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Study Finds Many New Cancer Drugs Show Limited Success

时间:2024-05-04 16:02:47

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A new study has found that 41 percent of cancer drugs receiving accelerated government approval do not improve survival or quality of life.

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.

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.

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.

The new study suggests most cancer drugs given accelerated approval do not improve or extend patients' lives within five years.

Dr. Ezekiel Emanuel is a cancer specialist and bioethicist at the University of Pennsylvania. He was not involved in the research.

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.

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.

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.

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.

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 uncertainty1 being conveyed to patients?" he said.

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.

"It might be shrinking of tumor2. It might be how long the tumor stays stable," Litton said. "You can provide the data you have, but you shouldn't overpromise."

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.

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.

Words in This Story

accelerate – v. speed up the process of something

bioethicist – n. someone who studies questions of right or wrong relating to new discoveries and methods in biology and medicine

convey – v. to express a thought, feeling or idea so that it is understood by other people

advanced –adj. having developed for a long time or to a high degree

tumor – n. a mass of diseased cells that might become a lump or cause sickness

stable – adj. firmly fixed3 or not likely to move or change

commitment – n. a promise of firm decision to do something

appropriate – adj. suitable or right for a particular situation


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1 uncertainty NlFwK     
n.易变,靠不住,不确知,不确定的事物
参考例句:
  • Her comments will add to the uncertainty of the situation.她的批评将会使局势更加不稳定。
  • After six weeks of uncertainty,the strain was beginning to take its toll.6个星期的忐忑不安后,压力开始产生影响了。
2 tumor fKxzm     
n.(肿)瘤,肿块(英)tumour
参考例句:
  • He was died of a malignant tumor.他死于恶性肿瘤。
  • The surgeons irradiated the tumor.外科医生用X射线照射那个肿瘤。
3 fixed JsKzzj     
adj.固定的,不变的,准备好的;(计算机)固定的
参考例句:
  • Have you two fixed on a date for the wedding yet?你们俩选定婚期了吗?
  • Once the aim is fixed,we should not change it arbitrarily.目标一旦确定,我们就不应该随意改变。

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