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Boston Scientific Begins Clinical Trial For Next-Generation Nitinol Stent To Treat Iliac Artery Disease
Boston Scientific Corporation (NYSE: BSX) announced the start of patient enrollment in the ORION clinical trial, which is designed to evaluate the Company"s EPIC(TM) Self-Expanding Nitinol Stent System for the treatment of iliac artery disease, a form of peripheral artery disease that impacts a patient"s lower extremities. The first U.S. patient was enrolled on May 14 by Nicolas W. Shammas, M.D., at Trinity Terrace Park Hospital in Bettendorf, Iowa.
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'SEE-ing' The Difference: Evaluation Shows $167 Million Investment Improves Community Mental Health System, But Many Still In Need
Can $167 million in provincial funding make a difference to Ontario"s community mental health system? According to the results from the Systems Enhancement Evaluation Initiative (SEEI), the answer is yes. Ontarians now have access to more appropriate community mental health services. But, the research also highlights the system"s limited res to serve all those in need.
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Health Reform Should 'Permanently Exclude' Funding Of Abortion Coverage, Family Research President Perkins Writes
"No matter what form of health care reform emerges from the current debates and discussion," Congress should include a "provision to the legislation to permanently exclude abortion from taxpayer-funded health care or health insurance," Family Research Council President Tony Perkins writes in a Politico opinion piece. Although some argue that the government "cannot or should not restrict benefits when it purchases insurance, the same way it does when reimbursing directly for medical procedures," that argument "already failed when it came up in the 1990s in the context of Medicaid managed care plans," Perkins writes, adding that the Hyde Amendment was "revised to cover them, as well." There also are arguments in Congress that "if people can opt for private health insurance that funds abortion and receive a tax break for their purchase of such insurance, then poor people dependent on direct government payments for their health insurance cannot be denied similar coverage," according to Perkins. However, "this presumes that there is no difference between what people may do with their own money and what they may do with the taxpayers" money," Perkins writes, adding that such an argument "makes sense only if we assume it"s all the government"s money in the end" (Perkins, Politico, 7/28).
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Watchdog May Sue Bayer Over Claim That Vitamin Pill Reduces Prostate Cancer Risk

US consumer watchdog Center for Science in the Public Interest (CSPI) has informed Bayer Healthcare that it will sue them and file a complaint with the Federal Trade Commission (FTC) if they continue to claim that the selenium in their One A Day vitamin tablet may reduce the risk of prostate cancer in men. CSPI said that Bayer"s advertisements and labels for their multivitamin product claim that "emerging research" suggests that the selenium they contain may reduce the risk of prostate cancer. The group announced its intention on Thursday, citing the claim made for products like One A Day Men"s 50+ Advantage and One A Day Men"s Health Formula, such as a radio advertisement that asks "Did you know that there are more new cases of prostate cancer each year than any other cancer?" and then says "Now there is something you can do." CSPI said leading researchers say there is little evidence to support such claims and have joined forces with the group in urging the FTC to stop them immediately. CSPI senior nutritionist David Schardt said Bayer was "ripping people off " by making unfounded claims. "The largest prostate cancer prevention trial has found that selenium is no more effective than a placebo," said Schardt, adding that the company was "exploiting men"s fear of prostate cancer just to sell more pills". CSPI litigation director Steve Gardner said: "With these indefensible claims, Bayer is thumbing its nose at the Food and Drug Administration, the FTC, and any number of state consumer protection laws." "A courtroom would be treacherous territory for Bayer, whose executives would be committing perjury just by reciting their ads under oath," said Gardner. The CSPI announcement referred to two trials that showed selenium was not effective in preventing prostate cancer. The first was a 7-year 118 million-dollar study funded by the National Institutes of Health that last year concluded that selenium did not prevent prostate cancer in healthy men. The second was a trial of 35,000 US and Canadian men (the Selenium and Vitamin E Cancer Prevention Trial, SELECT) that finished early when it found selenium was not preventing men from getting prostate cancer and may even have been causing diabetes in some of them. According to the CSPI, the only evidence that selenium might prevent prostate cancer in men was the results of the 1996 NPC (Nutritional Prevention of Cancer) trial that appeared to show selenium might prevent prostate cancer in men with a history of skin cancer, but on re-analysis showed the benefit was conferred only to a small proportion of men, and more importantly, the supplement was also linked to a tripling of diabetes risk. In an editorial in the same issue of the Journal of the American Medical Association, JAMA where the SELECT trial results appeared, Peter Gann of the University of Illinois at Chicago stressed that: "Physicians should not recommend selenium or vitamin E -- or any other antioxidant supplements -- to their patients for preventing prostate cancer." This also led the American College of Physicians to warn that "long-term selenium supplementation should not be viewed as harmless and a possibly healthy way to prevent illness," said the CSPI. Trish McKernan, spokeswoman for Bayer told CNN that the company was "standing behind all the claims we make in support of the products". The selenium claims were made by an FDA approved qualified health claim, she said, adding that: "We regularly review the evidence, and we change our claims if necessitated. The emerging science hasn"t compelled us to change our claims, and the FDA claim is intact." As well as threatening to sue the company, the CSPI has written a strong letter to the FTC about Bayer"s claims, and separately, leading US prostate cancer research scientists, including Peter Gann, have done the same. They wrote that: "Bayer Healthcare is doing a disservice to men by misleading them about a protective role for selenium in prostate cancer." CSPI has negotiated settelements or changes to marketing practices with several large companies in recent years, including: Kellogg, Frito-Lay, Airborne, Quaker Oats, Anheuser-Busch, and Pinnacle Foods. s: CSPI, CNN. Written by: Catharine Paddock, PhD Copyright: Medical News Today Not to be reproduced without permission of Medical News Today


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