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To: coyote who wrote (2013)	5/12/1999 2:53:00 PM
From: Dan Spillane	Respond to of 2539

Arthritis drug linked to serious infection Hmmm, Enbrel more dangerous than many thought. Note they say ANY active infection, "including chronic or localized infections"... This would include even a cut on the hand?!? (from story below) ''Because of new information obtained from adverse reaction reports to FDA and Immunex, the warning related to sepsis has been expanded to include patients with any active infection, including chronic or localized infections,'' according to the FDA. (full story) Wednesday May 12 2:24 PM ET Arthritis drug linked to serious infection NEW YORK, May 12 (Reuters Health) -- The recently approved arthritis drug, etanercept (Enbrel), may increase the chance of potentially life-threatening infections in some patients with rheumatoid arthritis, according to a warning issued Wednesday by the Food and Drug Administration (FDA). The drug, a genetically engineered protein, was approved for the treatment of moderate to severe, active rheumatoid arthritis (RA). The FDA notes that the drug ''can significantly reduce pain and swollen joints in people disabled with RA.'' But it is also known to suppress tumor necrosis factor, an important infection-fighting protein produced by immune system cells. Of an estimated 25,000 people given the drug, 30 have developed serious infections and 6 have died. Although people with rheumatoid arthritis are prone to infections, and many of the patients had a history of chronic infections, the deaths occurred within 2 to 16 weeks after starting treatment with Enbrel. This suggests that ''significant concerns remain that Enbrel may contribute to the occurrence of serious infections,'' according to a statement issued by the FDA. The drug's manufacturer, Immunex Corporation (Nasdaq:IMNX - news) of Seattle, Washington, along with Wyeth-Ayerst Laboratories in Philadelphia, Pennsylvania, is sending a letter to physicians to alert them of the potential risks. Etanercept was approved in November of 1998 for treatment of rheumatoid arthritis, an autoimmune disease that usually strikes between the ages of 36 and 50 and is characterized by painful inflammation and joint destruction. At that time, the drug was considered inappropriate for patients with sepsis, a widespread blood infection, or those who developed a serious infection. ''Because of new information obtained from adverse reaction reports to FDA and Immunex, the warning related to sepsis has been expanded to include patients with any active infection, including chronic or localized infections,'' according to the FDA. The agency suggests that doctors use caution in prescribing the drug to patients who are free of infection, but have a history of recurrent infections, or who have underlying conditions, such as diabetes, that increase their infection risk.

To: coyote who wrote (2013)	5/12/1999 6:55:00 PM
From: Dan Spillane	Read Replies (3) \| Respond to of 2539

Born in the USA, 1 May 1999 They're big, lean and cheap, so why does Europe hate them so much? BE THANKFUL the Kosovo war has nothing to do with food. If it did, Brussels and Washington would fall out immediately. So far this year, they have managed to clash over bananas and the segregation and labelling of GM foods. And now daggers are being drawn over hormones in beef (see p 15). Like many such battles, the background sounds simple enough, but all is definitely not what it seems. American beef producers have been merrily feeding steroid hormones to their cattle since the 1970s. When Europe banned the practice a decade ago it also closed the door to imports of hormone treated beef. The World Trade Organization has now called time on the ban, which the US, with one eye on the export ambitions of its GM food industry, is keen to overturn in the name of free trade. So Europe is upping the ante by attempting to do to American prime cuts what environmental groups have done to GM crops--creating the impression they're unsafe to eat. Are they? The scientific evidence to date suggests not. In 1995, the UN concluded that none of the growth hormones routinely used by American cattle farmers posed a health risk to consumers when used responsibly. In any case, three of the hormones, including testosterone and progesterone, are present in ordinary beef and at levels not hugely different from those in most hormone-fed cattle. So if you're going to argue that high-tech steaks from Wyoming can boost cancer rates, be prepared to admit that, to some extent, so can beef from Scotland. Given this "relative risk" catch, why is Brussels so keen to dig up evidence of harm? Partly because it doesn't trust cattle farmers to use the hormones sensibly--and, after BSE, why should it? But the main reason is economic. If Brussels gave the green light to all those cheap Wyoming steaks, Europe's farmers would struggle to compete and perhaps demand the hormones for their cattle. The result would be a beef glut, with many small producers going to the wall. This, alas, is not an argument you can make when you've signed up to a free trade agreement. Solution? Bring on the scientists and tell them to play the safety card for all it's worth. Europe's war on hormones in beef may be just, but there's something phoney about how it's being waged. From New Scientist, 1 May 1999