Scientists Dodge FDA to Offer a $1 Million Anti-Aging Treatment in Colombia
▻https://onezero.medium.com/scientists-dodge-fda-to-offer-a-1-million-anti-aging-treatment-in-co
Would you pay $1 million and fly to South America for a chance to live longer?
Libella Gene Therapeutics, a Kansas-based company that says it is developing a gene therapy that can reverse aging by up to 20 years, is hoping your answer is yes. In an interview with OneZero, the company says it is ready to give an experimental anti-aging therapy to older people at a clinic north of Bogota, Colombia. But that’s not all — it’s also charging people $1 million to participate. Scientists and ethicists say the company’s experiment is not only dubious but it also raises concerns about how anti-aging treatments should be tested in people.
The aim of Libella’s therapy is to lengthen a person’s telomeres, which sit at the tips of chromosomes like caps on the end of shoelaces. First discovered in the 1970s, telomeres have been linked to aging because they seem to shorten as a person gets older. By delivering a gene called TERT to cells, which in turn makes a telomere-rebuilding enzyme called telomerase, Libella thinks it can prevent, delay, or even reverse aging.
“I know what we’re trying to do sounds like science fiction, but I believe it’s a science reality,” Jeff Mathis, CEO of Libella Gene Therapeutics, tells OneZero.
The anti-aging field has drawn plenty of criticism for scams and overhyped products with no proven health benefits. Libella’s clinical trial listings also raise red flags. First among them is the fact that the company and its trials are located in different countries. Mathis, an occupational therapist who runs a rehabilitation practice in Manhattan, Kansas, says he chose Colombia for the trial because it was the “path of least resistance.” The company looked at eight different countries, and he says, “the easiest, the quickest, and the best way forward ended up being in Colombia.”
Leigh Turner, a bioethicist at the University of Minnesota who studies clinical trials that market unproven therapies, says he suspects the company chose to go outside the country to avoid the Food and Drug Administration, which oversees clinical trials in the United States. “Even though the company is based in the United States, they’ve managed to find a way to evade U.S. federal law by going to a jurisdiction where it’s easier to engage in this activity,” he tells OneZero.
Turner says the $1 million participation cost is alarming because most clinical trials are free. In fact, many pay people to participate because of the time commitment and the potential risks involved with receiving an experimental treatment. Andrews justifies the fee, saying it costs Libella “hundreds of thousands of dollars to produce enough of the gene therapy to treat one person.”
Some researchers in the field are concerned that putting a lot of telomerase into cells could make cells divide more quickly and promote tumor growth, says Austad. Previous research has linked longer telomeres to increased cancer risk, with scientists finding that cancer cells tend to have more telomerase that most normal cells. But telomere evangelists like Michael Fossel believe that shortened telomeres are a cause of age-related diseases like cancer and thus, lengthening them could help protect against these conditions.
How a dubious clinical trial was able to be registered into a government website in the first place has been a longstanding problem for the National Institutes of Health, which runs ClinicalTrials.gov. The website is the largest database of its kind and lists studies in more than 200 countries. It’s a tremendous resource for people with rare diseases, cancer, and those who have run out of treatment options, and physicians regularly refer their patients to the site.
But Turner says the site can be easily manipulated and taken advantage of because the process to register is automated. NIH does not screen studies that are submitted to the database, which allows companies to submit predatory and pay-to-participate studies on the site. This has been the case with many stem cell businesses marketing unproven therapies. “ClinicalTrials.gov can basically be used as a marketing platform,” Turner says.
Being registered on the site gives an air of legitimacy, and often patients can’t tell the difference between a scientifically sound clinical trial and one that’s suspicious. ClinicalTrials.gov listings also don’t include information about participation costs, so patients can’t tell if there’s a fee involved up-front.
#Pharmacie #Anti_âge #Arnaque #Vieillesse #Santé_publique #Génomique
