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 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.
Dr. 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.
“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.
And that’s the Health & Lifestyle report.
I’m Anna Matteo.
Matthew Perrone reported this story for the Associate Press. Anna Matteo adapted it for VOA Learning English. Mario Ritter, Jr. was the editor.
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 acceptable or desirable or that may be required by rules
disappointed –adj. feeling unhappy or displeased 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
Leaders of the North Atlantic Treaty Organization (NATO) on Monday said the growing influence of China was an important issue for the alliance.
In a final statement, NATO leaders described China’s growing military as “presenting challenges,” which some experts considered surprisingly strong language. The statement also described Russia as “a threat.”
U.S. President Joe Biden arrived at the 31st NATO leaders meeting in Brussels with an important goal. He said he wanted to get NATO allies to deal with problematic actions by China and Russia. He also said he wanted to win the trust of members of the 30-country alliance. “NATO stands together,” said Biden.
After arriving at NATO’s headquarters in Brussels, Biden spoke with NATO Secretary-General Jens Stoltenberg.
Biden has said he wants NATO members to speak out on issues of trade, defense and human rights that relate to China and Russia. The actions of those nations have become important foreign policy concerns for the Biden administration.
NATO members considered a new cyber defense policy. It would permit a country hit by a ransomware attack to work together with other members for their common defense. This comes after Russian-based hackers carried out a series of attacks targeting the U.S. government and worldwide businesses.
The update will mean that if an alliance member needs technological or intelligence support to fight a cyberattack, it would be able to call on Article 5 to receive assistance.
Article 5 of the alliance charter states that an attack on one member of NATO is an attack on all members.
Members also accepted a climate security action plan to reduce the release of gases linked to climate change from military activities.
Alliance members also accepted a commitment to strengthen NATO’s deterrence to meet threats from Russia and other places.
At a press event following the summit, Biden said that he will tell Russian President Vladimir Putin when they meet on Wednesday that he “will respond” to Russian aggression.
Biden also said that the possible death of Putin critic Alexei Navalny would be a “tragedy.” He said it would prove that Putin did not believe in human rights. Navalny is imprisoned in Russia and reported to be very sick.
Biden was also asked about the future of Ukraine and the possibility that it could join NATO in the future.
“They have to meet the criteria” Biden answered.
Biden called Article 5 “sacred” and added, “I want NATO to know America is there.”
I’m Mario Ritter, Jr.
The Associated Press reported this story. Susan Shand adapted it for Learning English. Mario Ritter, Jr. was the editor.
Words in This Story
challenge –n. a difficult task or problem
ransomware –n. a kind of attack in which online attackers infect the computer systems of organizations and hijack information in a way that leaves it unreadable
charter –n. a document that outlines important rules and requirements of a group
deterrence –n. the policy of developing a lot of military power so that other countries will not attack your country
criteria –n. something that is used as a reason for making a judgment or decision
sacred –n. highly valued and important : deserving great respect
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Israel’s parliament, known as the Knesset, ended Benjamin Netanyahu’s 12-year run as prime minister on Sunday. By a vote of 60-59, a coalition of eight parties joined together behind new leaders Naftali Bennett and Yair Lapid.
Bennett will serve as Israel’s prime minister for the next two years. And Lapid will take over in 2023. He will serve as foreign minister until then.
Bennett and Netanyahu met briefly on Monday to signal the change of government. But there was no traditional ceremony to go along with the meeting.
Minutes after the meeting, Netanyahu repeated his promise to unseat the new government. He told members of his Likud party, "It will happen sooner than you think.” Netanyahu remains the leader of Likud. His right-wing party still holds more seats than any other in the parliament.
The Bennett-Lapid government is a coalition of right-wing, centrist, left-wing, and Arab parties. They have little in common other than a desire to unseat Netanyahu. The efforts for a new government came together after Israel held four elections in two years.
U.S. President Joe Biden called Bennett late Sunday to wish him well. In a statement, Biden said he looks forward to working with Bennett’s government to “strengthen all aspects of the close and enduring relationship between our two nations.”
Lapid, the foreign minister, wrote on Twitter that he spoke with U.S. Secretary of State Antony Blinken. He added that the new government will work on important relationships, including those with American Jews, the Democratic Party in the U.S., countries in Europe, and neighboring Jordan.
The Bennett-Lapid government opposes a return to the 2015 nuclear agreement between world powers and Iran. In 2018, former President Donald Trump pulled the U.S. out of the deal. But the Biden administration wants to re-start talks with Iran. Lapid said that Israel would “prevent by all means the possibility of Iran getting nuclear weapons.”
On its first day, the new government faces a difficult decision over whether to permit a right-wing group to march through the Muslim part of East Jerusalem on Tuesday.
Palestinian groups called the planned event a “provocation.”
If the march goes ahead, it could start a new confrontation between the Jews and Arabs. And a change or cancellation of the march could reduce right-wing support for the new coalition government.
The Hamas militant group that rules the Gaza Strip also warned of the possibility of renewed hostilities if the march goes ahead. A ceasefire less than a month ago ended 11 days of fighting between Hamas and Israeli forces.
Despite the difficulties, Yohanan Plesner of the Israel Democracy Institute thinks the new government can succeed by centering on the economy and budget.
He said if this government can pass a budget in the next few months, “we can expect this government to serve for at least two or three years. Otherwise, the instability will continue."
I’m Dan Friedell.
Dan Friedell adapted this story for Learning English based on reporting by The Associated Press and Reuters. Hai Do was the editor.
What does the new government need to do to succeed? Tell us in the Comments Section and visit our Facebook page.
Words in This Story
wing- n. a particular part of a large organization or group
enduring- adj. a way to describe something that lasts for a long time
provocation –n. an action or occurrence that causes someone to become angry or to begin to do something
instability - n. the state of being likely to change
American vaccine maker Novavax says a large study found its COVID-19 shot is 90 percent effective against the coronavirus and several virus variants.
The results, announced Monday, were based on late-stage trials involving nearly 30,000 volunteers in the United States and Mexico.
Novavax said the two-shot vaccine was about 90 percent effective and data showed it was safe. The company says it plans to seek emergency approval for the vaccine in the U.S., Europe and elsewhere by the end of September.
It estimates it would then be able to start producing up to 100 million injections a month. The company says it aims to supply 110 million doses to the U.S. over the next year and a total of 1.1 billion doses to developing countries.
The vaccine -- which is easy to store and transport -- is expected to play an important part in increasing the availability of shots in the developing world.
“Many of our first doses will go to … low- and middle-income countries, and that was the goal to begin with,” Novavax Chief Executive Stanley Erck told The Associated Press.
While more than half of the U.S. population has had at least one vaccine injection, less than 1 percent of people in the developing world have had one shot, researcher Our World In Data reports.
The Pfizer, Moderna and Johnson & Johnson vaccines have already been approved for emergency use in the U.S. and Europe. Europe also uses a vaccine developed by AstraZeneca.
Novavax's study involved nearly 30,000 people ages 18 and up. Two-thirds of subjects received two injections of the vaccine, three weeks apart, with the rest receiving an inactive substance or placebo.
There were 77 cases of COVID-19 -- 14 in the group that got the vaccine and the rest in volunteers who received the placebo. None of the people in the vaccine group experienced moderate or severe disease.
The vaccine was similarly effective against several variants. One of the variants first appeared in Britain and is also found in the U.S. It has especially been affecting high-risk populations, including older people and those with other health problems.
Only minor side effects were reported in people taking part in the study, such as head and muscle aches, tiredness and pain at the injection site. The company said there were no reports of unusual blood clots or heart problems.
Novavax reported its results in a news release. It said it plans to publish the findings in a medical publication to be examined by independent experts.
I’m Bryan Lynn.
The Associated Press and Reuters reported on this story. Bryan Lynn adapted the reports for VOA Learning English. Hai Do was the editor.
Words in This Story
variant – n. different in some way from others of the same kind
dose – n. the amount of a medicine, drug or vitamin this is taken at one time
placebo – n. a substance that is given to a patient in a medical study that has no physical effect
ache – n. a feeling or pain over an area of the body that continues for a long time
clot – n. (medical) a mass of dried blood that stops blood from flowing through blood vessels
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The trial of Myanmar’s ousted leader Aung San Suu Kyi began on Monday. She faces several corruption-related charges. Many observers say the trial is an attempt by the country’s military to remove her as a political force and strengthen its power.
Myanmar had been making slow progress toward democracy in recent years. But a February coup prevented lawmakers from Suu Kyi’s National League for Democracy party from taking office following last year’s victory.
The rights organization Human Rights Watch said the charges being heard in a special court in Myanmar’s capital are “bogus and politically motivated.”
Phil Robertson is the deputy Asia director for Human Rights Watch. He said the trial is aimed at preventing Suu Kyi and her National League for Democracy party from becoming “a force that can challenge military rule in the future.”
The military seized power on February 1 before the new lawmakers could be seated. Soon after, they arrested Suu Kyi, along with President Win Myint and other members of her government and ruling party.
The military claimed the coup was necessary because the government failed to correctly investigate accusations of voting fraud. Since then, the military has said it has found evidence of fraud. But the independent Asian Network for Free Elections and other organizations dispute that claim. Military officials have threatened to break up the National League for Democracy. And if Suu Kyi is found guilty on any charges, she could be banned from politics.
The military government has claimed it will hold new elections within the next year or two. But the country’s military has a long history of promising elections and then not following through. The military ruled Myanmar for 50 years after a coup in 1962. Suu Kyi was kept under house arrest for 15 years after a failed 1988 uprising.
The military’s latest takeover set off nationwide protests that continue despite clashes that have killed hundreds of people. Street demonstrations have become smaller recently. But the military now faces armed resistance by some opponents in both cities and rural areas.
Suu Kyi’s lawyers spoke about her charges Sunday. They said she has been charged with illegally importing “walkie-talkie” radios and using the devices without registration. She is also charged with spreading information that could cause public alarm or unrest. In addition, Suu Kyi faces two counts of violating the Natural Disaster Management Law for supposedly breaking pandemic restrictions during the 2020 election campaign.
“All these charges should be dropped, resulting in her immediate and unconditional release,” said Human Rights Watch’s Robertson. But he added that “there is little likelihood [Suu Kyi] will receive a fair trial.”
Government lawyers will have until June 28 to finish their presentation. Then, Suu Kyi’s defense team will have until July 26 to present its case, the team’s senior member said last week. Court hearings are to be held on Monday and Tuesday each week.
Two other more serious charges against Suu Kyi are being handled separately. One charge is for violating Myanmar’s Official Secrets Act, which carries a prison term of up to 14 years. The other charge is for bribery, which carries a prison term of up to 15 years and a fine.
Suu Kyi faced her first charge just days after the February coup. However, she was not permitted to meet with her lawyers face-to-face until a pre-trial hearing on May 24. She was also able to briefly meet with them one other time before seeing them in court Monday.
I’m Jonathan Evans.
Grant Peck reported on this story for the Associated Press. Jonathan Evans adapted this story for Learning English. Bryan Lynn was the editor.
Words in This Story
coup – n. the violent overthrow or alteration of an existing government by a small group
bogus – adj. not real or genuine : fake or false
motivated – adj. provided with a motive having an incentive or a strong desire to do well or succeed in some pursuit
challenge – v. to question the action or authority of someone
fraud – n. the crime of using dishonest methods to take something valuable from another person; trickery; deceit
bribery – n. the crime of giving or taking a bribe