US Drug Agency Approves Disputed Alzheimer’s Treatment

From VOA Learning English, this is the Health & Lifestyle report.

U.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.

Last 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.

Biogen's stock value increased by 38 percent on the day of the FDA approval.

The 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.

However, Reuters news agency reported last week that two members of a group of advisors¹ 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.

The 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.

How 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.

Dr. Caleb Alexander was one of the FDA advisers² who warned against the drug's approval. The Associated Press reports that he said he was "surprised and disappointed" by the decision.

Alexander 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.

The 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.

Researchers do not fully³ understand what causes Alzheimer's. But there is agreement among some researchers that brain plaque⁴ may be one cause.

Aducanumab 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.

Dr. Patrizia Cavazzoni is the FDA's top drug regulator. She said there are "uncertainties⁵" about the drug. But Cavazzoni added that the drug's ability to reduce harmful plaque in the brain is expected to slow dementia.

"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.

Under 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.

Biogen 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.

Several 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.

Biogen 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.

Words in This Story

regulator –n. an official who works for the government and who controls a public activity by enforcing rules

standard –n. a level of quality that is considered acceptable⁶ or desirable or that may be required by rules

disappointed –adj. feeling unhappy or displeased⁷ because something was not as good as expected

plaque –n. a change in brain tissue that happens in Alzheimer's disease

data –n. information

clinical –adj. based on work done with real patients; relating to medical treatment that is given to patients in hospitals

1 advisors   

n.顾问，劝告者( advisor的名词复数 )；（指导大学新生学科问题等的）指导教授

参考例句：

• The governors felt that they were being strung along by their advisors. 地方长官感到他们一直在受顾问们的愚弄。 来自《现代汉英综合大词典》
• We will consult together with advisors about her education. 我们将一起和专家商议她的教育事宜。 来自互联网

2 advisers   

顾问，劝告者( adviser的名词复数 )； （指导大学新生学科问题等的）指导教授

参考例句：

• a member of the President's favoured circle of advisers 总统宠爱的顾问班子中的一员
• She withdrew to confer with her advisers before announcing a decision. 她先去请教顾问然后再宣布决定。

3 fully   

adv.完全地，全部地，彻底地；充分地

参考例句：

• The doctor asked me to breathe in,then to breathe out fully.医生让我先吸气，然后全部呼出。
• They soon became fully integrated into the local community.他们很快就完全融入了当地人的圈子。

4 plaque   

n.饰板，匾，(医)血小板

参考例句：

• There is a commemorative plaque to the artist in the village hall.村公所里有一块纪念该艺术家的牌匾。
• Some Latin words were engraved on the plaque. 牌匾上刻着些拉丁文。

5 uncertainties   

无把握( uncertainty的名词复数 )； 不确定； 变化不定； 无把握、不确定的事物

参考例句：

• One of the uncertainties of military duty is that you never know when you might suddenly get posted away. 任军职不稳定的因素之一是你永远不知道什么时候会突然被派往它处。
• Uncertainties affecting peace and development are on the rise. 影响和平与发展的不确定因素在增加。 来自汉英非文学 - 十六大报告

6 acceptable   

adj.可接受的，合意的，受欢迎的

参考例句：

• The terms of the contract are acceptable to us.我们认为这个合同的条件可以接受。
• Air pollution in the city had reached four times the acceptable levels.这座城市的空气污染程度曾高达可接受标准的四倍。

7 displeased   

a.不快的

参考例句：

• The old man was displeased and darted an angry look at me. 老人不高兴了，瞪了我一眼。
• He was displeased about the whole affair. 他对整个事情感到很不高兴。