US Drug Agency Approves Disputed Alzheimer's Treatment
2021-06-15
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1From VOA Learning English, this is the Health & Lifestyle report.
2U.S. government health officials have approved the first new drug for Alzheimer's disease in nearly 20 years.
3However, independent experts say the treatment has not been shown to help slow the brain disease, reported the Associated Press.
4Last week the Food and Drug Administration (FDA) approved the drug, called aducanumab.
5It was developed by the biotechnology company Biogen in Cambridge, Massachusetts.
6The drug will be sold under the name of Aduhelm.
7Biogen's stock value increased by 38 percent on the day of the FDA approval.
8The approval is based on results showing that the drug seemed "reasonably likely" to help Alzheimer's patients.
9It is the only treatment that U.S. regulators have said can treat the disease, rather than its resulting conditions, or symptoms.
10However, Reuters news agency reported last week that two members of a group of advisors to the FDA have resigned in protest.
11Dr. David Knopman and Dr. Joel Perlmutter said they strongly disagreed with the FDA's decision to approve Aduhelm for treatment of Alzheimer's.
12The decision to approve the drug could affect millions of Americans.
13It is likely to cause debate among doctors and researchers.
14The approval may also affect standards used to judge experimental treatments including those that seem to help patients only a little.
15How to judge treatments of difficult conditions is the subject of debate.
16Groups representing Alzheimer's patients and their families say any new treatment should be approved.
17But many experts warn that approving the drug could be a bad model and would open the door to poor treatments.
18Dr. Caleb Alexander was one of the FDA advisers who warned against the drug's approval.
19The Associated Press reports that he said he was "surprised and disappointed" by the decision.
20Alexander is a medical researcher at Johns Hopkins University.
21He said "the FDA gets the respect that it does because it has regulatory standards that are based on firm evidence."
22In this case, he said he thought the agency approved the drug without enough evidence.
23The World Health Organization estimates that 50 million people around the world have dementia.
24Alzheimer's disease might be the cause of 60 to 70 percent of those cases.
25Alzheimer's slowly attacks areas of the brain needed for memory, reasoning, communication and basic, daily tasks.
26Researchers do not fully understand what causes Alzheimer's.
27But there is agreement among some researchers that brain plaque may be one cause.
28Aducanumab helps clear a protein called beta-amyloid from the brain.
29Other experimental drugs have done that.
30But they did not help patients' ability to think, care for themselves or live independently.
31Dr. Patrizia Cavazzoni is the FDA's top drug regulator.
32She said there are "uncertainties" about the drug.
33But Cavazzoni added that the drug's ability to reduce harmful plaque in the brain is expected to slow dementia.
34"The data supports patients and caregivers having the choice to use this drug," Cavazzoni told reporters.
35Before joining the FDA, Cavazzoni worked in the drug industry for several years and held high positions in "clinical development, regulatory affairs, and safety risk management" for several large drug companies.
36Under the terms of approval, the FDA requires an additional study to see if the drug is working.
37If the study fails to show effectiveness, the FDA could withdraw the drug from the market.
38However, the agency rarely does this.
39Biogen said it aims to complete the study required by the FDA by 2030.
40Biogen stopped two studies in 2019 after disappointing results.
41The studies suggested that aducanumab would not meet its goal of slowing the loss of mental abilities in Alzheimer's patients.
42Several months later, the company announced that one of the earlier studies appeared to show that the drug was effective in higher amounts.
43However, the change raised questions among many experts, including those working for the FDA.
44Biogen said about 900 U.S. medical centers are ready to begin using the drug and more are expected to do so in the coming months.
45And that's the Health & Lifestyle report.
46I'm Anna Matteo.
1From VOA Learning English, this is the Health & Lifestyle report. 2U.S. government health officials have approved the first new drug for Alzheimer's disease in nearly 20 years. However, independent experts say the treatment has not been shown to help slow the brain disease, reported the Associated Press. 3Last week the Food and Drug Administration (FDA) approved the drug, called aducanumab. It was developed by the biotechnology company Biogen in Cambridge, Massachusetts. The drug will be sold under the name of Aduhelm. 4Biogen's stock value increased by 38 percent on the day of the FDA approval. 5The approval is based on results showing that the drug seemed "reasonably likely" to help Alzheimer's patients. It is the only treatment that U.S. regulators have said can treat the disease, rather than its resulting conditions, or symptoms. 6However, Reuters news agency reported last week that two members of a group of advisors to the FDA have resigned in protest. Dr. David Knopman and Dr. Joel Perlmutter said they strongly disagreed with the FDA's decision to approve Aduhelm for treatment of Alzheimer's. 7The decision to approve the drug could affect millions of Americans. It is likely to cause debate among doctors and researchers. The approval may also affect standards used to judge experimental treatments including those that seem to help patients only a little. 8How to judge treatments of difficult conditions is the subject of debate. Groups representing Alzheimer's patients and their families say any new treatment should be approved. But many experts warn that approving the drug could be a bad model and would open the door to poor treatments. 9Dr. Caleb Alexander was one of the FDA advisers who warned against the drug's approval. The Associated Press reports that he said he was "surprised and disappointed" by the decision. 10Alexander is a medical researcher at Johns Hopkins University. He said "the FDA gets the respect that it does because it has regulatory standards that are based on firm evidence." In this case, he said he thought the agency approved the drug without enough evidence. 11The World Health Organization estimates that 50 million people around the world have dementia. Alzheimer's disease might be the cause of 60 to 70 percent of those cases. Alzheimer's slowly attacks areas of the brain needed for memory, reasoning, communication and basic, daily tasks. 12Researchers do not fully understand what causes Alzheimer's. But there is agreement among some researchers that brain plaque may be one cause. 13Aducanumab helps clear a protein called beta-amyloid from the brain. Other experimental drugs have done that. But they did not help patients' ability to think, care for themselves or live independently. 14Dr. Patrizia Cavazzoni is the FDA's top drug regulator. She said there are "uncertainties" about the drug. But Cavazzoni added that the drug's ability to reduce harmful plaque in the brain is expected to slow dementia. 15"The data supports patients and caregivers having the choice to use this drug," Cavazzoni told reporters. Before joining the FDA, Cavazzoni worked in the drug industry for several years and held high positions in "clinical development, regulatory affairs, and safety risk management" for several large drug companies. 16Under the terms of approval, the FDA requires an additional study to see if the drug is working. If the study fails to show effectiveness, the FDA could withdraw the drug from the market. However, the agency rarely does this. Biogen said it aims to complete the study required by the FDA by 2030. 17Biogen stopped two studies in 2019 after disappointing results. The studies suggested that aducanumab would not meet its goal of slowing the loss of mental abilities in Alzheimer's patients. 18Several months later, the company announced that one of the earlier studies appeared to show that the drug was effective in higher amounts. However, the change raised questions among many experts, including those working for the FDA. 19Biogen said about 900 U.S. medical centers are ready to begin using the drug and more are expected to do so in the coming months. 20And that's the Health & Lifestyle report. 21I'm Anna Matteo. 22Matthew Perrone reported this story for the Associate Press. Anna Matteo adapted it for VOA Learning English. Mario Ritter, Jr. was the editor. 23____________________________________________________________ 24Words in This Story 25regulator -n. an official who works for the government and who controls a public activity by enforcing rules 26standard -n. a level of quality that is considered acceptable or desirable or that may be required by rules 27disappointed -adj. feeling unhappy or displeased because something was not as good as expected 28plaque -n. a change in brain tissue that happens in Alzheimer's disease 29data -n. information 30clinical -adj. based on work done with real patients; relating to medical treatment that is given to patients in hospitals