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.

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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