Between the webinar and the Fountain Life order form, attendees were told about a range of products that were claimed to either treat covid-19 or prevent it outright. What they were not told was that seven of the recommended products were also classified by the US Food and Drug Administration as “covid-19 fraudulent.”
The fraudulent cures included amniotic fluid, the liquid that surrounds a baby in utero and is rich in stem cells, and colloidal silver, a suspension of metal particles often touted as having antimicrobial effects, but which the FDA has said “is not safe or effective for treating any disease or condition.” Cook recommended taking both of them as an inhaled mist using a nebulizer, an electric machine similar to an asthma inhaler.
Other treatments put forward in the call and identified by the FDA as fraudulent for treating covid included two peptides (BPC-157 and thymosin-alpha-1), amino acids commonly used in anti-aging products; the vitamin supplement D3K2; and two metabolic enzymes, NAD and NMN. Another recommended product that had been called out by the FDA was ivermectin, an antiparasitic used to treat diseases such as scabies. Although the FDA has not classified it as fraudulent, it has warned against using the drug as a covid-19 treatment.
“Our protocols have gotten so good,” Cook said, that “generally, we almost always get people all the way back from that [covid] really, really fast … it’s not something that stresses us out too much like it did six months ago.”
“I’ve had people say, ‘I thought I was gonna die, and then I did the peptides, and then all of a sudden I felt like I was gonna be okay,’” Cook added.
He even had a suggestion to help deal with the emotional toll of having been exposed to covid at the event: he could “mail ketamine lozenges” to attendees as part of a “protocol for resetting fight-or-flight status.” (Ketamine, an anesthetic often taken as a party drug, has also been used experimentally to treat depression.)
While individual products weren’t all expensive—on the cheaper side, a two-month supply of colloidal silver cost about $25, according to Cook—a month of his full protocol aimed at preventing covid cost around $600, he said. Acute treatment for covid-19, which involved higher doses, could run “a couple thousand.” But, he added, “the dollar number is not that much.”
According to the FDA, “covid-19 fraudulent products” are ones that are promoted and sold using misleading “claims to prevent, treat, mitigate, diagnose, or cure coronavirus.” Not only do they have no tangible effect in treating or preventing covid, but they could “cause Americans to delay or stop appropriate medical treatment, leading to serious and life-threatening harm.”
An agency representative confirmed it has sent out at least 150 warning letters to companies marketing such products but declined to comment on the list of products offered by Diamandis’s affiliates.
“The FDA cannot speak to any specific products, cases, or its approaches regarding possible or ongoing investigations,” a spokesman said by email.
Cook: “I was aware of the risks” of A360
Cook demonstrates a nebulizer during his January 30 webinar.
Over the course of the 84-minute webinar, which was uploaded as an unlisted video to Diamandis’s YouTube channel and later shared with MIT Technology Review by an attendee, Cook told participants how he had developed his treatments for covid-19 based on his own experience with the virus.
He contracted the novel coronavirus “in the first week of covid,” he said, and after treating himself and his best friend, he’d “been on a journey of taking care of people who’ve had it.”
Some of those patients traveled great distances to see him, despite stay-at-home orders limiting nonessential travel. “A steady group of people in LA … would just get on their plane and fly up when they got sick [with covid-19],” he said.
Cook spent much of his webinar giving product recommendations—even going as far as discussing specific dosages for prevention or treatment that he claimed had worked for his patients. At times, Diamandis and Fountain Life’s chief medical officer, George Shapiro, a licensed physician, also provided advice to viewers; Daniel Kraft, a nonpracticing pediatrician who chairs a pandemic task force that Diamandis created last year, chimed in as well. All three had attended the A360 event.
Only once did the webinar discuss widely accepted preventive measures recommended by the CDC, like wearing masks, avoiding nonessential travel, and social distancing (all of which Diamandis’s Abundance 360 conference had ignored). Even then, it was only to suggest that Cook’s treatments could be an effective alternative. “Any time somebody gets on a plane … any time they are going to be in a group, or have any exposure on that front, I have them dose up,” he said.
He followed his own advice when it came to A360. “I was fairly aware of the risks when it came to that conference,” he said. “I triple-treated myself with peptides in the morning, and then I walked out, and then I treated myself again.”
“People were scared”
Diamandis, a Silicon Valley fixture, is perhaps best known for founding Singularity University, an unaccredited educational group that started out as an unofficial grad school for entrepreneurs before shifting its focus to teaching corporate executives to be more “disruptive.” He also started the X Prize Foundation, which runs competitions to encourage innovation, and has funded or helped found a range of other businesses, in areas from space to anti-aging and regenerative medicine to covid-19vaccine development.
The annual A360 event, which he has hosted since 2012, is part of a membership-based community where individuals pay $30,000 or more for a year-long “mastermind” program with two months of personal coaching by Diamandis himself.
I first heard of the webinar in mid-February, when I was reporting the story of how A360 turned into a superspreader event. In a phone interview on February 12, Diamandis told me that the webinar was an attempt to settle the worries of those who had been exposed—including many paying members of the A360 community.
“People were scared and … didn’t know where to go,” Diamandis told me. Cook, he said, was “an amazing, amazing soul” who “came down [to Los Angeles], provided support during the event and … post-event treatments.”
In that conversation, he said that physicians from Fountain Life, as well as Matt Cook, were among the small group that advised him on his plans to hold A360 in spite of public health orders banning all gatherings in California at the time. When we spoke, he had just published a public admission about the outbreak at his event, in which he blamed the spread on his trust in testing and his failure to enforce mask wearing.
“We were using the very best that science had to offer,” he wrote then, adding that he “engaged a professional medical organization” to provide licensed physicians, immunity-boosting vitamins and minerals, and regenerative treatments for the event. In our interview, he confirmed that the organization in question was Fountain Life, with its senior leadership, including Shapiro and the CEO, Bill Kapp, in attendance.
But in March, when I reached out to Diamandis again for comment on the specific products recommended in the webinar, he emailed multiple, sometimes contradictory statements.
The webinar was not meant to constitute medical treatment, he said, nor was it a “marketing or sales pitch,” and he said neither he nor the physicians who took part gained financially from any of the products or companies they were promoting. Cook’s clinic and Fountain Life had not sold any peptides or memberships at all, he said, despite the order form that attendees received, but Diamandis himself “paid 100% of all costs for any treatments provided by Dr. Cook/BioReset to any of the A360 attendees or staff.”
And despite an earlier statement about following “the best” science, Diamandis emailed that he was “unaware that products mentioned might be on the FDA’s list.”
Diamandis has also changed his public statements about the involvement of physicians. His blog post has now been edited to say that Cook was engaged only after the event, despite his telling me in the interview that Cook had come down to support it. In an email, Diamandis said that Shapiro “did not treat anyone for covid following A360.”
Cook did not respond to multiple requests for comment. Shapiro’s lawyers, who declined to comment on their client’s behalf, said that at no point during A360 did Shapiro serve in a physician’s capacity.
But during the webinar, both men made multiple offers to help participants access their recommended treatments. Fountain Life has “national accounts … with four of the five peptide companies,” Shapiro said. “We have good prices that we can get … to our members.”
“Deeply troubling”
Whether they were treating patients or simply promoting unapproved or fraudulent covid-19 “cures,” there are federal rules that apply, says Patti Zettler, an associate law professor at the Ohio State University Moritz College of Law, who focuses on health regulation.
The FDA does not typically regulate how physicians practice medicine, Zettler says, but because many covid-19 treatments were approved under emergency-use authorizations, “there are greater restrictions on what exactly they can be used for.”Currently, only two covid-19 treatments have received emergency authorization: the antiviral drug remdesivir, sold under the brand name Veklury, and bamlanivimab and etesevimab, antibody treatments that can be administered together for mild to moderate cases.
Michelle Mello, a professor of law and medicine at Stanford University, says that state medical boards can also be prompted to investigate such cases. “Promoting cures for which there’s no evidence, or scant evidence, is very unlikely, in my view, to meet what we’ve called a reasonable standard of care,” she says.
In an emailed statement, Carlos Villatoro, a spokesperson for the state medical board in California, where Cook practices, spoke to the importance of “following the standard of care when treating patients.”
“The Board’s mission is consumer protection and it takes that mission seriously,” he said. “For physicians that do not follow the standard of care, the Board’s discipline may include a public reprimand, probation, license suspension, or license revocation.”
Information provided in a webinar does not necessarily constitute medical advice or a doctor-patient relationship, according to both Zettler and Mello, but even if “they’re just selling crap … they would be regulated like just other kinds of product sellers,” Mello says.
“The prospect of health-care professionals encouraging patients to use products that the FDA has specifically identified as fraudulent … is deeply troubling,” says Zettler.
“Being a health-care professional is not a magic ‘Get out of FDA free’ card. Federal law still applies.”
“Makes our entire community look bad”
As far-fetched as many of the treatment options hawked by Cook and Shapiro were, some of the drugs they recommended are being researched for their potential to treat covid-19.
A team at the University of Utah, for example, is conducting randomized clinical trials in 60 patients on the efficacy of human amniotic fluid as a potential coronavirus treatment. Earlier this year it released initial findings from a much smaller study of 10 patients, but the principal investigator, Craig Selzman, cautioned, “You can’t really make any firm conclusions from 10 patients.”
Mello, the Stanford professor, recognizes that “the sciences move really fast and not always … in a linear way,” especially when it comes to covid. “There have been reversals where early research results suggested one thing and then later we learned something else,” she says.
But, she adds, this does not seem to be what happened with the treatments offered by the physicians affiliated with Diamandis. “It just doesn’t seem that different to me from other kinds of quackery,” she says.
Besides the ethics, many physicians and public health experts are concerned about the broader impact that medical misinformation proffered by professionals could have on the public’s trust in scientists.It “makes our entire community look bad,” says Selzman.
When I approached Diamandis in early March with a list of questions for this story, he initially did not address specific questions but responded with an emailed statement.
“As an MD and scientist, I have a special responsibility to learn from mistakes, lead by example, and use the resources at my disposal to make a positive difference and improve the health and safety of everyone on this planet,” he wrote.
When I asked how flouting public health guidance or federal laws was part of this contribution, however, he had no response.
The first step to finding out is to catalogue what microbes we might have lost. To get as close to ancient microbiomes as possible, microbiologists have begun studying multiple Indigenous groups. Two have received the most attention: the Yanomami of the Amazon rainforest and the Hadza, in northern Tanzania.
Researchers have made some startling discoveries already. A study by Sonnenburg and his colleagues, published in July, found that the gut microbiomes of the Hadza appear to include bugs that aren’t seen elsewhere—around 20% of the microbe genomes identified had not been recorded in a global catalogue of over 200,000 such genomes. The researchers found 8.4 million protein families in the guts of the 167 Hadza people they studied. Over half of them had not previously been identified in the human gut.
Plenty of other studies published in the last decade or so have helped build a picture of how the diets and lifestyles of hunter-gatherer societies influence the microbiome, and scientists have speculated on what this means for those living in more industrialized societies. But these revelations have come at a price.
A changing way of life
The Hadza people hunt wild animals and forage for fruit and honey. “We still live the ancient way of life, with arrows and old knives,” says Mangola, who works with the Olanakwe Community Fund to support education and economic projects for the Hadza. Hunters seek out food in the bush, which might include baboons, vervet monkeys, guinea fowl, kudu, porcupines, or dik-dik. Gatherers collect fruits, vegetables, and honey.
Mangola, who has met with multiple scientists over the years and participated in many research projects, has witnessed firsthand the impact of such research on his community. Much of it has been positive. But not all researchers act thoughtfully and ethically, he says, and some have exploited or harmed the community.
One enduring problem, says Mangola, is that scientists have tended to come and study the Hadza without properly explaining their research or their results. They arrive from Europe or the US, accompanied by guides, and collect feces, blood, hair, and other biological samples. Often, the people giving up these samples don’t know what they will be used for, says Mangola. Scientists get their results and publish them without returning to share them. “You tell the world [what you’ve discovered]—why can’t you come back to Tanzania to tell the Hadza?” asks Mangola. “It would bring meaning and excitement to the community,” he says.
Some scientists have talked about the Hadza as if they were living fossils, says Alyssa Crittenden, a nutritional anthropologist and biologist at the University of Nevada in Las Vegas, who has been studying and working with the Hadza for the last two decades.
The Hadza have been described as being “locked in time,” she adds, but characterizations like that don’t reflect reality. She has made many trips to Tanzania and seen for herself how life has changed. Tourists flock to the region. Roads have been built. Charities have helped the Hadza secure land rights. Mangola went abroad for his education: he has a law degree and a master’s from the Indigenous Peoples Law and Policy program at the University of Arizona.
Over the last couple of decades, scientists have come to realize just how important the microbes that crawl all over us are to our health. But some believe our microbiomes are in crisis—casualties of an increasingly sanitized way of life. Disturbances in the collections of microbes we host have been associated with a whole host of diseases, ranging from arthritis to Alzheimer’s.
Some might not be completely gone, though. Scientists believe many might still be hiding inside the intestines of people who don’t live in the polluted, processed environment that most of the rest of us share. They’ve been studying the feces of people like the Yanomami, an Indigenous group in the Amazon, who appear to still have some of the microbes that other people have lost.
But there is a major catch: we don’t know whether those in hunter-gatherer societies really do have “healthier” microbiomes—and if they do, whether the benefits could be shared with others. At the same time, members of the communities being studied are concerned about the risk of what’s called biopiracy—taking natural resources from poorer countries for the benefit of wealthier ones. Read the full story.
—Jessica Hamzelou
Eric Schmidt has a 6-point plan for fighting election misinformation
—by Eric Schmidt, formerly the CEO of Google, and current cofounder of philanthropic initiative Schmidt Futures
The coming year will be one of seismic political shifts. Over 4 billion people will head to the polls in countries including the United States, Taiwan, India, and Indonesia, making 2024 the biggest election year in history.
Generative AI’s ability to harness customer data in a highly sophisticated manner means enterprises are accelerating plans to invest in and leverage the technology’s capabilities. In a study titled “The Future of Enterprise Data & AI,” Corinium Intelligence and WNS Triange surveyed 100 global C-suite leaders and decision-makers specializing in AI, analytics, and data. Seventy-six percent of the respondents said that their organizations are already using or planning to use generative AI.
According to McKinsey, while generative AI will affect most business functions, “four of them will likely account for 75% of the total annual value it can deliver.” Among these are marketing and sales and customer operations. Yet, despite the technology’s benefits, many leaders are unsure about the right approach to take and mindful of the risks associated with large investments.
Mapping out a generative AI pathway
One of the first challenges organizations need to overcome is senior leadership alignment. “You need the necessary strategy; you need the ability to have the necessary buy-in of people,” says Ayer. “You need to make sure that you’ve got the right use case and business case for each one of them.” In other words, a clearly defined roadmap and precise business objectives are as crucial as understanding whether a process is amenable to the use of generative AI.
The implementation of a generative AI strategy can take time. According to Ayer, business leaders should maintain a realistic perspective on the duration required for formulating a strategy, conduct necessary training across various teams and functions, and identify the areas of value addition. And for any generative AI deployment to work seamlessly, the right data ecosystems must be in place.
Ayer cites WNS Triange’s collaboration with an insurer to create a claims process by leveraging generative AI. Thanks to the new technology, the insurer can immediately assess the severity of a vehicle’s damage from an accident and make a claims recommendation based on the unstructured data provided by the client. “Because this can be immediately assessed by a surveyor and they can reach a recommendation quickly, this instantly improves the insurer’s ability to satisfy their policyholders and reduce the claims processing time,” Ayer explains.
All that, however, would not be possible without data on past claims history, repair costs, transaction data, and other necessary data sets to extract clear value from generative AI analysis. “Be very clear about data sufficiency. Don’t jump into a program where eventually you realize you don’t have the necessary data,” Ayer says.
The benefits of third-party experience
Enterprises are increasingly aware that they must embrace generative AI, but knowing where to begin is another thing. “You start off wanting to make sure you don’t repeat mistakes other people have made,” says Ayer. An external provider can help organizations avoid those mistakes and leverage best practices and frameworks for testing and defining explainability and benchmarks for return on investment (ROI).
Using pre-built solutions by external partners can expedite time to market and increase a generative AI program’s value. These solutions can harness pre-built industry-specific generative AI platforms to accelerate deployment. “Generative AI programs can be extremely complicated,” Ayer points out. “There are a lot of infrastructure requirements, touch points with customers, and internal regulations. Organizations will also have to consider using pre-built solutions to accelerate speed to value. Third-party service providers bring the expertise of having an integrated approach to all these elements.”
