Monthly Archives: January 2021

I replied, Well, they showed that individuals who received the active vaccine injection were much less likely to get the infection than those who got a placebo or dummy injection without active vaccine.

She listened intently with a slightly worried expression.

But to make the study completely objective, it was double-blind, I said.

Whats that? she asked.

Double-blind means that both sides are blind or not given information about who got the real vaccine or placebo, I replied. Not the clinical team with the doctor, nurse, and other research staff on one side, and the patient and family and friends on the other side. No one directly involved with the patient in the study is allowed to know.

Her reaction was spontaneous and swift: But thats against human nature! How can we prevented from knowing if we are getting the real vaccine?

As a researcher, I have conducted many clinical trials with patients who express concern about the possibility of receiving a placebo, or find it hard to comprehend the restrictive rules of a double-blind design. These are counterintuitive methods, though required by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other agencies worldwide. They are intended to increase objectivity because there is ample evidence that a positive bias naturally occurs in most patients and clinicians involved in a study.They expect the vaccine to be safe and effective, and their expectation often has a healing power of its own.

A long history confirms the need for research objectivity. Until the 18th century, average human longevity ranged from 30 to 50 years; it barely budged despite the thousands of new therapies pursued across the world, some based on ancient texts from a variety of cultures. But scientific proof was gradually replacing beliefs. Revolutionary advances like the discovery of antibiotics in the mid-20th century transformed human survival. Experimental methods to improve the accuracy of research findings, including the objective methods used routinely nowadays in clinical studies, were codified by scientists in the 20th century. During the last 2 centuries, the average human lifespan nearly doubledto over 75 years. The FDA adopted scientific methods by requiring that research studies in humans be conducted in phases. Phase 1 involves small-scale studies to determine safety, and at different doses, phase 2 involves mid-sized, double-blind studies with a placebo group to obtain initial information on efficacy and safety of the optimal doses identified in phase 1, and phase 3 requires large-scale, double-blind clinical trials with placebo built upon results from phases 1 and 2. If phase 3 results are positive, with sufficient safety and efficacy, the vaccine or drug is approved. But the work is not done. Phase 4 then begins with post-approval monitoring of side and adverse effects in those receiving the approved treatment or vaccine in standard clinical care.

Why are there so many hurdles to cross before approval, and more afterwards? Less than 1 in every 100 potential treatments makes it all the way from the basic science laboratory through clinical trials and finally regulatory approval for patient care. In other words, if we did not have the current regulatory system, tens of thousands of new vaccines, drugs and medical devices would be used widely, despite over 99% of them not meeting necessary standards of safety and efficacy. That would be like throwing us back to the healthcare standards of medieval and even earlier times.

My experience during the early days of the COVID-19 pandemic highlights the struggle to balance scientific knowledge with private beliefs and intrinsic daily habits. In late February 2020, I acquired N-95 masks and face-shields from our hospitals central supply and instructed all my clinical research staff to wear the mask and face-shield when seeing patients. In March 2020, just before the lockdown, we saw our last outpatient, who subsequently was hospitalized a few days later with COVID-19. I did not become ill but a few of my research staff members did, fortunately only with moderate symptoms that resolved in several weeks. Judging by when they became ill, they probably got the infection from that patient. When I asked, they told me that they had not worn the mask and face-shield continuously, as I had instructed. These team members routinely follow my instructions in carrying out their daily work but wearing a mask and face-shield went against their usual habits and beliefs.

If this was happening in a healthcare setting, the problems that we have seen with the publics response to the pandemic should not come as a surprise. To ensure a robust pandemic response in 2021, we all will need to better understand why so many people do not act in their own interest, and that of others. Public education about the science and the studies that produced FDA approval is essential, as is modeling by trustworthy, influential and diverse people doing the right thing.

But will that be enough? What do we need to know about those individuals (and groups) who demonstrate vaccine hesitancy, as has been abundant in refusals of flu and even measles vaccinations? The beliefs that underlie vaccine hesitancy may seem counter-intuitive, but they are prevalent and constitute a danger to that individuals health and to that of others. These actions may seem to go against the self-protective and social compact in human nature, except that it is other aspects of human nature, instinctive fear of the new and unknown as well as entrenched beliefs and habits, that are driving them. Let us hope it does not take centuries to understand what is going on and what works to alter vaccine hesitancy. We do not have the time for that.

Dr Devanand is professor of Psychiatry and Neurology and Director of Geriatric Psychiatry, Columbia University Irving Medical Center.

Read more here:
Vaccines at the Dinner Table - Psychiatric Times

Go up a gear with jogs and bike rides

When you feel fitter, make some of this daily activity a more moderate intensity, such as a spin on an indoor bike, some fast-paced walking or a light jog. Moderate-level cardio should be done three days a week, says Roberts. The level should feel like a seven out of 10 intensity. You should be able to have a conversation but should also be raising a sweat.

This helps fortify the heart and control your blood pressure and blood glucose levels. We need to be more active than we think, says Roberts.

To really fine-tune your heart and lungs, and trigger cellular regeneration as you age, you need high-intensity exercise, too. We are designed to be challenged and we adapt fast, says Roberts. If we are not pushed, cellular redevelopment starts to slow.

Roberts recommends two to three high-intensity sessions per week. For those getting back into shape, a body weight circuit, or sprints on an indoor bike or rowing machine, are all good options. But if you are feeling fitter, try some sprint intervals outdoors, or a sweaty home cardio circuit with med ball throws and kettlebell swings.

Muscle mass and bone health decline with age, making you vulnerable to injuries and impairments, but there is a way to fight back. Weight training helps retain muscle mass and supports nerve function and bone density, explains Roberts. By increasing the resistance pressure, or the overload, we also increase our central nervous stimulation response which helps with our hormone production levels. This in turn helps to regenerate tissue cells, muscles, tendons, ligaments, hair and skin.

Roberts suggests doing resistance training twice a week. Start with simple exercises, such as squats, lunges and press-ups, for three to sixweeks, then build up to heavier weights, with 6-8 reps per lift. If you dont have dumbbells at home, you can try the smart body weight techniques Roberts is now using on Zoom workouts with his clients. The key is to keep it varied, he explains. You can build in pauses, holds, different ranges of motion and different speeds to work your muscle fibres. With a simple squat, for example, you might hold the position midway through, so you're building tension in the quads and inner thighs. This is called a static contraction and is used in rehab to create strength quickly. Just using a chair to do a step up, and changing the speed of that step up, by moving up slowly for 2 seconds, and down slowly for 3 seconds, is another good example.

Sitting on an indoor bike will build your fitness, yes, but playing a racket sport or team sport when were allowed to will also protect your grey matter. Find sports that encourage you to think, advises Roberts. Tennis is very analytical. Youre always working out a strategy, which is good for your synapses and your nerve endings. When you have to react quickly, it involves a vast amount of electronic responses in your brain, which is anti-ageing.

A strong core will protect your posture and flexibility as you age. As we get older, we get more joint issues and back pain which stops us doing things and leads to inactivity, explains Roberts. Thats why he suggests doing 10-15 minutes of mobility and activation exercises before each workout. Planks, V-sits and glute bridges work well, but yoga poses like the downward dog or child pose are also good for mobility.

This kind of supplementary work can also help to prevent more serious injuries as you age. If you lose your stability in your back, shoulders and hips, your chances of falling go up enormously, says Roberts. Even if you hurt your ankle or knee, your level of activity gets reduced and thats when people gain weight. So keep up a good mobility programme, whether it is through Pilates or foam roller work, so you keep feeling agile and young.

The moment we stop moving properly, the older we feel.

Read more:Matt Roberts: My body fat and fitness levels are the same at 46 as they were at 20

Read more:A health test said my biological age is 41, but Im only 30

Read more:
Matt Roberts: the exercise regime that will help you stay younger for longer - Telegraph.co.uk

MOUNTAIN VIEW, Calif., Jan. 12, 2021 /PRNewswire/ --Turn Biotechnologies, a company developing medicines for currently untreatable age-related conditions, announced that it has acquired the global rights for new technology that reprograms cells to undo many of the effects of aging.

The company licensed its epigenetic reprogramming of age (ERA) technology from Stanford University, where it was developed by three researchers who founded Turn. It is the first technology to maintain cellular identity while restoring specific cells' youthful functionality, to trigger the body's ability to fight age-related diseases.

The company announced that it has also filed for patents to protect its technology in major-market nations on six continents.

"ERA technology is an extremely powerful platform and can be used to treat a variety of diseases throughout the body," said Anja Krammer, Turn CEO. "The steps we have taken ensure that the fruits of our research can benefit millions of people around the world."

A study published last March in the journal "Nature Communications" highlighted the promise of Turn's ERA technology to treat age-related health conditions. The study found that old human cells can be induced into a more youthful and vigorous state when they are exposed to a rejuvenating treatment that triggers the limited expression of a group of proteins known as Yamanaka or transcription factors, which are important to embryonic development.

ERA uses messenger RNA (mRNA) to deliver these transcription factors to the cells' epigenome, which controls cellular activity. As the epigenome ages, it prevents a cell from functioning optimally. The transcription factors which can be delivered in a variety of combinations to target different cells effectively revitalize the epigenome, restoring the cells' ability to behave more youthfully.

"The ability to precisely control a cell's rejuvenation means we will be able to turn back the clock on cellular vitality, effectively restoring cells' ability to heal or regenerate damaged tissue," said Jay Sarkar, Turn's chief technology officer and a company founder who helped to develop the ERA technology. "Our research offers promise to people suffering from age-related diseases for which there are currently no cures."

Turn's technology uses mRNA to produce instructions that induce cells to treat or prevent disease. Messenger RNA made possible the speedy development of two recently announced COVID-19 vaccines. An advantage of mRNA is that it is safe because it never enters the cell nucleus where DNA is kept and the cell effectively gets rid of the mRNA after it has used the instructions carried by it.

Just as it led to the lightning-fast development of COVID-19 vaccines, use of mRNA promises to revolutionize the development of therapeutics by making that development safer, faster, more efficient and extremely tunable to patient need.

Turn is currently completing pre-clinical research on tailored therapies targeting indications in dermatology, osteo-arthritis and cartilage damage, ophthalmology and musculature.

ABOUT TURN BIOTECHNOLOGIES

Turn is a pre-clinical-stage company focused on repairing tissue at the cellular level. Our proprietary mRNA technology combats the effects of aging in the epigenome, thus restoring optimal gene expression and enabling cells to function as vigorously as when they were younger. Our technology provides a platform from which to attack a variety of diseases related to age. The company has the financial backing of Methuselah Fund, which focuses its investments to extend the healthy human lifespan; Formic Ventures, which invests in biotech start-ups focused on human longevity; and Shanda Group, a private global investment firm. For more information, see http://www.turn.bio.

FOR MORE INFORMATION, CONTACT:Jim Martinez, rightstorygroup[emailprotected] or (312) 543-9026

SOURCE Turn Biotechnologies

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Turn Biotechnologies Licenses Revolutionary Technology to Unwind the Effects of Aging at a Cellular Level - PRNewswire

SAN DIEGO (KUSI) An analysis of a national study by UC San Diego researchers published Monday found starting tobacco products, including e- cigarettes, before the age of 18 is a major risk factor for people becoming daily cigarette smokers.

In the report, published in Mondays online edition of Pediatrics, Herbert Wertheim School of Public Health and Human Longevity Science researchers found in 2014 people ages 12 to 24 using e-cigarettes were three times as likely to become daily cigarette smokers in the future.

Among those who reported using a tobacco product, daily use increased with age through age 28. Daily cigarette smoking nearly doubled among 18 to 21 year olds and 25 to 28 year olds from 12% to 21%.

This is the first paper that actually looks at progression to dependent cigarette smoking among young adults, saidthe studys first author, John Pierce, professor emeritus at the Herbert Wertheim school and UCSD Moores Cancer Center.

In these data, e-cigarettes are a gateway for those who become daily cigarette smokers. The start product has changed from cigarettes to e- cigarettes, but the end product has stayed the same. When users become dependent on nicotine, they are converting to cigarette smoking, Pierce said.

Researchers used data from the Population Assessment of Tobacco and Health Study, a study of tobacco use and its effect on the health of people in the United States. The PATH Study enrolled a nationally representative sample of 12 to 24 year olds between 2013 and 2014 and re-interviewed them annually for four years to explore progression to daily use among experimenters of 12 tobacco products.

In the first year, 45% of study participants reported using at least one tobacco product in their lifetime. By the fourth year, as participants aged, 62% reported some tobacco experimentation.

Among those who have experimented with tobacco, 73% had tried cigarettes and 72% had tried e-cigarettes. More than half tried hookahs and cigarillos. Traditional cigars, filtered cigars, smokeless products, pipes and snuffs were each tried by more than 10% of study participants.

The analyses revealed that, by year four, 12 % of participants were using tobacco products daily half of whom became daily users after the first year. Of daily users, 70% smoked cigarettes and 63% used cigarettes exclusively. Of those who smoked cigarettes and used another tobacco product, half vaped e-cigarettes on a non-daily basis.

Among the 17% of daily users who were vaping every day, almost half were also non-daily cigarette smokers. Further follow-up will determine whether these young daily tobacco users continue to use both products or whether they settle on a single product, Pierce said.

What were seeing is that the proportion who are daily e-cigarette users did not increase with age. Whereas with cigarettes the number of users jumps up rapidly with age, said Pierce. This rapid increase with age only occurred with cigarettes, not with any other tobacco products.

Less than 1% of study participants who experimented with just one tobacco product progressed to daily cigarette smoking. People who had tried five or more products increased their risk of becoming daily cigarette smokers by 15 percentage points.

Trying e-cigarettes and multiple other tobacco products before the age of 18 is also strongly associated with becoming daily cigarette smokers, said senior author Karen Messer, professor at the Herbert Wertheim School and director of biostatics at Moores Cancer Center.

We know that e-cigarette use among high school seniors, most under the age of 18, increased from 38% in 2016 to 45% in 2019. These results suggest that recent rapid growth in adolescent e-cigarette use will lead to increased daily cigarette smoking among young adults in the United States, reversing decades of decline in cigarette smoking, she said.

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UCSD report finds youth using e-cigs three times as likely to be daily smokers - - KUSI