Archive for the ‘Testing’ Category

International Pharmaceuticals Expert Exposes Pandemic Fakery!

https://principia-scientific.com/international-pharmaceuticals-expert-exposes-pandemic-fakery/

International Pharmaceuticals Expert Exposes Pandemic Fakery!

Written by John O’Sullivan

In a scathing assessment of governmental responses to the COVID-19 pandemic a respected former pharmaceutical assessor for Health Canada condemns systemic “lies”about antibody testing which, he says, “lacks scientific validity.”

Saeed Qureshi, Ph.D. is a top pharmaceuticals expert with over 30 years in the industry. He conducted hands-on and multi-disciplinary laboratory research for regulatory assessment purposes while working with Health Canada.

Heaping particular criticism on the FDA approved under Emergency Use Authorization or EUA, Dr Qureshi condemns the testing kits widely used as ineffective and “such tests should be avoided in making predictions or projections about the infection and its spread. It certainly is a false science.

We cite sections of Dr Qureshi’s findings below:

“Considering the statements below, from a randomly selected fact sheet FDA approved under Emergency Use Authorization or EUA, the current antibody testing lacks scientific validity. This is really sad that such tests [kits] are being promoted or used to establish COVID-19 [1]. As noted below the test monitors protein levels commonly known as [IgM, IgA and IgG] not specifically COVID-19. Logically data obtained from such tests should be avoided in making predictions or projections about the infection and its spread. It certainly is a false science.

  1. “A positive result with VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test may not mean that an individual’s current symptoms are due to COVID-19 infection.”
    2. “However, a negative result does not rule out COVID-19.”
    3. “The absolute sensitivity of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test is unknown.
    4. FDA statement [2] “This limits the test’s effectiveness for diagnosing COVID-19 and why it should not be used as the sole basis to diagnose COVID-19.”
    In addition, if vaccines would be developed based on such antibody tests, which does not appear to be sufficiently validated as noted above, then how reliable and valid vaccines would be? Please be cautious with claims in this regard.

Do FDA and USP lie? Of course, all the time!

For example:

FDA claims that it establishes and monitors quality of pharmaceutical products such as tablet and capsule. A lie – FDA neither defines quality of the products nor its measurable parameter hence it does not, or cannot, determine quality of the products.

FDA claims that it establishes safety and efficacy (as well as quality) of pharmaceutical products using valid clinical testing (e.g. bioequivalence assessment) and in vitro (drug dissolution) testing using USP apparatuses. A lie – these tests, along with associated testers, have never been validated for the intended purpose. In fact, these tests have been shown to be scientifically invalid and irrelevant for their intended purpose.

USP claims that it provides reference standards for establishing quality of the pharmaceutical products such as tablets and capsules. A lie – USP never provides reference standards for any product. It provides powder or liquid samples of pure chemical compounds, not the products which patients use, however falsely promotes as reference standards of medicines.

USP claims that it provides a valid analytical test for the assessment drug release characteristics of the products for establishing and monitoring quality of the products. A lie – the test has never been validated for the intended purpose. The test cannot determine drug dissolution/release characteristics of any product. It has been shown experimentally that the test provides irrelevant and highly unpredictable results/data with no relevance to product quality.

For more examples please visit here. Manufacturers and patients should be cautious in accepting such claims from FDA and USP as well as other national and international authorities which often follow FDA/USP claims and guidances.

Please consider accepting the Citizen Petition (under review with FDA for more than a year and a half, link) for addressing the underlying lies concerning products development, manufacturing and their regulatory approval.

Can we say?

  1. Flu came and gone!
  2. Why it was called a pandemic – not clear
  3. Discredited the bench top science – as disease state monitored with charts and their shapes (humpy or dumpy) with protocol/testing developed on the fly
  4. Discredited the medicines approval system with the approval of medicines without requiring established protocols
  5. Treatments could be suggested and implemented without having knowledge or expertise in the area of medicine.
  6. Exposed the great weakness, perhaps more accurately ignorance, of “science” at the authorities!
  7. Hope we learnt something not to repeat in future

(1) Coronavirus pandemic: Public/patients deserve better!

The unfortunate situation created by this Coronavirus pandemic is providing a serious opportunity for reassessing the current regulatory approaches in pharmaceutical products development as well as their manufacturing so that in future such irrelevant discussion can be avoided and patients can have access to modern and multiple options to treat ailments. Hopefully in the future patients will be treated with well-established products rather than products developed on the fly or with the use of disposable gowns, masks, washing hands and/or staying home policy which certainly are not the treatments – patients expect and deserve something better from us as scientists, physicians and regulators. Follow the link for complete article (link)

(2) Authorities (including FDA) and pharmacopeias (including USP) never establish quality of products!

Reasons:

(1) They do not define quality of the products, hence it cannot be measured and/or established (link).
(2) Suggested methods and procedures lack scientifically relevancy and validity (link)
(3) GMP practices, including inspections, are about operation of manufacturing not per se reflection of products quality (link).

(3) Is Coronavirus really causing abnormally higher number of deaths?

Mortality in the United States, 2018 (as of January 2020, link).

“The age-adjusted death rate decreased by 1.1{154653b9ea5f83bbbf00f55de12e21cba2da5b4b158a426ee0e27ae0c1b44117} from 731.9 deaths per 100,000 standard population in 2017 to 723.6 in 2018.” i.e. death rate is about 0.7236{154653b9ea5f83bbbf00f55de12e21cba2da5b4b158a426ee0e27ae0c1b44117}

For the USA, having population of 331 million (link), normal/standard death (attrition) rate should be 199,593 deaths/month. Now compare this number with the reported number of deaths caused by Coronavirus pandemic, which are 21,435 in about a month’s time as of April 12, 2020 (link) which is far less than normal/standard death (attrition) rate.

The death rate, therefore, does not appear to support the thesis that the pandemic is killing people with abnormally high numbers.

About the author: Dr. Qureshi gained extensive (30+ year) experience in conducting hands-on and multi-disciplinary laboratory research in pharmaceutical areas for regulatory assessment purposes while working with Health Canada.

He is an internationally recognised expert in the areas of pharmacokinetics, biopharmaceutics, drug dissolution testing, analytical chemistry as related to characterization of pharmaceuticals, in particular, based on in vitro (dissolution) and bioavailability/bioequivalence (humans and animals) assessments.

At present, Dr. Qureshi provides teaching, training and consulting services, in the area of his expertise as noted above, for improved pharmaceutical products development and assessments. Dr. Qureshi can be reached by email (principal@pharmacomechanics.com) or Tel (+1 613 797 9815)

Read more at www.drug-dissolution-testing.com


PRINCIPIA SCIENTIFIC INTERNATIONAL, legally registered in the UK as a company incorporated for charitable purposes. Head Office: 27 Old Gloucester Street, London WC1N 3AX. 

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**Comment**

Again, if I’ve said it before, I’ve said it 1,000 times: DO NOT GET TESTED if you do not have symptoms.  These tests are horrible. And even if you DO have symptoms, the tests are still inaccurate and you could just have the common cold:  https://madisonarealymesupportgroup.com/2020/07/22/cdc-website-positive-for-covid-19-you-might-have-just-a-cold-but-we-are-going-to-quarantine-you-anyway/

https://madisonarealymesupportgroup.com/2020/07/01/us-scientist-manufactured-pandemic-testing-people-for-any-strain-of-coronavirus-not-specifically-covid-19/

https://madisonarealymesupportgroup.com/2020/08/09/gov-mike-dewine-of-ohio-tests-positive-then-negative-for-coronavirus/?

https://madisonarealymesupportgroup.com/2020/05/18/coronavirus-covid-19-antibody-tests-do-you-really-want-one-think-hard-about-it-maybe-not/?r

https://madisonarealymesupportgroup.com/2020/08/09/gov-mike-dewine-of-ohio-tests-positive-then-negative-for-coronavirus/

COVID-19 Patients No Longer Need Tests to End Isolation

https://www.nytimes.com/2020/07/22/health/coronavirus-isolation-testing.html

Under new guidelines from the C.D.C., recovering coronavirus patients should be free to resume normal activity after 10 days, if they have no fever or other symptoms.
Coronavirus testing delays of up to two weeks persist in parts of the country.
Credit…Max Whittaker for The New York Times

Most Americans recovering from Covid-19 can come out of isolation without further testing to show they no longer carry the coronavirus, federal health officials said on Wednesday.

Instead, patients may be judged to have recovered if 10 days have passed since they first felt ill; they no longer have any symptoms, such as shortness of breath or diarrhea; and they have not had a fever for 24 hours without taking fever-reducing medicine.

The new recommendations are not rules but guidelines intended for patients, doctors and health policymakers. The revisions should help relieve the burden on the country’s testing system, the Centers for Disease Control and Prevention said. (See link for article)

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**Comment**

Ha ha, ha…..yeah right.…Lyme/MSIDS patients know all about “guidelines” that rule the land like the Iron Curtain.

Again, regarding COVID-19 testing – they are inaccurate, worthless, and not to be trusted –  whether they are PCR or antibody tests: https://madisonarealymesupportgroup.com/2020/07/01/us-scientist-manufactured-pandemic-testing-people-for-any-strain-of-coronavirus-not-specifically-covid-19/

https://madisonarealymesupportgroup.com/2020/08/09/gov-mike-dewine-of-ohio-tests-positive-then-negative-for-coronavirus/?

https://madisonarealymesupportgroup.com/2020/05/07/was-the-covid-19-test-meant-to-detect-a-virus/

 

 

Tests for SARS-CoV-2 in South Korea Can’t Distinguish Virus From Viral Fragments

https://thevaccinereaction.org/2020/07/tests-for-sars-cov-2-in-south-korea-cant-distinguish-virus-from-viral-fragments/

Tests for SARS-CoV-2 in South Korea Can’t Distinguish Virus from Viral Fragments

Tests for SARS-CoV-2 in South Korea Can’t Distinguish Virus from Viral Fragments

A team of South Korean infectious disease researchers has concluded there is no evidence that people can be reinfected with the SARS-CoV-2 virus. The researchers, led by Oh Myoung-don, MD, head of Seoul National University Hospital’s division of infectious diseases, believe that reports of patients who have recovered from COVID-19 and subsequently tested positive again for SARS-CoV-2 were not due to reinfection or reactivation but, rather, to testing errors.1 2 3 4 5 6

According to Dr. Oh, the PCR (polymerase chain reaction) tests used to determine the presence of the SARS-CoV-2 virus and help diagnose cases of COVID-19 cannot distinguish between the virus and harmless fragments of the virus.1 2 3 4 5 6 Vaccine developer Seol Dai-wu of Chung-Ang University in Seoul, South Korea agrees.

“The RT-PCR machine itself cannot distinguish an infectious viral particle versus a non-infectious virus particle, as the test simply detects any viral component,” Seol said.2

As immunologist Beda Stadler, PhD, former director of the University Institute of Immunology at the Insel Hospital in Bern, Switzerland notes, people who recovered from COVID-19 can still test positive for SARS-CoV-2 because…

… the coronavirus test measures only a very tiny tiny piece of the genome of the virus, and if your immune cells have killed the virus, then you have debris, you have rotten pieces of the nucleic acids in your blood and everywhere, and the assay can pick up these rotten pieces and then it look like as if you’re infected. You’re not. You have won the fight, you’re immune. So [the test] cannot discriminate.7

In a recent case involving 260 people in South Korea who had been diagnosed with COVID-19 and recovered, tests detected fragments of the SARS-CoV-2 virus weeks after their recoveries. “The tests detected the ribonucleic acid of the dead virus,” Dr. Oh said.1 2 3 4 5 6 He added:

PCR testing that amplifies genetics of the virus is used in Korea to test COVID-19, and relapse cases are due to technical limits of the PCR testing. The respiratory epithelial cell has a half-life of up to three months, and RNA virus in the cell can be detected with PCR testing one to two months after the elimination of the cell.1 3 5 6

The findings by Dr. Oh and his research team have been confirmed by the Korean Centers for Disease Control and Prevention (KCDC). On May 18, 2020, the KCDC announced that it had studied 285 cases of patients who had recovered from SARS-CoV-2 infection and later tested positive again for  the virus. Despite the positive tests, the agency determined that the patients were not contagious because they did not actually have the virus—that the PCR tests has “falsely identified dead viral matter as active COVID-19 infection.8 9

The new research from South Korea has led to new protocols in that country for handling cases involving people who recovered from COVID-19, completed a period of isolation and then retested positive for the SARS-CoV-2 virus. Now, in South Korea, there is no longer a requirement for people, who have recovered from COVID-19 and gone through isolation, to test negative for SARS-CoV-2 before going back to work or school.9


References:1

Betsaida A, Laguipo B. Dead virus fragments are causing COVID-19 reinfection false positives. Medical Life Sciences News May 4, 2020.
2Cha S,Smith J. Explainer: South Korean findings suggest ‘reinfected’ coronavirus cases are false positives. Reuters May 7, 2020.
3Chalmers V. South Korea admits 292 coronavirus ‘reinfections’ were false positives as officials warn fragments of the virus can linger in the body for MONTHS. Daily Mail Apr. 30, 2020.
4 Guzman J. No evidence of coronavirus reinfections, South Korean researchers say. The Hill May 1, 2020.
5 Kim B. Tests in recovered patients found false positives, not reinfections, experts say. The Korea Herald Apr. 29, 2020.
6 Leonardo A. South Korean scientists conclude people cannot be infected with coronavirus more than once. Washington Examiner May 1, 2020.
7 Cafe Weltschmerz. The tragic failure of science and the immunology behind Covid19. Prof. Beda Stadler and Ramon Bril. YouTube June 27, 2020.
8 Sternlicht A. South Korea Says Patients Who Retested Positive After Recovering Were No Longer Infectious. Forbes May 19, 2020.
9 Crist C. Former Patients Testing Positive Aren’t Infectious. WebMD May 20, 2020.

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**Comment**

Again – this is a comedy of errors – only it isn’t funny.

For more:  https://madisonarealymesupportgroup.com/2020/05/13/president-of-tanzania-punks-who-sending-samples-of-fruit-goats-sheep-even-motor-oil-for-covid-testing-nearly-half-come-back-positive/

https://madisonarealymesupportgroup.com/2020/05/07/was-the-covid-19-test-meant-to-detect-a-virus/

Excerpt:

I’m skeptical that a PRC test is ever true. It’s a great scientific research tool. It’s a horrible tool for clinical medicine.Dr. David Rasnick, bio-chemist, protease developer, and former founder of an EM lab called Viral Forensics  https://madisonarealymesupportgroup.com/2020/05/07/was-the-covid-19-test-meant-to-detect-a-virus/

Rasnick’s advice for people who want to be tested for COVID-19.

“DON’T DO IT, I SAY, WHEN PEOPLE ASK ME,” HE REPLIES. “NO HEALTHY PERSON SHOULD BE TESTED. IT MEANS NOTHING BUT IT CAN DESTROY YOUR LIFE, MAKE YOU ABSOLUTELY MISERABLE.”

https://madisonarealymesupportgroup.com/2020/08/09/gov-mike-dewine-of-ohio-tests-positive-then-negative-for-coronavirus/

https://madisonarealymesupportgroup.com/2020/07/01/us-scientist-manufactured-pandemic-testing-people-for-any-strain-of-coronavirus-not-specifically-covid-19/

Gov. Mike DeWine of Ohio Tests Positive, Then Negative, For Coronavirus & Are You Infectious If You Have a Positive PCR? (Maybe Not)

https://www.nytimes.com/2020/08/06/us/mike-dewine-coronavirus

The governor said he felt confident in the results of a negative test that was taken hours after he tested positive while being screened to greet President Trump.

Video player loading
CreditCredit…
Gov. Mike DeWine tested negative for the coronavirus hours after a positive rapid-result test had prevented him from welcoming President Trump to Ohio on Thursday, a whiplash reversal that reflected the nation’s increasingly complex state of testing.
In a high-profile example of a new testing frontier, Mr. DeWine first received an antigen test, which allows for results in minutes, not days, but has been shown to be less accurate. The positive result came as a “big surprise,” said Mr. DeWine, a Republican, who had not been experiencing symptoms other than a headache.
Later on Thursday, he was tested using a more standard procedure known as polymerase chain reaction, or P.C.R., an accurate but time-intensive method that requires samples to be processed at a laboratory. His wife, Fran, and staff members also tested negative.  (See link for article)
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**Comment**
And this is where testing remains…..
Important excerpt:
Public health experts say that widespread, rapid testing is necessary for quarantining and contact tracing to effectively control the virus.
This, not the virus, should frighten us.
They have been and will continue to use abysmal testing to take peoples’ freedoms away.

https://www.cebm.net/covid-19/infectious-positive-pcr-test-result-covid-19/

Are you infectious if you have a positive PCR test result for COVID-19?

August 5, 2020

Tom Jefferson, Carl Heneghan, Elizabeth Spencer, Jon Brassey


PCR detection of viruses is helpful so long as its accuracy can be understood: it offers the capacity to detect RNA in minute quantities, but whether that RNA represents infectious virus may not be clear.

During our Open Evidence Review of oral-fecal transmission of Covid-19, we noticed how few studies had attempted or reported culturing live SARS-CoV-2 virus from human samples.

This surprised us, as viral culture is regarded as a gold standard or reference test against which any diagnostic index test for viruses must be measured and calibrated, to understand the predictive properties of that test. In viral culture, viruses are injected in the laboratory cell lines to see if they cause cell damage and death, thus releasing a whole set of new viruses that can go on to infect other cells.

We, therefore, reviewed the evidence from studies reporting data on viral culture or isolation as well as reverse transcriptase-polymerase chain reaction (RT-PCR), to understand more about how the PCR results reflect infectivity.  (See link for article)

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**Comment**

In one of the best reviews I’ve read on PCR testing so far the authors point out the fly in the ointment: few studies have cultured live SARS-CoV-2 virus from human samples.  This is a big deal.  BIG.  Without injecting live viruses into cells lines to determine infectivity, it’s all theoretical.  And I’ll add one more to that: these viruses must be not only isolated but purified from all else.  In the case of COVID, to my knowledge, this has not been done.  According to David Crowe, all they have is pieces and parts they are labeling “virus.” This is an important distinction and quite fundamental.  For a great read on this:  https://madisonarealymesupportgroup.com/2020/03/16/does-the-coronavirus-exist/

Back to the paper on PCR testing.Viral cultures for COVID-19 infectivity assessment. Systematic review. Tom Jefferson, Elizabeth Spencer, Jon Brassey, Carl Heneghan medRxiv 2020.08.04.20167932; doi: https://doi.org/10.1101/2020.08.04.20167932

The authors reviewed 14 studies that they labeled of “moderate quality” due to being inadequately sized, lack of protocols, standardized methods and reporting and reporting bias. They hit on some interesting issues like time of testing in relation to symptom severity, viral shedding, etc.  They also pointed out that time of testing is important because:

The lower the cycle threshold level the greater the amount of RNA (genetic material) there is in the sample. The higher the cycle number, the less RNA there is in the sample.

What does this mean?

This detection problem is ubiquitous for RNA viruses detection. SARS-CoV, MERS, Influenza Ebola and Zika viral RNA can be detected long after the disappearance of the infectious virus.

In other words, the test is picking up RNA material but the patient isn’t infected any more. The authors point out that this material can linger for weeks in the body.

The authors then sum it up by stating that the 14 studies provided limited data of variable quality of PCR results and are unlikely to predict viral culture from human samples.  They state:

Insufficient attention may have been paid how PCR results relate to disease. The relation with infectiousness is unclear and more data are needed on this.

And the most important point:

If this is not understood, PCR results may lead to restrictions for large groups of people who do not present an infection risk.
BINGO!  This is exactly what is happening.

For more:  https://madisonarealymesupportgroup.com/2020/07/01/us-scientist-manufactured-pandemic-testing-people-for-any-strain-of-coronavirus-not-specifically-covid-19/

https://madisonarealymesupportgroup.com/2020/05/29/antibody-tests-for-covid-19-wrong-up-to-half-the-time-cdc-says/

https://madisonarealymesupportgroup.com/2020/03/21/study-shows-covid-19-testing-as-bad-as-lyme-msids-testing/

https://madisonarealymesupportgroup.com/2020/05/18/coronavirus-covid-19-antibody-tests-do-you-really-want-one-think-hard-about-it-maybe-not/

https://madisonarealymesupportgroup.com/2020/05/29/cdc-recommends-newborns-be-tested-for-coronavirus-twice-separate-from-mothers-with-confirmed-or-suspected-covid-19/

https://madisonarealymesupportgroup.com/2020/05/26/cdc-goes-door-to-door-for-covid-19-testing/

Right here in Wisconsin, Governor Evers is pushing ‘contact tracing’ as part of the Badger Bounce-Back Program based on faulty testing:  http://www.great98.net/2020/05/05/5-5-20-governor-evers-releases-more-information-on-contact-tracing/  DHS is coordinating the amount of tracers with the number of projected tests and positive cases with the goal of having 1,000 statewide tracers.

https://madisonarealymesupportgroup.com/2020/07/29/dane-county-catches-up-on-covid-19-testing-backlog-counts-17000-more-negative-results-oops/

https://madisonarealymesupportgroup.com/2020/07/15/fox-35-investigates-florida-department-of-health-says-some-labs-have-not-reported-negative-covid-19-results/

PCR testing:  https://madisonarealymesupportgroup.com/2020/05/13/president-of-tanzania-punks-who-sending-samples-of-fruit-goats-sheep-even-motor-oil-for-covid-testing-nearly-half-come-back-positive/

https://madisonarealymesupportgroup.com/2020/05/07/was-the-covid-19-test-meant-to-detect-a-virus/

Excerpt:

I’m skeptical that a PRC test is ever true. It’s a great scientific research tool. It’s a horrible tool for clinical medicine.Dr. David Rasnick, bio-chemist, protease developer, and former founder of an EM lab called Viral Forensics  https://madisonarealymesupportgroup.com/2020/05/07/was-the-covid-19-test-meant-to-detect-a-virus/

Rasnick’s advice for people who want to be tested for COVID-19.

“DON’T DO IT, I SAY, WHEN PEOPLE ASK ME,” HE REPLIES. “NO HEALTHY PERSON SHOULD BE TESTED. IT MEANS NOTHING BUT IT CAN DESTROY YOUR LIFE, MAKE YOU ABSOLUTELY MISERABLE.”

 

 

 

 

 

5 Blood Tests You Need Every Year

Regular blood testing is an important way to keep track of your overall well-being. Getting tested at routine intervals can allow you to see how your body is changing over time and empower you to make informed decisions about your health.

Here are five blood tests you should consider getting every year.

Complete Thyroid Panel

Most physicians, including endocrinologists, will only check one or two thyroid markers: TSH and/or total T4. These tests do not give you a complete picture of your thyroid function. At HMG, there are 6 additional thyroid-related values that we routinely check for our patients: Free T4, Total T3, Free T3, Reverse T3, anti TPO Ab, and anti Thyroglobluin Ab. If any of these blood test values are not optimal, we take the steps to prevent or treat thyroid dysfunction or disease.

Essential Nutrients

Nutrients such as iron, vitamin D, vitamin B12, and magnesium are important for optimal bodily function, but they’re rarely checked at a routine primary care visit. Many people are deficient in these nutrients, so it’s imperative they are checked and supplements suggested when levels are not optimal.

Complete Metabolic Panel and Complete Blood Count

Unlike the other tests we run, the comprehensive metabolic panel (CMP) and the complete blood count (CBC) are ordered when you see your primary care physician. These tests are essential to understanding electrolyte and hydration status, kidney function, liver function, and blood cell values. These values can also tell us if someone is fighting an acute or chronic infection.

Metabolic Markers

Metabolic markers such as Hemoglobin A1c, fasting glucose and insulin, and a lipid panel are essential to understanding how a person is processing macronutrients. Most primary care visits include a yearly basic lipid panel and glucose level – rarely will you receive a Hemoglobin A1c. These tests help determine whether there is an increased risk of heart disease from cholesterol levels or not. Many times people are told that they have high cholesterol levels when they are not actually a risk.

Inflammatory Markers

Inflammatory markers like hsCRP and homocysteine are rarely checked at a routine primary care visit. hsCRP is an inflammatory marker which can indicate general inflammatory status. An elevation can tell us there is inflammation happening in the body that should be addressed, whether it be from physical trauma, emotional stress, oxidative stress, environmental toxicity, allergy, sedentary lifestyle, or food sensitivities. Homocysteine is an amino acid that requires methylated-vitamin B12 and folate to be cleared. Elevations in this level can help us understand your stroke and heart disease risk, B vitamin status, ability to methylate, ability to detox, and make neurotransmitters.

https://www.holtorfmed.com/?

There’s many great articles on the Holtdorf site.  Check them out.