• Posted on March 25, 2013 12:15 pm
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    Contributed by Joseph KollarSource: http://bigstory.ap.org/article/heart-repair-breakthroughs-replace-surgeons-knife treating heart disease without surgery Heart repair breakthroughs replace surgeon's knife Mar. 25 1:39 SAN FRANCISCO (AP) — Have a heart problem? If it's fixable, there's a good chance it can be done without surgery, using tiny tools and devices that are pushed through tubes into blood vessels. Heart care is in the midst of a transformation. Many problems that once required sawing through the breastbone and opening up the chest for open heart surgery now can be treated with a nip, twist or patch through a tube. These minimal procedures used to be done just to unclog arteries and correct less common heart rhythm problems. Now some patients are getting such repairs for valves, irregular heartbeats, holes in the heart and other defects — without major surgery. Doctors even are testing ways to treat high blood pressure with some of these new approaches. All rely on catheters — hollow tubes that let doctors burn away and reshape heart tissue or correct defects through small holes in blood vessels. "This is the replacement for the surgeon's knife. Instead of opening the chest, we're able to put catheters in through the leg, sometimes through the arm," said Dr. Spencer King of St. Joseph's Heart and Vascular Institute in Atlanta. He is former president of the American College of Cardiology. Its conference earlier this month featured research on these novel devices. "Many patients after having this kind of procedure in a day or two can go home" rather than staying in the hospital while a big wound heals, he said. It may lead to cheaper treatment, although the initial cost of the novel devices often offsets the savings from shorter hospital stays. Not everyone can have catheter treatment, and some promising devices have hit snags in testing. Others on the market now are so new that it will take several years to see if their results last as long as the benefits from surgery do. But already, these procedures have allowed many people too old or frail for an operation to get help for problems that otherwise would likely kill them. "You can do these on 90-year-old patients," King said. These methods also offer an option for people who cannot tolerate long-term use of blood thinners or other drugs to manage their conditions, or who don't get enough help from these medicines and are getting worse. "It's opened up a whole new field," said Dr. Hadley Wilson, cardiology chief at Carolinas HealthCare System in Charlotte. "We can hopefully treat more patients more definitively, with better results." For patients, this is crucial: Make sure you are evaluated by a "heart team" that includes a surgeon as well as other specialists who do less invasive treatments. Many patients now get whatever treatment is offered by whatever specialist they are sent to, and those specialists sometimes are rivals. "We want to get away from that" and do whatever is best for the patient, said Dr. Timothy Gardner, a surgeon at Christiana Care Health System in Newark, Del., and an American Heart Association spokesman. "There shouldn't be a rivalry in the field." Here are some common problems and newer treatments for them: HEART VALVES Millions of people have leaky heart valves. Each year, more than 100,000 people in the United States alone have surgery for them. A common one is the aortic valve, the heart's main gate. It can stiffen and narrow, making the heart strain to push blood through it. Without a valve replacement operation, half of these patients die within two years, yet many are too weak to have one. "Essentially, this was a death sentence," said Dr. John Harold, a Los Angeles heart specialist who is president of the College of Cardiology. That changed just over a year ago, when Edwards Lifesciences Corp. won approval to sell an artificial aortic valve flexible and small enough to fit into a catheter and wedged inside the bad one. At first it was just for inoperable patients. Last fall, use was expanded to include people able to have surgery but at high risk of complications. Gary Verwer, 76, of Napa, Calif., had a bypass operation in 1988 that made surgery too risky when he later developed trouble with his aortic valve. "It was getting worse every day. I couldn't walk from my bed to my bathroom without having to sit down and rest," he said. After getting a new valve through a catheter last April at Stanford University, "everything changed; it was almost immediate," he said. "Now I can walk almost three miles a day and enjoy it. I'm not tired at all." "The chest cracking part is not the most fun," he said of his earlier bypass surgery. "It was a great relief not to have to go through that recovery again." Catheter-based treatments for other valves also are in testing. One for the mitral valve — Abbott Laboratories' MitraClip — had a mixed review by federal Food and Drug Administration advisers this week; whether it will win FDA approval is unclear. It is already sold in Europe. HEART RHYTHM PROBLEMS Catheters can contain tools to vaporize or "ablate" bits of heart tissue that cause abnormal signals that control the heartbeat. This used to be done only for some serious or relatively rare problems, or surgically if a patient was having an operation for another heart issue. Now catheter ablation is being used for the most common rhythm problem — atrial fibrillation, which plagues about 3 million Americans and 15 million people worldwide. The upper chambers of the heart quiver or beat too fast or too slow. That lets blood pool in a small pouch off one of these chambers. Clots can form in the pouch and travel to the brain, causing a stroke. Ablation addresses the underlying rhythm problem. To address the stroke risk from pooled blood, several novel devices aim to plug or seal off the pouch. Only one has approval in the U.S. now — SentreHeart Inc.'s Lariat, a tiny lasso to cinch the pouch shut. It uses two catheters that act like chopsticks. One goes through a blood vessel and into the pouch to help guide placement of the device, which is contained in a second catheter poked under the ribs to the outside of the heart. A loop is released to circle the top of the pouch where it meets the heart, sealing off the pouch. A different kind of device — Boston Scientific Corp.'s Watchman — is sold in Europe and parts of Asia, but is pending before the FDA in the U.S. It's like a tiny umbrella pushed through a vein and then opened inside the heart to plug the troublesome pouch. Early results from a pivotal study released by the company suggested it would miss a key goal, making its future in the U.S. uncertain. HEART DEFECTS Some people have a hole in a heart wall called an atrial septal defect that causes abnormal blood flow. St. Jude Medical Inc.'s Amplatzer is a fabric-mesh patch threaded through catheters to plug the hole. The patch is also being tested for a more common defect — PFO, a hole that results when the heart wall doesn't seal the way it should after birth. This can raise the risk of stroke. In two new studies, the device did not meet the main goal of lowering the risk of repeat strokes in people who had already suffered one, but some doctors were encouraged by other results. CLOGGED ARTERIES The original catheter-based treatment — balloon angioplasty — is still used hundreds of thousands of times each year in the U.S. alone. A Japanese company, Terumo Corp., is one of the leaders of a new way to do it that is easier on patients — through a catheter in the arm rather than the groin. Newer stents that prop arteries open and then dissolve over time, aimed at reducing the risk of blood clots, also are in late-stage testing. HIGH BLOOD PRESSURE About 75 million Americans and 1 billion people worldwide have high blood pressure, a major risk factor for heart attacks. Researchers are testing a possible long-term fix for dangerously high pressure that can't be controlled with multiple medications. It uses a catheter and radio waves to zap nerves, located near the kidneys, which fuel high blood pressure. At least one device is approved in Europe and several companies are testing devices in the United States. "We're very excited about this," said Harold, the cardiology college's president. It offers hope to "essentially cure high blood pressure." ___ Online: Heart conditions and treatments: http://www.nhlbi.nih.gov/health/public/heart/index.htm American Heart Association: www.heart.org Atrial fibrillation info: http://bit.ly/odcTTM ___

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  • Posted on February 13, 2013 9:56 pm
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    Source: http://www.alnmag.com/news/dogs-cured-type-1-diabetes Dogs Cured of Type 1 Diabetes If your looking for a cure for type 1 Diabetes You can now go to your local veterinarian for treatment News Posted: February 11, 2013 Researchers from the Universitat Autònoma de Barcelona (UAB), led by Fàtima Bosch, have shown for the first time that it is possible to cure diabetes in large animals with a single session of gene therapy. As published in Diabetes, the principal journal for research on the disease, after a single gene therapy session, the dogs recover their health and no longer show symptoms of the disease. In some cases, monitoring continued for over four years, with no recurrence of symptoms. The therapy is minimally invasive. It consists of a single session of various injections in the animal's rear legs using simple needles that are commonly used in cosmetic treatments. These injections introduce gene therapy vectors, with a dual objective: to express the insulin gene, on the one hand, and that of glucokinase, on the other. Glucokinase is an enzyme that regulates the uptake of glucose from the blood. When both genes act simultaneously they function as a "glucose sensor", which automatically regulates the uptake of glucose from the blood, thus reducing diabetic hyperglycemia (the excess of blood sugar associated with the disease). As Fàtima Bosch, the head researcher, points out, "this study is the first to demonstrate a long-term cure for diabetes in a large animal model using gene therapy.” This same research group had already tested this type of therapy on mice, but the excellent results obtained for the first time with large animals lays the foundations for the clinical translation of this gene therapy approach to veterinary medicine and eventually to diabetic patients. The study was led by the head of the UAB's Centre for Animal Biotechnology and Gene Therapy (CBATEG) Fàtima Bosch, and involved the Department of Biochemistry and Molecular Biology of the UAB, the Department of Medicine and Animal Surgery of the UAB, the Faculty of Veterinary Science of the UAB, the Department of Animal Health and Anatomy of the UAB, the Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), the Children’s Hospital of Philadelphia and the Howard Hughes Medical Institute of Philadelphia. A safe and efficacious gene therapy The study provides ample data showing the safety of gene therapy mediated by adeno-associated vectors (AAV) in diabetic dogs. The therapy has proved to be safe and efficacious: it is based on the transfer of two genes to the muscle of adult animals using a new generation of very safe vectors known as adeno-associated vectors. These vectors, derived from non-pathogenic viruses, are widely used in gene therapy and have been successful in treating several diseases. In fact, the first gene therapy medicine ever approved by the European Medicines Agency, named Glybera, makes use of adeno-associated vectors to treat a metabolic disease caused by a deficiency of lipoprotein lipase and the resulting accumulation of triglycerides in the blood. Long-term control of the disease Dogs treated with a single administration of gene therapy showed good glucose control at all times, both when fasting and when fed, improving on that of dogs given daily insulin injections, and with no episodes of hypoglycemia, even after exercise. Furthermore, the dogs treated with adeno-associated vectors improved their body weight and had not developed secondary complications four years after the treatment. The study is the first to report optimal long-term control of diabetes in large animals. This had never before been achieved with any other innovative therapies for diabetes. The study is also the first to report that a single administration of genes to diabetic dogs is able to maintain normoglycemia over the long term (more than 4 years). As well as achieving normoglycemia, the dogs had normal levels of glycosylated proteins and developed no secondary complications of diabetes after more than 4 years with the disease. Application in diabetic patients There have been multiple clinical trials in which AAV vectors have been introduced into skeletal muscle, so the strategy reported in this study is feasible for clinical translation. Future safety and efficacy studies will provide the bases for initiating a clinical veterinary trial of diabetes treatment for companion animals, which will supply key information for eventual trials with humans. In conclusion, this study paves the way for the clinical translation of this approach to gene therapy to veterinary medicine, and eventually to diabetic patients. Source: Universitat Autonoma de Barcelona

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  • Posted on February 13, 2013 9:38 pm
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    Contributed by Mike BennettSource: http://www.wakingtimes.com/2013/02/12/scientists-point-out-corruption-in-vaccines-promotion/   Scientists Point Out Corruption in Vaccine's Promotion   February 12, 2013   Using Merck’s Gardasil vaccine as a case in point, an investigation documents Big Pharma’s near-total control of governmental health agency decisions and the utter lack of concern by the decision makers. However, some scientists are speaking out, and here’s what they have to say.   Researchers are speaking out about the corruption in science with regard to vaccines. Certainly, they’re in the minority, but their expertise and solid evidence for their claims are resulting in both their studies and their concerns being published in medical journals.   The arena of vaccination, which has been adversely affecting so many children, is now a centerpoint for documenting how Big Pharma has taken over so much of science, resulting in outright fraud that’s used to promote their products. Scientists Lucija Tomljenovic, Christopher A. Shaw, Judy Wilyman, Eva Vanamee, and Toni Bark use the example of Merck’s Gardasil, a human papilloma virus (HPV) vaccine, to demonstrate the point that HPV vaccine activism is not based on science, but instead on misrepresentations of science.   In a letter signed by all five of these scientists, they point out several flaws in the claims that Merck’s Gardasil and Pfizer’s Cervarix make to sell their vaccines[1]:   HPV vaccines have never been shown to prevent cervical cancer.   The end-points used in the studies are based on infections and lesions that usually heal without help, so how can they demonstrate efficacy in preventing cancer several years later?   The trials are biased to produce false negatives and therefore cannot accurately estimate the risk of developing cancer.   Passive methods of recording adverse effects cannot accurately reflect how prevalent they are.   Accurate estimates of the actual frequency of HPV vaccine adverse effects cannot be made when such effects are automatically dismissed as unrelated to the vaccine.   Women are not informed that, in some instances, the HPV vaccines may increase the rate at which existing abnormalities develop, thus causing the cancer from which they’re supposedly being protected.   When information about HPV vaccine risks and limitations are not provided, women cannot possibly make informed decisions about whether to have the vaccine.   Health regulators are making decisions based on information provided by the same corporations that hope to profit from them. How can they possibly make rational decisions on such limited and biased information?   Investigation into Merck’s Murky Dealings with Government   “Pharmaceutical Companies’ Role in State Vaccination Policymaking” is an investigation into the lobbying efforts by Merck to promote the HPV vaccine, Gardasil.[2] It states:   Merck engaged in direct lobbying to varying degrees in all of the states we studied. Merck proactively contacted legislators to discuss strategies to maximize uptake of Gardasil, either directly through company employees or by using local political consultants, prominent physicians, or public relations firms.   Many respondents reported that company representatives proposed specific legislation, often drafting the bills and searching for a sponsor. In most states, their efforts focused on a school-entry mandate. Respondents pointed out that Merck’s activities were not unusual, although the public seemed to have been unaware that private companies played such a role in the legislative process. One commented,“Just about every vaccine mandate that we have lately has been the result, at least partially, of the drug industry’s efforts.” [Emphasis mine.]   They asked respondents, who included legislators, health officials, medical professional organizations, advocacy organizations, journalists, health insurers, and clinical researchers, what role pharmaceutical manufacturers should play. The respondents believed that pharmaceutical manufacturers should provide scientific information about the products they push and that it was appropriate for Merck reps to sit on task forces and committee meetings. Worse, though, not one person felt that there was any problem in Merck’s drafting legislation!   In my reading of the paper, it appeared that the respondents tended to hide behind the fact that Merck donated some vaccine, though there were a few who found Merck’s involvement to be inappropriate.   Women in Government (WIG) received funding from Merck, which some respondents felt was just fine, though opinions did vary on that point. It should come as no surprise that WIG heavily promoted implementation of the Gardasil vaccine.[3]   The investigation documented the extremely disturbing influence that pharmaceutical corporations have in governmental health decisions that affect us all.   Response to Investigation into Merck’s Influence in Government   “Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety?”[4] is a definitive statement regarding Merck’s influence in vaccine policy. Tomljenovic and Shaw state:   … [C]areful scrutiny of Gardasil clinical trials shows that their design, as well as data reporting and interpretation, were largely inadequate.   They go on to delineate that optimism about Gardasil’s clinical benefits rests “on an extremely weak base built on a number of untested assumptions and significant misinterpretation of factual evidence.” They cite these examples:   The claim that Gardasil will result in a 70% reduction in cervical cancer is made in spite of there being no clinical data to support it.   The claim that life-long protection is provided by three vaccine doses has no basis in fact, as studies lasted, at most, five years.   The claim that Gardasil’s adverse effects are minor are supported only by “highly flawed safety trial design”.   They also point out “evidence of biased and selective reporting of results from clinical trials”.   Their conclusion is:   Keeping in mind that “the primary interest of a pharmaceutical company is developing and selling pharmaceutical product,” one must ask whether rational vaccine policy decisions should be based on conclusions derived from an uncritical acceptance of flawed vaccine safety and efficacy estimates provided by the vaccine manufacturer. Failure to adhere to principles of evidence-based medicine with respect to Gardasil promotion and vaccination policymaking inevitably raises the question of whether we have learned anything from the Vioxx debacle.   Indeed! It most assuredly does look like nothing has been learned from past disastrous destruction of lives by Big Pharma. Just how many times must we go through such agony? The toll Gardasil has been taking is being swept under the table, but the evidence is growing, as Tomljenovic and Shaw have been documenting in their research.   How many more must suffer before we step back from the pharmaceutical juggernaut and refuse to let them manipulate and control our healthcare system?   These articles contain more information on Tomljenovic and Shaw’s research:   Mechanisms of Aluminum Adjuvant Revealed: Vaccine Risks to Children Clarified   Gardasil Destroys Girl’s Ovaries: Research on Ovaries Never Considered   Gardasil Destroys Girl’s Ovaries: It Should Have Been Predicted   Gardasil: Evidence of Immense Harm   Gardasil Is Probable Cause of Girls’ Deaths: Brain Histology Study   HPV Vaccines: Scientists Use Manufacturers’ Data to Prove Lack of Efficacy   Resources   HPV vaccines and cancer prevention, science versus activism, Infectious Agents and Cancer, Lucija Tomljenovic, Judy Wilyman, Eva Vanamee, Toni Bark, Christopher A. Shaw; doi:10.1186/1750-9378-8-6   Pharmaceutical Companies’ Role in State Vaccination Policymaking, American Journal of Public Health (on Medscape), Michelle M. Mello, JD, PhD, Sara Abiola, JD, PhD, James Colgrove, PhD   Women In Government Issues State Policy Recommendations for Cervical Cancer Vaccine   Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety?, American Journal of Public Health, Lucija Tomljenovic and Christopher A. Shaw; doi:10.2105/AJPH.2012.300837

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