The Truth About COVID-19 ‘Long-Haulers’

The Truth About COVID-19 ‘Long-Haulers’

You may have seen reports about COVID-19 patients who seem unable to fully recover. Some complain of lingering chronic fatigue symptoms. Others struggle with mental health problems.

In fact, a study1,2 from Oxford University published online November 9, 2020, in The Lancet Psychiatry, found 18.1% of individuals diagnosed with COVID-19 also received a first-time psychiatric diagnosis in the 14 to 90 days afterward. Most common were anxiety disorders, insomnia and dementia. A similar trend was also observable after COVID-19 relapses.

Interestingly, people with pre-existing mental illness were also found to be 65% more likely to be diagnosed with COVID-19 than those who did not have a pre-existing psychiatric problem.

Now, while this may sound terrifying, I would point out that, given the fearmongering surrounding COVID-19, it’s not surprising that receiving a diagnosis would trigger anxiety and insomnia in many. It doesn’t mean you end up with a chronic psychiatric disorder. It just tells us that getting a COVID-19 diagnosis is very stressful, even if you remain asymptomatic.

The link to dementia is interesting, however, and likely needs to be looked into further. This also applies to the higher risk of COVID-19 if you have a pre-existing mental health problem. It’s possible that people struggling with depression, anxiety and similar disorders are simply more likely to get tested for COVID-19 –; and end up receiving false positive diagnoses.

As discussed in “Asymptomatic ‘Casedemic’ Is a Perpetuation of Needless Fear,” mass testing of asymptomatic people doesn’t tell us anything of value since the test cannot discern between an active infection and the presence of nonreproductive (harmless) virus. It only makes the pandemic appear graver than it is.

That said, going through a severe bout of COVID-19 is also going to take a mental toll. As reported3 by a 40-year-old previously healthy man who underwent an apparent recurrence of COVID-19, after three weeks of fatigue, he started feeling “completely overwhelmed” and for the next 72 hours, he “felt unwell in a way that was bordering on not coping.”

He says he “felt physically exhausted” and “mentally drained.” Severe illness will do that. He says it took him nearly eight weeks before he started feeling “close to my normal self again,” but even then, he still struggled with “fatigue to the point of having to sleep in the day” and an inability to exercise.

COVID-19 ‘Long-Haulers’

He’s not alone in reporting such symptoms. An estimated 10% of patients treated for COVID-19 report fatigue, breathlessness, brain fog and/or chronic pain for three weeks or longer.4 This phenomenon occurs even among patients who had mild cases of COVID-19.

U.S. Centers for Disease Control and Prevention data5 show the rate of COVID-19 patients who continue experiencing lingering health problems after recovering from acute COVID-19 may be as high as 45%. Only 65% report having returned to their previous level of health within 14 to 21 days after receiving a positive test result.

Many of these “long COVID” patients do spontaneously recover –; albeit slowly –; with holistic support, rest, symptomatic treatment and gradual increase in activity.

The flowchart6 below, published in the European Respiratory Journal, is a tool you can use to measure your functional status over time after recovery from COVID-19.

post COVID-19 Functional Status

>>>>> Click Here <<<<<

Treatment Guidance for Post-Acute COVID-19

The good news is that, according to an August 11, 2020, article in The BMJ,7 which provides post-acute COVID-19 primary care guidance, many of these “long COVID” patients do spontaneously recover –; albeit slowly –; “with holistic support, rest, symptomatic treatment and gradual increase in activity.” To support recovery, the article suggests that:8

“…; patients should be managed pragmatically and symptomatically with an emphasis on holistic support while avoiding over-investigation. Fever, for example, may be treated symptomatically with paracetamol or non-steroidal anti-inflammatory drugs.

Monitoring functional status in post-acute COVID-19 patients is not yet an exact science. A post-COVID-19 functional status scale has been developed pragmatically but not formally validated9 …;

Referral to a specialist rehabilitation service does not seem to be needed for most patients, who can expect a gradual, if sometimes protracted, improvement in energy levels and breathlessness, aided by careful pacing, prioritization, and modest goal setting.

In our experience, most but not all patients who were not admitted to hospital recover well with four to six weeks of light aerobic exercise (such as walking or Pilates), gradually increasing in intensity as tolerated. Those returning to employment may need support to negotiate a phased return.”

The following graphic from that BMJ article10 provides a visual summary of the recommended assessment and management recommended for patients with lingering symptoms after recovering from acute COVID-19.

Long COVID in Primary Care

>>>>> Click Here <<<<<

Chronic Fatigue in the Limelight

As reported by Time magazine,11 that many COVID-19 patients report lingering fatigue, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has gained new attention. It seems many of these post-acute COVID-19 patients fit the diagnostic criteria for ME/CFS, which has been linked to viral infections.

For years, people with ME/CFS were disregarded as faking it. Many were told it was “all in their head.” The fact that COVID-19 patients are now reporting the same problem strengthens the theory that ME/CFS really is rooted in some sort of chronic infection.

“There is …; a critical mass of long-haulers getting sick and speaking out all at once, enough to draw attention from scientists, the media and the general public,” Time magazine writes.12

“Enough of these patients tested positive for COVID-19 or its antibodies to make a strong case that coronavirus is turning into ME/CFS …; The influx of new patients could go a long way toward figuring out why, exactly, a viral illness can last forever.

Though there are multiple theories in the ME/CFS research world, [Dr. Anthony] Komaroff [who treats ME/CFS at Brigham and Women’s Hospital in Boston] believes the cause of the condition can be traced back to a part of the brain that kicks on when you’re sick –; the part that saps your energy and appetite so your body can focus all its energy on clearing an infection.

‘This center in the brain gets flicked on, but for whatever reason it never gets switched off,’ Komaroff says. New research efforts spurred by the pandemic could help determine if that’s really happening, and why.”

In May 2020, Maryland Rep. Jamie Raskin introduced a bill13 to provide funding to study the connection between SARS-CoV-2 and ME/CFS. The bill, HR 7057 (The UCS ME/CFS Act) has not yet cleared the U.S. House of Representatives. It has no corresponding bill in the Senate. However, studies are already underway, and “COVID-19 longhaulers” can volunteer for them on the You + ME registry.14

A significant hurdle remains though: Few doctors are familiar enough with ME/CFS to treat these patients. If the pandemic results in a massive influx of ME/CFS patients, the medical system will be ill equipped to handle it and countless patients are bound to suffer without much hope. According to Time magazine:15

“[Dr. Ron] Tompkins [a surgeon from Massachusetts General Hospital who researches ME/CFS] adds that any progress for ME/CFS patients will hinge on doctors definitively determining that coronavirus can turn into ME/CFS, rather than making post-coronavirus syndrome a separate diagnosis.

‘It would be a disservice to make post-COVID something special,’ he says, because ME/CFS patients wouldn’t share the benefits. ‘I don’t think there’s a nickel of difference between the two,’ he adds.”

The Gut Connection

While conventional medicine has no cure to offer ME/CFS patients, there’s compelling evidence suggesting your gut health can play a significant role in this condition. Research published in 2017 linked both chronic fatigue and Parkinson’s to gut bacteria.

People with ME/CFS have distinctly different gut microbiomes than healthy controls,16 as determined by serial sequencing of bacterial RNA, and research17,18 has found 35% to 90% of ME/CFS patients “report abdominal discomfort consistent with irritable bowel syndrome.”

In related news,19 researchers have also discovered a link between COVID-19 and gut problems. A likely reason for this is because SARS-CoV-2 uses the ACE2 receptor to gain entry into the cell, and the greatest number of ACE2 receptors are found in the cells that line your gut.

According to one review,20 18.6% of COVID-19 patients had gastrointestinal symptoms such as diarrhea, nausea and vomiting. In another study,21 as many as 50.5% of COVID-19 patients admitted to the hospital had one or more digestive symptoms.

Abdominal pain is rare at just 1.9%,22 and theories of why COVID-19 would cause stomach pain include inflammation of the nerves in the gut23,24 and/or sudden loss of blood supply to abdominal organs resulting in tissue death.25

Incidentally, your gut microbiome is also known to influence your mental health, and has been linked to depression26 and anxiety,27 and a large portion of your immune system also resides in your gut.

All of these links between viral infection, gut problems, mental health issues, immune function and ME/CFS suggest restoring your gut health may be a crucial strategy if you come down with COVID-19.

How to Boost Your Gut Health

To optimize your gut microbiome, consider the following recommendations. Also keep an eye out for my interview with health scientist Rodney Dietert, which will be published shortly. In it, we discuss the connections between COVID-19 and gut health and review the importance of your gut for a well-functioning immune system.

; Avoid processed vegetable oils (polyunsaturated fats or PUFAs), as they promote inflammation, damage your endothelium (the cells lining your blood vessels) and your mitochondria, and lower your antioxidant defenses by stripping your liver of glutathione. For more details, see “The Case Against Processed Vegetable Oils.”

; Avoid processed foods and conventionally raised meats and other animal products as they are routinely fed low-dose antibiotics and genetically engineered feed grown with glyphosate, which is known to kill many beneficial bacteria.

; Increase your soluble and insoluble fiber intake. Short-chain fatty acids produced by bacteria that feed on plant fiber are major epigenetic communicators. In other words, they actually communicate with your DNA, thereby providing protection against a number of different diseases. If using a fiber supplement, make sure its unprocessed, such as organic whole husk psyllium. Processed supplement fiber does not provide gut bacteria with what they need.

; Avoid chlorinated and/or fluorinated water and antibacterial soap as all will kill off healthy bacteria.

; Eat plenty of traditionally fermented foods such as lassi, natto, fermented vegetables and fermented grass fed organic milk products like kefir and yogurt, and/or take a probiotic supplement. This is particularly important after a course of antibiotics.

Additional Advice for ME/CFS and ‘COVID-19 Long-Haulers’

In addition to addressing your gut health, there are many other strategies that can be helpful for ME/CFS, and yet others that appear extremely beneficial for the prevention and treatment of COVID-19 specifically. Important treatment strategies for ME/CFS include but are not limited to:

Exercising according to your ability, with a focus on increasing the amount of exercise you can handle. Gentle exercise such as yoga can also be an excellent part of your program, and yoga benefits your mind as well as your body.
Supplementing with nutrients important for cellular energy synthesis, such as ubiquinol, the reduced form of CoQ10, and D-ribose, a core building block of ATP.
Eating foods rich in glutathione precursors, sulfur and selenium to encourage glutathione production. Glutathione is one of your body’s most important antioxidants and a natural detoxification agent. Glutathione deficiency also appears to play a distinct role in COVID-19 and has been linked to increased severity.
Implementing a time-restricted eating schedule so that you’re eating all of your meals within a six- to eight-hour window. Also make sure your last meal is taken at least three hours before bedtime. The rationale for avoiding late night eating is directly tied to the way your body produces energy.
Addressing your mental outlook. I recommend trying the Emotional Freedom Techniques (EFT) to help normalize your bioenergetic circuitry. Emotionally traumatic events can leave “energy blockages” for many years, which then interfere with your overall health, including immune function. There are many different techniques that can be used, but EFT is my favorite, and it’s easy to learn and apply.

Lastly, recommendations that can be helpful to prevent and treat COVID-19, both in the short and long term include the following. Some of these also tie in with ME/CFS while other don’t:

; Improve your insulin sensitivity by adopting a diet high in healthy fats and low in processed carbs, implementing a time-restricted eating schedule and avoiding food for at least three hours before bed.

Research shows insulin resistance is a primary and independent risk factor for severe COVID-19, which makes sense when you consider it both increases inflammation and lowers immune function. You can learn more about all of this in “The Real Pandemic Is Insulin Resistance.”

Ketones –; produced when you eat a cyclical ketogenic diet and/or intermittently fast –; also appear to be very helpful against COVID-19, which adds further support for these lifestyle strategies.

; Supplement with:

◦ Lumbrokinase, an enzyme that helps combat blood clots (another symptom associated with more severe COVID-19) and breaks down biofilms associated with Lyme disease, an infection also linked to ME/CFS.

Quercetin and zinc. Like hydroxychloroquine, quercetin helps shuttle zinc into the cell, thereby stemming viral replication. COVID-19 patients with low zinc levels have a higher risk of poor outcome and death.28

Quercetin also boosts type 1 interferon, which signals infected cells to produce proteins that stop the virus from replicating. In addition, quercetin works synergistically with vitamin C, which is another powerful COVID-19 prophylactic.

◦ Vitamin D. More than 80% of COVID-19 patients are vitamin D deficient, and the evidence overwhelmingly supports the idea that raising your vitamin D level above 40 ng/mL can go a long way toward preventing SARS-CoV-2 infection, reducing severity, lowering the risk of death and improving outcomes overall.

; Use nebulized hydrogen peroxide. Nebulizing hydrogen peroxide into your sinuses, throat and lungs is a simple, straightforward way to augment your body’s natural expression of hydrogen peroxide to combat infections and can be used both prophylactically after known exposure to COVID-19 and as a treatment for mild, moderate and even severe illness.

Buy a desktop nebulizer and stock food-grade hydrogen peroxide and some saline. That way, you have everything you need and can begin treatment at home at the first signs of a respiratory infection. Keep in mind food grade hydrogen peroxide must be diluted down to a 0.1% dilution before use.

Read more: articles.mercola.com





An Owl Stowed Away On The Rockefeller Christmas Tree!

An Owl Stowed Away On The Rockefeller Christmas Tree!

An Owl Stowed Away On The Rockefeller Christmas Tree!

There was a stowaway on the Rockefeller Christmas Tree – a tiny owl!

The Saw-wheat owl was found in the branches of the tree by the staff as it was delivered to the Big Apple this week, and he’s now recuperating from his big trip at the Ravensbeard Wildlife Center.

The bird, apparently, couldn’t part with his favorite tree and took the trip all the way down to New York City, which was 170 miles away from home in Oneonta, New York.

“We”;ve given him fluids and are feeding him all the mice he will eat,” the center posted on Facebook, as they shared the cute story with their followers. “It had been three days since he ate or drank anything.”

The center added that the owl is doing good so far: “His eyes are bright and seems relatively in good condition with all he”;s been through. Once he checks in with the vet and gets a clean bill of health, he”;ll be released to continue on his wild and wonderful journey.”

The Rockefeller Christmas Tree got a lot of sideways looks this year, as it lost a branch or two in transport and many online have been comparing it to the tree seen in It’s Christmas, Charlie Brown!

The tree will be decorated and make its debut on December 1.

New York City is gearing up for the holiday festivities, starting with the Macy’s Thanksgiving Day Parade.

Find out who’s performing and how it’s being pulled off in the era of coronavirus…

Read more: justjared.com

Ask a Health Coach: How to Stop the Cycle of Overdoing It

Ask a Health Coach: How to Stop the Cycle of Overdoing It

busy mom cooking holding childHi folks, in this edition of Ask a Health Coach, Erin helps out her fellow over-doers with strategies for managing the hustle mentality, overthinking calories, and enjoying the holidays guilt free. Got questions? Share them in the comments or in our MDA Facebook Group.

Cassie asked:

“;I always burn the candle at both ends making sure everyone is happy this time of year, but I can already tell I”;m burning myself out. How do I get through the holidays without needing a vacation afterward?

Overdoing it is kind of my specialty. At least it has been in the past, so I totally get where you”;re coming from. If you”;re like me, you have a long history of being highly productive –; and wearing a huge badge of honor about it. The more hustle, the better. The less rest, the better. Even to the point of total burn out.

You might also be a bit of a people pleaser, which, by definition, suggests that you”;ve got a deep emotional need to please others at the expense of your own needs.1 For many of my clients, the eagerness to please ties into their self-worth and the need for approval and external validation. And it always gets put to the test around the holidays. By ensuring that everyone”;s dietary preferences are met at dinner or getting the decorations “;just right,”; they feel more worthy, likeable, and accepted.

Keep in mind that people pleasing isn”;t the same as being a good host.

To others, it probably just looks like you”;re being really gracious and accommodating –; and I have no doubt in my mind that you are. But being helpful at the expense of your own health and happiness isn”;t a good trade off if you ask me https://guilfordjournals.com/doi/abs/10.1521/jscp.2012.31.2.169.

If you”;ve always felt compelled to put everyone else”;s needs before your own, it”;s hard to imagine it being different, since people-pleasing isn”;t just what you do, it”;s a big part of who you think you are.

Here”;s the good news though. The fact that you”;re aware you”;re doing these things is a sign you”;re open to change. So, here are a few strategies you can start putting into practice right away:

1. Understand what you are and aren”;t responsible for. If you”;re hosting, providing food and conversation is likely in your responsibility wheelhouse; however, taking on the burden of ensuring your guests are happy every second of their visit isn”;t.

2. Determine your boundaries and be assertive about them. Are you really okay with making four kinds of potatoes or having people stay later than you wanted? Get clear on your boundaries and practice sticking to them. And remember, asserting yourself can be scary at first, but it”;s worth it in the long run.

3. Know that everything will work out fine. If 2020 has taught us anything, it”;s that the world is a crazy, unpredictable place and no amount of planning and people-pleasing can possibly ensure a perfect outcome.

I think that you”;ll find when you free yourself from the rigidity of hardcore hustling and people pleasing, you”;ll begin to experience your own state of flow. Heck, you might even enjoy the holidays this year.

Jason asked:

“;I want to enjoy the holidays without feeling guilty about it. I”;m sick of everyone posting healthy versions of desserts and drinks. Can I not just have the real thing without being shamed?”;

I have a hunch you”;re overthinking this a little. Yes, you absolutely can eat whatever you want. Who”;s stopping you? There”;s no keto police. And no one”;s going to pull your paleo card if you indulge in some pecan pie and eggnog.

Eat it whatever you want, I don”;t care. The problem is, I think you care. Maybe you care what other people think.2 Or you care how it will affect your goals.

I”;m not here to tell you to eat a whole sheet of sugar cookies or not, I”;m just here to help you have a more effortless relationship with food. One where you have a solid understanding of how certain foods work or don”;t work in your body. That way you”;re free to make choices that support you –; or don”;t support you. Which is totally okay too, as long as you”;re clear on the consequences, which might be anything from feeling sluggish and foggy to having pants that don”;t fit.

It”;s always your call.

That said, if someone is shaming you for your choices, that”;s a totally different topic.3 Food has become so controversial and everyone loves to point a finger at anyone who”;s got a different health ideology than they do.

Here”;s a note to all you shamers: if you”;ve decided to eat more plants, more meat, less sugar, less carbs zero carbs, or all the carbs, remember that everyone is different, and your beliefs don”;t need to be smeared all over someone else”;s. Ok, rant over.

If you”;re metabolically flexible, treating yourself to a few “;real”; goodies won”;t be a huge deal. As you go through the holidays, keep the 80/20 framework for the Primal lifestyle in mind. While it isn”;t meant to support cheat days, it is about navigating real life.

Cheri asked:

“;I”;m thinking about adding in a few more workouts a week so I can indulge in holiday treats without derailing my progress. What are your go-to exercises for burning extra calories?”;

Diet culture has sure done something to us, hasn”;t it? Weighing, calorie counting, macros tracking, step tracking, making sure you”;ve torched more calories than you”;ve consumed…;it”;s just too much. And don”;t get me started on those calculators that tell you how many sit ups or jumping jacks or hours of cardio you need to do in order to burn off whatever it is that you ate.

I”;m fed up with contrived nutrition and fitness messaging. It keeps us stuck in the pattern of deprivation and all the ways we”;re not good enough –; or worse yet, how *good* we”;ll be when we reach a certain weight or pant size.4

So, no. I don”;t have any go-to calorie burners. And I certainly don”;t have any low-cal diet recipes. What I do have is advice on how to stoke your metabolism and how to stop caring about how you aesthetically show up in the world.

Sounds like a pretty great gift, right? Not caring? Not scheduling in extra workouts to accommodate the holidays? The diet mentality has been hard-wired into a lot of us and one of my goals as a health coach is to help people break free from it. And that starts with three key things:

1. Releasing judgement toward food. Food isn”;t good or bad, it just has consequences. If you have a few treats, you might experience a sugar crash followed by more cravings. If you eat a protein rich meal, you might not have to white knuckle it past the candy dish.

2. Learn to listen to your body. Try tuning in to what your body is telling you https://www.marksdailyapple.com/whats-messing-with-your-appetite-three-possibilities/. Learn to recognize your body”;s hunger and thirst cues and how to separate physical hunger from emotional needs like comfort and personal growth.

3. Check your stories and limiting beliefs. Think you”;re only lovable at a certain weight? Or that “;treating”; yourself is a bad thing? Pay attention to the stories you tell yourself and see if you can shift them into a more positive light.

Do you have a habit of overdoing it? Got more questions? Share in the comments below.

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References https://www.psychologytoday.com/us/blog/what-mentally-strong-people-dont-do/201708/10-signs-youre-people-pleaserhttps://www.psychologytoday.com/us/blog/sapient-nature/201603/how-not-worry-about-what-others-think-youhttps://www.diabetesfoodhub.org/articles/food-shaming-changing-the-way-we-think-and-talk-about-food.htmlhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5421368/

The post Ask a Health Coach: How to Stop the Cycle of Overdoing It appeared first on Mark's Daily Apple.


Read more: marksdailyapple.com

J Balvin Reveals He ‘Didn’t Want to Live’ Amid Struggle with Depression

J Balvin Reveals He ‘Didn’t Want to Live’ Amid Struggle with Depression

J Balvin Reveals He 'Didn't Want to Live' Amid Struggle with Depression

J Balvin is getting candid about his struggle with depression.

During a candid conversation with Becky G on her Amazon Music podcast En La Sala, the 25-year-old reggaeton singer admitted that there was one point in his life where he “didn’t want to live” anymore.

“I was just crying for no reason. Didn”;t want to wake up. Didn”;t want to eat, didn’t even want to live,” J Balvin said, revealing that he’s been suffering from anxiety and depression since he was a kid.

“You lose hope and you feel strange at every place you go. You feel like you are outside of your body,” J Balvin explained. “I”;ve been shaking since I was a kid, and I’ve always had it, but I just didn”;t know it was anxiety.”

J Balvin said that he didn’t want to seek help because he want to think he “was crazy.”

“I remember that I was in bed for, like, five days and I was just waiting to die. ‘I don’t have the balls to kill myself but I will just wait,’” J Balvin recalled thinking at the time. “Of course, my whole family was devastated because at the time I wasn’t as known as I am right now…. At the time, I quit my career and I love music.”

Eventually, J Balvin went to see a doctor to get help and started treatment for depression.

“Since then, I have been medicated and I don’t feel bad about it,” J Balvin shared.

Now, J Balvin said he’s committed to destigmatizing treatment both in his music and on social media.

“What I tell kids is don’t believe everything you see on Instagram. I want to be a real man and show [the real me],” J Balvin said. “There’s a lot of people out there suffering like I am…;but when you’re going through a hard moment and have anxiety and depression, don’t check Instagram.”

“To me, everything, for real, is to have health and mental health and peace,” he continued. “I want to tell the kids, don’t be afraid to be who they are and this comes with everything, sexual identity, beliefs, religion, who you want to be as an artist, your career, don’t compare yourself to anybody else.”

Read more: justjared.com

First COVID-19 Vaccine 90% Effective?

First COVID-19 Vaccine 90% Effective?

With more than 180 COVID-19 vaccines currently in development1 –; 53 of them undergoing clinical trials in humans2 –; manufacturers are racing to be the first to reach the market. Pfizer, in a joint venture with Germany-based BioNTech, may have just taken the lead, with an announcement that their mRNA-based vaccine candidate, BNT162b2, was “;more than 90% effective”; in a Phase 3 trial.3

BNT162b2 was selected to move forward to a Phase 2/3 trial after an earlier version of the vaccine, BNT162b1–; another mRNA-based vaccine candidate –; resulted in considerable adverse events,4 including fever, which occurred in 50% of individuals who received the highest dose (100 micrograms), fatigue, headache and chills.

Side effects were even more common following the booster dose, after which more than 70% of participants experienced a fever at the mid-range (30 microgram) dose. In fact, those in the high-dose group didn”;t even get the booster dose after the side effects were deemed to be potentially too severe.

While the vaccines are similar, with the BNT162b2 vaccine, mRNA encodes the full-length spike protein. A spike protein is a glycoprotein protruding from the envelope of a coronavirus that allows entry into the cell.5 In an earlier study, while BNT162b2 appeared to cause fewer side effects, antibody titers were lower in a group of older individuals, ranging in age from 65 to 95 years, than in younger individuals.6

Geometric mean titers (GMTs), which are used as a measure of immune response, were about 40% lower among older individuals given Pfizer”;s BNT162b2 COVID-19 vaccine than they were in younger age groups, a concerning finding considering it”;s the older individuals who are most at risk from severe COVID-19.

Is Pfizer”;s COVID Vaccine Really 90% Effective?

In a Phase 3 efficacy trial, a vaccine is given to thousands of people, while researchers wait to see how many end up infected compared to those given a placebo.7 Pfizer”;s Phase 3 clinical trial began July 27, 2020 and enrolled 43,538 participants8 to date ranging in age from 12 years to over 55, with a minimum of 40% of participants in the over 55 age range.9

Participants received either a two-dose series of BNT162b2, given at the 30-microgram dose 21 days apart, or a placebo. Initially an interim analysis was set to be conducted after 32 COVID-19 cases, but “;after discussion with the FDA,”; they increased it to after a minimum of 62 cases. According to Dr. Albert Bourla, Pfizer Chairman and CEO, in a press release:10

“;Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC (Data Monitoring Committee) performed its first analysis on all cases.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.”;

Bourla added the caveat, “;As the study continues, the final vaccine efficacy percentage may vary.”; In fact, there are many questions that remain unanswered regarding the reported 90% efficacy rate.

While Pfizer did release a clinical protocol of its trial,11 data for the interim analysis have not been released. “This is science by public pronouncement,” William Haseltine, an infectious disease expert and former Harvard medical professor, told Business Insider.12

COVID-19 Vaccine Trials “;Designed to Succeed”;

In September 2020, Haseltine criticized COVID-19 vaccine trials, including Pfizer”;s, saying their protocols reveal that they”;re “;designed to prove their vaccines work, even if the measured effects are minimal.”;13

He points out that prevention of infection is a critical endpoint in a normal vaccine trial, but prevention of infection is not a criterion for success for COVID-19 vaccines in development by Pfizer, Moderna, AstraZeneca or Johnson & Johnson. According to Haseltine:14

“;Any vaccine trial should include regular antigen testing every three days to test contagiousness to pick up early signs of infection and PCR testing once a week to confirm infection by SARS-CoV-2 test the ability of the vaccines to stave off infection. Prevention of infection is not a criterion for success for any of these vaccines.

In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success, the only difference being the severity of symptoms between the vaccinated and unvaccinated. Measuring differences amongst only those infected by SARS-CoV-2 underscores the implicit conclusion that the vaccines are not expected to prevent infection, only modify symptoms of those infected.”;

He also explains that while most people expect that a vaccine will prevent serious illness in the event they”;re infected, “;Three of the vaccine protocols –; Moderna, Pfizer, and AstraZeneca –; do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache.”;15

Pfizer Didn”;t Release Key Vaccine Data

While Pfizer is touting its vaccine as more than 90% effective based on 94 cases in their trial, “There are many, many outstanding questions which are left unanswered,” Haseltine said.16

One of the main unanswered questions has to do with asymptomatic infections, which aren”;t regularly being tested for in Pfizer”;s trial. It”;s possible, then, that those who have been vaccinated could still be asymptomatic carriers of COVID-19, spreading the disease to others.

“That’s a major point that I don’t think most people appreciate,” Haseltine told Business Insider. “It doesn’t mean an end to the epidemic.”17 It”;s also unknown whether the vaccine reduced the number of cases of serious disease, hospitalizations and deaths, as no distinction was made between serious COVID-19 cases and those causing only minor symptoms.

Also missing from Pfizer”;s press release is how the vaccine fared in different age groups, a key data point since older people are those most at risk of serious disease outcomes. It also remains to be seen how long any protection offered by a vaccine may last, as the study just began in July.

As for side effects, Pfizer”;s Bourla said, “;The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.”;18 Again, however, it”;s far too soon to know whether the vaccine is safe. The timeline of the experimental COVID-19 vaccine is unprecedented as, on average, it can take 10 to 12 years for a vaccine to be developed and go through the normal licensing process.19

“We don’t know anything about groups they didn’t study, like children, pregnant women, highly immunocompromised people and the eldest of the elderly,” Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group in Rochester, Minnesota, told NBC News.20

As for potential adverse effects, in their clinical protocol Pfizer listed the following, noting that the first five participants in each group in phase 1 would be monitored for four hours after vaccination to assess adverse effects, while others would be observed for “;at least 30 minutes.”;21

Injection site redness, swelling and pain

Fever

Fatigue

Headache

Chills

Vomiting

Diarrhea

Muscle pain

Joint pain

Unknown adverse effects and laboratory abnormalities associated with a novel vaccine

Potential for increased exposure to SARS-CoV-2 because of the requirement to visit health care facilities during the trial

COVID-19 enhancement, stating, “;Disease enhancement has been seen following vaccination with respiratory syncytial virus (RSV), feline coronavirus, and Dengue virus vaccines.”;

Coronavirus Vaccines May Enhance Disease

Even Pfizer acknowledged in their clinical protocol that COVID-19 disease enhancement is a real risk following certain vaccinations.22 In what”;s known as antibody-dependent enhancement, or ADE, or sometimes called paradoxical immune enhancement (PIE). In these scenarios rather than enhance your immunity against the infection, the vaccine enhances the virus”; ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated.23

Th2 immunopathology, in which a vaccine induces a faulty T cell response, triggering allergic inflammation, poorly functional antibodies and airway damage, is another serious risk.

Both ADE and Th2 immunopathology occurred in the 1960s when a vaccination for respiratory syncytial virus (RSV) was being developed, resulting in the death of two toddlers and serious illness in several other children who received the experimental vaccine.24

Similar concerns again surfaced in testing for a potential vaccine against another coronavirus, SARS, about 20 years ago. At the time, even long-time pro-vaccine advocate Dr. Peter Hotez, dean of the National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, was shaken. According to a feature published in PNAS:25

“;When SARS, also a coronavirus, appeared in China and spread globally nearly two decades ago, Hotez was among researchers who began investigating a potential vaccine.

In early tests of his candidate, he witnessed how immune cells of vaccinated animals attacked lung tissue, in much the same way that the RSV vaccine had resulted in immune cells attacking kids”; lungs. “;I thought, “;Oh crap,”;”; he recalls, noting his initial fear that a safe vaccine may again not be possible.”;

Despite years of additional research and alternative development strategies, immune enhancement concerns remain, and, as explained by Robert F. Kennedy Jr. in our 2020 interview, coronavirus vaccines remain notorious for creating paradoxical immune enhancement.

mRNA Is a Novel Vaccine Technology

Pfizer”;s COVID-19 vaccine is relying on novel mRNA technology that has never previously been used in vaccines.26 It essentially instructs your cells to make the SARS-CoV-2 spike protein, which is what attaches to the ACE2 receptor of the cell. This is the first stage of the two-stage process viruses use to gain entry into cells.

The idea is that by creating the SARS-CoV-2 spike protein, your immune system will be stimulated to produce antibodies, without making you sick in the process. However, another key question that needs to be answered is which of two types of antibodies are produced through this process.

Coronaviruses produce both neutralizing antibodies,27 also referred to as immoglobulin G (IgG) antibodies, that fight the infection, and binding antibodies28 (also known as nonneutralizing antibodies) that cannot prevent viral infection. Instead of preventing viral infection, binding antibodies can trigger an abnormal immune response like ADE or PIE.

In trials of Moderna”;s experimental COVID mRNA vaccine, 25 participants who received two doses of its low or medium dose vaccine had levels of binding antibodies –; the type that are used by the immune system to fight the virus but do not prevent viral infections –; at levels approximating or exceeding those found in the blood of patients who recovered from COVID-19.29

Data for the more significant neutralizing antibodies, which stop viruses from entering cells, were reported for only eight people.

Pfizer Has $1.95 Billion Deal With US Government

While the results of Pfizer”;s Phase 3 trial remain murky, as part of Operation Warp Speed the drug giant has already struck a $1.95 billion deal with the U.S. Department of Health and Human Services and the Department of Defense to provide Americans with 100 million doses of its COVID-19 vaccine after it is licensed –; at no cost to recipients –; with an option for 500 million additional doses.30 The agreement is part of Operation Warp Speed.

Pfizer and BioNTech also have a deal with the U.K. government for 30 million initial doses.31 The FDA”;s guidance for a vaccine to receive Emergency Use Authorization requires only a median of two months of safety data following the second dose, which Pfizer expects to have by the third week of November.

At that point, they”;re hoping to bring the experimental vaccine to market, with promises to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses, globally, in 2021.32 Upon Pfizer”;s announcement that their vaccine showed 90% effectiveness, shares rose 16%. The next day, CEO Bourla sold 62% of his stock, an amount worth about $5.6 million.33

Does the Pfizer CEO know something we don”;t? If and when the vaccine does become available, be sure to carefully weigh the risks versus the benefits before making a choice of whether or not to receive it.

It may help in your decision to know that if you”;re under the age of 40, your risk of dying from COVID-19 is just 0.01%, meaning you have a 99.99% chance of surviving the infection34 –; and you could improve that to 99.999% if you”;re metabolically flexible and vitamin D replete.

Read more: articles.mercola.com

Alcohol dependence and mental health

Alcohol dependence and mental health

A man walking alone at night under street lamps in a city

There are an estimated 589,000 people who are dependent on alcohol in England and about a quarter of them are likely to be receiving mental health medication; mostly for anxiety and depression, but also for sleep problems, psychosis and bipolar disorder.

Graph from the Adult Psychiatric Morbidity Survey of 2014, showing the number of people reporting they are taking psychotropic medication, by type.

Deaths by suicide amongst mental health patients

People in touch with specialist mental health services who also have a history of alcohol problems can be at elevated risk of death by suicide. Between 2007 and 2017 there were 5,963 suicides in mental health patients with a history of alcohol misuse, an average of 542 deaths by suicide per year -; about 10% of all deaths by suicide in England.

NHS Trusts that have put in place a policy on the management of patients with co-morbid alcohol and drug misuse have reduced rates of suicide by patients by 25%.

Graph from the Office of National Statistics showing deaths by suicide of patients in touch with specialist mental health services and a history of alcohol misuse in England. Data is from 2007 to 2017. Numbers peak at 624 in 2011, from 501 in 2007. In 2017 the number was 482.

People in alcohol treatment

Data collected from over 72,000 people in alcohol treatment last year shows that more than half (55%) expressed a need for help with their mental health, and four in five (79%) of those said they were receiving some support. Accademic evidence suggests that the proportions of people in the alcohol treatment system with co-occuring mental ill-health is likely to be higher.

Graph from the Substance Misuse Treatment for adult Survey 2018-2019, showing numbers reporting a mental health need, by whether they are receiving treatment for that need. Numbers for alcohol misuse only, who are not receiving treatment, are greater than those reporting alcohol and opiate misuse.

However, of those expressing a need to the alcohol treatment system over half (56%) that reported a mental health need said that their support came through primary care, with a fifth (20%) saying that it was through community or other mental health services. Very few (2%) reported being supported through talking therapy services.

Addressing alcohol in mental health hospitals

PHE”;s guidance sets out two key principles for commissioning and providing better care for people with co-occurring mental health, and alcohol and drug use conditions.

Everyone”;s job. Commissioners and providers of mental health and alcohol and drug use services have a joint responsibility to meet the needs of individuals with co-occurring conditions by working together to reach shared solutions
No wrong door. Providers in alcohol and drug, mental health and other services have an open door policy for individuals with co-occurring conditions, and make every contact count. Treatment for any of the co-occurring conditions is available through every contact point

For the last two and a half years staff in mental health hospitals have been asking their patients about their alcohol consumption and any harms they”;ve experienced as a result. Where patients indicate that they”;ve been drinking at levels that increase their risk of health harm they”;ve been getting either brief advice on how to cut back, or if the problems are more severe a referral to more specialist advice and treatment.

The data returned by mental health hospitals shows that 16% of the inpatients who were screened were drinking at increasing or higher risk -; a little lower than is the case in the general population. However, the rate of possible alcohol dependence was 8% compared to 1.4% in the general population.

Finding ways of addressing alcohol use with patients experiencing mental health problems is likely to benefit them both in the short and longer term, and it has been fantastic to see the system respond so positively to the challenge of doing so.

This case study shows how one trust has made this a part of normal clinical practice. Some of the things they found that worked well were:

Integrating the screening (AUDIT)within the patient”;s electronic record ensured that the risk is automatically calculated and, based on the score, the system prompts the health professional to undertake the appropriate type of intervention
Ward managers could easily monitor the extent to which staff were screening patients

There are a range of resources available to health professionals to help address coexisting mental health and alcohol use conditions on PHE webpages.

These include the alcohol CLeaR approach to system improvement, an evidence-based approach that local alcohol partnerships can use to assess how effective their local system and services are at meeting need and preventing or reducing alcohol-related harm.

CLeaR promotes collaborative action and encourages all local stakeholders, including mental health and alcohol commissioners and providers, to develop a shared vision, then plan and work together to improve the outcomes achieved locally.

Local areas are strongly encouraged to use this approach to identify strengths and opportunities for development to progress this agenda.

Read more: publichealthmatters.blog.gov.uk