Tag Archives: states

A simple test for a significant health issue

I just read the most amazing article about detecting cervical cancer. Pap smears have significantly lowered the number of deaths in the United States. But what about the third world countries where women can't afford this test, let alone get the test to the poor living in slums or far-reaching small towns?  A simple vinegar test, which can be taught to one or two women in the villages, has shown to save 150,000 lives in India.  Cervical cancer is the leading women's cancer in India. This is how the test works: The cervix is swabbed with diluted vinegar solution, which makes abnormal cells briefly change color. It's remarkable. So many women in rural areas who never seek medical care can be saved. I will have my third CT scan for the phase one study this week.  The last two showed that my liver metastases had not grown, which is a win. I am hoping that this CT scan will show signs of the tumors getting smaller. That would be so great, and it will give me more resolve to accept these horrible side effects. I will be 60 in December and my life-long dream has been to go on a safari.  I was so scared to ask my oncologist if he saw a problem with this. He gave me the thumbs up and said that this trip would be great for me. I am in the planning stages now. I hope everyone is having a wonderful summer!Noreen Fraser is living with Stage IV metastatic breast cancer. She is the Founder and CEO of the Noreen Fraser Foundation, a 501(c)(3) non-profit organization dedicated to funding groundbreaking women's cancer research.& To stay in touch with Noreen, please 'LIKE' The Noreen Fraser Foundation on Facebook and follow her on Twitter. & Noreen can be contacted via email at noreen@noreenfraserfoundation.org.source : http://www.foxnews.com/health/2013/06/13/simple-test-for-immense-health-issue/

US births remain steady in 2012

The number of babies born yearly in the United States appears to be leveling off, after declining for the last few years, a new report says. In 2012, there were 3,958,000 babies born in the United States, according to early estimates from the Centers for Disease Control and Prevention. That's about the same as the number of births in 2011, the report says. The number of U.S. births has been decline since 2007, when a record-breaking 4,316,233 babies were born —more births than at the height of the baby boom in the 1950s. But the downward trend slowed between 2010 and 2011, and “essentially flattened” between 2011 and 2012, the report says. The country's birth rate has followed a similar trend, peaking in 2007 at 69.3 births per 1,000 women, and declining until 2011, after which it stabilized. In 2012, there were 63.2 births per 1,000 women between ages 15 and 44, essentially the same as the rate in 2011, the report says. The report is published June 6 by the CDC's National Center for Health Statistics. Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.source : http://www.foxnews.com/health/2013/06/06/us-births-remain-steady-in-2012/

Women willing to delay antibiotics for UTIs

More women than previously thought may be willing to delay taking antibiotics to treat a urinary tract infection in order to reduce the potentially unneeded use of antibiotics, a new Dutch study shows. More than one-third of women in the study with UTI symptoms said they were willing to wait a week to see if the infection would improve on its own before starting antibiotics. And more than 70 percent of the women who didn't use antibiotics for a week showed improvements or had their symptoms disappear completely, according to the study published May 30 in the journal BMC Family Practice. UTIs are more common in women than men, and are caused by E. coli bacteria in 80 to 90 percent of cases. The standard treatment for UTIs is a few days of antibiotic treatment, but the increasing emergence of antibiotic-resistant bacteria has become a serious concern, experts say. “To counteract this increasing resistance, the use of antibiotics should be limited in healthy patients who can also be cured without them,” study researcher Dr. Bart Knottnerus, from the University of Amsterdam said in an email. Studies show that when patients have UTI symptoms, most often, antibiotic treatment is started before the results of urine cultures, which look for the presence of bacteria, are known. “In fact, a culture is seldom done. Instead, the probability of a positive culture is estimated by asking questions and performing urine investigations,” Knottnerus said. “Since no test is perfect, some patients without UTI will get antibiotics, and some patients with UTI will not.” In the study, 137 patients were asked by their doctor to delay antibiotic treatment for one week. Fifty-one women were willing to wait. After one week, 28 of those women had still not used antibiotics and 20 of them reported clinical improvement. None of the participating women developed kidney infection, according to the study. Kidney infection is a serious condition that can occur if a UTI is left untreated, and needs a more aggressive antibiotic treatment. The researchers say that bladder infections seldom progress to the kidneys. “If a kidney infection occurs in a healthy woman, she can be cured by antibiotics,” Knottnerus said. “But to make sure that these antibiotics will still be effective in the future, it is important to limit their use in mild infections (like bladder infections).” It is important that women with UTI symptoms be monitored by a doctor if they choose to delay antibiotics. “If a woman gets ill (fever, shivering, flank pain), the infection may be progressing to the kidney,” Knottnerus said. Previous studies have shown that in somecases, patients recover from UTIs within a week without taking antibiotics. Knottnerus said the reason is that they either didn't have a UTI, or didn't need antibiotics to cure it. The body's defense mechanisms are often strong enough to fend off infections without any help from antibiotics, he said. Dr. Timothy Jenkins, assistant professor at the Division of Infectious Diseases, University of Colorado, said about the new study: “Progressive antibiotic resistance in bacteria is a major problem in the United States and worldwide, so it is very important that we develop novel strategies to reduce antibiotic use, such as the one proposed in this study.” Jenkins noted that antibiotic use in the Netherlands is extremely low, whereas antibiotic use in the United States is quite high. “Therefore, whether this study is applicable to women in the U.S. where the societal expectation for antibiotics is greater is not known,” he said. New guidelines published last week, from the Dutch College of General Practitioners, support the advice to delay antibiotic treatment for uncomplicated urinary tract infections, the researchers said. Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.source : http://www.foxnews.com/health/2013/06/04/women-willing-to-delay-antibiotics-for-utis/

Pork industry hunts for deadly pig virus

The sudden and widespread appearance of a swine virus deadly to young pigs - one never before seen in North America - is raising questions about the bio-security shield designed to protect the U.S. food supply. The swine-only virus, the Porcine Epidemic Diarrhea Virus (PEDV), poses no danger to humans or other animals, and the meat from infected pigs is safe for people to eat. Though previously seen in parts of Asia and Europe, the virus now has spread into five leading hog-raising U.S. states. How it arrived in the United States remains a mystery. While the U.S. imports millions of pigs each year from Canada, it imports pigs from virtually no other country, and no Canadian cases of PEDV have been confirmed. Veterinarians and epidemiologists say pigs are infected through oral means, and that the virus is not airborne and does it not occur spontaneously in nature. In recent years, with the emergence of dangerous pathogens such as H1N1, also known as swine flu, and bovine spongiform encephalopathy (BSE) or mad cow disease, the United States and other countries have sought to secure defenses both on the farm and at the national borders to protect against barnyard epidemics. “We're just trying to get a handle on what's happening,” said Tom Burkgren, executive director of the American Association of Swine Veterinarians. “It's like drinking water out of a fire hose. We're getting hits from all over the place.” Overall numbers of confirmed cases and mortality rates are not yet available, though anecdotal evidence suggests there are devastating losses for farms that are hit. “If you've got it, it's bad,” said Mark Greenwood, vice president of agri-business capital at AgStar Financial Services, who said none of his clients have been affected. “I spoke to a farmer in the Midwest who had it show up in a 2,000-head barn of pigs, and had a 40 percent death loss.” A spokeswoman for U.S. Department of Agriculture's Animal and Plant Health Inspection Service told Reuters the agency is working with state agencies and pork industry officials to discover where the virus originated. THE VIRUS SPREADS Confirmed cases have been reported in five hog-raising states including Iowa, the largest U.S. hog producer with 20 million hogs, according to the USDA. While only seven farms have had confirmed cases since May 17, more cases are expected as labs sift through samples, say sources investigating the outbreak. Colorado, Indiana, Illinois and Minnesota reportedly have positive tests for PEDV, according to state veterinarians and agriculture department officials, and the National Veterinary Services Laboratory in Ames, Iowa. PEDV, most often fatal to very young pigs, causes diarrhea, vomiting and dehydration. It also sickens older hogs, though their survival rate tends to be high. Known as a “coronavirus” because of the crown-like spikes on its surface, the virus afflicted China in recent years and killed more than 1 million piglets. PEDV is spread most commonly by pigs ingesting contaminated feces. Investigators are focused on physical transmission, perhaps a PEDV infected pig, equipment marred with feces, or even a person wearing dirty boots or with dirty nails. The mystery about how the virus entered the United States is raising concern about potential holes in the bio-security shield designed to protect the U.S. food and farming sectors. “Like everything else, we screw up from time to time,” said Ronald L. Plain, professor of agricultural economics at University of Missouri in Columbia, Missouri. “We know so little about the transmittal of this virus. We can't be sure if it's happening because of something we're supposed to do right and didn't - or by some mechanism we don't know that we're supposed to do differently.” Initial reporting about the virus may have been delayed, say sources, because its symptoms can be confused with a more common malady, transmissible gastroenteritis (TGE). Also, states are not required to report cases of PEDV to the federal government, and farmers are not required to report to state veterinarians. As part of its assessment of the situation, USDA will email epidemiological surveys to swine veterinarians who are dealing cases of PEDV. Meanwhile, the veterinarians are sending samples to diagnostic labs, where technicians are scrambling gathering the tools needed to check the samples for PEDV - supplies many labs did not have prior to the outbreak. While most farmers are taking a wait-and-see approach, some told Reuters they are turning away unnecessary visitors and double checking to ensure their safety protocols are being followed. LOOKING NORTH The search for leads also has turned to the nation's borders and ports of entry - specifically, Canada, where the United States imported 5.7 million head of live hogs last year. Canada has never had a confirmed case of the virus, though it does not test for it, government officials said. “Canada has very effective import measures in place to address this risk,” said Dr. Rajiv Arora, senior staff veterinarian for the Canadian Food Inspection Agency's foreign animal disease section. Canada can import live breeding pigs, under permits, from either the United States or the European Union, Arora said. The animals are quarantined by CFIA for a period of time, then inspected and tested - although not for PEDV - before released. Canada imported C$1.7 million ($1.6 million) worth of live swine in 2012, including both slaughter-ready and breeder pigs, according to Canada's Agriculture Department. CHINA HARD HIT Veterinarians and agricultural epidemiologists in the United States are drawing grim lessons from the devastating effect PEDV has had in other countries where it has hit. The first reports of suspected PEDV came in 1971 in the United Kingdom. As years passed, PEDV spread across parts of Europe and Asia. Veterinary researchers later concluded that lax bio-security measures contributed to PEDV's spread in Asia. One of the worst known outbreaks of the virus hit China's pig herds in late 2010, according to the Centers for Disease Control and Prevention's Emerging Infectious Diseases Journal. Vaccines had limited effectiveness and PEDV over ran southern China killing more than 1 million piglets. The death rate for virus-infected piglets ranged from 80 percent to 100 percent. Biosecurity measures in the U.S. food supply have been beefed up over the years, and especially after the outbreaks of mad cow disease and swine flu. Both outbreaks posed risks to human health. Today, trucks carrying live animals are supposed to be cleaned before entering and leaving farms. At commercial hog operations, visitors routinely shower and change clothing before stepping into a barn. Overseas visitors typically wait several days before being in the presence of a commercially raised hog. But the food shield is not impermeable. “If it becomes clear that this is not a novel way for to be transmitted, and that there had to be physical contact, that's going to be a major concern,” said William Marler, a leading food-safety attorney. “It means that there was a failure in the system.”source : http://www.foxnews.com/health/2013/05/29/pork-industry-hunts-for-deadly-pig-virus/

Heart device approval delays leave U.S. doctors frustrated

Americans accustomed to immediate access to the newest technology may be shocked to find that is not the case when it comes to devices that treat ailing hearts. U.S. approval requirements for cardiac devices are much more stringent than in Europe, where there is no centralized decision-making body. But a growing number of U.S. heart doctors feel the regulations are so demanding that patients are being denied access to beneficial therapies. From 2006 to 2011, European regulators approved mid-to-high-risk medical devices, including heart devices, an average of four years ahead of the more conservative U.S. Food and Drug Administration, according to a report last year by Boston Consulting Group. The quicker road to market in Europe did not lead to a discernible increase in recalls or safety problems, according to BCG and the California Healthcare Institute, which conducted the study, and Eucomed, the European trade group. “There is frustration among the U.S. investigators(researchers) and U.S. care providers around delayed access to certain interventions that appear to be a winner,” said Dr. Patrick O'Gara, a cardiologist with Brigham and Women's Hospital in Boston. An example cited by several doctors is a replacement for diseased heart valves made by U.S. device maker Edwards Lifesciences. The Sapien transcatheter aortic valve replacement (TAVR) system is particularly suited for elderly and frail patients, since it can be put in place via a catheter threaded through an artery rather than replacing a valve by cracking open the chest for heart surgery. “With this disease, if you wait two or three years, 60 or 80 percent of (patients) are dead. So not to have the most updated version of the device to treat more patients like this doesn't seem to be a particularly good idea,” said Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York. Heart disease remains the world's No. 1 killer. An estimated 500,000 Americans suffer from severely diseased heart valves, according to the American Heart Association. Many could be candidates for valve replacements. The approval delays are also costing device makers, such as Edwards and Medtronic Inc, hundreds of millions of dollars in potential sales while they are being asked to help pay for U.S. healthcare reform through new taxes. Dismay among heart doctors over delayed access to new devices gained momentum at this year's American College of Cardiology (ACC) meeting, which featured several U.S. clinical trials of devices long available in Europe. One top researcher at the meeting called the United States “a Third World country” when it comes to availability of cutting-edge heart devices. Only Edwards' original Sapien valve has U.S. approval - which it received in 2011, four years after Europe and elsewhere. European cardiologists have been using a next-generation version, which doctors find easier to maneuver into place and believe may cause less trauma to the artery, for three years. That is why Leon, who is co-lead investigator of U.S. clinical trials for both the original Sapien heart valve and the smaller, newer Sapien XT, sends some patients to Europe for treatment if he believes them better suited for the sleeker XT. Medtronic has a similar heart valve replacement awaiting U.S. approval that has been used in Europe since 2007. Asked at the ACC meeting if he found the situation frustrating, Dr. Gary Mintz, chief medical officer of the Cardiovascular Research Foundation in New York, shot back: “You mean because Algeria had TAVR before the U.S.?” “Even the FDA recognizes the problem, but they are answerable to Congress, not us,” Mintz said. FDA'S BID TO STREAMLINE The FDA requires proof of efficacy as well as safety through carefully controlled, randomized clinical trials before approving products, and may ask for long-term follow-up data. “We recognize that some of our regulatory requirements have been viewed as impediments compared to other parts of the world,” said Andrew Farb, medical officer in the FDA's division of cardiovascular device evaluation. The FDA is working on a new program to help streamline the path to U.S. approval that would involve the agency much earlier in device development - possibly discussing results with researchers after use in the first patient, according to Farb. The agency expects to publish this year its “early feasibility study guidance,” which it hopes will outline a path toward swifter reviews and approvals of devices in development in the United States, Farb said. “When you're starting a new way of thinking, getting this really ramped up is a challenge, but we're hopeful,” he said. Some companies, eager for faster returns on their investments, have moved early-stage device trials overseas, since they know they are likely to be able to begin selling the products there years earlier. That has added to delays of U.S. trials and approvals, Farb and others said. Enrolling patients in randomized U.S. trials mandated by the FDA is also being hampered by patient fear they would be put in a control group that did not get the new device, doctors said. Farb said the FDA is concerned by such trends and is seeking ways to move early-stage human trials back to the United States. EUROPE MAY SEEK TIGHTER CONTROLS In Europe, device makers must prove a product's safety to the satisfaction of one of some 80 designated regulator bodies and show it functions as intended. Effectiveness is determined through post-approval surveillance as it is used in patients. Some European politicians view the system as too lax and have called for a model closer to the U.S. “I think we need to meet somewhere in between,” said Dr. David Holmes, a cardiologist at the Mayo Clinic and a past ACC president, of the two regulatory systems. He said Europe may need to tighten its regulations without necessarily adding years to its process. One suggestion put forward by Eucomed - a device industry trade group that represents thousands of companies - and others would significantly cut the number of European regulators allowed to approve higher-risk devices. U.S. doctors are actively looking for ways to address the issue. “We need a coalition of involved, thoughtful and balanced individuals who see things on both sides of the equation and look for every opportunity to shorten this time line,” O'Gara said. Holmes said such a coalition, including researchers, manufacturers and physician groups like ACC and the Society of Thoracic Surgeons, is looking to work more closely with the FDA on the issue. He said the group is compiling a database of all patients getting TAVR to enhance understanding of the procedure's long-term performance and aid the FDA in making decisions. MILLIONS IN LOST SALES The approval lag means companies are leaving money on the table when it comes to their newest devices. Edwards' original Sapien sells for about $32,000 per patient and had U.S. sales of about $200 million in its first year on the market. Had it been available in the United States at the same time as Europe, the company could have rung up at least an additional $800 million in sales, said Joanne Wuensch, an analyst with BMO Capital Markets. “That assumes no growth, which is ridiculous, so that is an extraordinarily conservative number,” she said. Proving efficacy can be a lengthy process. St Jude Medical's Amplatzer Occluder device, used to close a tiny hole in the heart, is awaiting an FDA decision. The decisive U.S. trial, which was not deemed complete until a pre-specified number of patients suffered strokes or died, took eight years. Eucomed is campaigning to keep in place the system that brings new products to those markets earlier. “As you get physician experience developing, you also start immediately improving the product,” said Eucomed CEO Serge Bernasconi. “That explains why by the time it gets to market in the U.S., often in Europe we are already on the second or third generation.” Edwards, which considers the original Sapien valve to be obsolete and manufactures it only for U.S. use, expects European approval for its third-generation version by the end of 2013. Meanwhile, U.S. doctors still await its predecessor.source : http://www.foxnews.com/health/2013/05/28/heart-device-approval-delays-leave-us-doctors-frustrated/