Aluminum is an adjuvant used in vaccines licensed by the US Food and Drug Administration. James Lyons-Weiler, Ph.D., wanted to know how did the FDA determined what the safe levels are for aluminum in vaccines.
For most of my adult life, I never gave vaccine safety a second thought. Sure, I spaced my sons’ vaccines out, and none of the pediatricians in three states gave us a hard time. We were never kicked out of practice because we exercised our rights to choose if, how, and when to consume vaccine products.
But after writing a chapter on vaccines in one of my books, I grew increasingly concerned about whether something, or somethings were very wrong with my understanding of vaccines and how they were developed.”
Dr. Lyons-Weiler’s LinkedIn profile states that he is a long-time veteran in the areas of genomics, proteomics, bioinformatics and evolutionary biology. “He earned a Ph.D. in Ecology, Evolution & Conservation Biology, and won a US DOE/Sloan Postdoc in Computational Molecular Biology at Pennsylvania State University…”
Related: A Look At the Flu Shot in 2018
Dr. Lyons-Weiler’s published a study, Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum, that says the recognized safe aluminum levels in vaccines are based on immune efficacy and ignore body weight. James says that several critical mistakes have been made in the consideration of pediatric dosing of aluminum and that safety inferences of vaccine doses of aluminum have relied solely on dietary (ingested, not injected) exposure studies of adult mice and rats.
On Day 1 of life, infants receive 17 times more aluminum than would be allowed if doses were adjusted per body weight.
The FDA states that 850 mcg of aluminum is safe for an adult. With his research, James found that a series of errors led to the guidelines that state 850 mcg of aluminum is safe for an adult.
The first serious problem (Problem #1) is that a provisionally tolerable weekly limit assumed to be safe was, by a series of errors and bad assumptions, transformed into a daily limit that appeared to be backed by studies. The studies used were not up to date, and the FDA’s determination used spurious estimates to transform safety information from dietary studies of adult mice into injected safe limits in human infants. These errors were made, in part, in the pediatric limit consideration by the FDA, who used outdated information not consistent with other organizations like World Health Organization.
To add to the confusion, the 1 mg/kg/week was also then changed to 2 mg/kg/week. The ATDSR used information from one study, assumed 1 mg/kg/week, adjusted using arbitrary functions that are without a doubt as good as a bad guess.
The provenance of these errors is reviewed further below, and in our newly published study.”
We came across this study last week on Medium. It has since been deleted, along with Jame’s account. We checked on web.archive.org to see if the page had been preserved; it had not. We searched Google, but it’s gone from search results, but we did find the article republished by James on LinkedIn.
This Open Letter originally appeared on Medium.com. Due to their censorship, it is ported here.= JLW. It is based on peer-reviewed studies.” – Dear FDA: Please Reconsider “Safe” Levels of Aluminum…
We also noticed that Jame’s Medium account has been suspended. And Bing is a little slower to eliminate the search results. If you want, click here to see their Cached version while it’s still available, but you can also read the full article republished on LinkedIn.