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	<title>Lower Cholesterol &#187; Health</title>
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		<title>Government recalls faulty HIV test kits</title>
		<link>http://lowercholesterol.frasil.com/government-recalls-faulty-hiv-test-kits/</link>
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		<pubDate>Tue, 10 Jan 2012 04:52:46 +0000</pubDate>
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		<description><![CDATA[Dodoma, Tanzania (IRIN) &#8211; Tanzanian health authorities have announced the withdrawal of a South Korean HIV test kit from circulation following warnings about its poor quality. In November, the UN World Health Organization removed the Standard Diagnostics Bioline&#38;reg; HIV 1/2 3.0 Rapid HIV Test Kit from its list of approved rapid test kits with immediate [...]]]></description>
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<p>Dodoma, Tanzania (IRIN) &#8211; Tanzanian health authorities have announced the withdrawal of a South Korean HIV test kit from circulation following warnings about its poor quality.</p>
<p> In November, the UN World Health Organization removed the Standard Diagnostics Bioline&amp;reg; HIV 1/2 3.0 Rapid HIV Test Kit from its list of approved rapid test kits with immediate effect; the alert was issued after Bioline failed quality assurance tests.</p>
<p> The Tanzanian government has followed neighboring Kenya in issuing an immediate recall of all Bioline testing kits in the country.</p>
<p> &#8220;What we know so far is that 1,178 test kits have been used in the field, but we have yet to substantiate exactly how many of them were defective,&#8221; Hadji Mponda, Tanzania&#8217;s Health Minister, said at a news conference on 5 January.</p>
<p> jk/kr</p>
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<p> &#8211; Provided by <a rel="nofollow" target="_blank" href="http://www.irinnews.org" target="_blank">Integrated Regional Information Networks.</a></p>
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<p>View full post on <a rel="nofollow" target="_blank" href="http://www.feedsyndicate.com/articles/7037531695">Health Treatment Stories</a></p>

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		<title>More American patients seek treatment abroad to escape high medical costs</title>
		<link>http://lowercholesterol.frasil.com/more-american-patients-seek-treatment-abroad-to-escape-high-medical-costs/</link>
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		<pubDate>Tue, 01 Nov 2011 04:45:46 +0000</pubDate>
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		<description><![CDATA[Tom Ramstack &#8211; AHN News Legal Correspondent Washington, D.C., United States (AHN) &#8211; The number of Americans heading abroad for medical care rose sharply last year amid high health care costs and a poor economy in the United States, according to medical tourism industry figures. Some of their preferred locations for life-saving surgeries and other [...]]]></description>
			<content:encoded><![CDATA[<div>Tom Ramstack &#8211; AHN News Legal Correspondent</div>
<p>Washington, D.C., United States (AHN) &#8211; The number of Americans heading abroad for medical care rose sharply last year amid high health care costs and a poor economy in the United States, according to medical tourism industry figures.</p>
<p> Some of their preferred locations for life-saving surgeries and other procedures are India and Mexico, the health information company Health Digital Systems reported.</p>
<p> Surgeries like hip replacements, dental implants and heart bypasses can cost half as much in Southeast Asia and Latin America compared with the United States.</p>
<p> Among the six million Americans who traveled abroad for medical care last year, 45 percent traveled to Asia, 26 percent to Latin America and 2 percent to the Middle East, according to industry statistics.</p>
<p> Health care officials in the countries treating foreigners are upbeat about their patients. Medical tourism, primarily from the United States and Europe, represents a nearly $100 billion a year industry.</p>
<p> Mexico&#8217;s Health Ministry recently produced a report saying &#8220;the globalization of health services can offer excellent medical care at lower costs than developed countries.&#8221;</p>
<p> The health ministry has developed a strategic plan to encourage medical tourism by continuing &#8220;the effort to improve the perception of public safety and promote [Mexico's] image as a global capital of culture and entertainment.&#8221;</p>
<p> Any success by Mexico&#8217;s health providers in reaching American patients is most obvious in border cities like Monterrey, Tijuana and Chihuahua, according to the Health Digital Systems. Pharmacies, hospitals and medical specialty practices have sprung up to take care of them.</p>
<p> However, patients also assume risks by trusting their health care to foreign medical standards.</p>
<p> Only 2 percent of Mexico&#8217;s hospitals have earned &#8220;Joint International Commission&#8221; certification.</p>
<p> The certification means a hospital and its staff have met international standards that would allow them to be reimbursed by foreign medical insurance companies.</p>
<p> India&#8217;s medical tourism industry is losing patients to competing hospitals in Singapore, Thailand and Malaysia amid concerns about poor sanitation.</p>
<p> Indian hospitals have been struggling with a &#8220;superbug&#8221; that is resistant to disinfectant.</p>
<p> As a result, some patients are reporting they become sick when they enter Indian hospitals for other treatments.</p>
<p> Nevertheless, the discount price of foreign medical treatment is creating a backlog of patients for hospitals with good reputations.</p>
<p> Mediescape, an Indian medical tourism company, reports that India&#8217;s hospitals offering medical services to patients from the United States and Europe say their booked up to December.</p>
<p> Between 15 percent and 20 percent of India&#8217;s hospital income now comes from medical tourism, according to industry data.</p>
<p> There were 800,000 foreign patients in India last year. They are expected to generate a $3 billion a year industry for India by 2015, up by more than a third from 2010.</p>
<p> Behind the figures on rising medical tourism is the desperation of patients who cannot afford health care in the United States, where about 40 percent of the population lacks adequate medical insurance, according to U.S. government statistics.</p>
<p> Some Americans are even treating themselves for serious ailments, not always with successful outcomes, according to a recent survey by TMD Limited, a medical tourism company.</p>
<p> &#8220;Today we are seeing many breast cancer patients that self-treated for years,&#8221; said Antonio Jimenez, a doctor raised in New Jersey who now runs the Hope4Cancer Institute in Mexico&#8217;s Baja California. &#8220;Unfortunately, cancer treatment is not a do-it-yourself project.&#8221;</p>
<p> Many of the women search for treatments on the Internet.</p>
<p> &#8220;We see more and more women who have spent thousands of dollars on supplements and wonder cures they used at home,&#8221; Jimenez said. &#8220;When those treatments fail, they look for a clinic that can help.&#8221;</p>
<p> The American Cancer Society reports that 230,480 American women will be diagnosed with breast cancer this year. Of those, 39,520 will die.</p>
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		<title>Oakland clinic provides medical care to ex-offenders</title>
		<link>http://lowercholesterol.frasil.com/oakland-clinic-provides-medical-care-to-ex-offenders/</link>
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		<pubDate>Tue, 20 Sep 2011 04:48:51 +0000</pubDate>
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		<description><![CDATA[Oakland, CA, United States (KaiserHealth) &#8211; Most former inmates leave California prisons with no consistent place to get medical care. Instead, they rely on a scattershot of county-funded clinics or end up at county emergency rooms. But in California, that&#8217;s beginning to change. The state negotiated with the Obama administration to gain early access to [...]]]></description>
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<p>Oakland, CA, United States (KaiserHealth) &#8211; Most former inmates leave California prisons with no consistent place to get medical care. Instead, they rely on a scattershot of county-funded clinics or end up at county emergency rooms. But in California, that&#8217;s beginning to change.</p>
<p> The state negotiated with the Obama administration to gain early access to funds available under the federal health law. Starting last month, counties began enrolling all low-income residents &#8212; including ex-offenders &#8212; into a version of Medi-Cal.</p>
<p> Ex-convict Darren Thurmond wears a prison-issued grey sweat suit, stretched tightly over his large belly and carries a crumbled brown paper bag, as he climbs out of the prison van stopping just outside the metal gates of San Quentin.</p>
<p> Waiting for him is Don Williams &#8211; a counselor from a local health clinic who&#8217;s here to give Thurmond a ride to Oakland.</p>
<p> &#8220;I&#8217;m not sure how many times I can do this, man,&#8221; Thurmond says to Williams.</p>
<p> Thurmond has been in and out of prison in the last twenty years for cocaine and methamphetamine possession. Now at age 45, all the drug use and hard living has damaged his heart.</p>
<p> Like many ex-convicts, he says hasn&#8217;t had health insurance since he was a kid, and his heart problems were first diagnosed and brought under control in prison. But each time Thurmond gets out, he&#8217;s left with a 4-week supply of medication and no insurance. Now that&#8217;s changing.</p>
<p> With the early expansion of health coverage this summer, former inmates will be covered for preventive care, prescription drugs, specialty visits and mental health and substance abuse. One place where Thurmond will now get care is at the non-profit Healthy Oakland, his first stop after his release from prison.</p>
<p> This is one of the few clinics in the state that offers medical care to ex-convicts who have typically been excluded from public insurance programs like Medi-Cal.</p>
<p> Thurmond sits down for a full medical checkup with George Pearson, the clinic&#8217;s physician assistant. They discuss his heart problems, his weight and the painful arthritis that&#8217;s overtaking Thurmond&#8217;s hips.</p>
<p> Pearson says a 45-year old ex-convict will often have the ailments of someone 10 years older. They have higher rates of almost all chronic conditions, like high blood pressure, diabetes and asthma. To be sure, these ailments stem from living a hard life, but it&#8217;s also because they have common medical problems that go untreated.</p>
<p> &#8220;So the hypertension becomes heart failure. The diabetes becomes diabetic neuropathy, which can lead to amputation, even blindness,&#8221; Pearson says.</p>
<p> Researchers say that when these pervasive problems are left untreated, they can lead right back to prison or jail, and that giving ex-offenders health insurance and assigning them a regular doctor brings some order to their chaotic lives.</p>
<p> &#8220;Their whole life is transitional. And it lacks stability. You need a facility that&#8217;s going to be the home of their records, [that's] going to know them as a person,&#8221; Pearson says. Having a regular health care provider can prevent ex-offenders from over utilizing the ER.</p>
<p> <strong>Expansion of Care in Some Counties</strong></p>
<p> Some county health departments are using the new federal money to re-structure their safety nets to provide a fuller array of services. For example, Alex Briscoe of the Alameda County public health department says he&#8217;s adding mental health specialists to primary care clinics.</p>
<p> &#8220;Historically, services for this population are fragmented and tend to be episodic. And what we&#8217;re trying to do is prepare for health reform by assigning all consumers in our system, all clients in our system, to a medical home.&#8221;</p>
<p> Those preparations are especially important as California begins to comply with a court order to reduce its state prison population. To relieve overcrowding, tens of thousands of lawbreakers are expected to be put on probation in their home towns instead of going to state facilities. That means even more ex-offenders signing up for the expanded health coverage.</p>
<p> However, health researchers say the new enrollees will likely only add to a maxed out Medi-Cal system. Wait times for specialists have long plagued Medi-Cal across California, largely due to the state&#8217;s low reimbursement rate.</p>
<p> Still, providing coverage is important for public health, experts say. Emily Wang of the Yale School of Medicine says many former inmates return home with communicable diseases.</p>
<p> &#8220;Treating substance abuse, HIV, hepatitis C will reduce the disease rates in our communities,&#8221; she says.</p>
<p> But Wang and others say health insurance though is no magical cure for a group of people with more pressing, every day needs.</p>
<p> After Darren Thurmond finished his doctor&#8217;s visit at Healthy Oakland, this reporter drove him to a pharmacy to pick up his many prescriptions. By bus, this trip would&#8217;ve taken an hour, plus a painful walk with his arthritic hips.</p>
<p> Afterward, we headed to a Mexican restaurant in downtown Oakland for lunch. Thurmond says he had fantasized in prison about authentic enchiladas.</p>
<p> He&#8217;s thankful that he now has a regular doctor, he says. But he&#8217;s homeless. Living in his van, he&#8217;s unsure how he&#8217;ll get to his appointments to get his blood work checked or his prescriptions refilled.</p>
<p> &#8220;Being homeless, often I have the time to do it, but I don&#8217;t have the gas to get there,&#8221; Thurmond says.</p>
<p> For now, Thurmond is thinking pragmatically. On his first day out of San Quentin the basics are his main concerns: finding a job, getting money for food and gas, and a place to shower. &#8220;I&#8217;m pretty resourceful,&#8221; he says with no hint of pity. &#8220;I know a few places where I can shower.&#8221;</p>
<p> <em>Alex Liu contributed to this story.</em></p>
<p> &#8211; Provided by <a rel="nofollow" target="_blank" href="http://www.kaiserhealthnews.org" target="_blank">Kaiser Health News.</a></p>
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		<title>Soaring Health Costs Pinned On Medical Devices</title>
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		<pubDate>Tue, 07 Jun 2011 21:58:29 +0000</pubDate>
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		<description><![CDATA[United States (KaiserHealth) &#8211; While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending. The device industry has launched an aggressive campaign to avoid tighter [...]]]></description>
			<content:encoded><![CDATA[<div></div>
<p>United States (KaiserHealth) &#8211; While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending.</p>
<p> The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices &#8211; from heart valves and defibrillators to artificial knees and hips &#8211; are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.</p>
<p> Many medical specialists say tighter rules are needed to ensure newer devices are safe and effective, which could help hold down costs. &#8220;Better regulation of medical devices has the potential to reduce health care costs,&#8221; said Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. &#8220;New devices are often more complex and expensive than existing products, but may not offer any improvements in health outcomes. The current regulatory approach allows these devices to reach the market with little or no clinical data.&#8221;</p>
<p> &#8220;Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,&#8221; said Rita Redberg, editor of the <em>Archives of Internal Medicine</em> and a cardiologist at the University of California, San Francisco. &#8220;There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.&#8221;</p>
<p> Despite the cry for tighter rules, think tanks funded by industry in recent weeks have released several studies claiming that the FDA is standing in the way of improved devices getting to market. Congress is holding hearings to investigate the issue. And a third of the members of the House has signed a letter calling for legislation that would roll back a small excise tax that proponents claim is choking off &#8220;innovation.&#8221;</p>
<p> The 2.3 percent tax projected to generate $20 billion over the coming decade was part of the health care reform law and was similar to excise taxes slapped on the drug and insurance industries, which have not launched similar campaigns. All three industries are among the most profitable in America.</p>
<p> The controversy has important regional political significance because many of the device manufacturers are major employers in the Midwest &#8211; especially in Minnesota, Ohio, and Indiana. With the backing of Midwestern lawmakers, the industry is fighting back. Rep. Erik Paulsen, R-Minn., whose district abuts the headquarters of industry giant Medtronic, last week released a letter with 154 co-signers, including four Democrats, that called for repealing the $2 billion-a-year tax.</p>
<p> &#8220;Device manufacturers will have to cut R&amp;D or may be forced to lay off employees due to this disastrous tax,&#8221; the letter said.</p>
<p> Proponents of the industry warn that what they describe as hostile government action could lead to a loss of jobs. Moreover, some manufacturers claim that they are looking overseas for a more permissive regulatory environment. There are over 8,000 medical device companies in the U.S.; they generated about $136 billion in sales and employed over 422,000 last year, according to industry officials.</p>
<p> While the industry did better than the economy as a whole through the recession, losing only 1.1 percent of its jobs compared with nearly 5 percent of all manufacturing workers, its job performance lagged behind the rest of the health-care economy, which added employment throughout the downturn.</p>
<p> Two years ago, the medical device industry, which manufactures everything from heart valves to ace bandages, came under tougher scrutiny. The FDA had become more aggressive overseeing the industry in response to criticism that it had repeatedly caved to corporate and political pressure when approving new products. After health-care reformers targeted the industry for higher taxes to help pay for covering the uninsured, Democratic leaders in Congress asked the prestigious Institute of Medicine (IOM) to convene a blue-ribbon panel to determine if the industry needed tougher regulations to ensure the safety and effectiveness of its products. With the IOM&#8217;s final report due later this month, the industry is mounting a major public relations offensive to blunt calls for stronger oversight.</p>
<p> The Institute for Health Technology Studies, which is primarily funded by the industry, late last month released an industry survey showing American companies are increasingly going to Europe to get new devices approved. Industry executives also claimed that the FDA in the last few years has arbitrarily toughened its standards for new devices that are similar to products already on the market. In the past, those look-alike products usually received a less rigorous review than brand new medical innovations.</p>
<p> &#8220;As the FDA considers regulatory revisions, what&#8217;s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace,&#8221; said John Linehan, a professor of biomedical engineering at Northwestern University and lead author of the survey.</p>
<p> Paulsen, the Minnesota lawmaker, cited the example of Xtent, a Menlo Park, Calif., device maker that tried to gain approval to start a U.S. clinical trial for its coronary stent. Surgeons had already inserted the company&#8217;s stent in hundreds of European patients. When the FDA refused to consider data from the European experiences and insisted on a prospective clinical trial, the company closed its doors and sold the technology to foreign investors.</p>
<p> Last week, the House Oversight and Government Reform Committee called in the FDA&#8217;s top device regulator to explain the changes underway at the agency, which Republican members claimed had gone too far. &#8220;In some cases, the conveyor belt for medical devices has come to a grinding halt,&#8221; charged Rep. Trey Gowdy, R-SC., who chairs the health subcommittee.</p>
<p> Jeffrey Shuren, a lawyer and physician who 18 months ago replaced the previous head of the troubled Center for Devices and Radiological Health at FDA, promised to &#8220;do a far better job to make the process more efficient without compromising our standards for safety and efficacy.&#8221;</p>
<p> Earlier this year, the FDA proposed new rules that would give companies more certainty about what would be expected from them when bringing new products to the agency. But it postponed consideration of any major changes in the oversight process pending the IOM report, which could propose companies do more clinical trials proving efficacy for follow-on devices.</p>
<p> The current rules are a product of the 1976 law that ushered in the modern era of medical device regulation. They require any new device whose failure would pose a serious risk to public health to go through rigorous clinical trial testing in humans for both safety and effectiveness before going on the market. But the law also set up a regulatory scheme, known as the 510(k) process, which allows follow-on devices deemed substantially similar to something already on the market to get approved without the same level of testing. Regulators have discretionary power to order more tests.</p>
<p> The vast majority of new devices use the follow-on process, even though their manufacturers often claim superior performance to the older models and charge accordingly. The result is a lack of scientific data for making those comparisons, which leaves Medicare, private insurers and physicians in the dark as to their relative worth.</p>
<p> The regulatory framework for potentially life-saving devices differs from drugs, where follow-on products &#8211; say, the four or fifth statin to come to market for lowering cholesterol &#8211; must still go through rigorous clinical trial testing. While that doesn&#8217;t meet the gold standard of head-to-head comparisons between competing products, at least that gives medical analysts sufficient information to know if one drug is significantly better or worse than another product in the same class.</p>
<p> Safety issues can arise when there are no clinical trials for follow-on devices. And that also contributes to rising health care spending, since it can result in costly recalls or even follow-on operations to replace faulty devices. The updated devices often change materials or tweak the engineering, which can alter their performance once put in the body or deployed in health care settings.</p>
<p> A study published earlier this year in <em>Archives of Internal Medicine</em> found that of 113 major product recalls between 2005 and 2009, only&#8217; percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.</p>
<p> &#8220;Yes, the FDA&#8217;s getting tougher and it&#8217;s long overdue,&#8221; said the study&#8217;s lead author, Diana Zuckerman, executive director of the National Research Center for Women and Families. &#8220;Too many things were sailing through without clear evidence they were safe and effective.&#8221;</p>
<p> She cited last December&#8217;s recall of 359 million glucose test strips manufactured by Abbott Laboratories, whose malfunction could give diabetics false readings and lead to under or over-medication. Last week Redberg of UCSF told the oversight subcommittee to reject calls for speeding up the regulatory review process in the name of fostering greater innovation. She cited a 2009 Government Accountability Office report that found that a majority of high-risk devices do not go through clinical trial testing prior to marketing. &#8220;Only high-quality clinical trials can assure safety and effectiveness, especially when it comes to high risk devices that are used with invasive procedures,&#8221; she said.</p>
<p> &#8211; Provided by <a rel="nofollow" target="_blank" href="http://www.kaiserhealthnews.org" target="_blank">Kaiser Health News.</a></p>
<div>
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		<title>Soaring Health Costs Pinned On Medical Devices</title>
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		<pubDate>Tue, 07 Jun 2011 21:58:29 +0000</pubDate>
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		<description><![CDATA[United States (KaiserHealth) &#8211; While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending. The device industry has launched an aggressive campaign to avoid tighter [...]]]></description>
			<content:encoded><![CDATA[<div></div>
<p>United States (KaiserHealth) &#8211; While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending.</p>
<p> The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices &#8211; from heart valves and defibrillators to artificial knees and hips &#8211; are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.</p>
<p> Many medical specialists say tighter rules are needed to ensure newer devices are safe and effective, which could help hold down costs. &#8220;Better regulation of medical devices has the potential to reduce health care costs,&#8221; said Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. &#8220;New devices are often more complex and expensive than existing products, but may not offer any improvements in health outcomes. The current regulatory approach allows these devices to reach the market with little or no clinical data.&#8221;</p>
<p> &#8220;Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,&#8221; said Rita Redberg, editor of the <em>Archives of Internal Medicine</em> and a cardiologist at the University of California, San Francisco. &#8220;There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.&#8221;</p>
<p> Despite the cry for tighter rules, think tanks funded by industry in recent weeks have released several studies claiming that the FDA is standing in the way of improved devices getting to market. Congress is holding hearings to investigate the issue. And a third of the members of the House has signed a letter calling for legislation that would roll back a small excise tax that proponents claim is choking off &#8220;innovation.&#8221;</p>
<p> The 2.3 percent tax projected to generate $20 billion over the coming decade was part of the health care reform law and was similar to excise taxes slapped on the drug and insurance industries, which have not launched similar campaigns. All three industries are among the most profitable in America.</p>
<p> The controversy has important regional political significance because many of the device manufacturers are major employers in the Midwest &#8211; especially in Minnesota, Ohio, and Indiana. With the backing of Midwestern lawmakers, the industry is fighting back. Rep. Erik Paulsen, R-Minn., whose district abuts the headquarters of industry giant Medtronic, last week released a letter with 154 co-signers, including four Democrats, that called for repealing the $2 billion-a-year tax.</p>
<p> &#8220;Device manufacturers will have to cut R&amp;D or may be forced to lay off employees due to this disastrous tax,&#8221; the letter said.</p>
<p> Proponents of the industry warn that what they describe as hostile government action could lead to a loss of jobs. Moreover, some manufacturers claim that they are looking overseas for a more permissive regulatory environment. There are over 8,000 medical device companies in the U.S.; they generated about $136 billion in sales and employed over 422,000 last year, according to industry officials.</p>
<p> While the industry did better than the economy as a whole through the recession, losing only 1.1 percent of its jobs compared with nearly 5 percent of all manufacturing workers, its job performance lagged behind the rest of the health-care economy, which added employment throughout the downturn.</p>
<p> Two years ago, the medical device industry, which manufactures everything from heart valves to ace bandages, came under tougher scrutiny. The FDA had become more aggressive overseeing the industry in response to criticism that it had repeatedly caved to corporate and political pressure when approving new products. After health-care reformers targeted the industry for higher taxes to help pay for covering the uninsured, Democratic leaders in Congress asked the prestigious Institute of Medicine (IOM) to convene a blue-ribbon panel to determine if the industry needed tougher regulations to ensure the safety and effectiveness of its products. With the IOM&#8217;s final report due later this month, the industry is mounting a major public relations offensive to blunt calls for stronger oversight.</p>
<p> The Institute for Health Technology Studies, which is primarily funded by the industry, late last month released an industry survey showing American companies are increasingly going to Europe to get new devices approved. Industry executives also claimed that the FDA in the last few years has arbitrarily toughened its standards for new devices that are similar to products already on the market. In the past, those look-alike products usually received a less rigorous review than brand new medical innovations.</p>
<p> &#8220;As the FDA considers regulatory revisions, what&#8217;s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace,&#8221; said John Linehan, a professor of biomedical engineering at Northwestern University and lead author of the survey.</p>
<p> Paulsen, the Minnesota lawmaker, cited the example of Xtent, a Menlo Park, Calif., device maker that tried to gain approval to start a U.S. clinical trial for its coronary stent. Surgeons had already inserted the company&#8217;s stent in hundreds of European patients. When the FDA refused to consider data from the European experiences and insisted on a prospective clinical trial, the company closed its doors and sold the technology to foreign investors.</p>
<p> Last week, the House Oversight and Government Reform Committee called in the FDA&#8217;s top device regulator to explain the changes underway at the agency, which Republican members claimed had gone too far. &#8220;In some cases, the conveyor belt for medical devices has come to a grinding halt,&#8221; charged Rep. Trey Gowdy, R-SC., who chairs the health subcommittee.</p>
<p> Jeffrey Shuren, a lawyer and physician who 18 months ago replaced the previous head of the troubled Center for Devices and Radiological Health at FDA, promised to &#8220;do a far better job to make the process more efficient without compromising our standards for safety and efficacy.&#8221;</p>
<p> Earlier this year, the FDA proposed new rules that would give companies more certainty about what would be expected from them when bringing new products to the agency. But it postponed consideration of any major changes in the oversight process pending the IOM report, which could propose companies do more clinical trials proving efficacy for follow-on devices.</p>
<p> The current rules are a product of the 1976 law that ushered in the modern era of medical device regulation. They require any new device whose failure would pose a serious risk to public health to go through rigorous clinical trial testing in humans for both safety and effectiveness before going on the market. But the law also set up a regulatory scheme, known as the 510(k) process, which allows follow-on devices deemed substantially similar to something already on the market to get approved without the same level of testing. Regulators have discretionary power to order more tests.</p>
<p> The vast majority of new devices use the follow-on process, even though their manufacturers often claim superior performance to the older models and charge accordingly. The result is a lack of scientific data for making those comparisons, which leaves Medicare, private insurers and physicians in the dark as to their relative worth.</p>
<p> The regulatory framework for potentially life-saving devices differs from drugs, where follow-on products &#8211; say, the four or fifth statin to come to market for lowering cholesterol &#8211; must still go through rigorous clinical trial testing. While that doesn&#8217;t meet the gold standard of head-to-head comparisons between competing products, at least that gives medical analysts sufficient information to know if one drug is significantly better or worse than another product in the same class.</p>
<p> Safety issues can arise when there are no clinical trials for follow-on devices. And that also contributes to rising health care spending, since it can result in costly recalls or even follow-on operations to replace faulty devices. The updated devices often change materials or tweak the engineering, which can alter their performance once put in the body or deployed in health care settings.</p>
<p> A study published earlier this year in <em>Archives of Internal Medicine</em> found that of 113 major product recalls between 2005 and 2009, only&#8217; percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.</p>
<p> &#8220;Yes, the FDA&#8217;s getting tougher and it&#8217;s long overdue,&#8221; said the study&#8217;s lead author, Diana Zuckerman, executive director of the National Research Center for Women and Families. &#8220;Too many things were sailing through without clear evidence they were safe and effective.&#8221;</p>
<p> She cited last December&#8217;s recall of 359 million glucose test strips manufactured by Abbott Laboratories, whose malfunction could give diabetics false readings and lead to under or over-medication. Last week Redberg of UCSF told the oversight subcommittee to reject calls for speeding up the regulatory review process in the name of fostering greater innovation. She cited a 2009 Government Accountability Office report that found that a majority of high-risk devices do not go through clinical trial testing prior to marketing. &#8220;Only high-quality clinical trials can assure safety and effectiveness, especially when it comes to high risk devices that are used with invasive procedures,&#8221; she said.</p>
<p> &#8211; Provided by <a rel="nofollow" target="_blank" href="http://www.kaiserhealthnews.org" target="_blank">Kaiser Health News.</a></p>
<div>
    Article &#169; AHN &#8211; All Rights Reserved
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<p>View full post on <a rel="nofollow" target="_blank" href="http://www.feedsyndicate.com/articles/7028257309">Health Stories</a></p>
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		<title>Well: How to Add Flaxseed to Your Diet</title>
		<link>http://lowercholesterol.frasil.com/well-how-to-add-flaxseed-to-your-diet/</link>
		<comments>http://lowercholesterol.frasil.com/well-how-to-add-flaxseed-to-your-diet/#comments</comments>
		<pubDate>Fri, 03 Jun 2011 22:00:20 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[cholesterol foods]]></category>
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		<description><![CDATA[Flaxseed is credited with a number of health benefits, including better digestive health, lower cholesterol and fewer hot flashes during menopause. Martha Rose Shulman offers five delicious ways to add flaxseed to your diet. View full post on Health Stories]]></description>
			<content:encoded><![CDATA[
<p>                            Flaxseed is credited with a number of health benefits, including better digestive health, lower cholesterol and fewer hot flashes during menopause. Martha Rose Shulman offers five delicious ways to add flaxseed to your diet.</p>
<p>View full post on <a rel="nofollow" target="_blank" href="http://feeds.nytimes.com/click.phdo?i=584ab8497dc0d5cb4c5e30ea2c7273e8">Health Stories</a></p>
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		<title>Feds Cutting Fees, Requirements For High-Risk Health Insurance Pools</title>
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		<pubDate>Wed, 01 Jun 2011 22:51:53 +0000</pubDate>
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		<description><![CDATA[Washington, DC, United States (KaiserHealth) &#8211; Trying to spur enrollment in a key new benefit of the 2010 health law, the Obama administration announced today it is slashing premiums for new high-risk insurance plans and no longer requiring applicants to submit a rejection letter from private insurers. Since the plans were introduced in most states [...]]]></description>
			<content:encoded><![CDATA[<div></div>
<p>Washington, DC, United States (KaiserHealth) &#8211; Trying to spur enrollment in a key new benefit of the 2010 health law, the Obama administration announced today it is slashing premiums for new high-risk insurance plans and no longer requiring applicants to submit a rejection letter from private insurers.</p>
<p> Since the plans were introduced in most states last summer, enrollment has fallen far short of expectations; only about 18,000 people have signed up. The Congressional Budget Office had estimated that as many as 4 million uninsured Americans would be eligible and that 200,000 would be enrolled by 2013. The government set aside $5 billion to fund the plans.</p>
<p> Citing the low enrollment, some Republicans including Rep. Fred Upton, R-Mich, have criticized the administration&#8217;s handling of the program. Twenty-seven states run their own plans; the federal government operates them in 23 states and the District of Columbia. The changes, which occur July 1, affect only federally run plans. The plans are intended to serve as a bridge to help people with medical conditions until insurance market reforms required by the law are implemented in 2014. At that time, insurers will no longer be able to deny coverage or charge higher rates for people with pre-existing conditions, a major benefit of the law.</p>
<p> To be eligible for the plans, applicants have to be uninsured for at least six months and have a pre-existing condition.</p>
<p> In the states where the plans are run by the federal government, applicants will no longer have to prove they were denied coverage by an insurance company. Instead, they can provide a doctor&#8217;s letter stating that they have a medical condition. At least a dozen state-run plans do not ask for a denial letter from an insurer. The premiums will drop as much as 40 percent in 17 states plus the District where the federally administered plans operates, the administration estimates. These decreases will help bring premiums closer to the rates in each state&#8217;s individual insurance market. In the six states where high-risk plan premiums were already similar to what healthy people pay for individual plans, premiums will remain the same. States that will see a 40 percent drop in premiums are Alabama, Arizona, Delaware, Florida, Kentucky and Virginia. In other states, premium reductions range from 2.1 percent in Mississippi to 38.3 percent in Minnesota.</p>
<p> In Florida, where 770 people have enrolled, a person 55 and over who subscribes to the so-called standard plan will see his or her monthly premium for the standard plan fall by $150 to $376.</p>
<p> To further generate interest in the plans, HHS this fall will begin paying insurance agents and brokers for signing up people.</p>
<p> &#8220;These changes will decrease costs and help insure more Americans,&#8221; said Health and Human Services Secretary Kathleen Sebelius. The administration released a chart showing changes to premiums in states with federally administered plans.</p>
<p> pgalewitz@kff.org</p>
<p> &#8211; Provided by <a rel="nofollow" target="_blank" href="http://www.kaiserhealthnews.org" target="_blank">Kaiser Health News.</a></p>
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		<title>Hampster Study Of Blueberry&#8217;s Effects On Cholesterol</title>
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		<pubDate>Wed, 01 Jun 2011 22:00:01 +0000</pubDate>
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		<description><![CDATA[Laboratory hamsters that were fed rations spiked with blueberry peels and other blueberry-juice-processing leftovers had better cholesterol health than hamsters whose rations weren&#8217;t enhanced with blueberries. That&#8217;s according to a study led by U.S. Department of Agriculture (USDA) chemist Wallace H. Yokoyama. Yokoyama pointed out that further research is needed to confirm whether the effects [...]]]></description>
			<content:encoded><![CDATA[
<p>                            Laboratory hamsters that were fed rations spiked with blueberry peels and other blueberry-juice-processing leftovers had better cholesterol health than hamsters whose rations weren&#8217;t enhanced with blueberries. That&#8217;s according to a study led by U.S. Department of Agriculture (USDA) chemist Wallace H. Yokoyama. Yokoyama pointed out that further research is needed to confirm whether the effects observed in hamsters hold true for humans. He works at the Western Regional Research Center operated in Albany Calif&#8230;</p>
<p>View full post on <a rel="nofollow" target="_blank" href="http://feedproxy.google.com/~r/mnt/healthnews/~3/3nxuhM3wHaA/227131.php">Health Stories</a></p>
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		<title>Rain And Temperature Predict Cholera Risks</title>
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		<pubDate>Tue, 31 May 2011 23:16:17 +0000</pubDate>
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		<category><![CDATA[Temperature]]></category>
		<category><![CDATA[tropical medicine and hygiene]]></category>

		<guid isPermaLink="false">http://lowercholesterol.frasil.com/rain-and-temperature-predict-cholera-risks/</guid>
		<description><![CDATA[Bad blood pressure and cholesterol numbers are predictors for future health problems. You won&#8217;t definitely have a heart attack, for example, but your risk is higher. Now researchers have developed a similar-style early warning system for the public health of an entire region. They found that an analysis of particular environmental conditions helps predict the [...]]]></description>
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<p>Bad blood pressure and cholesterol numbers are predictors for future health problems. You won&#8217;t definitely have a heart attack, for example, but your risk is higher. Now researchers have developed a similar-style early warning system for the public health of an entire region. They found that an analysis of particular environmental conditions helps predict the risk of an outbreak of the deadly disease cholera. The work is in the American Journal of Tropical Medicine and Hygiene . [Citation to come] [More] </p>
<p>View full post on <a rel="nofollow" target="_blank" href="http://rss.sciam.com/click.phdo?i=fcfe1c9439392f0742a0c295515696b3">All Stories</a></p>
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		<title>¿Lifesaving¿ tomato dream turns rotten: Accusations fly over the health pill that reaped little in sales but made two directors £5m richer</title>
		<link>http://lowercholesterol.frasil.com/%c2%bflifesaving%c2%bf-tomato-dream-turns-rotten-accusations-fly-over-the-health-pill-that-reaped-little-in-sales-but-made-two-directors-5m-richer/</link>
		<comments>http://lowercholesterol.frasil.com/%c2%bflifesaving%c2%bf-tomato-dream-turns-rotten-accusations-fly-over-the-health-pill-that-reaped-little-in-sales-but-made-two-directors-5m-richer/#comments</comments>
		<pubDate>Sun, 29 May 2011 23:10:37 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[cholesterol]]></category>
		<category><![CDATA[Accusations]]></category>
		<category><![CDATA[capsule]]></category>
		<category><![CDATA[directors]]></category>
		<category><![CDATA[dream]]></category>
		<category><![CDATA[Hailed]]></category>
		<category><![CDATA[Health]]></category>
		<category><![CDATA[heart disease]]></category>
		<category><![CDATA[Little]]></category>
		<category><![CDATA[Made]]></category>
		<category><![CDATA[Over]]></category>
		<category><![CDATA[pill]]></category>
		<category><![CDATA[reaped]]></category>
		<category><![CDATA[richer]]></category>
		<category><![CDATA[rotten]]></category>
		<category><![CDATA[sales]]></category>
		<category><![CDATA[tomato]]></category>
		<category><![CDATA[turns]]></category>
		<category><![CDATA[£5m]]></category>
		<category><![CDATA[¿Lifesaving¿]]></category>

		<guid isPermaLink="false">http://lowercholesterol.frasil.com/%c2%bflifesaving%c2%bf-tomato-dream-turns-rotten-accusations-fly-over-the-health-pill-that-reaped-little-in-sales-but-made-two-directors-5m-richer/</guid>
		<description><![CDATA[Hailed as a lifesaving daily capsule to reduce the damaging effects of cholesterol and beat heart disease, the so-called ‘tomato pill’ appeared ready to conquer the world. View full post on All Stories]]></description>
			<content:encoded><![CDATA[
<p>                            Hailed as a lifesaving daily capsule to reduce the damaging effects of cholesterol and beat heart disease, the so-called ‘tomato pill’ appeared ready to conquer the world.</p>
<p>View full post on <a rel="nofollow" target="_blank" href="http://www.dailymail.co.uk/money/article-1392156/Lifesaving-tomato-dream-turns-rotten-Accusations-fly-health-pill-reaped-little-sales-directors-5m-richer.html?ITO=1490">All Stories</a></p>
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