Table of contents
- FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy
- Remdesivir ‘Disastrous’ as COVID Treatment, But Government Pays Hospitals to Use It - May 2022
- "Safety and effectiveness ... have not been established in pediatric patients younger than 12 years of age" (package insert)
- VitaminDWiki - Risk factors for severe COVID in children are all related to low vitamin D (same as adults) - April 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
- Probably would cost $50,000 to petition the FDA that Vitamin D can reduce COVID risk in children
- Many successful vitamin D early treatment trials for adults
- Vitamin D is much better than Remdesivir for adults
- VitaminDWiki - Infant-Child category has
859 studies and starts with - VitaminDWiki pages with FDA in the title (35 as of April 2022)
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy
- "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
- "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."
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"Safety and effectiveness ... have not been established in pediatric patients younger than 12 years of age" (package insert)
Natural Health May 2, 2022
VitaminDWiki - Risk factors for severe COVID in children are all related to low vitamin D (same as adults) - April 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
Vitamin D is much better than Remdesivir for adults
VitaminDWiki - Infant-Child category has
859 studies and starts with - No consensus on MINIMUM International Units (IU) for healthy infant of normal weight
- 400 IU Vitamin D is no longer enough
Was OK in the past century, but D levels have been dropping for a great many reasons.
FDA doubles the amount of vitamin D permitted in milk – July 2016 - No consensus: range is 600 to 1600 IU – based on many randomized controlled trials
- Review of 400 IU to 2000 IU daily and higher if non-daily
- Fewer pre-infants were vitamin D deficient when they got 800 IU – RCT Feb 2014
- 1600 IU was the conclusion of three JAMA studies
1000 IU recommended in France and Finland – 2013 - appears to be a good level - 5X less mite allergy after add vitamin D
- Child bone fractures with low vitamin D were 55X more likely to need surgery
- 75 % of SIDS had low vitamin D
- Children stayed in ICU 3.5 days longer if low vitamin D – Dec 2015
- 5 out of 6 children who died in pediatric critical care unit had low vitamin D – May 2014
- Infants have gotten free 400 IU of vitamin D in Turkey since 2005, More for longer would be even better – Feb 2022
- Preemies should have vitamin D supplements – reaching an agreement – April 2021
- Vitamin D loading dose was as effective as daily dosing (rickets in this case) – RCT July 2021
Having a good level of vitamin D cuts in half the amount of:
- Asthma, Chronic illness, Doctor visits, Allergies, infection
Respiratory Tract Infection, Growing pains, Bed wetting
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.
More than 100 IU/kg is probably better 859 items in the category Infant/Child See also - 34 pages in VitaminDWiki had BREASTFE*in title as of Jan 2022
- "BIRTH DEFECTS" 172 items as of July 2016
- Stunting OR “low birth weight” OR LBW OR preemie OR preemies OR preterm 1940 items as of Oct 2018
- 153 VitaminDWiki pages contained PRETERM or PREEMIE in title as of Nov 2024
- "SUDDEN INFANT DEATH" OR SIDS 214 items as of Dec 2020
- Overview of Rickets and Vitamin D
- Youth category listing has
175 items along with related searches - Down's syndrome and low vitamin D - several studies
- Rett syndrome associated with low vitamin D, treated by Omega-3
VitaminDWiki pages with FDA in the title (35 as of April 2022)
This list is automatically updated
Items found: 50
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