A Hollywood doctor known for his appearances on reality TV shows The Biggest Loser and Extreme Makeover has been criticized by scientists for giving nine Covid-19 patients a cocktail of unproven supplements to treat the illness, without obtaining institutional approval to carry out his research.
Dr. Robert Huizenga, or “Dr. H”, is known for being Charlie Sheen’s physician, and is based in Beverly Hills, California. In August, he published a “pre-print” — meaning as yet not peer reviewed — case series online, in which he described treating nine Covid-19 patients with a mixture combining a supplement called nicotinamide mononucleotide, along with other ingredients including zinc and salt.
A group of scientists criticized Huizenga’ claims, describing them as “magical” and called him out for publishing the study without disclosing a potential conflict of interest: namely, that the treatment had been created by his brother, an inventor and entrepreneur named Joel Huizenga.
Joel Huizenga’s product claims to be an “age-reversal” treatment. Named “EGA” – “age” spelled backwards – it has not been through a clinical trial. Prior to the pandemic, the only research undertaken for “EGA” was an observational study involving a group of 12 friends who paid to take part in the study under the care of their own physician and reported feeling mentally and physically better after taking the treatment. The product is not for sale, but the EGA website invites people to pay to participate in an ongoing study. Participants are asked to pay $461 for their own diagnostic testing, and an undisclosed amount for the supplement itself.
Scientists posted screenshots of Dr Robert Huizenga’s declaration on the Social Science Research Network, an online server for scientific drafts, which did not mention that this mixture is sold by a company founded by his brother.
“He’s treating them not with something that is scientifically sound,” said Elisabeth Bik, a scientific consultant who wrote a blogpost criticizing Huizenga’s study, and who was a key figure in debunking the supposed hydroxychloroquine “miracle cure.”
“With a magic concoction made by your brother, there can be all kinds of ingredients that actually can be more harmful than helpful,” she said.
When contacted by Coda Story, Robert Huizenga, who published the study in affiliation with Los Angeles’ Cedars Sinai hospital, said in an email that he had submitted details about his brother’s ownership of the product, but there had been an error on the journal’s side. “I saw my declaration of interest on their site was not entered properly and contacted SSRN that day and asked them what was up. They apologized,” said Huizenga. The declaration on the site has since been updated, though the paper itself makes no mention of Huizenga’s personal connection to the treatment.
“These critics you forwarded to me are savages – they accuse first and rarely if ever attempt to fact check,” Huizenga wrote in an email when presented with criticism from Bik and others.
Huizenga’s case series – which did not make use of a control group to test the effects of the cocktail against the effects of administering a placebo – described “rapid and dramatic” improvements in the conditions of the subjects who received the treatment. Huizenga said that pending placebo-controlled studies, he would “consider it unethical” not to treat severely ill, elderly Covid-19 patients with compounds like “EGA”.
“We have learned over and over again that we need to do well designed, randomized control trials to estimate the true effects,” said Kevin Klatt, a postdoctoral associate at Baylor College of Medicine in Houston, Texas. “You cannot just treat nine patients with something and think that you’ve observed the true effect of what happens.”
Klatt posted about Huizenga’s study on Twitter – “Pre print servers are a gem. Giving inpatients your brother’s company’s magical nutrient cocktail,” he wrote. “Sounds about 2020.” Scientists discussed the study in the comments. “I just saw this and now I’m adding the word dramatic seven times in my manuscript abstract,” wrote one scientist. “What a disaster,” wrote another, complaining of the lack of safety data in the paper.
Huizenga said he was unable to get approval for the case series from LA’s Cedars-Sinai Hospital Institutional Review Board (IRB), which oversees medical research on human subjects. “The current IRB and subsequent peer review ‘medical journal’ processes are both constricting, shortsighted, embarrassingly inaccurate and, yes, frankly way too unethical to continue operating unchallenged,” Huizenga said.
He argues that his research is exempt from any approval because the supplements he gave his patients are available over the counter. According to Klatt, the dosages in Huizenga’s brother’s patent “are tenfold higher than we recommend.”
Cedars-Sinai hospital distanced itself from Huizenga. “Dr Huizenga is an independent practitioner who is not on the Cedars-Sinai faculty, nor employed by us. He does not have any Cedars-Sinai IRB-approved studies,” said spokesperson Sally Stewart in an emailed statement.
In his pre-print, Huizenga described going into a hospital to administer the cocktail through a straw to a female patient in her fifties who was in a life-threatening condition. Huizenga said the patient had given signed informed consent allowing him to administer the treatment. He called her turnaround “the most unexpected recovery I have seen in 40 years of clinical medicine.”
“She dramatically improved within 48 hours,” Huizenga said. “The flip side ethical concern for frontline doctors like myself is the very real smell of death in every Covid-19 unit. Desperate situations require innovative solutions.”
Klatt, whose lab is researching the potential benefits of treatments like Huizenga’s in relation to aging and viral response, highlighted concerns about patient data. “The premise isn’t absurd, but the claims being made from this quality data – of 9 or 10 patients – is the absurdity,” he said. “Stuff like this degrades taking the whole thing seriously,” he said.
Earlier this year, reporting by Coda Story found that the rush to bypass the peer review process and publish Covid-19 research on open-access servers, while often useful to practicing researchers and scientists, can lead to misinformation and overinflated claims.
“We all want to believe the movies that show the scientist coming up with an idea, injecting eight monkeys, one monkey survives, you inject yourself, and you’ve saved the world,” said Bik. “But with fantastical claims need to come fantastical evidence.”