Haven't we all dreamed of staying young and healthy?
Some scientists at the Albert Einstein College of Medicine in New York say they have a pill that could help increase our healthy lifespan by reducing the contraction of age-related diseases. They suggest that metformin, a drug that has been in use in the US since 1994 to treat type 2 diabetes, could be this miracle solution.
While previous studies have shown that the drug can increase the longevity of some rodents and of nematode worms, Dr Nir Barzilai, the lead researcher on the project and director of the Institute for Ageing Research, thinks there is sufficient evidence that it would have a similar impact on humans.
"Our studies so far make us believe that metformin will work on humans," he said. "We have more data than any other study on the drug."
A meeting between Barzilai's team and the FDA on June 24 aimed to give directives for a future study called TAME (Targeting Ageing with Metformin), a clinical trial that would look at the effects of metformin on the human body.
A document submitted to the FDA prior to the meeting read: "We hypothesize that delaying ageing is the only effective way to significantly delay age-related diseases, compress morbidity (the time spent sick at the end of life) and extend active life expectancy (the number of years lived in a disability free state)."
The findings made through TAME, Barzilai said, will hopefully open the way for studying the effect of other drugs that could have a similar impact.
"We need to pave the way," he said. "We don't think that metformin is going to be the best drug—it will be the first drug. Better drugs will be developed in the future. But none of this can happen without the FDA's approval."
What the scientists behind the TAME project are aiming for is to get ageing approved as an "indication"—a condition that calls for a specific medical treatment—and thus a drug target.
"We believe that future drugs may be more potent in delaying ageing, but that pharmaceutical companies will not pursue development of such compounds without a precedent for this indication," Barzilai said.
"Our aim is to increase the health span of elderly people in order to increase our quality of life, and help lighten the economic burden that healthcare represents."
"But the advantage of metformin," Barzilai insisted, "is that it's been in use for the last 60 years for the treatment of diabetes. We know everything we need about it, including its side effects, and we know that it's safe."
The primary role of metformin when used to treat type 2 diabetes is to lower the levels of glucose in the blood. It does this by increasing the body's sensitivity to the effects of insulin, which helps cells to take in the right amount of glucose.
Work in animals by Barzilai and his co-researchers has however suggested that metformin could have a positive impact on a number of other diseases, including cardiovascular disease, cancer, and the impairment of cognitive functions.
One of the main explanations for this is that metformin is responsible for calorie restriction, which, according to a paper by Barzilai and his team, "represents the most robust intervention to extend both mean and maximum life span in mammals."
The TAME study, if it goes ahead, will bring together an advisory board of about 30 specialists. According to Barzilai, it will be spread among 15 different centres around the US, and might extend internationally if results are conclusive.
To conduct the study, researchers will recruit about 15,000 people for a double-blind, placebo controlled test, based on the following hypothesis: "Treatment with metformin will delay or prevent the occurrence of several age-related diseases in a cohort of at-risk older adults."
The recruits will include adults aged between 70 and 80 who are affected by one or two of the following conditions: ischemic heart disease, congestive heart failure, peripheral arterial disease, stroke, cancer (other than non-melanoma skin cancer), or mild cognitive impairment.
The study, which will spread over the course of five years, has an evaluated cost of $50 million. It's sponsored by the American Federation for Ageing Research, and the researchers are hoping that private donors will come forward too.
"We hope that people will adopt us, and understand how big this project is," Barzilai said. Another possibility for funding, he added, would be via the National Institutes of Health. "But that would extend the length of the process by two years, since their decision might take time."
If all goes as planned, the TAME researchers expect that about 30 per cent of the people treated with metformin will show positive results and distinguish themselves from the placebo group with fewer cases of of heart diseases, cancer, and cognitive decline.
Dr Barzilai also thinks the work could have an economic impact. "Our aim is to increase the health span of elderly people in order to increase our quality of life, and help lighten the economic burden that healthcare represents," he explained.
According to a 2013 text by the National Center for Biotechnology Information, "the economic value of delayed aging is estimated to be $7.1 trillion over fifty years."
"For us scientists, ageing is something that happens and has to be respected."
Furthermore, Barzilai hopes that the project could help fight against the ever-growing market of the existing anti-ageing industry.
"There are loads of unapproved, untested treatments that are marketed as having 'anti-ageing' effects out there," he said. "I'm thinking for example of growth hormone injections, or anti-ageing creams…"
"There's a big market for this right now, but once you set the bar high, it will help fight against those guys as well."
The researchers are however careful not to give out the wrong image of their aims. While they are firm believers that age can be efficiently targeted, they refuse to label it as a "disease" or say it should be "cured."
"For us scientists, ageing is something that happens and has to be respected," the lead researcher said. "It is part of our humanity."
"We never set off to 'delay ageing.' What we're trying to do via this study is to increase our health span, not our life span, though both are obviously inextricably linked. It shouldn't be seen as a 'fountain of youth.'"
The FDA refused to comment on the project at this stage.
Barzilai is however confident that things will go well. "I think at this point, the FDA understands that this [project] is important, and that if it works it will have a great impact," he said.
The FDA should present the scientists with their conclusions within the next couple of weeks.
Modern Medicine is a series on Motherboard about how health care and medical technology can move forward so rapidly while still being stuck in the past. Follow along here.