BioViva Illustrates the Tension Between Progress and Regulation

Elizabeth Parrish of BioViva, you might recall, has made every effort to publicize the follistatin and telomerase gene therapy that she underwent. This is a strategy intended to accelerate progress; I suspect she was not the first, and that others were just more circumspect. The technology exists, it is not expensive in the grand scheme of things, and at the very least hundreds of people have the laboratory access and the knowledge to carry out such an operation. BioViva's efforts, and those of other ventures such as the Odin and Ascendance Biomedical illustrate the tension between desire for progress and desire for regulation. As a general rule, the majority of people who are not suffering significantly at the present time are just fine with heavy-handed regulation that holds back progress towards cures and enhancements. The minority of people who are suffering want the option to undergo treatments that they have researched and chosen, that appear to have a good chance of working, but are not going to be approved by regulators in the foreseeable future. Unfortunately they are largely ignored by the powers that be, and vitriol is heaped upon anyone who flouts medical regulation. You can see how this plays out against a backdrop of technological progress by looking at the history of stem cell therapies. The primary goal of regulators is to avoid poor publicity, and they achieve this by putting as many roadblocks as possible in the way of new medical technology. Blocking new technologies causes a lot less bad publicity than is the case when something that causes harm slips though. Since medicine is uncertain and conditional, near every useful medical technology can, in some context, cause harm - or appear to cause harm in a naive view of the circumstances - so regulators become strongly biased against any form of progress. Look at how costs of FDA approval have doubled in the past decade - ever more is required of petitioners in the effort to reduce bad publicity for regulators by any and all means possible. The media is ever ready to broadcast any failure in medicine, but generally reluctant to talk about the very real cost of suppressing progress in medical technology. Regulators will continue to hold back new technologies until the widespread availability of said technologies in other regions makes them look like clowns for doing so. This is exactly what happened for first generation stem cell therapies, and is exactly what will happen for gene therapy technologies. Making new medicines available via experimentation and medical tourism is the only reliable path forward to faster general availability. Elizabeth Parrish is a proponent of controversial ideas. Rankled by barriers to trials on potential life-enhancing treatments, she used herself as a guinea pig and says the results have borne fruit - but she has irked the science community in the process. The CEO of Seattle-based BioViva, a biotechnology company that focuses on developing gene therapies to slow the ageing process, revealed that in September 2015 she flew to Colombia and tried two experimental gene therapies on herself. Six months later, BioViva claimed the experiment was a success against ageing and that the treatment lowered the biological age of Parrish's immune cells by 20 years. Parrish's actions caused a stir within the industry, mainly because BioViva had not done the pre-clinical work needed to progress to human studies or testing. Neither did the US Food and Drug Administration authorise Parrish's rogue experiment - hence the trip to Colombia. But Parrish denies her actions were reckless. "As a matter of fact, not intervening in one's health is more reckless because we already know how we'll die. We can actually use this powerful technology to treat many of the diseases of childhood and ageing. We studied a couple of gene therapies that had the most promise to treat not only adult diseases, but also childhood diseases, and I took them to prove they were safe to the world." Parrish's foray into longevity science began when she stumbled upon a SENS Research Foundation conference in Cambridge, UK, and discovered how gene modifications had extended the normal lifespan of worms and mice. It was there she learned ageing ought to be classified as a disease, a collection of conditions including cancer, heart disease, stroke, and dementia and that everyone will suffer. She wanted to tell the world and get people to put money behind finding a cure. "Ageing is the biggest killer on the planet - by 2050 it will be the biggest killer in every small pocket of the world. To think that ageing is a problem of industrialised countries is just not correct. In countries that are developing right now we see most of the causes of death are associated with ageing - cancer, heart disease and various other things." Since her personal experiment, Parrish says people have contacted her to ask if they can try her anti-ageing gene therapy. She admits this is not enough to expedite the official sanction for use of such therapies in humans. Instead, she is interested in asking countries to re-regulate. While the "EU has passed through regulations for a couple of gene therapies and the US FDA is following," Parrish wants to set up partnerships with governments, universities and paid-for trials (for those who can afford the hefty price tag). Scientific rigour in Parrish's work is the massive snag in her efforts to peddle gene therapies to the world. Many scientists, including those that are and have been a part of BioViva's scientific advisory board, have told the media that bypassing preclinical studies and trials raises serious ethical questions about how quickly such treatments can be tested on people, and whether medical regulators can be dodged. Parrish's goal of bringing gene therapies to thousands of people could well be a pipe dream, but her sense of urgency about solving the world's ageing crisis is real. "By 2050 there'll be ten times more people living over the age of 100. It's fantastic news that we're living longer, but we need to live healthy longer. Right now, if you're running a drug through innovation through the US Food and Drug Administration it's 15-plus years and costs at least a billion dollars. It's too slow. We lose 40 million people a year to ageing." Link: http://www.scmp.com/lifestyle/health-beauty/article/2125406/biotech-boss-backing-gene-therapy-solve-ageing-crisis-seeks

https://www.fightaging.org/archives/2017/12/bioviva-illustrates-the-tension-between-progress-and-regulation/

About Robert Zinn

Robert Zinn, M.D., Ph.D. is a medical doctor, physician, and web entrepreneur, who, for over 15 years was employed by academic and research institutions and focused his clinical practices on very specialized patient populations, such as those with rare genetic diseases or rare cancers. He shares his knowledge through his website, NutritionTheory.org

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