India posted a single-day world record Thursday of more than 6,000 COVID-19 deaths after one state revised a set of numbers.The eastern state of Bihar, one of India’s largest and poorest states, revised its death toll Wednesday from about 5,500 to 9,500 after the state’s high court ordered the government to review its records.Many experts have said India’s death toll is far higher than official reports after a devastating surge of new infections in April and May saw the emergence of hundreds of makeshift crematoriums and scores of bodies floating in rivers.The revised count pushed India’s one-day death toll to 6,148, outpacing the 5,444 recorded by the United States on February 12, according to Reuters.The world’s second-most populous nation now has 29.1 million total confirmed COVID-19 cases, including 355,705 deaths, according to Johns Hopkins Coronavirus Resource Center, second only to the United States with 33.4 million total cases and 598,766 deaths.In other news, a study published Wednesday in the journal Nature Medicine reveals a slightly higher risk of a bleeding disorder from the AstraZeneca COVID-19 vaccine.  Researchers discovered some people who received the AstraZeneca vaccine in Scotland had developed a condition called ITP, or immune thrombocytopenic purpura, which causes bruising in some cases and also serious bleeding in others.The study also found very small increased risks of arterial blood clots and bleeding possibly associated with the AstraZeneca vaccine. 
…

Hong Kong will allow children age 12 and above to receive the Pfizer coronavirus vaccine as it seeks to boost immunization rates in the city. Government officials said Thursday they will offer the vaccine to about 240,000 children from 12 to 15 years old starting Friday, joining other countries that have started vaccinating children. The move comes as Hong Kong is urging its 7.5 million population to get inoculated. Since its vaccination drive began in late February, just over 15% of the population has been fully vaccinated. The city has seen widespread vaccine hesitancy due to a mistrust of the government and outsized fears of side effects after several people died following inoculations, despite a determination that the deaths were not directly related to the vaccine. “The government attaches high importance to getting adolescents and students vaccinated, and it is the government’s hope that more students, parents and teachers will be vaccinated,” said Secretary for the Civil Service Patrick Nip. Since they are below 18, children must obtain parental approval before they can be vaccinated. Health minister Sophia Chan urged parents to let their children get vaccinated to “help them to go back to school for their normal lives as soon as possible.” Students in kindergarten through secondary school are currently attending only half-day classes as part of preventive measures during the pandemic. The semi-autonomous Chinese city is offering the Pfizer vaccine — better known as BioNTech in the city — and the Chinese-made Sinovac vaccine. Hong Kong officials say those wanting to receive the Pfizer vaccine must do so by the end of August before the doses expire, and that vaccination centers administering the Pfizer vaccine will cease operations in September. The private sector is offering a slew of incentives to encourage people to get vaccinated. Companies are offering gold bars, a Tesla car and even an apartment in lucky draws open to vaccinated residents. Hong Kong ended a 6-week streak with no local infections last week when a 17-year-old girl tested positive despite having no travel history. Her mother and sister later also tested positive. 
…

By any measure, the number of those being vaccinated against COVID-19 in Africa are running behind the rest of the world. Health experts warn that failure to inoculate the 1.3 billion people on the continent will have a huge impact on its health care systems and economies. More than a year into the COVID-19 pandemic, most African countries have vaccinated only a tiny fraction of their populations.Nigeria, the most populous nation in Africa, has fully vaccinated just 0.1% of its citizens.The Africa Center for Disease Control says three countries — Tanzania, Burundi, Eritrea — and the self-declared Sahrawi Republic have yet to receive any vaccines, while Burkina Faso has received 115,000 doses of the AstraZeneca vaccine but has not yet administered a single jab.Abdhalah Ziraba, an epidemiologist and the head of the health system at the African Population and Health Research Center in Nairobi, says the failure to inoculate is partly due to vaccine hesitancy among the population, and underdeveloped health care systems, especially in non-urban areas. “In Africa, most people live in rural areas. The health care system that should be the system to deliver the vaccines to the last person is not as elaborate as the population is distributed. So, people are far away from where they can get access to vaccines, and as a consequence, they are definitely left out, but they remain at risk of getting exposed to COVID-19,” Zariba said.Kenya has fully vaccinated just 13,000 people out of a population of 50 million, although about 1 million have received one dose of a vaccine. Davji Atellah, the secretary-general of the Kenya Medical Practitioners, Pharmacists and Dentists’ Union, calls for the government to allocate 1% of the country’s budget to purchase COVID-19 vaccines.“Countries like Uganda, or here in Kenya, we can still see there are waves, there is a surge in infections. So, the ultimate way to get things back to normal is to vaccinate. That’s why we are asking the government, if our current budget is 3.6 trillion Kenya shillings. If 1%, that’s about 35 billion shillings ($324.4 million) is put into buying the vaccines for the Kenyans, then we may have hope to see the opening up.” Atellah said.Kenya’s western region has been witnessing high rates of coronavirus infections in recent weeks, and officials have warned they may have to impose a new lockdown to curb transmissions. In neighboring Uganda, the government recently reintroduced a strict lockdown to fight an increase in infections. The lockdown includes the shutting down of schools and religious activities, and imposing travel bans within the country.Ziraba said African countries’ failure to vaccinate their population will disrupt everyday life and will pose a problem to the rest of the world.“It will be a cascade that will be very disruptive to the African countries’ economies and health care system. But the rest of the world will not sit pretty because while a big part of their population will be protected, they will not be comfortable knowing that there will be a new infection coming to their borders every now and then,” Ziraba said.Overall, Africa has recorded about 5 million cases of COVID-19 and 133,000 deaths.
…

When to unlock? Britain’s Boris Johnson is coming under mounting pressure from Conservative lawmakers and their allies in the media to keep to a previously outlined timetable that would see virtually all pandemic restrictions relaxed on June 21 in England.    But a sudden surge in coronavirus infections has triggered fierce counter-lobbying from the government’s scientific advisers, who want a delay to the final easing of restrictions to assess the latest data and to ensure that variants, including the now-dominant Delta variant, first detected in India, aren’t resistant to vaccines.  FILE – Pedestrians walk past a sign warning members of the public about a “Coronavirus variant of concern,” in Hounslow, west London, Britain, June 1, 2021.Ministers have been hinting for days of a delay in what was earmarked as the final unlocking phase, and government officials say they are in a race between vaccinating people and the Delta variant. Businesspeople are also expressing frustration at any delay. Those angered by talk of delay include Andrew Lloyd-Webber, theater impresario and the composer of musicals, “The Phantom of the Opera” and “Cats.” He issued a threat to the government Wednesday, vowing to risk arrest by reopening his London theaters on June 21. If the final stage of unlocking was postponed, “We will say, ‘come to the theater and arrest us,’” he told local media. The Delta variant is at least 40% more infectious than the previous strain dominating Britain, say government advisory panels, and the surge in cases is being seen largely among the unvaccinated under-30-year-olds. Some government advisers fear Britain’s national health service won’t be able to cope once again, if the virus is allowed to run rampant, and are predicting cases requiring hospitalizations could reach the previous peak seen in January.   More than 12,000 Delta-variant cases have been identified, and of those 126 led to hospital admissions. Eighty-three of those hospitalized hadn’t been vaccinated, 28 had received one vaccine dose and only three had received both jabs. Britain recorded more than 6,000 new daily coronavirus cases midweek, up 68% in the past seven days. Nonetheless, Cabinet ministers received a pessimistic briefing Wednesday from key advisers, Chris Whitty, chief medical officer for England, and Patrick Vallance, chief scientific adviser, with the pair telling the politicians that the latest data is “fairly grim,” according to Downing Street officials briefing local media. Government sources say they expect that Johnson on Monday will likely announce a delay of “between two weeks and a month” to the phase four reopening, but they say they are optimistic that the political fallout won’t be too great as many restrictions were lifted last month with non-essential shops and malls allowed to open. The government had planned to end on June 21 social distancing, dropping a one meter-plus rule between patrons of restaurants and bars. The rule of no more than six people gathering in homes would also be lifted, and nightclubs and discos would be allowed to operate. A 30-person limit on weddings would be lifted, and rules on wearing facemasks in public would be dropped. And the government would drop its guidance on people working from home, if their jobs allow it.    But traveling overseas for vacations is now being firmly discouraged after considerable government confusion and mixed messaging.FILE – People wait in queues at Faro airport amid the coronavirus disease (COVID-19) pandemic, in Faro, Portugal, June 6, 2021.Earlier this week more than 10,000 British vacationers rushed back from Portugal, one of just a handful of countries Britons are permitted to visit without having to undergo ten days of self-isolation on their return. The British government had put Portugal on a “safe list” of countries just two weeks earlier but abruptly removed from the list this week. On Tuesday former Conservative minister Steve Baker urged Johnson to go ahead and keep to the “freedom day” he had earmarked to “make life worth living” again. He called it the “last chance” to save Britain’s hospitality and tourism industries and said the time had arrived to allow people to “reconnect with family and friends and regain our mental health.”    Half of all adults in Britain have had both vaccine doses. And official government figures for England show that around four in five over-50s and a third of those in their 40s have had both jabs.   FILE – People queue outside a vaccination center for those aged over 18 years old at the Belmont Health Centre in Harrow, in London, Britain, June 6, 2021.Those who oppose any delay point to the huge fall in deaths and hospital admissions, arguing that they prove vaccines have broken the link between infection and severe disease. They say government cautiousness is based on the adoption of a delusion — namely that the country, or any country, can be COVID-free.   “Scientists seem to be quietly advocating a zero COVIVD approach, wherein case numbers in themselves are deemed to be concerning even if they do not lead to an uptick in hospitalizations or deaths,” says the Daily Telegraph newspaper, which once employed Johnson as its Brussels correspondent. “They argue that the borders should be closed until global case numbers are brought down, for fear of new variants. This is the sort of New Zealand-style logic that would leave the country locked off from the world indefinitely.”  The newspaper complained that there is “an apparent failure to account for the costs of the lockdown measures when deciding policy” and “the worst predictions are always heeded” by the politicians.    “One day soon freedom will return,” Britain’s health minister Matt Hancock told lawmakers this week. “We must proceed safely and not see this go backwards,” he added.   Meanwhile, WHO’s special pandemic envoy, David Nabarro, has warned that the world will have to learn to live with the coronavirus and people will have to adapt their lifestyles, whether they are vaccinated or not. “I’m trying to really re-iterate it can’t just be about restrictions,” he said. “The future for humanity is that we adapt our lifestyles, so we make it hard for this virus to spread.”    Nabarro told Britain’s Sky News: “We know that [the virus] is constantly changing which means that although vaccination is a marvelous asset, it’s not going to be enough. We are going to have to continue to behave as though the virus is an ever-present threat.”    The White House Wednesday said it had set up working groups with a number of foreign countries, including Britain, to determine how to restart international travel safely. World leaders are to discuss the issue at the G-7 summit in Cornwall later this week. 
…

The head of UNAIDS said Tuesday that inequalities are a chief driver of the HIV/AIDS epidemic, just as they are with COVID-19. “Inequalities in power, status, rights and voice are driving the HIV pandemic,” said Winnie Byanyima, executive director of UNAIDS. “Inequalities kill.” Since the first cases were reported 40 years ago, UNAIDS says 77.5 million people have been infected with HIV, and nearly 35 million have died from AIDS. Byanyima told a high-level meeting of the U.N. General Assembly that nations must end the inequalities that perpetuate HIV/AIDS if they want to meet their target of ending the epidemic by 2030. “Today we are setting bold, ambitious goals to reach 95% of those in need with HIV treatment and prevention,” she said. “To get there we need to re-imagine HIV services, making them easy to access and designed around people’s lives.” Byanyima said the COVID-19 pandemic has shown how political will can help push science and that the same sort of push needs to be made for HIV/AIDS treatments, prevention, care and vaccines. FILE – Charlize Theron attends a movie screening in Los Angeles, California, July 31, 2020.U.N. Messenger of Peace Charlize Theron addressed the meeting in a video message Tuesday. The South African actress said it is often the most vulnerable people who are the least likely to have access to the services they need. “Because the fact remains, that whether you live or die from AIDS is still too often determined by who you are, who you love and where you live,” Theron said. U.N. member states adopted a political declaration on scaling up progress in order to reach the 2030 goal, but it was not without some controversy. Just before the adoption, Russia’s representative tried to get the assembly to agree to three amendments, which would have eliminated language on respecting the human rights of persons living with HIV/AIDS and ending discriminatory and restrictive laws based on a person’s HIV status. The amendments were overwhelmingly voted down, and the original draft text, which was the result of lengthy negotiations and compromises among member states, was adopted with 165 votes in favor, four against and no country abstaining. Belarus, Nicaragua and Syria joined Russia in voting against the declaration.  
 
…

The World Meteorological Organization, the United Nations climate agency, reported Tuesday that Europe saw its coldest March through May since 2013, with temperatures 0.45 C below the 1991-2020 average.During a briefing from the agency’s headquarters in Geneva, Switzerland, WMO spokesperson Clare Nullis cautioned that Europe’s cool start did not reflect any pause in the world’s climate change problems.In fact, data from the European Union’s Copernicus Climate Change Service show that the global average temperature for May was 0.26 C higher than the 1991-2020 mean, according to the U.N. News website.  Greenhouse Gases Threaten Ocean Ecosystems: WMOThe ocean absorbs around 23 percent of the annual atmospheric emissions of carbon dioxide and acts as a buffer against climate changeAlso according to U.N. News: “Temperatures were well above average over western Greenland, north Africa, the Middle East and northern and western Russia while below-average May temperatures were reported over the southern and central United States, parts of northern Canada, south-central Africa, most of India, eastern Russia, and eastern Antarctica.”  Nullis said there was also “quite a considerable rise” in carbon dioxide (CO2) in the atmosphere at the Mauna Loa Observatory, an atmospheric monitoring station operated by the U.S. National Oceanic and Atmospheric Association in Hawaii.She said, “The fact CO2 does have such a long lifetime in the atmosphere does mean that future generations — and we’re not just talking about one or two, we’re talking about many generations — will be committed to seeing more impacts of climate change.”  Nullis warned rising CO2 levels will also have a “very serious impact” on the planet’s oceans, which absorb almost a quarter of CO2 emissions. 
…

The annual peak of global heat-trapping carbon dioxide in the air has reached another dangerous milestone: 50% higher than when the industrial age began.And the average rate of increase is faster than ever, scientists reported Monday.The National Oceanic and Atmospheric Administration said the average carbon dioxide level for May was 419.13 parts per million. That’s 1.82 parts per million higher than May 2020 and 50% higher than the stable pre-industrial levels of 280 parts per million, said NOAA climate scientist Pieter Tans.Carbon dioxide levels peak every May just before plant life in the Northern Hemisphere blossoms, sucking some of that carbon out of the atmosphere and into flowers, leaves, seeds and stems. The reprieve is temporary, though, because emissions of carbon dioxide from burning coal, oil and natural gas for transportation and electricity far exceed what plants can take in, pushing greenhouse gas levels to new records every year.”Reaching 50% higher carbon dioxide than preindustrial is really setting a new benchmark, and not in a good way,” said Cornell University climate scientist Natalie Mahowald, who wasn’t part of the research. “If we want to avoid the worst consequences of climate change, we need to work much harder to cut carbon dioxide emissions and right away.”Climate change does more than increase temperatures. It makes extreme weather — storms, wildfires, floods and droughts — worse and more frequent, and causes oceans to rise and get more acidic, studies show. There are also health effects, including heat deaths and increased pollen. In 2015, countries signed the Paris agreement to try to keep climate change to below what’s considered dangerous levels.The one-year jump in carbon dioxide was not a record, mainly because of a La Nina weather pattern, when parts of the Pacific temporarily cool, said Ralph Keeling, Scripps Institution of Oceanography geochemist. Keeling’s father started the monitoring of carbon dioxide on top of the Hawaiian mountain Mauna Loa in 1958, and he has continued the work of charting the now famous Keeling Curve.Scripps, which calculates the numbers slightly differently based on time and averaging, said the peak in May was 418.9.Also, pandemic lockdowns slowed transportation, travel and other activity by about 7%, earlier studies show. But that was too small to make a significant difference. Carbon dioxide can stay in the air for 1,000 years or more, so year-to-year changes in emissions don’t register much.The 10-year average rate of increase also set a record, now up to 2.4 parts per million per year.”Carbon dioxide going up in a few decades like that is extremely unusual,” Tans said. “For example, when the Earth climbed out of the last ice age, carbon dioxide increased by about 80 parts per million, and it took the Earth system, the natural system, 6,000 years. We have a much larger increase in the last few decades.”By comparison, it has taken only 42 years, from 1979 to 2021, to increase carbon dioxide by that same amount.”The world is approaching the point where exceeding the Paris targets and entering a climate danger zone becomes almost inevitable,” said Princeton University climate scientist Michael Oppenheimer, who wasn’t part of the research.
…

The U.S. Ambassador to the United Nations met Monday with the head of the U.N. Population Fund in the first such high-level engagement in more than four years.The U.S. Mission to the United Nations said Ambassador Linda Thomas-Greenfield highlighted the resumption of extensive support to the organization, which provides life-saving health care to millions of women and girls around the world.“I’m delighted to announce the resumption of U.S. humanitarian funding for UNFPA, including support for the Rohingya refugee crisis, Afghanistan, Sudan and those fleeing the Tigray region,” Thomas-Greenfield tweeted after the meeting. To mark our renewed commitment to @UNFPA, I met today with Executive Director Natalia Kanem. I’m delighted to announce the resumption of U.S. humanitarian funding for UNFPA, including support for the Rohingya refugee crisis, Afghanistan, Sudan and those fleeing the Tigray region. pic.twitter.com/aMJ9cAbgpL— Ambassador Linda Thomas-Greenfield (@USAmbUN) June 7, 2021In April 2017, the Trump administration withdrew funding to UNFPA, saying it “supports or participates in the management of a program of coercive abortion or involuntary sterilization” in China. For decades, China had a “one-child policy” for couples, which it revised in 2016 to a “two-child policy.” The country had been accused of using forced sterilization and abortions to enforce the restrictions. Last week, it relaxed the policy further, saying it would allow families to have up to three children, due to decreasing birth rates.The United Nations rejected the Trump administration’s accusation, but that did not persuade Washington to restore the nearly $76 million the U.S. contributed to the agency’s core operating budget. It was also the beginning of what many Western diplomats and activists said was the former Republican administration’s war on women’s health and reproductive rights at the United Nations.Since taking office in January, the Biden administration has offered the agency nearly $31 million toward its core operating budget. Washington has also resumed funding UNFPA’s humanitarian activities, including $2.6 million for the Rohingya refugee crisis and nearly $1.2 million for Ethiopian refugees in Sudan fleeing the conflict in the Tigray Region. The U.S. is also contributing nearly $1.5 million for international protection issues in Afghanistan and $1.3 million to assist Sudan in improving the response to gender-based violence for internally displaced persons and vulnerable communities.In 2015, UNFPA received $979 million in total contributions for its work in more than 150 countries. The United States provided nearly $76 million to the fund’s core budget and specific programs and initiatives, making it one of the top international donors. 
…

Health professionals continue to see heart disease in some young people who have had COVID-19, those who have been vaccinated against the virus, and among student athletes, in general.Cardiomyopathy is an inflammation and weakening in the walls of the heart.  The Centers for Disease Control and Prevention (CDC) in Atlanta has reviewed vaccine safety data weekly since the start of the U.S. vaccination program and cautions that cases among those who have received the COVID-19 vaccine are “mild and few.” The agency says the condition appears in males more than females, more often following the second shot in a two-dose regimen, and usually around four days after the vaccination.Coronavirus-related cardiomyopathy was first observed last year in younger people when college athletes resumed play as the pandemic spread in the United States. College sport events generate significant revenues for colleges and universities, and some big schools that draw thousands into stadiums returned players to campus with the hope of public events resuming sooner than later.In a study of college athletes conducted since last September, a higher incidence of cardiomyopathy, also called myocarditis, has been seen in athletes who contracted the coronavirus, or SARS-CoV-2. Symptoms include shortness of breath, weakness, tiredness, dizziness and abnormal heart rhythm, according to the Mayo Clinic in Minnesota.   “Myocarditis is a leading cause of sudden death in competitive athletes,” researchers wrote in JAMA Cardiology in May, adding, “Myocardial inflammation is known to occur with SARS-CoV-2,” the medical name for the coronavirus. Another study published in the Journal of the American College of Cardiology in March found that more than one in three “previously healthy college athletes recovering from COVID-19 infection showed … resolving pericardial inflammation.”Resolving is the key word here: Researchers concluded that “no athlete showed … features to suggest an ongoing myocarditis,” or inflammation of the heart walls. Knowing when athletes should play or rest is important, and research has not nailed down the long-term effects yet, the researchers said.“Further studies are needed to understand the clinical implications and long-term evolution of these abnormalities in uncomplicated COVID-19,” they wrote.  Pediatric cardiologist Geoffrey Rosenthal has observed myocarditis in young people, specifically during the pandemic. He has been the team cardiologist for the University of Maryland, College Park since 2020.  “Myocarditis is one of the more common causes of sudden death in athletes,” said Rosenthal.  “If someone had myocarditis, it’s one of the standard recommendations that they not exercise strenuously for three to six months after their diagnosis to allow time for their heart to heal, and lessen their risk of a sudden event,” he said.  The residual health of athletes who have had COVID is being assessed to try to understand the risks.  Ohio State University (OSU) was one of the big universities that brought players back to campus amid the pandemic and detected heart changes in athletes who tested positive for the infection.It has led the effort to monitor athletes by overseeing a registry of nearly 1,600 COVID-19 positive athletes in the Big Ten sports conference, or a division of 14 colleges and universities among other divisions nationally.  Looking at a smaller sample of 37 athletes diagnosed with myocarditis, 28 didn’t exhibit symptoms, reported OSU.Rosenthal noted that research and cooperation among universities has advanced detection of myocarditis among young people and student athletes, who are largely asymptomatic, by using magnetic resonance imaging (MRI). The University of Maryland adopted cardiac MRI screening for athletes before almost all other universities in the country as the pandemic was starting, he said.“The EKG is normal, and their blood tests are normal, and their echo [cardiogram] is OK,” Rosenthal explained. “And then we get the MRI and find out that there’s an abnormality that we weren’t expecting, and that we never would have found out about had we not done the MRI.“There’s still a lot of cardiac work that’s going on in the younger student population,” Rosenthal said.  And this advancement in detection will help other athletes, younger and older.  “There’s also hope that it will inform our understanding of COVID in older athletes, in older and non-elite athletes. … the weekend warriors,” he said.But this research will also help non-athletes whose jobs demand physical labor.  “Other populations that these results might help inform is the military and other professions and occupations in which physical activity is part of what people are doing,” Rosenthal said.  “First responders, firefighters, policemen, you know, other people whose jobs have physical demands. In addition to gaining insight into the health of our student athletes what other populations can we help through this work?” 
…

The first new drug against Alzheimer’s disease in nearly two decades received a conditional and controversial green light from U.S. drug regulators on Monday. The U.S. Food and Drug Administration approved biotech company Biogen’s antibody drug aducanumab. The drug reduces the amyloid plaques that riddle the brains of Alzheimer’s patients.  But the approval drew sharp criticism from experts who note that the company has not proved that it slows the debilitating cognitive decline in patients with the disease.  The FDA will require Biogen to continue testing the drug after it is released and ultimately demonstrate that patients actually do fare better on the drug.  In the meantime, the company said the drug will cost each patient $56,000 per year, but is likely to be covered by most insurers, including Medicare.  FILE – A sign marks a Biogen facility in Cambridge, Massachusetts, Jan., 26, 2017.Alzheimer’s, a degenerative neurological disease, is responsible for roughly two-thirds of the 50 million cases of dementia worldwide, according to the World Health Organization.  Aducanumab, marketed as Aduhelm, is the first approved treatment to target the underlying disease process of Alzheimer’s rather than just treat the symptoms.  In two clinical trials, aducanumab reduced amyloid plaques by 59% to 71% after 18 months.  However, those studies were stopped early because they did not show that patients taking aducanumab were declining in brain function any slower than patients who were not taking it.  Biogen reevaluated the data from a subset of patients in one trial and found a slight improvement in patients receiving the highest dose.  The FDA decided to approve the drug under what is called accelerated approval, which has a lower standard of evidence than full approval. The FDA said Biogen’s data show that reducing amyloid plaques is “reasonably likely to result in clinical benefit.”  “This pathway allows FDA to provide patients suffering with a serious disease earlier access to a potentially valuable drug when there is some residual uncertainty about the clinical benefit of the drug,” Patrizia Cavazzoni, director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, said on a call with reporters. Patients’ groups cheered. “This approval is a victory for people living with Alzheimer’s and their families,” Harry Johns, president and CEO of the Alzheimer’s Association, an advocacy group, said in a statement.  “It is a new day,” he said. “This approval allows people living with Alzheimer’s more time to live better. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.” Not everyone agreed. “The FDA is saying, ‘Never mind the lack of determined effectiveness,'” said Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California. Reducing plaques is not the same as slowing the patient’s decline, he noted. It will be like doctors telling patients, “‘You need to be confident (that) because we’re knocking down the plaques, you’re benefiting.'” Others were skeptical that Biogen will do a satisfactory follow-up study to show its drug really works. “Past experience with accelerated approval ‘conditions’ has been disappointing in a lot of respects,” said Harvard Medical School professor Aaron Kesselheim, “with too many cases of ‘confirmatory trials’ taking too long, still testing surrogate measures rather than real clinical endpoints, and even keeping the drug indication on the labeling when the confirmatory trials are negative.” Other therapies are in the pipeline, and some hope that the FDA’s move opens the door to better treatments down the road. “History has shown us that approvals of the first drug in a new category invigorates the field, increases investments in new treatments and encourages greater innovation,” the Alzheimer’s Association’s chief science officer, Maria Carrillo, said in a statement. “While today’s approval is an important first step in our ongoing fight against Alzheimer’s,” the FDA’s Cavazzoni said, “it’s just that: the first step.” 
  
…