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Inside the Secretive Life-Extension Clinic

Inside the Secretive Life-Extension Clinic<br />
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science
May 2023


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As far as we know, it went something like this.

One morning in September 2020, a van collected five elderly guests from a Marriott hotel in San Diego, California. It drove south, crossing the border into Mexico, and stopped in front of the mirrored windows of the Regenerative Medicine Institute in Tijuana. Among the passengers was MJ, who had recently been diagnosed with mild cognitive impairment, which is often followed by dementia. "My mind was not what it should be," she says. "I was having a lot of trouble with dates and the time."

The guests were helped out of the van and taken in twos into a room with two beds. "We really had no idea what to expect," MJ tells me. She is in her early eighties and lives in a retirement community with her husband in Kansas. They make a sweet couple. To protect MJ's privacy, I'm using only her initials. "I thought they were gonna give me a shot of some kind," she says. MJ had been told she was taking part in a trial for a new Alzheimer's treatment--a gene therapy, developed by the US biotech company BioViva.

Before arriving in Tijuana, MJ had had very little contact with the trial's doctor. "He came in and had these two syringes in his hand," she says. "He put one syringe up my nostril. I felt like he was sticking it up to my brain." The doctor squeezed the syringe and the treatment was over. "We were put back in this very nice car and brought back up to the hotel, and they said: 'We'll be in touch.'"

There are 5 million adults in the US living with dementia, with a further 50 million across the world. By 2050, it's estimated that this number will have roughly tripled. Alzheimer's is the most common form, and research into treatments is known as "the graveyard of drug development." Despite the billions of dollars spent and thousands of trials performed, there is no cure, and the few drugs that exist only slow its progress. But new treatments claim to be unearthing untold benefits if you know where to look--and are willing to take a risk.

MJ was willing to take that risk. To participate in the BioViva trial, she had paid only for her travel to Mexico, expenses, and some initial tests and scans--an organization called Maximum Life Foundation (MLF) had covered the treatment costs. Founded by David Kekich, a well-known figure among researchers and activists who believe lifespan can be greatly expanded, MLF says its aim is to "reverse the human aging process by 2033." It plans to do so by funding experimental technologies involving genomics, proteomics, regenerative medicine, nutraceuticals, nanotechnology, and artificial intelligence. "When people get diagnosed with Alzheimer's, everything stands still, it's a death sentence," Kekich told me in April 2020. "That's why we're doing what we're doing." Kekich died the following year, though not of dementia. His body was cryogenically frozen, in case he can one day be revived.

In the BioViva trial, MJ and the other patients had two "anti-aging" genes delivered into their brains, with a virus used for transport. Rather than treat dementia directly, these genes supposedly instruct brain cells to create two enzymes--telomerase and Klotho--that play a role in controlling cellular aging. The idea is that boosting levels of these enzymes helps rejuvenate cells in the brain, turning back the clock and erasing age-related conditions such as Alzheimer's.

When the trial's results were published in November 2021, BioViva boasted that it had done just that. "Despite decades of effort and billions of dollars devoted to dementia research, we have seen very little progress ... until now," founder CEO Liz Parrish declared in a press release. Working at the fringes of medicine, she claimed her company had succeeded where countless others had failed--by reversing the effects of aging.

Gene therapies, which modify a patient's cells, are at the forefront of medical research. Testing is highly regulated. In the US only a few dozen have been authorized, for treating serious conditions such as cancer, vision loss, or muscular dystrophy. But in 2015, the same year it was founded, BioViva became the first company in the world to try to use a gene therapy to reverse aging, injecting a treatment it had developed into a single person. The patient? Liz Parrish, the company's founder and CEO. This wasn't part of a clinical trial, and it didn't happen in the US; this wild, one-person experiment took place at a clinic in Bogota, Colombia, far from the oversight of the US Food and Drug Administration (FDA).

Shortly afterward, on Reddit's Futurology forum, Parrish announced that she had received this treatment in South America. She also announced that BioViva would be working to bring life-extension therapies like these to the general public. Parrish had seemingly uncovered the fountain of youth--or at least had convinced her followers of as much.

"The truth is, to treat very serious diseases, we are going to have to take risks."

After her self-experiment, Parrish carved out a successful career promoting the potential of gene therapies for life extension, speaking at events across the world (including at WIRED's own health summit). I first saw her in person at one of these events: the Longevity World Forum in Valencia in 2019. I would have guessed her to be in her late thirties, although by then she was almost 50. When we chatted afterward, she insisted I squeeze her arm to feel the toned muscles underneath--the product, she said, of an experimental, and as yet unapproved, gene therapy for follistatin, a protein involved in muscle growth, which she received alongside the therapy for telomerase, one of the enzymes given to MJ. A press release issued in 2016 stated that her experiment had wound back the clock 20 years, while a paper published last year claims that, thanks to subsequent gene therapy treatments, Parrish now apparently has a biological age of 25. She is, in fact, 52.

Parrish bemoans the lethargy with which these longevity treatments are making their way to the public. Regulatory authorities are the enemy of progress, she claims; they need to stand aside and let those who are willing try anti-aging treatments. This is not only pragmatic, according to Parrish, it is ethical. Millions of people die every year of something that might potentially be cured: aging.

Parrish has codified her philosophy into something she calls "best choice medicine." In the US, federal and state "right-to-try" laws allow doctors to offer experimental, unproven treatments to terminally ill patients. Parrish wants to see the same provisions extended to unapproved anti-aging gene therapies. When we met at her home in Bainbridge Island, Washington, last summer, she told me that the elderly should be allowed to put their lives on the line to improve their children's chances of reaching a healthy old age. It's the Silicon Valley "move fast and break things" mantra brought to medicine.

There has never been a shortage of medical salespeople with dubious credentials who claim to have discovered some potion or process to reverse aging. Humans have obsessed over finding a cure for aging for pretty much as long as they have been getting old. The idea that many age-related diseases could be expressions of a single underlying process--one that might be treatable--is powerful, intoxicating.

At least some of Parrish's claims are based on established science. Every time our cells divide, our telomeres--the protective caps on our chromosomes, the cell's DNA molecules--shorten. This gives our cells a limited lifespan: when the telomeres get too short, the cell can no longer survive. Sometimes, instead of dying, these cells fall into a moribund state called senescence. The gradual build-up of senescent cells is a hallmark of aging, and the damage they inflict is being investigated as the underlying cause of a wide range of seemingly different age-related diseases, from dementia to arthritis.

But some of our cells, such as stem cells, do not have this limiting factor. They express the gene for telomerase, and so produce this enzyme, which repairs telomeres, extending the lifespan of the cell. Artificially introduce that gene to other cells, and it might not only slow their aging, but even push those that are senescent back into healthy life by resetting their chromosomal clock.

Work carried out by Maria Blasco, director of the Spanish National Cancer Research Center in Madrid, shows that mice given injections of transporter viruses loaded with telomerase genes not only experience healthier aging with less disease, but also live longer--a heady 25 percent longer. Findings like this are fueling a tremendous interest in the potential for gene therapies to allow us to live longer, healthier lives. But science moves slowly--too slowly, apparently, for Parrish.

In December 2018, a little over three years after she was injected with telomerase gene therapy in Bogata, Colombia, Parrish spoke at People Unlimited, a membership organization in Scottsdale, Arizona, "for people passionate about radical life extension." It owes its existence to Charles Brown, a nightclub entertainer who claimed to have been rendered immune to death by "cellular awakening"--a quasi-religious experience he described as a "piercing through to the core of the cells and atoms of the body, which awaken the DNA."

Brown died in October 2015, of complications arising from Parkinson's and heart disease, but his adherents still come together every week to support one another in their quest to live forever. Ideas of cellular awakening passed away with Brown; these days the group invites speakers from across the world to discuss the latest longevity science has to offer--Parrish among them.

Speaking via video-link, she revealed that BioViva was engaged in human trials of anti-aging medicine. Her company had struck a partnership with Integrated Health Systems (IHS), a network of doctors in clinics outside the US that would carry out experimental gene therapies and share the data generated with BioViva to accelerate the development of these therapies. "Three steps to a healthier you," Parrish told the group. She rattled off a list of treatments on offer: klotho gene therapy for cognition, follistatin gene therapy for muscle growth, telomerase gene therapy for anti-aging.

Patients apply for treatments via the IHS website. When they do, they're told that safety is not guaranteed--and that neither, crucially, is efficacy. One thing is though: Prices start at $75,000. No refunds.

When I asked Parrish if promoting these unlicensed treatments was necessary, she was clear. "This is new technology that needs to get to humans. These terminally ill patients need access." I asked her if the terminal illnesses included aging. "Yeah, well," she replied, "that's the number one killer on the planet."

Longevity science, like all of medicine, moves slowly. There are good reasons for this. Stem cells aren't the only ones that express high levels of telomerase. The most notable exceptions are cancer cells. By manufacturing high amounts of telomerase, cancerous cells suspend the natural limit to replication. This allows them to grow and spread. It's a fair guess that this is why our cells have the limit in the first place: As they age, cells accumulate mutations that could be harmful to you. Making sure they die or are subsumed before they collect too many mutations is, quite likely, a safety measure. Injecting someone with a gene therapy that gets rid of this could be disastrous if their cells have other defects that allow them to become cancerous.

Operating outside of the FDA's reach, Parrish, BioViva, and its partners have adopted a shroud of secrecy. IHS is registered in the British Virgin Islands, a jurisdiction that does not require companies to disclose their directors or shareholders. And IHS doesn't list an address or a phone number on its website. "They seem really cryptic," says Leigh Turner, a bioethicist at the University of California, Irvine. "The details that have come out have not been reassuring in terms of the credentials and qualifications of clinicians involved, the clinical facilities that people go to, or the protocols that are in place."

The murkiness extends to the relationship between BioViva and IHS. Parrish insists they are separate, independent entities. She says she has no idea who runs IHS, despite their partnership. Yet the two companies seem to be incredibly, confusingly interlinked.

Enquiries to the IHS email address result in replies from BioViva. When I track down one of the doctors in the IHS network, Leonardo Gonzales of the Zelula Institute in Bogota, Colombia, he tells me that Parrish personally recruited him. Another of its doctors, Patrick Sewell, who injected MJ with the experimental gene therapy in Tijuana, is credited as BioViva's director of clinical affairs in the press release announcing the results of MJ's trial. That experiment was originally scheduled to take place in Mexico City, at the clinic of doctor Jason Williams, before the pandemic complicated air travel. Williams--who also administered the gene therapy to Parrish back in 2015--is the cofounder of BioViva, and its chief medical officer.

Shortly after I raised these connections with Parrish last year, Williams's profile vanished from the staff page on the IHS website, and numerous videos on BioViva's YouTube page featuring him and Parrish together were made private. BioViva and Parrish failed to provide an attributable response to a number of questions on issues raised by our reporting.

Turner, the bioethicist, has history with Williams. In 2013, Turner wrote to the FDA with his concerns about Precision StemCell, a company based in Gulf Shores, Alabama, where Williams--a radiologist by training--was administering unlicensed procedures to patients, extracting stem cells from their fat tissue and injecting these back into the body, including into the spine. Applications ranged from sports injuries to amyotrophic lateral sclerosis (ALS)--a progressive and deadly disease of the nervous system.

When representatives from the patient advocacy group ALS Worldwide visited the clinic, they were alarmed by what they said were dangerous interventions performed incompetently in unsanitary conditions. The group later warned members: "Patients and caregivers are urged to avoid any further procedures conducted by Williams or his colleagues in any locale." Williams strongly disputed the assessment, but soon after, under pressure from the FDA, he relocated to Colombia. "A great country with very nice people," he told his patients, where "they are very open to stem cells and gene therapy."

"The experiment that was done is not capable of producing meaningful results."

The evidence Parrish has offered in support of human telomerase therapy has been questioned by other scientists. The paper detailing the results of the Tijuana experiment--supposedly the world's first ever effective treatment for dementia--was published not in Nature or Science, but the little-known Journal of Regenerative Biology and Medicine, one of 22 launched in just the past four years by publisher Maples Scientific. Recent papers in the journal include "Control of Mind Using Nanotechnology" and "Zorbing in Impaired Children: An Innovative New Alternative for Better Self-Consciousness." Joel Osorio, editor-in-chief of the journal, has an anti-aging clinic in Cancun, Mexico, where he sells a penis enhancement injection called the I-Guana Shot. Maples Scientific did not respond when approached for comment.

Everything is wrong with the methodology of this paper, says Charles Brenner, a specialist in age-related diseases at the Beckman Research Institute of City of Hope in Los Angeles, California. "It's not established that telomerase activity limits human healthspan, and cognitive impairment is not very well understood." Despite this, the paper sets out a very firm hypothesis: Increase telomerase in patients with signs of cognitive decline, and very quickly they will show signs of improvement.

From here, the actual substance of the paper is lacking, says Brenner. The absence of a control group means that no conclusions can be drawn--any recorded changes could be attributed to other factors--and the impact of any change in telomerase activity was not properly investigated, he says. "The experiment that was done is not capable of producing meaningful results. I wouldn't expect it to work, and I doubt that it does."

Brenner also points to the known risks associated with this area of research, such as the viruses used in gene therapy producing adverse immune responses--which in extreme cases can be fatal--as well as the cancer risk from elevating telomerase expression.

Parrish's own claimed rejuvenation is equally problematic. According to Brenner, the concept of "biological age," determined by looking for certain signals and substances inside the body, is more of a research tool under development than an accepted measurement of anything useful. Besides, Bill Andrews, a telomerase specialist who prepared the gene therapy for Parrish's 2015 experiment in Colombia and who has been instrumental in BioViva's work, tells me that even he couldn't support the results she had claimed after receiving the gene therapy. He believes Parrish probably took only a thousandth of an effective dose.

Nor is there any reliable evidence of Parrish's purported 20-year reduction in biological age. The 2016 press release detailing her treatment says that the results were independently verified. But both the organizations that undertook this--a UK charity called the Biogerontology Research Foundation and the Healthy Life Extension Society, a European nonprofit--have links to Parrish. That press release was written by BioViva's chief technology officer, Avi Roy--who was serving as president of the Biogerontology Research Foundation at the time. Parrish has also served on the board of the International Longevity Alliance, an umbrella organization that counts the Healthy Life Extension Society as a member. To date, the results of Parrish's experiment, and the procedure carried out on MJ and her covolunteers, have never truly been independently verified.

It's easy to get swept up in the idea that aging might be curable. And it's no surprise that longevity medicine is also a profitable hunting ground for quacks. "Some really do think that they're offering meaningful interventions," says Turner. "Where this starts to get problematic is when they're driven entirely by enthusiasm."

Parrish--who often describes her interest in aging medicine as humanitarian--has no medical qualifications. Yet she is unapologetic about her gung-ho attitude to medicine. "I believe I'm on the right side of history," she says. "The truth is, to treat very serious diseases, we are going to have to take risks. What I would say is: Was anyone hurt? I seriously doubt it."

If you can convince people that aging is a disease, it's no surprise that some will clamor for a cure--and pay whatever they can for it. This, if anything, ought to underline exactly why medicine carried out under stringent regulations really is the best choice. "We need to protect patient populations," says Brenner.

For now, the medical establishment has little to offer those who are diagnosed with age-related diseases such as dementia. And warranted skepticism toward last-ditch efforts to cure them can come off like cynicism. MJ has no regrets about participating in the experiment in Tijuana. "I think somebody has got to go out there and try these things and see if they actually work," she tells me. "By the time we got home, I really did feel sharper. Now I'm fading, and I can tell I'm fading. I wanna go back for another shot. I'm ready."

This story is partially adapted from Buying Time: Exposing the Quest to Cure Ageing, a six-part series about BioViva and its founder Liz Parrish. It was produced by Vespucci. Listen now on Audible.

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