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 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. 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 advisers 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 fully understand what causes Alzheimer’s. But there is agreement among some researchers that brain plaque 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.
Title: US Drug Agency Approves Disputed Alzheimer’s Treatment
Content: <div id='article-page'><div id='article-content' data-media-url='//news-app-staging.s3.amazonaws.com' data-base-url='//news-app-staging.herokuapp.com' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/C.wav' data-capture-url='//staging.analytics.lingraphica.com/events/capture_news' data-article-title='US Drug Agency Approves Disputed Alzheimers Treatment' data-article-id='5694'><script src='//news-app-staging.herokuapp.com/javascripts/getscripts.js'></script><link rel='stylesheet' href='//news-app-staging.herokuapp.com/stylesheets/article.css' type='text/css' /><div class='article'><p><span data-start-time='0' data-end-time='10354'>U.S. government health officials have approved the first new drug for Alzheimer’s disease in nearly 20 years. </span> <span data-start-time='10354' data-end-time='22708'>However, independent experts say the treatment has not been shown to help slow the brain disease, reported the Associated Press.</span> <span data-start-time='22708' data-end-time='32938'>Last week the Food and Drug Administration (FDA) approved the drug, called aducanumab. </span> <span data-start-time='32938' data-end-time='41146'>It was developed by the biotechnology company Biogen in Cambridge, Massachusetts. </span> <span data-start-time='41146' data-end-time='45708'>The drug will be sold under the name of Aduhelm.</span> <span data-start-time='45708' data-end-time='54188'>Biogen’s stock value increased by 38 percent on the day of the FDA approval.</span> <span data-start-time='54188' data-end-time='64542'>The approval is based on results showing that the drug seemed “reasonably likely” to help Alzheimer’s patients. </span> <span data-start-time='64542' data-end-time='76646'>It is the only treatment that U.S. regulators have said can treat the disease, rather than its resulting conditions, or symptoms.</span> <span data-start-time='76646' data-end-time='89292'>However, Reuters news agency reported last week that two members of a group of advisors to the FDA have resigned in protest. </span> <span data-start-time='89292' data-end-time='104208'>Dr. David Knopman and Dr. Joel Perlmutter said they strongly disagreed with the FDA's decision to approve Aduhelm for treatment of Alzheimer's.</span> <span data-start-time='104208' data-end-time='110813'>The decision to approve the drug could affect millions of Americans. </span> <span data-start-time='110813' data-end-time='117000'>It is likely to cause debate among doctors and researchers. </span> <span data-start-time='117000' data-end-time='130708'>The approval may also affect standards used to judge experimental treatments including those that seem to help patients only a little.</span> <span data-start-time='130708' data-end-time='137979'>How to judge treatments of difficult conditions is the subject of debate. </span> <span data-start-time='137979' data-end-time='146979'>Groups representing Alzheimer’s patients and their families say any new treatment should be approved. </span> <span data-start-time='146979' data-end-time='159229'>But many experts warn that approving the drug could be a bad model and would open the door to poor treatments.</span> <span data-start-time='159229' data-end-time='169042'>Dr. Caleb Alexander was one of the FDA advisers who warned against the drug’s approval. </span> <span data-start-time='169042' data-end-time='178729'>The Associated Press reports that he said he was “surprised and disappointed” by the decision.</span> <span data-start-time='178729' data-end-time='185188'>Alexander is a medical researcher at Johns Hopkins University. </span> <span data-start-time='185188' data-end-time='197021'>He said “the FDA gets the respect that it does because it has regulatory standards that are based on firm evidence.” </span> <span data-start-time='197021' data-end-time='205896'>In this case, he said he thought the agency approved the drug without enough evidence.</span> <span data-start-time='205896' data-end-time='214354'>The World Health Organization estimates that 50 million people around the world have dementia. </span> <span data-start-time='214354' data-end-time='222708'>Alzheimer's disease might be the cause of 60 to 70 percent of those cases. </span> <span data-start-time='222708' data-end-time='235604'>Alzheimer’s slowly attacks areas of the brain needed for memory, reasoning, communication and basic, daily tasks.</span> <span data-start-time='235604' data-end-time='241521'>Researchers do not fully understand what causes Alzheimer’s. </span> <span data-start-time='241521' data-end-time='250000'>But there is agreement among some researchers that brain plaque may be one cause.</span> <span data-start-time='250000' data-end-time='258333'>Aducanumab helps clear a protein called beta-amyloid from the brain. </span> <span data-start-time='258333' data-end-time='261708'>Other experimental drugs have done that. </span> <span data-start-time='261708' data-end-time='269917'>But they did not help patients’ ability to think, care for themselves or live independently.</span> </p></div><div class='control-buttons-sticky' style='display:none;'><div class='control-buttons'><button title='Back' class='back' disabled='disabled'></button><button title='Play' class='play' disabled='disabled'></button><button title='Pause' class='pause' style='display:none;'></button><button title='Forward' class='forward' disabled='disabled'></button><button class='finished-reading' style='display:none;'>Done</button></div></div></div><div id='article-media'><div id='media-image'><img src='https://news-app-production.s3.amazonaws.com/articles/5156/C.jpeg'/></div></div><div id='question-content' style='display:none;'><div class='vocabulary_question question-container' data-question-id=17584 data-hint-location='64542' style='display:none;'><div class='question' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/what_is_a_regulator.wav'>What is a regulator?</div><div class='choices' data-correct-choice='a person or body that supervises a particular industry or business activity'><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/a_person_or_body_that_supervises_a_particular_industry_or_business_activity.wav'><span>a person or body that supervises a particular industry or business activity</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/a_generator_that_produces_an_alternating_current.wav'><span>a generator that produces an alternating current</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/a_large_semiaquatic_reptile_similar_to_a_crocodile_but_with_a_broader_and_shorter_head.wav'><span>a large semiaquatic reptile similar to a crocodile but with a broader and shorter head</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/a_starchy_plant_tuber_which_is_one_of_the_most_important_food_crops_cooked_and_eaten_as_a_vegetable.wav'><span>a starchy plant tuber which is one of the most important food crops, cooked and eaten as a vegetable</span></div></div></div><div class='multiple_choice_question question-container' data-question-id=17585 data-hint-location='0' style='display:none;'><div class='question' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/what_is_the_new_drug_aducanumab_used_to_treat.wav'>What is the new drug aducanumab used to treat?</div><div class='choices' data-correct-choice='Alzheimer's'><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/alzheimers.wav'><span>Alzheimer's</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/heart_disease.wav'><span>heart disease</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/type_2_diabetes.wav'><span>type 2 diabetes</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/glaucoma.wav'><span>glaucoma</span></div></div></div><div class='sentence_completion_question question-container' data-question-id=17586 data-hint-location='178729' style='display:none;'><div class='question' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/alexander_is_a_medical_researcher_at_johns_hopkins__blank__.wav'>Alexander is a medical researcher at Johns Hopkins <span class='blank'>University</span>. </div><div class='choices' data-correct-choice='University'><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/5156/university.wav'><span>University</span></div><div class='choice' 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