Antiviral, Anti-inflammatory, BCG and HCQ in Covid-19

By pjain      Published Aug. 4, 2020, 1:05 a.m. in blog Health   

Antiviral, Anti-inflammatory and HCQ

Other Anti-virals

Remdesivir

Studies show not as effective as Hydroxychloroquine with more side effects.

In Canada, now Remdesivir is approved. Canadians should have options to choose w/ doctor. Would you prescribe HCQ if a patient requested

HCQ

In the Middle East, HCQ is working extremely well treating pts early.

BCG works well - saves millions where it it already being used!

--- BCG General Immune System Booster, and Effective against Covid-19 --- XFR

What is BCG?

Bacillus Calmette-Guérin (BCG), a live attenuated strain of Mycobacterium bovis, the most commonly administered vaccine worldwide

BCG induces an ~38-45% overall mortality reduction in Infants to Children

Research studies

  • Biering-Sorensen S, Aaby P, Lund N, Monteiro I, Jensen KJ, Eriksen HB, SchaltzBuchholzer F, Jorgensen ASP, Rodrigues A, Fisker AB, Benn CS. Early BCG-Denmark and Neonatal Mortality Among Infants Weighing <2500 g: A Randomized Controlled Trial. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2017;65(7):1183-90. Epub 2018/03/27. doi: 10.1093/cid/cix525. PubMed PMID: 29579158; PMCID: PMC5849087.

  • Garly ML, Martins CL, Bale C, Balde MA, Hedegaard KL, Gustafson P, Lisse IM, Whittle HC, Aaby P. BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG? Vaccine. 2003;21(21-22):2782-90. Epub 2003/06/12. doi: 10.1016/s0264-410x(03)00181-6. PubMed PMID:12798618.

BCG Fights TB Aggressively

Originally developed to combat tuberculosis (TB) and Prevent leprosy

Research studies

  • Global tuberculosis programme and global programme on vaccines. Statement on BCG revaccination for the prevention of tuberculosis. Wkly Epidemiol Rec.1995;70(32):229-31. PubMed PMID: 7669527.
  • Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Karonga Prevention Trial Group. Lancet. 1996;348(9019):17-24. PubMed PMID: 8691924.
  • Whelan KT, Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Hill AV, McShane H. Safety and immunogenicity of boosting BCG vaccinated subjects with BCG: comparison with boosting with a new TB vaccine, MVA85A. PloS one. 2009;4(6):e5934. doi:10.1371/journal.pone.0005934. PubMed PMID: 19529780; PMCID: PMC2694271.
  • Nemes E, Geldenhuys H, Rozot V, Rutkowski KT, Ratangee F, Bilek N, Mabwe S, Makhethe L, Erasmus M, Toefy A, Mulenga H, Hanekom WA, Self SG, Bekker LG, Ryall R,Gurunathan S, DiazGranados CA, Andersen P, Kromann I, Evans T, Ellis RD, Landry B, Hokey DA, Hopkins R, Ginsberg AM, Scriba TJ, Hatherill M, Team CS. Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination. The New England journal of medicine. 2018;379(2):138-49. doi: 10.1056/NEJMoa1714021. PubMed PMID: 29996082; PMCID:PMC5937161.

BCG Fights Respiratory Infections

Not limited to neonates and children, BCG vaccinated elderly (age 60-75) individuals experience decreased respiratory infections.

Research studies

  • Hollm-Delgado MG, Stuart EA, Black RE. Acute lower respiratory infection among Bacille Calmette-Guerin (BCG)-vaccinated children. Pediatrics. 2014;133(1):e73-81. Epub 2014/01/01. doi: 10.1542/peds.2013-2218. PubMed PMID: 24379224.
  • Wardhana, Datau EA, Sultana A, Mandang VV, Jim E. The efficacy of Bacillus Calmette-Guerin vaccinations for the prevention of acute upper respiratory tract infection in the elderly. Acta Med Indones. 2011;43(3):185-90. Epub 2011/10/08. PubMed PMID: 21979284.
  • Spencer JC, Ganguly R, Waldman RH. Nonspecific protection of mice against influenza virus infection by local or systemic immunization with Bacille Calmette-Guerin. The Journal of infectious diseases. 1977;136(2):171-5. Epub 1977/08/01. doi:10.1093/infdis/136.2.171. PubMed PMID: 894076.

BCG Helps against Bladder Cancer

For bladder cancer, intravesicular BCG boosts host immunity, reduces tumor recurrence progression and decreases mortality and has been approved for use in bladder cancer since the 1990s.

Research studies

  • Kamat AM, Hahn NM, Efstathiou JA, Lerner SP, Malmstrom PU, Choi W, Guo CC, Lotan Y, Kassouf W. Bladder cancer. Lancet. 2016;388(10061):2796-810. Epub 2016/06/28. doi: 10.1016/S0140-6736(16)30512-8. PubMed PMID: 27345655.

BCG Safety

BCG global Vaccination Policies

BCG Industry

Research studies

  • Cernuschi T, Malvolti S, Nickels E, Friede M. Bacillus Calmette-Guerin (BCG) vaccine: A global assessment of demand and supply balance. Vaccine. 2018;36(4):498-506. Epub 2017/12/20. doi: 10.1016/j.vaccine.2017.12.010. PubMed PMID: 29254839; PMCID: PMC5777639.

Immune Fundas and Pathways of BCG

PATHWAYs: BCG strengthens immune system against TB

There is strong epidemiologic evidence that live, attenuated vaccines induce non-specific mortality benefits not just to one disease. Originally developed to combat tuberculosis (TB), the mortality benefit from BCG is not TB-specific, but due to a decrease in neonatal sepsis and respiratory tract infections.

Research studies

PATHWAYs: BCG strengthens immune system by training it!

Research studies

  • Arts RJW, Carvalho A, La Rocca C, Palma C, Rodrigues F, Silvestre R, Kleinnijenhuis J, Lachmandas E, Goncalves LG, Belinha A, Cunha C, Oosting M, Joosten LAB, Matarese G, van Crevel R, Netea MG. Immunometabolic Pathways in BCG-Induced Trained Immunity. Cell Rep. 2016;17(10):2562-71. doi: 10.1016/j.celrep.2016.11.011. PubMed PMID: 27926861; PMCID: PMC5177620.
  • Kleinnijenhuis J, Quintin J, Preijers F, Joosten LA, Ifrim DC, Saeed S, Jacobs C, van Loenhout J, de Jong D, Stunnenberg HG, Xavier RJ, van der Meer JW, van Crevel R, Netea MG. Bacille Calmette-Guerin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(43):17537-42. doi:10.1073/pnas.1202870109. PubMed PMID: 22988082; PMCID: 3491454.
  • Arts RJW, Moorlag S, Novakovic B, Li Y, Wang SY, Oosting M, Kumar V, Xavier RJ, Wijmenga C, Joosten LAB, Reusken C, Benn CS, Aaby P, Koopmans MP, Stunnenberg HG, van Crevel R, Netea MG. BCG Vaccination Protects against Experimental Viral Infection in Humans through the Induction of Cytokines Associated with Trained Immunity. Cell Host Microbe. 2018;23(1):89-100 e5. doi: 10.1016/j.chom.2017.12.010. PubMed PMID: 29324233.

PATHWAYs: BCG strengthens immune system against respiratory diseases

Research studies

PATHWAYs: BCG and Gene Expression - DNA Methylation Patterns

Research studies

  • Joosten SA, van Meijgaarden KE, Arend SM, Prins C, Oftung F, Korsvold GE, Kik SV, Arts RJ, van Crevel R, Netea MG, Ottenhoff TH. Mycobacterial growth inhibition is associated with trained innate immunity. The Journal of clinical investigation. 2018;128(5):1837-51. doi: 10.1172/JCI97508. PubMed PMID: 29461976; PMCID:PMC5919803.
  • Verma D, Parasa VR, Raffetseder J, Martis M, Mehta RB, Netea M, Lerm M. Antimycobacterial activity correlates with altered DNA methylation pattern in immune cells from BCG-vaccinated subjects. Sci Rep. 2017;7(1):12305. doi: 10.1038/s41598-017-12110-2. PubMed PMID: 28951586; PMCID: PMC5615063.

BCG and Coronavirus Effectiveness

By comparing countries that currently had BCG vs other countries where it was never used or had not been use for many years, it was found that over preceding 15 days, incidence of Covid-19 was 38.4 per million in countries with BCG vaccination compared to 358.4 per million in the absence of such a program. The death rate was 4.28/million in countries with BCG programs compared to 40/million in countries without such a program. - BCG vaccination may be protective against Covid-19, Mar 2020, Paul Hegarty, Kamat, Dinardo et al. DOI: 10.13140/RG.2.2.35948.10880

Research studies

  • Vrieze Jd. Can a century-old TB vaccine steel the immune system against the new coronavirus? [cited 2020 25 March 2020]. https://www.sciencemag.org/news/2020/03/can-century-old-tb-vaccine-steel-immunesystem-against-newcoronavirus.

HCQ in Covid-19 - Summary and Lessons

I am puzzled by the HCQ mess - can this be resolved?

CQ, HCQ approved decades ago - effective in Malaria, Lupus treatment

CQ chloroquine and HCQ hydroxychloroquine are anti-malaria drugs that were approved decades ago to treat and prevent malaria but are also used for other ailments, such as lupus and rheumatoid arthritis.

Current regulatory status

The Food and Drug Administration has revoked its emergency-use authorization for chloroquine and hydroxychloroquine for the treatment of Covid-19 after concluding they are unlikely to help fight the disease.

Vaccine Push - hundreds of billions of Profits at stake

Pharmas desire to push a more expensive medication onto the market, and to push a new vaccine on the world’s population. Due to the Covid fear - it becomes mandatory, and the price can be very high! In fact like the iPhone, "rationing" and national grabbing will help raise toe prices skyhigh.

Why Pharmas hate HCQ - Spanner in their Gold Making Machine

Hydroxychloroquine is a generic drug that is no longer covered by patent, and can be made and sold by any generic producer, for a fraction of the price that Gilead, for example, might charge for its still-patented Remdesivir. If it turns out that this “new” virus is easily treatable, with hydroxychloroquine or anything else, then the industry’s dreams go up in smoke.

Eventually, the silencing of dissenting voices, the “fact-checking” on social media, the campaigns against “misinformation” - will be revealed in plain sight, for what it has always been: Nothing more than a well-funded marketing campaign and damage-control effort on behalf of the industry that wants you to believe that you need to use its expensive products in order to go on living.

Pharmas control Narrative - Media Bias and control over Doctors XFR

Lobbyists and Capture of Congress

Pharmas totally control politicians such as Congressman Adam Schiff, who last year wrote to the CEOs of Amazon, Facebook and Google, requesting that those companies censor information and products that did not conform to the officially sanctioned position on vaccines. All three complied.

Media

Supposedly 70% of all US news ads come from pharmas .. “reporting” on medical issues can be difficult to distinguish from outright marketing for or representing positions of drug companies.

Doctors

Novartis was fined $700m (?) for trying to influence

Social-media platforms and Censoring

“partnerships” such as that between the CDC Foundation and MailChimp (which like many other platforms, has an explicit policy of censoring content about vaccines that does not align with the positions of the CDC and the WHO)

Pharmas totally control politicians such as Congressman Adam Schiff, who last year wrote to the CEOs of Amazon, Facebook and Google, requesting that those companies censor information and products that did not conform to the officially sanctioned position on vaccines. All three complied.

Twitter and Facebook have likewise removed posts about the drug, most notably–and with no visible sense of irony–removing posts of the video in which the Frontline Doctors speak out about widespread media censorship of the topic.

Capture of CDC

HCQ Major POSITIVE Studies and Thesis

HCQ Meta Studies

  • https://c19study.com/

Major NEGATIVE Studies

WRONG: LATE HCQ No benefit ALONE for mild illness - Boulware, July 15 2020

  • https://www.acpjournals.org/doi/10.7326/M20-4207

1. TRIAL SETUP - EARLY TREATMENT on SYMPTOMS, 40-year Average

Random assignment to placebo or HCQ. In Hydroxychloroquine arm, 201 received 800 mg, followed by 600 mg several hours later, and then 600 mg daily for four additional days. They were monitored for two weeks to track symptoms: whether they resolved or worsened, or if the patients needed hospitalization or died.

EARLY All subjects enrolled within four days of experiencing symptoms and were required to have either tested positive for Covid-19 or been exposed within two weeks to someone who had tested positive. More than half enrolled within one day of experiencing at least one symptom. Scope 491-person study

Sponsors: David Boulware, an infectious-diseases specialist at the University of Minnesota - https://covidpep.umn.edu/

The trial was double-blinded, meaning that neither the study subjects nor the researchers knew who received a drug or placebo.

2. RESULTS

About 24% of people or 49/201 given HCQ pills continued to show symptoms such as a cough or fever two weeks after first receiving the treatment, compared with 30% of people or 59/194 given a placebo.

3. SIDE-EFFECTS

Researchers didn’t find any serious safety problems associated with the drug’s use, such as irregular heart rhythms or deaths. Milder side effects such as nausea or diarrhea were more common in patients who received hydroxychloroquine in this study. Individuals with known heart arrhythmia problems weren’t included in the study.

ISSUES LEFT : ELDERLY

Dr. Boulware said the drug may still work early on in elderly Covid-19 patients who aren’t hospitalized, or in combination with other medications such as the antibiotic azithromycin.

CRITICISMS & REBUTTALs

PKJ COMMENT> This seems like a significant difference - but study seems to suggest not statistically conclusive ie could happen randomly. The conclusion of the study is actually a ~40% reduction in hospitalizations/deaths in patients treated with HCQ vs placebo (2.5% vs 4.1%). This did not reach significance, but would have been strong encouragement to proceed with additional higher powered RCTs. The study didn’t find that adding zinc or vitamin C to either the hydroxychloroquine or placebo treatment led to a faster resolution of symptoms, researchers said.

  1. Actual treatment was NOT early but LATE - 4 day after exposure and shipping delay - at least 1-2 days.

  2. Medical adherence was only 75% - with 16% not taking medication at all. This severely limits the conclusions.

  3. https://c19study.com/watanabe.html

  4. This was not really a RCT The Minnesota study is honestly an embarrassment to the term “randomized controlled trial” and should actually be called an “anonymous online survey” instead. The participants were evaluated via a static online survey and not actually seen by physicians or medical personnel.

  5. Only 34% of participants had a positive PCR test. The remaining 66% either did not have a PCR test or actually tested negative. This means that a positive diagnosis was made based on only SYMPTOMS for the vast majority of participants. What happens if a large percent of the participants didn’t actually have COVID-19? It would diminish the observed therapeutic effect of hydroxychloroquine (HCQ probably isn’t going to help allergies or the common cold).

  6. If the researchers had kept their original end point (hospitalization/death), the study would've actually shown a strong trend toward benefit for HCQ. Instead, the researchers changed the end point mid-study from hospitalizations/death to symptoms at 14 days.

  7. most criticisms from - https://twitter.com/JamesTodaroMD/status/1289563466819186695

LATE: Did not help Hospitalized Patients - NIH halted HCQ June 2020

National Institutes of Health halted its clinical trial of hydroxychloroquine, concluding the drug was very unlikely to help hospitalized patients.

Dr. Fauci & the NIH started a trial in May doing just this. The bad news is they cancelled the trial after enrolling only 20 subjects in order to focus on a new trial evaluating remdesivir plus baricitinib (another “novel” patented drug).

EARLY no HCQ benefit - Spain, July 16, 2020

Resources

Lessons about RCTs --- xfr ---

RCT ethics

  • How are they getting informed consent on these very sick patients? Double blind studies means some will not be treated which is unethical. You can’t pick and choose who lives & who dies in critically ill patients. john Veall @docveall

    It’s only unethical if there is an alternate treatment that has been proven to work. Treating someone with an ineffective drug with side effects is also unethical. Not treating something with an unproven drug— perfectly ethical and best practice

Nof1 - are they "Online Internet Surveys"

The Minnesota HCQ/Covid19 study is honestly an embarrassment to the term “randomized controlled trial” and should actually be called an “anonymous online survey” instead. The participants were evaluated via a static online survey and not actually seen by physicians or medical personnel.

Testing Limitations - Only take people tested positive - Can affect number in study.

A lack of testing availability was one limitation to the study. Some patients who initially enrolled after having been exposed to the virus ended up not having Covid-19 and needed to be excluded. This can affect study results if number of participants drops too much.

Random and Double Blind RCTs essential

Patients need to be randomly assigned to receive the drug or the placebo - so as to prevent bias or underlying "pre-selection" eg fraility, other disease loads, etc from affecting the split data! The trial was double-blinded, meaning that neither the study subjects nor the researchers knew who received a drug or placebo.

STAGE OF PATIENT: Minimum asymptomatic vs LATE stage/damaged lungs

PATIENT ENROLLMENT SCOPE: Early, or Late

  • Often to avoid side-effects, unnecessary deaths, exclude patients with proven other diseases or mortality. For example in HCQ studies looking at cardiac side effects - exclude people with prior Arrhythmia.

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