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Danila Medvedev

Alliance for Aging Research: Publications: 2007 Task Force Report on Aging Research Fun... - 1 views

  • 2007 Task Force Report on Aging Research Funding
  • Download - Adobe Acrobat (PDF), 1.37 MB
  • The 2007 Task Force on Aging Research Funding--more than 85 non-partisan disease groups, patient advocates, and foundations--urges Congress and the President to chart a better course for medical research on behalf of America's aging population. This year's report of the Task Force calls for a 6.7% increase in funding for the National Institutes of Health in FY 2008. It also presents data on the burden of 27 diseases and conditions that predominately affect older Americans, highlights some of the exciting work the NIH is doing to decrease these burdens, and serves as a resource for policymakers working to establish the funding levels necessary to advance healthy aging.
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    Оч. релевантный документ. Надо изучить. Касается Соединённых Штатов.
Danila Medvedev

Alliance for Aging Research: Publications: Redesigning Healthcare for an Aging Nation: ... - 0 views

  • transcripts of a Congressional forum on March 17, 2003
  • With the impending age boom in 2010, our nation must have a healthcare system in place that is prepared for the millions of Americans who will be living with chronic diseases, and that is able to foster the development of future treatments to meet their needs.
  • Download - Adobe Acrobat (PDF), 1.64 MB
Danila Medvedev

The Damage Done by the FDA, Symptom of the Deeper Problems - 0 views

  • FDA is a scientific bureaucracy with police powers. Patients and physicians are free to choose only those drugs and medical devices that it has approved. When FDA approves a therapy that later turns out to be unexpectedly risky, the agency is the subject of front-page headlines and congressional hearings. On the other hand, when FDA delays a badly needed new therapy, patients will suffer but hardly anyone will blame FDA.
  • Consider, for example, FDA's 10-year delay, in 1967-76, in approving beta-blockers to prevent death following heart attacks, because of the agency's fear that the drugs might be carcinogenic. During those years, the drugs saved lives in Europe and elsewhere, while an estimated 10,000 heart attack victims unnecessarily died in this country each year. When beta blockers were finally approved in the US, to wide acclaim, hardly anyone raised the lethal effects of FDA's slowness.
  • As it turns out, however, that extra agency caution doesn't actually improve drug safety. Studies conducted by FDA itself show that the rate of drug withdrawals has remained essentially unchanged over the last 25 years, despite rising and falling approval times during that period.
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  • But FDA is only criticized for approving risky medicines - never for keeping beneficial ones off the market.
  • Neither the Congress nor FDA (nor the IOM) is willing to admit that the agency's most significant problems are mismanagement and excessive risk-aversion.
  • The motivation for most of these recent attacks on the FDA? That would be coming from the other squirming pigs wrestling in the pen, such as the large pharmaceutical and medical development companies, trying to make the most money they can from the suppression of competition and progress. They might be working on progress, but they're working just as hard at pushing new and better ideas below the waterline - so long as there's the threat that someone else will make money or threaten the bottom line for an aspect of their business model.
    • Danila Medvedev
       
      При этом фармацевтические компании во многом не лучше FDA!
  • In the worst cases, such as Germany and France, you see entire countries that contribute next to nothing to the advance of medical science. This is not for lack of will or desire, but their research and medical industries are hamstrung by decades of destructive government intervention.
    • Danila Medvedev
       
      Франция и Германия
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    О негативной роли FDA
Danila Medvedev

National Institute on Aging - Wikipedia, the free encyclopedia - 0 views

  • The National Institute on Aging (NIA) is a division of the U.S. National Institutes of Health (NIH), located in Bethesda, Maryland. The NIA leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. In 1974, Congress granted authority to form NIA to provide leadership in aging research, training, health information dissemination, and other programs relevant to aging and older people. Subsequent amendments to this legislation designated the NIA as the primary Federal agency on Alzheimer's disease research.
Danila Medvedev

Apollo program - Wikipedia, the free encyclopedia - 0 views

  • In March 1966, NASA told Congress the "run-out cost" of the Apollo program to put men on the moon would be an estimated $22.718 Billion for the 13-year program which eventually accomplished six successful missions between July 1969 and December 1972. According to Steve Garber, the NASA History website curator, the final cost of project Apollo was between $20 and $25.4 billion in 1969 dollars (or approximately $135 billion in 2005 dollars). The costs associated with the Apollo spacecraft and Saturn rockets amounted to about $83 billion [Apollo spacecraft: $28 billion (Command/Service Module: $17 billion; Lunar Module: $11-billion), Saturn I, Saturn IB, Saturn V launch vehicles: about $46 billion] in 2005 dollars.
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    Общая информация о проекте "Аполлон"
Danila Medvedev

Pharmaceuticals and Aging - Interview with Dr. Larry Miller (SAGE CROSSROADS ) - 0 views

  • Dr. Miller formerly led business operations for the global Drug Discovery Division at pharmaceutical company Glaxo Smith Kline.
  • Well one thing that I think is going to be critical is that in the past, pharmaceutical companies had treated diseases of aging as discrete entities, that is to develop something for diabetes, to develop something for osteoporosis…that is to treat each one as a separate silo if you will.
  • in the future we are going to have to look at more central regulatory pathways that are being identified now for aging.
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  • I think this is quite a new concept because not until recently have we begun to understand a little bit more about the aging process and find some biochemical pathways that are at the root of aging processes.
  • Now what do you see as the greatest challenges for developing drugs that deal with aging? Would you say that it’s more regulatory and policy wise, or is this more scientific?
  • I think there is both.
  • When I was heading aging at Glaxo Smith Kline, the issues that I faced were that I was very interested in developing medications for frailty and weakness in muscle for when people get old because when people get weak they usually stop eating and then they fall and break a hip and end up in the hospital and die potentially, but the regulatory apparatus isn’t there yet.
  • Sarcopenia isn’t recognized as an official disease by the FDA, so the pathway to get drugs approved for frailty and to get more people mobile and into society is just not there, and so it’s a really difficult problem, and the pathways for osteoporosis are still very cumbersome, requiring fracture analysis.
  • There isn’t an approved, for example, like Jack Coralnick uses a scale at NIH to test people’s function. I think there is a critical need to have the FDA to recognize some battery of functional tests
  • how a reform would take place
  • Well we have a new FDA now, hopefully, but it’s going to take companies and scientists going to the FDA and to Congress to say “look the patient population is aging and currently we have a bottleneck, we can’t get these medicines through” and try to work out some new policy. Hopefully, the FDA will be a little more progressive about looking at endpoints. They are very, very conservative about what endpoints they will accept
  • You know, there is understandably some concern that people might use these drugs and abuse them for muscle building, but on the other hand, there is a critical unmet need out there in the elderly population
  • Well one thing is that it is quite difficult and expensive to develop drugs for aging per se because even to do pre-clinical models in animals is very expensive. It’s very expensive to get aged animals, and they don’t necessarily act like aged humans. So even in the pre-clinical stage, it’s a difficult area to work in.
  • find pathways to get these drugs approved
  • a lot of these companies are concerned as being seen as trying to produce “fountain of youth” drugs. I made it very clear when I was leading aging at GSK that I was not attempting simply to extend lifespan
  • I think this is a policy challenge and a perceptual challenge and if you will, a public relations challenge.
  • Potentially, I think we need to find more intelligent, creative ways to do clinical trials using biomarkers or other types of measures where we can get the trials through quickly
  • again, it goes back to the FDA policy. The FDA is going to have to be willing to accept some of these things, or we will not be able to get these drugs on the market
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    Фармацевтика и старения (лекарства от старости)
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