Senior FDA Scientist Removed -- for Voicing Concerns About Avandia
August 16, 2007
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The Food and Drug Administration (FDA) has reportedly removed a senior FDA scientist from work on diabetes drug Avandia because the unnamed scientist voiced concerns about the drug’s safety.
"This new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia," Congressional investigators said in a letter sent to the FDA.
Since 2005, the scientist, a medical officer who was once Avandia’s primary reviewer, believed that Avandia’s risks warranted a strong “black box” warning for its risk of congestive heart failure.
In May 2007, a study in the New England Journal of Medicine found that those taking Avandia had a 43 percent higher chance of having a heart attack.
The scientist was "sidelined after voicing safety concerns," the Congressional letter said, and “was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia.”
The FDA said it did ask for a black box warning for Avandia’s heart risks in June, and an outside advisory panel is meeting to discuss the risks further. The Agency has received the letter, according to FDA spokeswoman Julie Zawisza, and is planning to respond.
Avandia, made by GlaxoSmithKline Plc, brought in more than $3 billion in sales in 2006.
Reuters July 25, 2007
What Are GMOs?
From April 19th through April 25th we launch GMO Awareness Week. We set aside an entire week dedicated to providing you with information on GMOs and labeling initiatives.
GMOs are a product of genetic engineering, meaning their genetic makeup has been altered to induce a variety of “unique” traits to crops, such as making them drought-resistant or giving them “more nutrients.” GMO proponents claim that genetic engineering is “safe and beneficial,” and that it advances the agricultural industry. They also say that GMOs help ensure the global food supply and sustainability. But is there any truth to these claims? I believe not. For years, I've stated the belief that GMOs pose one of the greatest threats to life on the planet. Genetic engineering is NOT the safe and beneficial technology that it is touted to be.
Help Support GMO Labeling
The Grocery Manufacturers Association (GMA)—Monsanto’s Evil Twin—is pulling out all the stops to keep you in the dark about what’s in your food. For nearly two decades, Monsanto and corporate agribusiness have exercised near-dictatorial control over American agriculture. For example, Monsanto has made many claims that glyphosate in Roundup is harmless to animals and humans. However, recently the World Health Organization (WHO) had their research team test glyphosate and have labeled it a probable carcinogen.
Public opinion around the biotech industry's contamination of our food supply and destruction of our environment has reached the tipping point. We're fighting back. That's why I was the first to push for GMO labeling. I donated a significant sum to the first ballot initiative in California in 2012, which inspired others to donate to the campaign as well. We technically "lost the vote, but we are winning the war, as these labeling initiatives have raised a considerable amount of public awareness.
The insanity has gone far enough, which is why I encourage you to boycott every single product owned by members of the GMA, including natural and organic brands. More than 80 percent of our support comes from individual consumers like you, who understand that real change comes from the grassroots.
Thankfully, we have organizations like the Organic Consumers Association (OCA) to fight back against these junk food manufacturers, pesticide producers, and corporate giants.
Internet Resources Where You Can Learn More
Together, Let's Help OCA Get The Funding They Deserve
Let’s Help OCA get the funding it deserves. I have found very few organizations who are as effective and efficient as OCA. It’s a public interest organization dedicated to promoting health justice and sustainability. A central focus of the OCA is building a healthy, equitable, and sustainable system of food production and consumption. That's why I'm proud to announce I will be matching donations up to $250,000 this week.
Please make a donation to help OCA fight for GMO labeling.