Reponse to Gøtzsche from Dr. Anthony Mawson, DrPH and Binu Jacob, MPH

Submitted 02/25/2025

We thank the Editor of the Journal of the Academy of Public Health for the opportunity to respond to the review of our paper in Science, Public Health Policy, and the Law, “Vaccination and neurodevelopmental disorders: a study of nine-year-old children enrolled in Medicaid,” by Peter C. Gøtzsche.

First, let me assure readers that neither I nor my co-author Binu Jacob are against vaccination (“anti-vaxxers”), as if critics of cars are anti-cars. We are both trained in public health and recognize the importance of vaccines. Our concern is with the safety of the current childhood vaccination schedule, which has increased nearly three-fold compared to the schedule in the 1950s. Just as cigarette smoking was once assumed to be safe, so today the safety of vaccination is taken for granted. A few cigarettes will not cause lung cancer, but it was shocking to learn that packs smoked per day were directly associated with the risk of lung cancer and heart disease in a dose-response relationship. In the case of vaccines, previous studies have focused on single vaccines, with inconsistent results. But the cumulative impact of all the scheduled vaccinations has been ignored, as Gøtzsche notes. This gap in the evidence led to our own research.

The new study, comprising 47,155 nine-year-old children who had been continuously enrolled in the Florida Medicaid program, found that: 1) visits involving vaccinations were associated with significantly increased odds for all measured neurodevelopmental disorders (NDDs); 2) children born preterm and vaccinated were significantly more likely to have been diagnosed with at least one NDD than those born preterm and unvaccinated; and 3) the relative risk of diagnosis with ASD increased according to the number of visits that included vaccinations.

These results suggest that the current vaccination schedule may be contributing to multiple forms of NDD; that preterm birth, an inflammatory condition (1), coupled with vaccination appears to be strongly associated with increased odds of all of the measured NDDs compared to preterm birth in the absence of vaccination; and increasing numbers of visits that included vaccinations were associated with increased risks of ASD.  

Dr. Gøtzsche alleges that we did not discuss the most important limitation, that “the more often people visit a doctor, the greater the risk that they will get a diagnosis.” In any study comparing vaccinated and unvaccinated children, the only expected outcome would be that the vaccinated were protected against the targeted infectious diseases. In our study, on the contrary, we reported significantly increased odds of several NDDs in the vaccinated compared to unvaccinated children.  There is no doubt that some vaccinated children with NDDs unrelated to vaccination itself may have been so diagnosed simply because their condition was more likely to be recognized after increasing numbers of visits. Conversely, more unvaccinated children may have been diagnosed with an NDD if they had been seen at the office. However, it is implausible to suggest that our findings and the pattern of the findings on NDDs are due to numbers of office visits and greater exposure to being diagnosed, and that the absence of visits explains the lower frequency of NDDs in the unvaccinated. The implication is unreasonable that the parents of an unvaccinated child would not take their child to the doctor if his or her condition required it.

We stand by our study because the overall results, based on Medicaid claims data, closely match those of our 2017 pilot study based on mothers’ anonymous responses to an online questionnaire on the health outcomes of  666 children and their own experiences in pregnancy (2). The new results replicate and expand on the findings of the pilot study: vaccination was significantly associated with NDDs (combining ASD, ADHD, and learning disorders); preterm birth coupled with vaccination was associated with increased odds of NDDs compared to preterm birth in the absence of vaccination; and fully vaccinated children had significantly higher odds of NDDs than the partially vaccinated.

Reproducibility is a key criterion of validity. The strong reproducibility of our results supports their validity and our conclusions.  The organization Retraction Watch continues to post that our 2017 “pilot comparative study” paper was retracted twice. This is false. The paper was never retracted by any journal, and it remains online.

The fact that African Americans comprised the largest group of unvaccinated children reflects the demographics of the population and has no bearing on the validity of the overall results.

Gøtzsche further asserts that diagnostic criteria for autism and ADHD are vague and that people who don’t get vaccinated are less likely to see a doctor for other issues This comment unfairly implies that many of the unvaccinated may have had NDDs but were not diagnosed because of parental neglect. However, almost any child with an NDD, regardless of their vaccination status, will require at least one health care visit due to the disorder, involving the use of a diagnostic code for billing. The chance of a totally missing diagnostic code for an NDD in the Medicaid billing and claims data is therefore virtually zero.

ADHD was known as Minimal Brain Dysfunction in the 1960s and was rare. It was not officially recognized in the Diagnostic and Statistical Manual of Mental Disorders (DSM) until the second edition in 1968, where it was listed as "hyperkinetic impulse disorder".  In 2024, an estimated 7 million (11.4%) US children aged 3–17 years were diagnosed with ADHD, according to a national survey of parents using data from 2022 (3). Could this increase be due to greater recognition of the symptoms of ADHD in the general population? More likely it indicates a real increase in the prevalence of the condition.

We agree with Gøtzsche that the overall impact of the vaccination schedule on children’s health has been left unexplored. The studies mentioned by Gøtzsche suggest that increasing numbers of required vaccinations are linked not only to death but to adverse health outcomes in general, including NDDs, as our study suggests.

Gøtzsche’s suggestion to randomize children either to receive or not receive vaccines is a logical method in theory but it is universally rejected as unethical, since it would deprive some children of the needed vaccines. This restriction therefore requires observational studies comparing vaccinated and unvaccinated children.

Regarding Wakefield, he and his co-authors did not claim that the MMR causes autism. They wrote: “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue”(4).  It is also not true that the case-series study by 12 respected physicians was fraudulent (5). Importantly, it was the first study to draw attention to gastrointestinal issues in children with ASD.

The MMR vaccine is the last in a series of vaccinations in the first 12 months of life and could conceivably trigger ASD in susceptible children due to their net impact.  Importantly, none of the cited studies compared outcomes in totally vaccinated children and totally unvaccinated children.

Chalfont Research Institute is a start-up medical research and development company, of which I am the president. Until recently, due to my employment as a professor, I have not had the time to devote to building the institute. The electronic device is being developed based on my research on patients with spinal cord injury, who are most at risk of pressure injuries due to impaired circulatory function. My research showed that electrical stimulation can increase tissue oxygenation levels at the sacrum into the normal range within minutes (6). The prototype device will soon undergo randomized clinical trials.

In summary, readers should take Gøtzsche’s review with a large grain of salt.

References

1.  Humberg A, Fortmann I, Siller B et al.  German Neonatal Network, German Center for Lung Research and Priming Immunity at the beginning of life (PRIMAL) Consortium. Preterm birth and sustained inflammation: consequences for the neonate. Semin Immunopathol. 2020 Aug;42(4):451-468. doi: 10.1007/s00281-020-00803-2. Epub 2020 Jul 13. PMID: 32661735; PMCID: PMC7508934.

2. Mawson AR, Ray BD, Bhuiyan AR, Jacob B. Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children. J Transl Sci 2017; 3: DOI: 10.15761/JTS.1000186 https://www.oatext.com/pdf/JTS-3-186.pdf

3. Centers for Disease Control and Prevention | CDC. Data and statistics on ADHD. https://www.cdc.gov › adhd › data  (Accessed February 24, 2025).

4. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children [retracted in: Lancet.Nov 15, 2019] (https://pubmed.ncbi.nlm.nih.gov/9500320/).

5. Wakefield AJ. Callous Disregard: Autism and Vaccines—The Truth Behind a Tragedy. Chapter 12: Deer. Skyhorse Publishing, New York, 2010.

6. Mawson AR et al. Effect of high voltage pulsed galvanic stimulation on sacral transcutaneous oxygen tension levels in the spinal cord injured. Paraplegia  1993; 31:311-319 (Link to the patent: https://patents.google.com/patent/US9700717B2/en).

The authors fail to address my criticism and introduce new errors 

Reviewer Closure from Peter Gøtzsche

Submitted 02/27/2025

The authors have not resolved the key flaw of their study, which is that the more often people visit a doctor, the greater the risk that they will get a vague diagnosis that many of us could get if we visited a doctor.

Astonishingly, the authors claim in their reply that “It is not true that the case-series study by 12 respected physicians at the Royal Free Hospital in London was fraudulent.” To prove their point, they cite the fraudster, Wakefield, himself!

Wakefield’s study was the basis for the false claim that vaccines can cause autism, but it was a horrendous fraud at many levels and there was also financial corruption.[1-9] When Wakefield refused to carry out the replication research requested of him by his employers, they fired him. In January 2011, BMJ’s editor-in-chief called Wakefield’s research “an elaborate fraud” and accused the Royal Free medical school and The Lancet of “institutional and editorial misconduct.” [8,9] Although the GMC had found Wakefield guilty of some three dozen charges, The Lancet continued to cover up for him but ultimately retracted his paper.

Disclosures, Funding & Conflicts of Interest

None in relation to this paper.

Affiliations:

Peter C Gøtzsche, Professor emeritus, Institute for Scientific Freedom, Copenhagen, DK

Correspondence:

[email protected]

References

1. Gøtzsche PC. Vaccines: truth, lies, and controversy. New York: Skyhorse; 2021.

2. Deer B. How the case against the MMR vaccine was fixed. BMJ 2011;342:c5347.

3. Deer B. The Lancet’s two days to bury bad news. BMJ 2011;342:c7001.

4. Deer B. How the vaccine crisis was meant to make money. BMJ 2011;342:c5258.

5. Deer B. Who saw the “histological findings”? BMJ2011;343:d7892.

6. Deer B. Pathology reports solve “new bowel disease” riddle. BMJ 2011;343:d6823.

7. Deer B. Andrew Wakefield concocts a conspiracy. Undated. 

8. Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ 2011;342:c7452.

9. Godlee F. Institutional and editorial misconduct in the MMR scare. BMJ 2011;342:d378.