A COVID-19 related preprint – that quickly disappeared and reappeared after being discussed on social media – was brought to my attention by Dr. Kevin C Klatt via Twitter.
This preprint, authored by Robert Huizenga, is called Dramatic clinical improvement in nine consecutive acutely ill elderly COVID-19 patients treated with a nicotinamide mononucleotide cocktail: A retrospective case series.
In the study, Dr. Huizenga describes nine COVID-19 patients whom he treated with a mixture containing nicotinamide mononucleotide (NMN).
Unfortunately, Robert Huizenga failed to disclose that this mixture is sold by a company founded by his brother, Joel Huizenga. He also treated these patients without the approval of an institutional review board (IRB).
Update: As I was writing this post last night, the preprint suddenly disappeared. Here are an archived version of the preprint and a copy of the PDF. In my copy of the PDF, the manuscript is called ‘a retrospective case series’, while the word ‘retrospective’ was deleted on the abstract/title page. The page appears to work again this morning (September 12, 2020).
The sole author on the preprint, which was deposited at SSRN.com, an Elsevier-owned online repository for scientific drafts, is Robert Huizenga, MD. According to his Wikipedia page, Dr. H., as he is often called, left his position at Cedars-Sinai Medical Center in the 1980s to work for the Los Angeles Raiders. He was a witness on the OJ Simpson murder trial, wrote books about steroid use and weight loss, and made several TV appearances on shows such as The Biggest Loser, Extreme Makeover, and Gone Girl.
In 2013, Dr. H. opened The Clinic, a spa/retreat center to treat obese patients in Malibu. Although it is not clear if he still works at Cedars-Sinai Medical Center, this Los Angeles-based hospital is used as Dr. H’s affiliation on the preprint.
EGA, the fountain of youth
Dr. H. treated his COVID-19 patients with an ‘NMN cocktail’ called “EGA®”. The composition of this mixture is not described in great detail, but it contains ‘over-the-counter nicotinamide mononucleotide (NMN), betaine, sodium chloride and zinc sulfate‘.
What Huizenga does not mention in his paper is that EGA (‘age’ spelled backwards) is a concoction sold by Egaceutical. And the CEO of this company is a person called Joel Huizenga – who happens to be Robert’s brother (HT: Kevin Klatt). Joel is a serial entrepreneur in the medical field, with several startups in his past, such as No Lie MRI and ISCHEM Corporation.
Egaceutical claims that EGA can reverse aging in humans, although no proof of that is given. In this video, Joel (who sounds alarmingly out of breath) explains how we can all pull a Benjamin Button if we use EGA, the ‘fountain of youth’.
There are no published studies on the efficacy of EGA, just a report of 12 men (Joel and his friends) [archived] who had to pay to be treated and who all reported feeling younger and playing better chess.
The company is recruiting new volunteers, but you still have to pay the company to participate. That is remarkable because the company might be making a lot of money on the back of these volunteers. Why does the company not pay the volunteers?
Thus, if the brother of the CEO selling the product is recommending the product, there appears to be a clear conflict of interest. Yet, the older Huizenga brother, Robert, did not ‘delcare‘ (sic) any conflict of interest. He did not just forget to include it, he actually stated that there was no interest to declare.
One could also question how honest the reporting of the patients’ dramatic improvement was, because there was only one author, with a clear conflict of interest.
The preprint describes eight patients who tested positive for SARS-CoV-2 by PCR, and one who was clinically diagnosed with COVID-19. These nine patients were seen in Dr. H’s private practice, as described in the manuscript. Some patients appear not to have been in the hospital at the time of treatment, and not all of them presented as severely ill.
Most of the X-rays presented in the pdf were taken at Robertson Diagnostic (RobertsonDx.com is also used as the email address of the author), which appears to be a clinic at North Robertson Blvd in Beverly Hills associated with Cedars-Sinai.
This study did not have a control group, so it is impossible to know if a person with a positive SARS-CoV-2 test and a mild fever, who was not hospitalized, would have gotten better without any treatment. Most patients with mild COVID-19 will get better by themselves, so without a control group we cannot be sure if the EGA concoction played any role in the improvement of symptoms.
In at least one case, Dr. H. appears to have administered the ‘supplement’ to one of his hospitalized patients himself. It is not clear if she had to pay for it and if he asked permission from the hospital staff.
The word ‘dramatic’, not a word one sees very often in scientific papers, appears 12 times throughout the manuscript. Dr. H. appears to love this word – perhaps a leftover from his Hollywood past. ‘Dramatic’ is the first word of the title, and it also repeatedly appears in the detailed description of the patients to describe how spectacularly their clinical symptoms improved.
He also uses the word in the title of another SSRN preprint describing the miracle EGA drug: Dramatic Cytokine Storm Reversal with an Over the Counter NMN Cocktail [archived, PDF]. This June 2020 manuscript describes one of the nine patients featured in the August 2020 manuscript.
No IRB approval
One would hope that doctors experimenting on COVID-19 patients with a new, not-FDA-approved, treatment would apply for IRB approval. But that did not happen here.
Dr. Huizenga declared that the patients signed a consent form, but that no IRB approval was required. He refers to a section on the HHS website, but it is not clear why he thinks this study is exempt, because the text he links to offers no clues.
Dr. H also claims that the EGA drug is an “over the counter food supplement” but this does not appear to be completely true. Although the main compound, nicotinamide mononucleotide (NMN), is sold as a food supplement and is a molecule naturally found in cells, that does not necessarily mean it is safe to consume in large quantities. To give an example, bitter almonds contain small amounts of hydrogen cyanide, a compound that is extremely toxic if consumed in high amounts. Just because a molecule is found in nature, does not make it innocent.
Also, EGA does not only contain NMN, there are other ingredients as well, such as betaine (an additive used in PCR reactions), sodium chloride (kitchen salt), and zinc sulfate (which can be used to restore zinc deficiencies). All these compounds may be safe to consume in low amounts, but it is unclear what concentrations of each were in the EGA concoction, and also if the combination of these four ingredients is safe to give to COVID-19 patients.
In the Netherlands, there was a famous and funny TV commercial in the 1990s for WC Eend (Toilet Duck), a cleaning product for toilet bowls. In the commercial, the voiceover says ‘Wij van WC-Eend adviseren … WC-Eend’ (‘We, the people of Toilet Duck, recommend … Toilet Duck’).
This slogan is still being used to point out that one should be cautious if a company recommends its own product.
This paper has a very high Toilet Duck feel.