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Friday, June 9, 2023

‘Reckless in the Extreme’: FDA Panel Recommends New RSV Shot for Use in Healthy Infants • Children's Health Defense

Reckless in the Extreme’: FDA Panel Recommends New RSV Shot for Use in Healthy Infants

Advisors to the U.S. Food and Drug Administration on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect infants and toddlers up to age 2 from respiratory syncytial virus, but medical experts interviewed by The Defender called the move “reckless” and “preposterous.”


RSV (Respiratory Syncytial Virus) is a common respiratory virus that typically causes mild, cold-like symptoms in older children and adults. However, RSV can be more serious in infants, particularly those younger than six months old. In fact, RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia in infants.

The severity of RSV in infants can vary. Some infants may only experience mild symptoms, such as a runny nose, cough, and low-grade fever, similar to a common cold. However, in other cases, RSV can lead to more severe respiratory symptoms, including:

1. Rapid or difficult breathing: Infants may breathe rapidly, struggle to catch their breath, or show signs of labored breathing.
2. Wheezing: RSV can cause wheezing, which is a high-pitched whistling sound during breathing.
3. Cyanosis: Infants with severe RSV infection may develop a bluish coloration of the lips, face, or fingernails due to inadequate oxygen supply.
4. Poor feeding: Infants may have difficulty feeding or show a decrease in appetite due to breathing difficulties.
5. Dehydration: Severe RSV infection can lead to dehydration if the infant is unable to take in enough fluids.

Certain factors can increase the risk of severe RSV infection in infants, including premature birth, a weakened immune system, and underlying medical conditions such as congenital heart disease or chronic lung disease.

If you suspect that your infant has RSV or is experiencing severe respiratory symptoms, it's essential to seek medical attention promptly. Healthcare professionals can evaluate the severity of the infection, provide supportive care, and monitor the infant's breathing and overall condition. In severe cases, hospitalization may be required for infants with significant breathing difficulties or dehydration.

Prevention is also crucial in reducing the risk of RSV in infants. Practicing good hand hygiene, avoiding close contact with sick individuals, and keeping infants away from crowded places during the RSV season (typically fall and winter in temperate climates) can help minimize the risk of infection. Additionally, certain high-risk infants may be eligible for palivizumab medication, which can provide temporary protection against severe RSV disease. It's important to consult with a healthcare professional to determine if your infant is a candidate for this preventive treatment.

Remember, if you have concerns about your infant's health or suspect RSV, it's always best to consult with a healthcare professional for an accurate diagnosis and appropriate management.

Here we go again !  99% of infants who contract RSV have cold-like signs and symptoms. 

Advisors to the U.S. Food and Drug Administration (FDA) on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect infants and toddlers up to age 2 from respiratory syncytial virus (RSV).

Monoclonal antibodies are not vaccines and do not give long-lasting immunity, but only last as long as t he synthetic antibody is present.  The titers decrease rapidly and must be given annually

The drug, nirsevimab, would be delivered to newborns in a single shot at birth or “just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable,” CNN reported.

Here lies another COVID scenario, overreacting to a perceived nonexistent threat.

Common sense on the part of pediatricians should make this 'shot' unnecessary in almost all cases. Some children with serious pulmonary problems, such as cystic fibrosis, would be suitable for this prophylactic drug.

But medical experts interviewed by The Defender raised a number of concerns, including what they said was inadequate safety testing.

“It’s preposterous to give this drug prophylactically, especially without adequate safety testing,” said Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense (CHD).

AstraZeneca reported only 48% efficacy for the drug. And Hooker noted that the “circulating half-life of the antibodies is probably less than one month, so the protection would be minimal at best.”

Hooker also commented on the fact that 12 infant deaths were recorded during the clinical trial, which the FDA committee claimed were “unrelated” to the antibody:

“It appears that this vote was meant to bolster the uptake and popularity of the RSV vaccines that are now approved for maternal use. The very low rate of effectiveness for such a therapy is troubling as the conservative estimate is below 50%, which is usually a hard metric for drug approval.

“Also, it seems odd that four infants in the trial would die of cardiac arrest — with no information given, it leaves one to wonder why these children would die in such a way. Also, there should be further investigation into the two SIDS [sudden infant death syndrome] deaths that occurred during the trial.”
Since the monoclonal AB












‘Reckless in the Extreme’: FDA Panel Recommends New RSV Shot for Use in Healthy Infants • Children's Health Defense

This is the Waste from a Surgery

 Hospitals produce an enormous amount of waste.  Much of it is a biological hazard from infectious diseases, blood products, and as a result of operations.


Most Hospital waste cannot be recycled or reused due to concerns for sterility. At one time, many hospital drapes were cloth and could be reused. Most surgical instruments can be reused except for some unique instruments.  As time has passed, more and more instruments are disposable and can be used only once.

Surgical gloves cannot be reused or recycled, nor can plastic drapes, for the same reasons.
These items are not only used in the operating room but also on the hospital floors and rooms. IV containers are made of polyvinyl.  At one time, glass was used for transfusions.

There is a downside to using reusable items in terms of labor, cleaning, and sterilizing items. This becomes expensive in terms of time and personnel.

Hospital and Medical Waste are divided into Regulated and Non-Regulated. Hospitals usually contract with a Medical Waste Provider.  States such as California identify wastes and how they must be processed.

A hospital would need to perform an evaluation and cost analysis to determine if it would be a cost advantage.  Hospitals have lean operating margins and may have found that waste management depends upon disposable products that are an adverse effect on the environment. 

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