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Thursday, June 8, 2023

Pfizer and Moderna are Circling the Wagons



New York-based Promosome filed separate lawsuits against Moderna and Pfizer, accusing both companies of violating patent protections related to mRNA technology.

In the filings submitted to the Southern District Court of California, Promosome claims that in 2009 company-affiliated scientists “discovered a method for increasing protein expression by making small changes to the mRNA that could affect the amount of protein produced without altering the amino acid sequence encoded by the mRNA.” The technology is based on the discoveries of Promosome CSO Dr. Vincent P. Mauro and the late Nobel Laureate Dr. Gerald M. Edelman of The Scripps Research Institute (TSRI) in La Jolla, California. Leveraging their expertise in the area of mRNA translation resulted in pioneering technologies that Promosome licenses to companies seeking to improve biotherapeutic and bio-industrial protein expression.


COVID Patent Lawsuits

Promosome’s Tuesday filings are the latest in the intellectual property battle over COVID-19 vaccines. n April 2023, Arbutus Biopharma sued Pfizer and BioNTech, alleging that their coronavirus vaccine used proprietary lipid nanoparticle (LNP) technology protected by five patents. The lawsuit claims that the delivery system that Comirnaty uses could not have been produced without Arbutus’ technology.

Alnylam also filed patent infringement lawsuits against Pfizer and Moderna in March 2022, accusing both companies of formulating their vaccines using Alnylam’s proprietary LNP drug delivery technology. Massachusetts Biopharma is seeking “fair compensation” for this infringement.

Moderna and Pfizer are also locked in a legal tussle with each other. In August 2022, Moderna sued Pfizer and BioNTech, claiming that the companies “unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” Shannon Thyme Klinger, chief legal officer of Moderna, said at the time.

Pfizer returned with a countersuit in December 2022, seeking to dismiss Moderna’s lawsuit.

Pfizer, Moderna, and Bionet reaped tremendous profits from research based on the discoveries of Promosome CSO Dr. Vincent P. Mauro and the late Nobel Laureate Dr. Gerald M. Edelman of The Scripps Research Institute (TSRI) in La Jolla, California

This is only the beginning. in a tug of war as others pursue gains from Pfizer-Moderna.

In April 2023, Arbutus Biopharma sued Pfizer and BioNTech, alleging that their coronavirus vaccine used proprietary lipid nanoparticle (LNP) technology protected by five patents. The lawsuit claims that the delivery system that Comirnaty uses could not have been produced without Arbutus’ technology.


Pfizer and Moderna are Circling the Wagons

Saturday, June 3, 2023

How to Reinvent your Health - by Gary Mark Levin


Peter Attia gives a holistic overview of why our health care is so broken. In the past decade, social determinants of health have become a part of the health record. This is a measure of societal impact on your life. Attia has noted when he travels the difference in societal stress from America. America ranks #35 in terms of our overall health, and #55 in terms of life expectancy.

Societal issues such as work/life balance, cooking more at home, eating out less (processed foods), and walking more, as seen in Europe all contribute to life expectancy.

One good measurement of health is longevity. The United States is not a winner in that regard. The only category we are number one in is our expense. From 1980 to 2019, Commonwealth Fund found that the U.S. spent nearly 17 percent on health care as a percentage of its gross domestic product (GDP). Other countries, like Switzerland, the U.K., Australia, Norway, and more, spent well below that but still earned higher healthcare performance scores. The forecast is not good. Our life expectancy is decreasing, and this was true pre-COVID.

Life expectancy has dropped: Why it matters


This chart is for the overall life expectancy for Americans, however, there are large deviations for some demographics.

Here are the states with the largest declines in life expectancy

The U.S. fares significantly worse than other developed countries, with the Commonwealth Fund finding Japan has an average life expectancy of 84.4 years, Spain and Switzerland at 84 years and Canada averaging 82.3 years.

The chart below is another view.


African Americans have consistently lagged in life expectancy although the gap is closing.

Economic Growth and Life Expectancy – Do Wealthier Countries Live Longer?

There are many determinants of longevity, and do not always correlate with income, or race. Nutrition and lifestyle are important as well.

Health expenditure as a percentage of gross domestic product (GDP) in selected countries

Prevention

Certain diseases can be detected, however, no one test detects early disease.

Breast Cancer, Cervical Cancer, Colon Cancer, and Prostate Cancer can be detected early.

Mental health issues are significant factors, depression, suicide, and risky behavior all contribute to premature death. There is little doubt smallpox, poliovirus and measles have been eliminated which has increased longevity in the past century.

There are many things in action that can contribute to improved quality of life and life expectation.


During the past decade, we have progressed from Health 2.0 and Health 3.0. Today we have entered Health 4.0. Despite rapid technological advances such as remote monitoring, electronic health records, and fewer uninsured our life expectancy has decreased. Peter Attia seems to have put all of it together and I hope my article can disseminate his words and a few of my own.

Medical 4.0 is the fourth medical revolution, employing emerging technologies to create significant advancements in healthcare. New medical 4.0 technology has advanced significantly, ranging from mobile computing to cloud computing, over the previous decade and is now ready to be employed as a commercially accessible, networked system. Such things as virtual reality, artificial intelligence, networked hospitals and medical clinics create huge data banks for analysis.

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How to Reinvent your Health - by Gary Mark Levin

Friday, May 26, 2023

The Kids Need a Diagnosis, Right? - by Edwin Leap

What happens when the parents search Google and/or ChatGPT


“Well, doctor, the thing is, my little Tricia here is eight and she has ADD, ADHD, PTSD, ODD and bipolar, with depression and anxiety. Of course, her daddy and I have schizoaffective with some ADHD and PTSD as well, and he’s bipolar but I’m not. But I have opioid use disorder, you see. Anyway, none of these here medicines are doing a thing for her. She keeps talking about dying and I really think she needs to be in the hospital for a few days to get things settled down.”


So much of this; so very much. And on the bed, a child with a coloring book and crayon, who may or may not look anxious or upset. Often, a child who is calm as can be when mom or dad aren’t in the room. Equally problematic, their parents have struggled with inner demons since their own childhoods; wounded adults, uncertain how to navigate their own problems, much less those of their children.

They grab what is offered to them. Lists of diagnoses offered by professionals. Diagnoses that frequently change over and over from year to year, crisis to crisis. Struggling parents, themselves bearers of many diagnostic labels and traumas who wouldn’t dare resist a new category if they thought it might help their children.


Now, I would never suggest that children can’t or don’t have mental illness. The last few years have brought us an explosion in pediatric and adolescent psychiatric issues. Indeed, an explosion that has far outstripped our resources and understanding. I know that most mental health professionals are doing their best in what must seem the psychic equivalent of the late pandemic. (And intricately connected to boot.)


What I don’t always get, what I struggle with, is the way our system is desperate to give these children assorted diagnoses, and to then sedate their developing brains with ever more potent drugs, the long term effects of which we really can’t begin to predict.


The field of mental health is complex. I have great respect for all of those who labor in it. However, for all of our advances psychiatric care has had a sometimes storied past. (Not throwing stones here; it’s true of all of medical science.)


Last Summer while on vacation with my wife’s family we toured the Transallegheny Lunatic Asylum, a tourist attraction in Weston, WV. From 1864 to 1994 this vast, stone building was actually a psychiatric hospital (with the term hospital being used in the loosest of manners for a good portion of its existence).


In fact, when I was in medical school at West Virginia University, a few years before the asylum closed, we actually toured this facility. I well remember the area where the criminally insane stayed; it was a sparse room where we walked past frightening and largely undressed men, milling about and sitting on bare benches.


These days it’s an interesting place that still has haunting echoes of a darker time when diagnoses of mental illness could be remarkably unscientific. (For a list, here’s a great link: https://mentalhealthathome.org/2020/02/24/lunatic-asylum-crazy-1864/)


There were times in the asylum when a man could put his wife and children away out of convenience. It was a place where PTSD might simply be diagnosed as “The War” and where even “Political Excitement” might land one in the facility. (Maybe that wasn’t such a bad one…)


Later in that dark place, where people now tour the halls on Halloween, frontal lobotomy was performed on many poor, helpless individuals. The very walls now seem embedded with suffering and loneliness, even on a Summer day.


Without a doubt, there were men, women, boys and girls who languished there with very real mental illness. And although the physicians, nurses and others did the best they knew in those times, they were wrong…a lot. Doubtless many of their therapies did far more harm than good. The unmarked graves on on the adjacent hillside are testament to the fact that all too many of those suffering in mind also perished in body in that lonely, Gothic building.


I suppose, when I see this desperate need that people have to apply diagnoses, or medications, which are not well understood, I think back to the asylum. In those days family members felt helpless in an era of limited science and had no idea how to help their troubled, frantic or catatonic loved ones; or they were nefarious and hoping to remove problematic individuals from their lives.


These days? I think the desire for even poor diagnostics and therapeutics, especially for children, has to do with several things. Of course, it’s related to the enormous amount of sympathy we try to extend to all of those with mental health issues.


In addition, it has to do with the reductionism of modern medicine in general and psychiatric care in particular. Unable to ascribe the woes of kids (or adults) to home, culture, economics, education, philosophy or theology, their problems have to be pathophysiologic. It’s why we give medications for ‘chemical imbalances’ without every really being able to see if we’ve rebalanced those naughty chemicals after all.


Finally, we have so many lonely, struggling parents and kids with a powerful need to belong to a group. Especially as the ancient bonds of family, clan and nation blow away like so much dust in the wind.


That new group may be defined by diagnoses, or equally often defined by being a caregiver for someone with a diagnosis. It’s very validating to know that one isn’t alone in the struggle. Unfortunately, I wonder sometimes if it doesn’t come much closer to Muchausen’s by Proxy as the need for an “in-group" may suggest the need for a diagnosis, rather than the opposite.


The asylum was great reminder that we have to be very, very careful when we become too comfortable in our understanding of the travails of the human psyche. It’s easy enough for us to look back on “hysteria” or “gathering in the head” and chuckle about the Neanderthals of our not so distant professional past. But I feel bad, not okay for those bygone patients but for their physicians who labored in much more of a scientific fog than we can imagine.


We might be wiser to wonder who will shake their heads and tsk tsk in the future when they see how many adults and children alike in our time walked around, on brain bending chemicals, for the often poorly understood diagnoses we so casually apply.


I fear we’re not so far from that old asylum as we might think. And that makes me sad for the brokenness and helplessness we all feel these days.


The Kids Need a Diagnosis, Right? - by Edwin Leap

Common symptoms of long Covid identified in new scientific research

The new research is meant to help scientists move forward in finding a treatment for a condition that still plagues millions of Americans.



A long-awaited study that zeroes in on the most common groups of symptoms for people with long Covid may not bring the relief millions of Americans and doctors have been wanting.

The study, some of the first research from the National Institutes of Health’s billion-dollar RECOVER program, does not provide a standardized definition of the condition. Researchers say it is a first step in identifying a "common language" for scientists working toward treatments for the condition.

"I think that the amount of science that's going to come after this is going to be an avalanche," said study author Dr. Leora Horwitz, a professor of population health and medicine at New York University Grossman School of Medicine, as well as the director of the Center for Healthcare Innovation and Delivery Science at NYU Langone Health.

The new study, published Thursday in the Journal of the American Medical Association, looked at data from 9,764 adults in the RECOVER trial, which has been recruiting participants since last year. The vast majority, 8,646 people, had previously been diagnosed with Covid. 


Long Covid defies definition.  There are many protean symptoms that overlap with other disease states. Chronic fatigue syndrome which is now called Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) .


While hundreds of symptoms possibly associated with long Covid have long been reported — mostly through anecdotes from patients — the new study homes in on 12 of the most common.

Ongoing fatigue.
Dizziness.
Thirst.
Cough.
Chest pain.
Heart palpitations.
Abnormal movements.
Upset stomach.
Lack of sexual desire.
Loss of smell or taste.
Feeling sick or overly exhausted after physical activity, also known as post-exertional malaise.

There are some biomarkers associated with Long Covid, also known as Long Haul Covid. This list is exhaustive and non-specific and may occur in other inflammatory and autoimmune conditions.

A total of 239 candidate biomarkers were identified, consisting mainly of immune cells, immunoglobulins, cytokines, and other plasma proteins. 19 of the 239 candidate biomarkers identified were evaluated by the authors, by means of receiver operating characteristic (ROC) curves

The answers thus far are nonspecific and no specific treatments are available other than the usual attempt to maintain good nutrition, exercise and a wellness approach to minimizing symptoms.