双语新闻：研究发现，美国41%的新的癌症药物不能提高患者生存率
A new study has found that 41 percent of cancer drugs receiving accelerated government approval do not improve survival or quality of life.
一项新的研究发现，在获得政府加速批准的癌症药物中，41%的药物并不能提高生存率或生活质量。
The U.S. Food and Drug Administration's (FDA's) accelerated approval program aims to get new drugs to patients as quickly as possible. But the effectiveness of the drugs differs.
美国食品药品监督管理局（FDA）的加速审批计划旨在尽快为患者提供新药。但药物的有效性各不相同。
The program was created in 1992 to speed up the approval of HIV drugs. Today, about 85 percent of accelerated approvals go to cancer drugs.
该项目创建于1992年，旨在加快批准艾滋病毒药物。如今，大约85%的加速审批都是针对癌症药物。
The program helps the FDA collect data on early results of approved drugs. In exchange, drug companies are expected to use the data to do additional testing. They are to produce better evidence before drugs receive normal approval.
该项目帮助美国食品药品监督管理局收集已批准药物的早期结果数据。作为交换，制药公司预计将利用这些数据进行额外的测试。他们将在药物获得正常批准之前提供更好的证据。
The new study suggests most cancer drugs given accelerated approval do not improve or extend patients' lives within five years.
这项新研究表明，大多数癌症药物被加速批准后，不会在五年内改善或延长患者的生命。
Dr. Ezekiel Emanuel is a cancer specialist and bioethicist at the University of Pennsylvania. He was not involved in the research.
Ezekiel Emanuel博士是宾夕法尼亚大学癌症专家和生物伦理学家。他没有参与这项研究。
Emanuel told The Associated Press (AP) he thinks five years should be enough time to examine the effectiveness of new drugs. "Thousands of people are getting those drugs. That seems a mistake if we don't know whether they work or not," he added.
伊曼纽尔告诉美联社，他认为五年的时间应该足够检查新药的有效性。他补充道：“成千上万的人正在服用这些药物。如果我们不知道它们是否有效，那似乎是一个错误。”
It is up to the FDA or the drug company to withdraw drugs that do not perform well. Sometimes the FDA decides that less clear evidence is good enough to give full approval.
这取决于美国食品药品监督管理局或制药公司是否撤回表现不佳的药物。有时，美国食品药品监督管理局认为不太清楚的证据足以给予充分批准。
The new study found that between 2013 and 2017, 46 cancer drugs were given accelerated approval. Of those, 63 percent were moved to normal approval. Forty-three percent demonstrated a good medical result in tests.
新研究发现，2013年至2017年间，46种癌症药物获得了加速批准。其中，63%被转为正常审批。43%的人在测试中表现出良好的医疗结果。
The study was published in the Journal of the American Medical Association. It was also discussed at the recent meeting of the American Association for Cancer Research in San Diego, California.
这项研究发表在《美国医学会杂志》上。美国癌症研究协会最近在加利福尼亚州圣地亚哥举行的会议上也讨论了这一问题。
Dr. Edward Cliff of Harvard Medical School was a co-writer of the study. He told the AP it is unclear how much cancer patients understand about drugs with accelerated approval. "We raise the question: Is that uncertainty being conveyed to patients?" he said.
哈佛医学院的Edward Cliff博士是这项研究的合著者。他告诉美联社，目前尚不清楚癌症患者对加速批准的药物了解多少。他说：“我们提出了一个问题：这种不确定性是否传达给了患者？”
Drugs that received accelerated approval may be the only chance for patients with rare or advanced cancers, said Dr. Jennifer Litton. She is with the MD Anderson Cancer Center in Houston, Texas. Litton, who was not involved with the study, said it is important for doctors to carefully explain the evidence.
詹妮弗·利顿博士说，获得加速批准的药物可能是罕见或晚期癌症患者的唯一机会。她在得克萨斯州休斯敦癌症医学博士中心工作。利顿没有参与这项研究，他说医生仔细解释证据很重要。
"It might be shrinking of tumor. It might be how long the tumor stays stable," Litton said. "You can provide the data you have, but you shouldn't overpromise."
利顿说：“这可能是肿瘤的缩小，也可能是肿瘤稳定的时间。”“你可以提供你所拥有的数据，但你不应该过度承诺。”
Congress recently changed the program to give the FDA more power and to simplify the process of withdrawing drugs when companies do not meet their commitments.
国会最近修改了该计划，赋予美国食品药品监督管理局更多的权力，并简化了在公司不履行承诺时撤回药物的程序。
The changes permit the FDA "to withdraw approval for a drug approved under accelerated approval, when appropriate, more quickly," said FDA spokesperson Cherie Duvall-Jones. The agency can now require that confirmatory tests be started when the agency gives the first approval. This can speed up the process of confirming how effective a drug is, Duvall-Jones said.
美国食品药品监督管理局发言人Cherie Duvall Jones表示，这些变化允许美国食品药品管理局“在适当的时候更快地撤销对加速批准药物的批准”。该机构现在可以要求在该机构首次批准时开始验证测试。Duvall Jones说，这可以加快确认药物有效性的过程。
一项新的研究发现，在获得政府加速批准的癌症药物中，41%的药物并不能提高生存率或生活质量。
The U.S. Food and Drug Administration's (FDA's) accelerated approval program aims to get new drugs to patients as quickly as possible. But the effectiveness of the drugs differs.
美国食品药品监督管理局（FDA）的加速审批计划旨在尽快为患者提供新药。但药物的有效性各不相同。
The program was created in 1992 to speed up the approval of HIV drugs. Today, about 85 percent of accelerated approvals go to cancer drugs.
该项目创建于1992年，旨在加快批准艾滋病毒药物。如今，大约85%的加速审批都是针对癌症药物。
The program helps the FDA collect data on early results of approved drugs. In exchange, drug companies are expected to use the data to do additional testing. They are to produce better evidence before drugs receive normal approval.
该项目帮助美国食品药品监督管理局收集已批准药物的早期结果数据。作为交换，制药公司预计将利用这些数据进行额外的测试。他们将在药物获得正常批准之前提供更好的证据。
The new study suggests most cancer drugs given accelerated approval do not improve or extend patients' lives within five years.
这项新研究表明，大多数癌症药物被加速批准后，不会在五年内改善或延长患者的生命。
Dr. Ezekiel Emanuel is a cancer specialist and bioethicist at the University of Pennsylvania. He was not involved in the research.
Ezekiel Emanuel博士是宾夕法尼亚大学癌症专家和生物伦理学家。他没有参与这项研究。
Emanuel told The Associated Press (AP) he thinks five years should be enough time to examine the effectiveness of new drugs. "Thousands of people are getting those drugs. That seems a mistake if we don't know whether they work or not," he added.
伊曼纽尔告诉美联社，他认为五年的时间应该足够检查新药的有效性。他补充道：“成千上万的人正在服用这些药物。如果我们不知道它们是否有效，那似乎是一个错误。”
It is up to the FDA or the drug company to withdraw drugs that do not perform well. Sometimes the FDA decides that less clear evidence is good enough to give full approval.
这取决于美国食品药品监督管理局或制药公司是否撤回表现不佳的药物。有时，美国食品药品监督管理局认为不太清楚的证据足以给予充分批准。
The new study found that between 2013 and 2017, 46 cancer drugs were given accelerated approval. Of those, 63 percent were moved to normal approval. Forty-three percent demonstrated a good medical result in tests.
新研究发现，2013年至2017年间，46种癌症药物获得了加速批准。其中，63%被转为正常审批。43%的人在测试中表现出良好的医疗结果。
The study was published in the Journal of the American Medical Association. It was also discussed at the recent meeting of the American Association for Cancer Research in San Diego, California.
这项研究发表在《美国医学会杂志》上。美国癌症研究协会最近在加利福尼亚州圣地亚哥举行的会议上也讨论了这一问题。
Dr. Edward Cliff of Harvard Medical School was a co-writer of the study. He told the AP it is unclear how much cancer patients understand about drugs with accelerated approval. "We raise the question: Is that uncertainty being conveyed to patients?" he said.
哈佛医学院的Edward Cliff博士是这项研究的合著者。他告诉美联社，目前尚不清楚癌症患者对加速批准的药物了解多少。他说：“我们提出了一个问题：这种不确定性是否传达给了患者？”
Drugs that received accelerated approval may be the only chance for patients with rare or advanced cancers, said Dr. Jennifer Litton. She is with the MD Anderson Cancer Center in Houston, Texas. Litton, who was not involved with the study, said it is important for doctors to carefully explain the evidence.
詹妮弗·利顿博士说，获得加速批准的药物可能是罕见或晚期癌症患者的唯一机会。她在得克萨斯州休斯敦癌症医学博士中心工作。利顿没有参与这项研究，他说医生仔细解释证据很重要。
"It might be shrinking of tumor. It might be how long the tumor stays stable," Litton said. "You can provide the data you have, but you shouldn't overpromise."
利顿说：“这可能是肿瘤的缩小，也可能是肿瘤稳定的时间。”“你可以提供你所拥有的数据，但你不应该过度承诺。”
Congress recently changed the program to give the FDA more power and to simplify the process of withdrawing drugs when companies do not meet their commitments.
国会最近修改了该计划，赋予美国食品药品监督管理局更多的权力，并简化了在公司不履行承诺时撤回药物的程序。
The changes permit the FDA "to withdraw approval for a drug approved under accelerated approval, when appropriate, more quickly," said FDA spokesperson Cherie Duvall-Jones. The agency can now require that confirmatory tests be started when the agency gives the first approval. This can speed up the process of confirming how effective a drug is, Duvall-Jones said.
美国食品药品监督管理局发言人Cherie Duvall Jones表示，这些变化允许美国食品药品管理局“在适当的时候更快地撤销对加速批准药物的批准”。该机构现在可以要求在该机构首次批准时开始验证测试。Duvall Jones说，这可以加快确认药物有效性的过程。
