EVER SINCE I first published a reveal that pharmaceutical companies have successfully orchestrated a take-over of regulatory agencies at the expense of objectivity in the science of public health, I’ve been attacked for daring to hold the view that Science is for asking questions, and that, above all, objectivity should play a role in all of Science, including vaccine safety science. Among those assailing such an evidently revolutionary concept is an MD who has evidently assigned himself the role of gatekeeper over the safety of vaccines as a liability-free commercial product. While not trolling papers in journals requesting their retraction if they shine a bad light on vaccines, this MD’s latest assault occured a few days after independent investigative journalist and author James Grundvig revealed the irksome Orca’s identity as David Gorski, questioning whether a person employed in vocation as austere and revered as a medical doctor should conduct themselves in public like a five-year-old spewing filth and personal attacks on stewards of Objectivity in Science, allegedly in the name of Science, skewing his five followers’ perception of how one should think about vaccine safety science.
Among the most important of Orca’s (David’s) complaints about our latest objective Scientific research on the toxicity of aluminum in CDC’s pediatric schedule is his claim that our model has a flaw the he “immediately spotted”:
“I immediately spotted the sloppy, false assumption behind Lyons-Weiler’s (sic) ‘model,’ namely its use of data from intravenous, one dose administration of aluminum to base its model for IM doses of aluminum on and its failure to take into account the much lower bioavailability of aluminum from IM administration compared to IV…”
Well, good for you, David. We immediately spotted that flaw in the aluminum modeling area as well.
Here, David is referencing the Priest study. It’s too bad that Orca did not also “immediately spot” that the Priest study was used by the FDA and is the very keystone of FDA’s allowance of aluminum in vaccines is safe in their Mitkus et al . study.
Thank you, David. You have in one fell swoop made our entire points all the more clear and validated our conclusions. You’ve slayed Mitkus.
We at IPAK have bent over backwards to lament the lack of actual empirical data underlying the claims that aluminum dosing in vaccines is safe. Anyone who actually read and understood our first, or our second study will find that we have made extra effort to lay out the limitations of our study, including the weakness of the available data upon which our assumptions are based.
All of these concerns are to be foisted equally upon the FDA’s Apology-for-Not-Conducting-Science, the Mitkus study.
Every. Last. One.
Like McFarland et al. 2020, The Mitkus Aluminum Apology study uses models based on Priest’s extremely limited empirical data. That is one of the reasons why I started our research in this area in the first place: Thus, our study. Since FDA has not published nor enforced any aluminum adjuvant dose limits for pediatric vaccines or vaccine schedules, we reverse-engineered a pediatric dose limit based on an adult limit FDA has published – 850 mcg per adults – and, using a very commonly used rule to estimate pediatric doses limits when none exists, we published our FDA-based PDL. As I have published in my last response to an equally baseless attack by AAAB, the Mitkus study is dead, and these two have made what is perhaps their most significant intellectual contribution in Science by killing it.
David claims, incorrectly, that the FDA’s limit is based on Bishop et al., and therefore a new limit is not needed. Here is part of the abstract from Bishop et al.(1997) that tells us that David is not even reading his own source material and knows nothing whatsoever of the provenance of information leading to 850 mcg per dose in the limit set by the FDA:
We randomly assigned 227 premature infants with gestational ages of less than 34 weeks and birth weights of less than 1850 g who required intravenous feeding before they could begin enteral feeding to receive either standard or specially constituted, aluminum-depleted intravenous-feeding solutions. The neurologic development of the 182 surviving infants who could be tested was assessed by using the Bayley Scales of Infant Development at 18 months of age.
The 90 infants who received the standard feeding solutions had a mean (±SD) Bayley Mental Development Index of 95±22, as compared with 98±20 for the 92 infants who received the aluminum-depleted solutions (P = 0.39). In a planned subgroup analysis of infants in whom the duration of intravenous feeding exceeded the median and who did not have neuromotor impairment, the mean values for the Bayley Mental Development Index for the 39 infants who received the standard solutions and the 41 infants who received the aluminum-depleted solutions were 92±20 and 102±17, respectively (P = 0.02). The former were significantly more likely (39 percent, vs. 17 percent of the latter group; P = 0.03) to have a Mental Development Index of less than 85, increasing their risk of subsequent educational problems. For all 157 infants without neuromotor impairment, increasing aluminum exposure was associated with a reduction in the Mental Development Index (P = 0.03), with an adjusted loss of one point per day of intravenous feeding for infants receiving the standard solutions.
In preterm infants, prolonged intravenous feeding with solutions containing aluminum is associated with impaired neurologic development.
If David were correct (which he certainly is not), he would also criticize the FDA for setting a limit based on IV-sourced aluminum, just as he criticized McFarland et al. (2020) for using IV-sourced aluminum. David, however, is known his penchant for selective criticism, inconsistently applying standards of evidence to science he does, or does not agree with. David Gorski, MD is a master subjectivist when it comes to matters of science.
IPAK Did Its Homework PRIOR to Starting Any Study of Its Own
IPAK’s first foray into aluminum safety science was to map the provenance of the claim by FDA that 850 mcg of aluminum is safe regardless of body weight. One can find a reference to an 850 mcg limit as far back as 1984
Gupta (1995) (before Bishop) wrote:
“We, therefore, recommend that for immunogenicity studies of aluminum compound-adsorbed antigens in animals, the formulation intended for human use should be injected with a minimum dilution, preferably undiluted. The usual dose of aluminum used for human vaccines is around 0.5 mg. The upper allowable limit of aluminum adjuvants for injection in humans is 1.25 mg aluminum as per World Health Organization regulations (1990) and 0.85 to 1.25 mg aluminum as per United States Food and Drug Administration guidelines (May et al., 1984).”
May et al. (1984) cites the FDA’s 850 mcg to CFR 610.15 to the year 1982:
So much for Orca’s absolutely false knowledge claim.
During the 1990-2011 expanse of the vaccine schedule following the abandonment of Ethyl mercury (for all but influenza vaccine, preferentially prescribed, btw, by ACIP/CDC for pregnant women), the WHO, The CNANIC, the ATSDR, and the FDA all relied very heavily on animal studies fed a different type of aluminum than is injected into newborns in a flurry of considerations to the question of ‘how much is too much’. Worse, the animals were adults. Still worse, FDA cherry-picked one study, ultimately leaning on Golub et al., an oral exposure study, and they misrepresented the findings of that study to make injected doses of aluminum hydroxide doses appear safe.
A rough outline is provided over this timeframe:
1981 CFR amended to include 1250 mg/dose
1996-2007 PTWI estimated at 1 mg/kg/week; 0.5 mg/kg-day US child > 2 years of age (WHO Evaluation and Certain Food Additives and Contaminants. Section 4.1 Aluminum, 1996-2007)
1996 Committee on Nutrition Aluminum Neurotoxicity in Infants and Children (J Pediatrics),
1 mg/kg-day (in error as to PTWI- “provisional tolerable intake”)
2001 0.85 mg “selected empirically from data because it enhance the antigenicity and effectiveness of the vaccine” (Baylor et al 2001)
2001-2008 ATSDR set MRL/NOAEL to 1 mg/kg-day from all sources based on Golub 26 mg/kg-day NOAEL (ATSDR references Baylor et al (2001),
2001 MRL/NOAEL 2 mg/kg-day in adult humans from dietary sources (Golub et al 2001 (62 mg/kg-day, Keith et al)
2011 MRL=1 mg/kg bw/day (ATSDR, 2008), Mitkus (2011)
During this period of time, a discord between two committees’ recommendations was discovered.
What we did not find were dose-escalation studies in mice matching per-bodyweight injections of aluminum forms in vaccines in infant mice. We found the Flarend et al. rabbit study, which reported that only 6% of the injected aluminum hydroxide had left the body after 28 days. In that study, btw, the authors lost one of the rabbit brains. Where is Orca’s outrage?
It goes without saying that David Gorski knows nothing about aluminum safe levels in vaccines, and would prefer that the public know nothing, as well.
2019: CFR is still 850 mcg/DOSE, no published or enforced restrictions on pediatric dosing of aluminum, no information available on body weight considerations for aluminum dosing limits, and no additional information on CDC Catch-Up schedule aluminum dosing limits.
The second fatal error that Orca makes, which is the same error made by his hero Pharmacist hiding away in a major medical school (who, Orca gushes, uses “equations and everything!“) is to claim that plasma clearance rates have any relevance whatsoever on aluminum salt toxicology. The false narrative that “low bioavailability” for metals such as Ethyl mercury and aluminum oxihydroxide equal safety has now fallen completely apart and lies in shambles at the feet of these two individuals. As explained in many places now in the peer-reviewed literature which Orca conveniently ignores, most of which is cited by our two studies, or cites our first study, the issue of aluminum toxicity is tissue-based, cellular, right down to the organelles that make our cells work. In other words, not plasma.
I don’t defend our research with a childish glee that David appears to enjoy in his ineffectual hit pieces, but I relish the opportunity to educate the public precisely why IPAK deserves monthly donations to keep asking questions, doing analyses, and posing solutions to the problem of the abject poverty of objectivity in public health science, and wherever it is missing in biomedical research as well.
Sadly, there is no credible empirical Science that shows that the amount of aluminum in the CDC’s pediatric vaccination schedule is safe in the short or long-term. There is no credible empirical Science that shows that the use of a thimerosal-containing influenza vaccine and aluminum-containing vaccines in the same office visit, or in successive office visits, does not induce serious synergistic toxicity, especially for low-birthweight babies, or infants of mothers with low income, or African American males. Sadly, none of the Science that one would expect to have been done has been conducted.
Instead, we are left with a bloated, beached whale wondering how it became stranded, high and dry, and a Pharmacist who likely by now wishes he never engaged with a bona-fide, publicly funded working Scientist.