Technology

First he held a superspreader event. Then he recommended fake cures.

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-19 vaccine 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.

“Being a health-care professional is not a magic ‘Get out of FDA free’ card. Federal law still applies.”

Health law professor Patti Zettler

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.”

In June 2020, Shapiro was censured and reprimanded by the New York State Medical Board for “professional misconduct” after a disciplinary panel found that he had failed to perform appropriate tests and treatments for a number of patients over a four-year period. He was fined $50,000 and is currently under a 36-month probation that allows him to practice medicine only when monitored by a board-certified internist or cardiologist. In 2005, he was arrested, fined, and put on probation by the FBI on charges that he had provided Viagra and other drugs to members of the Gambino drug family, as Bloomberg reported.

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.” An FDA fact-sheet last updated in December lists only eight covid-19 treatments that have received emergency use authorization; none of which were on offer during the webinar.

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.”

“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.”

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.

Correction: We amended a statement to clarify that the FDA has given emergency authorization to eight covid-19 treatments, not two as we originally reported.

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