It is possible to think that (a) FDA regulators are not all that interested in much other than protecting their own positions, and their actions impose a terrible cost on health and longevity by suppressing progress in medicine, (b) that some degree of reviews and trials and data and proof are a great idea, necessary to the development of new therapies, and can be handled in a distributed way in a free market, and (c) people who run so far from the FDA that they drop the reviews and trials and data and proof, replacing them with marketing and wishful thinking, are not doing anyone any favors.
This collection of sensible ideas is, sadly, somewhat distant from the mainstream position these days, which appears to be that anything that isn't the full and complete FDA process (twice as lengthy and expensive today as it was ten years ago) is so dangerous as to be unworthy of consideration. This absolutism is unhelpful, to say the least. It is particularly pernicious when biased against patient paid trials, as is the case in the article here, for no particularly solid reason. Patient paid studies are a powerful tool when arranged well, carried out in search of large and reliable effects. The rest of the population is the control group, and it is sometimes possible to find funding in this way for very useful studies that would otherwise be overlooked.
When it comes to balancing scientific rigor against other influences, the anti-aging movement has long been a mixed bag. In many cases, the heart is in the right place, yearning after therapies that will help restore health to the aged, to make the world better, to help end suffering and death. But where this manifests in concrete actions, in all too many places the result is nothing but varieties of snake oil: a melange of outright nonsense, cherry-picked studies, the selling of nostrums and supplements that cannot possible have any significant effect. The sellers who found that they were too early became corrupted by the opportunity to make profit, or deluded themselves regarding the value of what was available. The financial success of this industry, while failing to achieve any of its original aims, is a noteworthy cautionary tale.
As time goes on and efforts progress in the production of calorie restriction mimetics, senolytics, and various other legitimate first generation attempts that either slightly slow or modestly reverse aging, the line between snake oil and marginal but real treatment will become indistinct and fuzzy. That has been going on for some years now. The Life Extension Foundation and its principals have given far more funding than I will ever manage to SENS rejuvenation research and various other legitimate scientific studies, yet this is also an organization that pumps out the traditional forms of misinformation about supplements and the value of dubious health gurus. Just as Isaac Newton was as much an alchemist as a scientist, so does the nonsense of the anti-aging marketplace at its worst and the promise of modern rejuvenation research at its best merge in many members of the community. Their projects cheerfully move back and forth across any line I'd care to draw between useful work and snake oil, between viable levels of testing and mere wishful thinking.
For the crowd of mostly baby boomers the warning could not have been more dire: You're running out of time. "We can't sit still. We don't have the time to do that," bellowed Bill Faloon, the 63-year-old former mortician addressing them from the stage. To his left and right, giant screens projecting government actuarial tables reminded the group of the "projected year of our termination." Men of Faloon's age could expect to die in 2037. Any 83-year-old women in the room? They've got until only 2026. "Take that initiative," Faloon urged his audience of about 120 people who had flown in from as far as California, Scotland, and Spain. How? Paying to participate in a soon-to-launch clinical trial testing transfusions of young blood "offers the greatest potential for everyone in this room to add a lot of healthy years to their life," Faloon said. "Not only do you get to potentially live longer ... but you're going to be healthier. And some of the chronic problems you have now may disappear."
The symposium attendees complained about ailments that hadn't bothered them when they were younger: Back problems. Bad hips. The aftermath of a stroke. Parkinson's disease. Arthritis. Many of them voiced frustration with the medical establishment and pharmaceutical companies, which they said pay too little attention to fixing the root cause of disease. Others voiced fears of spending their final days hooked up to machines in a hospital bed.
This $195-a-head symposium was held last month in this wealthy beachside community. It offered a striking view of how promoters aggressively market scientifically dubious elixirs to aging people desperate to defy their own mortality. Eight independent experts reviewed informational handouts about the clinical trial, and all sharply criticized the study's marketing, design, and scientific rationale. "It just reeks of snake oil," said Michael Conboy, a cell and molecular biologist at the University of California, Berkeley, who's collaborated on studies sewing old and young mice together and transfusing blood between them. "There's no evidence in my mind that it's going to work."
Beyond the questionable science, participants have to pay big money to join the trial. Faloon, an evangelist of anti-aging research who cut a slim figure in his black suit and had the thick dark hair of a younger man, acknowledged during his talk that it would be "expensive" to sign up for the trial. People considering enrolling said they had been told they would have to pay $285,000. But the Florida physician running the trial said the final price tag is still being discussed in consultation with the Food and Drug Administration and is likely to change. To evaluate whether the experimental treatment is safe and whether it might be able to reduce frailty, it is planned to run a battery of baseline testing on each clinical trial participant before they get their first infusion of young plasma and then monitor their changes for two years: That means cognitive exams, questionnaires about their quality of life and their indicators of frailty, and tests to measure biomarkers believed linked with aging, such as telomere length and DNA methylation.
Experiments like this operate on the fringes of science, yet they have captured the public imagination. The trial wouldn't be the first to transfuse plasma from young donors into older people. A biotech startup called Alkahest, spun out from a Stanford lab, reported results in November from a placebo-controlled safety trial testing the effect of plasma from young donors on 18 patients with mild to moderate Alzheimer's. The patients who got the plasma didn't suffer serious side effects, but the group didn't see a statistically significant improvement in their scores on a widely used cognitive exam. Meanwhile, a company called Ambrosia recently completed a clinical trial that charged about 80 people over the age of 35 a sum of $8,000 to get an infusion of plasma from a donor between the ages of 16 and 25. Ambrosia plans later this year to try to publish those results in a peer-reviewed journal.
Clinical trials that charge enrollees to participate are ostensibly aimed at giving patients early access to promising therapies - often in the fields of stem cells or aging reversal - that are too unusual or have too little profit potential to get funding from traditional sources such as companies, foundations, or the National Institutes of Health. But critics worry that such trials too often exploit desperate patients, offering them false hope of restored health while doing little or nothing to advance scientific research.