Science
Iran’s sole nuclear power plant undergoes emergency shutdown
Iran’s sole nuclear power plant has undergone an unexplained temporary emergency shutdown, the country’s state TV reported.
An official from the state electric company Tavanir, Gholamali Rakhshanimehr, said on a talk show that aired on Sunday that the Bushehr plant shutdown began on Saturday and would last “for three to four days.” Without elaborating, he said that power outages could result.
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This is the first time Iran has reported an emergency shutdown of the plant in the southern port city of Bushehr. It went online in 2011 with help from Russia. Iran is required to send spent fuel rods from the reactor back to Russia as a nuclear nonproliferation measure.
The report came as top diplomats said that further progress had been made at talks Sunday between Iran and global powers to try to restore a landmark 2015 agreement to contain Iranian nuclear development that was abandoned by the Trump administration. They said it was now up to the governments involved in the negotiations to make political decisions.
Earlier in the day, Tavanir released a statement saying that the Bushehr nuclear plant was being repaired, without offering further details. It said the repair work would take until Friday.
In March, nuclear official Mahmoud Jafari said the plant could stop working since Iran cannot procure parts and equipment for it from Russia due to banking sanctions imposed by the U.S. in 2018.
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Bushehr is fueled by uranium produced in Russia, not Iran, and is monitored by the United Nations’ International Atomic Energy Agency. The IAEA acknowledged being aware of reports about the plant, but declined to comment.
Construction on the plant, on the coast of the northern reaches of the Persian Gulf, began under Iran’s Shah Mohammad Reza Pahlavi in the mid-1970s. After the 1979 Islamic Revolution, the plant was repeatedly targeted in the Iran-Iraq war. Russia later completed construction of the facility.
The plant, which sits near active fault lines and was built to withstand powerful quakes, has been periodically shaken by temblors. There have been no significant earthquakes reported in the area in recent days.
Meanwhile, the European Union on Sunday chaired the final meeting in Vienna of the sixth round of talks between Russia, China, Germany, France, Britain and Iran.
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The nations involved in the negotiations have been trying to resolve the major outstanding issues on how to return the U.S. into the landmark nuclear agreement, which then-President Donald Trump pulled Washington out of unilaterally in 2018. Trump also restored and augmented sanctions to try to force Tehran into renegotiating the pact with more concessions.
The meeting was the first since Iran’s hard-line judiciary chief won a landslide victory in the country’s presidential election last Friday. Some diplomats expressed concern that the election of Iran’s incoming President Ebrahim Raisi could complicate a possible return to the nuclear agreement.
EXPLAINER: The significance of China’s new space station
Adding a crew to China’s new orbiting space station is another major advance for the burgeoning space power.
Here’s a look at key developments:
WHAT’S THE MISSION’S PURPOSE?
The three-member crew is due to stay for three months in the station’s main living module, named Tianhe, or Heavenly Harmony. They will be carrying out science experiments and maintenance, space walks and preparing the facility to receive two additional modules next year.
While China concedes it arrived late at the space station game, it says its facility is cutting-edge. It could also outlast the International Space Station, which is nearing the end of its functional lifespan.
Read:Chinese cargo spacecraft docks with orbital station
The launch Thursday also revives China’s crewed space program after a five-year hiatus. With Thursday’s launch, China has now sent 14 astronauts into space since it first achieved the feat in 2003, becoming the third country after the former Soviet Union and the U.S. to do so.
WHY IS CHINA BUILDING THE STATION?
As the Chinese economy was beginning to gather steam in the early 1990s, China formulated a plan for space exploration, which it has carried out at a steady, cautious cadence. While China has been barred from participation in the International Space Station, mainly over U.S. objections to the Chinese program’s secretive nature and close military connections, it’s likely the country would have built its own station anyway as it sought the status of a great space power.
At a news conference Wednesday, China Manned Space Agency Assistant Director Ji Qiming told reporters at the Jiuquan launch center that the construction and operation of the space station will raise China’s technologies and “accumulate experience for all the people.”
The space program is part of an overall drive to put China on track for even more ambitious missions and provide opportunities for cooperation with Russia and other, mostly European, countries along with the United Nations Office for Outer Space Affairs.
Read:China delays supply mission to newly launched space station
POLITICS AND SECURITY
China’s space program has been a massive source of national pride, embodying its rise from poverty to the world’s second-largest economy over the past four decades. That has helped shore up the power of the Communist Party, whose authoritarian rule and strict limits on political activity have been tolerated by most Chinese as long as the economy is growing.
President and head of the party Xi Jinping has associated himself closely with that success, and Ji in his remarks cited Xi as setting the updated agenda for China’s rise to prominence in space. The first mission to the station also coincides with the celebration of the party centenary next month, an important political milestone.
At the same time, China is modernizing its military at a rapid pace, raising concerns from neighbors, the U.S. and its NATO allies. While China espouses the peaceful development of space on the basis of equality and mutual respect, many recall that China in January 2007 sent a ballistic missile into space to destroy an inactive weather satellite, creating a debris field that continues to be a threat.
WHO ARE THE ASTRONAUTS?
Mission commander Nie Haisheng, 56, and fellow astronauts Liu Boming, 54, and Tang Hongbo, 45, are former People’s Liberation Army Air Force pilots with graduate degrees and strong scientific backgrounds. All Chinese astronauts so far have been recruited from the military, underscoring its close ties to the space program.
Read:China’s Mars rover touches ground on red planet
For Nie, it is his third trip to space, and for Liu, his second following a mission in 2008 that included China’s first space walk. Tang, who was recruited as one of the second batch of candidates in 2010, is flying in space for the first time.
Future missions to the station will include women, according to officials, with stays extended to as long as six months and as many as six astronauts on the station at a time during crew changeovers. With China stepping up international cooperation and exchanges, it’s only a matter of time before foreign astronauts join the Chinese colleagues on missions to the station, Ji told reporters Wednesday.
WHAT ELSE IS CHINA DOING IN SPACE?
Along with its crewed space program, China has been moving boldly into exploration of the solar system with robotic space ships. It landed a probe on Mars last month that carried a rover, the Zhurong, which is conducting a range of surveys, looking particularly for frozen water that could provide clues as to whether the red plant once supported life.
Earlier, China landed a probe and rover on the moon’s less explored far side, joining the Yutu, or Jade Rabbit, rover that was part of an earlier lunar exploration mission. China also brought back the first lunar samples by any country’s space program since the 1970s and officials say they want to send Chinese astronauts to the moon and eventually build a research base there.
Novavax: Large study finds COVID-19 shot about 90% effective
Vaccine maker Novavax said Monday its COVID-19 shot was highly effective against the disease and also protected against variants in a large study in the U.S. and Mexico, potentially offering the world yet another weapon against the virus at a time when developing countries are desperate for doses.
The two-shot vaccine was about 90% effective overall, and preliminary data showed it was safe, the American company said. That would put the vaccine about on par with Pfizer’s and Moderna’s.
While demand for COVID-19 shots in the U.S. has dropped off dramatically and the country has more than enough doses to go around, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting supplies in poor parts of the world.
Read:As COVID-19 cases wane, vaccine-lagging in USA still see risk
That help is still months away, however. The company, which has been plagued by raw-material shortages that have hampered production, said it plans to seek authorization for the shots in the U.S., Europe and elsewhere by the end of September and will be able to produce up to 100 million doses a month by then.
“Many of our first doses will go to … low- and middle-income countries, and that was the goal to begin with,” Novavax CEO Stanley Erck said.
While more than half of the U.S. population has had at least one vaccine dose, less than 1% of people in the developing world have had one shot, according to a data collection effort run in part by the University of Oxford.
The Novavax shot stands to become the fifth Western-developed COVID-19 vaccine to win clearance. The Pfizer, Moderna and Johnson & Johnson vaccines are already authorized for use in the U.S. and Europe. Europe also uses AstraZeneca’s formula.
Novavax’s study involved nearly 30,000 people ages 18 and up. Two-thirds received two doses of the vaccine, three weeks apart, and the rest got dummy shots. Nearly half the volunteers were Black, Hispanic, Asian American or Native American, and 6% of participants were in Mexico. Altogether, 37% had health problems that made them high risk, and 13% were 65 or older.
There were 77 cases of COVID-19 — 14 in the group that got the vaccine, the rest in volunteers who received the dummy shots. None in the vaccine group had moderate or severe disease, compared with 14 in the placebo group. One person in that group died.
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The vaccine was similarly effective against several variants, including the one first detected in Britain that is now dominant in the U.S., and in high-risk populations, including the elderly, people with other health problems and front-line workers in hospitals and meatpacking plants.
“These consistent results provide much confidence in the use of this vaccine for the global population,” said Dr. Paul Heath, director of the Vaccine Institute at the University of London and St. George’s Hospital.
Side effects were mostly mild — tenderness and pain at the injection site. There were no reports of unusual blood clots or heart problems, Erck said.
A study underway in Britain is testing which of several vaccines, including Novavax’s, works best as a booster shot for people who received the Pfizer or AstraZeneca formula. Industry analyst Kelechi Chikere said the Novavax shot could become a “universal booster” because of its high effectiveness and mild side effects.
Novavax reported the results in a news release and plans to publish them in a medical journal, where they will be vetted by independent experts. The Gaithersburg, Maryland-based company previously released findings from smaller studies in Britain and South Africa.
COVID-19 vaccines train the body to recognize the coronavirus, especially the spike protein that coats it, and get ready to fight the virus off. The Novavax vaccine is made with lab-grown copies of that protein. That’s different from some of the other vaccines now widely used, which include genetic instructions for the body to make its own spike protein.
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The Novavax vaccine can be stored in standard refrigerators, making it easier to distribute.
As for the shortages that delayed manufacturing, Erck said those were due to restrictions on shipments from other countries.
“That’s opening up,” he said, adding that Novavax now has weeks’ worth of needed materials in its factories, up from just one week.
The company has committed to supplying 110 million doses to the U.S. over the next year and a total of 1.1 billion doses to developing countries.
In May, vaccines alliance Gavi, a leader of the U.N.-backed COVAX project to supply shots to poorer countries, announced it signed an agreement to buy 350 million doses of Novavax’s formula. COVAX is facing a critical shortage of vaccines after its biggest supplier in India suspended exports until the end of the year.
Novavax has been working on developing vaccines for more than three decades but hasn’t brought one to market. Its coronavirus vaccine work is partly funded by the U.S. government.
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Dr. Peter English, a vaccine expert previously with the British Medical Association, called the Novavax results “excellent news.” English said that because vaccine production is complicated, it’s crucial to have as many shots as possible.
“Any minor imperfection in the production plant can shut down the production for days or weeks,” he said in a statement. “The more different manufacturers we have producing vaccine, the more likely it is we will have availability of vaccines.”
He said it was also encouraging news that Novavax would be able to adapt its vaccine to any potentially worrying variants in the future if necessary.
US deaths from heart disease and diabetes climbed amid COVID
The U.S. saw remarkable increases in the death rates for heart disease, diabetes and some other common killers in 2020, and experts believe a big reason may be that many people with dangerous symptoms made the lethal mistake of staying away from the hospital for fear of catching the coronavirus.
The death rates — posted online this week by federal health authorities — add to the growing body of evidence that the number of lives lost directly or indirectly to the coronavirus in the U.S. is far greater than the officially reported COVID-19 death toll of nearly 600,000 in 2020-21.
For months now, researchers have known that 2020 was the deadliest year in U.S. history, primarily because of COVID-19. But the data released this week showed the biggest increases in the death rates for heart disease and diabetes in at least 20 years.
“I would probably use the word `alarming,’” said Dr. Tannaz Moin, a diabetes expert at UCLA, said of the trends.
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Earlier this year, the Centers for Disease Control and Prevention reported that nearly 3.4 million Americans died in 2020, an all-time record. Of those deaths, more than 345,000 were directly attributed to COVID-19. The CDC also provided the numbers of deaths for some of the leading causes of mortality, including the nation’s top two killers, heart disease and cancer.
But the data released this week contains the death rates — that is, fatalities relative to the population — which is considered a better way to see the impact from year to year, since the population fluctuates.
Of the causes of death for which the CDC had full-year provisional data, nine registered increases. Those included Alzheimer’s disease, Parkinson’s, chronic liver disease, stroke and high blood pressure.
Some of the increases were relatively small, but some were dramatic. The heart disease death rate — which has been falling over the long term — rose to 167 deaths per 100,000 population from 161.5 the year before. It was only the second time in 20 years that the rate had ticked up. This jump, of more than 3%, surpassed the less than 1% increase seen in 2015.
In raw numbers, there were about 32,000 more heart disease deaths than the year before.
Diabetes deaths rose to 24.6 per 100,000 last year, from 21.6 in 2019. That translated to 13,000 more diabetes deaths than in 2019. The 14% increase was the largest rise in the diabetes death rate in decades.
The death rate from Alzheimer’s was up 8%, Parkinson’s 11%, high blood pressure 12% and stroke 4%.
Read:EXPLAINER: The US investigation into COVID-19 origins
The CDC offered only the statistics, not explanations. The agency also did not say how many of the fatalities were people who had been infected with — and weakened by — the coronavirus but whose deaths were attributed primarily to heart disease, diabetes or other conditions.
Some experts believe a larger reason is that many patients did not seek treatment in an emergency because they feared becoming infected with the virus.
“When hospitalization rates for COVID would go up, we would see dramatic declines in patients presenting to the emergency room with heart attacks, stroke or heart failure,” Dr. Donald Lloyd-Jones, a Northwestern University researcher who is president-elect of the American Heart Association.
Other possible explanations also point indirectly to the coronavirus.
Many patients stopped taking care of themselves during the crisis, gaining weight or cutting back on taking high blood pressure medications, he said. Experts said the stress of the crisis, the lockdown-related disappearance of exercise options, and the loss of jobs and the accompanying health insurance were all factors, too.
Increases in Kentucky, Michigan, Missouri, and West Virginia pushed the four into the group of states with the highest rates of death from heart disease, the CDC data showed. For diabetes, similar changes happened in Indiana, New Mexico, West Virginia and some other Southern and Plains states.
The death rate from the nation’s No. 2 killer, cancer, continued its decline during the year of COVID-19. It fell about 2% in 2020, similar to the drop seen from 2018 to 2019, even though cancer screenings and cancer care declined or were often postponed last year.
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Lloyd-Jones’ theory for the decline: Many of the virus’s victims were fighting cancer, “but COVID intervened and became the primary cause of death.”
Earlier research done by demographer Kenneth Johnson at the University of New Hampshire found that an unprecedented 25 states saw more deaths than births overall last year.
The states were Alabama, Arizona, Arkansas, Connecticut, Delaware, Florida, Indiana, Kentucky, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, West Virginia, and Wisconsin.
Traditionally the vast majority of states have more births than deaths.
Spacecraft buzzes Jupiter’s mega moon, 1st close-up in years
NASA’s Juno spacecraft has provided the first close-ups of Jupiter’s largest moon in two decades.
Juno zoomed past icy Ganymede on Monday, passing within 645 miles (1,038 kilometers). The last time a spacecraft came that close was in 2000 when NASA’s Galileo spacecraft swept past our solar system’s biggest moon.
Read:NASA picks Venus as hot spot for two new robotic missions
NASA released Juno’s first two pictures Tuesday, highlighting Ganymede’s craters and long, narrow features possibly related to tectonic faults. One shows the moon’s far side, opposite the sun.
“This is the closest any spacecraft has come to this mammoth moon in a generation,” said Juno’s lead scientist, Scott Bolton of the Southwest Research Institute in San Antonio. “We are going to take our time before we draw any scientific conclusions, but until then we can simply marvel at this celestial wonder – the only moon in our solar system bigger than the planet Mercury.”
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Ganymede is one of 79 known moons around Jupiter, a gas giant. Italian astronomer Galileo Galilei discovered Ganymede in 1610, along with Jupiter’s three next-biggest moons.
Launched a decade ago, Juno has been orbiting Jupiter for five years.
EXPLAINER: The US investigation into COVID-19 origins
Once dismissed by most public health experts and government officials, the hypothesis that COVID-19 leaked accidentally from a Chinese lab is now receiving scrutiny under a new U.S. investigation.
Experts say the 90-day review ordered on May 26 by President Joe Biden will push American intelligence agencies to collect more information and review what they already have. Former State Department officials under President Donald Trump have publicly pushed for further investigation into virus origins, as have scientists and the World Health Organization.
Many scientists, including Dr. Anthony Fauci, say they still believe the virus most likely occurred in nature and jumped from animals to humans. Virus researchers have not publicly identified any key new scientific evidence that might make the lab-leak hypothesis more likely.
Virologists also say it is unlikely that any definitive answer about virus origins will be possible in 90 days. The work to fully confirm origins and pathways of past viruses — such as the first SARS or HIV/AIDS — has taken years or decades.
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A look at what is known about the U.S. investigation of the virus.
WHAT ARE INTELLIGENCE AGENCIES REVIEWING?
Biden ordered a review of what the White House said was an initial finding leading to “two likely scenarios,” an animal-to-human transmission or a lab leak. The White House statement says two agencies in the 18-member intelligence community lean toward the hypothesis of a transmission in nature; another agency leans toward a lab leak.
One document drawing new attention is a State Department fact sheet published in the last days of Trump’s administration. The memo notes that the U.S. believes three researchers at a Wuhan, China, lab sought medical treatment for a respiratory illness in November 2019. However, the report is not conclusive: The origin and severity of the staffers’ illness is not known — and most people in China regularly go to hospitals, not primary-care physicians, for routine care.
The memo also pointed to “gain of function” studies — which in theory could enhance the lethality or transmissibility of a virus — allegedly done at the Wuhan lab with U.S. backing. However, National Institutes of Health Director Francis Collins has since adamantly denied that the U.S. supported any “gain-of-function” research on coronaviruses in Wuhan.
David Feith, who served as deputy assistant secretary of state for East Asian and Pacific Affairs under Trump, said he supported Biden’s call for an enhanced review. “Implicit in the president’s statement is that there is more to analyze and more to collect than has been analyzed or collected to date,” Feith said.
The Director of National Intelligence declined to comment.
IS CHINA HAMPERING INVESTIGATIONS?
The White House statement criticized China for a lack of transparency, echoing previous criticisms by Democrats and Republicans. “The failure to get our inspectors on the ground in those early months will always hamper any investigation into the origin of COVID-19,” the White House said.
The Associated Press has reported on China’s interference in the World Health Organization’s probes of the virus and its fanning of conspiracy theories online. China has also forced journalists to leave the country in recent years and silenced or jailed whistleblowers from Wuhan and elsewhere.
The lack of transparency in China is a significant and familiar challenge. But that does not in itself signal that something in particular is being hidden.
“The problem is when you make that announcement (Biden’s call for investigation) in a highly politicized environment, it makes it even less likely that China will cooperate with efforts to find the origins of the virus,” said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations.
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WHAT DO SCIENTISTS BELIEVE ABOUT VIRUS ORIGINS?
The most compelling argument for investigating the possibility of a lab leak is not any new hard evidence, but rather the fact that another pathway for virus spread has not been 100% confirmed.
“The great probability is still that this virus came from a wildlife reservoir,” said Arinjay Banerjee, a virologist at the Vaccine and Infectious Disease Organization in Saskatchewan, Canada. He pointed to the fact that spillover events – when viruses jump from animals to humans – are common in nature, and that scientists already know of two similar beta coronaviruses that evolved in bats and caused epidemics when humans were infected, SARS1 and MERS.
However, the case is not completely closed. “There are probabilities, and there are possibilities,” said Banerjee. “Because nobody has identified a virus that’s 100% identical to SARS-CoV-2 in any animal, there is still room for researchers to ask about other possibilities.”
HOW LONG DOES IT TAKE TO CONFIRM THE ORIGIN OF A VIRUS?
Confirming with 100% certainty the origin of a virus is often not fast, easy, or always even possible.
For example, scientists never confirmed the origin of smallpox before the disease was eradicated through a global vaccination program.
In the case of Severe Acute Respiratory Syndrome (SARS) – a disease caused by a beta coronavirus, like the current coronavirus – researchers first identified the virus in February 2003. Later that year, scientists discovered the likely intermediary hosts: Himalayan palm civets found at live-animal markets in Guangdong, China. But it wasn’t until 2017 that researchers traced the likely original source of the virus to bat caves in China’s Yunnan province.
HOW IMPORTANT IS IT TO UNDERSTAND THE ORIGIN?
From a scientific perspective, researchers are always keen to better understand how diseases evolve. From a public health perspective, if a virus has transitioned to being spread mostly by human-to-human contact, discovering its origins is not as essential to strategies for containing the disease.
“Questions of origins and questions of disease control are not the same thing once human-to-human transmission has become common,” said Deborah Seligsohn, an expert in environment and public health at Villanova University.
Republicans have pressed for more inquiries into a possible lab leak as part of a broader effort to blame China and vindicate Trump’s handling of the pandemic. Nearly 600,000 people in the United States have died of COVID-19, the highest toll of any country.
Read:US to swiftly boost global vaccine sharing, Biden announces
WHAY HAPPENS AFTER THE 90 DAYS?
Many scientists caution that it’s unlikely a 90-day investigation will yield definitive new answers.
“We rarely get a ‘smoking gun,’” said Stephen Morse, a disease researcher at Columbia University. “Even under the best of circumstances we rarely get certainty, just degrees of likelihood.”
Any findings will likely be politically explosive, especially if new evidence comes to light supporting or dismissing the zoonotic transfer or lab-leak theory. And a failure to reach definitive conclusions, almost inevitable after a 90-day review, could provide grist for Trump supporters and opponents alike, as well as embolden conspiracy theorists.
Meanwhile experts like the Council on Foreign Relations’ Huang suspect China may simply clamp down more, adding another complication to already tense relations. “This will likely make it even more challenging to extract concessions from China to allow another team to visit Wuhan, or have unfettered access to investigate there,” he said.
FDA approves much-debated Alzheimer’s drug panned by experts
Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.
The Food and Drug Administration approved the drug from Biogen based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.
The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.
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Dr. Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision.
“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a medical researcher at Johns Hopkins University.
The FDA’s top drug regulator acknowledged that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain is expected to help slow dementia.
“The data supports patients and caregivers having the choice to use this drug,” Dr. Patrizia Cavazzoni told reporters. She said the FDA carefully weighed the input of people living with the “devastating, debilitating and deadly disease.”
Under terms of the so-called accelerated approval, the FDA is requiring Biogen to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.
Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and said the price would not be raised for four years. Most patients won’t pay anywhere near that thanks to insurance coverage and other discounts. The company said it aims to complete the FDA-mandated follow-up trial by 2030.
Biogen shares jumped 38% in trading Monday on the news, with analysts forecasting billions in future sales. The Cambridge, Massachusetts-based company plans to begin shipping millions of doses within two weeks.
The non-profit Institute for Clinical and Economic Review, which studies drug value, said Biogen’s drug would have to halt dementia entirely to justify its $56,000 per-year price tag.
Some 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.
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Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) helps clear a protein called beta-amyloid from the brain. Other experimental drugs have done that but they made no difference in patients’ ability to think, care for themselves or live independently.
The pharmaceutical industry’s drug pipeline has been littered for years with failed Alzheimer’s treatments. The FDA’s greenlight Monday is likely to revive investments in therapies previously shelved by drugmakers.
The new medicine is manufactured from living cells and will be given via infusion at a doctor’s office or hospital.
Researchers don’t fully understand what causes Alzheimer’s but there’s broad agreement the brain plaque targeted by aducanumab is just one contributor. Evidence suggests family history, education and chronic conditions like diabetes and heart disease may all play a role.
“This is a sign of hope but not the final answer,” said Dr. Richard Hodes, director of the National Institute on Aging, which wasn’t involved in the Biogen studies but funds research into how Alzheimer’s forms. “Amyloid is important but not the only contributing factor.”
Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a placebo.
But that meant a difference of just 0.39 on an 18-point score of cognitive and functional ability. And it’s unclear how such metrics translate into practical benefits, like greater independence or ability to recall important details.
The FDA’s review of the drug has become a flashpoint in longstanding debates over standards used to evaluate therapies for hard-to-treat conditions. On one side, groups representing Alzheimer’s patients and their families say any new therapy — even one of small benefit — warrants approval. But many experts warn that greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit.
The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed the drug was effective.
Biogen halted two studies in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients.
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Several months later, the company reversed course, announcing that a new analysis of one study showed the drug was effective at higher doses and the FDA had advised that it warranted review. Company scientists said the drug’s initial failure was due to some patients not receiving high enough doses to slow the disease.
But the changes to dosing and the company’s after-the-fact analysis made the results hard to interpret, raising skepticism among many experts, including those on the FDA panel.
The FDA isn’t required to follow the advice of its outside panelists and has previously disregarded their input when making similarly high-profile drug decisions.
About 900 U.S. medical facilities are ready to begin prescribing the drug, according to Biogen, with many more expected in coming months. But key practical questions remain: How long do patients benefit? How do physicians determine when to discontinue the drug? Does the drug have any benefit in patients with more advanced dementia?
With FDA approval, aducanumab is almost certain to be covered by most insurers, including Medicare, the government plan for seniors that covers more than 60 million people.
Insurers could try to manage the drug’s costs by requiring strict conditions, including brain scans to confirm plaque, before agreeing to cover it.
Additional scans will be needed to monitor potential side effects. The drug carries a warning about temporary brain swelling that can sometimes cause headaches, confusion and dizziness. Other side effects included allergic reactions, diarrhea and disorientation.
Although Biogen studied the drug in people with mild dementia or early-stage Alzheimer’s, the FDA label approved the drug for anyone with Alzheimer’s, a sweeping population given doctors have broad leeway in diagnosing the condition.
“The FDA is empowering the physician to make the decision on diagnosis,” Biogen CEO Michel Vounatsos said in an interview.
Read:US to swiftly boost global vaccine sharing, Biden announces
For patients already enrolled in Biogen’s trials, Monday’s announcement means they can continue taking a drug many believe has helped.
Phillip Lynn, 63, was diagnosed with Alzheimer’s in the spring of 2017 after having trouble with conversation and memory, including forgetting a recent vacation to Hawaii.
His husband Kurt Rehwinkel says Lynn’s cognitive ability has stabilized since starting on Biogen’s drug more than three years ago. And his performance on short-term memory tests has actually improved, though the couple acknowledges most patients are unlikely to see similar results.
“But even for those who it has little or no effect, I think hope is a good thing,” said Rehwinkel. “I don’t think there’s such a thing as false hope.”
NASA picks Venus as hot spot for two new robotic missions
NASA is returning to sizzling Venus, our closest yet perhaps most overlooked neighbor, after decades of exploring other worlds.
The space agency’s new administrator, Bill Nelson, announced two new robotic missions to the solar system’s hottest planet, during his first major address to employees Wednesday.
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“These two sister missions both aim to understand how Venus became an inferno-like world capable of melting lead at the surface,” Nelson said.
One mission named DaVinci Plus will analyze the thick, cloudy Venusian atmosphere in an attempt to determine whether the inferno planet ever had an ocean and was possibly habitable. A small craft will plunge through the atmosphere to measure the gases.
It will be the first U.S.-led mission to the Venusian atmosphere since 1978.
The other mission, called Veritas, will seek a geologic history by mapping the rocky planet’s surface.
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“It is astounding how little we know about Venus,” but the new missions will give fresh views of the planet’s atmosphere, made up mostly of carbon dioxide, down to the core, NASA scientist Tom Wagner said in a statement. “It will be as if we have rediscovered the planet.”
NASA’s top science official, Thomas Zurbuchen, calls it “a new decade of Venus.” Each mission — launching sometime around 2028 to 2030 — will receive $500 million for development under NASA’s Discovery program.
The missions beat out two other proposed projects, to Jupiter’s moon Io and Neptune’s icy moon Triton.
The U.S. and the former Soviet Union sent multiple spacecraft to Venus in the early days of space exploration. NASA’s Mariner 2 performed the first successful flyby in 1962, and the Soviets’ Venera 7 made the first successful landing in 1970.
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In 1989, NASA used a space shuttle to send its Magellan spacecraft into orbit around Venus.
The European Space Agency put a spacecraft around Venus in 2006.
Chinese cargo spacecraft docks with orbital station
An automated spacecraft docked with China’s new space station Sunday carrying fuel and supplies for its future crew, the Chinese space agency announced.
Tianzhou-2 spacecraft reached the Tianhe station eight hours after blasting off from Hainan, an island in the South China Sea, China Manned Space said. It carried space suits, living supplies and equipment and fuel for the station.
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Tianhe, or Heavenly Harmony, is third and largest orbital station launched by China’s increasingly ambition space program.
The station’s core module was launched April 29. The space agency plans a total of 11 launches through the end of next year to deliver two more modules for the 70-ton station, supplies and a three-member crew.
China was criticized for allowing part of the rocket that launched the Tianhe to fall back to Earth uncontrolled. There was no indication about what would happen to the rocket from Saturday’s launch.
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Beijing doesn’t participate in the International Space Station, largely due to U.S. objections. Washington is wary of the Chinese program’s secrecy and its military connections.
Buildup to super blood moon eclipses the finale
In the end, the buildup seemed to eclipse the finale.
People across New Zealand and around the world stayed up Wednesday to watch a cosmic event called a super blood moon, a combination of a total lunar eclipse and a brighter-than-usual supermoon.
During the buildup, a glittering moon rose above the horizon. As the Earth’s shadow began taking bites from the moon, it created a dramatic effect. Half the moon vanished, leaving it looking like a black-and-white cookie.
When the full eclipse took hold, however, the moon darkened, turning a smudgy burnt orange color for many viewers.
Read:Cosmic 2-for-1: Total lunar eclipse combines with supermoon
In celestial terms, it was a wonder: a projection of the world’s sunsets and sunrises onto the black canvas of the eclipsed moon. But for people peering up from their backyards, it wasn’t quite the brilliant display they had anticipated. Not quite super or blood-colored.
“It was not that vivid for those on ground,” said Ben Noll, a meteorologist with New Zealand scientific research agency NIWA. “Personally, I thought there would be a bit more red in the sky.”
Still, Noll thought that overall, the evening was sensational. He heard plenty of people cheering and cars honking in downtown Auckland where he watched it all unfold.
John Rowe, an educator at the Stardome Observatory & Planetarium in Auckland, said it was like the moon turned into a big, spooky smile looking down at him. That’s because of a bright rim that remained at the bottom.
Rowe also enjoyed seeing surrounding stars appear to brighten as the light from the moon dimmed.
The full eclipse lasted about 15 minutes, while the whole cosmic show lasted five hours. A partial eclipse began as the moon edged into the Earth’s outer shadow, called the penumbra, before moving more fully into the main shadow and then reversing the process.
Rowe likes to imagine it as if he’s standing on the moon. The Earth would come across and block out the sun. The reddish light around the edges would be the sunsets and sunrises happening at that time on Earth, projected onto the moon’s surface. Pretty cool, he reckons.
The color of the moon during the total eclipse can appear different depending on where people are in the world, and by factors like the amount of dust in the atmosphere and global weather.
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In much of New Zealand, the weather remained calm and clear on Wednesday, providing excellent viewing conditions.
The same was true in Australia, although those in South Korea struck out because rain and cloudy weather across much of the country obscured the eclipse. There also was disappointment in Japan because of cloudy weather, with many posting messages like “I can’t see anything” on Twitter.
Some places in the Pacific and East Asia got to see the show before midnight, while night owls in Hawaii and the western part of North America got to watch it in the early morning hours.
Sky gazers along the U.S. East Coast were out of luck because the moon was setting and the sun rising. Europe, Africa and western Asia all missed out as well.
In Anchorage, Alaska, Doug Henie didn’t know what to expect from his first lunar eclipse. He and his wife saw just a sliver of the moon as they drove to a prime viewing spot, on a hill off a winding road between Cook Inlet and the Anchorage airport.
Once they arrived, he set up his camera as the eclipse neared totality just after 3 a.m. local time, when it looked more like dusk than night. That’s because Anchorage had more than 18 hours of sunlight on Wednesday.
“It’s kind of cool,” Henie said. “I was kind of hoping to see a little more action, I guess, but now it’s lightened up. The light is certainly coming back.”
In Hong Kong, Dickson Fu left work early to watch the eclipse from a seaside promenade in the Sai Kung neighborhood.
Fu, who is president of Hong Kong’s Sky Observers’ Association, picked that particular spot because it would give him an unobstructed view.
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“In recent years I’m more interested in taking photos, and in the past few days I have already done rehearsals, testing out equipment such as the camera and lenses,” said Fu.
For those living in places where the eclipse wasn’t visible, there were livestreams available. And everyone around the world got to see the bright moon, weather permitting.
It was the first total lunar eclipse in more than two years.
The moon was more than 220,000 miles (357,460 kilometers) away at its fullest. It was this proximity, combined with a full moon, that qualified it as a supermoon, making it appear slightly bigger and more brilliant in the sky.