Monthly Archives: June 2020

BetterLife Pharma Inc. (OTCMKTS:PVOTF) Announce Proposed Merger With Altum Biotechnology and Release Exploratory Study Results – FactsAboutCBD

Posted: June 11, 2020 at 4:47 am

NewLeaf Brands Inc (OTCMKTS:NLBIF) informed the shareholders about its recent developments. We Are Kured, which belongs to NewLeaf, introduced innovative CBD flower pre-rolled joints on April 9. The company received an overwhelming response from the customers. To meet the growing demand from customers, the company expects to improve the distribution network in the US.

NewLeaf entered a share swap pact on April 23, 2020, with Levee Street Holdings, LLC, to acquire a stake of 50% for CAD 450,000. Levee Street is established to venture into an alternative beverage like CBD products. Greg Kassanoff founded companies such as Levee Street, and Pioneer Wine and Spirits. He is also working as CEO at MPWS (Mexcor Pioneer Wine and Spirits), which maintains several restaurants and retail relationships across Texas.

The network developed by Greg is playing a vital role in introducing a product line of NewLeaf across the state of Texas. CEO of NewLeaf, Joshua Bartch, said its team is working hard to become a leading player in product categories like hemp, mushroom, and cannabis.

NewLeaf entered pact on April 29, 2020, to take over a vertically integrated firm Mydecine Group, which uses wellness, health, and medicinal properties of compounds available in mushrooms.

NewLeaf signed an accord on May 5, 2020, to clinch a 37.5% stake in Trellis Holdings Oregon, LLC. As per the terms of share exchange the deal, NewLeaf will acquire all of the issued and outstanding capital of Trellis from Benjamin Martch and David Joshua Bartch.

Trellis, which owns several licenses with OLCC in the Oregon state, conducts business operations in recreational and medical cannabis. The company also maintains recreational cannabis cultivation on eleven-acre land in Southern Oregon. In Portland, Oregon, Trellis operates recreational and medical cannabis dispensaries. The company seeks additional licenses to improve canopy cultivation outdoor on 40,000 Sq. Ft.

NewLeaf inducted Robert Roscow as CSO and Damon Michaels as COO on May 12, and 11 2020. The company entered a share exchange deal on May 21, 2020, to acquire MindLeap Health Inc., an advanced telemedicine platform.

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Meditation app improves pain management at Hartford Hospital – Healthcare IT News

Posted: June 11, 2020 at 4:46 am

Medical staff at Hartford Hospital in Hartford, Connecticut, have long been believers in meditation as a powerful integrative wellness method. However, many of the staffs issues with the use of meditation in a clinical environment revolve around the consistency of meditations, the variety of meditations and the scalability of meditation.

THE PROBLEM

In looking for a way to provide consistency to patients, Hartford Hospital sought to partner with a local company with expertise in both meditation and technology that thought in a similar way to the hospitals staff.

HIMSS20 Digital

Our partnership requirements included four things, said Dr. Eric R. Secor, chief of integrative medicine at Hartford Hospital. First, provider and practitioner involvement in the process. Second, high-grade, consistent meditations designed using evidence-based rubric. Third, ease of access. And fourth, ability to track the patients use of the meditations.

Hospital staff need to understand who is using meditation, how often they are using meditations and which ones they are using. In addition, the ability to collect data on outcomes was a critical decision-making factor for staff.

PROPOSAL

Hartford Hospital went with MediGrade, a vendor of machine learning-powered mobile health technology designed to reshape pain therapy and enhance self-care.

Dr. Eric R. Secor, Hartford Hospital

The company was very proactive in working with granting agencies such as the Connecticut Innovations, the state of Connecticuts venture arm, to raise funds with the goal of collecting data, Secor explained. In my 25 years in integrative medicine, we have seen a wide variety of breadth and depth of experience of folks who wanted to provide meditations, whether it be in hospital, in the ambulatory setting or in group settings. All these folks, although well-meaning, had such a wide diversity in experience and certifications that it was very difficult to provide a consistent meditation experience.

The nice thing about the mobile health platform, he added, is once its built and deployed, anyone within the hospital, in the ambulatory setting or at home can use the same, consistent meditation no matter where they are being seen throughout the health system.

MEETING THE CHALLENGE

Our app, which is now in a clinical pilot, eliminates the dependency on individualized meditation facilitators and the logistics of hosting group meditation events, Secor said. Our app provides us with a reliable, consistent, data-driven solution that allows us to solve the issues and bridge the gap.

To start, staff has deployed the m-health, machine learning meditation app to patients who are being treated for chronic pain, specifically neck pain, back pain, neuropathy and migraine headache. A future integration with Hartford Hospitals Epic EHR is in the early planning stages. Staff also is piloting bringing in telehealth access into Epic MyChart Plus to broaden use on the patient end.

RESULTS

Secor is in the process of writing the next innovations grant and preparing to analyze clinical pilot data.

Weve learned a lot about not only partnering with the folks on the digital meditation side, but also who are the champions for meditation within our system, he said. This grant had two big phases. Phase one was to build and deploy a white-labelled app within Hartford Healthcare, which we have achieved. Phase two was to launch a feasibility pilot, which is underway.

Now there is widespread interest in the digital delivery of meditation across the organization. In the process of building the app, it was surprising to Secor that there were more interested parties among more subspecialists than he ever thought possible.

Just in the process of hearing about the app, downloading the app and trying the app, we generated interest from specialists in addiction, orthopedics, oncology, womens health and migraine headache, he noted. Our migraine center is now interested in customizing some aspect of the app in their practice for their patients.

ADVICE FOR OTHERS

Partner with reputable people who understand how health systems operate and are reliable business partners, Secor advised. Your partner should possess expertise in delivering a high-quality application, but also offer evidence-based rubric in their writing that includes provider and patient input, high-quality voiceover talent, and custom-composed ambient music. Your partner should be able to edit, update and change your app with agility, and be flexible.

This movement is advancing Hartford Hospitals patients ability to become even more active members on their own wellness team, Secor concluded.

Twitter:@SiwickiHealthITEmail the writer:bill.siwicki@himss.orgHealthcare IT News is a HIMSS Media publication.

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Reiki that – how some Americans use alternative medicine to deal with stress – Yahoo News

Posted: June 11, 2020 at 4:46 am

When Black Lives Matter protests started around the world, Reiki Level 3 student, Indra Gandy, decided to use her skills in the alternative healing technique to help.

"At this point, I become a conduit of positive energy," Gandy described the Reiki ritual she performed on a pier bench, a walking distance from her Staten Island home. "You are purposely giving them love and pure energy, health, stability and positive strength."

Reiki, which was developed in Japan in early 20th century, is often described as alternative medicine through energy healing.

In Japanese, the first part of the word, 'rei,' means "spiritual" and the second, 'ki,' stands for 'vital energy' or 'life force.'

Practitioners believe that a Reiki treatment can be performed from a distance.

"A Reiki practitioner doesn't actually have any secret powers," said Reiki Master Erin Tschantret. "Anyone can practice Reiki. It's really, like, if a plumber were to open up a pipe and then suddenly water can flow through it, the practitioner is the pipe in the Reiki is the water. And it works on every level, so mental, emotional, physical, spiritual."

Tschantret's client, Rachel Garbow Monroe, said distance Reiki helped her fight COVID-19.

"The first time I talked to her when I was ill, I had had almost an entire week of a fever," Rachel Garbow Monroe said. "And the next day, my fever broke."

Tschantret's another client, writer and an author of a book "Zen Bender," in which she explored many alternative healing techniques of dealing with stress, Stephanie Krikorian, said distance Reiki has been helpful in the coronavirus era.

"People are afraid, we are at the end of our rope and feeling very stressed and anxious," Krikorian said. "You can do something without being near somebody, when we're all sort of separated and trying to hunker down and things are easing up a little, but everybody is still not comfortable."

Over the past 20 years, Reiki has become more and more popular in some of the most respected American hospitals, such as Yale Cancer Center.

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"I'm not going to be the first person to tell you that there's a ton of evidence behind it," said Dr. Gary Soffer, who runs the Integrative Medicine Program at the Cancer Center and Smilow Cancer Hospital in New Have, Connecticut. "But what I will tell you is that when we deal with patients one on one, it's really meaningful, and it's really helpful."

Several studies showed that Reiki helps diminish negative side effects of chemotherapy, recover from surgery, regulate nervous system, and deal with pain.

But there is no research paper that explains how Reiki works.

There is also no proof that healing energy can pass between people on command.

(Production: Aleksandra Michalska)

- They treating us like this.

- You are visualizing in your heart and minds the protesters, and the fear, and the anger, and all the things that are happening. And you are purposely giving them love and pure energy, health, stability, and positive strength.

- So what a Reiki practitioner does is they channel that energy to the person. So it's like you're getting flooded with this intense energy, knowledge, intelligence that knows how to get you to your best place. So it only ever works for your highest and greatest good. And it works on every level, so mental, emotional, physical, spiritual. And it helps get you back in alignment.

- I suffered both from COVID, and then a few weeks later, I had another acute illness. And she took care of being in touch with me and asking how I was doing. And you know, she believes very strongly in the power of Reiki, whether she's in the room or not.

And I leave it to you to determine the results. But I-- the first time I talked to her when I was ill, I had had almost an entire week of a fever. And she was incredibly sweet, and solicitous, and wanted to know how I was feeling and what specifically I was struggling with. And the next day, my fever broke.

- It's a great thing for the time. Distance Reiki, that you can do something without being near somebody when we're all sort of separated, and trying to hunker down. And things are easing up a little, but everybody's still not comfortable.

- The first question we ask ourselves in integrative medicine is, is this invasive? Is this going to be harmful to the patient? And then the next question is, is this helpful? Right? Is there evidence behind it?

So with Reiki, I'm not going to be the first person to tell you that there's a ton of evidence behind it. But what I will tell you is that when we deal with patients one on one, it's really meaningful, and it's really helpful. And because it's non-invasive, because it does no harm to our patients, it's a really meaningful and helpful intervention for them.

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Why smarter self-care is a win-win for doctorsand their patients – American Medical Association

Posted: June 11, 2020 at 4:46 am

Nutrition plays an important role in the maintenance of a persons health and well-being. While system level solutions to address physician burnout are most effective, self-care can also play a role. And a big part of self-care for physicians is eating right. By learning more about nutrition and keeping the topic front and center, physicians can take better care of themselvesand their patients.

TheCME module, Nutrition Science for Health and Longevity: What Every Physicians Needs to Know, isenduring material and designated by the AMA for a maximum 4 AMA PRA Category 1 Credit, and helps physicians begin an effective nutrition conversation with patients. The four-hour, self-paced course is developed and hosted by the Gaples Institute for Integrative Cardiology, a nonprofit focused on enhancing the role of nutrition and lifestyle in health care.

The course includes four modules that are distributed in collaboration with the AMA Ed Hub, an online platform with high-quality CME/MOC from many trusted sources to support lifelong learning of physicians and other medical professionals. With topics relevant to youincluding numerous CME modules on physician burnoutthe AMA Ed Hub also offers an easy, streamlined way to find, take and track educational activities in one place, with automatic CME/MOC credit reporting for some state and specialty boards.

Nutrition is a huge gap in physician training, said AMA member Stephen Devries, MD, a cardiologist and executive director of the Gaples Institute in Deerfield, Illinois. As a result, physicians tend to make decisions about their own health the same way the general public does, often based on what they read in the lay press.

Interestingly, recent physician training program guidelines stress the importance of a healthy diet for physician self-care and mitigation of burnout, but how can physicians make meaningful dietary changes themselves without a solid background in nutrition? he said.

Dr. Devries shared these key tips that can help physiciansand their patients.

Many physicians are stressed and dont have enough time to do what they need to do. And when it comes to eating, physicians are like many other Americans and too often choose a quick and convenient option such as fast food.

Although the donut or bag of fries might seem like an appealing distraction during a stressful day, most people find so-called comfort food to be distinctly uncomfortable half an hour later. However, meals made from colorful vegetables, whole grains, predominantly plant sourced proteins (beans and tofu) and fruit leave them feeling more alert and in a brighter mood throughout the day.

Its also important to think about the culture of eating in medical settings. Hospital noon conferences are often accompanied by pizza and sugar sweetened drinks, exactly the foods we urge our patient to avoid.

Learn more with the AMA about how to give patients good nutrition advice when time is short.

When physicians adopt healthy lifestyle practices, they are more likely to counsel their patients to do the same. Doctors should lead by example on healthy eating.

As a first step, look in the mirror and work on making positive changes in your own diet, first and foremost because you deserve it, said Dr. Devries. But the kicker is that better self-care also translates into better patient care. You will be sharper and more available to your patients, and also more likely to counsel them to adopt healthier habits.

Sharing how physicians overcame lifestyle related health challenges in their own livessuch as lack of time and stresscan also help advance discussions with patients.

Most patients want to feel like their physician has a personal interest in them and nothing conveys a personal interest more than a physician or nurse who shares a bit of their own personal story and how it led to their own better health, said Dr. Devries. That is a great opportunity to increase trust.

Read more about how burnout can hinder patient-physician communication.

Another factor that promotes burnout in medicine is a sense of lost professional purpose.

Medicine has become so mechanized and algorithm-driven and electronic medical record-focused that some of the original appeal of medicine can get lost, said Dr. Devries, adding that connecting with patients for even a brief period of time on the topic of nutrition and lifestyle really brings physicians back to why they went into medicine in the first place.

Learn more about AMA CME accreditation.

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Why a wellness routine is your top priority amid protests and the pandemic and how to start – ABC17News.com

Posted: June 11, 2020 at 4:46 am

As states gradually reopen even as the pandemic wears on, many of us are concerned about our health and well-being. Especially now, with some continuing to stay at home and social distance while others join the throngs at nationwide Black Lives Matter protests, it may even be a priority.

From state to state, the loosening of restrictions vary, and within our local communities, the reality is that not only do people have different ideas on what constitutes social distancing but for many others still, in the face of racial inequality, the desire to create social change far outweighs the potential risk of spreading or catching the virus.

Its all the more reason to make sure were taking the best care of ourselves to fortify against the disease. But while living a healthy life may be a desired goal, how to achieve it is another story.

Even if youre someone whose healthful habits were perfected to a tee during pre-pandemic times, you may find yourself struggling to engage in even the most basic self-care in these increasingly unpredictable days.

Thats where a wellness routine can come in handy.

Im not talking about a spa escape every so often or even regular massages or chef-prepared meals (though all of that may sound really nice). Im talking about creating your own personalized routine that will benefit you physically and emotionally, one that simply requires a regular commitment to yourself.

Creating a wellness routine allows you to shift from diet culture and adopt healthy habits that easily fit into your daily lifestyle. Whats more, having a routine allows you to focus on health goals by creating structure and organization, which can be particularly beneficial when things seem out of your control, like life during an unprecedented pandemic and simultaneous upheaval as people fight against social injustice.

In fact, predictable routines, or ritualistic behavior developed as a way to induce calm and manage stress caused by unpredictability and uncontrollability, heightening our belief that we are in control of a situation that is otherwise out of our hands, according to researchers at Tel Aviv University.

We need an internal structure because our external lives have become totally unstructured and that triggers anxiety and stress, said Robin Foroutan, a New York City-based integrative medicine dietitian and spokesperson for the Academy of Nutrition and Dietetics.

In the beginning, we thought this was going to be a little break; a couple of short weeks, and then wed resume life as we knew it. Now we know that probably is not going to be the case. We dont know how long this will last, but we can find ways to stay steady and structured on the inside amidst the chaos outside.

Engaging in a wellness routine with a focus on good nutrition, exercise, sleep and stress management can boost our health and well-being and strengthen our immunity during a time when we may need it most.

And while social obligations, travel and other commitments typically make it challenging to start new habits, being stuck at home without these distractions provides an opportune time to start creating a wellness routine that is accessible, doesnt require a lot of money and is something that you can count on during this uncertain time and in the future, too.

Health experts say its important to create a manageable routine that you can stick with as part of a lifestyle not something overly ambitious that you cant sustain. One way to do that is to start small and build upon it, as you feel comfortable.

Here are some tips to get started in creating your personal wellness routine.

Most people feel better when they are going to bed and waking up at consistent times, eating regular meals and snacks and getting a steady dose of exercise, said Marysa Cardwell, a registered dietitian, nutrition therapist and certified personal trainer based in Salt Lake City, Utah.

For sleep: Everyones sleep schedule is different, and thats OK, as long as you stick to your natural circadian rhythms, experts say. That means going to sleep when the sun is setting (or a bit later) and waking up when sun is rising (or a little later, according to your individual needs).

Aiming for seven to nine hours of sleep is key, as it helps to reduce the stress hormone cortisol and your adrenal load, Cardwell said.

Getting adequate sleep also bodes well for engaging in other healthful behaviors by going to bed at a reasonable hour, youll be less likely to engage in nighttime eating or mindless eating in front of the TV, and youre more likely to wake up early and start exercise, Cardwell explained.

For eating: Setting regular meal times, and taking a break to eat your food mindfully is key, Cardwell advised, but when you actually eat is up to you. Some do well on three meals per day with an afternoon snack; others prefer three smaller meals and three snacks.

Regardless of the pattern you choose, aim to eat at least every four hours, which prevents blood sugar from crashing and can lead to overeating. For example, if youre eating three meals and one afternoon snack, you might choose to eat breakfast at 8 a.m., lunch at 12 p.m., a snack at 4 p.m. and dinner at 7 p.m.

Taking a few deep breaths, enjoying the wonderful smells of the food you are about to eat and chewing food really well can all help make mealtime a healthful ritual, Foroutan explained.

Additionally, dinnertime can become a daily social ritual by sharing the meal with family or friends, advised Jen Scheinman, a Denver-based registered dietitian nutritionist and owner of Jen Scheinman Nutrition, a virtual nutrition coaching practice. Even a Zoom dinner with a friend if youre by yourself can help you feel connected.

For fitness: Pick a time that youre most likely to stick with. That might mean taking a morning walk before your day gets started, or scheduling your favorite fitness class on your calendar so you wont forget.

I shut my day down with a run or yoga at around 5:30 p.m. Thats my last thing for the day. The more you can make it a routine, the less you have to think about it, Scheinman said.

Planning what you will eat and how you will exercise means that you are more likely going to do what you intend to do, which will ultimately help you achieve your health goals. For example, planning meals in advance means youll be less likely to reach for quick sugary snacks when you run out of energy. It also helps to limit shopping trips.

Not only does planning your meals ahead of time help cut down on the number of times youre going to the grocery store, but it can also help reduce food waste and ensure you have meals that were intentionally picked to fit your nutritional goals, said Denver-based registered dietitian nutritionist Kelli McGrane.

For food: Eating a nutrient-rich breakfast sets the stage for making other healthful choices throughout the day.

Choose protein-rich breakfasts like egg whites, cottage cheese or smoked salmon on a bagel; Greek yogurt, smoothies with low-fat milk, high fiber cereals with milk or peanut butter on whole wheat toast.

Scheinman recommended preparing breakfast foods ahead of time, like making overnight oats with milk. It makes the breakfast routine less daunting.

For lunch and dinner, Cardwell encouraged a fist-size portion of protein, such as fish, chicken or beans; a fistful of carbohydrates like whole wheat pasta or brown rice; and a half plate of veggies. This will help meet your micronutrient needs, as well as fiber. Use fats sparingly, as a condiment, to make your food taste better, but limit fried foods and saturated fat, Cardwell advised.

For snacks, choose protein and carb combos, like cheese with crackers, sliced fruit with peanut butter, nuts and seeds with dried fruit or Greek yogurt. Pairing protein with carbs helps keep your blood sugar level stable, and helps you stay fuller longer, Cardwell said.

Scheinman recommended using the weekends for batch cooking, like making chili or soups, which you can freeze to enjoy later in the week. Washing and chopping veggies and fruit during the weekend can also save you time during the week.

For fitness: Pick a fitness activity that inspires you and is doable. There are a lot of fitness apps offering free trials and online Zoom fitness classes, so you can use this time as an opportunity to try something new. Cardwell recommended aiming for at least 30 minutes per day, if possible.

If you are looking for a simple at-home cardio workout, MaryAnn Browning, founder and CEO of Browningsfitness in New York, recommended jumping jacks, high knees, butt kicks, burpees and switch jumps during which youll jump to turn 180 degrees and then back again for 15 seconds each. Then repeat the circuit five to 10 times, depending on what you can handle.

For at-home fitness essentials, Browning recommended getting a set of yellow, green and red resistance bands, which can be used for back, bicep, triceps, shoulders and leg work. She also recommended looped bands to go around the calves or thighs, which strengthen the glutes and can help prevent knee and back injuries.

If you want to weight train but dont have equipment, anything that will give you muscle tension will be beneficial, such as jugs of water, books or even your children. I use my kids Ill do planks and have them sit on me or Ill do leg presses while letting them do airplane, Cardwell said.

And dont forget to keep moving throughout your day. Tracking apps like Lose It! are a good way to see how normal daily activities can all count toward our daily fitness goals.

Dancing with your kids or partner, yard work, house projects, sex and cleaning are all trackable activities. Doing these activities with intention and extra vigor all count towards a healthy lifestyle, said Cardwell, who is also a contributing dietitian for Lose It!

For sleep: Engage in a bedtime routine where you can quiet down and prepare for sleep. Turn off electronics, including the TV, iPad, and cell phones an hour before bedtime, Scheinman advised. This helps to reduce exposure to blue light, which the brain perceives as daylight, so your brain is not quite getting the signal that its nighttime and melatonin is not produced.

Unplugging also prevents you from checking one more email or scrolling through social media while in bed, which can be stimulating and interfere with sleep, Scheinman explained.

Most experts recommended engaging in a morning ritual that brings you pleasure. Starting your day with the same routine each morning can bring steadiness and calm to the rest of the day. You are starting from a more grounded and positive place, versus waking up; grabbing the phone and checking the news and getting stressed out, Foroutan said.

The morning is a nice time to start integrating things you didnt have time for previously like taking the dog for a longer walk in the morning, making a nice cup of coffee you can sit and enjoy or engaging in a meditation practice, Scheinman added.

It sets the day off with a healthy intention, with a sense of comfort. I know this is what I do, Scheinman said.

Foroutan enjoys waking up and writing down three things she is grateful for. Starting the day with a thought about gratitude can be really centering. Writing it down does something extra it solidifies the thought and intention. Not every day is good but theres something good in every day. Even if its one small thing that gives you a sense of gratitude thats really grounding and it can help shift your perspective.

Stretching your body after you wake up or doing a sun salutation can help to get your blood flowing and your body moving in the morning.

Its also important to prioritize self-care. Make stress relievers like enjoyable activities a non-negotiable right now, Cardwell said. That may include knitting, taking an extra-long shower or bath, reading, taking a tea break, enjoying a glass of wine or calling family members. Even better, schedule these stress relievers into your day just like mealtimes and other obligations.

Were taking stock of whats important and [our] health is important. Doing these things now can help you deal with the stress of right now, Cardwell said.

It can also keep you healthy and feeling good well into the future, too. Thats a gift from quarantine life if there ever is one.

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Impact of Covid-19: Health Coaching Market Climbs on Positive Outlook of Excellent Growth by 2027: Aetna, American Association for Health Education -…

Posted: June 11, 2020 at 4:46 am

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Princeton Researchers Catalog the Gut Microbiomes Impact on Medications – SciTechDaily

Posted: June 11, 2020 at 4:46 am

Study investigates potential for the intestinal microbial community to alter drug safety and efficacy.

Researchers at Princeton University have developed a systematic approach for evaluating how the microbial community in our intestines can chemically transform, or metabolize, oral medications in ways that impact their safety and efficacy.

The new methodology provides a more complete picture of how gut bacteria metabolize drugs, and could aid the development of medications that are more effective, have fewer side effects, and are personalized to an individuals microbiome.

The study was published today (June 10, 2020) in the journal Cell.

Researchers at Princeton created a system for evaluating how the bodys gut bacteria alter the safety and efficacy of everyday drugs. The system can be used in pharmaceutical research to improve drug discovery and development. Credit: Janie Kim. Published in Cell

Previous studies have examined how single species of gut bacteria can metabolize oral medications. The new framework enables evaluation of a persons entire intestinal microbial community at once.

Basically, we do not run and hide from the complexity of the microbiome, but instead, we embrace it, said Mohamed S. Donia, assistant professor of molecular biology. This approach allows us to gain a holistic and more realistic view of the microbiomes contribution to drug metabolism.

The team used the approach to evaluate the gut microbiomes effect on hundreds of common medications already on the market. The intestines are the primary region where pills and liquid medications are absorbed into the body.

The researchers identified 57 cases in which gut bacteria can alter existing oral medications. Eighty percent of those had not been previously reported, emphasizing the potential of the method for revealing unknown drug-microbiome interactions.

These alterations range from converting the medicine into an inactive state which can reduce its efficacy to converting the drug into a form that is toxic, potentially causing side effects.

The framework could aid drug discovery by identifying potential drug-microbiome interactions early in development, informing formulation changes. The approach can also help during clinical trials to better analyze the toxicity and efficacy of drugs being tested.

The intestines are home to hundreds of species of bacteria. The makeup of these communities what kinds of bacteria and how many of each species can vary considerably from person to person.

This inter-person variability underscores why studying a single bacterial species makes it impossible to compare the microbiomes metabolism of drugs between individuals, Donia said. We need to study the entire intestinal microbial community.

The researchers found that some peoples microbiomes had little effect on a given drug, while other microbiomes had a significant effect, demonstrating how important the community of bacteria rather than just single species is on drug metabolism.

Everyones microbiome is unique, and we were able to see this in our study, said Bahar Javdan, an M.D.-Ph.D. student in molecular biology and a co-first author on the study. We observed three main categories drugs that were consistently metabolized by all the microbiomes in our study, drugs that were metabolized by some and not by others, and drugs that were not subject to any microbiome-derived metabolism.

The methodological approach could be valuable for personalizing treatment to the microbiome of each patient. For example, the framework could help predict how a certain drug will behave, and suggest changes to the therapeutic strategy if undesired effects are predicted.

This is a case where medicine and ecology collide, said Jaime Lopez, a graduate student in the Lewis-Sigler Institute for Integrative Genomics and a co-first author on the study, who contributed the computational and quantitative analysis of the data. The bacteria in these microbial communities help each other survive, and they influence each others enzymatic profiles. This is something you would never capture if you didnt study it in a community.

The framework involves four steps for systematically evaluating the intestinal microbiomes effect on drugs.

First, the researchers collected 21 fecal samples collected from anonymous donors and cataloged the bacterial species living in each individual. They found that the donors each had a unique microbial community living in their guts, and that the majority of these personalized communities can be grown in a lab culturing system that they developed.

Next, they tested 575 FDA-approved drugs to see if they are chemically modified by one of the 21 cultured microbiomes, and then tested a subset of the drugs with all the cultured microbiomes. Here, they found microbiome-derived metabolites that had never been previously reported, as well as ones that have been reported in humans and associated with side effects but their origins were unknown. They found cases where all the donor microbiomes performed the same reactions on the drug, and others where only a subset did.

Then they examined the mechanisms by which some of the modified drugs are altered by the cultured microbiomes. To understand exactly how the transformations occurred, they traced the source of the chemical transformations to particular bacterial species and to particular genes within those bacteria. They also showed that the microbiome-derived metabolism reactions that are discovered in this manner can be recapitulated in a mouse model, the first step in adapting the approach for human drug development.

###

Reference: Personalized mapping of drug metabolism by the human gut microbiome by Bahar Javdan, Jaime G. Lopez, Pranatchareeya Chankhamjon, Ying-Chiang J.Lee, Raphaella Hull, Qihao Wu, Xiaojuan Wang, Seema Chatterjee and Mohamed S. Donia, 10 June 10, 2020, Cell.DOI: 10.1016/j.cell.2020.05.001

Additional contributors to the study were postdoctoral research associates Pranatchareeya Chankhamjon, Qihao Wu and Xiaojuan Wang; graduate student in molecular biology Ying-Chiang J. Lee, graduate student at Cambridge University Raphaella Hull; and Seema Chatterjee, research lab manager.

Funding for this study was provided by the Princeton Department of Molecular Biology, the National Institutes of Health, the New Jersey Commission on Cancer and the National Science Foundation.

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Calgary’s Neurvana Health maps your brain to deliver results-based wellness solutions – LiveWire Calgary

Posted: June 11, 2020 at 4:46 am

Your brain could be the road map to better health. CONTRIBUTED

Think of your brain as the road map to better health.

It can tell you exactly how to get to the root cause of nagging health issues then the best way to solve it.

Calgarys Neurvana Health uses that map to deliver results-oriented care to its patients and has since 2016. They dont want to just manage symptoms; they want to fix your health problems.

One of the co-founders and the groups medical director, Corey Deacon, who has degrees from the University of Alberta and University of Greenwich in Neuroscience and Biomedical Science, was on a mission to find answers to his own health issues.

At the time, he was a researcher, finishing up his bachelors degree.

I started getting some problems with memory and focus and attention. I started developing anxiety and it slowly worked into the point where I was getting panic attacks every day, said Deacon.

Doctors couldnt tell him why. They told him as a student he was dealing with a great deal of stress and anxiety, so here, take this pill, Deacon said.

Being a researcher, Ive been taught to figure out whats the answer, why is this happening? Deacon said.

Deacon considers himself more research based than anything else. Hes pulled together the best of different principles of medical care. Thats when he found brain mapping.

One of the most profound discoveries there are all these good doctors utilizing technology to basically figure out whats going on in somebodys brain, he said.

Once he plugged into the neurological aspect of disease, Deacon said it helped him further understand what was going on with patients health.

The brain is essentially talking to us all the time, he said, calling the brainwaves a language.

Weve just been learning how to decipher it.

Using a database of more than 5,000 brain maps, Deacon and his team can navigate a patients specific condition and deliver potential treatments.

Its called quantified electroencephalograph qEEG is easier. Its a non-invasive way to track body function based on the brains electrical activity.

It measures what MRI or CT scans cant necessarily see: Brain function.

Once a they pinpoint a potential problem, theyre able to employ a plan of action to get results.

You get an actual objective measure, said Deacon.

Deacon said they use an integrative approach to care. They provide patients with options, including naturopathic and homeopathic remedies, acupuncture, chiropractic and aromatherapy whatever achieves the ideal patient results.

Theres a place for traditional medicine, too.

The problem that Ive found is that weve taken traditional medicine and weve tried to put it into every single box, Deacon said.

And it doesnt fit in every box.

He said quite often they bring in traditional medicine when theyre working on primary conditions that take some time to deal with. Traditional medicine comes in to take the edge off, Deacon said.

Its not about ignoring conventional medicine because theres a place for it, Deacon said.

It just doesnt fix everything.

In the end, Deacon just wants to use all the tools at his disposal to find the cause and fix it. Not just manage the symptoms.

We know the body has an innate ability to heal, he said.

We just need to remove the barriers that are preventing it from getting that and give the body what it needs to heal. And it will.

If you have a nagging health issue and you want a different approach to find the root cause, visit the Neurvana Health website for more information.

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Texas Stem Cell Law Opens Door for Controversial Treatments

Posted: June 11, 2020 at 4:44 am

Hospital Galenia in Cancun, Mexico, where Celltex administers autologous mesenchymal stem cells to clientsKERRY GRENSOn a main thoroughfare running along the east side of Cancun, Mexico, sits Hospital Galenia, a small, private facility with crisp, white walls and slick marble floors. On a Friday morning in February, the lobby is quiet, its palm-filled courtyard unoccupied, belying activity in parts unseen, including an emergency room and a maternity ward.

Cancuns beaches draw in visitors by the millions each year, while Galenia attracts a distinctive kind of tourist: those seeking health treatments not sanctioned by the U.S. and governments elsewhere. A number of medical tourism companies operate out of Galenia, including Houston-based Celltex Therapeutics, a company that offers stem cell therapies to mostly American customers. Celltex claims to use patients own mesenchymal stem cells (MSCs) to treat diseases as wide-ranging as amyotrophic lateral sclerosis (ALS), renal failure, and chronic obstructive pulmonary disease (COPD).

Originally, Celltex administered cells to its clients out of a laboratory site in Sugar Land, Texas. But the company had to cease offering such treatments in Texas in 2013 after the US Food and Drug Administration (FDA) sent Celltex a warning letter in 2012 stating that the patient-derived cells it was harvesting and injecting were considered drugs under US federal law, thereby requiring clinical trials and regulatory approval. The FDA review also revealed that the company mishandled the cells, failing to keep them in sterile conditions and mislabeling containers.

Rather than cede to federal laws and go the standard drug-approval route through the FDA, Celltex instead shifted its clinical operations south of the border, shipping ready-to-use MSCs in syringes to Hospital Galenia. But with a newly passed law in Texas known as Charlies Law, Celltex might have the opportunity to resume treating patients stateside. The new law could allow Texas clinics to administer certain non-FDA-approved stem cell treatments, like those offered by Celltex, to select patients.

State law is subordinate to federal FDA rules, according to the agency. Therefore, the new Texas stem cell law potentially sets up a state-federal conflict. Paul Knoepfler, a stem cell biologist at the University of California, Davis, and coauthor of a recent study that analyzed stem cell clinics in the U.S., tells The Scientist that proponents of direct-to-consumer stem cell clinics could use the law as an opportunity to challenge the FDAs authority, which could result in a federal court case.

While Texas is loosening regulations on unproven stem cell treatments, the FDA and health authorities in other countries are going in the opposite direction.

Celltexwhose board of directors includes Texass former first lady, Anita Thigpen Perrywas actively involved in the bill, according to a Celltex spokesperson. The law is a step in the right direction, according to the firm, but still far from a law which would allow us to provide high-dose adult stem cell banking and therapy in the United States.

Direct-to-consumer stem cell clinics, influential Texas politicianssome with ties to Celltexand some patients eager for alternative therapeutic options applaud the law. But scientists question the cells efficacy, and bioethicists voice concerns about selling a therapy before the evidence is all in. Without rigorous testing and FDA oversight, critics say, there are no guarantees that these direct-to-consumer stem cell clinics abide by rigorous laboratory practices and that the interventions are not putting patients at risk.

Its true that we are very excited about the ability to develop effective new therapies using stem cells but there is a tremendous amount of research required to figure out how to do this effectively and safely, says Sean Morrison, a stem cell biologist and director of the Childrens Medical Center Research Institute at the University of Texas Southwestern Medical Center in Dallas. There are many companies short-circuiting that process and selling patients unproven entities that they have not shown to be effective nor safe. In some cases, the unproven therapies are scientifically implausible based on what we know about the biology.

According to Celltex, the company treats about 400 to 500 people each year using MSCs harvested from the patients own belly fat. The cells are then purified, expanded, and frozen in Texas before being infused intravenously or injected into the affected tissue. According to the medical director of Celltexs Galenia clinic, Gabriel Salazar, most patients come for relief of inflammatory conditions, especially arthritis. There are people who come for wellness as well, says Salazar. They arent sick, but they have risk factors.

The physiological mechanism of MSCs is unclear. Salazar says they initiate anti-inflammatory pathways, a phenomenon that researchers have observed in vitro in the lab. From animal models, scientists understand that these are cells that regulate the microenvironment at sites of injury . . . but no one really understands how they function in vivo, says Arnold Caplan, an MSC researcher at Case Western University.

All [of our clients] have received improvements, some minimally and some miraculously. And no one has had a problem.David Eller,CEO, Celltex

Clinicaltrials.gov lists 243 ongoing MSC trials, including some in the U.S., sponsored by industry, the National Institutes of Health, and others. Yet there are no FDA-approved therapies using MSCs for any condition. The FDA, for its part, is studying MSCs to develop standardized isolation methods and to learn how MSCs behave when injected into the body.

Anecdotal testimonials from clients of Celltex and other firms abound, but rigorous clinical evidence is hard to come by, as companies selling stem cell therapies dont often publish in peer-reviewed journals. In fact, there are no published data on MSCs efficacy in ameliorating arthritis or the numerous other conditions that patients pay Celltex to treat. Thus far, Celltex has one publication documenting MSC use in patientsa 2017 case report of two individuals with a nervous system disorder that suggests the autologous adipose-derived MSCs they received resulted in symptom improvements.

Celltex CEO David Eller says the company has safely administered MSCs to more than 4,500 clients. All of them have received improvements, some minimally and some miraculously, he tells The Scientist. And no one has had a problem. In opposition to the FDAs stance, Eller considers clinical trials a waste of patients time. We can wait another decade or more for costly clinical trials and watch as our loved ones deteriorate, or we can do something about it now. In our eyes, doing nothing is the real risk, he writes on the Celltex website.

Nevertheless, Celltex has pledged to conduct its first clinical trial. Just last month (February 27), the firm announced that the Comisin Federal Para La Proteccin Contra Riesgos Sanitarios Comisin de Autorizacin Sanitaria (COFEPRIS, the Mexican equivalent of the US FDA) had given the go-ahead for Galenia to start a clinical trial in patients with osteoarthritis and rheumatoid arthritis. The Phase 2 study will use Celltexs protocols to generate cells in quantities never possible for use in therapies for vascular, autoimmune, and degenerative diseases, as well as injuries, according to a company press release.

Details on the trial are scant. The press release states that the trial will measure the quality of life (QoL) of subjects prior to and after receiving the therapy. Celltex tells The Scientist that the trial will have a safety and toxicity monitoring component and that participants will not incur cost of the cell procedure. According to the Celltex website, the company charges $6,500 to obtain, process, and store a clients MSCs for one year, while the pricing for an injection varies depending on each individuals situation.

Im all for investigating QoL self-assessments in the context of clinical research, says Leigh Turner, a bioethicist at the University of Minnesota who studies direct-to-consumer stem cell clinics, but one obvious concern in the case of this particular study is that it will do little more than capture a placebo [effect].

According to Turner, Celltex is not the first US business selling unapproved stem cell interventions to conduct a QoL study rather than one specifically designed to test for safety and efficacy endpoints. For marketing approval, the FDA requires that stem cell products be tested for safety and efficacy and that the company developing the product file an IND application with the agency. Yet trials can be listed on registries such as clinicaltrials.gov whether or not they comply with FDA regulatory standards and safety oversight.

I hope [Celltex] pursues an Investigational New Drug application [IND] in the U.S. and conducts a placebo-controlled, double-blinded study, writes Knoepfler in an email to The Scientist. If their product is safe and clearly effective, such a rigorous study could prove that fairly conclusively.

Human mesenchymal stem cells with nuclei labeled blue and actin filaments greenFLICKR, ENGINEERING AT CAMBRIDGE

The new Texas stem cell law has yet to go into effect; the states Health and Human Services Commission is still developing the procedures of how the law will be implemented. As Celltex and other direct-to-consumer stem cell companies wait for lawmakers to clarify details on the new rules, Celltex will continue with its cell-banking operations in Texas and its infusions in Mexico, a Celltex spokesperson tells The Scientist.

According to State Senator Paul Bettencourt (R-Houston), an author of the bill, the plan is for each stem cell treatment course to be reviewed by an Independent Review Board (IRB). After a favorable review, the treatment could then be administered in one of the hundreds of medical institutions in Texas.

The Texas law is unique in its permissiveness, says Turner. A new law in California, which took effect January 1, requires that direct-to-consumer stem cell clinics disclose to potential customers that their products are not approved by the FDA. Other states appear to be looking for ways to better protect patients and consumers instead of looking for ways to lower regulatory standards, writes Turner.

While Texas is loosening regulations on unproven stem cell treatments, the FDA and health authorities in other countries are going in the opposite direction, focusing more oversight and scrutiny on direct-to-consumer stem cell clinics. The FDA has recently warned consumers about stem cell clinics touting unproven treatments, and in August 2017, the FDA commissioner announced plans for better enforcement of federal laws and oversight of stem cell clinics. Australia recently announced a higher level of stem cell clinic regulation, as have health agencies in Canada and India.

To be a candidate to receive the therapy under Charlies law, the patient must have a severe, chronic disease or be terminally ill. And the treatment must be registered in a clinical trial database somewhere in the world. According to Bettencourt, the next step is for the Texas Medical Board to draw up the process for how to evaluate and oversee each patients case.

But the bill does not include any details on product oversight or quality control, and reporting by The Scientist reveals questionable practices.

When The Scientist spoke to Eller, he said that Celltex uses the MD Anderson Flow Cytometry Facility weekly to validate that the cells are 100 percent patient-derived MSCs. And in follow-up emails, a spokesperson for Celltex also stated that members of the MD Anderson core staff independently conduct quality control and validation.

However, the cytometry facility had a different story.

Scott Melville, an MD Anderson spokesperson, tells The Scientist that Celltex has paid to use the public Flow Cytometry Facility since 2015, but that that no one at the facility independently assesses the quality and content of the [Celltex] samples. According to MD Andersons recent records from the last several months up to March 23, 2018, Celltex used the facility for two hours on November 2, 2017, and for one hour each on January 18 and January 19, 2018.

Critics of the Texas stem cell law say that the language in the bill is too vague and are skeptical that there will be enough independent scrutiny to make sure patients are not exposed to unsafe treatments. Im concerned that businesses could use it to make money by putting patients at risk, says Knoepfler.

Reporting from Mexico by Kerry Grens

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A Primer On The Push To Combine COVID-19 Coverage Cases – Law360

Posted: June 10, 2020 at 8:50 am

By Jeff Sistrunk

Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our daily newsletters. Signing up for any of our section newsletters will opt you in to the daily Coronavirus briefing.

Law360 (June 9, 2020, 7:00 PM EDT) -- Insurers and policyholders have weighed in on two petitions to centralize disputes over businesses' coronavirus-related losses in multidistrict litigation, with supporters touting the efficiency of consolidation and opponents arguing that differences in companies' policies and claims make an MDL inappropriate.

From early May through last Friday, the Judicial Panel on Multidistrict Litigation received 63 responses to the dueling petitions filed by two groups of policyholder plaintiffs, one seeking to centralize the cases in Illinois and the other asking for them to be centralized in Pennsylvania. The JPML is expected to issue a decision on the petitions after it meets in Boston at the end of July.

Of the responses submitted to the JPML, 20 of them all filed by policyholders support some form of coordination. The other 43, filed by a mix of insurers, policyholders and advocates for both, oppose MDL treatment.

Here, Law360 provides a primer on the debate surrounding the MDL petitions.

The Petitioners' Positions

The MDL push dates back to late April, when two groups of businesses affected by COVID-19 shutdown orders filed petitions with the JPML asserting that the business interruption coverage battles in federal court across the country are well-suited for consolidated or coordinated pretrial proceedings. At the time, fewer than 20 cases were pending in federal district courts nationwide; as of Friday, that number had expanded to at least 140 in more than 30 district courts.

In the first petition, filed April 20, a pair of Philadelphia-based restaurants argued that the availability of business interruption coverage in light of the novel coronavirus would be a key question requiring a uniform answer as the country deals with the economic fallout of the pandemic.

"This issue whether business interruption insurance policies will cover losses incurred by businesses forced to shutter their business as a result of the governmental orders is one of national importance and great significance to the ultimate survival of many businesses," the petitioners said. "Addressing this issue in a uniform manner as opposed to potentially disparate treatment by different courts throughout the country helps to serve one of the main purposes" of multidistrict litigation.

The petition asked that cases be centralized before U.S. District Judge Timothy J. Savage of the Eastern District of Pennsylvania, in Philadelphia, who is already presiding over 17 business interruption coverage cases in his district.

"When you look at the mid-Atlantic region, from New York down to D.C., Philadelphia seems to be a natural location," Richard Golomb of Golomb & Honik PC, one of the firms representing the restaurants, told Law360. "Judge Savage is an experienced MDL judge, and very efficient and no-nonsense. He can move a case like this along the way it needs to be moved."

A day later, a group of policyholders in a slew of proposed class actions pending in multiple states filed a second petition to the JPML.

That petition emphasized the importance of coordinating expert witnesses in the cases, as policyholders will need to present "epidemiological modeling of the spread of the virus in order to ascertain its likely presence and impact."

"If these myriad cases were not coordinated for discovery, thousands of plaintiffs would potentially be seeking to retain the same limited pool of epidemiological modelers," the petition said. "Not only would that competition create a costly logistical nightmare for litigants, but that same pool of experts is also needed to help lawmakers fashion the best policies for dealing with the pandemic."

The second group of petitioners suggested the cases be centralized before U.S. District Judge Matthew F. Kennelly of the Northern District of Illinois, in Chicago, who is overseeing an MDL regarding cardiovascular issues allegedly caused by a testosterone replacement therapy drug.

Adam Levitt of DiCello Levitt Gutzler LLC, which is among the firms representing the second group of petitioners, told Law360 that centralization before Judge Kennelly would best serve the principles of the MDL system's enabling statute.

"The insurance industry has obviously elected to take an industry-wide position to oppose JPML centralization, and to keep things as fragmented as possible because each insurer thinks that keeping things fragmented is more strategically advantageous. At the end of the day, all of the industry responses tried to argue how fragmented this all is," Levitt said. "The insurance industry traffics in creating confusion. We don't think it is an appropriate argument here, nor do we think it is valid."

Supporters' Stances

The petitioners' calls for an MDL attracted 20 supporting briefs from individual companies or groups of policyholders. While the supporters all argued that centralization can help streamline the resolution of the many COVID-19 business interruption cases, they offered diverse views on where the proceedings should be placed and how they should be structured.

Among the 20 briefs, seven backed the choice of the Northern District of Illinois and five favored the Eastern District of Pennsylvania.

In the Illinois camp, for instance, one group of 41 policyholders with cases pending in seven states, dubbed the Truehaven plaintiffs, highlighted the central geographic location of the Prairie State and Judge Kennelly's MDL bona fides. The other supporters of the Illinois proposal plaintiffs in another eight business interruption casesvoiced similar views.

Meanwhile, the proponents of centralization in Pennsylvania comprised of plaintiffs in 38 cases across 11 statesemphasized that Judge Savage is already handling a lot of business interruption cases and that the Eastern District of Pennsylvania has about half as many active cases on its docket as the Northern District of Illinois, 8,704 versus 15,874.

Five other groups of policyholder plaintiffs expressed support for the creation of an MDL based in a single federal court but proposed the respective courts in which they are currently litigating cases. Two groups pitched the Southern District of Florida, and one apiece requested the Western District of Missouri, the Western District of Washington and the Northern District of California.

The remaining three supporting briefs asked the JPML to consider forming not one but multiple MDLs, with cases lumped together either by state, region or insurer defendant.

For example, San Francisco-based children's clothing boutique Mudpie Inc., which is pursuing a proposed class action against a Travelers unit in California federal court, proposed the creation of "a small number of MDLs corresponding with states in which numerous actions, filed by different counsel, are pending before different federal judges in different districts." The retailer said that as of Friday, six states would qualify: California, Illinois, Florida, New Jersey, New York and Texas.

"There are still efficiencies to be gained from an approach to centralization that focuses on litigation hot spots, and the panel should follow that approach to steer such controversies on a prudent course," Mudpie wrote.

Cincinnati-based Belgian restaurant chain Taste of Belgium LLC, which is pursuing a proposed class action against The Cincinnati Insurance Co. in Ohio federal court, suggested it would make sense to create multiple MDLs grouped by insurer, as different insurers' policies may contain substantially different terms.

"All actions brought against a given insurer are based on the same or substantially similar questions of law and fact," Taste of Belgium wrote. "Moreover, transfer will promote the convenience of the parties and efficiency in the pretrial proceedings by eliminating duplicative discovery and the potential for inconsistent rulings, including determinations on class certification."

Opponents' Views

The two MDL petitions also drew strong opposition, with 43 briefs urging the JPML to reject the efforts to combine the nation's business interruption cases.

The insurance industry formed a unified front against centralization. Insurers lodged 29 opposition filings, and the industry's two leading trade groups, the American Property and Casualty Insurance Association and the National Association of Mutual Insurance Companies, also weighed in against an MDL. But a dozen individual policyholders and groups of policyholder plaintiffs also opposed consolidated or coordinated proceedings, as did the nonprofit advocacy group United Policyholders.

The opposition briefs generally argued that an MDL would be an inappropriate vehicle for resolving insurance cases, given the differences in insurers' policy language, policyholders' losses during the pandemic and states' laws on the requirements for business interruption insurance.

In a brief joined by 10 other insurance groups, Chubb Ltd. units Westchester Surplus Lines Insurance Co. and Indemnity Insurance Co. of North America contended that combined proceedings would create a logistical nightmare. They pointed out that, while more than 100 insurers are facing suits around the country, only 5% of them have been named as defendants in more than five actions, and most have been named in only one or two cases.

"Every insurer would need (and have a right) to be heard on every issue including discovery and other pretrial rulings affecting it," Westchester and IINA wrote. "The transferee court could not effectively implement a bellwether process, given the lack of overlapping parties among the cases. Resolution of one case would not resolve any other. The resulting proceeding would be unmanageable and delay would be inevitable."

A Chubb spokesman did not immediately respond to a request for comment.

APCIA and NAMIC similarly argued that an MDL could produce delays.

"In view of the extraordinary circumstances created by the COVID-19 pandemic, the parties, courts, and public would be better served by permitting resolution of these cases in their home courts on their individual merits," the trade groups argued.

James Martin of Zelle LLP, who represents APCIA and NAMIC, told Law360 in a statement, "The brief speaks for itself in setting forth why our clients firmly believe that a nationwide federal MDL is not appropriate for these types of matters."

United Policyholders' brief encapsulated the concerns expressed by the policyholder plaintiffs that filed opposition briefs, asserting that there is no "cookie-cutter" scenario for a business interruption claim over losses tied to the COVID-19 pandemic and saying that forcing smaller companies to litigate in courts far removed from their home states would impose undue financial burdens.

"From the beginning, we have been saying you cannot lump all these together, because the policy language is all over the map, different businesses have unique challenges and losses, and insurance is regulated on the state not federal level," United Policyholders executive director Amy Bach told Law360. "We knew it would be a balancing act between judicial efficiency and fairness, having each case resolved on its merits."

--Editing by Brian Baresch and Michael Watanabe.

For a reprint of this article, please contact reprints@law360.com.

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