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The Inquiry
A presidential panel, known as the Rogers Commission, was formed to explore the causes of the tragedy. The commission included astronauts Neil Armstrong (far left, first row) and Sally Ride (second from right, first row). The panel traced the disaster to a failure in the O-rings sealing
中央通訊社 | 我國投資環境 亞洲第二佳 【本報台北訊】經濟部投資業務處表示，美國商業環境風險評估公司（簡稱BERI）二○一○年第三次（十二月）的「投資環境風險評估報告」指出，我國的投資環境評比總分七十 ... 人間福報 - 35 則相關文章 |
西布曲明之后，全球減肥藥領域安全事件再度升級。
法國公共事務監察總局日前公布的一項調查報告顯示，法國施維雅公司“Mediator”減肥藥涉嫌致死500人。更為嚴重的是，制藥企業存在涉嫌故意隱瞞藥品的副作用、欺騙消費者等行為。
調查部門的報告指出，“Mediator”主要成分苯氟雷司可能引起患者心臟功能損害，甚至危及生命。
作為法國第二大制藥公司，施維雅目前境外業務量占其業務總量的88%，產品以自行研發為導向，2009/2010財政年度的總銷售額達37億歐元。
“我們國家沒有批準使用苯氟雷司，國內目前作為藥品批準的唯一產品就是羅氏公司的賽尼可。”昨日，衛生部全國合理用藥監測系統專家孫忠實告訴《第一財經日報》，由於存在抑制食欲中樞等作用機理，對心臟存在潛在危險，苯氟雷司在國內并未被使用。
2010年10月30日，國家食品藥品監督管理局（SFDA）緊急宣布，停止西布曲明制劑和原料藥在我國的生產、銷售和使用，代表品種“曲美”等陸續退市，目前全國減肥藥市場上，作為治療藥品出現的僅余羅氏賽尼可。
孫忠實告訴記者，截至目前，賽尼可使用“相對安全”，主要是因為其作用機理和西布曲明不一樣，屬於非中樞神經控制，并不作用於全身。
事實上，由於與右芬氟拉明作用機理相近，醫學界對於苯氟雷司對心臟的潛在危害一直態度謹慎。
“因為存在引起心臟瓣膜缺損的嚴重不良反應，美國食品和藥物管理局（FDA）在1997年就對芬氟拉明和右芬氟拉明同時進行了召回，我國隨后也在1998年進行了安全召回。”孫忠實告訴本報，而苯氟雷司與前兩者作用機理類似，臨床使用上一直非常謹慎。
而苯氟雷司的使用與糖尿病市場的迅速擴張關系密切。
“苯氟雷司1976年投放市場時，施維雅公司以它的潛在藥效介紹這種新藥，稱它為治療高血脂和Ⅱ型糖尿病的輔助藥品。”這份報告指出。
作為最早進入中國的國際醫藥企業之一，早在1979年，施維雅就開始了與中國醫藥（行情，資訊）（600056）界的接觸。1980年，施維雅與中華醫學 會合作創辦了中國第一個中法醫學交流項目，并將治療糖尿病的藥物達美康及治療腦血管疾病的藥物都可喜引入中國。
除總部和研發中心設在北京，施維雅另在濟南、上海、杭州、廣州、武漢設有分支機構，在天津設有合資工廠。2009年，施維雅在中國注冊并上市的新藥達到13種，尤其在心血管、糖尿病及神經精神方面，近幾年來，每年的業務平均增長率保持在30%以上。
與此同時，特別值得注意的是，由於研究證明，苯氟雷司可能引起心臟功能損害，甚至危及生命，因此早在2009年就被法國政府列入禁售藥品名單。但此次施維雅事件明顯暴露出，藥物監管當局存在失察行為。
有媒體報導，鑒於該事件的嚴重后果，法國勞工、就業與衛生部長格扎維埃·貝特朗16日回應，這是一起“丑聞”，他將采取措施全面改革藥品監管系統。
幾乎與之同時爆出的美國強生藥物召回事件中，業內人士透露，FDA已經開始加大對藥品質量的督查力度和財政撥款。
而SFDA參考歐盟標準的新版GMP規範（《藥品生產質量管理規範》）已經進入最後的文件簽字階段，對藥品質量的動態監管是這部即將公布的文件中早已明確的核心內容。
Spotlight:
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A recreation room at the Shanghai No. 3 Elderly Home, which cares for people with Alzheimer’s disease or dementia.
SHANGHAI — Last year, an expensive, red-brick residential complex opened here, equipped with a hair salon, cinema, toy-cluttered game rooms and a karaoke suite offering the latest in pop music.
A Difficult Road Ahead
Articles in this series are examining the worldwide struggle to find answers about Alzheimer’s disease.
Qiu Jinzhen, who is suffering from dementia, at the nursing home in Shanghai.
The residents are not Chinese yuppies. They are older patients with Alzheimer’s disease or dementia in a nursing home that is on the forefront of a new effort by China to deal with its exploding elderly population.
“This is the best place we could imagine,” says Miao Yuqiang, a 49-year-old Shanghai bus driver who helped his 81-year-old mother enroll here. “By the time we found this nursing home, we were desperate.”
While many countries are struggling to cope with rapidly aging populations, in China there are forecasts that within three decades there could be nearly 400 million people over the age of 60 and, partly because of the one-child policy, a declining number of working-age people to care for them.
Recognizing the difficult road ahead, China is beginning to educate the public and the medical community about dementia, and big cities are making plans to build new facilities, like the Shanghai No. 3 Elderly Home.
The shift in attitudes is remarkable. A decade ago, many families were ashamed to admit that their elders had such a disease. And because of a lack of awareness about the disease, many dementia patients were confined to the psychiatric wards of hospitals, which placed steel bars over the windows.
But today, a growing number of families are desperate to place relatives in a nursing home. The problem, health experts say, is that there simply are not enough.
Health experts are predicting severe strains on the state and on working families here. And those strains could be compounded by the lack of awareness about Alzheimer’s disease and other forms of dementia, even among medical professionals in China.
“This is an impending health crisis for China, and it may even exceed what’s happening in the U.S. because of the one-child policy,” said Rhoda Au, an associate professor at the Boston University School of Medicine.
In Shanghai, China’s wealthiest and most dynamic city, an estimated 120,000 residents have Alzheimer’s disease or some form of dementia. But city officials can identify only a handful of nursing homes trained to care for dementia patients.
Worries about the growing ranks of the elderly are amplified by what is being dubbed the 4-2-1 problem. In part because of the one-child policy, soon a single person in China will be expected to help support two parents and four grandparents. And as the elderly live longer, they are more likely to develop dementia, which requires expensive care.
To cope with a severe shortage of nursing homes, Shanghai is proposing what it calls the 90-7-3 plan, which means 90 percent of the elderly will need to be cared for at home, while 7 percent make occasional visits to a community center and 3 percent live in nursing homes.
“We’re planning to build at least one nursing home that can care for dementia patients in every district,” Zhang Fan, deputy director of social welfare at the Shanghai Civil Affairs Bureau, said in a telephone interview. “Every year, we’ll need at least 5,000 additional beds.”
One of the major challenges will be figuring out who will pay for professional care. In the 1990s, China dismantled its old “iron rice bowl” system of cradle-to-grave financial support from the state. It was part of a move toward a more market-oriented economy. But it now means the nation’s social safety net is weak, and care for the elderly is underfunded.
Boston University is now conducting a study to measure dementia rates in China and to identify the factors that lead to higher risk. The aim is to slow the onset of the disorder and alleviate the heavy health care costs.
There is now pressure for speedier action. Although the Chinese have a tradition of caring for their elders at home, families in big cities complain about a lack of options.
Lu Peiyu has been struggling to find a place for her 63-year-old husband, who received a diagnosis of dementia three years ago. A former accountant, he is sitting at home because no one can be found to treat him.
“We thought about sending him to hospitals, but he ran away twice in two years,” said the man’s son-in-law. “The problem is there’s so far not a single nursing home that offered a suitable place for my father-in-law. Professional hospitals are all filled up, and private nursing homes don’t have qualified people.”
Mr. Miao, the Shanghai bus driver, is among those fortunate enough to have found a nursing home that can treat dementia.
His family’s ordeal is common here. Two years ago, his elderly mother began showing signs of memory loss after striking her head on the pavement outside her home.
She was hospitalized for a month. When she returned home — where she lived with her youngest son, Mr. Miao, his wife and their then 20-year-old son — she began to show signs of severe memory loss.
“She started getting lost on the street,” said the woman’s daughter-in-law, Luo Yuqin. “She’d even forget to turn off the boiling water on the stove.”
Today, Mr. Miao’s mother is at the Shanghai No. 3 Elderly Home and uses a wheelchair. She has lost her ability to speak and is prone to emotional fits, Mr. Miao said.
Mr. Miao visits her twice a week. A few Saturdays ago, he came with snacks and a plastic bag stuffed with hard-boiled eggs.
“Ma, is everything O.K.?” he said as he fed his mother from a small bottle of milk. Then, Mr. Miao’s wife jumped in, saying: “They really take care of her. We’re working people. We both drive a bus long hours. What would we do without this place?”
Dr. Zhang Naizi, president of the Shanghai No. 3 Elderly Home, says the center tries to care for dementia patients with a system of personalized attention that was first developed in Europe. The system includes keeping the patients active with memory games and insisting that the nursing staff constantly make hand contact with the patients, by simply rubbing their arms or hands while speaking to them, hoping to make them feel more secure.
He says the new facility has a multimedia room that can display images of Shanghai streets, and even images that appear to show the neighborhoods of the patients. This is supposed to make them feel at home. Many patients also wear GPS armbands that help the staff monitor their locations.
“I am proud to say we’re the first professional center for dementia patients,” Dr. Zhang said. “We are the first in the whole country. Ten years ago, dementia patients were sent to psychiatric wards. Things are different now.”
The pharmaceutical company Sirtris announced last month that it had halted the last of its clinical trials of resveratrol, the minor ingredient of red wine that some researchers see as a drug that can extend life.
The decision signifies an apparent divergence of views on the merits of resveratrol between the current head of the company, which was bought by GlaxoSmithKline in 2008 for $720 million, and its founders.
George Vlasuk, Sirtris’s chief executive, said in an interview last week that SRT501, Sirtris’s formulation of resveratrol, “was not an important part of the acquisition of Sirtris by GSK.” Resveratrol has several features that make it unsuitable as a drug, he said. These include the fact that it is hard to maintain a consistent level of resveratrol in the bloodstream and that it seems to have different effects at different doses.
Resveratrol is thought to work in humans by activating a protein called SIRT1, but at some doses it actually inhibits SIRT1, Dr. Vlasuk said.
In addition, from a commercial point of view, resveratrol is a natural substance and not patentable.
Glaxo’s purchase of Sirtris, Dr. Vlasuk said, was more because the company afforded an entry into a new research field, and had developed several small, synthetic, patentable chemicals that mimic resveratrol in activating SIRT1. SIRT1 is thought to extend life in mice fed low-calorie diets, and researchers hope it may do the same in people by enhancing tissue maintenance and postponing the usual diseases of age.
Sirtris has completed three clinical trials with its synthetic resveratrol-mimicking drugs and will announce the results next year. These drugs work fairly specifically on SIRT1, unlike resveratrol, which also affects many other processes in the cell. “We have much more confidence that we are targeting SIRT1 and that it’s an important target. Resveratrol is not that important any more,” Dr. Vlasuk said.
But the co-founders of Sirtris, David Sinclair and Christoph Westphal, retain their confidence in resveratrol. Dr. Sinclair, a researcher at the Harvard Medical School, has long taken resveratrol. Referring to the unpublished results of a new trial with rhesus monkeys, he said that resveratrol “was and remains an excellent proof-of-concept molecule.”
Dr. Westphal said he believed there is accumulating evidence that resveratrol and Sirtris’s resveratrol-mimicking chemicals activate SIRT1, and that sirtuin-activating drugs have beneficial effects in animal and human studies.
Based on preliminary data about the synthetic drugs tested by Sirtris, “I’m as optimistic about the science and the potential of sirtuin activators as I’ve ever been,” Dr. Sinclair said. Sirtuin is the name of a family of proteins of which SIRT1 is the most important. Humans have seven sirtuins, all with different roles.
The rhesus monkey trial has been conducted by Rafael de Cabo, a researcher at the National Institute on Aging. It is similar to a study on mice in which he and Dr. Sinclair showed resveratrol extended the life of obese mice fed on a high-fat diet, but not of normal mice. Even the normal mice, however, showed some improvement on measures of heart function and bone loss. Dr. de Cabo said he could not discuss the results of the study until it is published. It looked at various markers of disease but did not try to assess resveratrol’s effect on longevity, given that rhesus monkeys live 40 years and it takes a long time assess any effect on life span.
“Resveratrol is a complex molecule in that it has many targets, and it behaves differently depending on the tissue and the metabolic status of the organism,” Dr. de Cabo said. That may make it too complex for a pharmaceutical company, which must prove to the Food and Drug Administration that a new drug works by a defined mechanism on a specific target. But resveratrol remains of great interest to researchers. “What is the actual use for humans still needs to be discovered,” he said.
Dr. de Cabo said he does not take resveratrol. “I don’t think it’s a reasonable thing for people to start consuming these compounds without more information,” he said.
〔國際新聞中心／綜合報導〕研究指出，中風之後5到10天內服用抗憂鬱藥物「百憂解」（Prozac），有助改善行動控制能力、即使中風也有機會自主生活。
刺胳針神經學期刊10日刊登的法國研究指出，在針對抗憂鬱藥物對中風復元療效迄今最大型的研究中，科學家發現，中風患者服用百憂解之後，在動作能力測驗中，表現比服用安慰劑的病患來得好。評論的專家表示，這項成果有「極大潛力改變臨床作法」。
法 國土魯斯大學醫院研究人員，在2005年3月到2009年6月間以118名中風患者為研究對象，他們在這些人中風5到10天之後將其分成兩組，一組讓他們 服用百憂解，一組讓他們吃安慰劑，時間持續3個月，期間患者持續接受物理治療，並在實驗之初及3個月期滿之後，分別接受動作技巧測試。
研究結果發現，服用百憂解的組別，3個月後的行動能力有顯著改善，平均分數提高34分，而服用安慰劑的組別，平均分數增加24.3分。
中 風之後最常見的問題就是半身不遂，之前已有小型研究顯示，百憂解等藥物或許有助中風患者恢復部分行動功能。科學家認為，服用隸屬於「選擇性血清素再回收抑 制劑」（selective serotonin re-uptake inhibitors，SSRIs）的百憂解等藥物，之所以對恢復行動能力有幫助，可能是這類藥物可增加中樞神經系統的血清，因此有助改善行動能力。
A new law came into effect on January 1 that requires stores to supply their customers with biodegradable bags. However, customers are also being encouraged to cart home their goods in reusable cloth bags or shopping carts. But as Nancy Greenleese points out in this postcard from Rome, that may be going a little too green for many fashion-conscious Italians.
The explosion that triggered last year's Gulf of Mexico oil spill was an avoidable disaster that resulted from management failures by BP PLC and its contractors, a presidential commission has concluded. But the accident also reflected systemic failures by oil companies and regulators to deal with the risks of deep-water exploration, the panel said.
A report by the National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling castigates BP and two of the British oil giant's contractors—Transocean Ltd. and Halliburton Co.—for missteps that contributed to the worst offshore oil spill in U.S. history and the deaths of 11 rig workers.
The problems go far beyond BP, however, the report concludes—disputing oil-industry arguments that the April 20 explosion on the Deepwater Horizon rig was a one-time event caused by unusual and risky decisions by the oil company.
A presidential commission investigating the Gulf of Mexico oil spill has concluded that "systemic failures" and avoidable missteps contributed to the disaster. WSJ's Stephen Power discusses the implications for the oil industry in an interview with Kelsey Hubbard.
The panel said all three companies did a poor job of assessing the risks associated with their decisions and failed to adequately communicate, either with one another or with their own employees. Federal regulators lacked training and manpower to properly police the industry, the report finds.
The blowout "was not the product of a series of aberrational decisions made by rogue industry or government officials that could not have been anticipated or expected to occur again," according to a chapter of the report released Wednesday. "Rather, the root causes are systemic and, absent significant reform in both industry practices and government policies, might well recur."
The commission plans to issue the full report next week.
That conclusion could give regulators more ammunition to pursue tougher safety rules. At the same time, such efforts may be muted by pressure from lawmakers in both parties to allow deep-water drilling to resume.
BP said the excerpt released Wednesday, like the company's own internal investigation, concluded the accident "was the result of multiple causes, involving multiple companies."
BP added that it was working to ensure that lessons learned led to improvements in deep-water drilling, and that it had already made changes to strengthen safety and risk management.
A Transocean spokesman said procedures at the well in the final hours were directed by BP and approved by regulators. "Based on the limited information made available to them, the Transocean crew took appropriate actions to gain control of the well," he said.
Halliburton, which handled a cement seal on the well, said cement jobs "can go wrong even under optimal conditions." The company added that its cement mixture was designed to BP's specifications and passed its final laboratory test.
President Barack Obama, in setting up the seven-member panel last summer, said he wanted it to recommend safety and environmental precautions the government should take to prevent mishaps. Several other government entities, including the Justice Department, are conducting their own investigations.
The Deepwater Horizon rig burns in April after an explosion that sent oil spewing into the Gulf of Mexico.
A U.S. Department of Interior spokeswoman said the Obama administration had announced a slew of new safety regulations since the accident, including requirements that drilling projects meet new standards for well design, casing and cementing, and be independently certified by a professional engineer.
But the economic and political environment has changed since the summer, when images of oil fouling Gulf beaches provoked outrage toward BP and rekindled worries about the safety of offshore oil drilling.
Since then, U.S. gasoline prices have risen to an average of more than $3 a gallon, unusually high for winter. Republicans, who are generally more supportive of the oil industry and domestic exploration, have regained control of one chamber of Congress.
The report is likely to turn attention back to BP after several months in which the oil giant sought to turn the spotlight on its contractors.
In September, BP issued its own internal investigation into the disaster, which concluded that although its workers bore partial responsibility for misinterpreting a key pressure test, most of the blame for the disaster lay with its contractors. In particular, BP blamed a bad cementing job by Halliburton and the failure of Transocean workers to detect and react to signs that explosive natural gas was entering the well.
The commission's report criticizes all three companies, but focuses most heavily on BP, which owned the well and oversaw drilling operations.
The report identifies nine decisions that increased risk while potentially saving time, and said BP was responsible for at least seven of them. The report doesn't accuse BP of actively choosing cost savings over safety, but says the company failed to put in place procedures to ensure that efforts to curb costs didn't compromise safety.
The report slams BP for making repeated alterations to the well design and procedure and says the company didn't "adequately identify or address risks" created by the changes. Among the changes: delaying setting a final plug in the well, which might have stopped gas from reaching the rig.
The report also criticizes BP for its "long-string" well design, which the commission says made it difficult to get a good cement seal at the bottom of the well. BP's internal report dismissed criticisms of the design as irrelevant.
The report does echo BP's criticism of Halliburton, however, arguing that the cement seal that should have prevented gas from entering the well failed. The commission chides Halliburton over what it says was the company's failure to immediately review the cement used at the well and to alert BP after tests indicated the mixture was unstable. Halliburton has previously said a final test showed the cement would work.
In a June 23, 2010 file photo, crews worked to clean up oil from the Deepwater Horizon oil spill washed ashore at Pensacola Beach in Pensacola Fla.
The panel also criticizes Transocean for failing to detect signs of trouble and for not adequately communicating to its crew lessons learned from "an eerily similar" near-mishap on one of its rigs in the North Sea four months before the Gulf blowout.
"Given the documented failings of both Transocean and Halliburton, both of which serve the offshore industry in virtually every ocean, I reluctantly conclude we have a system-wide problem," commission co-chairman William K. Reilly said in a statement Wednesday.
Write to Stephen Power at stephen.power@wsj.com and Ben Casselman at ben.casselman@wsj.com
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