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Remdesivir approved to treat COVID in Infants, yet Vitamin D is 3000 X more cost effective and widely used - April 2022


FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy

The Defender

  • "According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds."
  • "The study is underway and will not be completed until February 2023. There are no published results."
  • "However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:"
    • A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
    • 72% suffered adverse events.
    • 21% suffered serious adverse events determined to be unrelated to the drug.
    • Three children died from either underlying conditions or COVID-19.


Note: Gilead saw $5.6B in remdesivir sales in 2021
Assuming $3,100 per dose, Gilead sold 1.8 million doses in 2022
Well over 1 billion doses of vitamin D were sold in 2022


Remdesivir ‘Disastrous’ as COVID Treatment, But Government Pays Hospitals to Use It - May 2022

The Defender

  • "Remdesivir, which to this day is the primary COVID drug approved for use in U.S. hospitals, routinely causes severe organ damage and, often, death."
  • "Despite its horrible track record, the U.S. government actually pays hospitals a 20% upcharge for sticking to the remdesivir protocol, plus an additional bonus. Hospitals must also use remdesivir if they want liability protection."

___

"Safety and effectiveness ... have not been established in pediatric patients younger than 12 years of age" (package insert)

Natural Health May 2, 2022


VitaminDWiki - Children with higher Vitamin D had less severe COVID (no surprise) – April 2022
VitaminDWiki - Severe pediatric COVID 5.5 more likely if low vitamin D (review of 6 studies) -July 2021
VitaminDWiki - Vitamin D might reduce Multisystem Inflammatory Syndrome in children – March 2021
Vitamin D is 3000 X more cost-effective, studied on 16X more patients, with virtually no side effects however, Gilead Sciences had the money to petition for the FDA approval

5,000 X ROI for Gilead Sciences ($5,000 of profit for every $1 invested)
Guessing: $1 billion in profit in 2 years for $200,000 cost (trial + FDA petition)

Probably would cost $50,000 to petition the FDA that Vitamin D can reduce COVID risk in children

Unfortunately, there are >100 Vitamin D suppliers,. so the additional total Vitamin D sales ($3 million?) would be greatly deluted
Addional sales:<$3 million $1 of vitamin D per infected child X 24 million children X 1 in 10 are infected
Guess increased profit = 20% X increased sales = $600,000
Ther might be a single manufactuer that has 5% of the market - it would get increased revenue of $30,000
This would not repay the $50,000 cost to petition the FDA


Many successful vitamin D early treatment trials for adults

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Vitamin D is much better than Remdesivir for adults

https://c19early.com/#fpearly
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https://c19rmd.com/
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VitaminDWiki - Infant-Child category has 710 studies and starts with

Having a good level of vitamin D cuts in half the amount of:

Need even more IUs of vitamin D to get a good level if;

  • Have little vitamin D: premie, twin, mother did not get much sun access
  • Get little vitamin D: dark skin, little access to sun
  • Vitamin D is consumed faster than normal due to sickness
  • Older (need at least 100 IU/kilogram, far more if obese)
  • Not get any vitamin D from formula (breast fed) or (fortified) milk
    Note – formula does not even provide 400 IU of vitamin D daily

Infants-Children need Vitamin D

  • Sun is great – well known for 1,000’s of years.
    US govt (1934) even said infants should be out in the sun
  • One country recommended 2,000 IU daily for decades – with no known problems
  • As with adults, infants and children can have loading doses and rarely need tests
  • Daily dose appears to be best, but monthly seems OK
  • Vitamin D is typically given to infants in the form of drops
       big difference in taste between brands
       can also use water-soluable form of vitamin D in milk, food, juice,
  • Infants have evolved to get a big boost of vitamin D immediately after birth
    Colostrum has 3X more vitamin D than breast milk - provided the mother has any vitamin D to spare
  • 100 IU per kg of infant July 2011, Poland etc.
    1000 IU per 25 lbs.jpg
    More than 100 IU/kg is probably better

Did you know that:


Getting Vitamin D into infants
Many infants reject vitamin D drops, even when put on nipple
I speculate that the rejection is due to one or more of: additives, taste, and oils.
Infants have a hard time digesting oils, 1999  1997   and palm oils W.A. Price 1 2 3
Coconut oil, such as in D-Drops, is digested by infants. 1,   2   3
Bio-Tech Pharmacal Vitamin D has NO additves, taste, nor oil
One capsule of 50,000 Bio-Tech Pharmacal Vitamin D could be stirred into monthly formula or given once a month
   this would result in ~1,600 IUs per day for infant, and higher dose with weight/age/formula consumption


VitaminDWiki pages with FDA in the title (35 as of April 2022)

This list is automatically updated

Items found: 36
Title Modified
FDA approved 5-11 vaccine booster (based tiny unpublished study without asking advisory panel) May 2022 17 May, 2022
FDA allows 2 specific Vitamin D and 2 Omega-3 health claims - 2019 31 Dec, 2021
New FDA head chosed because he had the fewest ties to big Pharma - Nov 2021 12 Nov, 2021
Off topic: Conflicts of Interest at the FDA - NYT April 2015 07 Sep, 2021
America Desperately Needs a Much Better FDA - NYT Sept 2, 2021 07 Sep, 2021
After 57 years FDA is declaring NAC to be a drug (note: 16 trials are investigating NAC ability to fight COVID-19) – June 2021 18 Jun, 2021
The FDA should consider vitamin D as a pharmaceutical agent for COVID - Dec 21, 2020 22 Dec, 2020
New drug application to FDA for a probiotic which might treat COVID-19 – Nov 19, 2020 20 Nov, 2020
Off Topic: FDA does change after lots of money and decades of pressure (amalgum in this case) - Oct 2020 06 Oct, 2020
1,200 IU of Vitamin D now recommended if you consume 3,000 calories daily (FDA) – 2018 06 Oct, 2020
Synthetic EPA drug recommended to FDA for Cardio (Omega-3 is 8 X better) – Nov 2019 13 Jan, 2020
FDA allows the claim that Vitamin D “supports healthy pregnancies and promotes full-term births” – Oct 2019 11 Oct, 2019
Kellogg petitions FDA to raise the Vitamin D fortification of cereals and bars– Sept 2019 06 Sep, 2019
Graphic warnings on cigarette packages in 118 countries, US FDA trying again – Aug 2019 15 Aug, 2019
More than half of the FDA entire budget now comes from Big Pharma, not the govt. – Sept 2018 28 Sep, 2018
Vitamin D Council vs FDA concerning vitamin D deficiency in blacks and others - June 2011 13 May, 2018
FDA petitioned to acknowledge that vitamin D cuts preterm birth rate in half – May 2018 13 May, 2018
FDA decided to double vitamin D in milk after talking 4 times with by Dr. Matthews – July 2016 03 Apr, 2018
Vitamin D does not reduce the risk of Multiple Sclerosis – FDA conclusion which ignored 5 studies – Jan 2018 16 Jan, 2018
Vitamin D does not reduce the risk of Multiple Sclerosis – FDA incorrect conclusion – Jan 2018 16 Jan, 2018
Vitamin D food labeling requirements by FDA – May 2016 07 May, 2017
FDA says all blood should be tested for Zika – at a cost of 150 dollars per unit – Aug 2016 26 Aug, 2016
FDA raised Vitamin D to 800 IU (now to be designated as 20 micrograms) July 2016 27 Jul, 2016
FDA doubles the amount of vitamin D permitted in milk – July 2016 23 Jul, 2016
FDA raises the amount of vitamin D2 fortification in bread – Aug 2012 17 May, 2016
Antibiotic resistance will kill 300 million in 35 years, FDA doing nothing, UK considering wrong things – Feb 2015 18 Feb, 2015
FDA considering raising adult Vitamin D, but not for adults who are senior or pregnant- Feb 2014 18 Feb, 2015
Off topic – FDA buried evidence of fraud in 78-600 clinical trials – Feb 2015 13 Feb, 2015
Off Topic: FDA advisors have many conflicts of interest 24 Sep, 2014
FDA considering raising Vitamin D RDA to 800 IU - Feb 2014 27 Mar, 2014
Application to FDA for use of active Vitamin D for hemodialysis patients – July 2011 18 Feb, 2014
Far too expensive to have FDA approve vitamin D – Dec 2013 22 Dec, 2013
Most young Americans not getting even 600 IU of vitamin D from the sun – FDA Aug 2011 29 Jun, 2013
Off topic: 'War on Health' video by Garry Null focusing on the FDA – July 2012 07 Jul, 2012
FDA warns against over 400 IU vitamin D for infants, especially with droppers - June 2010 25 Jun, 2012
A Vitamin D lable that FDA would not approve 25 Nov, 2011


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Created by admin. Last Modification: Friday May 13, 2022 01:03:37 GMT-0000 by admin. (Version 27)

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