Tuesday, 19 November 2013

China medical news roundup for Tuesday 19 November


BP lowering drugs of no benefit in stroke


Use of antihypertensive drugs to lower systolic blood pressure by close to 13% as part of acute treatment of ischemic stroke did not reduce early mortality or disability compared with patients who did not receive antihypertensive therapy, Chinese researchers have shown.
At 14 days after randomization, there were 683 events among patients who received early aggressive antihypertensive therapy versus 681 events in the control group  and at 3 months, there were 500 additional events in the treatment arm versus 502 among controls, said Dr He Jiang of Suzhou University
He reported the findings from China Antihypertensive Trial in Acute Ischemic Stroke (CATIS) at the American Heart Association scientific sessions here and the results were simultaneously published online by the Journal of the American Medical Association.
The lack of benefit occurred despite the fact that antihypertensive therapy achieved a rapid and significant reduction in systolic blood pressure "from 166.7 mmHg to 144.7 mmHg (−12.7%) within 24 hours, versus 165.6 mm Hg to 152.9 mm Hg (−7.2%) in the control group (P<0.001)," he said.
Read the full paper at JAMA


China produces 650,000 tonnes of medical waste a year


China produces half a billion tonnes of medical waste a year and the danger of pollution from such waste remains very real despite regulations on its disposal, experts have warned.
In 2003, the central government regulated the administration of medical waste, requiring county level governments to build disposal centers where all biohazardous material is treated. The regulations led to collective treatment of medical waste and many disposal centers were established.
Despite regulations, problems continue to crop up. Dangers of pollution still loom, said Luo Jiefeng, deputy director of the health bureau's office of medical affairs in Guangxi Zhuang Autonomous Region. "While the law requires all medical scrap to be treated collectively, many hospitals and clinics are not abiding by law due to poor management and substandard facilities,"  Luo said.
Medical waste can carry transmittable disease and chemical risk for those who come into contact with it. Plastic in the waste can cause  "white pollution",  said Yang Li, deputy director of nursing at the First Affiliated Hospital of Guangxi Medical University.
In 2002, total production of medical waste stood at about 650,000 tonnes, averaging 1,780 tonnes per day. The figure has increased by 10 percent every year since, and now stands at roughly three times that amount, consisting of disposable items including sharps, human tissue and organs, bodies of animals used in experiments, dressings, patients'body fluids including blood, etc., said Huang Zhiyong, vice principal of Guangxi Academy of Social Sciences.
In 2011, the municipal government of Guangxi' s Qinzhou City, home to over 300 rural hospitals and clinics, invested more than 18 million yuan (about 3 million U.S. dollars) in building a disposal center 13 kilometers from the city, but it is not living up to expectations.
"We send trucks all over to make collections every day, but many hospitals and clinics are far from arterial roads,"  said Pan Ling, deputy general manager of the center's operating company. The company can only make collections from 118 medical institutions, leaving more than 200 to basically clean up their own mess.
"The center can deal with about five tonnes a day, but we are only processing three,"  Pan said.
Way off the beaten track, the problematic material is simply burnt using diesel oil at appointed places without any decontamination, according to Xie Xiuchuang, from the health bureau of Lingshan County, Qinzhou. "This is bound to cause air and water pollution, and things like glass bottles are never completely destroyed,"  he said.
Another issue for local governments is poor management of disposal centers, mainly due to a lack of qualifications.
In August, residents in Chongkou Village, Guilin City started a blockade against a local disposal center they accused of irresponsiblity. The people of Chongkou have never been happy since a disposal center was established just 600 meters away from the village in 2003. The center was upgraded in 2010, becoming a disposal center for Guilin City, and suddenly about six tonnes of medical waste from more than 300 hospitals and clinics was arriving there every day. Earlier this year, local people discovered that waste was frequently lying in the open air for months without any treatment. Regulations state that the material should be disposed of within 24 hours. The furious villagers took it upon themselves to shut down the center.
The revolt of the local population created quite a panic among hospitals in Guilin, which cannot handle waste on site. Wang Changming, head of the Affiliated Hospital of Guilin Medical University, said that his hospital produces about one tonne of waste which is collected and sent to the center every day. "The center did not collect the garbage for days and the rubbish piled up in out temporary storage,"  Wang said.
Villagers soon found out that the center's operating company was not qualified to run it, and their equipment had not been tested.
Chongkou has now stopped their blockade, which lasted over a month,  thanks to the intervention of the Guilin government, but the worries live on, said Qin Zengrong, a local villager. "I hope that the government can find safer and more efficient measures to deal with this problem,"  Qin said.
Further complicating the process are the high expenses, Pan Ling said.
Medical waste in Guangxi was handled by sanitation departments in the past, and hospitals and clinics only had to pay one yuan for each bed. Now, expenses have surged to at least 2.5 yuan per bed. Some institutions have refused to pay the increase, putting heat on the treatment centers. This will eventually lead to cessation of operations, and a huge amount of medical waste will go untreated, according to Pan, who added that similar problems have been reported in other areas.
Yang Li believes that waste processing should be a public service, and that governments, rather than hospitals, should pay for it.
"If the situation continues, hospitals will transfer the increased cost onto patients, which will only add to their burdens,"  Yang said.
Huang Zhiyong urged the government to allocate more funds, build more standard facilities, improve training for staff in the centers, to reduce the problem of secondary pollution.
Source: China Daily



China’s new FDA faces big problems


China’s new Food and Drug Agency faces uphill struggle for medical safety
The mainland has a new super-agency to clean up the food and drug sectors, which have been plagued by corruption and safety scandals. But it has a long way to go before it catches up with advanced economies like the United States in food and drug regulations, speakers at a recent conference in Beijing on food and drug laws said. Timothy Stratford, a partner at US law firm Covington & Burling, cited the case of one of his clients that was building an instant noodle plant on the mainland. It was prevented from opening for six months because tainted raw materials were discovered.
"This is a very serious challenge in China," Stratford said. Shen Weixing, vice-dean of the Tsinghua University law school, said Beijing was strengthening its supervision of food and drugs.
"The Chinese government is putting strong efforts into food safety at a remarkably fast pace. Food packaging regulations in China have strengthened in the past three to four years," said David Ettinger, a lawyer at US law firm Keller and Heckman.
David Acheson, chief executive of the Acheson Group, a US food and drug consultancy, said the government realised following the melamine scandal in 2008 that it had to straighten out food safety.
In 2007, the US Food and Drug Administration (FDA) discovered some food products contaminated with melamine were exported from China. In 2008, the discovery of melamine in baby formula led to a massive recall of product recall on the mainland, with the deaths of at least six children blamed on melamine-tainted milk powder.
"There is no doubt the melamine scandal was a factor in China implementing a food safety law in 2009," said John Chapple, a general manager of Sino Analytica, a mainland-based food testing company.
In August, Beijing halted all milk powder imports from New Zealand after several major drinks and baby formula companies were found to have used products contaminated with bacteria that could cause botulism. In recent months, the Chinese government has launched investigations of foreign drug firms including GlaxoSmithKline and Sanofi for allegedly bribing mainland doctors and hospitals.
With the recent restructuring of government agencies, Beijing is actively revising laws and regulations on food, drugs, medical devices and health supplements, said Yang Chen, a partner at Sidley Austin, an international law firm. "The top priority is safety."
On March 22, the China Food and Drug Administration (CFDA) was established as part of the government's plan to raise food and drug safety standards, said Zhang Qi, head of laws and regulations at CFDA. The new agency replaces the State Food and Drug Administration (SFDA).
CFDA will incorporate the functions of not only SFDA, but also the food production safety functions of the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and the food distribution safety functions of the State Administration of Industry and Commerce, said Helen Zhang Haixiao, a partner at Zhong Lun, a Chinese law firm. The food import safety functions of AQSIQ will remain in AQSIQ. "There will be more concentrated administrative powers in CFDA," Helen Zhang said.
Yang said the mainland was consolidating into CFDA regulations that used to be scattered over multiple authorities.
"What we are seeing in China is akin to what was happening in the US in the early 20th century, when food safety crises led to the establishment of the FDA," said Laurel West, Asia director of industry and management research at the Economist Intelligence Unit.
Previously, SFDA had 10 departments, but now CFDA has 17 departments, Zhang Qi said. With an increased number of departments, CFDA has a wider range of functions that are more specialised, Zhang Qi said. Other changes include putting the supervision of cosmetics under CFDA, she said. The central government was expected to approve soon a new set of rules that would regulate CFDA's drafting of food and drug regulations in future, Zhang Qi said.
"The main motivation of creating these rules is to raise the standards of our ability to create regulations. The demands of the Chinese government on food and drugs have changed," she added.
Annie Yin, regulatory affairs director of Medtronic, a US medical technology firm, said CFDA had the power to approve some regulations, but more important regulations required approval by higher central government authorities. The agency has the responsibility to draft food and drug laws, but these laws require the central government to pass them, Yin clarified.
"At the moment, CFDA procedures for products are getting more standardised and specific. The situation in China is improving a lot," Yin said.
Since the mainland implemented its food safety law in 2009, it had proved difficult to implement, Chapple said. "There are 240 million farmers and one million food production establishments in China. How do you control them?" he said.
"It is wrong to say China's food safety law is a failure, but it has not gotten where it wanted. What is implemented in Beijing may not be implemented similarly elsewhere. That is why the Chinese government set up CFDA this year, to strengthen food safety," Chapple added.
Yang said the central government had made it a priority to revise the Food Safety Law, which was in the process of being amended. In addition, CFDA is revising regulations on labelling, manufacturing and other aspects of the mainland's food and drug industries, Yang added. There would be increased pricing control through regulations, Yang predicted. However, she was unable to forecast what the new laws would be in future.
"Institutions like CFDA cannot be expected to move up overnight. CFDA is going to take time to build institutional experience and expertise," said Alex Fowkes, vice-president of WuXi AppTec, a pharmaceutical, biopharmaceutical and medical device outsourcing company based in the US and China.
Chen Shaoyu, a partner at Covington & Burling, said the CFDA has 15 lawyers, while the US FDA has more than 100. In overall numbers, the Chinese agency has 375 people, while its US counterpart has more than 10,000 staff.
Source: SCMP 

US company to open paediatric clinic in Kunming


Sanford Health announced today it is working with a health care system in the rapidly growing city of Kunming, China, as part of its World Clinics initiative. Sanford’s collaboration is with YMCI Calmette Medical Investment & Management Company, Ltd., a state-owned company of the Yunnan Provincial government. Together, the two entities intend to develop a pediatric clinic.
With a population of more than 6 million, Kunming is the political, economic, communications and cultural hub of Yunnan and the seat of the provincial government. Northern Kunming is experiencing tremendous growth and has a significant need for primary care for children. Currently, northern Kunming has 60 kindergartens, 30 primary schools and 11 middle schools.
"Kunming, particularly the area surrounding the pediatric clinic, is experiencing significant growth with tremendous numbers of young families. With this growth comes the increased need for health care," said Li Li, MD, YMCI Calmette’s general manager. "We look forward to working with Sanford to provide care to children of this rapidly expanding region of China."
The new two-story, 18,000-square-foot Sanford World Clinic in Kunming will have the capacity to hold up to 10 primary care pediatric physicians. YMCI Calmette may also utilize the clinic for rotating pediatric sub-specialists.
YMCI Calmette currently operates the non-profit First Hospital of Kunming, which was established in 1914 and is rated as one of the top 100 hospitals in China. YMCI Calmette is developing a new 1,100-bed hospital complex in the northern part of Kunming, which also will include a consolidated and expanded outpatient pediatric clinic in collaboration with Sanford. The hospital and clinic are expected to open in the spring of 2014.
Under the parties’ agreement, YMCI Calmette will own the pediatric clinic, and Sanford World Clinic will manage the day-to-day operation as well as provision of medical services. The children’s clinic will also have connection to Sanford Health’s extensive clinical, research and administrative expertise in South Dakota.
"The decision to expand into China stems from our goal to expand health care services to areas of need, especially where children need health care. This clinic also allows us to better understand how health care is delivered and financed around the world," said Dave Link, Sanford’s senior executive vice president. "We are confident that we can assist YMCI Calmette achieve its mission to deliver the best care in the region, and we look forward to this collaboration."
The connection to Kunming and YMCI Calmette was made possible through Zhiguang Guo, PhD, a research scientist with Sanford who previously worked with YMCI Calmette physicians.
In addition to the planned clinic for Kunming, China, Sanford World Clinics has opened facilities domestically in Oklahoma, California and Oregon and has internationally developed four clinics in Ghana, Africa. Sanford also is pursuing projects in Israel and Mexico and is evaluating several other locations worldwide.
YMCI Calmette Medical Investment & Management Company, which is owned by Yunnan Metropolitan Construction Investment Co, LTD and Kunming Department of Health, is established by the Kunming Government. YMCI Calmette, as the sole investor, is now constructing the new hospital of The First Hospital of Kunming-Calmette International Hospital located on the bank of the Panlong River, north of Kunming, Yunnan, China. Calmette International Hospital, a new and world-class hospital complex, includes 151475 square meters and a total investment of about 1.1 billion Chinese Yuan. The facility includes 1100 in-patient beds as well as 6 separate medical towers, a medical technology building and a 19-floor inpatient building. The new hospital is expected to open in 2014.
Source: PRWeb

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