

>such as heart attacks and other cardiovascular ailments. But a paper just

>published in The New England Journal of Medicine suggests that Avandia may

>instead increase the risk of a heart attack by 43 percent and perhaps the

>risk of cardiovascular deaths as well.

>

>The study — an analysis of the combined results of 42 previous studies

>that compared people who took the drug with people who did not — is not

>definitive, and the absolute risk to any given patient is small. But the

>study points to a risk that could potentially harm thousands of patients a

>year. Its lead author was Steven Nissen, a cardiologist at the Cleveland

>Clinic, who blew the whistle on the cardiovascular risks of Vioxx, which

>adds to the sense of déjà vu.

>

>What’s most troubling is the possibility that early warning signs were not

>adequately heeded.

>

>Seven years ago a leading diabetes doctor warned the F.D.A. of “a

>worrisome trend in cardiovascular deaths,” two years later a safety

>monitoring group within the agency expressed concern over cases of heart

>failure in patients taking the drug. In late 2005 and again in August 2006

>the drug’s manufacturer — GlaxoSmithKline — informed the F.D.A. that its

>own combined analysis of various studies showed a 31 percent increase in

>adverse cardiovascular events. But the company also cited studies that it

>said showed no evidence of harm, and the F.D.A. concluded the findings

>were too mixed to take immediate regulatory action.

>

>Now, prodded by Dr. Nissen’s article, the agency has issued a safety

>alert, is completing its own safety analysis and will convene a panel of

>experts to review the data. The best hope for a definitive answer may lie

>in a clinical trial that won’t finish monitoring all enrolled patients

>until late next year.

>

>If the verdict goes against Avandia, the F.D.A. and Glaxo will have a lot

>to explain. Congress will need to probe hard to determine what risks the

>agency and the manufacturer were aware of and what they did — or didn’t do

>— to mitigate them.

>

>Copyright 2007 The New York Times Company

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>

>US: 1 in 150 children has Autism

>US: 1 in 6 children suffers a developmental disorder

>New Jersey: 1 in 94 has Autism

>UK: 1 in 86 has Autism

>

>China : Over 20 lakh autistic children,

>India : No authentic figures, expected one crore+ (1 in 250)

>AUTISM IS NOTHING BUT MERCURY POISONING.

>THERE IS MERCURY IN VACCINES!!

 

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