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valerija

KLRI: Newsletters - 0 views

  • "Survey Finds Surprising Results With Research Study Participants" discusses the concerns of participating in clinical research and how KLRI protects the welfare of study participants
  • "Looking Back on 2006 and Looking Forward to 2007" reviews KLRI's accomplishments in 2006 and plans for 2007.
  • Director's Message: KLRI's Research Agenda, Today and Where to Next?
  • ...10 more annotations...
  • "The Importance of Translational Research"-what it is, why is it important, and how you can help.
  • Director's Message: 2nd International Conference on Healthy Ageing & Longevity
  • Director's Message: Choosing Your Mode of Exit
  • "Improving Health Outcomes For Older Adults" focuses on strategies to improve health and quality of life.
  • "Focus on Healthy Lifestyles" highlights strategies to improve health and quality of life.
  • Director's Message: Funding Translational Clinical Research
  • "What's So Important About Aging Research" discusses the justification for performing aging research.
  • "2003 Biomedical Gerontology Symposium"—an overview.
  • Director's Message: Health/Longevity Interventions
  • "KLRI 2002 Symposium"—an overview.
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    разные ценные куски
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
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