'Cures' for Autism, and Conflicts of Interest

Case Reports

To begin, it’s important to understand what a case report is and isn’t. Typically, case reports document novel diagnoses or atypical presentation of conditions. They report on one person or occasionally become a case series if multiple patients are seen. Case reports, by their nature of reporting on a single patient, are not generalizable. They can serve as a first alert system for public health officials (e.g., the first few COVID-19 patients were case reports) and are often used to generate study hypotheses. They are not research studies or methodologically rigorous. 

The Case 

A case report published in the Journal of Personalized Medicine described two fraternal twins diagnosed with autism when they were 20 months old. The case report and corresponding headlines claim complete reversal of symptoms. The diagnosis itself is not worthy of a case report. However, how the providers subsequently cared for the children is what warranted the case report.

Allostatic load is the cumulative wear and tear that the body experiences after repeated chronic stressors. This was the driving theory behind the treatment modalities in this case. Specifically, the twins were treated with a combination of:

• “A strictly gluten-free, casein-free diet that was low in sugar and had no exposure to artificial colors, dyes, or ultra-processed foods. An emphasis was placed on consuming organic, unprocessed, freshly prepared, and home-cooked food from local sources when possible.
• A number of dietary supplements, including omega-3 fatty acids, a multivitamin, vitamin D, carnitine, 5-methyltetrahydrofolate, and bio-individualized homeopathic remedies, were taken by both girls.
• The family consulted a naturopathic doctor who guided them in some DNA-targeted precision medicine using the IntellxxDNA genomics tool.”

Lead Author

The lead author of this case report is Chris D’Adamo, PhD, an assistant professor at the University of Maryland in Family and Community Medicine as well as Epidemiology and Public Health. However, this is not the only hat he wears. He is affiliated with the Institute for Functional Medicine; and Protren, a probiotic company marketing products for autism. Finally, he is also the scientific director and principal investigator for Documenting Hope, the research program of Epidemic Answers, which seeks to “better understand why our kids are impacted by so many health conditions so that we can reverse the impacts and help them heal.”

Both Documenting Hope and Epidemic Answers are mentioned in the Therapeutic Intervention section of the case report.

“The parents were exposed to this concept [allostatic load] by reading popular books on the topic …, listening to autism-focused audio materials … and subsequently taking the Child Health Inventory for Resilience and Prevention (CHIRP) survey of the Documenting Hope Project, a comprehensive assessment of total allostatic load among children. In addition to completing the CHIRP survey and receiving the report, the twins’ mother also utilized additional resources through Epidemic Answers, including free webinars offered by different experts on the topic of autism and a parent forum called Healing Together.”

Documenting Hope Project and Epidemic Answers

Epidemic Answers and Documenting Hope are partnered with, i.e., sponsored by, several companies across five tiers of partnerships: premier, major, sustaining, supporting, and ambassador. There is one premier partner, Pure Encapsulations. It is a dietary supplement company. There are two major partners: Bioray, a supplement company, and Dr. Kings, a homeopathic remedy manufacturer. Among the 15 sustaining partners, five are supplement companies, one lobbies to keep dietary supplements unregulated (Alliance for Natural Health), and another sells water filters that ostensibly remove the fluoride from your water (Pur2O). There are three supplement companies and one company that coaches people on how to successfully launch as a wellness company (Freedom Practice Coaching) among the seven supporting firms. The ambassador partnerships are similar: lots of supplements. 

Methodology

Methodology and ethics are critical to the advancement of science. Not for nothing, honoring the scientific method has advanced medicine and, as a result, lifespans. However, the internet is making certain aspects of this harder. The internet allows anyone anywhere to find “evidence.” This provides quite the conundrum for evidence-based medicine. The quality of evidence becomes more important than how much evidence exists in the form of articles, mentions, shares, or likes. 

Notably, the methods used in this case report are dubious at best. Some questions about why certain aspects were included need to be raised. 

• What does precision medicine mean in the context of autism spectrum disorder when we know so little about the genetics of autism?
• Why was a naturopath consulted for precision medicine, especially considering that the lead author is faculty at a medical school?
• Why were homeopathic remedies used? 
  • No evidence to support this. 
• Why were these supplements used? 
  • They weren’t consistent with the labs reported.
  • There isn’t good evidence to support that they are effective for treating symptoms of autism.

While these questions about the methodology are important because they help us to understand more about the quality of the evidence provided, they are also inextricably linked to the question of the ethics of the article. 

“The authors declare no conflicts of interest.”

Is that true? How a study was conducted and how it was funded matter. Both can influence biases and conclusions. That’s why we have statements on conflicts of interest, which should cover even the perception of a conflict of interest.

Dr. D’Adamo listed joint affiliation on his authorship with the University of Maryland and Documenting Hope. Supplements and homeopathic remedies were used in the care of these children. He is heavily involved with and sponsored by supplement and homeopathy companies. The organizations (i.g., Epidemic Answers and Documenting Hope) he mentions in the Therapeutic Interventions section are sponsored by supplement and homeopathy companies.

If a lead author had ties to a pharmaceutical company (or companies!) in the way that D’Amado has to supplement and homeopathy companies and the supplement industry in general and failed to declare those ties, people would rightly be screaming foul. If that’s not a potential conflict of interest, then I don’t know what is. The potential conflicts of interest are substantial, and the methodology is questionable. No conclusions should be drawn from this case report except an explanation about why this study was allowed to be published as is.