Recently, Physicians for Informed Consent (PIC) claimed they hold a bombshell, by claiming there is an erratum in the study published by Mitkus and colleagues (1). Using some PR mouthpiece (such as PRNewswire) to spread the breaking news around, PIC, under the patronage of Shira Miller (who runs PIC), claimed they provided a rebuttal to the study of Mitkus stating that there is an important factual error.
In this breaking news, Physicians for Informed Consent announced that a study published by Mitkus and colleagues (1) contained a major flaw in the estimation of aluminum burden, using differences in oral bioavailability used in the study (allegedly 0.78%) and reported by the FDA (0.1%). In their conclusion, the authors claim that such differences were significantly underestimating the exposure of aluminum from vaccines with the claim that the actual “safe” level is 7.8X lower than Mitkus established.
Is there any part of the truth in it? And does the PIC statement hold any scientific evidence? Let’s figure this out.
- 1 What is the Physicians for Informed Consent (PIC)?
- 2 Where is the statement published and why it matters?
- 3 What is the main point of refutation delivered by Miller?
- 4 MRL and differences in bioavailability: Does it matter?
- 5 Bioavailability with respect to other routes of administration
- 6 Lack of transparency in the mathematical model
- 7 Conclusions
- 8 Notes
- 9 Citations
What is the Physicians for Informed Consent (PIC)?
Physicians for Informed Consent is an organization with the vision that “doctors and the public are able to evaluate the data on infectious diseases and vaccines objectively, and voluntarily engage in informed decision-making about vaccination.” Behind this pretty vague statement, a quick look at the materials shared on the website brings names of various anti-vaccine personalities:
- Dr. Paul Thomas, MD, a notorious anti-vaccine physician,
- Neil Z Miller, a journalist with questionable scientific credentials, who also claimed that “extraterrestrial entities” counseled him against vaccines,
- Dr. Tetyana Obukhanych, Ph.D., a scientist who abused her credentials, and often claims the title of “Harvard scientist” despite failing to demonstrate her appointment as faculty. Her employment at Harvard was not only secured by soft money through her principal investigator but also have an unimpressive track record when it comes to publications during her presence there,
- Dr. Jane Orient, MD, a physician who is notoriously known for blending politics with science-denialism.
This group already raises alarms.
According to the PIC statement, Dr. Shira Miller was the author behind the claim made. She is also an MD Yet navigating through her website indicates her main occupation is “Certified Professional Co-Active Coach (CPCC), writer and speaker” on her website. The only publication I have found is an obscure paper published in 2003 about ear decompression sickness in recreational diving (3).
Taken altogether, even before addressing my concerns about the validity of the claim made, I have serious concerns about someone in PIC, including the author of the statement, have the scientific credibility and credentials to truly address flaws in the Mitkus study. But let’s not run in early judgment and let’s see if the statement made holds up.
Where is the statement published and why it matters?
In science, it is not unheard to have other scientists disagree with your findings or hypotheses. Such disagreements are usually in many different forms, from informal discussion within the scientific community (the weakest form of refutation) to a letter to the editor as a response to a study (a medium form of refutation) to a full-text study using experimental evidence to demonstrate flaws and limitations of a study published in a peer-reviewed journal (the highest form of refutation).
The summit is a study that overwhelmingly refutes a published study with the quality and quantity of data that contradicts the initial study in a magnitude order higher than the study published.
Here comes the second issue with this statement: there is no publication of the refutation in any peer-reviewed journal. Not even a letter to the editor. The only evidence mentioned to the refutation is an obscure allusion to ResearchGate.
ResearchGate is a social media platform for scientists. A blend of Facebook and LinkedIn tailored to scientists. I have a ResearchGate profile as well.
ResearchGate will allow you to showcase your work, list your publications, use a bulletin board service to ask questions for troubleshooting a technique or a protocol. All of these are integrated into a ResearchGate (RG) score. The higher the RG score is, the more relevant you are considered.
Miller’s RG score is less than 3. Mine is about 35. If I take James Lyons-Weiler score, it is about a 25. Even considering myself as a small fish and average scientist, I have to say that Miller is far from being impressive.
A caveat of RG is you need to have an account to access it. Nevertheless, I have screenshot the “smoking gun” touted by Miller on PIC (see Picture1).
It seems that the only piece of evidence that is traceable with the information given is merely a comment left by Miller on Robert Mitkus page of his 2011 paper (1). Indeed two comments are visible: hers, and a comment by James Lyons-Weiler (JLW) with a laconic comment that such rebuttal “put the nail in Mitkus”.
Excuse me, but a mere comment on a non-peer-reviewed website is everything but what I would refer to as a “pathetic petard” for the rest of the discussion. If Miller (and Lyons-Weiler) have substantial material to refute and provide a solid rebuttal, it would have it at least being published directly in “Vaccines” (the journal that published the Mitkus paper) as a “Letter to Editor”.
Even if we assume some sort of censorship (which actually does not happen, unless your letter to the editor is so slanderous towards an author that it ends up retracted, as it happens with other “aluminum experts”: ).
You would expect at least Miller and Lyons-Weiler to provide a detailed rebuttal, right? Well if you are a bit seasoned with pharmacokinetics, you quickly realize that such a “smoking gun” and “nail in the coffin” is an absolute joke, scientifically speaking that we will extend in the next section.
What is the main point of refutation delivered by Miller?
The comment left by Miller is a basic copy-paste of the PIC statement:
In 2008, the ATSDR lowered the MRL to 1 mg Al/kg/day for aluminum using a more recent aluminum lactate study. When computing the new MRL, the ATSDR included an additional modifying factor to “account for possible differences in the bioavailability of the aluminum lactate used in the Golub and Germann (2001) study and the bioavailability of aluminum from drinking water and a typical U.S. diet.” Additionally, in explaining the uncertainty factors used to derive the new MRL, the ATSDR cited studies that found “the bioavailability of aluminum from the typical U.S. diet was 0.1%.
Thus, an aluminum absorption of 0.1% was used to calculate the Agency for Toxic Substances and Disease Registry (ATSDR)’s 2008 MRL (maximum recommended limit) of 1 mg Al/kg/day.
Although Mitkus et al. included the ATSDR’s most recent MRL of 1 mg Al/kg/day in their computations, they used the aluminum absorption percentage of 0.78% from Keith et al.’s analysis instead of the 0.1% absorption that the 2008 ATSDR had accounted for in its computation of the new MRL. Consequently, the MRL curves calculated by Mitkus et al. are 7.8 times (0.78%/0.1%) greater than they would have been if they had used the aluminum absorption percentage that was used to calculate the ATSDR’s 2008 MRL for aluminum. Scaling down the MRL curves calculated by Mitkus et al. by a factor of 7.8 produces results that contradict the conclusions reached by Mitkus et al. concerning the safety of aluminum quantities in vaccines (Fig. 1).”
There is a lot of unpack here, and let’s go point by point what does it mean.
MRL and differences in bioavailability: Does it matter?
The first issue that someone with a basic knowledge of pharmacokinetics would point out after reading it is how does bioavailability factors in with the MRL. MRL stands for “maximum recommended limit”. If I use the ATSDR document cited by Miller (2) in her statement, it is defined as “An estimate of daily human exposure to a hazardous substance that is likely to be without an appreciable risk of adverse noncancer health effects over a specified route and duration of exposure.” (p.307).
In other words, it is a daily dose of a chemical in which we recommend a daily exposure not exceeding this value. The ATSDR sets it as 1 mg/kg/day.
However, this value is much lower than the actual toxicity reported in the literature. If we consider that the main concern of aluminum toxicity is its brain toxicity (neurotoxicity), the lowest dose in which signs of neurotoxicity were observed was at 100mg/kg/day for neurotoxicity (p.245). This is telling us that we set ourselves a daily limit of exposure to 1mg/kg/day which is 100-times lower than the lowest concentration in which some signs of toxicity were reported (remember, the dose makes the poison). Also, it is important to note such MRL was set as food/drink exposure from birth (P0, which is about 15th week of gestation in humans) up to P35 (35 days post-birth, which is about the early teenage year in humans).
Yet, an MRL will only tell you how much of chemical X (in this case aluminum) present in food and drinking water is deemed safe or toxic. You can absolutely NOT use an MRL to determine the bioavailability of a chemical.
The first strike on Miller’s rebuttal is to falsely use the MRL as indicative of bioavailability and extrapolate any change in bioavailability into the MRL. This is a blatant mistake that a healthcare professional in training (medical doctor, pharmacist) should not be doing since pharmacokinetics is taught in both schools. Even worse, it took two of them (Miller and Lyons-Weiler) to make the same mistake without even realizing it.
Score : Mitkus 1 – Miller/JLW 0.
Bioavailability with respect to other routes of administration
The second issue I have with the statement is to take the bioavailability of one route and consider it is identical for another route. As mentioned in the text: “the bioavailability of aluminum from the typical U.S. diet was 0.1%.” and “scaling down the MRL curves calculated by Mitkus et al. by a factor of 7.8 produces results that contradict the conclusions reached by Mitkus et al. concerning the safety of aluminum quantities in vaccines (Fig. 1)”.
These quotes highlight the oversimplification and the lack of understanding from both Miller and JLW about basic tenets of pharmacokinetics (although JLW showed us two times in this blog post his obvious lack of understanding basic concepts of pharmacokinetics).
When you want to establish the bioavailability of a compound, you have to compare your administration route of interest (for example oral route) versus an intravenous (IV) route. This is what we call the absolute bioavailability – it will tell us the fraction of the drug reaching the bloodstream from the administration site if the drug is given by a route other than an IV route when compared to the same drug given directly via IV route (which is the gold standard).
Experimentally, we will measure plasma concentrations of drug X following administration IV versus the other route of administration. From these concentrations, we calculate a parameter called area under the curve (AUC) and by the calculation of ratio (AUCroute/AUCIV), we can determine the absolute bioavailability (F).
By knowing the absolute bioavailability of two different routes (for instance oral versus IM route), you can assess and gauge them. Oral bioavailability used by Mitkus was 0.78% (F=0.0078). Miller claims it is overestimated and should be 0.1% (F=0.0010).
Nevertheless, you cannot use any of those and claim that such values reflect the bioavailability for the IM route is equal to the oral route.
The second strike on Miller and JLW is to wrongly claim that you can use the F value of the oral route and extrapolate it to the IM route. Even worse, there is absolutely no evidence that a change in oral F will have a direct repercussion on the F value of the IM route, and affect the safety levels of aluminum adjuvants.
The burden of proof is on them to show that a change in oral bioavailability impact the bioavailability of vaccines adjuvants (unless you ingest your vaccines, which is another story).
Score: Mitkus 2 – Miller/JLW 0.
Lack of transparency in the mathematical model
Transparency is tantamount to any scientific discussion, especially when you are talking about the validity of a mathematical model. As I have mentioned, the authors claimed that an erratum in bioavailability (0.1% instead of 0.78%) will affect the aluminum burden associated with vaccines. In order to make this valid, you have to show the mathematical model used by Mitkus is mathematically inaccurate and highlights the flaws in it.
The only documentation provided by Miller is the “Figure 1” cited as an addendum to her comment on the paper. For those familiar with the Mitkus paper, we can see it is a copycat of the Figure 4 (depicting aluminum hydroxide profile). Yet, Miller simply adjusted the MRL by a factor of 7.8 (0.78/0.1) and run with it.
That’s not how it works. You cannot simply use a difference in aluminum burden (using MRL data) and change the value based on a change in bioavailability. You need the AUC values (and therefore plasma concentrations) for this MRL to be able to modify the bioavailability values at your convenience (and assuming you ingest your vaccines, instead of injecting them).
The second problem is the lack of the integration of bioavailability in the calculation of aluminum burden from vaccines. If you read carefully the methodology used by Mitkus, he used a three model compartment to model aluminum burden from aluminum adjuvants (given IM). Bear with me, this is some math-intensive:
The following dietary exposures of infants to aluminum, published previously by Keith et al.  and adjusted for 0.78% oral absorption, were utilized in our model: (1) age 0–6 months: 0.03 mg (breast milk) and 0.15mg (formula); (2) age >6 months: 0.7mg (breast milk or formula). Retention of aluminum following infant dietary exposures, exposures from vaccines according to the 2011 ACIP schedule, and safe doses of aluminum were then estimated over the first 400 days of life using Eqs. (1)–(7). Retention curves were generated using the publicly available statistical modeling software, R (R Foundation for Statistical Computing ).
Here are the equations used:
R = 29.3 × e−0.595×t + 11 × e−0.172×t + 6.5 × e-0.000401×t (1)
CCr(t)=aˆ+b t+cˆ =50.871+90.044 t+231.462 (2)
f(t)= a^/(a^+b^)+ b^/(a^=b^) * (t/t+c^) =0.361+0.639 t+231.462 (3)
k10(t) = k10 × f (t) = 0.41095 (0.361 + 0.639 (t/t + 231.462)) (4)
dX1/dt =−k10(t)X1+k21X2+k31X3−k12X1−k13X1 (5)
dX2/dt =k12X1−k21X2 (6)
dX3/dt =k13X1−k31X3 (7)
You can note two things here:
- Firstly, there is no presence of the 0.78% bioavailability (F=0.0078) anywhere in the equation (simply because it makes no sense to compare oral and IM routes with the taking the bioavailability of one and assuming it is the same to the other).
- Secondly, neither Miller and JLW had the guts to flatten their equation used to model the aluminum burden in their figure. It tells me that neither of them knows as much pharmacokinetics at a level equal or better than Mitkus, but they also completely got their pharmacokinetics flat-out wrong from the beginning (because you cannot compare apples to oranges and claim these are the same things). I suspect the “Figure 1” was drawn by JLW as I can recognize his signature (and a deeply flawed basic understanding of pharmacokinetics).
- The third strike on Miller and JLW is to apply changes in bioavailability to a model in which the data used is irrelevant (you need AUCplasma values to determine how changes in bioavailability impacts the aluminum burden over time), but also the complete omission of equations modeling their graph is indicative that none of them have the brain and the guts to perform a pharmacokinetic study at a level similar or better than Mitkus.
Score: Mitkus 3 – Miller/JLW 0.
To conclude that epic failure served to us by the so-called “Physicians for Informed Consent” along with their blatant lack of basic math and reading skills makes me seriously consider how much knowledge they are of basic science to make informed consent decisions.
This is an epic failure of a so-called professional society that rather seems like the hive of scum and villainy in the medical profession. They sold a silver bullet aimed to kill the work of Mitkus.
Or maybe we should follow the words of JLW caught off-camera by CBC reporters following his legal chicanery to avoid being labeled as a lobbyist: “Keep their head-spinning”.
The only thing that James Lyons-Weiler and his ilk spin is the truth, and that’s pretty pathetic.
This article is by VaultDwellerSYR, a pseudonym used by a faculty member of a School of Pharmacy within a large medical school. They have significant research and publications in the effect of certain chemicals on the brain. Although we are opposed to all arguments from authority, the author has a substantial record of actual, published research in this field of brain cell biology and biochemistry.
The author has stated that he has no conflict of interest to disclose.
- Mitkus RJ, King DB, Hess MA, Forshee RA, Walderhaug MO. Updated aluminum pharmacokinetics following infant exposures through diet and vaccination. Vaccine. 2011 Nov 28;29(51):9538-43. doi: 10.1016/j.vaccine.2011.09.124. Epub 2011 Oct 11. PubMed PMID: 22001122.
- Agency for Toxic Substances and Disease Registry (ATSDR). Toxicological profile for aluminum. Washington, D.C.: U.S. Department of Health and Human Services; 2008.
- Shupak A, Gil A, Nachum Z, Miller S, Gordon CR, Tal D. Inner ear decompression sickness and inner ear barotrauma in recreational divers: a long-term follow-up. Laryngoscope. 2003 Dec;113(12):2141-7. doi: 10.1097/00005537-200312000-00017. PubMed PMID: 14660917.
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