Warnings about the Use of Dietary Supplements.

While the age of health and wellness and good nutrition are upon us, the marketplace is overrun about natural supplements. 

These supplements are regulated by the Federal Food, Drug, and Cosmetic Act (FDCA). It is enforced by the Department of Justice.  Despite the regulations, supplements are sold which do not meet the requirements, nor have ever been subject to regulation.  Many are imported from foreign countries and manufactured in uninspected facilities.

 The United States Court for the Eastern District of New York has permanently enjoined a New York company and its operators from manufacturing or distributing dietary supplements unless and until they comply with the law, the Department of Justice Civil Division’s Consumer Protection Branch, and the United States Attorney’s Office for the Eastern District of New York announced today.

A complaint filed May 23, 2019, alleged that defendants Confidence USA Inc., of Port Washington, New York, the company’s president Helen Chian, and manager Jim Chao violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing adulterated dietary supplements. The complaint alleged that inspections conducted by the U.S. Food and Drug Administration (FDA) in 2016, 2017, and 2018 showed that the defendants repeatedly failed to verify that their finished dietary supplements met product specifications for identity, purity, strength, composition, and contamination limits, and failed to verify the identity of each dietary ingredient used in the manufacture of the supplements. The United States filed the complaint in U.S. District Court for the Eastern District of New York at the request of the FDA.

According to the complaint, the defendants made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store.

The current opioid addiction has stimulated the marketing of some herbal compounds alleged to aid withdrawal symptoms (Kratom)

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” Ned Sharpless, the current acting FDA chief, said in a statement. “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.

Kratom, the herb of last resort was used by opioid users in the period 2011-2017 despite reports of illness, and deaths.   Investigations revealed troubling incidents, side effects, and deaths of people using Kratom

District Court Orders Long Island Company and its Operators to Stop Distributing Adulterated Dietary Supplements | USAO-EDNY | Department of Justice

OrCam Read - For theVisually Impaired

This is a well-designed device that converts text to speech.  It has been designed for all visually impaired people.  The video explains the OrCam Read.  It is expensive.  While there are other devices for the 'low vision' community, they are inadequate in many circumstances.

Many of these patients are in the senior group, covered by Medicare.  However Low Vision devices, magnifiers, or optical lenses are NOT covered by CMS.  In 2017 H.R. 2050 was proposed by Rep. Carolyn Maloney (D N.Y.). However, it was not passed.  CMS reimburses for other aids, such as wheelchairs, crutches, and other ambulatory aids.  Vision is certainly necessary to ambulate safely.

This a glaring discrimination again low vision patients.   It is expensive however it can be purchased over time at a reasonable rate.  CMS often leases expensive wheelchairs or another prosthesis.  Why not the Orcam.  I urge you to call your representative today to lobby for the legislation to be reintroduced and ask them to sign on to the bill.

Please consider signing the petition. You will find it at change.org.

OrCam Reader

Some Covid-19 Vaccines Are Effective After One Dose, Can Be Stored in Normal Freezers, Data Show - WSJ

In a win for global vaccination goals, the BioNTech-Pfizer (Moderna)vaccine is shown to generate a strong response with one dose and to maintain potency in standard freezers for two weeks.

The daily story of the covid19 vaccine is a story of poor logistics and outright lies.  The plan for distribution was not well thought out.  Perhaps it was written down in a "playbook" and it was not implemented as written.  Although the vaccine was developed in record time, the amounts to be produced were exaggerated to fit political ambitions during a year of a Presidential election.  It was delayed by political rhetoric, and the covid pandemic itself requiring distancing, masking, and sanitizing requirements.   It is an ongoing learning experience.

The Israel's seem to have a leg up with their process. This is no surprise, it is a small country of about 8-10 million, with a universal health care system. There is a centralized health information system

https://www.wsj.com/21e48f86-5968-47d4-b508-a418d0056e5f










Some Covid-19 Vaccines Are Effective After One Dose, Can Be Stored in Normal Freezers, Data Show - WSJ: In a win for global vaccination goals, the BioNTech-Pfizer vaccine is shown to generate a strong response with one dose and to maintain potency in standard freezers for two weeks.

Build a Revolutionary Healthcare Model

I hear many organizations bandying terms like Exponential Medicine, The Future of Medicine , Singularity, Precision Medicine, Personalized Medicine, and many others. Health care delivery has changed radically during the past ten years.  2020 presented a crisis that stimulated the use of already existing technology that had been under-utilized.

One of the most comprehensive patient-centered models of health care is that of "Forward" Forward is a revolutionary startup with offices in San Diego, San Francisco, Newport Beach, Glendale, and San Diego California.

It is funded by 24 private investors, initiated in 2015, with its headquarters in San Francisco.. Funding off 

Forward came inin January 2016 by former executives and engineering leaders from Google and Uber and led by serial entrepreneur Adrian Aoun. Forward was funded by some of the world's best

investors and entrepreneurs including First Round Capital, Eric Schmidt (Google/Alphabet chairman), Marc Benioff (Salesforce founder), Joe Lonsdale (Palantir founder), Joshua Kushner (Oscar co-founder), and Garrett Camp (Uber co-founder)

Forward Medical Lead, Dr. Nate Favini provides an in-depth tour of one of Forward's clinics, highlighting our biometric monitoring technology, rapid blood testing, genetic analysis, and more. Learn about how Forward's top-rated doctors leverage advanced technology to take a preventive approach to healthcare.

The video details the appearance of the clinic, it's examination rooms and the innovative means of gathering critical vital signs, as well as laboratory work, including genetic analysis.

Forward's stated goals are  Preventive primary care, powered by technology. On a mission to bring healthcare to the people who need it most.  Forward is a new approach to primary care that combines world-class doctors and leading-edge technology. Control the future of your health.

Forward Careers - Help Build a Revolutionary Healthcare Model

The methamphetamine crisis silently burns in the background. – Scientific Inquirer

Public attention has been drawn to the 'Opioid Addiction" drugs which are legally prescribed for pain management.  The misuse of these useful medications was fueled by overzealous prescribing by physicians and marketing by unscrupulous pharmaceutical companies. 

Several large previously reputable pharmaceutical companies (privately owned) were brought down by the opioid scandal (Purdue), and a rich philanthropic family's wealth destroyed by multiple large judgments (states) who sued for damages for medical treatments and therapy for addicted patients.  This will serve as a warning to those in the future who plan to profit from marketing dangerous and/or addicting drugs.

There are also many other non-opioid compounds that are used by patients who seek highs or other body experience, ranging from nitrous oxide to sniffing glue or other volatile compounds.  Many have serious effects on other body systems such as the heart, liver, and kidneys.

Methamphetamine, the chief ingredient for 'crack' is easily manufactured from some legal prescriptions including many over-the-counter cold remedies.  It became so well known that retail pharmacists no longer place them on open shelves, and although unregulated by the Drug Enforcement Agency (DEA) keeping them under lock and key elsewhere. The key ingredient, Sudafed is a main ingredient for nasal decongestants and is nonaddictive. Its main danger is the combination of readily available supply and dangerous side effects when concentrated into 'crack" 

 

Desoxyn Methamphetamine

Blu Crystal Meth

The methamphetamine crisis silently burns in the background. – Scientific Inquirer

Covid 19 vaccine was not a miracle...read more

Many politicians claim the vaccine is a miracle, however like magic the truth is in the science.

History of  CIRM

Over 15 years ago, in California, proposition 71 was presented to the voters to create the California Institute of Regenerative Medicine and funded it with a 3 billion dollar bond issue. This occurred when then President George Bush placed a ban on harvesting human fetal tissue for stem cell research. The reason was the hot topics of right to life and faith issues.  It was a political issue. 

The CIRM allowed stem cell research to continue using adult stem cells in lieu of fetal stem cells. Certain adult organs contained primitive and only partially differentiated stem cells. Tissues that rapidly multiply such as bone marrow and skin were likely candidates.  Fortunately, this hypothesis was true. 

This formed the foundation for the Moderna and Pfizer-Bionet covid 19 vaccines. CIRM  is an interesting story in itself and worth reading about. 

Had CIRM not been formed there would have been other significant delays in the basic science of stem cells.

To learn more and attend the Webinar

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Patients

Researchers

About CIRM 

The Stem Cellar (blog)

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Cancer patients and Covid 19 Vaccinations.

As two new COVID-19 vaccines become more widely available, patients with cancer and cancer survivors may wonder if it's safe to be vaccinated.

"Because cancer patients and survivors are at higher risk for severe effects from COVID-19 infection, we recommend they get vaccinated as soon as they can," says Robert McWilliams, M.D., a medical oncologist at Mayo Clinic. "Patients who are immunosuppressed due to active cancer treatment may not get the same effective response as someone without immune compromise, but it should still be safe for them to receive the vaccine."

There is no definitive data on the efficacy of the COVID-19 vaccines from Pfizer/BioNTech and Moderna in patients with cancer or cancer survivors. "However, the few patients with cancer who were studied as part of the clinical trials leading to the approval of these vaccines did not experience any unique side effects," says Joleen Hubbard, M.D., a medical oncologist at Mayo Clinic.

The good news for patients with cancer and cancer survivors is that the Pfizer/BioNTech and Moderna COVID-19 vaccines are not live virus vaccines. That makes them less likely to cause side effects in immunosuppressed patients. "Both vaccines are mRNA (messenger RNA) vaccines, which means they teach our bodies how to make a protein that will trigger an immune response without the use of a live virus that causes COVID-19," says Dr. Hubbard. "Once triggered by the protein, our immune system makes antibodies to protect us if we are exposed to the virus."

Now that the vaccine is becoming available in the United States, expect to see more cases of side effects, however, the incidence rate remains the same.

Average daily case rate of Covid 19 positive cases.  Many of these patients have mild, moderate, or no symptoms.

Moderna Vaccine

Pfizer-Bionet

Newsfeed Detail | Mayo Clinic Connect

The Relationship Between Alzheimer’s Disease and Diabetes

Society for Neuroscience - Inside Neuroscience: The Relationship Between Alzheimer’s Disease and Diabetes

Inside Neuroscience: The Relationship Between Alzheimer’s Disease and Diabetes

Regions of the “social brain,” including the medial prefrontal cortex (mPFC), temporoparietal junction (TPJ), posterior superior temporal sulcus (pSTS), amygdala, and anterior cingulate cortex (ACC). Source: Sarah Jayne Blackmore, Nature Reviews Neuroscience 2008.

Alzheimer’s disease is the most common form of dementia, affecting over 50 million people worldwide, with rates expected to triple in the next 30 years. The disease is characterized by aggregates of amyloid-beta outside neurons and tangles of hyperphosphorylated tau within neurons. More recently, evidence suggests a disturbance in glucose metabolism in the Alzheimer’s brain as well, although whether this is a cause or symptom of the disease remains unclear. Type 2 diabetes — in which blood glucose levels are elevated — increases the risk for Alzheimer’s disease about two-fold.

A better understanding of the relationship between these two diseases may yield novel therapies. At the Neuroscience 2019 press conference “Untangling the Link Between Diabetes and Alzheimer’s Disease,” researchers shared new insights into how glucose metabolism problems and Alzheimer’s pathology could be related, disrupted, and potentially fixed.

Test your knowledge about Viruses Quiz gone viral - Cold Spring Harbor Laboratory

Coronavirus (COVID-19) Self-Checker

John. Hopkins is one of the best sources for Covid 19.  Beginning in January 2020 JHU has reported daily on the extent of the pandemic with an interactive global map detailing the number of cases worldwide by country.

Covid Dashboard

COVID-19 has caused a sea-change for business, social activities, health care, education, and government. There have been few other cataclysmic events in our history such as Pearl Harbor, Nine-eleven, and the Civil War.  It unleashed public outcry for police reform, justice, and too many others to list here.

In order to understand what Covid-19 is all about we are going to point readers to credible references.

Covid-19 is the first recent pandemic to affect the globe. Several other epidemics such as Ebola, Zika, SARS and H1N1 influenza pale in the extent of global involvement.  Ebola, Zika was a regional disease that did not extend to a pandemic.

This brief discussion is expanded by clicking here

Dr. Vivek Murthy Champions the Power of Togetherness

In our youth and middle age, we all wish a long and healthy life to our family and friends, no more so than at this holiday season.  We pause now between Christmas and New Year during winter's annual break.

As we age and have expectancies of our golden years that may or may not be realistic, how many of us could not save for retirement due to illness, disability, never-ending family responsibility, catastrophic events such as floods, tornadoes, firestorms, or hurricanes, most Americans will come up short in their savings plans.  Very few people begin savings early.  Even well educated people with good incomes now service huge education debt in line with what used to be a mortgage payment.  Housing costs have become ridiculous, and despite recessions, the pandemic real estate values continue to outpace inflation. Add to this is a housing shortage.  The housing market is very much divided.  There seems to be no shortage in t he market for the wealthy. 

As we age if you are unfortunate enough to outlive family and friends our support group shrinks and may disappear.  We become dependent upon social organizations, assisted living and/or care at home.  Some cannot afford those 'luxuries' and must manage 'alone, with devastating effects on health and emotional wellness.  It is a gradual decline, sometimes not noticed by those around the aged.

I often hear people saying I don't want to outlive my bank account.

As a physician and as Surgeon General, Murthy found that loneliness was a profound problem that can lead to public health concerns from addiction to depression, yet it was rarely discussed.

Dr Murthy wrote,

Together: The Healing Power of Human Connection in a Sometimes Lonely World.

Dr. Vivek Murthy: What's really interesting is that there are many manifestations of loneliness in any age group. And this is why loneliness can often be so invisible, including among those who are older, because we stereotypically think about loneliness as the person who is living alone at home and has no one coming to visit, or the person who is living in an institution and no family ever stops by. 

"If there's a gap between the connections you feel you need and the connections you have in your life, then you can feel lonely regardless of how many people you have around you." 

But I call it the great masquerader because it can look like depression, it can look like anxiety. Loneliness can look like anger and irritability, which is often how it shows up among men in particular, but also sometimes among women. It can look like being socially withdrawn. It can look like being bored and disinterested. 

And when you start to think about that broader context then you start to realize, gosh, I might actually know a lot of people who might be struggling with loneliness. It doesn't mean that everyone who is depressed is lonely, it doesn't mean that everyone who has anger issues is lonely. But I have found more often than not that loneliness is contributing to many of these feelings. 

We need to define the difference between loneliness and isolation.  Isolation is an objective term that describes the number of people we have around us. Loneliness is a subjective term that describes how we feel about the connections we have in our life. And if there's a gap between the connections you feel you need and the connections you have in your life, then you can feel lonely regardless of how many people you have around you. 

A couple of studies have found that older adults are actually in general doing better emotionally during the pandemic.  

Dr. Vivek Murthy Champions the Power of Togetherness | Next Avenue

Type of mask matters for COVID-19 protection. – Scientific Inquirer

Not all Covid Masks are equal, There is a lot of hype and fake news about masks. The demand for masks has attracted shrewd marketers and outright frauds. The gold standard remains the N95 or KN95.  The homemade variety and fashionable masks may or may not satisfy the requirements to block particles less than 2.5 microns, which is the standard for N95 masks.

                                    Best                             Not as Safe             Useless for COVID

Even though it has been widely known that wearing a face mask will help mitigate the community spread of COVID-19, less is known regarding the specific effects of masks in reducing the viral load in the respiratory tracts of those wearing them. In Physics of Fluids, by AIP Publishing, researchers from the University of Massachusetts Lowell…and California Baptist University examined the effect of wearing a three-layer surgical mask on inspiratory airflows and the mask’s effects on the inhalation and deposition of ambient particles in the upper respiratory airways. “It is natural to think that wearing a mask, no matter new or old, should always be better than nothing. Our results show that this belief is only true for particles larger than 5 micrometers, but not for fine particles smaller than 2.5 micrometers,” said author Jinxiang Xi.

The researchers found that wearing a mask with low (less than 30%) filtration efficiency can be worse than without.

They developed a computational face mask model using a physiologically realistic model of a person wearing a surgical mask with pleats and then using numerical methods to track the particles through the mask. They examined the behavior and fates of aerosols passing through the mask, onto the face, into the airway, and, eventually, where they deposit in the nose, pharynx, or deep lung.

The model showed a mask changes the airflow around the face, so that instead of air entering the mouth and nose through specific paths, air enters the mouth and nose through the entire mask surface but at lower speeds.

The lower speed near the face favors the inhalation of aerosols into the nose, so even though masks filter out certain numbers of particles, more particles escaping mask filtration can enter the respiratory tract.

The video clearly elaborates on what type of mask you should be wearing.

Despite warnings about distancing sanitizing and mask-wearing the pandemic is presently in an explosive phase (logarithmic). This is undoubtedly caused by holiday activities.  The fact is that even if you invite only family you are at risk of contracting COVID 19.

Chris Christy, Governor of New Jersey confessed on CNN how wrong he was about wearing masks. He was caught up in political expediency during an election cycle. Christy explained how everyone was tested at the Republican event at the White House.  He was told everyone was tested and could only enter if testing was negative.  This raises serious questions about rapid testing and if it is reliable.  The results speak for themselves.  

There are almost as many opinions about wearing masks.  Infection rates were very high in Texas since many people would not wear masks, businesses remained open and life was about 80% of pre-Covid times.  Ross Perot gave an interesting assessment of Texas' economy

The virus is out there.

You can find the complete report below

Type of mask matters for COVID-19 protection. – Scientific Inquirer: 

To Vaccinate or not to Vaccinate

That is the question, and the answer is a definite and resounding yes.   There are many 'anti-vaxxers' out there.  No matter what the vaccine their clear message is 'hell no, I won't go' or over my dead body (and that can happen)

Even if you have had previous vaccines and had a reaction, the COVID19 vaccine is a totally new game in town.  It does not use a whole viral particle, live, or deactivated. The covid protein spike cannot reproduce. It is not grown in an egg or any other living cell.  There is little to no chance of an allergic reaction.  

There are many reasons to get the vaccine. For your own protection, to prevent someone else who may be at risk of death due to age, compromised immunity or chronic health issues.  Children are important as well even though most do not get very sick or even have symptoms, and just carriers.  Children represent a large viral pool in the general population and will spread it to other children and adults.

No one has mentioned that SARS viruses mutate often, at times into even worse viral pathogens.  The more viral divisions, the greater the chance of a harmful genetic mutation.  The longer the pandemic lasts the increased chance of another even more severe novel Corona Virus.  How much time we have, no one really knows.  SARS outbreaks occur at 10-15 year intervals from past experience. But not one can be certain.

In addition to the usual concerns, there is a new excuse for not vaccinating. This has to do with the new manufacturing process using messenger RNA.  There is some confusion.  Some patients think that Messenger RNA is being injected into humans and the vaccine is generated in our own cells. There is concern that this is human genetic engineering. There are no human genes involved.

Messenger RNA is not injected into humans.  The only substance injected is the coronavirus protein spike which is manufactured in a laboratory container filled with the correct amino acids and a specific mRNA to construct an artificial protein spike. 

The artificial covid spike is so unstable that it must be kept very cold in order to prevent it from degrading. Not only do the amino acids have to be in the correct sequence the protein must be in a specific 3D shape held together by the bonding of the amino acids in order to be active.  Scientists have been at work developing the technique for more than 25 years.

The FDA consults with scientists who have no conflicting interest and who review all the literature dating back to the seminal articles of DNA, RNA, proteomics, and manufacturing processes down to inspection of pharmaceutical plants. The FDA has enforcement authority to shut down any plant not meeting their regulations for deviations from the manufacturing process, lack of sterility, and more. The process is exhaustive.

The Manufacturing Sounds of a Virus

Marcus Buehler's Sound Cloud Music of Virus Production

What is messenger RNA ?

Graphic Representations of Covid 19 Vaccine Production

Covid19 spike configuration

How it works

Tracking the Development of COVID19 Vaccine

Thousands of scientists were involved in developing a safe and effective vaccine. This groundbreaking development is a catalytic innovation and a paradigm shift for vaccine production reducing the process from several years to several months.

And the winners are:  BionTech/Pfizer and Moderna

Covid 19 Depression ?

How are you coping with almost a year of social distancing, wearing a mask, and not being able to use many facilities such as gyms, restaurants, clubs, and more?  Those who seem to be coping the best have already established routines of meditation, yoga, exercise routines, and eating a healthy diet.

Health Train Express today is focusing on mental health, whether it is depression, anxiety or fear. All of those are a natural outcome of what we all have experienced with COVID 19.  This may have affected young people even more than adults or older people. Children and adolescents are highly social in a critical time of development learning to socialize and deal with adolescent anxiety and changes.  Most of these ideas will help you and your kids.  Arrested social development can be a serious long term outcome of COVID19, as schools are closed.  Remote learning is not suitable for children who complain they miss their friends.

Health Train Express does not usually endorse specific products, however today we are making an exception, and the reason is a unique partnership with Synctuition. This partnership will promote Health Train Express on their site, and also some of their content will appear here today and in the future.

Here is a sample of their content:

Like any other major, worldwide events, the COVID-19 crisis has forever changed our routines and the way we see life. It has also reshaped our romantic relationships. As several nations across the world slowly emerge from lockdown, we reflect on the way we’ve been separated from our loved ones or been obliged to live in close proximity with our partners. Every experience has been unique, but it has raised some concerns. 

For some, the high confinement has created tensions and caused serious conflict. In March, for example, China saw a dramatic peak in divorce requests. Something similar has happened in other European nations. 

However, this is not something exclusive of the current health emergency. Romantic relationships are hard work. With everything going around you — your career, children, hobbies, and personal goals — it’s easy to lose sight of how much you care about your significant other. Especially when you’re going through a rough patch. 

Leave a comment or give it a thumbs up or down.  You also will find more information on their Facebook page

https://app.synctuition.com/