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The Gatekeepers of Medical Regulation are Horrified by Freedom, Responsibility, and Progress

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Posted 04 May 2021 - 08:11 PM

Much pearl-clutching is in evidence in a recent article on the existence of groups, such as Libella Gene Therapeutics, attempting to prototype telomerase gene therapies via patient paid trials, or such as Integrated Health Systems and BioViva, trying to develop markets for such therapies via medical tourism. The gatekeepers of medical regulation stand in opposition to the idea that patients and their supporters can make responsible decisions about risk, based on the available data. Medicine is somehow a privileged space, different from every other human endeavor, in which only the anointed priesthood are allowed to determine what is and is not allowed. It is reprehensible. Analysis has shown that this attitude, and the system of regulation that accompanies it, costs a great many lives by slowing the development of new therapies and limiting the opportunities for treatment.

Medicine, like every form of service, works best in an environment of review organizations, competition, and due diligence by customers. At the end of the day, it is always a matter of caveat emptor. And this already happens, as anyone who has been through a scheduled surgery can tell you. Patients absolutely shop the market to the degree that present regulation allows them to do so, and there is a robust system of legal culpability by which fraud and harm can be prosecuted. As is the case in every other industry, providers of medical services have financial and other incentives to produce good results for patients.

I personally do not have a strong opinion on whether the telomerase gene therapy that is the subject of this article will help with Alzheimer's disease; it seems indirect and compensatory, improving cell function rather than striking directly at the known causes. That said, several noted research groups are very much in favor of developing telomerase based therapies for human use, and at least one company in the longevity industry, Telocyte, is seeking to raise funding to run a formal trial of telomerase gene therapy for Alzheimer's disease within the existing regulatory system. It is an entirely mainstream goal.

At some point all new medical technologies must be tried for the first time in humans. Is that to be left to the anointed priesthood, with its impossible goal of zero patient risk, ever increasing costs of certification, and ever fewer approvals with each passing year? Or should we live in a more reasonable world in which more sensible and cost-effective choices regarding risk, pace of development, and availability of treatments are made by patients, supporters, and networks of review organizations, rather than by uncaring bureaucrats? I would vote for the latter of these two options.

Six patients with dementia went to Mexico for an unproven gene therapy, a biotech CEO claims

Six patients with dementia traveled to Mexico last year to be injected with a gene therapy not authorized for use in the U.S., according to the CEO of a Seattle-area startup that wants to accelerate testing of unproven anti-aging medicines and views U.S. drug safety regulations as a hindrance. At the heart of the project is a controversial biotech called BioViva, whose CEO had herself injected with an experimental gene therapy in Colombia and whose advisory board includes renowned Harvard geneticist George Church. It is part of a growing ecosystem of entrepreneurs and scientists, dreamers and schemers, who believe aging is not inevitable and aim to develop treatments to extend the human life span.

Last month, during a talk hosted by the National University of Singapore, the CEO, Elizabeth Parrish, divulged that she was eagerly awaiting data from a human study involving six patients who received an experimental gene therapy. On Friday, she told STAT the procedures were done last year in Mexico. If true, it would be the first known attempt to use the technique to treat age-related dementia, which is most often caused by Alzheimer's disease.

STAT set out to independently verify the accuracy of Parrish's claims. While many key details could not be confirmed, including the identities of these six patients and how the purported treatment affected them, STAT found evidence that BioViva and partners were recruiting patients. A newsletter emailed by BioViva in 2019 said 10 patients over age 50 with mild to moderate Alzheimer's were needed for a study of a gene therapy. The one-hour procedure, according to an FAQ linked from the email, would be done in Mexico City and involved a one-time injection. The effort raises the specter of an overseas medical tourism industry targeting patients desperate to lengthen their lives and offering unproven treatments that would permanently alter the genetic code inside recipients' cells.

View the full article at FightAging
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