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WASHINGTON, Nov. 18 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday revoked its approval of Avastin for treating the breast cancer after concluding that the drug has not been shown to be safe and effective for that use.Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer."After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks," FDA Commissioner Margaret Hamburg said in a statement. "Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life. "Avastin's risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.Avastin was approved for metastatic breast cancer in February 2008 under the FDA's accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. After the approval, the drug's sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone -- not enough to outweigh the risk of taking the drug.FDA's Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.Genentech did not agree with the Center's evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center's withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, included recommendations from the FDA 's Oncologic Drugs Advisory Committee, voting 6-0 in favor of withdrawing approval of Avastin's breast cancer indication.
WELLINGTON, Oct. 17 (Xinhua) -- Parents wanting to help their children avoid asthma and other allergies are being told to give their toys a frosty reception by sticking them in the freezer.Medical scientists in New Zealand and Taiwan have discovered that freezing children's soft toys can kill almost all house dust mites (HDMs), the microscopic bugs associated with a range of allergies, including asthma.Other effective remedies for killing HDMs, commonly found in children's soft toys, were tumble drying and washing with eucalyptus oil and detergent, the scientists from New Zealand's University of Otago and Taiwan's Changhua Christian Hospital found.HDMs were strongly associated with the development of asthma in children, and the severity of asthma was in proportion to the number of house dust mites a child was exposed to when sleeping with soft toys, said a statement from the university Monday."Children frequently sleep with their favorite toys close to their airways and this may be important for HDM-sensitized asthmatic children," said University of Otago Associate Professor Rob Siebers.The scientists tested the three different cleaning methods on 36 toys divided into three groups of 12.Freezing toys for at least 16 hours at minus 15 degrees centigrade resulted in a 95-percent reduction of HDMs, as did soaking in an emulsion of eucalyptus oil and liquid detergent for one hour before rinsing and drying.Hot tumble drying for one hour reduced mites by 89 percent, the study found."Washing and soaking with eucalyptus oil and detergent is very effective in not only reducing live mites, but also reducing house dust mite allergens, compared to freezing and tumble drying," said Siebers.Ten of the 12 toys cleaned this way showed no live mites at all.Siebers said all three methods were more effective than just washing toys, because water needed to be above 55 degrees centigrade to kill HDMs, but this usually damaged the toys."My advice for parents is to either tumble dry for one hour, or freeze the soft toy overnight, and then wash it in a cold wash to remove any allergens."Siebers said the thickness of the material used in making the toys could alter the effectiveness of the three methods.The scientists would conduct further research to determine how quickly HDMs recolonized soft toys and how often toys should be treated.The study has been published in the European journal, Paediatric Allergy and Immunology.
WASHINGTON, Nov. 8 (Xinhua) -- NASA plans to add an unmanned flight test of the Orion spacecraft in early 2014 to its contract with Lockheed Martin Space Systems for the multipurpose crew vehicle's design, development, test and evaluation, the U.S. space agency announced Tuesday.This test supports the new Space Launch System (SLS) that will take astronauts farther into space than ever before, and provide the cornerstone for America's future human spaceflight efforts."President Obama and Congress have laid out an ambitious space exploration plan, and NASA is moving out quickly to implement it," NASA Associate Administrator for Communications David Weaver said in a statement. "This flight test will provide invaluable data to support the deep space exploration missions this nation is embarking upon."Orion is part of the now defunct Constellation program canceled under President Barack Obama's 2011 budget proposal. Instead Obama urged NASA to work toward sending humans to an asteroid and then on to Mars -- and NASA says it wants to go ahead with that as quickly as possible.This Exploration Flight Test, or EFT-1, will fly two orbits to a high-apogee, with a high-energy re-entry through Earth's atmosphere. Orion will make a water landing and be recovered using operations planned for future human exploration missions. The test mission will be launched from Cape Canaveral to acquire critical re-entry flight performance data and demonstrate early integration capabilities that benefit the Orion, SLS."The entry part of the test will produce data needed to develop a spacecraft capable of surviving speeds greater than 20,000 mph and safely return astronauts from beyond Earth orbit," Associate Administrator for Human Exploration and Operations William Gerstenmaier said. "This test is very important to the detailed design process in terms of the data we expect to receive."
BEIJING, Jan. 20 (Xinhua) -- China will regulate the production and sale of cosmetic colored contact lenses by including them in its list of items classified as "medical apparatus."Some people wear such non-corrective colored contacts to change or enhance eye color for cosmetic and fashion purposes.As these contacts are not for vision correction and medication purposes, they are currently off limits to the country's medical administration and regulators, said a statement published on the website of the State Food and Drug Administration on Thursday.However, with the increasingly popular use of cosmetic contacts, safety and quality problems due to the regulation loophole are likely to harm consumers' health, and the administration has decided to expand the current medical regulation on contact lenses to cover cosmetic ones, the statement said.It explained that the administration will soon issue a notice to ban the manufacture and sale of these contacts without proper registration and licenses.The statement also warned consumers of the risks of these contacts and suggested they carefully choose and use such products.
ISLAMABAD, Nov. 14 (Xinhua) -- Pakistan ranks the seventh in the world in terms of diabetes prevalence rate and over 7.1 million people in the country are diabetes patients, reported local media on Monday.Quoting a report by the World International Diabetes Federation, a local English newspaper "The News" said that every year 89,000 people die of diabetes in Pakistan and the number of diabetes patients in the country could hit 11.5 million by the year 2025 if proper measures were not taken.This would make Pakistan the world's fifth largest country in terms of its number of diabetes patients 14 years later, warned the report.At a seminar organized Monday in Islamabad to observe the World Diabetes Day which falls on Nov. 14, Dr. Abdus Salam from Shifa International Hospital, a private-run hospital in the capital city, said that every ten seconds, two people are diagnosed with diabetes and one person dies of diabetes-related causes.The average age of diabetes patients in Pakistan is one of the lowest in the world, said the report. In a bid to raise public awareness about the harmful effects of diabetes, various diabetes camps, scientific sessions, seminars and walks were organized across the country on Monday to mark the World Diabetes Day.In a message delivered on Sunday, Pakistani Prime Minister Yusuf Raza Gilani said that the World Diabetes Day draws attention to the lethality of the disease and underscores the need of preventive measures at individual and collective levels."Diabetes is a killer which is taking the life of one person out of every 800," said the prime minister, adding that "this disease hits people of all age groups, rich and poor alike without any discrimination."