Publisher Health

Middle-aged women with higher blood concentrations of common synthetic chemicals called per- and polyfluoroalkyl substances (PFAS), also called “forever chemicals” and found in water, soil, air and food, were at greater risk of developing high blood pressure, compared to their peers who had lower levels of these substances, according to new research published today in Hypertension, an American Heart Association journal.
PFAS, are a class of synthetic chemicals and according to the U.S. Environmental Protection Agency, there are thousands of different PFAS that are used in everyday household items, such as certain shampoo, dental floss, cosmetics, non-stick cookware, food packaging, stain-resistant coatings for carpeting, upholstery and clothing. The “forever chemicals” also enter the food system through fish caught in PFAS-contaminated water and dairy products from cows exposed to PFAS through fertilizers on farms, for example.
Even at low levels in the blood, research has shown PFAS can have detrimental health effects. Some PFAS have been linked to cardiovascular risk, including endothelial dysfunction (impaired blood vessel function), oxidative stress and elevated cholesterol. However, no previous studies have evaluated whether PFAS levels affect blood pressure control among middle-aged women.
Previously published data from the National Health and Nutrition Examination Survey (NHANES) demonstrates how common PFAS exposure is, as nearly all Americans have detectable concentrations of at least one PFAS in their blood.
“PFAS are known as ‘forever chemicals’ because they never degrade in the environment and contaminate drinking water, soil, air, food and numerous products we consume or encounter routinely. One study estimated that two of the most common ‘forever chemicals’ are found in most household drinking water and are consumed by more than two-thirds of Americans,” said study lead author Ning Ding, Ph.D., M.P.H., a post-doctoral fellow in the department of epidemiology at the University of Michigan School of Public Health in Ann Arbor, Michigan.
“Women seem to be particularly vulnerable when exposed to these chemicals,” she said. “Our study is the first to examine the association between ‘forever chemicals’ and hypertension in middle-aged women. Exposure may be an underappreciated risk factor for women’s cardiovascular disease risk.”
Using data from the Study of Women’s Health Across the Nation-Multi-Pollutant Study (SWAN-MPS), a prospective study of women from diverse racial and ethnic backgrounds at midlife, researchers examined blood concentrations of specific PFAS and the risk of high blood pressure. Data included more than 1,000 women, 45-56-years old who had normal blood pressure when they enrolled in the study. Blood concentrations of PFAS were measured at the start of the study. All participants were followed almost-annually from 1999-2017. Participants were recruited from five institutional sites (Boston; Pittsburgh; Southeast Michigan; Los Angeles; and Oakland, California) across the U.S., and they self-identified as Black (15.2%), Chinese (14.1%), Japanese (16.2%) or white women (54.5%). All sites enrolled non-Hispanic white women in addition to one additional racial/ethnic group.
The analysis found: During 11,722 person-years of follow-up for all study participants, 470 women developed high blood pressure. Women with higher concentrations of specific PFAS were more likely to develop high blood pressure: women in the highest one-third concentrations of perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and 2-(N-ethyl-perfluorooctane sulfonamido) acetic acid (EtFOSAA, a PFOS precursor) had 42%, 47% and 42% higher risks, respectively, of developing high blood pressure, compared to women in the lowest one-third concentrations of these PFAS. Women in the highest one-third concentrations of all seven PFAS examined had a 71% increased risk of developing high blood pressure.”It’s important to note that we examined individual PFAS as well as several PFAS together, and we found that the combined exposure to multiple PFAS had a stronger effect on blood pressure,” said study senior author Sung Kyun Park, Sc.D., M.P.H., an associate professor of epidemiology and environmental health sciences at the University of Michigan School of Public Health. “Some states are beginning to ban the use of PFAS in food packaging and cosmetic and personal care products. Our findings make it clear that strategies to limit the widespread use of PFAS in products need to be developed. Switching to alternative options may help reduce the incidence of high blood pressure risk in midlife women.”
“We have known for some time that PFAS disrupt metabolism in the body, yet, we didn’t expect the strength of the association we found. We hope that these findings alert clinicians about the importance of PFAS and that they need to understand and recognize PFAS as an important potential risk factor for blood pressure control,” Park said.
The study was limited in that it only included middle-aged women, so the findings may not translate to men or to younger or older women. The authors note that more research is needed to confirm these associations and to address ways to reduce PFAS exposure.
The study was funded by the National Institutes of Health.

The size of our primary visual cortex and the amount of brain tissue we have dedicated to processing visual information at certain locations of visual space can predict how well we can see, a team of neuroscientists has discovered. Its study, which appears in the journal Nature Communications, reveals a new link between brain structure and behavior.
“We have found that we can predict how well someone can see based on the unique structure of their primary visual cortex,” explains lead author Marc Himmelberg, a postdoctoral researcher in New York University’s Center for Neural Science and Department of Psychology. “By showing that individual variation in the structure of the human visual brain is linked to variation in visual functioning, we can better understand what underlies differences in how people perceive and interact with their visual environment.”
As with fingerprints, the bumps and grooves on each person’s brain surface are unique. However, the significance of these differences is not fully understood, especially when it comes to their impact on behavior, such as distinctions in our ability to see.
In the Nature Communications study, Himmelberg and his co-authors, Jonathan Winawer and Marisa Carrasco, professors in NYU’s Center for Neural Science and Department of Psychology, sought to illuminate the relevance of these brain traits to how we see.
The primary visual cortex (V1) is arranged into a map of the image projected from the eye. But like many kinds of maps, it is distorted, with some parts of the image enlarged compared to others.
“Think of a subway map of New York City which makes Staten Island look smaller than Manhattan,” explains Winawer. “The map maintains some degree of accuracy, but it enlarges regions likely to be of broader interest. Similarly, V1 enlarges the center of the image we see — that is, where our eyes are fixating — relative to the periphery.”
This is because V1 has more tissue dedicated to the center of our field of view. Likewise, V1 also enlarges locations to the left and right of where our eyes are fixating relative to locations above or below, again because of differences in the arrangement of cortical tissue.
Using functional magnetic resonance imaging (fMRI), the scientists mapped the primary visual cortex (or “V1”) size of more than two dozen humans. The researchers also measured the quantity of V1 tissue these individuals have dedicated to processing visual information from different locations in their field of view — locations to the left, right, above, and below fixation.
These participants also undertook a task designed to assess the quality of their vision at the same locations in their field of view as the V1 measurements. The participants discriminated among the orientation of patterns shown on a computer screen, which were used to gauge “contrast sensitivity,” or the ability to make distinctions among images.
Their results showed that differences in V1 surface area could predict measurements of people’s contrast sensitivity. First, people with a large V1 had better overall contrast sensitivity than did those with a small V1 (the largest surface area being 1,776 square millimeters [mm2] and the smallest being 832 mm2). Second, people whose V1 had more cortical tissue processing visual information from a specific region in their field of view had higher contrast sensitivity at that region relative to those with less cortical tissue dedicated to the same region. Third, across participants, higher contrast sensitivity at a specific location (e.g., left) than at another location equidistant from fixation (e.g., above) corresponded to regions with more or less cortical tissue, respectively.
“In sum, the more local V1 surface area dedicated to encoding a specific location, the better the vision at that location,” concludes Carrasco. “Our findings show differences in visual perception are inextricably linked to differences in the structure of the primary visual cortex in the brain.”
The research was supported by a grant from the National Institutes of Health (R01-EY027401).
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In the United States, substance use disorders are a leading cause of death among young people. Treatments such as deep brain stimulation hold promise for helping people overcome addiction, but many questions remain about what brain areas should be targeted. Researchers are gaining new insights from patients who are no longer addicted to nicotine after experiencing a brain lesion, such as a stroke. Using a new technique known as lesion network mapping, researchers at Brigham and Women’s Hospital have mapped addiction remission to entire brain circuits rather than specific brain regions, pointing to new targets for treatment. Their results are published in Nature Medicine.
“By looking beyond individual brain regions and, instead, at the brain circuit, we have found targets for addiction remission and are eager to rigorously test them through clinical trials,” said Michael Fox, MD, PhD, of the Department of Neurology at the Brigham. “Ultimately, our goal is to take larger steps towards improving existing therapies for addiction and open the door for remission.”
Neuromodulation therapies, such as deep brain stimulation, transcranial magnetic stimulation, and MRI-guided focused ultrasound, allow clinicians at the Brigham’s Center for Brain Circuit Therapeutics to directly target brain circuits and improve symptoms in ways that may not be possible through treatment with medication. But knowing the location to target is critical. In a previous study, researchers used lesion network mapping to examine patients whose essential tremors resolved, confirming targets used in treatment with deep brain stimulation. The study authors set out to apply the same approach to addiction remission.
“Although we know a great deal about the neurobiological mechanisms in addiction, treatment options are still very limited. Our findings with essential tremor made us realize the potential of this approach to localize key brain circuits mediating symptom improvement,” said Juho Joutsa, MD, PhD, of the Turku Brain and Mind Center and Clinical Neurosciences at the University of Turku.
Fox and colleagues used data from two independent cohorts of patients addicted to nicotine who then suffered a brain lesion, usually from a stroke. Fox’s team compared lesions in patients who were unable to quit smoking to lesions resulting in remission of smoking addiction. They then used a database known as the human connectome to map each lesion to the larger brain circuit. They found that the two smoking lesions datasets that led to remission of smoking addiction mapped to a specific brain circuit. To their surprise, they also discovered in a third alcoholism lesion dataset that a reduced risk of alcoholism mapped to a similar brain circuit, suggesting a potentially therapeutic, targetable neural pathway for addiction in general, rather than addiction to a specific substance.
“Although neuromodulation treatments using electricity or even brain lesions have shown promise in relieving substance addiction, the therapeutic target has been unclear,” said Fox. “Now that our study has identified a target — a specific human brain circuit — we hope to test whether targeted neuromodulation to this brain circuit provides sustainable symptom relief to our patients.”
The authors acknowledge two primary study limitations. First, the results are solely based on retrospective analysis of existing datasets and, second, the datasets examined only covered specific substances of abuse. The researchers therefore advocate for prospective validation of their findings through clinical trials testing and an examination of additional substances of addiction to determine if their findings can be applied widely.
“We were excited to discover that our mapped lesions associated with addiction remission led back to a common brain circuit. While our findings point towards therapeutic targets for addiction, we need to test these targets in randomized clinical trials,” said Fox. “We study brain lesions in the context of the brain circuit because it provides a powerful way to understand the causal links between addiction and our neuroanatomy. We have hope that we can make significant strides towards helping patients with substance use disorders.”
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Later-born generations of older adults in the United States are more likely to have a greater number of chronic health conditions than the generations that preceded them, according to a study conducted by Penn State and Texas State University.
According to the researchers, the increasing frequency of reporting multiple chronic health conditions — or multimorbidity — represents a substantial threat to the health of aging populations. This may place increased strain on the well-being of older adults, as well as medical and federal insurance systems, especially as the number of U.S. adults older than age 65 is projected to grow by more than 50% by 2050.
Steven Haas, associate professor of sociology and demography at Penn State, said the results fit with other recent research that suggests the health of more recent generations in the U.S. is worse than that their predecessors in a number of ways.
“Even before the COVID-19 pandemic, we were beginning to see declines in life expectancy among middle-aged Americans, a reversal of more than a century long trend,” Haas said. “Furthermore, the past 30 years has seen population health in the U.S. fall behind that in other high-income countries, and our findings suggest that the U.S. is likely to continue to fall further behind our peers.”
The researchers said the findings could help inform policy to address the potentially diminishing health in our expanding population of older adults. The paper was recently published in The Journals of Gerontology, and was also worked on by Ana Quiñones, Oregon Health & Science University.
For the study, the researchers examined data about adults aged 51 years and older from the Health and Retirement Study, a nationally representative survey of aging Americans. The study measured multimorbidity using a count of nine chronic conditions: heart disease, hypertension, stroke, diabetes, arthritis, lung disease, cancer (excluding skin cancer), high depressive symptoms and cognitive impairment. The researchers also explored variation in the specific conditions driving generational differences in multimorbidity.

Researchers have uncovered new details about how bacteria hook up to exchange DNA that helps them resist antibiotics.
One of the primary ways harmful bacteria acquire resistance to antibiotics is by receiving DNA from other bacteria that are already resistant. This DNA exchange is made via a process called conjugation, akin to bacterial sex, whereby two bacteria form an intimate attachment, and one transfers a packet of DNA to the other.
This is important because antibiotic resistance is causing previously treatable diseases to become deadly. The O’Neill review, commissioned by the UK government, estimates that 10 million deaths could be attributed to infection with resistant bacteria by 2050. Understanding the molecular basis of bacterial conjugation could enable researchers to develop new approaches that slow the spread of antimicrobial resistance.
Since the discovery of bacterial conjugation in the 1940s, much research has been done to show how two bacterial cells initially contact each other in preparation for transfer. However, the mechanism by which donor and recipient bacteria made the intimate attachments that enabled efficient DNA transfer was unknown.
Now, a team led by Imperial College London researchers have uncovered the proteins that mediate these intimate contacts. The results are published today in Nature Microbiology.
The new knowledge could also help scientists predict the spread of emerging resistance amongst bacterial pathogens, as it demonstrates why some DNA packets, called plasmids, are found in specific bacterial species.

Scientists have reported good news on the pandemic preparedness front: A cocktail of four manufactured antibodies is effective at neutralizing a virus from the Henipavirus family, a group of pathogens considered to be a global biosecurity threat.
The study focused on protection against a recently identified variant of the Hendra virus, which, along with Nipah virus, has been responsible for deadly animal and human infection outbreaks in the Eastern Hemisphere. The 2011 movie Contagion depicts a fictional viral outbreak traced to an infected pig that is modeled on the Nipah virus.
The Hendra variant, identified in two fatally diseased horses and sick bats in Australia, featured dramatic genetic changes from the original virus — which created a sense of urgency among scientists to learn how existing countermeasures stack up against the restructured pathogen.
Researchers screened and determined in cell studies that several previously developed monoclonal antibodies designed to neutralize the original virus are also effective against the variant. The team also designed an additional antibody that could join three others in a powerful cocktail that would leave the virus with minimal ability to further mutate its way out of antibody recognition.
“These four antibodies can bind simultaneously, which is important for preventing future escaping mutants,” said co-lead study author Kai Xu, assistant professor of veterinary biosciences at The Ohio State University.
“If you have only one or two antibodies, the virus can easily develop a mechanism to escape antibody recognition. If you have more antibodies in a cocktail developed as a therapeutic, it will decrease the chances of an escape mutant by many orders of magnitude.”
The study was published online recently in Proceedings of the National Academy of Sciences.

Researchers from the University of Kentucky’s Sanders-Brown Center on Aging say a paper recently published in Acta Neuropathologica is the most definitive assessment yet of the prevalence of a form of dementia classified in 2019 and now known as LATE. The results show that the prevalence of brain changes from LATE may be roughly 40% in older adults and as high as 50% in people with Alzheimer’s disease.
“This is a fundamental question about any disease or condition, ‘How commonly is it seen in peoples’ brains?’ and it is deceptively challenging to answer that question,” said Pete Nelson, M.D., Ph.D., neuropathologist and the R.C. Durr Foundation Chair in Alzheimer’s Disease at UK.
In 2019 Nelson and large group of international experts, working together, named this new form of dementia named limbic-predominant age-related TDP-43 encephalopathy (LATE).
The data for this new research came from 13 existing community and population-based study cohorts. The study included autopsy, genetic and clinical data from more than 6,000 brains. Five different countries across three continents are represented in the samples and data. The results indicated that more than a third of the brains had LATE pathology.
Symptoms of LATE mimic Alzheimer’s disease by causing memory loss and problems with thinking and reasoning in old age. But researchers found the LATE-affected brain looks different from the Alzheimer’s brain, and the therapies that may work for one probably would not work for the other.
Ten NIH-funded Alzheimer’s Disease Research Centers, including University of Kentucky, were represented and worked together as a large coherent team. In addition to these U.S. centers, two cohorts from the United Kingdom, and one cohort each from Brazil, Austria, and Finland took part in this study.
“Not only is the size of this combined analysis important but also the fact that those who took part in the studies leading to brain donation were derived from longitudinal studies in researched populations. Due to this we can say more about the contribution of LATE to dementia in older populations. This is quite different from most research which is effectively from individuals without that anchoring,” said Carol Brayne, M.D., British academic and Professor of Public Health Medicine at the University of Cambridge. “Given older ages are when dementia is most common, the LATE findings are particularly important. Although there are many differences between the studies that are combined here — from design to methodologies — they all reveal the importance of LATE and suggest our findings will be relevant beyond any individual country or region of the world.”
In addition to the University of Kentucky, other U.S. Alzheimer’s Disease Research Centers involved in this work include Northwestern University Medical Center, Rush University Medical Center, Mayo Clinic (both MN and FL campuses), Duke University, University of California (Davis), University of California (Irvine), University of California (San Francisco), University of Washington, and Stanford University. Nelson says that ultimately this study helps indicate that LATE is an extremely common contributor to the devastating clinical syndrome that is often referred to as Alzheimer’s disease or dementia. While looking at the findings, Nelson and the other researchers indicated that LATE was even more common in brains with severe Alzheimer’s disease neuropathologic change (ADNC) — over half of severe ADNC cases also had LATE.
With the first clinical trial in the world for LATE currently underway at the University of Kentucky, and attention turning towards preventing LATE and Alzheimer’s, Nelson says basic information gained through studies like this one is crucial. “It helps us frame key questions like, ‘Who should be recruited into a research study? What should we be looking for?’ It can also help guide us on how to better study LATE and Alzheimer’s disease when those two brain diseases are so often present in the same person.”
While progress is being made, there still are many knowledge gaps.
“We need more information in more diverse cohorts. People with African or Asian heritage were relatively under-sampled in this study. So far, it does not appear that people with different ethnic backgrounds have differing risk for LATE but further work is required in this important area,” said Nelson.
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The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.An experimental therapy for A.L.S., the paralyzing and fatal neurological disorder, has been approved in Canada, adding a new treatment option for a disease for which there are few effective therapies.The approval, which comes with the condition that the drug company later provide better evidence that the treatment works, is likely to be of major interest to patients with A.L.S. (amyotrophic lateral sclerosis) in the United States, where the same therapy — AMX0035, to be marketed as Albrioza — is being evaluated by the Food and Drug Administration, which has raised questions about the treatment’s effectiveness.An F.D.A. review earlier this year found Albrioza to be safe, but said there was not enough evidence that it was effective either in helping patients live longer or slowing the rate at which they lose functions like muscle control, speaking or breathing without assistance. A committee of independent advisers to the F.D.A. voted by a narrow margin in March that the therapy was not ready for approval.The F.D.A. had been scheduled to issue a final decision this month, but recently extended the deadline to Sept. 29, saying it needed more time to review additional analyses of data submitted by the company.In the meantime, Calaneet Balas, president and chief executive of the A.L.S. Association, one of several patient advocacy organizations pressing for F.D.A. approval, said, “We expect that Americans living with A.L.S. will try to access Albrioza in Canada, just as we have heard reports of people trying to buy the ingredients on Amazon.” A.L.S., also called Lou Gehrig’s disease, is diagnosed in about 6,000 people worldwide each year and often causes death within two to five years. There are only two approved A.L.S. medications in the United States: riluzole, which can extend survival by several months, and edaravone, which can slow progression by about 33 percent.Albrioza is a combination of two existing drugs in the form of a bitter-tasting powder that is mixed with water and drunk or ingested through a feeding tube twice daily. It is produced by a small Massachusetts company, Amylyx Pharmaceuticals, whose founders, Justin Klee and Joshua Cohen, conceived of the therapy when they were undergraduate students at Brown University less than a decade ago.The Fight Against A.L.S.The illness, also called Lou Gehrig’s disease, robs people of their ability to move, speak, eat and ultimately breathe.Lacking Evidence: A new treatment held promise for slowing A.L.S., but an F.D.A. panel found that there’s not enough data to show that it works.A Runner’s Mission: After surpassing the average life expectancy for people with the disease, Andrea Peet decided to race a new kind of clock: 50 marathons in 50 states.Brain Implant: A man who is fully paralyzed by A.L.S. was able to communicate using only his thoughts.Rethinking Care: In 2017, Brian Wallach was diagnosed with A.L.S. Now, his startup aims to help other patients make the most of their time.Their idea was that combining taurursodiol, a supplement sometimes used to regulate liver enzymes, and sodium phenylbutyrate, a medication for a pediatric urea disorder, could safeguard neurons by preventing dysfunction of two structures in cells: mitochondria and the endoplasmic reticulum.The data comparing Albrioza to a placebo has so far come from one Phase 2 trial (which is smaller than the Phase 3 studies regulatory agencies generally require); additional information came from an open-label extension study that followed some patients after the trial ended, when they were knowingly taking the medication. The F.D.A. typically requires two persuasive clinical trials of a drug for approval, but in cases of severe disease with few available treatments, it can consider evidence from one clinical trial plus additional supporting data.A box of packets being used in a clinical trial of the two-drug combination AMX0035, which will be marketed as Albrioza.Aileen Perilla for The New York TimesHealth Canada greenlighted Albrioza under a program called Notice of Compliance with Conditions, which allows for approval of drugs that appear promising for serious diseases, but have incomplete evidence that they work. The central condition the agency set is that Amylyx “verify the clinical benefit of this drug” with data from a Phase 3 clinical trial that is underway and expected to conclude in 2024, according to agency documents sent to the company on Friday. The company must also conduct additional pharmacological studies and provide periodic safety reports. “Patients should be advised of the nature of the authorization,” the documents said.The F.D.A. has a similar program called accelerated approval that allows conditional approval of drugs with incomplete evidence of effectiveness, but that program also requires that a drug show that it targets part of the underlying biological mechanism of a disease. Experts have said that if Albrioza does not win standard F.D.A. approval, it would be unlikely to meet accelerated approval criteria because too little is known about the underlying biology of A.L.S., and how and whether Albrioza might address it.Last month, 38 doctors who treat A.L.S. patients sent a letter to the F.D.A. urging approval. The A.L.S. Association said its campaign for approval had in recent weeks generated more than 6,000 emails asking the agency to greenlight the drug.A member of the F.D.A.’s independent advisory committee, Dr. G. Caleb Alexander, who voted in March that there was insufficient evidence the therapy works, said he continues to think the F.D.A. should wait for the Phase 3 trial’s results and that “it would be a mistake to approve it based on the single trial alone.”Dr. Alexander, an internist and epidemiologist at the Johns Hopkins Bloomberg School of Public Health, said there was desperate need for effective therapies for A.L.S., but that for Albrioza, “it’s unfortunate, but the magnitude of unmet need is not matched by the quality of evidence to date.”He added that “approval in Canada could only further increase the pressure that the F.D.A. faces to rule favorably and to approve this product.”It is generally illegal for Americans to import drugs that haven’t been approved in the U.S. for personal use. But the F.D.A. website lists some exceptions that might apply to Albrioza, including if the drug has no serious safety issues and if it is to treat “a serious condition for which effective treatment is not available in the United States.”Dr. Angela Genge, director of the A.L.S. Global Centre for Excellence at the Montreal Neurological Institute, who has received fees from Amylyx for serving on an advisory board, said American patients would be legally able to receive Albrioza in Canada if it were prescribed by a Canadian physician and obtained from a Canadian pharmacy, though they would not be eligible for insurance coverage under Canada’s public or private system.In an interview, Mr. Cohen and Mr. Klee declined to disclose the price that Amylyx is considering for Albrioza, saying it was still being negotiated. They said that the therapy would be available in about six weeks for people who were paying privately, but would take longer, possibly months, for people to receive coverage under Canada’s public system. Amylyx has already been providing Albrioza at no cost under compassionate-use arrangements to 250 patients in the United States, they said.Until last summer, the F.D.A. had recommended that Amylyx not apply for approval until the drug had completed its Phase 3 trial, but in July, officials began suggesting that Amylyx submit an application for approval using existing data. The timing followed vociferous pressure from A.L.S. advocacy groups in the wake of the approval of the new Alzheimer’s drug, Aduhelm, which was controversial because many experts said there was insufficient data that Aduhelm worked.In the Phase 2 trial, two-thirds of the 137 participants received Albrioza, and over 24 weeks, they experienced a 25 percent slower decline than the participants receiving placebo — declining 2.32 points less on a 48-point A.L.S. scale that rates 12 physical abilities, including walking, speaking, swallowing, dressing, handwriting and breathing.The open-label extension study involved 90 of those patients, including 34 from the placebo group, who began taking the medication about seven months after those who had received it from the beginning. Those who received the treatment the longest had a median of 4.8 months more time before being hospitalized, being put on a ventilator or dying, Amylyx reported. Researchers involved in the study published more data last month that suggested additional benefit.Amylyx financed the bulk of its research on Albrioza, but the A.L.S. Association contributed $2.2 million, using money raised through the 2014 Ice Bucket Challenge. Amylyx has agreed to use sales of the drug to repay 150 percent of the association’s grant to fund more research.The clinical trials involved patients who developed symptoms within 18 months before the trial and were affected in at least three body regions, generally signs of fast-progressing disease. Health Canada’s approval did not place restrictions on which A.L.S. patients could take Albrioza, but the Amylyx founders and Dr. Genge said it is possible that such limitations might be established by the Canadian coverage system or by pharmaceutical formularies in some of Canada’s provinces.

The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid illness in children under 5, judging by the level of virus-blocking antibodies the shots induced.The agency’s evaluation was posted online ahead of Wednesday’s meeting of outside vaccine experts, summoned to recommend how the F.D.A. should rule on applications from both Pfizer and Moderna on vaccinating the nation’s youngest children.Some public health experts are expecting the F.D.A. to authorize both Moderna’s and Pfizer’s vaccines, offering parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the F.D.A. acts. Roughly 18 million children younger than 5 are the only Americans who are not yet eligible for shots.In a staff analysis, the F.D.A. said the data submitted by Pfizer and its German partner, BioNTech, suggests that three doses are more effective than two. But the agency said it was hard to draw definitive conclusions because there were so few cases of Covid among the 1,415 children who received three doses of the vaccine during the clinical trial.Pfizer has said only eight children in the placebo group and two in the vaccinated group fell ill. The trial protocol said 21 cases were required to render a judgment on efficacy.So far, the F.D.A. appears to view both Pfizer’s and Moderna’s requests for pediatric vaccines favorably. Parents are so eager to have a coronavirus vaccine for their youngest children that some have said they would accept even low rates of effectiveness, as long as the vaccines were safe.In its analysis of Pfizer’s data, the agency said that rates of hospitalization and death due to Covid among children under 5 were higher than among those age 5 to 17, “underscoring the benefit of an effective Covid- 19 vaccine in this age group.”The agency also noted that among children 5 or older, who are already eligible for Pfizer’s vaccine, the shots have helped prevent hospitalization and other serious outcomes, including during the current year, when the highly contagious Omicron variant and its rapidly evolving subvariants became the dominant forms of the virus.“Given the uncertainty of the Covid-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on Covid-19-associated morbidity and mortality in this age group,” the F.D.A. said. The agency identified minimal side effects.On Friday, the F.D.A. said Moderna’s coronavirus vaccine for children under 6 was also effective in preventing symptomatic infection without causing worrisome side effects. The two vaccines are based on the same type of technology, but the dosage and regimens differ. Moderna is proposing two doses at one-quarter the strength of adult doses. Pfizer is proposing three doses at one-tenth the strength of adult shots.

SharecloseShare pageCopy linkAbout sharingImage source, ReutersA total of 166 Covid infections in China have been linked to a single bar in the capital Beijing, officials say.A government spokesman described the outbreak as “ferocious”. All residents living in the area where the bar is located will be tested over the next three days. The number of infections in the city is low by international standards but high for China, which is the world’s only major economy still maintaining a “zero Covid” policy.The outbreak was traced to a venue called the Heaven Supermarket Bar, in the well-known entertainment area of Sanlitun in Chaoyang district. Two buildings housing hundreds of people in Chaoyang were put under strict lockdown on Sunday after a positive case was reported, a residential committee worker told Reuters news agency.Some people in Beijing said they were sent texts telling them to report to authorities if they had recently visited Sanlitun’s bars.Chinese officials have reversed the relaxation of some Covid rules in Beijing because of the outbreak.Most children in the capital will not return to school next week as originally planned, officials said.The capital has reported 1,997 local Covid cases since 22 April.Relief and caution as Shanghai returns to lifeChina’s overall policy of “zero Covid” remains in place and people catching Covid face quarantine or hospital.Their close contacts also face the prospect of removal to quarantine and the area immediately around where they live being locked down again.The city of Shanghai, the country’s economic centre and a global trade hub, recently eased Covid curbs after a two-month lockdown.This video can not be playedTo play this video you need to enable JavaScript in your browser.More on this storyRelief and caution as Shanghai returns to life