Regulators pave way for biosimilar drug breakthrough
source : http://www.foxnews.com/health/2013/06/28/regulators-pave-way-for-biosimilar-drug-breakthrough/
source : http://www.foxnews.com/health/2013/06/28/regulators-pave-way-for-biosimilar-drug-breakthrough/
source : http://www.foxnews.com/health/2013/06/19/call-for-overhaul-drug-industry-business-model/
source : http://www.foxnews.com/health/2013/06/18/autism-linked-with-air-pollution-exposure-during-pregnancy/
Antibodies to a high-risk type of a virus that causes mouth and throat cancers when transmitted via oral sex can be detected in blood tests many years before onset of the disease, according to a World Health Organisation-led team of researchers. In a study in the Journal of Clinical Oncology, the researchers said their findings may in future lead to people being screened for human papillomavirus (HPV) antibodies, giving doctors a chance to find those at high risk of oral cancers. “Up to now, it was not known whether these antibodies were present in blood before the cancer became clinically detectable,” said Paul Brennan, of the WHO's International Agency for Research on Cancer (IARC), who led the study and described the findings as “very encouraging”. “If these results are confirmed, future screening tools could be developed for early detection of the disease,” he said. While HPV is better known for causing cervical and other genital cancers, it is also responsible for an increasing number of cancers of the mouth and throat, particularly amongst men. The issue was highlighted earlier this month by Hollywood actor Michael Douglas, who said his throat cancer was caused by HPV transmitted through oral sex. Oral, head and neck cancers are traditionally associated with heavy smoking and alcohol consumption, but over the past few decades rates of the diseases have increased dramatically, especially in Europe and North America. Brennan said this is probably due to HPV infections because of changing sexual practices, such as an increase in oral sex. According to IARC data, about 30 percent of all oral cancers are estimated to be HPV-related, and the main type of HPV associated with these tumours is HPV16. EARLIER DETECTION A study in the British Medical Journal in 2010 also found rates of head and neck cancer linked to HPV were rising rapidly, prompting calls from some doctors for boys as well as girls to be offered vaccinations to protect them against HPV. Two vaccines - Cervarix, made by GlaxoSmithKline, and Gardasil, made by Merck & Co - can prevent HPV. This new study, by scientists from IARC as well as the German Cancer Research Center and the U.S. National Cancer Institute, used data from a large study known as EPIC, which involves 500,000 people from 10 European countries who were recruited in the 1990s and have been followed up since. Researchers found that of the 135 people in the study who developed oral cancers, 47, or about one third of them, had HPV16 E6 antibodies up to 12 years before the onset of disease. In a telephone interview, Brennan said early detection would also allow doctors to track patients with antibodies and intervene early if tumours develop. “The earlier the detection, the better the treatment and the greater the survival,” he said. The antibody test used in the study was relatively simple and cheap and could be developed as a tool for more widespread screening within about five years if these results are confirmed in future studies, he added. He cautioned, however, that more work was needed to improve the tests' accuracy, since in this research there were about 1 in 100 “false positives” - where a person with the HPV16 antibodies did not go on to develop an oral cancer. Brennan said another significant finding of the study was that patients with oral cancers linked to HPV16 were three times more likely to be alive five years after their diagnosis than oral cancer patients whose tumours were not HPV-related and may have been linked to other risks such as smoking or drinking.source : http://www.foxnews.com/health/2013/06/18/blood-tests-could-detect-sexually-transmitted-oral-cancers/
In their study, at least 1 in 3 individuals with oropharyngeal cancer had antibodies to HPV, compared to fewer than 1 in 100 individuals without cancer. When present, these antibodies were detectable many years before the onset of disease. …
Living in an area with few general surgeons may make people with appendicitis more likely to turn into ruptured appendix cases by the time they get to surgery, according to new research. “The study shows that access to surgical care, especially general surgical care, is important and low access can have real impacts that affect peoples' health,” coauthor Thomas Ricketts of the University of North Carolina at Chapel Hill told Reuters Health by email. The Affordable Care Act includes a provision for incentive payments to increase the supply of doctors in areas with shortages, but those bonuses only apply in places with too few primary care doctors. General surgeon and primary care shortage areas don't always line up, Ricketts said, and even when they do, general surgeons can't move to areas that don't already have primary care physicians to serve the community and refer patients back to them. Almost 30,000 patients with appendicitis - a quarter of whom suffered a burst appendix - were discharged from hospitals in North Carolina between 2007 and 2009, according to data from hospitals and surgery centers in the state analyzed by the researchers. There are 95,000 burst appendices per year in the U.S. according to the Agency for Healthcare Research and Quality. A 2008 study found that an appendectomy can cost between $10,000 and $18,000 more when the appendix has burst. With surgery before a rupture, typically about 20 hours or less after abdominal pain begins, patients usually recover quickly. If the appendix has burst (roughly 40 hours after symptoms begin), that could mean repeat operations and longer recovery time, according to the Merck Manual. To see whether a surgeon shortage was linked to more burst appendices in an area, the researchers compared the number of cases of appendicitis, and specifically burst appendices, with the number of general surgeons in “surgical service areas” of the state that roughly align with zip codes. Having less than 3 general surgeons per 100,000 people increased the likelihood of having a ruptured appendix by five percent, compared to areas with at least 5 surgeons, Ricketts and his colleague report in the Annals of Surgery. However, areas with the most severe shortage had a 25 percent rate of rupture, compared to 24 percent in areas with no shortage. According to Dr. Edward Livingston, who has written about using ruptured appendices as a measure of care but was not involved in the new study, that is much too small a difference to draw any conclusions. Logic dictates that ruptures would be more common in rural areas, since patients have to travel farther to get to care, but that's the opposite of what the study found if the results are reliable, said Livingston, the deputy editor for clinical content at the Journal of the American Medical Association in Chicago. There were fewer surgeons relative to the population in urban areas, but the study didn't account for the residents, physician's assistants and nurse practitioners who add to the surgical work force in large urban medical centers, Livingston said. The results of the same study with more patients from more diverse regions might not show any difference between groups at all, Livingston told Reuters Health in an email. It would make more sense to measure the delay between when symptoms begin and when the patient reaches surgery in several different areas, and see if areas with longer delays correspond to areas with fewer surgeons, in order to infer that fewer surgeons lead to delays which lead to ruptures, Livingston said. “They would have to measure the delay to prove their point,” Livingston said. “This highlights a problem in studies like this one, where conclusions are made based on assumptions about what happens without really knowing what is happening at a patient level,” he said.source : http://www.foxnews.com/health/2013/06/17/surgeon-shortage-linked-to-burst-appendices/
Baby Matters LLC is recalling baby recliners linked to five infant deaths as part of a settlement with the Consumer Product Safety Commission, the U.S. agency said on Friday. The settlement calls for the company, based in Berwyn, Pennsylvania, to recall its foam rubber Nap Nanny and Nap Nanny Chill infant recliners and their covers, in exchange for the CPSC dropping an administrative complaint that it filed in December 2012, the agency said in a statement. Four infants have died in the Nap Nanny Generation Two recliners, and a fifth death involved the Chill model, the agency said. The CPSC also received 92 reports of infants hanging or falling over the side of the recliners, including some children who were restrained in the product's harness. The agency urged consumers to stop using Nap Nanny and Nap Nanny Chill recliners. It said Baby Matters was no longer in business and was not accepting returns. About 165,000 of the Nap Nanny and Chill products were sold between 2009 and 2012 for about $130 each. In December 2012, Amazon.com Inc, Buy Buy Baby Inc, Diapers.com, and Toys R Us/Babies R Us {TOY.UL] announced a voluntary recall of Nap Nanny and Chill models sold in their stores. Consumers who bought a Nap Nanny from one of those retailers should contact them for information on receiving a refund, the CPSC said. “CPSC urges other consumers to immediately dispose of the products to ensure that they are not used again,” the statement said.source : http://www.foxnews.com/health/2013/06/14/baby-matters-recalls-recliner-linked-to-infant-deaths/
For people with existing heart problems, exposure to high levels of air pollution can trigger the irregular heartbeats that may lead to a stroke or heart attack, according to a new study. Past research has linked air pollution to ventricular fibrillation, electrical confusion in the lower chambers of the heart which can cause sudden death. The new study also finds an association with atrial fibrillation (AF), erratic quivering in the heart's upper chambers and the most common type of irregular heartbeat. “As in all epidemiological studies we do not prove causation, but rather an association,” said lead author Dr. Mark Link, a cardiologist at Tufts Medical Center in Boston. His study included people with so-called implantable cardioverter defibrillators (ICDs), which record when the heart's electrical activity is abnormal and deliver shocks to try to right the rhythm. Link and his colleagues analyzed data from the ICDs of 176 heart patients and compared it to air quality data collected in the region. Over about two years, 49 of those people had a total of 328 AF episodes. The researchers found that the level of air pollution, including soot-like particles, on a given day was directly tied to heart rhythm problems. With every 6 microgram per cubic meter increase in fine particulate pollution, for example, people were 26 percent more likely to have an AF episode in the next two hours, the study team reported in the Journal of the American College of Cardiology. That extra risk is greater than the 1 percent increased risk of death from heart attack and the 18 percent increased risk of stroke seen with each 10 microgram per cubic meter rise in pollution in other studies, Link noted. The daily average particulate pollution level in Massachusetts, where the study took place, was 8.4 micrograms per cubic meter, well below the upper limit of 35 set by the Environmental Protection Agency (EPA). More than two million Americans have AF, according to the Centers for Disease Control and Prevention. Although it can cause rapid heartbeat, lightheadedness and fatigue, AF doesn't always come with symptoms. “This study does show that there is an increased association, especially within two hours of air pollutant levels being high, with a person having an irregular heart rhythm,” said Dr. Comilla Sasson, who studies community-wide risk for cardiac arrest at the University of Colorado in Denver. But it does not look at how often those irregular rhythms lead to more deadly problems such as heart attack or sudden death, she added. “Although this is interesting, it still leaves a lot more questions than providing answers,” Sasson said in an email. She questioned whether or not the EPA should reevaluate its air quality standards and if doctors should be talking to patients about increased risks on pollution-heavy days. “There is much more research that will need to be done, especially in other cities, to see if these results hold true,” she said. Although the study focused on people at unusually high risk already, an increase in the chance of AF could have implications for anyone, Link said. “Unfortunately, all of us are at risk for AF, especially as we age. It is by far the most common arrhythmia in the U.S. and for that matter, the entire world,” he said. Boston has relatively clean air, which makes the results all the more troubling, Link said. “Imagine what the effect of air pollution is in cities without the clean air of Boston,” he said.source : http://www.foxnews.com/health/2013/06/14/air-pollution-can-trigger-heart-arrhythmias-study-shows/
Britain is set to regulate electronic cigarettes as non-prescription medicines from 2016 in an attempt to improve quality, though the country's drugs watchdog said they would still be sold in convenience stores. Healthcare authorities around the world are grappling with how to deal with the battery-driven devices, which allow users to inhale nicotine-laced vapor and are increasingly popular as an apparently less harmful alternative to smoking. A few countries have banned them outright - such as Brazil, Norway and Singapore - while others are opting for varying degrees of regulation, in some cases including limits on advertising and curbs on their use in public places. Sales of e-cigarettes have boomed in recent years, prompted in part by restrictions on smoking. But their long-term effects are as yet unproven and some doctors argue their popularity could undermine anti-smoking efforts. They could also affect sales of regulated nicotine-replacement products, such as patches, sold by drugmakers like Pfizer and GlaxoSmithKline. Under the new British system, manufacturers will have to prove the quality of their products and demonstrate that they deliver the correct amount of nicotine. But they will not need to conduct clinical trials. The Medicines and Healthcare products Regulatory Agency (MHRA) said on Wednesday that existing e-cigarettes on the market were not good enough, with contaminants found in some products and nicotine levels often varying widely. However, manufacturers will have time to raise their game and apply for a license, allowing them to sell regulated devices as over-the-counter products in a wide range of retail outlets from 2016. A growing number of established tobacco companies are investing in the e-cigarette market worldwide, including Lorillard, British American Tobacco, Imperial Tobacco, Reynolds American and Altria. They are competing against a plethora of smaller private firms, all of which see a growing sales opportunity. Research indicates that around 1.3 million people currently use e-cigarettes in Britain alone, up from 700,000 a year ago. Biggest risk is smoking Jeremy Mean of the MHRA said the government had decided against banning existing poor-quality e-cigarettes, even though they did not meet desired safety and standards, since this could tip some people back into smoking. “Smoking is the riskiest thing you can do and we want to enable people to cut down and quit. We don't think a ban is proportionate to the risk, when the alternative is people continuing to smoke,” he told reporters. Britain's chief medical officer, Sally Davies, said smokers were harmed by tar and toxins in tobacco smoke, not nicotine, so it made sense to ensure e-cigarettes were properly regulated, as already happens with nicotine patches and gums. The new approach could be a boon for those companies that successfully secure a license, since licensed e-cigarettes will be able to carry smoking-cessation claims and could be prescribed by doctors to help smokers quit. Mead said there were likely to be fewer products of higher quality on the market from 2016, when pan-European regulations on e-cigarettes are also due to come into effect. Adrian Everett, chief executive of E-Lites, Britain's biggest seller of e-cigarettes, said his company was well-placed to meet the new regulatory standards but he cautioned against excessively tight rules that could reduce customer choice. “It would be a significant public health loss if electronic cigarettes were made less available to purchase or less available to use during the transition from a consumer product to a medicinal product,” he said.source : http://www.foxnews.com/health/2013/06/12/britain-to-regulate-e-cigarettes-as-medicine-from-2016/
The Food and Drug Administration is cracking down on sex supplements again, warning the public on Monday about six products that were found to contain hidden drugs. The names of the tainted products are: Reload, Get It Up, Super Cheetah, Cave Diver, Nights to Remember and X Zen Platinum. All of the products are marketed for sexual enhancement, and sold on various websites and in some retail stores, the FDA said. All of the products were found to contain the drug sildenafil (sold under the brand name Viagra), and one was found to contain tadalafil (brand name Cialis). Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction. Sex supplements are not allowed to contain prescription drugs, and the drugs are not included on the products' labels. Undeclared drugs in supplements are dangerous because consumers ingest these drugs without being told about their risks. Sildenafil and tadalafil can cause adverse reactions, including dangerously low blood pressure, if taken along with other prescription drugs that contain nitrates, the FDA says. (Some drugs prescribed to treat chest pain and heart disease contain nitrates.) Consumers who take the products listed in today's warnings should stop using them immediately, and throw them away, the FDA says. Last month, the FDA recalled two sex supplements, called Vicerex and Black Ant, because the products contained sildenafil and tadalafil. Earlier this year, the FDA warned consumers that several other sexual enhancement supplements contained undeclared drugs. Because the FDA is unable to test and identify all tainted sexual enhancement products, consumers should exercise caution before buying any products in this category, the agency 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/2013/06/10/6-sex-supplements-contain-hidden-drugs-fda-warns/