<html><head></head><body>Here is an interesting article in <i>Nature</i>. 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<br>http://www.healthspancampaign.org/2015/04/28/dr-nir-barzilai-on-the-tame-study/ for more details of the study). <br><br>http://www.nature.com/news/anti-ageing-pill-pushed-as-bona-fide-drug-1.17769<br><br><blockquote>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. <p>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.”</p> <p>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.</p> <p>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.</p> <p>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.</p>
<p>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.”</p> <p>Ageing research has hit bumps in the past decade, as companies marketing drugs touted to prolong life have gone bust (see <a href="http://www.nature.com/uidfinder/10.1038/464480a"><i>Nature </i><b>464, </b>480–481; 2010</a>).
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 pathways<sup><a class="ref-link" title="Miller, R. A. et al. J. Gerontol A Biol. Sci. Med. Sci. 66A, 191–201 (2010)." id="ref-link-1" href="http://www.nature.com/news/anti-ageing-pill-pushed-as-bona-fide-drug-1.17769#b1">1</a></sup>.</p> <p>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.</p> <p>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 drug<sup><a class="ref-link" title="Mannick, J. B. et al. Sci. Transl. Med. 268, 268ral179 (2014)." id="ref-link-2" href="http://www.nature.com/news/anti-ageing-pill-pushed-as-bona-fide-drug-1.17769#b2">2</a></sup>.
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.</p> <h2>Safety first</h2> <p>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
worms<sup><a class="ref-link" title="Onken, B. & Driscoll, M. PLoS ONE 5, e8758 (2010)." id="ref-link-3" href="http://www.nature.com/news/anti-ageing-pill-pushed-as-bona-fide-drug-1.17769#b3">3</a></sup> and in some mouse strains<sup><a class="ref-link" title="Miller, R. A. et al. J. Gerontol A Biol. Sci. Med. Sci. 66A, 191–201 (2010)." id="ref-link-4" href="http://www.nature.com/news/anti-ageing-pill-pushed-as-bona-fide-drug-1.17769#b1">1</a></sup>. Data also suggest that it could delay heart disease, cancer, cognitive decline and death in people with diabetes<sup><a class="ref-link" title="Bannister, C. A. et al. Diabetes Obes. Metab. 16, 1165–1173 (2014)." id="ref-link-5" href="http://www.nature.com/news/anti-ageing-pill-pushed-as-bona-fide-drug-1.17769#b4">4</a></sup>.
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.</p> <p>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.</p> <p>“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.</p>
<br>Nature<br>522<span>,</span><br>265–266<br>(<time datetime="2015-06-18">18 June 2015</time>)<br><abbr title="Digital Object Identifier">doi</abbr>:10.1038/522265a<br></blockquote><br><br><br>Anders Sandberg,
Future of Humanity Institute
Philosophy Faculty of Oxford University</body></html>