发布时间: 2024-04-24 08:00:00
A new study has found that 41 percent of cancer drugs receiving accelerated government approval do not improve survival or quality of life.
一项新研究发现，41% 获得政府加速批准的抗癌药物并不能改善生存或生活质量。
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.
美国食品和药物管理局 (FDA) 的加速审批计划旨在尽快为患者提供新药。 但药物的功效不同。
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.
该计划创建于 1992 年，旨在加快艾滋病毒药物的审批速度。 如今，大约 85% 的加速批准用于抗癌药物。
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.
该计划帮助 FDA 收集已批准药物的早期结果数据。 作为交换，制药公司预计将使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，大多数加速批准的癌症药物在五年内不会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的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（美联社），他认为五年应该有足够的时间来检验新药的有效性。 “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，”他补充道。
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.
FDA 或制药公司有权撤回表现不佳的药物。 有时 FDA 认为不太明确的证据足以给予完全批准。
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，有46种抗癌药物获得加速批准。 其中，63% 转为正常批准。 百分之四十三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.
该研究发表在《美国医学会杂志》上。 最近在加利福尼亚州圣地亚哥举行的美国癌症研究协会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.
哈佛医学院的爱德华·克里夫博士是该研究的合著者。 他告诉美联社，目前尚不清楚癌症患者对加速批准药物的了解程度。 “我们提出一个问题：这种不确定性是否传达给了患者？” 他说。
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.
Jennifer Litton 博士表示，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。 她在德克萨斯州休斯顿的 MD 安德森癌症中心工作。 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.”
“这可能是肿瘤缩小了。 这可能是肿瘤保持稳定的时间，”利顿说。 “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 FDA 更多权力，并简化公司未履行承诺时撤回药品的流程。
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.
FDA 发言人 Cherie Duvall-Jones 表示，这些变化允许 FDA“在适当的情况下，更快地撤回对加速审批下批准的药物的批准”。 该机构现在可以要求在首次批准时开始验证性测试。 杜瓦尔-琼斯说，这可以加快确认药物有效性的过程。