How Vision Loss Can Affect the Brain

A growing body of evidence suggests that when older people’s brains have to work harder to see, declines in language, memory, attention and more could follow.

Medical practice tends to divide its clients — you and me — into specialties defined by body parts: ophthalmology, neurology, gastroenterology, psychiatry and the like. But in fact, the human body doesn’t function in silos. Rather, it works as an integrated whole, and what goes awry in one part of the body can affect several others.

I’ve written about the potential harm of hearing loss to brain health, as well as to the health of our bones, hearts and emotional well-being. Untreated hearing loss can increase the risk of dementia. Even those with slightly less than perfect hearing can have measurable cognitive deficits.

Now, a growing body of research is demonstrating that vision loss can affect the brain’s function, too. As with hearing, if the brain has to work extra hard to make sense of what our eyes see, it can take a toll on cognitive function.

The latest study, published in JAMA Network Open in July, followed 1,202 men and women aged 60 to 94 for an average of nearly seven years. All were part of the Baltimore Longitudinal Study of Aging, and had vision and cognition tests every one to four years between 2003 and 2019.

The researchers found that those who scored poorly on initial tests of visual acuity — how well, for example, they could see the letters on an eye chart from a given distance — were more likely to have cognitive decline over time, including deficits in language, memory, attention and the ability to identify and locate objects in space.

Other vision issues, like with depth perception and the ability to see contrasts, also had deleterious effects on cognitive ability. The lead researcher, Bonnielin Swenor, an epidemiologist at the Johns Hopkins Wilmer Eye Institute, said that the new study “adds to mounting longitudinal data showing that vision impairment can lead to cognitive decline in older adults.”

Lest you think that the relationship is reversed — that cognitive decline impairs vision — another study that Dr. Swenor participated in showed that when both functions were considered, vision impairment was two times more likely to affect cognitive decline than the other way around.

This study, published in 2018 in JAMA Ophthalmology and led by Diane Zheng from the University of Miami Miller School of Medicine, included 2,520 community-dwelling adults ages 65 to 84, whose vision and cognitive function were periodically tested. She and her co-authors concluded that maintaining good vision as one ages may be an effective way to minimize the decline in cognitive function in older adults.

“When people have vision loss, they change the way they live their lives. They decrease their physical activity and they decrease their social activity, both of which are so important for maintaining a healthy brain,” Dr. Swenor said. “It puts them on a fast tack to cognitive decline.”

But identifying and correcting vision loss early on can help, Dr. Zheng said. She suggested regular eye checkups — at least once every two years, and more often if you have diabetes, glaucoma or other conditions that may damage vision. “Make sure you can see well through your glasses,” she urged.

There are “vision impairments that glasses won’t fix,” Dr. Swenor said, like age-related macular degeneration and glaucoma. Retinal disease began to compromise Dr. Swenor’s vision in her mid-20s. Those with problems like hers can benefit from something called low vision rehabilitation, a sort of physical therapy for the eyes that helps visually impaired people adapt to common situations and help them function better in society.

Dr. Swenor, for instance, can see objects in a high-contrast situation, like a black cat against a white fence, but has trouble seeing the difference between similar colors. She can’t pour white milk into a white mug without spilling it, for example. Her solution: Use a dark-colored mug. Finding such accommodations is an ongoing task, but it enables her to continue to function well professionally and socially.

Society, too, needs to help people with visual impairment function safely outside the home. Most things in hospitals are white, for example, which creates safety hazards for people with diminished contrast sensitivity. As a driver of 50 years, I’ve noticed that road barriers that used to be the same color as the road surface are now more often rendered in high contrast colors like orange or yellow, which undoubtedly reduces crashes even for people who can see perfectly.

“We need to create a more inclusive society that accommodates people with vision impairment,” Dr. Swenor said.

People who have trouble with depth perception can also incorporate helpful design features into the home. Placing colored strips on stair risers, varying textures of furniture and color-coding objects can all improve the ability to navigate safely. People who can no longer read books may also listen to audiobooks, podcasts or music instead, Dr. Swenor said.

The link between visual impairment and cognitive impairment “is not a doomsday message,” she added. “There are many ways to foster brain health for people with vision loss.”

Step one may be getting a Medicare extension bill through congress, which in turn might prompt private insurers to also cover vision care and rehabilitation. The Democrats’ current proposal to extend Medicare benefits to cover vision care would more than pay for itself in the long run by diminishing already-covered medical costs for cognitive and physical decline.

Case in point: The cost of a single hip replacement resulting from a vision-impaired fall would exceed the cost of many hundreds of eye exams and needed vision corrections.

Portrait of Jane E. Brody

Source: How Vision Loss Can Affect the Brain – The New York Times

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Branch retinal vein occlusion

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A review of central retinal artery occlusion: clinical presentation and management

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Pediatric, Adult Glaucoma Differ in Management: Patient Populations Not Same

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Circadian Rhythm Sleep Disorder

A comparison of the causes of blindness certifications in England and Wales in working age adults

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Census Figures Show Americans’ Incomes Fell in 2020

Americans last year saw their first significant decline in household income in nearly a decade, government data showed, with economic pain from the Covid-19 pandemic prompting government aid that helped keep millions from falling into poverty.

An annual assessment of the nation’s financial well-being, released Tuesday by the Census Bureau, offered insight into how households fared during the pandemic’s first year. It arrives as Washington debates how much more to spend to bolster the economy during the worst public-health crisis in a century.

Median household income was about $67,500 in 2020, down 2.9% from the prior year, when it hit an inflation-adjusted historical high. It came as the U.S. last year saw millions lose their jobs and national unemployment soar from a 50-year low to a high of 14.8%.

The last time median household income fell significantly was 2011, in the aftermath of the 2007-09 recession.

The Census Bureau’s top-line income figure includes unemployment benefits but doesn’t account for income and payroll taxes nor stimulus checks or other noncash benefits like federal food programs. If those had been counted, the median household income would have risen 4% to $62,773.

As was the case with the income measure, the report offered conflicting takes on poverty trends because of differing definitions and approaches to the topic.

The bureau said the traditional poverty rate in 2020 was 11.4%, an increase of 1 percentage point from 2019 and the first increase after five consecutive years of declines. That translated to 37.2 million people in poverty, an increase of 3.3 million from 2019. For a four-person household, the threshold for meeting the definition of poverty was about $26,000 in 2020.

The official poverty measure doesn’t reflect how much a household pays in taxes, and it also omits noncash government aid like tax credits, housing subsidies and free school lunches. A broader poverty measure that accounts for such expenses and income actually fell last year to 9.1%, down 2.6 percentage points from 2019.

The decrease, coinciding with an increase in the official poverty rate, highlighted the role of the government safety net, which was expanded during the pandemic. The two poverty yardsticks have tracked closely for a decade, but last year was the first time that the supplemental measure dropped below the official measure.

Without the first two rounds of stimulus checks issued last year, the broader poverty measure would have risen by almost a percentage point instead of dropping, the bureau said.

Specifically, stimulus checks moved 11.7 million people above the poverty threshold if their effect was calculated alone. In the same manner, expanded unemployment programs did so for 5.5 million people. Refundable tax credits, such as the earned-income tax credit, did so for 5.3 million people. The Social Security program, however, remained the largest safety net program, lifting 26.5 million people above the poverty line.

“The increase in poverty would have been even larger if it were not for the ample fiscal support provided over the past year,” said Shannon Seery, an economist at Wells Fargo & Co.

After continued direct federal payments made to households in 2021 and enhanced unemployment benefits that expired in early September, Ms. Seery said, an improving unemployment picture should help households.

“With a robust demand for labor, exhibited by the record 10.9 million job openings in July, and average hourly earnings rising across industries, the current environment should help lure workers back to the job site,” she said.

The bureau also said Tuesday the proportion of Americans without health insurance for all of 2020 was 8.6%, essentially unchanged from 2018. About 28 million Americans lacked health insurance, according to the survey.

Median earnings in 2020 of those who worked full time, year-round increased 6.9% from 2019. The 2020 female-to-male earnings ratio was 83%, essentially unchanged from the previous year.

The distribution of incomes changed little. The top fifth of households—with incomes above $141,100—collected 52.2% of household income, while the top 5% alone—with incomes above $273,700—collected 23%. The bureau reported that the income shares collected by the lowest groups dropped slightly. The lowest fifth of households—making less than $27,000—collected 3%, down from 3.1% in 2019. The second fifth—with incomes from $27,000 to $52,000—collected 8.1%, down from 8.3% in 2019.

In 2020, median household incomes decreased 3.2% in the Midwest and 2.3% in the South and West, the bureau said. The change in the Northeast between 2019 and 2020 wasn’t statistically significant.

Median incomes were highest in the Northeast ($75,211) and the West ($74,951), followed by the Midwest ($66,968) and the South ($61,243). Households with the lowest levels of educational attainment logged the greatest declines in their incomes. For those headed by someone without a high school diploma, incomes dropped 5.7%, while those headed by someone with some college education or a bachelor’s degree or higher recorded a 2.8% decline.

The road ahead for the U.S. economy looks more uncertain than earlier in 2021. In recent weeks, growing evidence has built of lost momentum as Covid-19 cases rose again. Supply-chain challenges and a lack of workers for lower-paying jobs also are weighing on economic growth.

Rocky Smith Jr., a 41-year-old union worker who cuts metal parts down to size after they exit a furnace, said things are looking up for his family of four in Muskegon, Mich. After being laid off in April 2020, he said, he wasn’t hired back until July 2021.

Mr. Smith said he is now making more than $20 an hour at his full-time job. His wife, he said, resumed working during his unemployment and the family skipped meals out and other luxuries.

“We rolled with the punches,” said Mr. Smith, a former boxer. “Life hit us, but we made it work.”

By: John McCormick and Paul Overberg

Source: Census Figures Show Americans’ Incomes Fell in 2020 – WSJ

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Why Some COVID-19 Infections May Be Free of Symptoms But Not Free of Harm

Scientists are studying the potential consequences of asymptomatic COVID-19 and how many people may suffer long term health problems. Eric Topol was worried when he first saw images of the lungs of people who had been infected with COVID-19 aboard the Diamond Princess, a cruise ship that was quarantined off the coast of Japan in the earliest weeks of the pandemic.

A study of 104 passengers found that 76 of them had COVID but were asymptomatic. Of that group, CT scans showed that 54 percent had lung abnormalities—patchy grey spots known as ground glass opacities that signal fluid build-up in the lungs.

These CT scans were “disturbing,” wrote Topol, founder and director of the Scripps Research Translational Institute, with co-author Daniel Oran in a narrative review of asymptomatic disease published in the Annals of Internal Medicine. “If confirmed, this finding suggests that the absence of symptoms might not necessarily mean the absence of harm.”

One recent study estimated that a staggering 35 percent of all COVID-19 infections are asymptomatic. “That’s why it’s important to know if this is a vulnerability,” Topol says.

But Topol says he hasn’t seen any further studies investigating lung abnormalities in asymptomatic people in the more than a year and a half since the Diamond Princess cases were first documented. “It’s like we just gave up on it.”

He argues that asymptomatic disease hasn’t gotten the attention it should amid the race to treat severe disease and develop vaccines to prevent it. As a result, scientists are still largely in the dark about the potential consequences of asymptomatic infections—or how many people are suffering those consequences.

One stumbling block that scientists worry could keep them from truly understanding the scope of the problem is that it’s incredibly challenging to pinpoint how many people had asymptomatic infections. “There’s probably a pool of people out there who had asymptomatic disease but were never tested so they don’t know they had COVID at that time,” says Ann Parker, assistant professor of medicine at Johns Hopkins and a specialist in post-acute COVID-19 care.

Still, there is some evidence that asymptomatic disease can cause serious harm among some people—including blood clots, heart damage, a mysterious inflammatory disorder, and long COVID, the syndrome marked by a range of symptoms from breathing difficulties to brain fog that linger after an infection. Here’s a look at what scientists know so far about the effects of asymptomatic COVID-19 and what they’re still trying to figure out.

Heart inflammation and blood clots

Just as imaging scans have revealed damage to the lungs of asymptomatic individuals, chest scans have also shown abnormalities in the hearts and blood of people with asymptomatic infections—including blood clots and inflammation.

Thrombosis Journal and other publications have described several cases of blood clots in the kidneys, lungs, and brains of people who hadn’t had any symptoms. When these gel-like clumps get stuck in a vein, they prevent an organ from getting the blood it needs to function—which can lead to seizures, strokes, heart attacks, and death.

There have been relatively few of these case reports—and it’s unclear whether some patients might have had other underlying issues that could have caused a clot. But the Washington State researchers who reported on one case of renal blood clot write that it “suggests that unexplained thrombus in otherwise asymptomatic patients can be a direct result of COVID-19 infection, and serves as a call to action for emergency department clinicians to treat unexplained thrombotic events as evidence of COVID-19.”

Meanwhile, studies also suggest that asymptomatic infections could be causing harm to the heart. In May, cardiac MRI scans of 1,600 college athletes who had tested positive for COVID-19 revealed evidence of myocarditis, or inflammation of the heart muscle, in 37 people—28 of whom hadn’t had any symptoms, says Saurabh Rajpal, a cardiovascular disease specialist at the Ohio State University and lead author on the study.

Myocarditis can cause symptoms such as chest pain, palpitations, and fainting—but sometimes it doesn’t produce any symptoms at all. Rajpal says that while the athletes in the study were asymptomatic, “the changes on the MRI were similar to or almost the same as those who had clinical or symptomatic myocarditis.”

Although these chest scans are worrisome, Rajpal says that scientists don’t know yet what they ultimately mean for the health of asymptomatic patients. It’s possible that myocarditis might resolve over time—perhaps even before patients know they had it—or it could develop into a more serious long-term health issue. Long-term studies are necessary to suss that out.

The athletes’ heart inflammation might also be completely unrelated to their COVID-19 infection. Scientists would need to compare the scans with a set taken just before an individual was infected with COVID-19. So that, Rajpal says, will still need to be teased out.

Long COVID

Additionally, people with asymptomatic infections are at risk of becoming so-called COVID-19 long-haulers, a syndrome whose definition has been hard to pin down as it can include any combination of diverse and often overlapping symptoms such as pain, breathing difficulties, fatigue, brain fog, dizziness, sleep disturbance, and hypertension.

“There’s a myth out there that it only occurs with severe COVID, and obviously it occurs far more frequently in mild COVID,” Topol says.

Linda Geng, co-director of Stanford Health Care’s Post-Acute COVID-19 Syndrome Clinic in the U.S., agrees. “There is actually not a great predictive factor about the severity of your illness in the acute phase and whether you will get long COVID,” she says. “And long COVID can be quite debilitating, and we don’t know the endpoint for those who are suffering from it.”

Studies attempting to assess how many asymptomatic infections account for long COVID symptoms have varied. FAIR Health, a healthcare nonprofit in the U.S., found from an analysis of healthcare claims that about a fifth of asymptomatic patients went on to become long-haulers. Another study, which is under peer review, used data from the University of California’s electronic health records and estimated that number could be as high as 32 percent.

Melissa Pinto, a co-author of the latter study and associate professor in the Sue & Bill Gross School of Nursing at University of California Irvine, says the researchers examined healthcare records of people who tested positive for COVID-19 but hadn’t reported symptoms at the time of infection—only to come in later with symptoms associated with long COVID-19. To ensure they were identifying long-haulers, the researchers screened out anyone with a preexisting illness that could explain their later symptoms.

“This is not from another chronic disease,” she says. “These are new symptoms.”

But it’s unclear how accurate any of these estimates might be. Pinto says that some long-haulers are wary of seeking care after having their symptoms dismissed by physicians who weren’t familiar with long COVID-19 syndrome. That’s why she believes that the rates of asymptomatic infections among long-haulers are an underestimate.

Anecdotally, Geng and Parker both say that while they’ve seen plenty of patients with mild symptoms that initially went unrecognised, they’ve had little experience treating patients who were truly asymptomatic.

“We saw many patients who didn’t think they had symptoms except in retrospect because they found out that they had tested positive,” Geng says. “Because they’ve had these long unexplained symptoms of what’s presumed to be long COVID, they think, well, maybe that wasn’t allergies.”

But she thinks that most people who were truly asymptomatic are unlikely to have gotten tested and therefore wouldn’t think to consult a specialist in post-COVID-19 care if they started experiencing unexplained symptoms like brain fog and dizziness.

Parker says that ultimately physicians are still trying to understand the broad symptoms seen in long-haulers. “When a patient comes to see us, we do a very thorough evaluation because we still don’t know exactly what to attribute to COVID and what might be a pre-existing underlying syndrome,” she says. “The last thing I want to have happen is to say to a patient, yes, this is because you had COVID and miss something else that we could have addressed.”

Mysterious inflammation in children

Physicians have also seen troubling clinical manifestations of asymptomatic COVID-19 in children. Early in the pandemic, reports emerged of a rare and mysterious inflammatory syndrome similar to Kawasaki disease that typically sets in weeks after an initial infection.

“Six weeks down the line these people, especially children, will develop inflammation throughout their body,” Rajpal says.

The condition—now called multisystem inflammatory syndrome in children, or MIS-C—typically causes fever, rash, abdominal pain, vomiting, and diarrhoea. It can have harmful effects on multiple organs, from hearts that have trouble pumping blood to lungs that are scarred. It is typically seen among children under 14, although adults have also been diagnosed with this syndrome.

MIS-C is incredibly rare. Kanwal Farooqi, assistant professor of paediatrics at Columbia University Vagelos College of Physicians and Surgeons, says that less than one percent of paediatric COVID-19 patients present with some type of critical disease—and MIS-C is just one of them. However, asymptomatic infections do play a role in the syndrome: A recent study of 1,075 children who had been diagnosed with MIS-C showed that three-quarters had originally been asymptomatic.

But there’s reason to hope that this syndrome might not cause long-term effects in patients, symptomatic or otherwise. Farooqi was the lead author on a recent study of 45 paediatric patients showing that their heart problems—which ranged from leaky valves to enlarged coronary arteries—mostly resolved within six months.

“That is reassuring,” Farooqi says. Still, she recommends administering follow-up MRI scans even to patients whose heart troubles seem to have resolved to make sure there’s no longer-term damage, such as scarring. She also says that it’s “really reasonable” to be cautious about asymptomatic infections and encourages parents to have their child evaluated if they have any persistent symptoms even if the original infection was mild or asymptomatic.

“What’s important is that we can’t right now say that there are no consequences,” she says.

Calls for more studies

Scientists caution that there’s still so much we don’t know about the potential harm of asymptomatic infections. Many have called for more rigorous studies to get to the bottom of the long-term effects of asymptomatic disease, why those effects occur, and how to treat them.

Rajpal points out that his study was only possible because the Big 10 athletic conference requires athletes to get tested every few days. Regular testing is key for uncovering asymptomatic cases, he says, which means that most data on asymptomatic disease is likely to come from healthcare workers, athletes, and other workplaces with strict testing protocols.

It’s also unclear what could be causing these lingering side effects. Scientists hypothesise that it could be an inflammatory response of the body’s immune system that persists long after an infection has been cleared. Others suggest there could be remnants of the virus lingering in the body that continue to trigger an immune reaction months after the COVID-19 infection peaked.

“This is all unchartered, unproven, just a lot of theories,” Topol says.

Yet even if asymptomatic infections aren’t linked in high rates to death and hospitalisation, Pinto and others say it’s important to keep in mind that long COVID-19 symptoms can be debilitating to a patient’s quality of life.

“Even if people survive, we don’t want them to be having a lifelong chronic disease,” Pinto says. “We don’t know what this does to the body, so it’s not something that I would want to take my chances with.”

The bottom line

With so much we don’t know about the long-term effects of asymptomatic COVID-19, scientists insist it’s better to err on the side of caution.

“The full impact can take years to show,” Rajpal says. Although the chances are slim that an individual with asymptomatic infection will have a really bad outcome, he points out that the continuing high rate of infections means that more people are going to suffer.

“Even rare things can affect a lot of people,” he says. “From a public health perspective if you can reduce the number of people that get this infection, you will reduce the number of people who get severe outcomes.”

Parker agrees, adding that it’s particularly important to prevent infection now as the more transmissible Delta variant drives surges in cases and hospitalisations across the country.

“We have had an amazing breakthrough in terms of the rapid development of effective and safe vaccines,” she says. Although Parker and other scientists remain uncertain of the health effects of asymptomatic COVID-19, “we do know that vaccinations are safe and effective and available.”

By Amy McKeever

Source: Why some COVID-19 infections may be free of symptoms but not free of harm | National Geographic

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Scientists Figured Out How Much Exercise You Need to ‘Offset’ a Day of Sitting

We know that spending hour after hour sitting down isn’t good for us, but just how much exercise is needed to counteract the negative health impact of a day at a desk? A 2020 study suggests about 30-40 minutes per day of building up a sweat should do it.

Up to 40 minutes of “moderate to vigorous intensity physical activity” every day is about the right amount to balance out 10 hours of sitting still, the research says – although any amount of exercise or even just standing up helps to some extent.

That’s based on a meta-analysis across nine previous studies, involving a total of 44,370 people in four different countries who were wearing some form of fitness tracker.

The analysis found the risk of death among those with a more sedentary lifestyle went up as time spent engaging in moderate-to-vigorous intensity physical activity went down.

“In active individuals doing about 30-40 minutes of moderate to vigorous intensity physical activity, the association between high sedentary time and risk of death is not significantly different from those with low amounts of sedentary time,” the researchers wrote in the British Journal of Sports Medicine (BJSM) in 2020.

In other words, putting in some reasonably intensive activities – cycling, brisk walking, gardening – can lower your risk of an earlier death right back down to what it would be if you weren’t doing all that sitting around, to the extent that this link can be seen in the amassed data of many thousands of people.

While meta-analyses like this one always require some elaborate dot-joining across separate studies with different volunteers, timescales, and conditions, the benefit of this particular piece of research is that it relied on relatively objective data from wearables – not data self-reported by the participants.

The study was published alongside the release of the World Health Organization 2020 Global Guidelines on Physical Activity and Sedentary Behavior, put together by 40 scientists across six continents. In fact, in November 2020 BJSM put out a special edition to carry both the new study and the new guidelines.

“These guidelines are very timely, given that we are in the middle of a global pandemic, which has confined people indoors for long periods and encouraged an increase in sedentary behavior,” said physical activity and population health researcher Emmanuel Stamatakis from the University of Sydney in Australia.

“People can still protect their health and offset the harmful effects of physical inactivity,” says Stamatakis, who wasn’t involved in the meta-analysis but is the co-editor of the BJSM. “As these guidelines emphasize, all physical activity counts and any amount of it is better than none.”

The research based on fitness trackers is broadly in line with the new WHO guidelines, which recommend 150-300 mins of moderate intensity or 75-150 mins of vigorous-intensity physical activity every week to counter sedentary behavior.

Walking up the stairs instead of taking the lift, playing with children and pets, taking part in yoga or dancing, doing household chores, walking, and cycling are all put forward as ways in which people can be more active – and if you can’t manage the 30-40 minutes right away, the researchers say, start off small.

Making recommendations across all ages and body types is tricky, though the 40 minute time frame for activity fits in with previous research. As more data are published, we should learn more about how to stay healthy even if we have to spend extended periods of time at a desk.

“Although the new guidelines reflect the best available science, there are still some gaps in our knowledge,” said Stamatakis.

“We are still not clear, for example, where exactly the bar for ‘too much sitting’ is. But this is a fast-paced field of research, and we will hopefully have answers in a few years’ time.”

The research was published here, and the WHO guidelines here, in the British Journal of Sports Medicine.

By: David Nield

Source: Scientists Figured Out How Much Exercise You Need to ‘Offset’ a Day of Sitting

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Scientists Must Speak Out Against Misinformation About Immune Boosting Supplements

The COVID-19 pandemic saw huge increases in searches for immunity boosters, including for things like supplements claiming to improve immune function. But even before COVID-19 scared people into their nearest supermarket aisle, “wellness” through supplements was a multi-billion dollar industry.

Celebrities and influencers across social media platforms regularly advertise and promote a myriad of supplements to improve health and the immune system. However, there are some major problems with these claims — namely, vitamin companies are not regulated by the Food and Drug Administration (FDA) as drugs, and many supplements don’t work as claimed.

Unlike pharmaceuticals, which must undergo clinical trials that are reviewed by the FDA for the product’s safety and efficacy, dietary supplements have a less stringent path to market shelves. Even though they are most often found in or next to the store pharmacy, dietary supplements are regulated as food, not as drugs. This means that they have not been evaluated or proven effective.

Furthermore, while the manufacturer must prove the ingredients are “reasonably safe”, none of these products are formally “approved” by the FDA. But these supplements are not always inherently harmless options for people trying to live a healthy lifestyle. A 2015 study concluded adverse effects from dietary supplements caused an “estimated 23,000 emergency department visits in the United States every year.”misperception

Despite these risks, there has been an unfortunate absence of expert voices contesting supplement company claims with real data. “There needs to be a more robust response from the science community in the face of pseudoscience and misinformation,” says Tim Caulfield, a professor of health law at the University of Alberta, who has worked on studies and books examining ads and posts claiming to support the immune system on social media.

He explains that supplement marketing often builds on the common misperception that if the right amount of a vitamin is good for you, more is better. “That’s not the case at all,” he says. On the topic of supplement misinformation, Pieter Cohen, an associate professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance, says, “The main problem is that the law permits companies to promote supplements as if they have important benefits for health even if there has never been a single study in humans to study the product’s efficacy or safety.”

Indeed, dietary supplements are not required to be reviewed by the FDA before they are distributed because they are not considered medications. Vitamins say right on the bottle that their claims “have not been reviewed by the FDA.” Instead, they are predominantly regulated by the Federal Trade Commission, or FTC, which monitors the claims the labels make; however, this is limited to ensuring that the supplement makers are not explicitly claiming the product can be used as a treatment.

The FTC does allow companies to suggest a range of benefits their products provide, which may be why up to 70 percent of adults in the United States take at least one dietary supplement daily, with the most common reason being to try to maintain or improve their health. While some individuals with specific vitamin deficiencies may benefit from these products (under a doctor’s supervision), most of us do not. However, those marketed as “immune boosters” or “immune boosting” are more problematic.

Despite suggestive labels, there is no way to “boost” the immune system. The immune system is a complicated and dynamic network of cells, proteins, hormones, and other biological components. Even if it were possible to ratchet up such a complex system, you wouldn’t necessarily want to, because the immune system operates primarily by inducing inflammation. This alerts various immune cells to mobilize and fend off danger.

In moderation, this is perfectly healthy, and the system has a braking mechanism all its own. But if a product were to truly “boost” the immune system, this mechanism would be amplified. We know what too much inflammation looks like: autoimmune disorders, inflammatory disease, and allergies.

Ironically, in some cases, products heralded to improve immune function can actually suppress it. Take vitamin D, touted for its ability to enhance “immunity.” While it may increase the inflammatory response, it has been shown to actually reduce the activity of other cell types—namely T cells, which are critical in forming long-term memory. The same is true of many other popular supplements, such as zinc, when a person takes substantially more than the recommended daily amount.

Supplements can be actively harmful in other ways too. Since supplements aren’t regulated by the FDA, they aren’t evaluated for safety in the same way as pharmaceuticals. Of course, the manufacturers cannot knowingly use or include compounds that are known health hazards — legislation from 1994 dictates that ingredients used in supplement products must not have been shown to cause harm.

But that doesn’t mean these products aren’t without yet unrecognized risks. “I think one of the biggest things that gets overlooked is the potential for a drug-drug interaction,” says Dr. Kathryn Nelson, a medicinal chemist at University of Minnesota. Physicians need patients to disclose what supplements they are using, including multivitamins, because they might interact with prescribed medications.

From inactivating a pharmaceutical prescription, to dangerously exacerbating its effects, these products can have significant consequences. Yet many patients do not disclose or discuss their supplement use with their healthcare providers, due to their misguided perception that vitamins are safe or not worth mentioning.

Additionally, the active ingredient in vitamins must be either be purified from a natural source or synthesized in a lab, and both methods have the potential for carry-over from compounds used in these methods. Such contamination is called “residual complexity,” Nelson says.

This is particularly concerning when heavy metals are used and possibly present in the final product. In pharmaceutical drugs, these compounds would usually go to clinical trials, and any potential introductions of heavy metals removed in what’s called “process chemistry” to gain FDA approval. But the purification process of supplements are not reviewed by the FDA. This has opened the door for potential contaminants-heavy metals as well as other drugs and even pathogens-into these products.

Given all of this negative and even contradictory information about these products, why is the supplement market a multi-billion dollar industry? Much of the answer lies in its advertising. Companies often collaborate with social media influencers, who talk up how great the product is. And despite thousands of scientists across the country with expertise in nutrition and immunology, experts rarely publicly contradict these statements.

Science communication is an important part in the scientific process. However, more often than not, important conversations happen only with other scientists at scientific conferences, or in journals behind paywalls. As a result, the larger non-expert community is left in the dark. Daniel Pham, the associate director of the Milken Institute’s Center for Strategic Philanthropy, wrote an essay in 2016 which detailed the lack of support for science outreach by scientists, and an absence of communication training.

Almost five years later, he says, “The same issues have resonated with me even more in the times of COVID. I feel like there’s a bigger sense of the need for improved communication of science to the public. But the tools we’re using are just woefully inadequate.” The evidence of his statement can be seen in a recent study by Arizona State University, which showed the majority of scientists believe that it is important to inform and engage the general public about science topics.

However, when asked about their personal interest or intentions of doing this, the answers are less enthusiastic. Often scientists are not encouraged or even rewarded for public outreach, which doesn’t aid securing funding, publishing, or gaining tenure. One possible solution might be to reform the funding and promotion institutions so they reward researchers for this kind of public service.

However, scientists should also not anticipate their feedback will be immediately accepted based on their resumes. As Nelson points out, the first step in improving the public’s access to verified information is building trust with experts. That includes breaking down the stigmas surrounding what it means to be a scientist, and making expertise more accessible.

A recent example is the initiative Science on Tap, where a scientist describes their research in general terms to patrons at a local bar or venue. Pham has also started a similar effort at Johns Hopkins University, called Project Bridge, bringing small, introductory science demonstrations to public spaces such as farmer’s markets. Specific tactics to counter supplement marketers could also include partnering with influencers who are willing to share verified research, as well as lobbying for legislative reform.

The supplement industry is a prime example of the dangers of misinformation, which is damaging to both science and the public at large. Cohen notes that the next steps are to urge the FDA and FTC to enforce existing laws prohibiting the promotion of products with disease claims, in an attempt to get them off the shelves. In the long-term, he notes the existing law on these products needs to be reformed so that “all products [are] registered with the FDA.”

Scientists and researchers have the expertise to get information to the public and enact policy change. But it will require getting creative. “A lot of the misinformation really has become a social media story,” Tim Caulfield says, “so we need to go to where the misinformation resides.” Scientists, he adds, “need to find their own voice.

By Shelby Bradford

Source: Scientists must speak out against misinformation about “immune-boosting” supplements | Salon.com

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The Great Millennial Blood Pressure Problem

You know the guy. You work with him, or you’re friends with him, or maybe you even are him. He’s youngish. Fit-ish. Flirting with fasting and CBD. Always tracking his steps, his sleep, his heart rate, his meditation streaks. But these trackers overlook one metric: blood pressure. Those two numbers measure how well your blood vessels handle the 2,000 gallons of blood your heart pumps around your body in a day. And young guys’ vessels aren’t doing the job so well.

In 2019, Blue Cross Blue Shield released data from the claims of 55 million people in its Health of Millennials report. One of the most shocking stats: From 2014 to 2017, the prevalence of high blood pressure in people ages 21 to 36 jumped 16 percent, and compared with Gen Xers when they were the same age, high blood pressure among millennials was 10 percent more prevalent.

So what exactly do we mean by “high”? We mean blood pressure that measures above 130 systolic (the pressure in your arteries when your heart contracts) or 80 diastolic (the pressure between beats). And when that happens, explains preventive cardiologist Michael Miedema, M.D., M.P.H., of the Minneapolis Heart Institute Foundation, your blood vessels stiffen up, forcing blood pressure even higher. That can create stress on vessel walls, leading to an ugly chain of inflammation, plaque buildup, and higher risk for heart attack and stroke.

For the longest time, most young people didn’t have to worry about this. “Youth has always been a relative Teflon coating,” says Eric Topol, M.D., founder and director of the Scripps Research Translational Institute in La Jolla, California. Blood-pressure issues were strictly for older people, and the idea that this protection might be eroding is forcing doctors to examine what’s really going on. Here’s what they’re finding.

All That #Wellness Isn’t Making you Healthy

You’d think customized vitamins, kombucha, and cryotherapy would get you to #peakwellness, but when it comes to blood pressure, they’re not doing much. “With millennials, you hear a lot about wellness and not as much about health—and they’re different,” says Christopher Kelly, M.D., a cardiologist at North Carolina Heart and Vascular Hospital, and a millennial himself.

“Wellness trends promise great results with little effort, but few have any proven long-term benefits,” he says. “You won’t see ads on Instagram for the few things that we know promote health, including regular exercise, not smoking, being at a healthy weight, and screening for blood-pressure and cholesterol issues.”

Being Broke Can Break You

Millennials carry more than $1 trillion in debt. A large chunk of that is due to student loans—millennials owe more than four times what Gen Xers do. Add this weight to other pressures and it makes sense that millennials reported the highest average stress level of any generation, at 5.7 out of 10, in the American Psychological Association’s Stress in America survey. (Gen Xers came in at 5.1, Gen Zers at 5.3, and boomers at a relatively zen 4.1.)

“Most of us overlook that the medical word we use for high blood pressure, hypertension, is really hyper and tension,” says cardiologist Andrew M. Freeman, M.D., of National Jewish Health in Denver. Not only does chronic stress play a role in high blood pressure, but the responses we often have to what’s stressing us out—like binge eating and cutting sleep short—jack it up, too.

Blame Seamless and Postmates

The Johns Hopkins Bloomberg School of Public Health found that people who ate home-cooked meals almost every day consumed nearly 1,000 fewer calories a week than those who went with home-cooked once a week or less. And that’s bad news for millennials: The average millennial eats out or buys takeout food five times per week, according to a Bankrate survey, which means they’re devouring all the pressure-boosting sodium and calories that come with it.

(Sodium is particularly sneaky: In one study, 90 percent of people thought their restaurant meal had about 1,000 milligrams—around half a day’s worth—less than it did.) And sodium ends up in your diet via some surprising foods, like bread (see the top sources here).

Then there’s the weight factor. Millennials are on track to be the heaviest generation in history, and extra weight on a young adult can ratchet up blood pressure and thicken the heart muscle early, inviting heart disease later on.

It’s Easy to Avoid Moving

“The heart requires the challenge of moving blood through the body to keep things supple and functioning normally,” says Aaron Baggish, M.D., of Massachusetts General Hospital. And between more screen time, longer commutes, and more labor-saving devices, Dr. Baggish explains, “many millennials are just not doing enough activity.” See the best exercises to get started with.But There’s Good News About Young Guys’ Blood Pressure

You can head off this whole saga with some pretty simple lifestyle changes. Start with the six basic steps at right, and keep on top of your blood-pressure rates with the three gizmos below. Even minor adjustments can bring down your BP, especially the ones below.

6 Small Changes That Take Blood Pressure Down

1.) Lose two pounds. For every two pounds or so you shed, you could see a one-point drop in systolic blood pressure (the top number).

2.) Get up every 45 minutes and walk around. This simple move was enough to significantly lower diastolic blood pressure in one study.

3.) Eat for your heart. “Following a heart-healthy diet can drop systolic blood pressure as much as a pill can,” says cardiologist Michael Miedema, M.D., M.P.H. That’s about three to five points.

4.) Fill up on potassium. This mineral can counteract the effects of sodium in your diet. Help it out and counter sodium yourself by nixing key sources like bread, cold cuts, and pizza.

5.) Say yes to pickup basketball. The adrenaline and cortisol that swirl around when you’re stressed can hike up blood pressure. In fact, one recent study found that male med students were 13 times as likely to have elevated numbers as their female counterparts. Friends help buffer stress. Bonus if you combine hanging out with a workout.

6.) Monitor pressure at home. Everyone should check their BP once a month at home, even if they’re healthy, says John Elefteriades, M.D., director of the Aortic Institute at Yale-New Haven Hospital. It can help you ID triggers so you can keep them from messing with your numbers and your life.

By: Cassie Shortsleeve

Cassie Shortsleeve is a skilled freelance writer and editor with almost a decade of experience reporting on all things health, fitness, and travel. A former Shape and Men’s Health editor, her work has also been published in Women’s Health, SELF, Runner’s World, Men’s Journal, CNTraveler.com, and other national print and digital publications. When she’s not writing, you’ll find her drinking coffee or running around her hometown of Boston.

Source: The Great Millennial Blood Pressure Problem

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Non-Negotiable Diet, Sleep and Exercise Routines For a Longer Life

Thanks to today’s advanced research and new innovations, it’s more than possible for us to live longer, stronger and healthier lives. While life expectancy in the U.S. dropped one full year during the first half of 2020, according to a CDC report, much of that was attributed to the pandemic. Prior to Covid, however, life expectancy in the U.S. was 78.8 years in 2019, up a tenth of a year over 2018.

As a longevity researcher, I’ve spent the bulk of my career gathering insights from world-leading health experts, doctors, scientists and nutritionists from all over the world. Here’s what I tell people when they ask about the non-negotiable rules I live by for a longer life:

1. Get regular checkups

Early diagnosis is critical for the prevention of disease and age-related decline, so it’s important to get yourself checked regularly, and as comprehensively as possible.

At the very least, I make it a point to have a complete annual physical exam that includes blood count and metabolic blood chemistry panels, a thyroid panel and testing to reveal potential deficiencies in vitamin D, vitamin B, iron and magnesium (all nutrients that our body needs to perform a variety of essential functions).

2. Let food be thy medicine

Poor diet is the top driver of noncommunicable diseases worldwide, killing at least 11 million people every year.

Here are some of my diet rules for a longer life:

  • Eat more plants: To reduce your risk of cardiovascular disease and diabetes, try to have every meal include at least one plant-based dish. I typically have broccoli, cauliflower, asparagus or zucchini as a side for lunch and dinner. When I snack, I opt for berries, nuts or fresh veggies.
  • Avoid processed foods: Many products you find in grocery stores today are loaded with salt, sugar, saturated fats and chemical preservatives. A 2019 study of 20,000 men and women aged 21 to 90 found that a diet high in processed foods resulted in an 18% increased risk of death by all causes.
  • Drink more water: Most of us drink far too little water for our optimal health. I keep a bottle of water with lemon slices at hand wherever I spent most of my day.
  • Include healthy fats: Not all fats are bad. High-density lipids (HDL), including monounsaturated and polyunsaturated fats, are considered “good fats,” and are essential to a healthy heart, blood flow and blood pressure.

3. Get moving (yes, walking counts)

Just 15 to 25 minutes of moderate exercise a day can prolong your life by up to three years if you are obese, and seven years if you are in good shape, one study found.

I try not to focus on the specific type of exercise you do. Anything that gets you up out of the chair, moving and breathing more intensely on a regular basis is going to help.

That’s why the method I practice and recommend the most is extremely simple: Walking. Brisk walking can improve cardiovascular health and reduce risk of obesity, diabetes and high blood pressure. It can even ease symptoms of depression and anxiety.

4. Eat early, and less often

Clinical data shows that intermittent fasting — an eating pattern where you cycle between periods of eating and fasting — can improve insulin stability, cholesterol levels, blood pressure, mental alertness and energy.

To ease into the “eat early, and less often” diet, I started with a 16:8-hour intermittent fasting regimen. This is where you eat all of your meals within one eight-hour period — for instance, between 8 a.m. and 4 p.m., or between 10 a.m. and 6 p.m.

But keep in mind that a fasting or caloric-restricted diet isn’t for everyone; always talk to your doctor before making any drastic changes to your diet and eating routine.

5. Constantly work on quitting bad habits

One of the biggest toxic habits is excessive use of alcohol. Studies show that high and regular use can contribute to damages your liver and pancreas, high blood pressure and the immune system.

Large amounts of sugar consumption is another bad habit. Sure, in the right doses, sugars from fruits, vegetables and even grains play an important role in a healthy diet. I eat fruits and treat myself to some ice cream once in a while. But make no mistake: Excess sugar in all its forms is poison. To lessen my intake, I avoid processed foods and sugary drinks.

Lastly, I don’t smoke — but for anyone who does, I recommend quitting as soon as possible. According to the CDC, cigarette smoking is behind 480,000 deaths per year in the U.S.

6. Make sleep your superpower

A handful of studies of millions of sleepers show that less sleep can lead to a shorter life. Newer studies are strengthening known and suspected relationships between inadequate sleep and a wide range of disorders, including hypertensionobesity and diabetes and impaired immune functioning.

I aim for at least seven hours of sleep per night. For me, an essential ingredient for getting quality sleep is darkness; I make sure there’s no light and no electronic devices in my room before bedtime.

 

By: Sergey Young, Contributor

Sergey Young is a longevity researcher, investor and the founder of Longevity Vision Fund. He is also the author of “The Science and Technology of Growing Young: An Insider’s Guide to the Breakthroughs That Will Dramatically Extend Our Lifespan.” Sergey is on the Board of Directors of the American Federation of Aging Research and the Development Sponsor of Age Reversal XPRIZE global competition, designed to cure aging. Follow him on Twitter @SergeyYoung200.

Source: ‘Non-negotiable’ diet, sleep and exercise routines for a longer life

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Covid’s Forgotten Hero: The Untold Story Of The Scientist Whose Breakthrough Made The Vaccines Possible

In the summer of 2020, as the pandemic raged, infecting more than 200,000 people a day across the globe, Pfizer CEO Albert Bourla and BioNTech CEO Uğur Şahin boarded an executive jet en route to the hilly countryside of Klosterneuburg, Austria. Their destination: a small manufacturing facility located on the west bank of the Danube River called Polymun Scientific Immunbiologische Forschung.
Bourla and Şahin were on a mission to get the company to manufacture as many lipid nanoparticles as possible for their new Covid-19 vaccine, which was on a fast track to receive emergency authorization from the U.S. Food and Drug Administration.

The Pfizer-BioNTech vaccine had been engineered with messenger RNA technology that instructs the body’s immune system to combat the coronavirus. But to get it safely into human cells, the mRNA needed to be wrapped in microscopic fragments of fat known as lipids. The Austrian manufacturing plant was one of the few places on earth that made the required lipid nanoparticles, and Bourla insisted Şahin go with him personally to press their case.

“The whole mRNA platform is not how to build an mRNA molecule; that’s the easy thing,” Bourla says. “It is how to make sure the mRNA molecule will go into your cells and give the instructions.”

Yet the story of how Moderna, BioNTech and Pfizer managed to create that vital delivery system has never been told. It’s a complicated saga involving 15 years of legal battles and accusations of betrayal and deceit. What is clear is that when humanity needed a way to deliver mRNA to human cells to arrest the pandemic, there was only one reliable method available—and it wasn’t one originated in-house by Pfizer, Moderna, BioNTech or any of the other major vaccine companies.

A months-long investigation by Forbes reveals that the scientist most responsible for this critical delivery method is a little-known 57-year-old Canadian biochemist named Ian MacLachlan. As chief scientific officer of two small companies, Protiva Biotherapeutics and Tekmira Pharmaceuticals, MacLachlan led the team that developed this crucial technology. Today, though, few people—and none of the big pharmaceutical companies—openly acknowledge his groundbreaking work, and MacLachlan earns nothing from the technology he pioneered.


“I look at the news, and 50% of it is vaccines—it’s everywhere—and I have no doubt the vaccines are using the technology we developed.”


“I just wasn’t going to spend the rest of my life dealing with it, but I can’t escape it,” MacLachlan says. “I open my browser in the morning and look at the news, and 50% of it is vaccines—it’s everywhere—and I have no doubt the vaccines are using the technology we developed.”

Moderna Therapeutics vigorously disputes the idea that its mRNA vaccine uses MacLachlan’s delivery system, and BioNTech, the vaccine maker partnered with Pfizer, talks about it carefully. Legal proceedings are pending, and big money is at stake.

Moderna, BioNTech and Pfizer are on their way to selling $45 billion worth of vaccines in 2021. They don’t pay a dime to MacLachlan. Other coronavirus vaccine makers, such as Gritstone Oncology, have recently licensed MacLachlan’s Protiva-Tekmira delivery technology for between 5% and 15% of product sales. MacLachlan no longer has a financial stake in the technology, but a similar royalty on the Moderna and Pfizer-BioNTech vaccines could yield as much as $6.75 billion in 2021 alone. In an ironic twist of fate, though, President Biden’s proposal to waive Covid-19 vaccine patents would make it unlikely that the intellectual property related to MacLachlan’s advances could be a source of riches.

Despite their denials, scientific papers and regulatory documents filed with the FDA show that both Moderna and Pfizer-BioNTech’s vaccines use a delivery system strikingly similar to what MacLachlan and his team created—a carefully formulated four-lipid component that encapsulates mRNA in a dense particle through a mixing process involving ethanol and a T-connector apparatus.

For years, Moderna claimed it was using its own proprietary delivery system, but when it came time for the company to test its Covid-19 vaccine in mice, it used the same four kinds of lipids as MacLachlan’s technology, in identical ratios.

Moderna insists the preclinical formulation of the vaccine was not the same as the vaccine itself. Subsequent regulatory filings by Moderna show its vaccine uses the same four types of lipids as MacLachlan’s delivery system but with a proprietary version of one of the lipids and the ratios “slightly modified” in a still undisclosed manner.

It’s a similar story for Pfizer and BioNTech. FDA documents show their vaccine uses the same four kinds of lipids in nearly the exact ratios that MacLachlan and his team patented years ago, albeit with one of those lipids being a new proprietary variation.

Not everyone ignores MacLachlan. “A lot of credit goes to Ian MacLachlan for the LNP [lipid nanoparticle],” says Katalin Karikó, the scientist who laid the groundwork for mRNA therapies before joining BioNTech in 2013. But Karikó, now a frontrunner for a Nobel Prize, is angry that MacLachlan didn’t do more to help her use his delivery system to build her own mRNA company years ago. “[MacLachlan] might be a great scientist, but he lacked vision,” she says.

Seven years ago, MacLachlan quit his position at Tekmira, walking away from his brilliant discovery and any potential financial rewards. Messy legal battles and political infighting within the biopharma industry over the delivery system had taken a toll on him. His emotions are complex. He may be overlooked, but he knows that he helped save the world.

“There’s a team of people who gave a great deal of their lives to the development of this technology. They gave their heart and soul,” MacLachlan says. “These people worked like dogs and gave the best part of themselves to develop it.”

Perched on a hilltop, Hohentübingen Castle towers above the town of Tübingen, Germany. In October 2013, MacLachlan, then the chief scientific officer of Tekmira Pharmaceuticals, trudged up the hill to the castle to attend a cocktail party at the first International mRNA Health Conference. During the evening, MacLachlan struck up a conversation with Stéphane Bancel, the CEO of an upstart mRNA company called Moderna Therapeutics. MacLachlan suggested Tekmira and Moderna collaborate using his innovative drug delivery system. “You are too expensive,” Bancel told him.

The exchange gave MacLachlan a bad feeling. So did the presence of a former colleague, Thomas Madden, who had been fired by Tekmira five years earlier. By this point MacLachlan had spent more than a decade working on his delivery system, yet people like Bancel seemed more interested in working with the London-born Madden.

The rivalry between these two scientists is the root of the controversy over the delivery technology that today’s Covid-19 vaccines rely on. MacLachlan and Madden met 25 years ago, when they worked together at a small Vancouver-based biotech called Inex Pharmaceuticals. With a Ph.D. in biochemistry, MacLachlan joined Inex in 1996, his first job after completing a postdoctoral fellowship in a gene lab at the University of Michigan.

Inex was cofounded by its chief scientific officer, Pieter Cullis, now 75, a long-haired physicist who taught at the University of British Columbia. From his perch there Cullis started several biotechs, cultivating an elite community of scientists that made Vancouver a hotbed of lipid chemistry.

Inex had a small-molecule chemotherapy drug candidate, but Cullis was also interested in gene therapy. His goal was to deliver large-molecule genetic material, like DNA or RNA, inside a lipid bubble so it could be safely ferried as medicine to the inside of a cell—something biochemists had dreamed about for decades but had been unable to accomplish.

Using a new method that mixed detergent with liquid, Cullis and his team at Inex successfully encapsulated small pieces of DNA in microscopic bubbles called liposomes. Unfortunately, the system could not consistently deliver bigger molecules, the type needed for gene therapy, in medically useful ways. They tried other approaches, including using ethanol, but didn’t succeed.

“We assembled all the LNP [lipid nanoparticle] pieces at Inex, but we didn’t get it to work” for genetic material, Cullis says.

Inex was a business, not a research lab, so it shifted its emphasis to the more promising chemotherapy drug. The gene therapy group was largely disbanded. MacLachlan ran what was left of it until, in 2000, he too decided to quit. Rather than let him completely walk away, Cullis persuaded MacLachlan to take the firm’s delivery assets and spin them out in a new company. Thus was born Protiva Biotherapeutics (MacLachlan became chief scientific officer), in which Inex retained a minority stake. MacLachlan recruited Mark Murray, now 73, a longtime American biotech executive with a Ph.D. in biochemistry, to be CEO.

It wasn’t long before two Protiva chemists, Lorne Palmer and Lloyd Jeffs, made a crucial discovery that led to a new mixing method. They put lipids dissolved in ethanol on one side of a physical T-connector apparatus, and, on the opposite side, genetic material dissolved in saltwater, then shot streams of the two solutions at each other. It was the moment they had been hoping for. The collision resulted in lipids forming a dense nanoparticle that instantly encapsulated the genetic material. The method was elegantly simple, and it worked.


In the midst of all this furious legal fighting, Hungarian biochemist Katalin Karikó showed up at MacLachlan’s door. Karikó was early to grasp that MacLachlan’s delivery system was key to mRNA therapies.


“The various methods that had been used previously were all highly variable and ineffective,” MacLachlan says. “Completely unsuitable for manufacturing.

The team he led quickly went on to develop a new lipid nanoparticle made of four specific kinds of lipids. Though these were among the lipids Inex had also been using in its experiments, MacLachlan’s LNP had a dense core that differed significantly from the sac-like liposome bubbles developed by Inex. MacLachlan’s team had figured out the specific ratios of the four kinds of lipids that worked best relative to one another. Everything was dutifully patented.

Moderna and Pfizer’s Covid vaccines use a type of gene therapy based on the messenger RNA molecule. Protiva’s scientists, though, initially gravitated toward a different type of gene therapy using RNA interference, or RNAi. While mRNA instructs the body to create therapeutic proteins, RNAi aims to silence bad genes before they cause disease. With MacLachlan’s delivery system in hand, Protiva started collaborating with Alnylam, a Cambridge, Massachusetts–based biotech, to make RNAi therapy viable.

Meanwhile, MacLachlan’s old company, Inex, was imploding after the FDA denied accelerated approval to its chemotherapy drug. Inex fired most of its staff and then—despite having spun off Protiva only a few years earlier—looped back to drug delivery. It, too, started working in partnership with Alnylam. In 2005 Cullis quit, leaving none other than MacLachlan’s archrival Thomas Madden to run Inex’s delivery efforts.

In 2006, Protiva and Alnylam published a landmark study in Nature demonstrating the first effective gene silencing in monkeys. The study used the delivery system MacLachlan’s team had developed.

Alnylam went on to develop Onpattro, an RNAi drug used to treat nerve damage in adults with a certain hereditary condition. The drug would become the first RNAi medicine ever approved by the FDA. Regulatory filings show Alnylam used MacLachlan’s delivery system for Onpattro—with one exception. For one of the four kinds of lipids, Alnylam used a modified version it developed with Thomas Madden.

In October 2008, Mark Murray, the CEO MacLachlan had recruited to run Protiva, stood in a room at Tekmira Pharmaceuticals, a small publicly traded shell company he had just taken over. Like Protiva, Tekmira had been created by Inex, which had finally burned out a year earlier, but not before transferring all its remaining assets to Tekmira. Assembled before Murray were some 15 former Inex scientists who had come along in the deal, including Thomas Madden.

“Unfortunately, we are not going to be able to keep you guys any longer,” Murray told them.

Madden’s firing was one result of a massive legal brawl sparked by the fact that both Inex and Protiva had been working separately with Alnylam on drug delivery. The dispute would continue for years. In each iteration, Murray and MacLachlan would accuse Madden and Cullis of having improperly taken their ideas. Cullis and Madden, offended by the accusations, denied them. Sometimes they sued back, claiming Murray and MacLachlan had acted wrongly.

The first round of litigation resulted in a 2008 settlement that saw Protiva take over Tekmira, with Murray as CEO, MacLachlan as chief scientific officer and Madden soon fired. Despite the bruising, Madden and Cullis founded a new company in 2009 to continue working with Alnylam.

Tekmira responded by suing Alnylam, claiming the Massachusetts biotech conspired with Madden and Cullis to cheaply gain ownership of the delivery system developed by MacLachlan. Alnylam denied wrongdoing and—of course—filed counterclaims, saying it simply wanted to work with Madden and Cullis, who had created an improved variation of one of the four kinds of delivery-system lipids.

That round of the legal brawl was settled in 2012, with Alnylam paying Tekmira $65 million and agreeing to assign dozens of its patents back to Tekmira. Those patents included ones for the improved lipid that Madden had developed for Onpattro. Under the deal, Cullis and Madden’s new company was granted a narrow license to use the MacLachlan delivery system to create new mRNA products from scratch.


Feeling defeated, MacLachlan quit Tekmira. He sold his stock, purchased a used Winnebago Adventurer for $60,000 and set off with his wife, two kids and their dog for a 5,200-mile road trip. “I was exhausted and demoralized.”


It was in the midst of all this furious legal fighting that Hungarian biochemist Katalin Karikó first showed up at MacLachlan’s door. Karikó was early to grasp that MacLachlan’s delivery system held the key to unlocking the potential of mRNA therapies. As early as 2006, she began sending letters to MacLachlan urging him to encase her groundbreaking chemically altered mRNA in his four-lipid delivery system. Embroiled in litigation, MacLachlan passed on her offer.

Karikó didn’t give up easily. In 2013, she flew to meet with Tekmira’s executives, offering to relocate to Vancouver and work directly under MacLachlan. Tekmira passed. “Moderna, BioNTech and CureVac all wanted me to work for them, but my number one choice, Tekmira, didn’t,” says Karikó, who took a job at BioNTech in 2013.

By this time, Moderna CEO Stéphane Bancel was also trying to solve the delivery puzzle. Bancel held discussions with Tekmira about collaborating, but talks stalled. At one point, Tekmira indicated it wanted at least $100 million up front, plus royalties, to strike a deal. Instead, Moderna partnered with Madden, who was still working with Cullis at their drug delivery company, Acuitas Therapeutics.

In February 2014, MacLachlan turned 50. His life partner, Karley Seabrook, lured him to Vancouver’s Imperial theater, which was packed with friends and family. She surprised him in a wedding dress, and their two children greeted MacLachlan with cards that read WILL YOU MARRY MOMMY? Seabrook had never thought it important that they get married, but a brush with cancer had altered her perspective—and the wedding would alter his.

For the workaholic scientist, dealing with lawyers and endless corporate maneuvering had taken its toll. Feeling defeated, MacLachlan quit Tekmira in 2014. He sold his stock in the company, purchased a used Winnebago Adventurer for $60,000 and set off with his new wife, two kids and their dog for a 5,200-mile road trip across Canada.

“I was exhausted and demoralized,” he says. With MacLachlan gone, CEO Murray renamed Tekmira, calling it Arbutus BioPharma, and decided the company should focus on creating hepatitis B treatments with New York drug development company Roivant Sciences. Yet he held on to the patents for the four-lipid drug delivery system.

Then Madden’s company, Acuitas, sublicensed the delivery technology to Moderna for the development of an mRNA flu vaccine. Murray was confident Madden had no right to do so, and in 2016 he gave notice that he intended to terminate Acuitas’ licensing agreement. Per custom, two months later, Acuitas sued in Vancouver, denying that it had violated any deal. On cue, Murray countersued, initiating a fresh round of legal combat. Importantly, though, this batch of lawsuits directly involved mRNA.

After battling for two more years, the parties settled. Murray terminated Thomas Madden’s license to MacLachlan’s delivery technology for any future medicines other than four products Moderna had already begun to develop (Murray also lost the rights to some of Madden’s technology). Murray and Roivant then created another company, Genevant Sciences, specifically to house the intellectual property related to the four-lipid delivery system and commercialize it.

Some companies were quick to come on board. Within a few months BioNTech CEO Şahin struck a deal with Genevant to use the delivery system for five of BioNTech’s existing mRNA cancer programs. The companies also agreed to work together on five other mRNA programs targeting rare diseases. There was no provision in the agreement about using the delivery technology for something completely unforeseen—something like Covid-19.

Moderna pursued a different strategy. It filed lawsuits with the U.S. Patent and Trademark Office seeking to nullify a series of patents related to MacLachlan’s delivery system, now controlled by Genevant. But in July 2020, as Moderna was pushing its vaccine through clinical trials, an adjudicative body largely upheld the most important patent claims. (Moderna is appealing.)

After the Moderna and Pfizer-BioNTech vaccines were authorized, Drew Weissman, a prominent mRNA researcher at the University of Pennsylvania, concluded in a peer-reviewed journal that both use delivery systems that are “similar to the Alnylam Onpattro product” but with a proprietary version of one of the lipids. Weissman noted both companies were using T-junction mixing.

Thomas Madden worked on the Pfizer-BioNTech vaccine delivery system and says he used enhanced versions of two of the four kinds of lipids. Madden says neither Onpattro nor the Pfizer-BioNTech vaccine would have been green-lighted by the FDA without his team’s improvements to the lipids.

MacLachlan dismisses the new variations as “iterative innovation.”

In a written statement to Forbes, Ray Jordan, Moderna’s corporate affairs chief, stated, “I can confirm that we did take a license to Tekmira’s IP for certain of our older products. But our newer products (including the Covid vaccine) have moved on with new technology.”

BioNTech declined to comment. Mikael Dolsten, Pfizer’s chief scientific officer, says the Pfizer-BioNTech vaccine is fully covered by patents and that in creating the first authorized mRNA product, Pfizer modified the delivery system to produce 3 billion doses annually.

“It’s different to have a process that may work for a very small scale than a large scale, and some of the assumptions that may look similar are based on how the scientific field evolved and [on] contributions from many different sources,” Dolsten says. “One needs to be careful in assuming that [if] things have similar names and similar molar ratios, it means it’s the same thing.”

Genevant declined to comment, but it could be fighting an uphill battle. In May, the Biden Administration backed waiving intellectual property protection on Covid-19 vaccines. Ironically, such a move might benefit, not hurt, Moderna, BioNTech and Pfizer by preventing Genevant from making any claims on their gigantic vaccine cash pile.

That’s just as well for Ian MacLachlan, whose role in what may be the most important medical advance in a century has been all but erased by the biotech industry.

“I definitely feel I made a contribution,” he says. “I have mixed feelings because of the way it’s being characterized, and I know the genesis of the technology.”

Send me a secure tip.

U.S. Set To Recommend Booster Covid-19 Vaccine Dose For Most People, Reports Say

U.S health officials are expected to recommend Covid-19 vaccine booster doses for Americans across all eligible age groups eight months after they received their second vaccine dose, to ensure lasting protection against the coronavirus as the more infectious delta variant spreads across the country partially blunting the efficacy of existing vaccine regimens.

According to the Associated Press, health officials could announce the booster recommendation as soon as this week, just a few days after an additional vaccine dose was recommended for people with weakened immune systems.

The Biden administration could then begin rolling out the third shots as early as mid-to-late September, the New York Times reported, citing unnamed officials.

The first booster shots will likely be administered to nursing home residents, health care workers and elderly Americans who were among the first people in the country to be inoculated.

The Associated Press notes that the formal deployment of the booster doses can only take place after the vaccines have been fully approved by the Food and Drug Administration—an action that is expected for the Pfizer jab in the next few weeks.

The Food and Drug Administration is expected to fully approve the Pfizer vaccine in the coming weeks which will formally open the door for it to be offered as a booster to millions of Americans who have already received two vaccine doses.

Big Number

59.4%. That’s the percentage of the eligible U.S. popuplation (12 years of age and older) that has been fully vaccinated against Covid-19, with 70% receiving at least one dose, according to the CDC’s tracker.

Surprising Fact

An estimated 1.1 million people have already received an unauthorized booster dose of the Moderna or Pfizer vaccine, ABC News reported last week, citing an internal CDC document reviewed by the broadcaster. The number is likely an undercount as it only accounts for people who received a third dose of an mRNA vaccine but does not count those who may have received a dose of the one-shot Johnson & Johnson vaccine and then received a second dose of either the Moderna or Pfizer vaccines.

Key Background

Last week, the U.S. Food and Drug Administration approved a booster dose of the Covid-19 vaccines made by Pfizer and Moderna for people with compromised immune systems. The targeted move was aimed at providing better protection for people who have undergone solid organ transplants or those diagnosed with conditions that are considered to be immunocompromised.

Unlike the eight-month gap being proposed for booster doses for the general population, immunocompromised patients can receive their third dose as early as 28 days after their second shot. The FDA’s decision followed similar moves undertaken by Israel, France and Germany who began administering an additional dose to vulnerable populations amid the threat of the more infectious delta variant of the virus.

Contra

As the more infectious delta variant of the coronavirus takes hold across the U.S. questions about the effectiveness or even the necessity of a booster dose remain unanswered. While some vaccines are slightly less effective against the variant, it is still unclear if protection against more severe disease and hospitalizations have been impacted significantly as well.

This makes any decision to authorize booster doses remains a controversial one in the global context as critics decry the fact that developed nations are administering an additional dose at a time when several poorer nations have limited access to vaccines. Earlier this month, the World Health Organization (WHO) called for a moratorium on Covid-19 vaccine booster shots until at least the end of September.

Further Reading

U.S. to Advise Boosters for Most Americans 8 Months After Vaccination (New York Times)

US to recommend COVID vaccine boosters at 8 months (Associated Press)

More Than 1 Million Have Received Unauthorized Third Dose (WebMD)

FDA Authorizes Extra Covid-19 Vaccine Dose For Those With Weakened Immune Systems (Forbes)

How Good Are Covid-19 Vaccines At Protecting Against The Delta Variant? (Forbes)

I am a Breaking News Reporter at Forbes, with a focus on covering important tech policy and business news. Graduated from Columbia University with an MA in Business and Economics Journalism in 2019. Worked as a journalist in New Delhi, India from 2014 to 2018. Have a news tip? DMs are open on Twitter @SiladityaRay or drop me an email at siladitya@protonmail.com.

Source: U.S. Set To Recommend Booster Covid-19 Vaccine Dose For Most People, Reports Say

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3 Critical Metrics You Need to Assess the Overall Health of Your Workplace

Early on in the summer, no one would fault you for exuberantly plotting your back-to-the-office plan. Hospitalizations for Covid-19 were waning and it suddenly seemed like life was once again approaching normal. However, with the more contagious Delta variant now spreading across the U.S., you’ll want to assess the potential health risks of opening up the office.

Here are a few questions you should ask yourself before bring employees back:

How safe is your physical workspace?

Your office or physical space may have been suitable for work prior to the pandemic, but that doesn’t mean it will be moving forward. One major example is air quality.

Business owners need to focus on having enhanced ventilation and filtration, says Dr. Joseph Allen, director of the Healthy Buildings program and an associate professor at Harvard’s T.H. Chan School of Public Health. Breathing and talking constantly admit respiratory aerosols that can build up indoors unless diluted out of the air or cleaned out of the air through filtration. And most buildings are designed to a minimum standard that was never intended to be protection against infectious diseases.

Before fixing anything, though, you have to know what your system is doing. Dr. Allen recommends every company “commission” their building, a process by which the heating, ventilation, and air conditioning (HVAC) systems of a building are tested for performance and functionality. “It’s the equivalent of giving your car a tune-up every year, and it’s not done enough,” Dr. Allen says.

There are also many ways to measure and verify the performance of your building, he adds. You can hire a mechanical engineer to determine how much air flow you’re getting. Low-cost real-time sensors can be used to verify ventilation rates. In a typical building, carbon dioxide concentrations are going to be about 1,000 parts per million, and ideally to slow the rate of infection levels, they should be under 800 parts per million.

And fixes don’t have to be laborious or expensive. Bringing a bit more outdoor air in can be as easy as opening windows or spending a couple of dollars to upgrade to quality air filters such as MERV 13 filters. Portable air filters are a bit more expensive at roughly $100 a piece, but they can greatly improve air quality.

How many employees are vaccinated?

You can absolutely ask employees whether they’re vaccinated, and if you’re bringing people back, or considering doing so, it’s not a bad idea. Northwell Health has done numerous surveys to assess their 15,000-person workforce to determine who is vaccinated and the reasons why those who have not gotten the vaccine are hesitant.

“When we started evaluating metrics around why people weren’t getting vaccinated, we got better insight into how to communicate with them and manage our concern,” says Joseph Moscola, executive vice president of enterprise services at Northwell Health.

One survey revealed that 7 percent of Northwell’s workforce didn’t get vaccinated because they were scared of needles. So the company crafted safe environments with music and comfortable chairs to help make the experience more inviting for those employees. Moscola says Northwell is aiming for a vaccination rate of 90 percent or higher before it considers its space safe. Currently 77 percent of Northwell’s 75,000 employees are fully vaccinated.

Also remind people of the risks of not getting a jab. While a vaccinated individual may still get Covid, they’re significantly less likely to have severe symptoms or be at risk of hospitalization than unvaccinated folks. That’s why it’s crucial to continue to encourage workers with any symptoms to stay home and get tested, as well as follow CDC and Occupational Safety and Health Administration (OSHA) directives in the workplace. It’s also crucial to educate employees and your community on the advantages of vaccination.

Are employees are taking care of themselves?

One way to stay abreast of the physical health of employees is to check in and see if they’re taking care of themselves. This can be done through surveys, asking people if they describe themselves as healthy and well and also how often they take advantage of any medical benefits.

Self-insured employers also have access to claims data through their third-party administrator that can share general information like what percentage of employees had a primary care visit in the past 12 months, or what percentage of people have been seriously hospitalized, says Dr. Shantanu Nundy, chief medical officer at Accolade, a benefit provider for health care workers.

Consider also assessing how employees are doing mentally, he adds. You can ask employees to take surveys such as the Maslach Burnout Inventory, a psychological assessment comprising 22 symptom items pertaining to occupational burnout; the PHQ-9, a nine-question questionnaire measuring depression; and the GAD seven, a seven-item questionnaire measuring anxiety. Employees may not feel comfortable sharing this information, so it’s best to make it optional and tell employees that results are kept confidential.

Want some more information and tips?

Find more information on what you can do as an organization, manager or employee:

“While a lot of people are dealing with clinical depression or clinical anxiety, many are dealing with a new kind of emotional stress due to the pandemic, which can include not feeling safe or heard or included in the workplace,” says Dr. Nundy. “These surveys can offer a comprehensive clinical health and environmental view of how your workforce is doing.”

Source: 3 Critical Metrics You Need to Assess the Overall Health of Your Workplace | Inc.com

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More Contents:

Health & Safety Executive (HSE)

Safer Highways launched the first industry benchmarking exercise

HSE’s annual statistics on work-related stress, depression and anxiety

Study of Mental Health First Aid (MHFA) England training in UK workplaces

Your legal rights and responsibilities to reduce stress or risk factors

How comfortable are you with discussing your employees’ mental health?;

Creating a mentally healthy workplace: A guide for managers (PDF)

]Why you should offer mental health support to employees with physical conditions;

How managers can shape ‘healthy hybrid’ working

How to manage severe mental health problems;

Mental health: the costs to employees and businesses.

‘It’s okay not to be okay,’ in conversation with The Mental Health Runner

Developing a workplace mental health strategy: A how-to guide for organisations (PDF)

My experience of workplace stress, in an organization that didn’t see occupational stress as an issue: In conversation with Kate Field

‘We cannot underestimate the impact that the pandemic has had on the nation’s mental health’

Work-related psychological health and safety: A systematic approach to meeting your duties

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