[ExI] Regulators asked to consider ageing a treatable condition

Anders Sandberg anders at aleph.se
Thu Jun 18 14:18:00 UTC 2015

Here is an interesting article in Nature. What appeals to me is not so much the science, but that they aim to get regulatory approval for seeing ageing as a potentially treatable condition. (See
http://www.healthspancampaign.org/2015/04/28/dr-nir-barzilai-on-the-tame-study/ for more details of the study). 


Doctors and  scientists want drug regulators and research funding agencies to  consider medicines that delay ageing-related disease as legitimate  drugs. Such treatments have a physiological basis, researchers say, and  could extend a person’s healthy years by slowing down the processes that  underlie common diseases of ageing — making them worthy of government  approval. On 24 June, researchers will meet with regulators from the US  Food and Drug Administration (FDA) to make the case for a clinical trial  designed to show the validity of the approach. 
Current  treatments for diseases related to ageing “just exchange one disease  for another”, says physician Nir Barzilai of the Albert Einstein College  of Medicine in New York. That is because people treated for one  age-related disease often go on to die from another relatively soon  thereafter. “What we want to show is that if we delay ageing, that’s the  best way to delay disease.” 
Barzilai  and other researchers plan to test that notion in a clinical trial  called Targeting Aging with Metformin, or TAME. They will give the drug  metformin to thousands of people who already have one or two of three  conditions — cancer, heart disease or cognitive impairment — or are at  risk of them. People with type 2 diabetes cannot be enrolled because  metformin is already used to treat that disease. The participants will  then be monitored to see whether the medication forestalls the illnesses  they do not already have, as well as diabetes and death. 
On  24 June, researchers will try to convince FDA officials that if the  trial succeeds, they will have proved that a drug can delay ageing. That  would set a precedent that ageing is a disorder that can be treated  with medicines, and perhaps spur progress and funding for ageing  research. 
During a meeting on 27 May at the US  National Institute on Aging (NIA) in Bethesda, Maryland, Robert Temple,  deputy director for clinical science at the FDA’s Center for Drug  Evaluation and Research, indicated that the agency is open to the idea. 
Barzilai and his colleagues eschew claims  of a quest for immortality, because they think that such assertions have  led to a perception that the field is frivolous and irresponsible. “The  perception is that we are all looking for a fountain of youth,” says  Stephanie Lederman, executive director of the American Federation for  Aging Research in New York. “We want to avoid that; what we’re trying to  do is increase health span, not look for eternal life.” 
Ageing research has hit bumps in the past decade, as companies marketing drugs touted to prolong life have gone bust (see Nature 464, 480–481; 2010).  But organizers of the TAME trial think that the field is now in a  better position because animal studies have shown that some drugs and  lifestyle practices can extend life by targeting physiological pathways1. 
For  instance, the NIA-sponsored Interventions Testing Program, in which  investigators at three sites are systematically trialling candidate  age-delay treatments, has shown that a handful of interventions  convincingly and reproducibly prolong the lives of various strains of  mice. Those include cutting down on calorie intake and taking a drug  called rapamycin that is used to prevent rejection of transplanted  organs. 
And researchers from the Novartis  Institutes for Biomedical Research in Cambridge, Massachusetts, reported  in December that elderly people develop a stronger immune response to  an influenza vaccination if they also take a rapamycin-like drug2.  Rapamycin, which acts on a biological pathway involved in cell growth,  is now seen as one of the most promising drugs for delaying ageing, but  given over long periods of time it also suppresses the immune system. Safety first 
The  TAME test is for metformin, which suppresses glucose production by the  liver and increases sensitivity to insulin. The drug has been used for  more than 60 years and is safe and prolongs healthy life and lifespan in  worms3 and in some mouse strains1. Data also suggest that it could delay heart disease, cancer, cognitive decline and death in people with diabetes4.  Plans call for the trial to enrol 3,000 people aged 70–80 years at  roughly 15 centres around the United States. The trial will take 5–7  years and cost US$50 million, Barzilai estimates, although it does not  yet have funding. 
Matt Kaeberlein at the  University of Washington, Seattle, who is running a trial of rapamycin  in elderly dogs, says that the concept behind Barzilai’s trial is sound.  Even though other drugs might be more effective at delaying ageing in  animal studies, he says, the many years of experience with metformin in  people, combined with data suggesting that it impacts the ageing process  in people, make it a good candidate for a first clinical trial in the  field. 
“It’s a smart way to engage the FDA in a  discussion about recognizing ageing as an indication that is  appropriate for clinical trials,” Kaeberlein says. 
(18 June 2015)

Anders Sandberg, Future of Humanity Institute Philosophy Faculty of Oxford University
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