Thursday, November 18, 2004

DSHEA:  Is this the beginning of the end? THE DANGER IS REAL: WE COULD LOSE ALL OUR - VITAMINS SOON! (This just in from our Canadian friends): Despite our most valiant efforts, it looks like we're losing the fight with the EU to safeguard our vitamins and traditional medicines.  But throughout, we were always able to look to the USA as an example of consumer power over the large multi- nationals.  Back in the early 1990s, America's vitamin industry faced a similar threat to that being posed by the EU.  But there was such an outcry that Congress safeguarded vitamin supplies in the Dietary Supplement Health and Education Act of 1994 (DSHEA).  The deal was simple: don't make any health claims for the products on the labels, and you can freely distribute and sell them. There have been a few attempts to amend, or even overthrow DSHEA in the last couple of years, but they have so far failed. But the threat is getting stronger.  Last week the Food and Drug Administration (FDA) announced three major regulatory initiatives to change DSHEA. The FDA says it intends "to improve the transparency, predictability, and consistency of its scientific evaluations and regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false, or misleading claims". The process begins with a "signal detection".  Signals of a possible safety concern can come from Federal, state and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. This may sound reasonable enough, but we understand that it is anything but.  It will become open season for anyone to make claims about any supplement, which may quickly lead to its removal from the shelves. Our friends in the States have been warning us that once the EU restrictions were introduced, the USA would follow.  It's just happening sooner than even we thought. Perhaps we could negotiate for a black box warning instead. IF YOU CARE FOR YOUR HEALTH AND LIFE, COMTACT ALL YOUR REPRESENATIVES NOW 8:26:47 PM    comment [] CAN FDA-APPROVED PAIN-KILLERS TURN INTO HEART-KILLERS? NEW STUDY SAYS "YES" - Suggests How COX Drugs Cause Heart Disease Painkillers suspected of causing fatal heart disease may act by starting the process of hardening the arteries, researchers proposed on Thursday. http://story.news.yahoo.com/news?tmpl=story&;cid=571&ncid=751&e=1&u=/nm/20041118/hl_nm/health_cox_dc DRUG ALERT: If you thought Vioxx was bad, Bextra could be worse This is a special alert for anyone taking drugs for their arthritis, and especially if you are taking a COX-2 inhibitor, supposedly a safer option than the older NSAID painkillers, or a TNF-blocking drug for rheumatoid arthritis. You've probably all read about Vioxx being pulled after it was associated with heart problems, but there's more bad news in the offing for this new family of drugs.  After Vioxx disappeared, doctors quickly turned to another COX-2, Bextra, as their drug of choice, but this is already being linked to similarly serious problems. A pooled analysis of clinical trial results has shown patients taking Bextra were twice as likely to have a heart attack or stroke as those taking a placebo. In fact, an analysis of nearly 6,000 patients showed the risk of Bextra to be higher than Vioxx. The American drug regulator, the Food and Drug Administration (FDA), is so concerned by the latest findings that it is expected to order a complete review of the Cox-2 drugs.  It joins the European Medicines Evaluation Agency, which has already ordered a safety review. The FDA's move seems to be an attempt to redeem itself.  Regular readers will recall that the agency had approved the use of Vioxx among children just days before it was removed from the market.  This was an extraordinary decision for a drug that almost doubles the risk of heart attack and stroke in patients who had taken it for 18 months. The FDA reckons that Vioxx may have caused more than 27,000 heart attacks in the four years it has been on the market, of which 7,000 have been fatal. The agency is also concerned about another class of anti-arthritics, the TNF (tumour necrosis factor)-blocking drugs.  The TNF-blockers, which include Enbrel and Remicede, block the overproduction of TNF, an inflammation-regulating protein that medicine believes is behind the inflammation seen in rheumatoid arthritis. But the agency is worried by reports that the drugs may be linked to 170 cases of lymphoma that have cropped up among patients in the past five years. The agency has already asked manufacturers to include a box warning with its product information sheets.  As regular readers will know, the black box is a venomous device that usually puts big pharma in its place.  The warning has to appear in an emboldened typeface, and put in a box, thus ensuring that drug companies cannot kill and harm with impunity. *  So what are the safe - and effective - options if you have arthritis?  The WDDTY Arthritis Manual is the most comprehensive review of the condition, and all the treatments available.  Conventional and alternative therapies are assessed, based on all the available scientific data.  It's presented as a ring-bound manual that can be constantly updated.  To order your copy, click on this link: http://www.wddty.co.uk/shop/details.asp?product=366 7:47:16 PM    comment []

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