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Biotechnology and health

A Tale of Do-It-Yourself Gene Therapy

An American biotech CEO claims she is the first to undergo gene therapy to reverse aging. Judge for yourself.
October 14, 2015

Can aging be slowed by using gene therapy to make permanent changes to a person’s DNA?

One Seattle-area woman says she has tried exactly that. Her claim has entangled some high-profile American academics in a strange tale of do-it-yourself medicine that involves plane flights to Latin America, an L.A. film crew, and what’s purported to be the first attempt to use gene therapy to forestall normal aging.

Elizabeth Parrish, the 44-year-old CEO of a biotechnology startup called BioViva, says she underwent a gene therapy at an undisclosed location overseas last month, a first step in what she says is a plan to develop treatments for ravages of old age like Alzheimer’s and muscle loss. “I am patient zero,” she declared during a Q&A on the website Reddit on Sunday. “I have aging as a disease.”

Since last week, MIT Technology Review has attempted to independently verify the accuracy of Parrish’s claims, particularly how she obtained the genetic therapy. While many key details could not be confirmed, people involved with her company said the medical procedure took place September 15 in Colombia.

Illustration by Daniel Zender

The experiment seems likely to be remembered as either a new low in medical quackery or, perhaps, the unlikely start of an era in which people receive genetic modifications not just to treat disease, but to reverse aging. It also raises ethical questions about how quickly such treatments should be tested in people and whether they ought to be developed outside the scrutiny of regulators. The field of anti-aging research is known for attracting a mix of serious scientists, vitamin entrepreneurs, futurists, and cranks peddling various paths to immortality, including brain freezing.

Parrish’s assertions set off a scramble among members of her company’s scientific advisory board to understand what had occurred. One distanced himself from the company. “This is a big problem,” says George Martin, a professor at the University of Washington and the former scientific director of the American Federation of Aging Research. He says he’d agreed to advise Parrish several months ago but resigned his role over the weekend. “I am very upset by what is happening. I would urge lots of preclinical studies,” he says.

Although she lacks formal scientific training, over the last two years Parrish has emerged as an enthusiastic spokesperson for the life-extension movement on blogs and podcasts. According to documents filed with the Securities and Exchange Commission on April 27, she’d raised $250,000 for BioViva, which lists a modest two-bedroom home outside Seattle as its headquarters. Her LinkedIn profile lists a work history going back six years, including administrative roles at software companies.

Parrish said in an interview she chose to bypass the U.S. Food and Drug Administration by trying the procedure overseas. The FDA requires costly trials, and aging itself is not generally recognized as a disease that can be addressed by drugs. “What we did is we moved forward to try to treat biological aging,” Parrish says. “We are attempting to reverse aging at a biological level.”

Her claims appear to raise the possibility of a market in overseas medical tourism for unproven genetic therapies. Gene-therapy preparations, which use a virus to shuttle DNA into human cells, could prove risky. But the technology has advanced so far in the last decade that it is within reach of a small company.

Another prominent science advisor listed by BioViva is Harvard Medical School genomics expert George Church, who includes BioViva in a list on his website of around 100 companies he collaborates with. Church said last week he was also trying to learn what exactly had occurred in Latin America. “I think it is real,” he said in an interview. “There were some indications it might happen. Companies in stealth mode can do anything they want.”

Church says he didn’t agree with dodging regulators and added that BioViva appears to be “a one-person show.” But he says he found Parrish’s claims plausible. A student in his lab, he says, could prepare a genetic treatment suitable for experiments in animals in a matter of days.

Parrish says she had received two forms of gene therapy produced under contract with a commercial laboratory, which she did not identify, outside the United States. In one treatment, she says, she received injections into her muscles containing the gene follistatin, which in animal experiments is shown to increase muscle mass by blocking myostatin, itself an inhibitor of muscle growth. She says she also received an intravenous dose of viruses containing genetic material to produce telomerase, a protein that extends telomeres, a component of chromosomes known as the “aging clock.” Telomerase is a frequent target of anti-aging research because the molecule is present in cells that can continue to divide indefinitely, like stem cells and tumors.

BioViva appears to have taken its inspiration, and its basic genetic recipes, from research published by mainstream labs. The idea for extending life span using telomerase, for instance, is based on work by the laboratory of Maria Blasco, a Spanish scientist who in 2012 showed that telomerase gene therapy could extend the life span of mice by as much as 20 percent.

Parrish says the second treatment she received was “very similar” to a study of a follistatin gene therapy under way in boys with muscular dystrophy at Nationwide Children’s Hospital in Columbus, Ohio. Details of that technique have been published in scientific journals.

Church, the Harvard professor, says he thinks targeted DNA changes could in fact extend the normal human life span, which has a maximum length of about 120 years. Earlier this month, at a meeting of the National Academy of Sciences organized to weigh policy on genetic interventions, Church proposed telomerase as one bearing serious consideration. “I think we are very close. I think the world is close, so long as we don’t have a setback,” he says. “The extension of life span is quite dramatic in model organisms … it would be amazing in humans.”

Parrish is described as very effective at signing up others to join her efforts, despite her lack of medical expertise. “It’s hard to say no to her. She is so charming. She gets a foot in the door,” says Michael Fossell, an entrepreneur and doctor who recently started his own gene-therapy company, Telocyte, to work with telomerase to treat Alzheimer’s.

One current collaborator on the BioViva project is Jason Williams, a radiologist who has attracted scrutiny for offering unlicensed stem-cell treatments to patients suffering from amyotrophic lateral sclerosis, or ALS. Williams says he ceased providing those treatments in the United States in 2013, after the FDA asked him to stop, saying they required agency approval. Williams later established a clinic in Bogotá, Colombia.

In an interview, Williams said he was a co-owner of BioViva and had assigned rights in a patent to the company. He said the treatment had occurred in Colombia, although not at his clinic. Both he and Parrish declined to name the doctor involved; Parrish would not confirm the country where it took place.

MIT Technology Review attempted to confirm aspects of Parrish’s story, in part by speaking to Matthew Andrews, a Los Angeles filmmaker who said he filmed Parrish’s treatment in September inside a modestly equipped doctor’s office, where she was attended by one doctor and one nurse, who also collected blood tests. “It was a procedure room, not a lot of high-tech gadgets. She was lying on the bed, awake, receiving the injections and connected to an IV,” he said. “It was uneventful from a spectator’s point of view, though I don’t know what was going on inside the body when it happened.”

Matthew Scholz, CEO of Immusoft, a venture-capital-backed startup planning an FDA study of a gene therapy for a metabolic disorder, says Parrish’s claims might inspire enthusiastic amateurs to try to modify their own DNA, or someone else’s, thereby “shifting the balance of power to patients.”

For instance, Scholz, who says he also offered Parrish technical advice, says that during the Ebola outbreak he was able to quickly and cheaply carry out a test of a gene therapy in monkeys, so their bodies would produce an antibody against the virus. “It makes you ask, what if you could do gene therapy in the garage?” he says. Scholz says he did not have advance knowledge of Parrish’s plans to carry out an actual treatment.

Parrish says she did not seek approval from anyone to carry out the experiment. In the U.S., medical research is typically approved by boards including medical ethicists. “We as a company have our own ethics,” she says, referring to what she calls the need for inexpensive gene therapy treatments. “I am certainly not going to ask someone’s permission to potentially create new industries and cures.”

Fossell, the anti-aging entrepreneur, says even if Parrish were to somehow succeed in slowing the aging of her body, an outcome he rated as unlikely, the experiment would have no impact because of how it was carried out. “The problem is that no one is going to believe them,” he says. “The credibility will be zero even if they are right on the money.”

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