Study Finds Many New Cancer Drugs Show Limited Success
2024-04-16
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1A new study has found that 41 percent of cancer drugs receiving accelerated government approval do not improve survival or quality of life.
2The U.S. Food and Drug Administration's (FDA's) accelerated approval program aims to get new drugs to patients as quickly as possible.
3But the effectiveness of the drugs differs.
4The program was created in 1992 to speed up the approval of HIV drugs.
5Today, about 85 percent of accelerated approvals go to cancer drugs.
6The program helps the FDA collect data on early results of approved drugs.
7In exchange, drug companies are expected to use the data to do additional testing.
8They are to produce better evidence before drugs receive normal approval.
9The new study suggests most cancer drugs given accelerated approval do not improve or extend patients' lives within five years.
10Dr. Ezekiel Emanuel is a cancer specialist and bioethicist at the University of Pennsylvania.
11He was not involved in the research.
12Emanuel told The Associated Press (AP) he thinks five years should be enough time to examine the effectiveness of new drugs.
13"Thousands of people are getting those drugs. That seems a mistake if we don't know whether they work or not," he added.
14It is up to the FDA or the drug company to withdraw drugs that do not perform well.
15Sometimes the FDA decides that less clear evidence is good enough to give full approval.
16The new study found that between 2013 and 2017, 46 cancer drugs were given accelerated approval.
17Of those, 63 percent were moved to normal approval. Forty-three percent demonstrated a good medical result in tests.
18The study was published in the Journal of the American Medical Association.
19It was also discussed at the recent meeting of the American Association for Cancer Research in San Diego, California.
20Dr. Edward Cliff of Harvard Medical School was a co-writer of the study.
21He told the AP it is unclear how much cancer patients understand about drugs with accelerated approval.
22"We raise the question: Is that uncertainty being conveyed to patients?" he said.
23Drugs that received accelerated approval may be the only chance for patients with rare or advanced cancers, said Dr. Jennifer Litton.
24She is with the MD Anderson Cancer Center in Houston, Texas.
25Litton, who was not involved with the study, said it is important for doctors to carefully explain the evidence.
26"It might be shrinking of tumor. It might be how long the tumor stays stable," Litton said.
27"You can provide the data you have, but you shouldn't overpromise."
28Congress 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.
29The changes permit the FDA "to withdraw approval for a drug approved under accelerated approval, when appropriate, more quickly," said FDA spokesperson Cherie Duvall-Jones.
30The agency can now require that confirmatory tests be started when the agency gives the first approval.
31This can speed up the process of confirming how effective a drug is, Duvall-Jones said.
32I'm Bryan Lynn.
1A new study has found that 41 percent of cancer drugs receiving accelerated government approval do not improve survival or quality of life. 2The 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. 3The program was created in 1992 to speed up the approval of HIV drugs. Today, about 85 percent of accelerated approvals go to cancer drugs. 4The 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. 5The new study suggests most cancer drugs given accelerated approval do not improve or extend patients' lives within five years. 6Dr. Ezekiel Emanuel is a cancer specialist and bioethicist at the University of Pennsylvania. He was not involved in the research. 7Emanuel 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. 8It 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. 9The 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. 10The 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. 11Dr. 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. 12Drugs 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. 13"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." 14Congress 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. 15The 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. 16I'm Bryan Lynn. 17The Associated Press reported this story. Bryan Lynn adapted the report for VOA Learning English. 18__________________________________________ 19Words in This Story 20accelerate - v. speed up the process of something 21bioethicist - n. someone who studies questions of right or wrong relating to new discoveries and methods in biology and medicine 22convey - v. to express a thought, feeling or idea so that it is understood by other people 23advanced -adj. having developed for a long time or to a high degree 24tumor - n. a mass of diseased cells that might become a lump or cause sickness 25stable - adj. firmly fixed or not likely to move or change 26commitment - n. a promise of firm decision to do something 27appropriate - adj. suitable or right for a particular situation