AI

Researchers Find Flaws in Algorithm Used To Identify Atypical Medication Orders (venturebeat.com) 9

Can algorithms identify unusual medication orders or profiles more accurately than humans? Not necessarily. From a report: A study coauthored by researchers at the Universite Laval and CHU Sainte-Justine in Montreal found that one model physicians used to screen patients performed poorly on some orders. The study offers a reminder that unvetted AI and machine learning may negatively impact outcomes in medicine. Pharmacists review lists of active medications -- i.e., pharmacological profiles -- for inpatients under their care. This process aims to identify medications that could be abused, but most medication orders don't show drug-related problems. Publications from over a decade ago illustrate technology's potential to help pharmacists streamline workflows by taking on tasks like reviewing orders. But while more recent research has investigated AI's potential in pharmacology, few studies have demonstrated its efficacy. The coauthors of this latest work looked at a model deployed in a tertiary-care mother-and-child academic hospital between April 2020 and August 2020. The model was trained on a dataset of 2,846,502 medication orders from 2005 to 2018. These had been extracted from a pharmacy database and preprocessed into 1,063,173 profiles. Prior to data collection, the model was retrained every month with 10 years of the most recent data from the database in order to minimize drift, which occurs when a model loses its predictive power.
Medicine

MIT Team's Cough Detector Identifies 97% of COVID-19 Cases Even In Asymptomatic People 43

Scientists from MIT have developed a new AI model that can detect COVID-19 from a simple forced cough. ScienceAlert reports: Evidence shows that the AI can spot differences in coughing that can't be heard with the human ear, and if the detection system can be incorporated into a device like a smartphone, the research team thinks it could become a useful early screening tool. The work builds on research that was already happening into Alzheimer's detection through coughing and talking. Once the pandemic started to spread, the team turned its attention to COVID-19 instead, tapping into what had already been learned about how disease can cause very small changes to speech and the other noises we make.

The Alzheimer's research repurposed for COVID-19 involved a neural network known as ResNet50. It was trained on a thousand hours of human speech, then on a dataset of words spoken in different emotional states, and then on a database of coughs to spot changes in lung and respiratory performance. When the three models were combined, a layer of noise was used to filter out stronger coughs from weaker ones. Across around 2,500 captured cough recordings of people confirmed to have COVID-19, the AI correctly identified 97.1 percent of them -- and 100 percent of the asymptomatic cases.

That's an impressive result, but there's more work to do yet. The researchers emphasize that its main value lies in spotting the difference between healthy coughs and unhealthy coughs in asymptomatic people -- not in actually diagnosing COVID-19, which a proper test would be required for. In other words, it's an early warning system. The researchers now want to test the engine on a more diverse set of data, and see if there are other factors involved in reaching such an impressively high detection rate. If it does make it to the phone app stage, there are obviously going to be privacy implications too, as few of us will want our devices constantly listening out for signs of ill health.
The research has been published in the IEEE Open Journal of Engineering in Medicine and Biology.
Medicine

No, Mouthwash Will Not Save You From the Coronavirus (nytimes.com) 186

You may have noticed a rash of provocative headlines this week suggesting that mouthwash can "inactivate" coronaviruses and help curb their spread. While the news is based on a new study from researchers at the Penn State College of Medicine, it's important to note that the study focused on a coronavirus that causes common colds -- not the one that causes COVID-19. "Not only did the study not investigate this deadly new virus, but it also did not test whether mouthwash affects how viruses spread from person to person," adds Katherine J. Wu via The New York Times. From the report: "I don't have a problem with using Listerine," said Angela Rasmussen, a virologist at Columbia University. "But it's not an antiviral." The study, which was published last month in the Journal of Medical Virology, looked only at a coronavirus called 229E that causes common colds -- not the new coronavirus, which goes by the formal name of SARS-CoV-2, and causes far more serious disease. Researchers can study SARS-CoV-2 only in high-security labs after undergoing rigorous training. The two viruses are in the same family, and, in broad strokes, look anatomically similar, which can make 229E a good proxy for SARS-CoV-2 in certain experiments. But the two viruses shouldn't be thought of as interchangeable, Dr. Rasmussen said.

The researchers tested the virus-destroying effects of several products, including a watered-down mixture of Johnson's baby shampoo -- which is sometimes used to flush out the inside of the nose -- and mouthwashes made by Listerine, Crest, Orajel, Equate and C.V.S. They flooded 229E coronaviruses, which had been grown in human liver cells in the lab, with these chemicals for 30 seconds, 1 minute or 2 minutes -- longer than the typical swig or spritz into a nose or mouth. Around 90 to 99 percent of the viruses could no longer infect cells after this exposure, the study found.

But because the study didn't recruit any human volunteers to gargle the products in question, the findings have limited value for the real world, other experts said. The human mouth, full of nooks and crannies and a slurry of chemicals secreted by a diverse cadre of cells, is far more complicated than the inside of a laboratory dish. Nothing should be considered conclusive "unless human studies are performed," said Dr. Maricar Malinis, an infectious disease expert at Yale University. [...] Even if people did a very thorough job coating the inside of their mouths or noses with a coronavirus-killing chemical, a substantial amount of the virus would still remain in the body. The new coronavirus infiltrates not only the mouth and nose, but also the deep throat and lungs, where mouthwash and nasal washes hopefully never enter. Viruses that have already hidden away inside cells will also be shielded from the fast-acting chemicals found in these products.

Medicine

Remdesivir Has Little Effect on Covid-19 Mortality, WHO Study Says (ft.com) 162

The Covid-19 treatment remdesivir has no substantial effect on a patient's chances of survival [Editor's note: the link may be paywalled; alternative source], a clinical trial by the World Health Organization has found, delivering a significant blow to hopes of identifying existing medicines to treat the disease. From a report: Results from the WHO's highly anticipated Solidarity trial, which studied the effects of remdesivir and three other potential drug regimens in 11,266 hospitalised patients, found that none of the treatments "substantially affected mortality" or reduced the need to ventilate patients, according to a copy of the study seen by the Financial Times. "These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little effect on in-hospital mortality," the study found. The results of the WHO trial also showed that the drugs had little effect on how long patients stayed in hospital. However, WHO researchers said the study was primarily designed to assess impact on in-hospital mortality. The study has not yet been peer-reviewed. Remdesivir was one of a series of drugs used to treat US President Donald Trump after he tested positive for Covid-19. It was developed by US drugmaker Gilead Sciences, initially as a potential medicine to treat Ebola.
Medicine

The Race for a Super-Antibody Against the Coronavirus (nytimes.com) 98

A network of scientists is chasing the pandemic's holy grail: an antibody that protects against not just the virus, but also related pathogens that may threaten humans. From a report: Dozens of companies and academic groups are racing to develop antibody therapies. Already Regeneron and the drug company Eli Lilly have requested emergency use authorizations for their products from the Food and Drug Administration. These drug companies have the long experience and deep pockets needed to win the race for a powerful antibody treatment. But some scientists are betting on a dark horse: Prometheus, a ragtag group of scientists who are months behind in the competition -- and yet may ultimately deliver the most powerful antibody. Prometheus is a collaboration between academic labs, the United States Army Medical Research Institute of Infectious Diseases, and a New Hampshire-based antibody company called Adimab. The group's antibody is not expected to be in human trials until late December, but it may be worth the wait. Unlike the antibodies made by Regeneron and Eli Lilly, which fade in the body within weeks, Prometheus's antibody aims to be effective for up to six months. "A single dose goes a long way, meaning we can treat more people," said Kartik Chandran, a virologist at Albert Einstein College of Medicine and the group's leader.
Medicine

What if a Medical Treatment Could Change Your Political Or Religious Beliefs? (scientificamerican.com) 233

A research fellow at the University of Oxford's Wellcome Centre for Ethics and Humanities writes in Scientific American: How would you feel about a new therapy for your chronic pain, which — although far more effective than any available alternative — might also change your religious beliefs? Or a treatment for lymphoma that brings one in three patients into remission, but also made them more likely to vote for your least preferred political party?

These seem like idle hypothetical questions about impossible side effects. After all, this is not how medicine works. But a new mental health treatment, set to be licensed next year, poses just this sort of problem. Psychotherapy assisted by psilocybin, the psychedelic compound in "magic mushrooms," seems to be remarkably effective in treating a wide range of psychopathologies, but also causes a raft of unusual nonclinical changes not seen elsewhere in medicine...

[E]merging evidence suggests the relationship could be causal, with clinically administered psilocybin actively shifting political values, just as it shifts many other nonclinical characteristics. Notably, one study of psilocybin for treatment-resistant depression reported that the treatment decreased authoritarian political views in patients. That clinical trial also detected another effect that had previously been reported in healthy participants: psilocybin use leads to increases in the personality domain of openness, itself a predictor of liberal values... With sample sizes currently small, more research is needed to understand whether there truly is a causal relationship at work, and, if so, what its nature might be. Perhaps psilocybin doesn't so much induce liberal values, but rather consolidates whatever values were present before treatment. A health care modality that entrenches preexisting political sentiments is, at the least, unlikely to make enemies.

The same could not be said of a treatment that shifts patients in one direction along the political spectrum.

Medicine

New England Journal of Medicine Resoundingly Endorses Biden (nejm.org) 363

BishopBerkeley writes: In another first, the editors of the The New England Journal of Medicine (NEJM) endorse Joe Biden by stating that the current government needs to be fired. Although they don't mention any names, the editors of the NEJM state in shockingly forceful and accusatory language that the current administration is totally incompetent and does not deserve to keep its job. The editorial, somberly titled "Dying in a Leadership Vacuum" bases its opinion on some dispiriting statistics:

"The magnitude of this failure is astonishing. According to the Johns Hopkins Center for Systems Science and Engineering, the United States leads the world in Covid-19 cases and in deaths due to the disease, far exceeding the numbers in much larger countries, such as China. The death rate in this country is more than double that of Canada, exceeds that of Japan, a country with a vulnerable and elderly population, by a factor of almost 50, and even dwarfs the rates in lower-middle-income countries, such as Vietnam, by a factor of almost 2000. Covid-19 is an overwhelming challenge, and many factors contribute to its severity. But the one we can control is how we behave. And in the United States we have consistently behaved poorly."

The Administration's extreme rhetoric and extreme actions are earning extreme reactions.
Last month, Scientific American broke a 175-year tradition of not endorsing a presidential candidate by throwing their support behind Joe Biden. "We'd love to stay out of politics, but this president has been so anti-science that we can't ignore it," editor in chief, Laura Helmuth told The Washington Post.

The editor in chief of Science Magazine also denounced Trump, but stopped short of endorsing presidential candidate Joe Biden.
Medicine

Electric Shocks To the Tongue Can Quiet Chronic Ringing Ears 75

Scientists have shown shocking the tongue -- combined with a carefully designed sound program -- can reduce symptoms of tinnitus, not just while patients are being treated, but up to 1 year later. Science Magazine reports: In the team's experiment, 326 people with tinnitus sat for up to 1 hour at a time with a small plastic paddle on their tongue. Tiny electrodes in the paddle delivered an electrical current designed to broadly excite the brain, getting activity going through a number of interconnected regions. The electrical stimulation feels a little like pop rocks candy fizzing in your mouth, [says Hubert Lim, a biomedical engineer at the University of Minnesota, Twin Cities]. Subjects also wore headphones that delivered a more targeted hit to the brain's auditory system. Each person heard a rapidly changing series of pure tones at different frequencies, against a background noise that sounds "kind of like electronic music," Lim says. The goal of the two together was to distract the brain by heightening its sensitivity, forcing it to suppress the activity that causes tinnitus. "The brain can only pay attention to so many things," Lim says.

Over the 12 weeks of treatment, the patients' tinnitus symptoms improved dramatically. More than 80% of those who complied with the prescribed regimen saw an improvement. And they saw an average drop of about 14 points on a tinnitus severity score of one to 100, the researchers report today in Science Translational Medicine. When the team followed up after 12 months, 80% of the participants still had lower tinnitus scores, with average drops of 12.7 and 14.5 points.
Medicine

Nobel Prize in Medicine Awarded To Scientists Who Discovered Hepatitis C Virus (nytimes.com) 17

Raisey-raison writes: The Nobel Prize in Physiology or Medicine was awarded jointly to Dr. Harvey J. Alter, Michael Houghton and Charles M. Rice on Monday for the discovery of the hepatitis C virus, a breakthrough the Nobel committee said had "made possible blood tests and new medicines that have saved millions of lives." "For the first time in history, the disease can now be cured, raising hopes of eradicating hepatitis C virus from the world population," the committee said in a statement. They announced the prize at the Karolinska Institute in Stockholm. About 71 million people worldwide live with a chronic infection of the hepatitis C virus, a blood-borne pathogen that can cause severe liver inflammation, or hepatitis, and is typically transmitted through shared or reused needles and syringes, infected blood transfusions and sexual practices that lead to blood exposure. Tests and treatments "all start with being able to recognize the virus exists," said Craig Cameron, chair of the department of microbiology and immunology at the University of North Carolina at Chapel Hill and a hepatitis C virus researcher.
Security

Some Coronavirus Vaccine Trials Resort To Pen and Paper After Ransomware Hits Software (nytimes.com) 81

A software company supporting hundreds of clinical trials — including coronavirus vaccine trials — has been hit by a ransomware attack that "has slowed some of those trials over the past two weeks," reports the New York Times.

Employees "discovered that they were locked out of their data by ransomware..." eResearchTechnology (ERT) said clinical trial patients were never at risk, but customers said the attack forced trial researchers to track their patients with pen and paper. Among those hit were IQVIA, the contract research organization helping manage AstraZeneca's Covid vaccine trial, and Bristol Myers Squibb, the drugmaker leading a consortium of companies to develop a quick test for the virus. ERT has not said how many clinical trials were affected, but its software is used in drug trials across Europe, Asia and North America. It was used in three-quarters of trials that led to drug approvals by the Food and Drug Administration last year, according to its website.

On Friday, Drew Bustos, ERT's vice president of marketing, confirmed that ransomware had seized its systems on September 20. As a precaution, Mr. Bustos said, the company took its systems offline that day, called in outside cybersecurity experts and notified the Federal Bureau of Investigation. "Nobody feels great about these experiences, but this has been contained," Mr. Bustos said. He added that ERT was starting to bring its systems back online on Friday and planned to bring remaining systems online over the coming days...

One of ERT's clients, IQVIA, said it had been able to limit problems because it had backed up its data. Bristol Myers Squibb also said the impact of the attack had been limited, but other ERT customers had to move their clinical trials to move to pen and paper.

The Times notes it's just one of "more than a thousand ransomware attacks on American cities, counties and hospitals over the past 18 months." Other interesting details from the article:
  • Two companies working on a coronavirus vaccine — Pfizer and Johnson & Johnson — emphasized to the Times that they weren't affected by ERT's issues, with a Pfizer spokesperson stressing they're not even using ERT's software.

Medicine

Hydroxychloroquine Advocate Angry Donald Trump Took 'Experimental Antibody Stupidness' (newsweek.com) 287

"A doctor notorious for claiming hydroxychloroquine is a 'cure' for COVID-19 has denounced White House doctors for not giving President Donald Trump the drug to treat his infection..." reports Newsweek.

"Other unsubstantiated claims from Immanuel include declarations that fasting can cure those affected by 'witchcraft,' that having sex with demons while dreaming can cause gynecological problems and that certain medications contain the DNA of extraterrestrial aliens." Dr. Stella Immanuel, who gained fame in July after Trump retweeted a video showing her touting the malaria drug, expressed outrage in a series of tweets on Friday, condemning the medical decisions of "bozo doctors" who surrounded the president after he tested positive for COVID-19. "Instead of giving the president of the United States a known safe drug," Immanuel tweeted. "They gave him some experimental antibody stupidness. This is so dumb. Please potus family you guys wake up. Give him HCQ, Zpack & zinc asap." "Whoever told the president to stop taking HCQ should be punched in the face," she said in an earlier tweet. "This did not have to happened. I am so upset. This is our president for crying out loud. No one need to get sick or pcr positive."

Leonard Schleifer, CEO of Regeneron Pharmaceuticals, insisted that taking his company's experimental treatment, made of potentially virus-neutralizing antibodies, could see the president's condition improve within one week. Although the treatment is widely viewed as having potential, some medical experts have expressed less confidence in its effectiveness. Conley issued a second memorandum late Friday night, revealing that "in consultation with specialists, we have decided to initiate Remdesivir therapy" for Trump, referring to the antiviral drug that gained an emergency use authorization from the Food and Drug Administration (FDA) over the summer after studies showed it could reduce the length of time a person is ill with COVID-19.

Newsweek reminds its readers that early in the pandemic Trump did take a two-week course of hydroxychloroquine "as a preventative measure, hoping it would prevent his infection..."
Medicine

The Apple Watch Heart Monitor Sends Too Many People To the Doctor 43

The heart monitoring feature on the Apple Watch may lead to unnecessary health care visits, according to a new study published this week. The Verge reports: Only around 10 percent of people who saw a doctor at the Mayo Clinic after noticing an abnormal pulse reading on their watch were eventually diagnosed with a cardiac condition. The finding shows that at-home health monitoring devices can lead to over-utilization of the health care system, said study author Heather Heaton, an assistant professor of emergency medicine at the Mayo Clinic College of Medicine, in an email to The Verge. That may be expensive for patients and for the system as a whole, and it may take up doctor and patient time unnecessarily.

Heaton and the study team scanned patient health records at every Mayo Clinic site, including offices in Arizona, Florida, Wisconsin, and Iowa, for mentions of the term "Apple Watch" over a six-month period from December 2018 to April 2019. The window came just after Apple introduced a feature to detect abnormal heart rhythms and after publication of a study tracking how well the watches could detect atrial fibrillation. They found records of 264 patients who said their Apple Watches flagged a concerning heart rhythm. Of that group, 41 explicitly mentioned getting an alert from their watch (others may have had an alert, but it wasn't mentioned specifically in their health record). Half of the patients already had a cardiac diagnosis, including 58 who'd been previously diagnosed with atrial fibrillation. About two-thirds had symptoms, including lightheadedness or chest pain. Only 30 patients in the study got a cardiac diagnosis after their doctors visit. Most of the concerning heart monitor data, then, were probably false positives, the study concluded.
Government

Trump Goes To Hospital After Testing Positive For COVID-19 (bbc.com) 279

President Donald Trump has been flown to the hospital less than 24 hours after testing positive for COVID-19. The BBC reports: The White House said the decision to transport him to Walter Reed National Military Medical Center was taken "out of an abundance of caution." Mr Trump began exhibiting "mild symptoms" of Covid-19 on Thursday. He said early on Friday he and First Lady Melania Trump had tested positive. The White House said he was feeling "fatigued but in good spirits."

Wearing a mask and suit, Mr Trump walked out across the White House lawn on Friday afternoon to his helicopter, Marine One, for the short trip to hospital. He waved and gave a thumbs-up to reporters but said nothing before boarding the aircraft. In a video posted to Twitter, Mr Trump said: "I want to thank everybody for the tremendous support. I'm going to Walter Reed hospital. I think I'm doing very well. But we're going to make sure that things work out. The first lady is doing very well. So thank you very much, I appreciate it, I will never forget it -- thank you."

China

550 Million Chinese Traveling In Biggest Holiday Since COVID-19 48

hackingbear shares a report from CNN: As October 1 arrives, hundreds of millions of people in China are expected to pack highways, trains and planes for the National Day holiday, one of the busiest times for travel in the world's most populous country. In a sign of the government's confidence in keeping the virus under control, the Chinese Center for Disease Control and Prevention said last week that domestic travels can be arranged "as normal" for the upcoming holiday, given all cities in mainland China are marked as low risk for the coronavirus. The expected 550 million trips during the 8-day holiday will be a much-awaited boost to Chinese economic recovery. "I think China has (the virus) under pretty good control," said a 29-year-old traveler flew from Guangzhou to Shanghai. "I'm wearing masks and bringing alcohol wipes with me to clean my hands, especially before eating -- although in Shanghai, few people wear masks now." More than eight months on, China's restrictions on domestic movement have all been lifted. Officially, some cities still require passengers to produce a green health code on their smartphones at train stations and airports to show they're safe to travel, but implementation can be lax in practice. China has not reported any locally transmitted symptomatic case since mid-August, and is rigorously screening overseas arrivals and workers at risk of exposure to the virus. In other coronavirus-related news, vaccine trial participants are reporting day-long exhaustion, fever and headaches -- but say it's worth it. Slashdot reader gollum123 shares a report from CNBC: Luke Hutchison woke up in the middle of the night with chills and a fever after taking the Covid-19 booster shot in Moderna's vaccine trial. Another coronavirus vaccine trial participant, testing Pfizer's candidate, similarly woke up with chills, shaking so hard he cracked a tooth after taking the second dose. High fever, body aches, bad headaches and exhaustion are just some of the symptoms five participants in two of the leading coronavirus vaccine trials say they felt after receiving the shots. While the symptoms were uncomfortable, and at times intense, they often went away after a day, sometimes sooner, according to three participants in the Moderna trial and one in Pfizer's as well as a person close to another participant in Moderna's trial. Hutchison said he's concerned that the pharmaceutical manufacturers have not sufficiently informed the public about potential side effects. If the vaccines are approved, he fears, it might cause a widespread backlash if word spreads, which is why he decided to go public now.
Medicine

Great North Air Ambulance Trials Paramedic Jet Suit (bbc.com) 53

A jet suit for paramedics which would see patients reached in minutes by a "flying" medic has been tested by the Great North Air Ambulance Service. The BBC reports: After a year of talks between GNAAS and Gravity Industries, a first test flight was carried out in the Lake District. Andy Mawson, director of operations at GNAAS, came up with the idea and described seeing it as "awesome." He said it meant a paramedic could "fly" to a fell top in 90 seconds rather than taking 30 minutes on foot.

The test flight was carried out by Richard Browning, founder of Gravity Industries. He said the suits had two mini engines on each arm and one on the back allowing the paramedic to control their movement just by moving their hands. "The biggest advantage is its speed," Mr Mawson said. "If the idea takes off, the flying paramedic will be armed with a medical kit, with strong pain relief for walkers who may have suffered fractures, and a defibrillator for those who may have suffered a heart attack. In a jet pack, what might have taken up to an hour to reach the patient may only take a few minutes, and that could mean the difference between life and death."

Medicine

In Brazil's Amazon a COVID-19 Resurgence Dashes Herd Immunity Hopes (reuters.com) 134

Anthony Boadle, reporting for Reuters: [...] In April and May, so many Manaus residents were dying from COVID-19 that its hospitals collapsed and cemeteries could not dig graves fast enough. The city never imposed a full lockdown. Non-essential businesses were closed but many simply ignored social distancing guidelines. Then in June, deaths unexpectedly plummeted. Public health experts wondered whether so many residents had caught the virus that it had run out of new people to infect. Research posted last week to medRxiv, a website distributing unpublished papers on health science, estimated that 44% to 66% of the Manaus population was infected between the peak in mid-May and August.

The study by the University of Sao Paulo's Institute of Tropical Medicine tested newly donated banked blood for antibodies to the virus and used a mathematical model to estimate contagion levels. The high infection rate suggested that herd immunity led to the dramatic drop in cases and deaths, the study said. Scientists estimate that up to 70 pct of the population may need to be protected against coronavirus to reach herd immunity. In Manaus, daily burials and cremations fell from a peak of 277 on May 1 to just 45 in mid-September, the mayor's office said. The COVID-19 death toll that officially peaked at 60 on April 30 dropped to just two or three a day by late August. Now the numbers are on the rise again.

Medicine

'Why Modeling the Spread of COVID-19 Is So Damn Hard' (ieee.org) 117

Slashdot reader the_newsbeagle writes: At the beginning of the pandemic, modelers pulled out everything they had to predict the spread of the virus. This article explains the three main types of models used: 1) compartmental models that sort people into categories of exposure and recovery, 2) data-driven models that often use neural networks to make predictions, and 3) agent-based models that are something like a Sim Pandemic.
"Researchers say they've learned a lot of lessons modeling this pandemic, lessons that will carry over to the next..." the article points out: Finally, researchers emphasize the need for agility. Jarad Niemi, an associate professor of statistics at Iowa State University who helps run the forecast hub used by the CDC, says software packages have made it easier to build models quickly, and the code-sharing site GitHub lets people share and compare their models. COVID-19 is giving modelers a chance to try out all their newest tools, says biologist Lauren Ancel Meyers, the head of the COVID-19 Modeling Consortium at the University of Texas at Austin. "The pace of innovation, the pace of development, is unlike ever before," she says. "There are new statistical methods, new kinds of data, new model structures."

"If we want to beat this virus," says Mikhail Prokopenko, a computer scientist at the University of Sydney, "we have to be as adaptive as it is."

Medicine

Johnson & Johnson's Covid-19 Vaccine Produces Strong Immune Response in Early Trial (newsweek.com) 48

Newsweek reports: Pharmaceutical manufacturer Johnson & Johnson announced Friday that early trials of a COVID-19 vaccine showed a 98 percent success rate in showing a boost in the immune system. According to research from Johnson & Johnson, the vaccine enabled 98 percent of those who took it to create antibodies that fight off the coronavirus infection. Those neutralizing antibodies were present 29 days after receiving the vaccination...

Currently, four U.S. vaccines are in the final trial stages. Vaccines from other pharmaceutical companies such as Pfizer and Moderna are administered in two doses while the Johnson & Johnson vaccine only requires one.

"Based on the current results, Johnson & Johnson on Wednesday kicked off a final 60,000-person trial," reports Reuters, "which could pave the way for an application for regulatory approval. The company said it expects results of that so-called Phase 3 trial by the end of the year or early next year."
Medicine

Vaccine Maker Novavax Enters Final Large-Scale Testing of Its Covid-19 Vaccine (deccanherald.com) 57

The New York Times reports: Vaccine maker Novavax said Thursday that it would begin the final stages of testing its coronavirus vaccine in the United Kingdom and that another large trial was scheduled to begin next month in the United States. It is the fifth late-stage trial from a company supported by Operation Warp Speed, the federal effort to speed a coronavirus vaccine to market, and one of 11 worldwide to reach this pivotal stage.

Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials. The new study, known as a Phase 3 trial, is expected to enroll up to 10,000 people in the United Kingdom. Half of the volunteers will receive two doses of the experimental vaccine, 21 days apart, and the others will receive a placebo.

Although Novavax is months behind the front-runners in the vaccine race, independent experts are excited about its vaccine because its early studies delivered particularly promising results. Monkeys that were vaccinated got strong protection against the coronavirus. And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus. It is not possible to make a precise comparison between early clinical studies of different vaccines, but John Moore, a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results. "You just can't explain that away," he said. The Phase 3 trials will determine if Novavax can live up to that promise.

Medicine

MS Treatment a Step Closer After Drug Shown To Repair Nerve Coating (theguardian.com) 20

An anonymous reader quotes a report from The Guardian: Doctors believe they are closer to a treatment for multiple sclerosis after discovering a drug that repairs the coatings around nerves that are damaged by the disease. A clinical trial of the cancer drug bexarotene showed that it repaired the protective myelin sheaths that MS destroys. The loss of myelin causes a range of neurological problems including balance, vision and muscle disorders, and ultimately, disability.

While bexarotene cannot be used as a treatment, because the side-effects are too serious, doctors behind the trial said the results showed "remyelination" was possible in humans, suggesting other drugs or drug combinations will halt MS. "It's disappointing that this is not the drug we'll use, but it's exciting that repair is achievable and it gives us great hope for another trial we hope to start this year," said Prof Alasdair Coles, who led the research at the University of Cambridge. The drug had some serious side-effects, from thyroid disease to raised levels of fats in the blood, which can lead to dangerous inflammation of the pancreas. But brain scans revealed that neurons had regrown their myelin sheaths, a finding confirmed by tests that showed signals sent from the retina to the visual cortex at the back of the brain had quickened. "That can only be achieved through remyelination," said Coles.

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