Stories
Slash Boxes
Comments

SoylentNews is people

posted by takyon on Friday June 19 2015, @01:55AM   Printer-friendly
from the immortality-committee dept.

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."

takyon: The "pill" in question is the drug metformin, currently used to treat type 2 diabetes under the brand name Glucophage. People with type 2 diabetes will not be enrolled in the anti-aging trial.


Original Submission

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
  • (Score: 0) by Anonymous Coward on Friday June 19 2015, @02:09AM

    by Anonymous Coward on Friday June 19 2015, @02:09AM (#198062)
  • (Score: 2) by takyon on Friday June 19 2015, @02:20AM

    by takyon (881) <takyonNO@SPAMsoylentnews.org> on Friday June 19 2015, @02:20AM (#198070) Journal
    • (Score: 2) by frojack on Friday June 19 2015, @02:48AM

      by frojack (1554) on Friday June 19 2015, @02:48AM (#198080) Journal

      But, its still not clear to my semi-functioning brain if we are talking about a placebo on not.

      Because if it didn't have to have any actual ingredients we sohould be able to get the price down to 5 cents.

      --
      No, you are mistaken. I've always had this sig.
      • (Score: 2) by takyon on Friday June 19 2015, @03:00AM

        by takyon (881) <takyonNO@SPAMsoylentnews.org> on Friday June 19 2015, @03:00AM (#198086) Journal

        Check the Wikipedia article in the summary if you want to know more about metformin.

        The proponents mentioned in the Nature article are also interested in having the FDA acknowledge a broad category of "anti-aging" drugs as a valuable and achievable goal. See also this comment [soylentnews.org].

        --
        [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
        • (Score: 3, Informative) by Anonymous Coward on Friday June 19 2015, @06:29AM

          by Anonymous Coward on Friday June 19 2015, @06:29AM (#198137)

          Meh, the FDA... They got gutted by underfunded mission creep years ago:

          The themes raised by the previous committees, as well as the present Subcommittee, are very consistent: 1) the criticality of high-quality science to the regulatory mission; 2) the need for the science to be mission driven; 3) persistent expressions of dissatisfaction with the quality and credibility of the scientific programs; 4) consistent calls for major change in the organization and management of the Agency’s scientific endeavors; and 5) consistent inability of the Agency to implement needed changes.
          [...]
          We conclude that FDA can no longer fulfill its mission
          [...]
          Numerous reports by the National Academies of Science (including two recent reports by the Institute of Medicine [IOM] on drug safety)10, the Government Accountability Office (GAO), the Health and Human Services (HHS) Inspector General, Congressional committees, and other expert groups have come to the same conclusion. The opinion of these studies is unanimous
          [...
          Although there is indeed great urgency to stem the tide of continued deterioration in the science that supports the regulatory decisions of the FDA, the magnitude of changes that are needed will require a phased approach based on a well-thought-out plan.
          [...]
          The magnitude of the resources required to restore scientific capability and capacity is substantial.
          [...]
          Finally, the Subcommittee notes that the public is understandably confused by the growing disconnect between the promises of cutting-edge science and the reality of clinical benefit.
          [...]
          The Subcommittee found that FDA’s ability to provide its basic food system inspection, enforcement and rulemaking functions is severely eroded, as is its ability to respond to outbreaks in a timely manner and to develop and keep pace with the new regulatory science needed to prevent future problems arising
          [...]
          Rapid changes in biological sciences and bioinformatics are exceeding the capacity of current FDA science capabilities to keep pace and adequately support the Agency’s safety mission. The FDA lacks sufficient expertise to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced.
          [...]
          The Subcommittee found that the FDA lacks sufficient expertise in quantitative methods, such as statistics and biomathematics, to effectively assess products and guide sponsors to design valid and informative studies.
          [...]
          The Subcommittee found that the FDA also has a lack of expertise in risk/benefit assessment.
          [...]
          All of the working group subcommittees discovered significant deficiencies in the ability of regulatory programs to access and utilize information
          [...]
          The Subcommittee found that the FDA’s current critical information supply chains are, at best, inefficient, cost intensive and prone to promote errors in regulatory science due to the inability to access, integrate and analyze data. Incredibly, critical data resides in large warehouses sequestered in piles and piles of paper documents. There are no effective mechanisms to protect these paper records, which include very valuable clinical trial data.
          [...]
          There is a long history of excellent reviews of the FDA that have been followed by little to no action taken to achieve the recommendations. Our final recommendation is based in our belief that effective resolution of the issues outlined in this report is urgent. In contrast to previous reports that have issued many of the same warnings, there are now sufficient data proving that failure to act in the past has jeopardized the public’s health.

          http://www.fda.gov/ohrms/dockets/AC/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf [fda.gov]