J. Mark Anderson, M.D. and Walter Gaman, M.D.

J. Mark Anderson, M.D. and Walter Gaman, M.D.

  • June 30, 2020

J. Mark Anderson, M.D. and Walter Gaman, M.D. – Southlake Style — Southlake’s Premiere Lifestyle Resource








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Teeccino Launches New Optimal Wellness Lines

  • June 30, 2020

SANTA BARBARA, Calif.– Teeccino, known for bold tasting, roasted herbal coffees & teas, announced the launch of two new unique wellness lines featuring adaptogenic mushrooms and botanicals and prebiotic herbs plus extracts: Mushroom Adaptogen Herbal Coffees & Teas and Prebiotic Superboost™ Herbal Coffees & Teas. The newest additions to Teeccino’s portfolio of rich and satisfying herbal coffees & teas come in a variety of flavors, which are made with the highest quality, organic ingredients without the effects of caffeine and acidity.

Teeccino is a family-owned business that is committed to authenticity, transparency, and sustainable sourcing of its ingredients. Their herbal coffees and teas contain the highest quality, non-GMO, organic ingredients and prebiotics without any artificial flavors, preservatives, chemicals or stimulants, to meet the needs of those who want rich, bold flavor without the effects of caffeine and acidity.

Dedicated to supporting consumers’ optimal health, Teeccino continues to push boundaries of innovation with unique, intentionally blended botanicals that produce wellness effects with delicious flavor from its roasted herbs, roots, fruits and nuts that are ground to brew like coffee or steep like tea. Teeccino’s herbal teas have 3 times more herbs than standard tea bags providing maximum wellness in every cup.

  • Teeccino’s Mushroom Adaptogen blends offer deliciously robust flavor with adaptogens aimed at protecting the mind & body. Adaptogens help the body adapt to all different kinds of stress, while providing much needed endurance and vitality. TheMushroom Adaptogen flavors include; Lion’s Mane Rhodiola Rose, Tremella Tulsi Cardamom, Cordyceps Schisandra Cinnamon Berry, Chaga Ashwagandha Butterscotch Cream, Turkey Tail Astragalus Toasted Maple, and Reishi Eleuthero French Roast.
  • Teeccino’s Prebiotic Superboost™ blends include the ever popular, roasted chicory root, with its natural prebiotic, inulin, as well as a concentrated blend of two plant-based prebiotics, vegan GOS,galacto-oligosaccharide. and organic XOS, xylo-oligosaccahride, which result in an even greater beneficial impact on overall gut health. The Prebiotic Superboost™ flavors include; Macadamia Nut, Dark Chocolate, and Mango Lemon Balm.

“With our two new categories, we wanted to bring an elevated level of wellness to our customers,” said Caroline MacDougall, CEO and Founder of Teeccino. “I’ve always been fascinated by the effects that adaptogenic herbs and prebiotics have on the body, a subject which I’ve been studying over my 40+ year career. Our goal was to create two lines that are packed with optimal wellness due to the blending of nutrient-rich herbs that are known to nourish, protect and revitalize the mind, body and gut. Our purpose is to stay true to our mission to bring the healthiest herbal coffees & teas to our customers and provide them with beverages that will continue to support their lifestyle by improving digestion, elimination and the immune system.”

Teeccino’s two new lines, Mushroom Adaptogen and Prebiotic SuperBoost™, can be found directly ontheir site, and will be available nationwide on Amazon on July 1 and in select retailers. For more information about Teeccino, visit Teeccino.com or follow @Teeccino onInstagram.

About Teeccino

Caroline launched Teeccino at Expo West in 1995 to satisfy both coffee and tea drinkers alike with its rich, bold full-bodied flavor and its many health benefits. Nationally distributed in specialty grocery chains like Whole Foods, Sprouts, and Wegmans as well as etailers like Amazon and Vitacost, Teeccino’s 36 flavors and counting are widely available. Unique among all teas and coffees, people often ask, is Teeccino coffee or is it tea? The answer is simple, it is Teeccino!

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Explainer: how is the vaccine pipeline for Covid-19 looking? | News

Explainer: how is the vaccine pipeline for Covid-19 looking? | News

  • June 30, 2020

Let’s start with the basics. What is a vaccine?

All vaccines look to show the body one or more molecules – antigens – that are made by or which mirror a specific disease-causing microbe. These do not cause the disease, but trigger an appropriate immune response. Afterwards, the body’s immune system is left with a memory of how to respond effectively when it actually encounters this specific pathogen.

How many vaccines for Covid-19 are in the works?

The World Health Organization posts a notice board of vaccine candidates each week. As of 29 June, 16 vaccine candidates are in clinical trials. An impressive 129 candidate are in preclinical evaluation.

You can split the vaccines into four categories. The first are vaccines based on the inactivated Sars-CoV-2 coronavirus that causes Covid-19. The second class of vaccine is based on nucleic acids – there are five based on RNA, and two on DNA. The third class rely on other viruses to deliver antigens. The final strategy is a subunit vaccine: a viral glycoprotein with an immune boosting adjuvant.

Who’s in the lead?

Pharmaceutical firms and research groups working on DNA and RNA vaccines can move fastest, followed by those based on fragments of the virus (subunit vaccines), according to the Coalition for Epidemic Preparedness (CEPI). DNA and RNA vaccines can be made quickly as they require no culture or fermentation, and are synthesised chemically. Research groups and companies that have experience with Sars and/or Mers were out of the blocks early.

Which RNA vaccine is furthest advanced?

US biotech Moderna’s – it’s based on messenger RNA for the Sars-CoV-2 spike protein encapsulated in lipid nanoparticles. These particles are engulfed by immune cells and our cellular machinery then converts this synthetic mRNA into viral proteins. These proteins are then used to teach our immune system to recognise the virus (it is hoped), mirroring the natural process.

However, there are no RNA vaccines on the market. This leaves a question mark over whether they actually work in humans.

BioNTech and Pfizer have also announced their own trials of RNA vaccines. BioNTech has experience developing RNA vaccines, although its vaccine pipeline focuses on cancer. Imperial College, the Chinese army in concert with Walvax Biotech, and Curevac are the other developers.

Altogether 15 firms and research groups have an RNA vaccine in pre-clinical assessment.

What about DNA vaccines?

Inovio Pharmaceuticals has been trialling spike glycoprotein-based DNA vaccines. Volunteers receiving the vaccine have been treated with a handheld device that delivers electrical pulses that create temporary pores in cells near the injection site, allowing viral DNA to enter them. This strategy was first developed for Mers.

DNA vaccines have been in the works for some time. They have a good safety record, but again none have been approved, mostly because they did not generate a strong enough immune response. Vaccines that require an electroporation device may be a drawback when administering them to millions of people, although not all DNA vaccines need them.

Eleven other DNA vaccine candidates are in pre-clinical tests. A handful of DNA-based vaccines are approved for veterinary use showing that they do work – in other animals at least.

Vaccinating with inactivated viruses is an old strategy – could it work for Covid-19?

This approach worked for polio, rabies, hepatitis A and other diseases. The entire virus goes into the vaccine to stimulate a broad immune response. However, generating functional viruses could be time consuming and tricky for Sars-CoV-2 because, as a biosafety level 3 pathogen, it requires extra precautions until it is chemically inactivated.

Sinovac in Beijing is testing an inactivated vaccine. It reported last month that this vaccine induced neutralising antibodies in rodents and in macaques.

The University of Oxford’s vaccine caused a buzz. What’s this all about?

The team led by Sarah Gilbert had been developing vaccine candidates for Mers, influenza, TB, Zika and plague using a viral vector. This vector is a weakened version of a common cold virus (adenovirus) that infects chimps, which was tweaked to deliver its cargo to humans. The genetic material to build Sars-CoV-2 spike glycoproteins was then inserted into the vector, in the hope that this would elicit an immune response to this vital viral protein.

Preliminary results from six vaccinated monkeys challenged with Sars-CoV-2 found that they didn’t develop Covid-19 in their lungs, but virus levels in their noses were the same as unvaccinated monkeys. This might mean that those receiving the vaccine would be protected, but could still infect others. This phenomenon has been recorded with the acellular pertussis vaccine.

There are at least a dozen other viral vector vaccines in pre-clinical tests.

Forget about other viruses – what about injecting weakened Sars-CoV-2 itself?

Injecting weakened or attenuated microbes has a long history. The extremely effective yellow fever vaccine is a live vaccine in use since the 1930s, as is the measles vaccine. The old-fashioned approach was to culture the virus in suboptimal conditions, so that it adapted, for example, to a lower temperature than the human body. A modern alternative is to edit an organism using Crispr, so that it triggers an immune response but no disease.

The advantage of a live Sars-CoV-2 vaccine is that it could be administered nasally. No live Sars-CoV-2 vaccines are in clinical trials, but Codagenix has one under development with the Serum Institute of India. It already has a universal flu vaccine in clinical trials, while its preclinical pipeline includes Zika, dengue and respiratory syncytial virus (RSV).

Manipulating the genome of Sars-CoV-2 isn’t straightforward though. It has one of the largest genomes of an RNA virus. Another downside of live viruses is that they can cause the disease in immunocompromised people.

What about subunit vaccines?

Instead of relying on a whole virus, these vaccines pack the Sars-CoV-2 spike protein in a nanoparticle to elicit an immune response. An extra adjuvant is often needed with this approach. Novavax is trialling a vaccine in Australia that uses this technology with results expected in July. A collaboration between GSK, Clover Pharmaceutical and Dynavax also has one in clinical trials. Despite there only being two subunit vaccines in clinical trials this approach is extremely popular with vaccine makers – almost 50 are in preclinical development.

Are any other novel approaches in the pipeline?

The WHO lists eleven groups using virus-like particles (VLPs), which mimic the structure of the coronavirus but are not infectious. Artes Biotechnology has a particle based on duck hepatitis B virus. Medicago derives VLPs from plants and has vaccine candidates for flu, rotavirus and norovirus in clinical trials too. It is carrying out pre-clinical studies of a Sars-CoV-2 VLP, with human trials planned this summer.

What pitfalls in vaccine development have scientists worried?

Lab animal tests with Sars and Mers vaccine candidates have raised concerns that they might worsen the severity of the disease. This has happened before with an inactivated vaccine for a cat coronavirus and for a viral respiratory disease in children.

This may be linked to a particular immune response, called a type 2 helper T-cell response (TH2). A vaccine that induces a strong TH2 response can lead to a more severe case of the disease following subsequent infection. The preferred response for a virus is a TH1-type immune response, which is often reduced in the elderly.

It is crucial that the chemistry and contours of the spike protein are displayed correctly in any vaccine. Mistakes here might generate antibodies that bind to, but do not neutralise the virus. This can boost viral replication or form complexes that trigger more inflammation. These are hypothetical concerns thus far.

With the pandemic waning in many countries is a vaccine still a priority?

Most people have yet to encounter the virus. Recent tests showed that, on average, only around 5% of people have antibodies to the virus. The result of repeated epidemics will be unacceptably high mortality, severe economic disruption and major changes to our way of life. Also, it seems that having the infection is no guarantee of future protection.

Could this rush to develop a vaccine compromise patient safety?

A vaccine that harms people’s health would be a disaster and could setback future vaccination efforts. Despite pressure for a vaccine, regulators will want to proceed cautiously.

Good animal data can highlight safety and efficacy issues, but ultimately vaccines have to be tested in people. One way to speed things up would be to deliberately infect healthy vaccinated adults with a live virus – a strategy that comes with obvious dangers.

Who will the likely winner be in the vaccine race?

Impossible to say. What is almost certain is that eventually there will be multiple approved vaccines for Covid-19. The leaders now are the 16 vaccine candidates in clinical trials.

When will mass vaccination start?

Depends how you define start. It might be possible to expand Phase 3 trials, perhaps starting with medical workers and moving onto other sections of society who are more exposed, in ever larger groups.

A number of vaccine producers say they are aiming for an autumn rollout. Some scientists guesstimate that vaccines could be more widely available in early 2021 in Europe and North America. The challenge of manufacturing billions of doses of vaccines, especially in the case of newer platforms, should not be underestimated.

Thanks to Florian Krammer, immunologist at Icahn School of Medicine at Mount Sinai, and Wolfgang Leitner, chief of innate immunity section at the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

How to live inside, from the author of The Great Indoors.

How to live inside, from the author of The Great Indoors.

  • June 30, 2020
A woman's hand is seen watering house plants on a windowsill.
Ronstik/iStock/Getty Images Plus

If you’re bored by the idea of spending yet more time locked down in your home, let science writer Emily Anthes convince you that it’s at least an interesting place to be. Her new book, The Great Indoors, explores all manner of things that happen between walls, from the microscopic creatures that live in shower heads to the reasons it’s healthy for bedrooms to have windows. The book also tours the research and design behind other indoor spaces outside the home, from the dimensions of operating rooms, to the seating plans of offices, to features of hypothetical outposts on Mars. It’s hard to read the book without constantly thinking about how everything relates back to the coronavirus. How spaces can be configured to facilitate or reduce human contact—and what playing with that does to our happiness, productivity, and health—is a big theme. (Plus, doesn’t Mars sound nice right now?)

Anthes describes herself as an “unapologetically indoorsy” person who has been working from home since before the pandemic. I talked to her about what we can all be doing to improve our indoor spaces, and the very weird timing of her book. Our conversation has been lightly edited and condensed for clarity.

Shannon Palus: What does the indoor space where you work look like?

Emily Anthes: I work in my living room sitting on my couch, which is extremely non-ergonomic, but it’s habit.

What I like about this workspace is I have a lot of natural light, and over the course of reporting the book, I became extremely convinced about the power of plants. I have steadily converted my living room into a small jungle. I have, probably, 20 plants in here of various types and sizes. I find it calming and restful to be surrounded by greenery. When people ask me what they can do to improve their indoor space—which a lot of people are doing these days—the No. 1 recommendation I make is plants.

What does research say about the power of plants? 

We know that they are really good stress relievers. They seem to have cognitive benefits. People who are surrounded by greenery tend to have longer attention spans and focus better. Kids who go to school in classrooms that are surrounded by nature tend to have better test scores. They have healing effects; patients who are hospitalized and have a view that looks out to greenery or some sort of natural scenery tend to use fewer painkillers. Plants can really have a powerful effect on all sorts of aspects of our functioning. They don’t even have to be real plants. Artificial plants can have the same benefits. So do things like photographs of nature—or, some studies suggest, nature sounds, like the rustling of trees, a babbling brook, or birdsong, can have some of the same benefits of bringing a real plant into your home.

How could an artificial plant be helpful?

There are a couple of different theories about why greenery is beneficial. They’re probably operating in concert—there’s no definitive explanation. One is the biophilia hypothesis, which posits that because we evolved surrounded by plants and greenery, we have an innate affinity for them. They make us feel restful and calm; the subsequent benefits come from that stress reduction. There’s a similar but slightly different theory known as the attention restoration theory. That holds that nature and plants engender what’s called a soft fascination. They’re engaging and interesting, but it doesn’t take a lot of cognitive work to look at a plant. It gives your brain a break. Then there have been some mechanistic studies that have come out more recently that look at how walking in a forest seems to actually boost the immune system: You can quantify the changes in immune cells. There do seem to be some real physiological changes happening, but there’s still a lot to learn about how it’s all playing out.

One claim you see a lot is that plants will be good for your air. In theory, that is true. Plants can absorb certain air pollutants. But in practice the studies show that you would have to have a basically impossible density in your home for it to make a difference—numerous plants per square foot to even begin to make a dent in the air quality.

One thing you wrote about where the science is not there is probiotic spray for homes. Can you talk about that?    

The promise is you can spray this good bacteria around your home and that will boost your immune system. The science is not even close to there yet. Even studies of oral probiotics have been disappointing. Even if we discovered what effective probiotics were, one of the scientists told me, it seems unlikely that the best way to take a vitamin would be to spray it around your room and walk through the cloud.

If you were doing reporting for the book now, during the pandemic, what would you be exploring more?

There’s been a lot of focus now on how can we stay connected with friends and family, how can we set up all these remote social events. There’s not as much attention paid to our need for privacy and personal space, which is a fundamental need we have, and can be hard to achieve when you’re sharing a tiny apartment with another person 24/7. I’m interested to see if there are time-tested, evidence-based ways to carve out personal space even when the total amount of indoor space is not huge. We’ve seen problems related to this in outer space, or Antarctic bases, where people are stuck with the same crew day in and day out for months. We know that there can be irritability and depression as a result of not having enough personal space.

“There’s not as much attention paid to our need for privacy and personal space, which is a fundamental need we have.”

— Emily Anthes

Is there anything that you’ve done to create more private space for yourself during the pandemic? 

I was thinking about what one of the researchers who has studied simulated space missions told me, which is that privacy isn’t just visual privacy. It isn’t just closing yourself behind a door. There’s olfactory privacy and auditory privacy. Inspired by that, I’ve been doing things like sitting on the same couch as my boyfriend but we both have headphones on and are listening to our own music or podcasts. It’s the smallest thing, but it creates a sense of refuge, a little way in which you can create your own world when you don’t have your own space to work with.

What’s it been like promoting a book right now?

I think most authors who have books out right now would say it’s been strange. I feel like it’s been particularly strange for this book because it’s been so unexpectedly timely. This is not a news hook that I ever would have asked for. If I could snap my fingers and make the pandemic go away, I would do that in a heartbeat. I do think one of the slight silver linings is a lot of people are thinking about their indoor environments more and paying more attention to them. COVID-19 is essentially a disease of the indoors; it’s being spread almost entirely indoors. I think there is an opening here if we want to take it, if we want to really think through how we can make healthier indoor environments. That includes environments that protect us from COVID-19, but it goes a lot further than that.

Homeopathic drugs such as Arsenicum Album 30, promoted by AYUSH, do not boost immunity against COVID

Homeopathic drugs such as Arsenicum Album 30, promoted by AYUSH, do not boost immunity against COVID

  • June 30, 2020

Overview:

Despite the order from the Ministry of AYUSH to prevent the public advertisement of AYUSH-related claims for COVID-19, many Indian states, particularly larger cities such as Pune, Vadodara, Mumbai have been found distributing homeopathy drugs such as Arsenicum album 30 by both public and private means. The distribution of Arsenicum Album 30 was done according to the previous AYUSH guidelines on COVID-19. In addition, state authorities in Kerala, Andhra Pradesh, Rajasthan, and even Mumbai BMC has suggested the use of homeopathy prophylactically to increase immunity.

Further, due to the lack of effective treatment and the growing number of COVID positive cases even during the lockdown period, Prime Minister Modi had emphasised to follow the AYUSH guidelines with homeopathy and Ayurveda for protection against COVID-19. These AYUSH guidelines released in January 2020 can be found on the PIB website (link to the release here). After facing criticism in India and internationally, the ministry of AYUSH released Annexure I & Annexure II, that quoted an Italian research review (Bellavite et al. 2015) to stand behind the statements made earlier and to give proof of a mechanistic understanding of Arsenicum Album 30 in ‘boosting immunity’ against COVID-19.

As a result, many now believe that homeopathic pills called Arsenicum album 30 increase the body’s natural defence mechanism. Since none of the homeopathic drugs has been scientifically demonstrated to produce proven action on cells and its receptors, the Central Council of Homeopathy (CCRH) uses “a wide-range mechanism of action review article” (Bellavite et al. 2015) to prove that the homeopathy drugs indeed work in the claimed manner. This paper regularly quoted by CCRH claims to ‘review’ the hypotheses about homeopathic drug action at the cellular and molecular levels.

We sci-checked this review paper’s relevant arguments about the drug Arsenicum album 30 that claims its ‘mechanism of action’.

Claim:

Homoeopathy drugs protect from the coronavirus by increasing the body’s innate immunity.

Verdict:

False

Fact-check:

Our body’s immune system is of two types:

1. Inherent or innate immunity

This is our body’s own natural response to an external pathogen invasion. It is the kind of immunity which we are born with and does not deteriorate unless our body is subjected to immune altering drugs, diseases or process, a few examples of these could be – an HIV infection, a corticosteroid drug administration for immunosuppression or chronic insomnia.

2. Adaptive immunity

This is the immunity that can be altered using natural or artificial factors. It could be acquired in a child through the mother during pregnancy, or via a later infection such as chickenpox; or, it could be through artificial means such as vaccination, and in some cases, antibody transfer from an immune positive individual to a non-infected person.

How does homeopathy claim to interact with the immunity using Arsenicum album 30?

Homeopathy has allegedly considered a method to activate or ‘boost’ the inherent or innate immunity of the person by consuming Arsenicum album 30 pills, which may incur the strength to our bodies to fight against external pathogens such as the coronavirus.

These claims of homeopathy treatment were made on the basis of studies conducted in the human population that claimed to show a change in the expression of proteins such as inflammatory mediators and cytokines. The proteins are released in the body, and largely measured in the blood. The quantity of these proteins in the blood shows the extent of an existing infection or inflammation. Their release also shows a functional immune system and a reduced release during an active infection could show some immune-suppression because of disease or external drugs.

The research quoted by CCRH on Arsenicum album 30

Below, we will review all the studies quoted in Bellavite et al. 2015 that suggest that Arsenicum album 30 helps to ‘boost’ our immune system by causing a change in the release of immune-proteins.

1. Claim of the Arsenicum album 30 as a protective compound for cellular damage against arsenic and UV induced toxicity via controlling genetic modulation.

Studies De et al. 2012, Das et al. 2012 & Das et al. 2011 were referenced to suggest that Arsenicum album 30 may reduce the toxicity of Arsenite in two bacterias E. coli and S. Cerevisae. Since these three referenced research studies were conducted on bacteria, and not conducted in infected humans or even in lab animals, they cannot be used as a proof of mechanism of action.

Further, a study (Marotti et al. 2014) conducted in wheat seedlings was used as proof of protection against genetic modulation by using Arsenicum. Firstly, they extracted RNA and conducted gene expression analysis from seeds of wheat. Gene expression is a method by which the information in the genes is used to instruct protein manufacturing in the body. Despite the results in this study, it cannot be applied to animal cells, or even live animals and humans. Secondly, a change in expression of the gene, i.e. the change in instructions for protein design, does not determine protective or toxic effects of a compound. Genes can be expressed in both scenarios, i.e. for the manufacturing proteins causing detriment, or, manufacturing proteins for the benefit of a living system.

Thus, the research does not have sufficient data to prove that Arsenicum album 30 can modulate genetic expression to provide protection from cellular damage.

2. Claim of change in expression of specific immune-related proteins in such a way that “important genes (turn) on or off, initiating a cascade of gene actions to correct the gene expression that has gone wrong and produced the disorder or disease”- Bellavite et al. 2015

This claim means that, allegedly, a homeopathy drug will change the expression of immunity-related genes in our DNA, i.e. change the information that codes the protein design. It is claimed that the change due to the drug will be in such a way that the new protein manufactured (linked to immunity) will eventually ‘correct’ the initial gene expression. This initial gene expression, which will be corrected by this protein, is also allegedly the process which has caused the disease.

This means that all diseases are caused by their corresponding gene expression and its protein manufacturing, and all cures can be initiated by changing the expression of immunity-related genes. This is a highly canonical argument as many diseases or disorders are unrelated to the genetic factors – environmental and other pathophysiologies play a huge role in treating diseases. This is the most widely quoted and accepted claim of homeopathy.

Also, the discovery of homeopathy by Hanemann was in 1796 and did not come out in print until 1807. However, the first experiment in inheritable units, now we call them genes, was not conducted by Gregor Mendel until 1857-1864, nearly 50 years after the discovery of homeopathy. The founder of homeopathy had died in 1843. So, the mechanism with which homeopathy works in the above research paper does not match on a timeline. Perhaps, Hanemann did not understand the modern mechanisms proposed for homeopathy, which have not been proven till date by homeopaths.

The paper elaborated that (Bellavite et al. 2015), “Mother tinctures and highly diluted drugs were tested in human tumour cell lines or cells challenged with carcinogens; they affected the modulation of the expression of specific mRNA markers (NF-κB, Akt, p53, Bax, Blc-2, caspase 3, Cyt-c) and increased tumour cell death (Sunila et al. 2009, Hofbauer et al. 2010, Sikdar et al. 2014 & Mukherjee et al. 2013).”

Protein markers such as NF-κB can be important in the regulation of innate or the body’s own immunity. However, referenced studies quoted to make such claims do not reflect the strength required to assert such a claim since the studies are not specific to Arsenicum album 30, and most of them in fact do not even refer to the said drug. For example, Sunila et al. 2009 does not have any mention of Arsenicum album 30 and the research was conducted in cultivated cell lines in the lab. Hofbauer et al. 2010 also did not mention arsenicum, while the effect was studied in bacteria.

Further, the research in Sikdar et al. 2014 was conducted in cell lines as well as laboratory rats with lung cancer models, but did not mention homeopathic formulations or Arsenicum or infectious diseases. Finally, the study Mukherjee et al. 2013 mentions the use of another homeopathic drug called ‘Thuja’ in cancer cell lines acquired from the lungs of mice, while no mention of Arsenicum occurs.

Thus, one of the most cited papers in homeopathy, specifically by the CCRH to prove that there is a mechanism of action with Arsenicum drugs, even though the testing hasn’t been conducted in COVID-19 patients, has no mention of Arsenicum album 30 in any of the quoted studies and have not been conducted in humans or in lab animals with infectious diseases.

3. Claim of highly toxic substances used in low doses as therapeutic formulations in homeopathy

In the final claim, studies Betti et al. 1997, Bode & Dong 2002 & Khuda-Bukhsh et al. 2011, were referenced in the article (Bellavite et al. 2015). Amongst the three referenced studies, Bode & Dong 2002 discussed undiluted arsenic which can either cause cancer as well as be therapeutic in cancer, the study Betti et al. 1997 was again a study of toxicity in wheat seedlings. And the final study Khuda-Bukhsh et al. 2011, was the only one conducted in humans, but it was to determine the impact of Arsenicum album 30 on arsenic toxicity.

Thus, no study in the review paper given in the ‘Annexure’ by AYUSH proves that low doses of arsenic or any other drug can be therapeutic. Further, it is evident from years of pharmacological research that the right amount of dose is imperative for the drug to have an effect.

Conclusion:

None of the studies mentioned in the Bellavite et al. 2015 review article proves that Arsenicum album 30 will boost immunity in humans or in animals to protect against infectious diseases. In fact, the claims of cell protection, genetic modulation or the high potency of low doses, has not been conducted systematically in any infectious disease models. Thus, homeopathy as an immune booster against COVID-19 remains heavily marketed and the most dangerous pseudoscience that the AYUSH ministry has produced during this pandemic.

Our previous sci-check at Alt News Science reviewing and questioning the scientific literature on the mechanisms of homeopathy drugs can be found on this link. Further, we have also found that the claimed Arsenicum album 30 has never been tested in human infections in clinical trials (link here) to yield the results that the CCRH claims.

The CCRH scientific advisory board had also confirmed that the medicine advised for recent coronavirus crisis (Arsenicum album 30) had been advised previously for the prevention of Influenza-like Illness (Mathie et al. 2009, Chakraborty et al. 2013, Varanasi, Gupta, et al. 2019). Thus, the drug has neither been specifically developed for the current or previous coronavirus epidemics nor has been tested systematically for efficacy against any coronavirus infections.

Besides the government and media’s dispersal of unchecked science on homeopathy, corporators have been buying the drug at a mass scale to protect themselves, their families and their communities to form ‘herd immunity’ via the administration of Arsenicum album 30. A corporate giant Rajiv Bajaj, Bajaj Auto suggested that Homeopathy and herd immunity, not lockdown, are the best strategy to fight the coronavirus pandemic.

Although it may be possible to increase immunity via lifestyle changes, vitamin D, sleeping efficiently, etc. so far, no drugs have shown the evidence to ‘boost the immunity’ to protect against the COVID-19 pandemic. The most reliable method to protect against the infection is suggested hygiene, physical distancing from humans and fomites as well as using protective gear when required.

Consumption of such untested drugs on such a large scale gives false protection and increases the spread of coronavirus, especially when the country has not been able to control the spread despite the enforcement of physical distancing.

References:

  1. Mathie, R. T., Baitson, E. S., Frye, J., Nayak, C., Manchanda, R. K., & Fisher, P. (2013). Homeopathic treatment of patients with influenza-like illness during the 2009 A/H1N1 influenza pandemic in India. Homeopathy, 102(03), 187-192.
  2. Chakraborty, P. S., Lamba, C. D., Nayak, D., John, M. D., Sarkar, D. B., Poddar, A., … & Prusty, A. K. (2013). Effect of individualized homoeopathic treatment in influenza like illness: A multicenter, single blind, randomized, placebo controlled study.
  3. Varanasi, R., Gupta, J., Raju, K., Prasad, R. V., Sadanandan, G., Arya, J. S., … & Pramanik, A. (2019). Management of early years of simple and mucopurulent chronic bronchitis with pre-defined Homoeopathic medicines–a Prospective Observational Study with 2-Years Follow-Up. International Journal of High Dilution Research-ISSN 1982-6206, 18(3-4), 47-62.
  4. Bellavite, P., Signorini, A., Marzotto, M., Moratti, E., Bonafini, C., & Olioso, D. (2015). Cell sensitivity, non-linearity and inverse effects. Homeopathy, 104(02), 139-160.
  5. De A., Das D., Dutta S., Chakraborty D., Boujedaini N., Khuda-Bukhsh A.R. Potentiated homeopathic drug Arsenicum Album 30C inhibits intracellular reactive oxygen species generation and up-regulates expression of arsenic resistance gene in arsenite-exposed bacteria Escherichia coli . Zhong Xi Yi Jie He Xue Bao 2012; 10: 210-227.
  6. Das S., Saha S.K., De A., Das D., Khuda-Bukhsh A.R. Potential of the homeopathic remedy, Arnica Montana 30C, to reduce DNA damage in Escherichia coli exposed to ultraviolet irradiation through up-regulation of nucleotide excision repair genes. Zhong Xi Yi Jie He Xue Bao 2012; 10: 337-346.
  7. Das D., De A., Dutta S., Biswas R., Boujedaini N., Khuda-Bukhsh A.R. Potentized homeopathic drug Arsenicum Album 30C positively modulates protein biomarkers and gene expressions in Saccharomyces cerevisae exposed to arsenate. Zhong Xi Yi Jie He Xue Bao 2011; 9: 752-760.
  8. Marotti I., Betti L., Bregola V., Bosi S., Trebbi G., Borghini G. et al. Transcriptome profiling of wheat seedling following treatment with ultrahigh diluted arsenic trioxide. Evid Based Complement Altern Med 2014; 2014: 851263.
  9. Betti L., Brizzi M., Nani D., Peruzzi M. Effect of high dilutions of Arsenicum album on wheat seedlings from seed poisoned with the same substance. Br Hom J 1997; 86: 86-89.
  10. Khuda-Bukhsh A.R., Banerjee A., Biswas S.J., Karmakar S.R., Banerjee P., Pathak S. et al. An initial report on the efficacy of a millesimal potency Arsenicum Album LM 0/3 in ameliorating arsenic toxicity in humans living in a high-risk arsenic village. Zhong Xi Yi Jie He Xue Bao 2011; 9: 596-604.
  11. Bode A.M., Dong Z. The paradox of arsenic: molecular mechanisms of cell transformation and chemotherapeutic effects. Crit Rev Oncol Hematol 2002; 42: 5-24.
  12. Sunila E.S., Kuttan R., Preethi K.C., Kuttan G. Dynamized preparations in cell culture. Evid Based Complement Altern Med 2009; 6: 257-263.
  13. Hofbauer R., Pasching E., Moser D., Frass M. Heparin-binding epidermal growth factor expression in KATO-III cells after Helicobacter pylori stimulation under the influence of strychnos Nux vomica and Calendula officinalis . Homeopathy 2010; 99: 177-182.
  14. Sikdar S., Mukherjee A., Ghosh S., Khuda-Bukhsh A.R. Condurango glycoside-rich components stimulate DNA damage-induced cell cycle arrest and ROS-mediated caspase-3 dependent apoptosis through inhibition of cell-proliferation in lung cancer, in vitro and in vivo. Environ Toxicol Pharmacol 2014; 37: 300-314.
  15. Mukherjee A., Boujedaini N., Khuda-Bukhsh A.R. Homeopathic Thuja 30C ameliorates benzo(a)pyrene-induced DNA damage, stress and viability of perfused lung cells of mice in vitro. J Integr Med 2013; 11: 397-404.
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BetterLife Pharma (OTCQB:BETRD) Believe Inhalation Device Containing Proprietary Interferon May Fight Off COVID-19

BetterLife Pharma (OTCQB:BETRD) Believe Inhalation Device Containing Proprietary Interferon May Fight Off COVID-19

  • June 30, 2020

New York, June 30, 2020 (GLOBE NEWSWIRE) — BetterLife Pharma (OTCQB:BETRD) (CSE: BETR) (FRANKFURT: NPAT), an emerging clinical stage pharmaceutical development company, believe that a coronavirus inhaler therapeutic may hold the key to helping patients fight off symptoms of coronavirus as soon as symptoms start.  In a trial planned for later this summer, the company intends to begin a 150 patient Phase II study to test such a nebuliser (a device to turn the treatment into a fine mist), treating patients with pre-existing conditions early after COVID-19 infection.

BetterLife hope that their inhalation device – an experimental delivery system already used during the Wuhan crisis – along with its patent pending interferon alpha2b drug AP-003 will help patients by bolstering their own immune systems, to prevent them progressing to more severe stages of the disease and help avoid potential damage to their lungs, and then eventually heart, kidneys and the brain – the leading cause of death amongst COVID-19 patients.

Interferon beta is already used as an injection to boost the immune response of people with multiple sclerosis. But if the drug is inhaled via a handheld nebuliser, IFNa2b can be delivered directly to the lungs where it can help fight COVID-19 at the source.

In BetterLife’s planned trial, which is being designed with FDA guidance, patients will be treated within 5 days of being assessed and tested and before they develop dyspnea (when patients develop breathing problems and are rushed to hospital).  The premise being put forward by the company is that an intervention with AP-003 within 7 days of exposure will inhibit the viral proliferation and allow the immune system to respond and prevent organ damage, thereby preserving life. 

At the moment there is no approved treatment for COVID-19 and anyone who shows symptoms or tests positive for the virus is told to self-isolate until the symptoms become serious. The closest to a treatment and with relatively positive results is Gilead’s remdesivir. 

This antiviral drug was been widely considered a front-runner in the rush to find viable treatments for a disease that has sickened more than ten million people worldwide and killed over 500,000, according to data aggregated by Johns Hopkins University. It is the first new drug to get emergency use authorization from the US FDA but hope for this being a viable therapeutic experienced a sharp correction on June 1 when the results of the remdesivir Phase III trial showed only modest improvement amongst patients receiving the experimental drug. The FDA  in March authorized chloroquine and hydroxychloroquine to be repurposed for some COVID-19 patients though this has proven to be unsuccessful and at times lethal.  

The company hopes that an inhaler delivering AP-003 directly to a patient’s lungs could make a difference by not only treating those who are seriously ill in hospital, but by eventually also being used as a coronavirus prophylaxis/prevention, allowing sufferers and those at high risk the ability to treat themselves at home before even becoming ill.

A number of recent studies have investigated the use of interferon alpha 2b (IFNa2b) on patients with cases of COVID-19 and found that the drug significantly accelerated clearance of the virus from the airways of patients.  Dr. Eleanor Fish, a researcher with Toronto’s University Health Network and the senior author on one of the interferon studies commented that “awareness of interferon as a potential COVID-19 treatment has been slow to build and should be prioritized for larger-scale clinical trials.”

Dr. Fish is now on the Advisory Board of BetterLife Pharma and is advising on the upcoming trials.

AP-003 will contain BetterLife’s patent-pending and purer composition of IFNa2b, which our bodies produce when we get a viral infection.

In a recent release, BetterLife CEO Ahmad Doroudian said: “We are encouraged by the results of recent studies on the use of interferon for COVID-19 which further support the approach being taken by BetterLife.”

Disclosure: BetterLife Pharma is a client of BDA International.

About BDA International, Inc.:

BDA International is an independent global firm offering a wide range of IR and PR related analysis, research and advisory services. In particular, we provide and are compensated for service packages that include strategic action plans and investor/market perception studies to help entities improve communication with customers and investors, and to increase their visibility. BDA International has received no direct compensation related to this release but its principles hold shares of client companies in our personal portfolios, including BETRF. BDA International accepts sole responsibility for the content and distribution of the foregoing release, which does not contain any previously unpublished or non-public information. Parties interested in learning more about the relationship between BDA and BETRF may do so via the contact information at the bottom of this release.

Disclaimer

The information, opinions and analysis contained herein are based on sources believed to be reliable, but no representation, expressed or implied, is made as to its accuracy, completeness or correctness. The opinions contained in this analysis reflect our current judgment and are subject to change without notice. We do not accept any responsibility or liability for any losses, damages or costs arising from an investor’s or other person’s reliance on or use of this analysis. This analysis is for information purposes only, and is neither a solicitation to buy nor an offer to sell securities, nor a recommendation of any security, although members of the BDA may at times hold a position in the company covered within the article. BetterLife Pharma is a client of BDA International. Past gains are not a representative of future gains. The opinions herein contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning manufacturing, marketing, growth, and expansion. When used herein, the words “anticipate,” “intend,” “estimate,” “believe,” “expect,” “plans,” “should,” “potential,” “forecast,” and variations of such words and similar expressions are intended to identify forward-looking statements. Such forward-looking information involves important risks and uncertainties that could affect actual results and cause them to differ materially from expectations expressed herein. A company’s actual results could differ materially from those described in any forward-looking statements contained herein. BDA is not a licensed broker, broker dealer, market maker, investment advisor, analyst or underwriter. We recommend that you use the information found herein as an initial starting point for conducting your own research in order to determine your own personal opinion of the companies discussed herein before deciding whether or not to invest. You should seek such investment, tax, financial, accounting or legal advice appropriate for your particular circumstances. Information about many publicly traded companies and other investor resources can be found at www.sec.gov. Investing in securities is speculative and carries risk.

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Bonn Group launches ''immunity-boosting'' herb and seeds bread

Immunity booster tablets to be distributed free in rural Maha

  • June 30, 2020


Immunity booster tablets to be distributed free in rural Maha








outlookindia.com

1970-01-01T05:30:00+0530

Mumbai, Jun 30 (PTI) Arsenic Album tablets and
Ayurvedic medicines will be distributed free of cost to five
crore people in rural Maharashtra to boost their immunity
against the coronavirus infection, state minister Hasan
Mushrif said on Tuesday.

According to an official statement, Rural Development
Minister Mushrif said Zilla Parishad committees have been
authorised to purchase the medicines.

The minister has instructed the ZP authorities to
complete the tender process for purchasing the tablets as soon
as possible, the statement said.

The state rural development department had decided to
purchase Arsenic Album tablets after the Union Ayush Ministry
issued a circular saying they help boost immune system in
people. PTI ENM
RSY RSY



Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI


More from Outlook Magazine

Beautiful young african woman enjoying a cup of coffee

15 Caffeine Alternatives: Healthy Alternatives To Caffeine

  • June 30, 2020

If you’re addicted to that morning cup of coffee, you’re not alone—but there are plenty of healthy alternatives to caffeine that can get us just as energized in the morning.

While there are notable health benefits of coffee, there can be downsides to your AM habit, too. “Caffeine drains your body of minerals and ultimately creates an energy crash,” says Dr. Daryl Gioffre, Kelly Ripa’s longtime nutritionist and author of Get Off Your Acid. He adds that some of the additional downsides of caffeine can include low energy, mineral deficiency (especially magnesium) sugar cravings, poor sleep, digestive inflammation, and weight gain and bloat around the belly area.

This is where simple (and delicious) swaps come in: Starting your day with healthy alternatives to caffeine can still provide you with the energy you’re looking for, and may even come with an added slew of health benefits, like detoxification, the consumption of different types of superfoods, and more.

If you’re looking for caffeine alternatives, we talked to a handful of nutritionists to find out what we should be drinking instead.

Caffeine alternatives

Teeccino

Teeccino is an herbal blend made with chicory root, cocoa, herbs, berries and other plants that give it a similar flavor to coffee, but it contains no caffeine. “It isn’t actually made with coffee beans, so it’s not the same as decaf coffee,” explains clinical nutrition specialist and founder of Ancient Nutrition, Dr. Josh Axe. Because it’s made with some nutrient-dense ingredients, Axe notes that this alternative to coffee contains antioxidants that can help to fight oxidative stress/free radical damage.

Related: Can Green Tea Extract Give Your More Energy? 

Smoothies

“The healthiest caffeine alternatives come from easy swaps,” explains Gioffre. “If you want a cleansing and filling beverage, go for a green juice or a smoothie packed with veggies and fruits low in sugar,” he said. This will give you a dose of sustained energy without the caffeine crash.

Golden milk

Gioffre swears by homemade tonics like this Golden Coconut Mylk recipe. “Theres’s nothing like a warm beverage to soothe,” Gioffre says, noting that this Golden Coconut Mylk is loaded with turmeric, which is anti-inflammatory, anti-bacterial, and highly alkalizing.

Homemade hot cocoa

“Hot chocolate is simple to make at home. All you need is 1 tablespoon 100% cacao powder, 1/2 teaspoon cinnamon, 1 cup plant-based milk of choice, and 1 teaspoon maple syrup (more or less depending on sweetness),” says is Jazz Leaf, a private chef for NBA athletes. Cacao powder, she explains, is high in antioxidants, magnesium (for healthy muscle function), and provides fiber to stimulate the body’s digestive enzymes. She added that cacao powder is a natural way to provide energy to your body when feeling fatigue, thus making it a healthy alternative to caffeine from beverages like coffee.

Detox tea

If you’re trying to kick the caffeine habit, Gioffre suggests trying this Acid-Kicking Detox Tea every morning by chopping a 1-inch piece of ginger and turmeric, pinch of black pepper, adding it to water, and steeping for 15 minutes. Add a fresh lemon slice to your mug before serving. “This healing tonic is the triple A for your health—anti-inflammatory, antioxidant, and alkaline,” he added. The Acid-Kicking Detox Tea, he explains, “will give you instant energy to begin your day, and because it lowers inflammation by reducing acidity, and you’ll experience less bloating and better digestion.

MUD/WTR

MUD/WTR is a coffee alternative that contains black tea powder, ginger, cardamom, nutmeg, black pepper, cloves, cinnamon, cacao, Himalayan salt, cinnamon, and mushrooms like lion’s mane, cordyceps, chaga, and reishi.

The small amount of black tea powder the mix contains does have a bit of caffeine, but Axe says MUD/WTR may give you a bit of a boost in energy due to its antioxidant, vitamin, and mineral content. “It’s made with a blend of superfood ingredients like medicinal mushrooms, spices, and cocoa, which are high in antioxidants and may help your body deal with stressors better,” he explains. “Cocoa is not only high in antioxidants but also naturally has some caffeine, potentially helping you focus and supporting higher energy levels.”

Dandy blend

Dandy blend is for those who love the taste of coffee, but not the caffeine,” explains Molly Knauer, a registered dietitian and Love Wellness advisor. This healthy alternative to caffeine is made of the water-soluble extracts of dandelion root, chicory and beets and the extracts of barley and rye grains. “This blend has no acidity, another reason people make the switch from coffee,” she explains. In addition, dandy blend has detoxification benefits, is high in antioxidants and contains low acidity, which makes it a healthy alternative to caffeine.

Herbal tea

Herbal tea like rooibos and chai tea can be great healthy alternatives to caffeine. “Most herbal teas are caffeine-free, although it depends on the exact kind,” says Axe. “They may help to support your energy levels by keeping you calm and aiding in sleep quality, and by supporting digestive/gut health,” he explains.

Protein shakes

When her body needs a pick me up, registered dietitian Pam Nisevich Bede, MS, RD, turns to high-quality protein. “It’s a healthy swap for caffeine and I find it can help keep my energy levels up throughout even the busiest of days,” she says.

Bede notes that not consuming enough protein during the day can be a primary reason for fatigue, as protein sources provide the body with fuel to repair and build muscles, tissues, bones and antibodies, which in turn, helps increase your strength and stamina. To get an adequate dose, she recommends fueling up in the morning with a protein shake. Add a scoop of your favorite whey or plant-based protein powder to a banana and some almond milk and you’ll be energized in no time.

A glass of water

Sounds too simple to be true, right? But research shows that even mild dehydration can affect mood and cause fatigue, so the next time you’re feeling sluggish in the morning or afternoon, try drinking a glass of water.

“One sign of dehydration is lack of energy or sleepiness. So, anytime you feel tired, drink a glass of water and reassess your fatigue in 30 minutes,”Amanda A. Kostro Miller, a registered dietitian and licensed dietitian nutritionist with Fitter Living. “You may find that you perked up with some fluid!:

Hot lemon water

“For those who enjoy a hot drink in the morning but don’t want the caffeine, I recommend starting your day with hot lemon water,” explains Knauer. She explains that when we wake up, our body is dehydrated and that the hot lemon water rehydrates our bodies along with providing the vitamin C from the lemon. “Vitamin C boosts immunity as well as collagen production, which keeps our skin looking youthful and glowing. The polyphenol antioxidants found in lemons have also been found to reduce weight gain in studies done on mice as well as improve insulin resistance,” she says.

Related: 32 Refreshing  Detox Water Recipes 

Pomegranate juice

Pomegranate juice, per certified nutritionist Ashley Reinke, is a great caffeine alternative, as it will also leave you feeling more hydrated and its natural sugar will give you a refreshing boost. This potent juice has been shown to improve blood circulation, flow, and help with muscle recovery,” she says. “These qualities make a it a great swap to your pre-workout caffeine routine as it is also high in vitamin C, E, and folate, which helps with cellular repair and regrowth,” she adds.

Kombucha

“Kombucha, a fermented tea drink, as well as other probiotic drinks are great for supporting gut health since they provide you with healthy bacteria that help inhabit your microbiome/gut,” says Axe. He cites Kevita, a sparkling probiotic beverage, as another example of a healthy alternative to caffeine. “Good bacteria in your gut can have many benefits such as supporting nutrient absorption, aiding in immunity and helping to control your appetite,” he explains.

Related: Should You Try Kombucha? 

Hot apple cider

“Cider made with real apple cider vinegar is great for supporting digestion, since apple cider vinegar contains enzymes that can help balance blood sugar levels, control your appetite, and potentially ward off issues like heartburn and indigestion,” says Axe. Upon waking up in the morning, Leaf suggests adding 1 tablespoon of apple cider vinegar, 1 tablespoon of fresh lemon juice, 1/2-teaspoon honey (more or less depending on your sweetness preference) and hot water to a mug. “Sip on it (with a straw to protect your enamel) first thing to feel your digestive system begin to work,” she suggests.

Adaptogenic tea

“For someone trying to avoid caffeine completely but looking for an energy boost, I’d recommend tea made from energizing, adaptogenic herbs such as Siberian ginseng (also known as eleuthero), ashwaganda root powder and/or rhodiola,” says Maggie Jones, a certified holistic nutritionist. These herbs, she says, are long recognized for their ability to improve energy and mood, boost the immune system, and improve stress management. “Many adaptogens have added benefits such as reducing inflammation, lowering blood sugar, improving brain function, and managing anxiety and depression,” Jones adds.

Next up: 10 Foods to Eat for Extra Energy 

June new product launches: from anti-inflammatories to zinc

June new product launches: from anti-inflammatories to zinc

  • June 30, 2020

Orgain

Orgain introduced its new Orgain Organic Sport Line of organic, plant-based powders. The food-based anti-inflammatory ingredients are high in vitamin C and adaptogens. The three new products aim to provide a clean energy boost to aid workout performance and recovery.

Orgain Organic Sport Protein Powder: Before or after a workout, this plant-based powder packs clean nutrition to aid performance and recovery. Orgain’s 30g Organic Sport Protein is a blend of organic, food-based ingredients, including 5g BCAAs to support muscle growth and reduce soreness, tart cherry powder and fermented turmeric powder to provide anti-inflammatory benefits. ($39.99)

Orgain Organic Sport Energy Powder: A plant-based energy boost that includes organic beets known for their energizing and anti-inflammatory properties, 80mg caffeine naturally divided from green coffee beans, and is high in Vitamin C from organic amla fruit. Orgain Sport Energy also offers ginseng and cordyceps mushrooms, two adaptogenic ingredients that offer a natural energy and vitality boost, while helping to support endurance and physical performance. ($27.99)

Orgain Organic Sport Recovery Powder: Orgain’s Sport Recovery Lemonade incorporates organic apple cider vinegar for electrolyte replenishment, amla fruit for Vitamin C, turmeric and ginger to reduce inflammation, and an adaptogenic blend of reishi mushrooms and ashwagandha to help reduce stress. Together, these unique ingredients aid in post-workout muscle recovery and help to reduce muscle soreness.  ($27.99)

Unleashing the Power Within Using Tumor-Infiltrating Lymphocyte Therapy

Unleashing the Power Within Using Tumor-Infiltrating Lymphocyte Therapy

  • June 30, 2020

Across cancer types, a unique immune-stimulating treatment called tumor-infiltrating lymphocyte therapy produces durable remissions that could last for decades.

 

When Teresa Byrd stepped out of the shower in February 2012, she noticed an ominous black mole, about half the size of a pencil eraser, toward the back of her right shoulder. A former hairstylist in rural Missouri who was then 44, Byrd had grown up living on a farm and baking in the sun. She had never been to a dermatologist.

“The way I was raised, we didn’t go to the doctor unless we were in pain,” Byrd says. Still, she was concerned and made an appointment with a local dermatologist. “He took one look and said, ‘I’m almost certain it’s cancer,’” she recalls. Two weeks later, Byrd received the official diagnosis: melanoma.

An estimated 100,000 Americans receive melanoma diagnoses each year. Once incurable in advanced stages with dismal survival rates, the disease has emerged as one of the most responsive cancers to immunotherapy, a treatment that harnesses the power of the immune system to fight cancer.

“Despite the best application of surgery, radiation and chemotherapy, 600,000 Americans die of cancer each year. Immunotherapy has become a fourth arm that has been very effective at treating cancer, especially melanoma,” says Dr. Steven Rosenberg, a senior investigator at the National Cancer Institute (NCI) who has been instrumental in advancing immunotherapy research for nearly 40 years. This category of treatment includes approaches ranging from checkpoint inhibitors and vaccines to cell-based strategies, including techniques like tumor-infiltrating lymphocyte (TIL) therapy, which multiplies a patient’s own cancer-fighting immune cells so they can better attack the disease.

Because Byrd’s cancer had spread to her lymph nodes and adrenal glands, she began an aggressive course of early immunotherapy called interferon. “I took a shot every Sunday night for a year,” Byrd says. “I called it the devil drug because it made every part of my body ache for several days each week.”

Interferon held Byrd’s cancer at bay until 2013, when a knot she discovered under her arm seemed to double in size by the day. Doctors treated her with 25 rounds of radiation, followed by immunotherapy with the checkpoint inhibitor Yervoy (ipilimumab) in 2014, but the cancer continued to spread. “My oncologist leaned back in his chair, put his arms behind his head and said, ‘There’s nothing more we can do for you,’” Byrd says.

When the couple left the oncologist’s office on Oct. 7, 2015, Byrd’s husband, Wesley, called The University of Texas MD Anderson Cancer Center in Houston. A clinical trial preparing to start would be investigating a new therapy; if MD Anderson doctors could tide her over until January, she would be eligible to participate.

Enter TIL therapy, a form of adoptive cell treatment that relies on patients’ own fighter T cells, a type of white cells called lymphocytes, to obliterate solid tumors. Doctors remove a metastatic tumor, identify the fighter T cells that already recognize and attack the cancer, grow them by the billions in the lab, and then infuse them back into the patient to launch a sustained attack.

It sounds like science fiction, but scientists are increasingly discovering that TIL therapy is not only possible but also could offer the best chance of durable remission among a subset of patients with hard-to-treat disease. “What better place to find cells doing battle against cancer than within the cancer itself?” Rosenberg asks.

GRUELING PREPARATION

Dating back to 1988, Rosenberg’s team showed that extracting lymphocytes from newly removed melanomas, expanding them in the lab and using interleukin 2 (IL-2), a lymphocyte growth factor, to further boost T-cell activity could produce impressive response rates.

“That was the first direct demonstration that T cells were responsible for immunotherapy-mediated rejection of cancer,” Rosenberg says. His team went on to treat hundreds of individuals who had melanoma with TILs and discovered that nearly 40% of patients experience durable remissions and long-term survival. The latest research suggests that TIL therapy may produce results in other cancer types.

Unlike chimeric antigen receptor T-cell therapy, which is approved to treat some blood cancers and relies on genetically engineered immune cells to battle disease, TIL therapy recruits the patient’s unaltered T cells — but only the rare subset demonstrating a natural ability to zero in on the cancer. The rub: “Doctors have to deplete the patient’s immune system so that, when you infuse the TILs back into patients, they don’t have to compete against other immune cells for resources,” says Dr. Amod Sarnaik, a surgical oncologist at Moffitt Cancer Center in Tampa, Florida.

To temporarily annihilate any cancer cells circulating in the blood, patients go on lymphodepleting chemotherapy, which is essentially an amped-up regimen. Side effects include diarrhea, vomiting, mouth sores and debilitating fatigue. Patients may also experience anemia and reduced platelet and white cell counts.

The treatment is so grueling and the risk of opportunistic infection so great that patients are often hospitalized until after their TIL infusion takes place seven to 10 days later.

In November 2015, doctors at MD Anderson removed a piece of Byrd’s tumor from her lung, separated out the fighter T cells and began growing them in a facility lab. To complete the treatment, the Byrds moved to Houston in February 2016, leaving their youngest son at home during his senior year of high school with their oldest son, who was student teaching at a nearby school.

“I was gone for so much of Collin’s senior year,” Byrd says. “Colton, my oldest, recorded every event, every basketball game, every important moment. They would even FaceTime me and tell me what they were fixing for supper.”

While Byrd pushed through chemotherapy, scientists grew her T cells in the lab, expanding the count to 20.1 million. Then, on her husband’s 48th birthday, it was party time. “Everyone from the nurses to the doctors to the laboratory technicians came to my hospital room,” Byrd says. “It was like a big celebration. Our friends had planned to surprise Wesley with a birthday party in my room. They brought in pizza and beverages at the same time doctors came into my room with the infusion bag.”

Byrd wasn’t out of the woods yet. After TIL therapy, patients receive treatment with IL-2, a protein called a cytokine that helps the fighter T cells grow. It’s the same agent used in the lab to spur TILs to multiply. “IL-2 stimulates the T cells that have been infused back into the patient to grow and establish themselves as part of the patient’s immune system,” says Dr. Amir Jazaeri, director of the gynecologic cancer immunotherapy program at MD Anderson.

T cells sometimes cause fever and chills as they’re being infused, and the IL-2 administered afterward has potentially significant side effects, including changes in blood pressure and heart rate. Some patients even require treatment in the intensive care unit. “The chills and shakes were so violent that Wesley had to put a stocking hat on my head and a scarf around my neck.

I was layered in three heated blankets, and when the chills started up, he would sit on the bottom of my legs so I wouldn’t fall off the bed,” Byrd says.

Most of the side effects of treatment occur during the hospital stay and shortly thereafter. Because it’s a one-time treatment, the more time that passes after the T-cell infusion, the fewer the significant side effects. That’s a departure from immune checkpoint inhibitors, infused drugs that disable certain proteins to activate the immune system against cancer; patients need to stay on that treatment for months or even years at a time. As a result, “with checkpoint inhibitors, the onset of side effects could happen months after starting therapy,” Jazaeri says.

By the end of March 2016, Byrd was back home, preparing for her son’s high school graduation, and she hasn’t been on any therapy since. “It was one of the most emotional moments of my life,” Byrd says. “I didn’t realize how hard my illness was for my son until graduation, but I think the experience made us feel stronger and closer as a family.”

With the help of the single TIL treatment, Byrd’s body continued fighting the cancer for the next four years. As of February 2020, she has had no evidence of disease.

TIL THERAPY IN TRIALS

The success of TIL therapy rests largely on whether scientists can identify mutations inside the tumor. This allows them to test which T cells are able to recognize and attack the “drivers” of a cancer and then focus on multiplying that special population of immune cells in the lab.

Melanoma is the low-hanging fruit of immunotherapy targets because it’s usually induced by ultraviolet radiation and resulting DNA damage. “That’s why melanoma has a much higher rate of mutations compared to other types of cancers,” Sarnaik says. It also allows the immune system to distinguish a melanoma cancer cell from a normal cell, just as it would recognize bacteria or viruses.immunotherapy TIL tumor-infiltrating lymphocyte cancer white blood cells treatment

Scientists are investigating whether cervical cancer would also be amenable to TIL therapy, because about 90% of these cancers are caused by HPV. “Cervical cancer doesn’t have the high mutational burden of melanoma, but it can still display targets on the surface of the tumor cells because it tends to be caused by a virus,” Sarnaik says. That makes it more detectable by the immune system.

Iovance Biotherapeutics in San Carlos, California, is already proving to be a leader in this space, with TIL technology in phase 3 clinical trials for advanced cervical cancer and metastatic melanoma. In May 2019, the company reported a 44% response rate among 27 women with advanced cervical cancer that had progressed on previous treatments, including three patients whose disease disappeared. Among 66 melanoma patients, 38% responded, including two who had no evidence of disease.

Rosenberg emphasizes that this kind of treatment is not cancer type-specific. The past decade brought an explosion of trials investigating whether TIL therapy may have a role in various cancers, including breast, colorectal and head and neck. “All cancers have mutations. The key is targeting them effectively,” he says.

That can be tricky, especially for common epithelial cancers. These types, which represent about 90% of new cancer diagnoses in the United States, begin in the cells that line organs such as the breasts, lungs and ovaries. Although Rosenberg’s team has developed highly selective techniques to identify the rare immune cells in these tumors that recognize the cancer, they amount to about 1 in every 10,000 to 1 in every 100,000 lymphocytes — like a needle in a haystack.

Even with these minuscule numbers, if doctors identify the right lymphocytes and expand them in the lab by the billions, some patients can achieve durable response rates. Judy Perkins, a nature lover and former engineer from Port St. Lucie, Florida, is just one example.

She received a diagnosis of stage 0 breast cancer in 2003, and her only treatment was surgery. A decade later, when her youngest child was graduating from eighth grade and her oldest was a high school sophomore, Perkins’ breast cancer returned. For two years she tried hormonal therapies and chemotherapies. She had even been in a clinical trial for a targeted drug called lucitanib. When those treatments failed and doctors told her she had only a few months to live, she started working on her bucket list.

“I spent as much time with my friends and family as I could. I intended to curl up with my cats and read books or watch TV until I died,” says Perkins, who was 50 at the time. A lobbyist and advocate for breast cancer research, Perkins decided to attend one last training conference: Project LEAD, sponsored by the National Breast Cancer Coalition. While there, she learned that an NCI-sponsored clinical trial was underway to investigate TIL therapy in metastatic cancers.

To be eligible, patients had to have at least two tumors, one to be removed to obtain the TIL and one for doctors to monitor to see if the treatment was working. Perkins was a good candidate because, unlike many other patients with breast cancer, she had tumors to work with. “Patients with (advanced) breast cancer often have bone-only disease. By the time they develop tumors that can be surgically removed, usually in the liver and lungs, patients are too sick to tolerate treatment,” Perkins says.

A few weeks after the training, scientists sequenced DNA and RNA from one of Perkins’ tumors, as well as normal tissue to determine which mutations were unique to her cancer. They identified 62 mutations in her tumor cells. The TILs recognized four of them. Researchers expanded those four TILs to 81 billion in the lab before reinfusing them back into Perkins.

Between her surgery in August 2015 and when the multiplied TILs were ready in December, Perkins had deteriorated dramatically. By the time she arrived at the National Institutes of Health, she was in a lot of pain and tumors had spread throughout her liver. She knew the odds of the TILs working were less than 15%, but she also knew it was her last chance for a viable treatment.

“Within days, I could tell the tumor was getting softer and smaller,” Perkins says. “By February, I had a 60% reduction in tumor size. By April, I was backpacking on the Appalachian Trail. And in May, I had my first clean scan.” The cancer was gone and has been ever since.

Perkins is still an outlier for her ability to receive TIL therapy and her dramatic response; her case was featured in a 2018 paper in Nature Medicine. Researchers have seen similar results using TIL treatment for patients in the same trial with other cancers, including liver, lung and colorectal. “For those of us who were fortunate enough to have a complete response, none of us have ever relapsed,” Perkins says.

CAVEATS WITH CUSTOMIZATION

TIL therapy, though decades in the making, is still in its infancy, and the process is complex. “It’s important to understand that TIL is still a highly experimental treatment that’s only available at a few institutions,” Rosenberg says.

The ultimate in personalized immunotherapy, TIL therapy requires customizing a treatment for each patient. The time-consuming and expensive endeavor is expected to cost about half a million dollars, rising to over $1 million when hospital stays are added. Before receiving treatment, patients have to wait for scientists to identify the effective lymphocytes and grow them in a lab, a process that can take months. Many people with aggressive, metastatic disease don’t have that kind of time.

Plus, people with advanced disease may not be able to tolerate the high-dose chemo- therapy required to deplete the immune system or the IL-2 needed to boost T-cell production after infusion. Therapy requires two to three weeks of inpatient treatment, and even under ideal circumstances, there are no guarantees that it will work.

“A lot of research is going into exploring the responders versus the non-responders,”

Jazaeri says. Studies suggest that younger patients have higher odds that their TILs will successfully multiply in the lab than other groups — 94% for patients under 30 compared with 46% for those over 60. Women, too, produce a higher TIL generation rate than men at 71% versus 57%, respectively. Byrd and Perkins, both women, were well under 60 when they underwent TIL infusion.

Researchers are working hard to iron out these kinks. Iovance has already halved the time it takes to make TIL therapy, from 42 days to 22. And as a one-and-done treatment for metastatic cancers, TIL therapy could save health care dollars over the long run. “If a treatment works, it has been my experience that the genius of American industry will find a way around obstacles like production time and cost,” Rosenberg says.

 

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