New safety concerns raised about the quantities of aluminum in childhood vaccines

NEWPORT BEACH, CALIF. (PRWEB) March 6, 2020

The U.S. Food and Drug Administration (FDA) and the Agency for Toxic Substances and Disease Registry (ATSDR), a division of the U.S. Department of Health and Human Services (HHS), have raised concerns about the negative effects of aluminum exposure in humans. Because some vaccines contain aluminum, the FDA published a paper in 2011 (Mitkus et al.) to address concerns about aluminum exposure from vaccines in infants. The paper compared the aluminum exposure from vaccines in infants to a safety limit of oral aluminum determined by the ATSDR. However, this study incorrectly based its calculations on 0.78% of oral aluminum being absorbed into the bloodstream rather than the value of 0.1% used by the ATSDR in its computations. As a result, the FDA paper assumed that nearly 8 (0.78%/0.1%) times more aluminum can safely enter the bloodstream, and this led the authors to incorrectly conclude that aluminum exposure from vaccines was well below the safety limit.

Physicians for Informed Consent (PIC), an educational nonprofit organization dedicated to delivering data on infectious diseases and vaccines, posted a detailed description of this error today on ResearchGate.

Dr. Christopher Shaw, professor at the University of British Columbia, has performed numerous studies on the effects of injected aluminum on mice, and commented: “We knew that the Mitkus et al. paper modeling aluminum clearance had to be inaccurate since it was assuming that injected aluminum kinetics were the same as the kinetics of aluminum acquired through diet. Now, in addition, we see that they did their modeling based on using the incorrect level of aluminum absorption. What is particularly striking is that despite all these errors, since 2011, Mitkus et al. is used by CDC and other entities as the basis for claiming that aluminum adjuvants are safe.”

Dr. Shira Miller, president of PIC, said, “We posted the Mitkus 2011 erratum on ResearchGate in hopes of bringing it to the attention of scientists and researchers who are interested in the safety of the quantities of injected aluminum found in childhood vaccines and would be in a position to further research the safety concern.”

About Physicians for Informed Consent

Physicians for Informed Consent is a 501(c)(3) educational nonprofit organization focused on science and statistics. PIC delivers data on infectious diseases and vaccines, and unites doctors, scientists, healthcare professionals, attorneys, and families who support voluntary vaccination. In addition, the PIC Coalition for Informed Consent consists of more than 200 U.S. and international organizations. To learn more or to become a member, please visit physiciansforinformedconsent.org.

Click here to read on PRWEB.

In 2011, Mitkus et al.¹ published “Updated aluminum pharmacokinetics following infant exposures through diet and vaccination” in Vaccine, which updated an analysis published earlier by Keith et al.² in 2002 that “analyzed the pharmacokinetics of aluminum for infant dietary and vaccine exposures,” and compared the resulting body burdens to those based on the minimal risk level (MRL) established by the Agency for Toxic Substances and Disease Registry (ATSDR).³

In their analysis, Keith et al. used the MRL of 2 mg Al/kg/day for aluminum established by the ATSDR in 1999, based on Golub et al.’s 1989 aluminum lactate study. Since the ATSDR, at that time, did not account for the amount of aluminum absorbed by the gastrointestinal tract through aluminum lactate in its computations, Keith et al. relied on other studies that observed a 0.78% absorption from aluminum lactate and used that statistic in their calculations.

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 uncertainly 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 ATSDR’s 2008 MRL 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).

Shira Miller, M.D.
Founder and President
Physicians for Informed Consent

References

1. 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. https://www.ncbi.nlm.nih.gov/pubmed/22001122
2. Keith LS, Jones DE, Chou CH. Aluminum toxicokinetics regarding infant diet and vaccinations. Vaccine. 2002 May 31;20 Suppl 3:S13-7. https://www.ncbi.nlm.nih.gov/pubmed/12184359
3. Agency for Toxic Substances and Disease Registry (ATSDR). Toxicological profile for aluminum. Washington, D.C.: U.S. Department of Health and Human Services; 2008. https://www.atsdr.cdc.gov/toxprofiles/tp22.pdf

 

Click here to read on ResearchGate (requires ResearchGate login).

Group Dedicated to Safeguarding Informed Consent

FOR IMMEDIATE RELEASE: December 20, 2016
CONTACT: pr@picphysicians.org

Los Angeles, Calif.—Parents and doctors—not politicians—should be making medical decisions for children. A newly launched nonprofit called Physicians for Informed Consent (PIC) is now joining the cause to get the government out of some of the most important conversations parents have with their pediatrician. PIC is committed to protecting the rights of parents to make medical decisions for their children, and safeguarding doctors’ professional responsibility to act ethically and in the best interests of their individual patients.

PIC is dedicated to raising public awareness about the problems posed for both parents and doctors by mandatory vaccination laws. In June 2015, Gov. Jerry Brown signed SB277, one of the most expansive and intrusive mandatory vaccination laws in the U.S. These laws discriminate against families who, in the best interest of their child’s health, do not follow the CDC’s recommended schedule. Politicians have forced their way into the conversation about one of the most important medical decisions families will make in consultation with their doctors.

“I started researching the childhood vaccine schedule when I was pregnant, and my husband and I decided not to follow the CDC’s recommended schedule. When SB277 passed, I felt like our personal medical decisions were under attack,” stated Dr. Shira Miller, who founded Physicians for Informed Consent in 2015. “Fortunately, I found a doctor who had the necessary knowledge to evaluate the risks vaccines posed to my children, but I realized the average parent was not going to seek an in–depth personalized vaccine risk evaluation and would just do whatever their child’s school was now saying needed to be done in order to attend.”

The National Childhood Vaccine Injury Act of 1986, passed by Congress at the behest of drug companies faced with mounting lawsuits, served to protect doctors and vaccine manufacturers from liability for injuries caused by vaccines. The law prevents parents from suing doctors or vaccine manufacturers if their child dies or suffers a disability due to a vaccine. Stripped of the legal recourse afforded to other medical procedures, parents must instead go through a lengthy and complicated application process for compensation and apply within the 2-3 year statute of limitations. Two out of three claims are denied, and many times parents do not know this option is available. Additionally, doctors are not held accountable for failure to fully disclose possible vaccine risks or for failure to report adverse events following vaccination.

“Since 1988, the Vaccine Injury Compensation Program has awarded $3.2 billion in compensation to families who have met the extremely stringent injury requirements,” explained pediatrician and PIC founding director, Dr. Paul Thomas. “How many of these and other families could have avoided the pain of seeing their child injured if doctors were held responsible for their recommendations and were incentivized to give patients all of the information about the risks of vaccines?”

“As a mom I understood the violation of my parental right to informed refusal of a medical treatment, and as a physician I understood how medically dangerous this one-size-fits-all vaccine schedule was for children at large and I just had to do something,” said Dr. Miller. “The only people who should be making vaccine decisions for children are their parents and physicians, not politicians.”

PIC is a 501(c)(3) tax-exempt resource for doctors and parents who believe in the importance of informed consent and want to get the government out of personal medical decisions. PIC has 150 members across the U.S. who are united in a simple mission: End mandatory vaccination laws and promote and preserve the right to informed consent for any medical procedure, including vaccination.

For more information on Physicians for Informed Consent, visit:

https://physiciansforinformedconsent.org/

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CLICK HERE to view this press release on PRWeb.
CLICK HERE to view more PIC news.