Medicine

Maker of Dubious $56K Alzheimer's Drug Offers Cognitive Test No One Can Pass (arstechnica.com) 56

An anonymous reader quotes a report from Ars Technica: Do you ever forget things, like a doctor's appointment or a lunch date? Do you sometimes struggle to think of the right word for something common? Do you ever feel more anxious or irritable than you typically do? Do you ever feel overwhelmed when trying to make a decision? If you answered "no, never" to all of those questions, there's a possibility that you may not actually be human. Nevertheless, you should still talk to a doctor about additional cognitive screenings to check if you have Alzheimer's disease. At least, that's the takeaway from a six-question quiz provided in part by Biogen, the maker of an unproven, $56,000 Alzheimer's drug.

The six questions include the four above, plus questions about whether you ever lose your train of thought or ever get lost on your way to or around a familiar place. The questions not only bring up common issues that perfectly healthy people might face from time to time, but the answers any quiz-taker provides are also completely irrelevant. No matter how you answer -- even if you say you never experience any of those issues -- the quiz will always prompt you to talk with your doctor about cognitive screening. The results page even uses your zip code to provide a link to find an Alzheimer's specialist near you. Biogen says the quiz website is part of a "disease awareness educational program." But it appears to be part of an aggressive strategy to sell the company's new Alzheimer's drug, Aduhelm, which has an intensely controversial history, to say the least.
What's the controversial history you may ask? According to Ars, the drug "flunked out of two identical Phase III clinical trials in 2019." A panel of expert advisors for the FDA overwhelmingly voted against approval, yet it still was approved by the FDA on June 7. It also has a list price of $56,000 for a year's supply.

The report goes on to say that the company is basically making up the statistic that "about 1 in 12 Americans 50 years and older" has mild cognitive impairment due to Alzheimer's. Experts say they know of no evidence to back up that statistic and it appears to be a significant overestimate.

Furthermore, two medical experts from Georgetown University said the company's quiz website "appears designed to ratchet up anxiety in anyone juggling multiple responsibilities or who gets distracted during small talk." They added: "Convincing perfectly normal people they should see a specialist, be tested for amyloid plaque, and, if present, assume they have early Alzheimer's is a great strategy for increasing Aduhelm prescriptions... [It] could lead to millions of prescriptions -- and billions of dollars in profit -- for an ineffective and expensive drug."
NASA

Jeff Bezos and Sir Richard Branson Not Yet Astronauts, US Says (bbc.com) 80

New Federal Aviation Administration (FAA) rules say astronaut hopefuls must be part of the flight crew and make contributions to space flight safety. That means Jeff Bezos and Sir Richard Branson may not yet be astronauts in the eyes of the US government. The BBC reports: These are the first changes since the FAA wings program began in 2004. The Commercial Astronaut Wings program updates were announced on Tuesday -- the same day that Amazon's Mr Bezos flew aboard a Blue Origin rocket to the edge of space. To qualify as commercial astronauts, space-goers must travel 50 miles (80km) above the Earth's surface, which both Mr Bezos and Mr Branson accomplished. But altitude aside, the agency says would-be astronauts must have also "demonstrated activities during flight that were essential to public safety, or contributed to human space flight safety." What exactly counts as such is determined by FAA officials.

In a statement, the FAA said that these changes brought the wings scheme more in line with its role to protect public safety during commercial space flights. On July 11, Sir Richard flew on-board Virgin Galactic's SpaceShipTwo to the edge of space as a test before allowing customers aboard next year. Mr Bezos and the three other crew members who flew on Blue Origin's spacecraft may have less claim to the coveted title. Ahead of the launch, Blue Origin CEO Bob Smith said that "there's really nothing for a crew member to do" on the autonomous vehicle. Those wishing for commercial wings need to be nominated for them as well. An FAA spokesperson told CNN they are not currently reviewing any submissions.

There are two other ways to earn astronaut wings in the US - through the military or Nasa. However, a glimmer of hope remains for Sir Richard, Mr Bezos and any future stargazers hoping to be recognized as astronauts. The new order notes that honorary awards can be given based on merit -- at the discretion of the FAA's associate administrator. Astronaut wings were first awarded to astronauts Alan Shepard Jr and Virgil Grissom in the early 1960s for their participation in the Mercury Seven program.

Earth

A 3-degree Celsius World Has No Safe Place (economist.com) 229

The extremes of floods and fires are not going away, but adaptation can lessen their impact. Economist (paywalled): If temperatures rise by 3C above pre-industrial levels in the coming decades -- as they might even if everyone manages to honour today's firm pledges -- large parts of the tropics risk becoming too hot for outdoor work. Coral reefs and the livelihoods that depend on them will vanish and the Amazon rainforest will become a ghost of itself. Severe harvest failures will be commonplace. Ice sheets in Antarctica and Greenland will shrink past the point of no return, promising sea rises measured not in millimetres, as today's are, but in metres.

Six years ago, in Paris, the countries of the world committed themselves to avoiding the worst of that nightmare by eliminating net greenhouse-gas emissions quickly enough to hold the temperature rise below 2C. Their progress towards that end remains woefully inadequate. Yet even if their efforts increased dramatically enough to meet the 2C goal, it would not stop forests from burning today; prairies would still dry out tomorrow, rivers break their banks and mountain glaciers disappear. Cutting emissions is thus not enough. The world also urgently needs to invest in adapting to the changing climate. The good news is that adaptation makes political sense. People can clearly see the need for it. When a country invests in flood defences it benefits its own citizens above all others -- there is no free-rider problem, as there could be for emissions reduction. Nor does all the money come from the public purse; companies and private individuals can see the need for adaptation and act on it. When they do not do so, insurance companies can open their eyes to the risks they are running.

Some adaptation is fairly easily set in place. Systems for warning Germans of coming floods will surely now improve. But other problems require much larger public investment, like that which has been put into water-management in the Netherlands. Rich countries can afford such things. Poor countries and poor people need help, which is why the Paris climate agreement calls for annual transfers of $100bn from rich to poor. The rich countries have not yet lived up to their side of this. On July 20th John Kerry, President Joe Biden's special envoy on climate change, reiterated America's pledge to triple its support to $1.5bn for adaptation in poorer countries by 2024, part of a broader move to increase investment in adaptation and mitigation in developing countries. More such efforts are vital.

Medicine

Most Unvaccinated Americans Don't Want Shots: AP-NORC Poll (apnews.com) 657

Most Americans who haven't been vaccinated against COVID-19 say they are unlikely to get the shots and doubt they would work against the aggressive delta variant despite evidence they do, according to a new poll that underscores the challenges facing public health officials amid soaring infections in some states. AP: Among American adults who have not yet received a vaccine, 35% say they probably will not, and 45% say they definitely will not, according to a poll from The Associated Press-NORC Center for Public Affairs Research. Just 3% say they definitely will get the shots, though another 16% say they probably will. What's more, 64% of unvaccinated Americans have little to no confidence the shots are effective against variants -- including the delta variant that officials say is responsible for 83% of new cases in the U.S. -- despite evidence that they offer strong protection. In contrast, 86% of those who have already been vaccinated have at least some confidence that the vaccines will work.

That means "that there will be more preventable cases, more preventable hospitalizations and more preventable deaths," said Dr. Amesh Adalja, an infectious disease specialist at Johns Hopkins University. "We always knew some proportion of the population would be difficult to persuade no matter what the data showed, (and) a lot of people are beyond persuasion," said Adalja. He echoed Centers for Disease Control and Prevention Director Rochelle Walensky in calling the current surge "a pandemic of the unvaccinated" because nearly all hospital admissions and deaths have been among those who weren't immunized.

Medicine

39-Year-Old Becomes First US Patient To Receive 'Aeson' Artificial Heart Implant (sciencealert.com) 25

An anonymous reader quotes a report from ScienceAlert: [A] team of surgeons has successfully completed the first human implantation in the US of an artificial heart device called the 'Aeson', developed by French company CARMAT. The artificial heart has two ventricular chambers and four biological valves, just like the real organ, and is powered by an external device. Made from "biocompatible materials" including bovine tissue, the artificial heart uses a combination of sensors and algorithms to maintain its pace and keep blood circulating through the body. "We are encouraged that our patient is doing so well after the procedure," says cardiologist Carmelo Milano from the Duke University School of Medicine. "As we evaluate this device, we are both excited and hopeful that patients who otherwise have few to no options could have a lifeline."

The patient in question is 39-year-old Matthew Moore, from Shallotte in North Carolina. Moore was initially due to have heart bypass surgery, but as his condition deteriorated the medical staff started to run out of options; he became so ill that even a regular heart transplant was too risky. Fortunately, he was in the right place: the Aeson device is being tested at Duke University, pending approval from the US Food and Drug Administration (FDA). It's already been given the green light for use by regulators in Europe, after several years of tests in European patients, not all of which have been successful. The artificial heart has been developed specifically to help those whose hearts can no longer pump enough blood through both chambers. It replaces the entire natural heart, although it's not intended to be permanent -- it's designed to be a bridge towards a full heart transplant within six months or so.

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