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Between 2005 and 2011, nearly half of all new drugs were FDA approved without demonstration of tangible benefits

Between 2005 and 2011, nearly half of all new drugs were FDA approved without demonstration of tangible benefits | Gp Issues: Science & Technology | Scoop.it

Between 2005 and 2011, nearly half of all new drug formulations in the US were approved without companies having to demonstrate a tangible benefit, such as relieving disease symptoms, extending life, or improving someone’s ability to go about normal activities.

 

What patients really want is evidence that the drug they are taking will actually improve their condition. But the FDA, the American drug regulator, doesn’t routinely consider this for new molecular entities (NMEs) – drugs that have innovative chemical structures that have never been marketed before.

 

The findings come in a new paper by Nicholas Downing of Yale University and colleagues, part of a series on the drug approval process published in the Journal of the American Medical Association (JAMA), that found there was wide variation in the quality of evidence considered by the FDA. They also found that nearly two out of five drugs approved by the FDA was brought to market after a single pivotal trial.


Via Dr. Stefan Gruenwald
The Gp Tutor's insight:

Will it get any easier for the consumer when customized medicines eventually become main stream?

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Carlos Garcia Pando's comment, January 23, 2014 3:35 PM
Well done! Invest in useless drugs and leave those "rare" diseases or conditions unattended.
Jose Mejia R's comment, January 24, 2014 8:52 AM
there is growing evidence that … [the FDA] has become the servant of the industry it regulates.” So sad to confirm it.
Gp Issues: Science & Technology
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New Drugs May Help Heal Old Psychological Traumas

New Drugs May Help Heal Old Psychological Traumas | Gp Issues: Science & Technology | Scoop.it

Researchers at The Picower Institute for Learning and Memory at Massachusetts Institute of Technology have found a class of drugs that show promise for helping to heal traumatic memories. 

The Gp Tutor's insight:

Will humans become less resilient?

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Rescooped by The Gp Tutor from Amazing Science
Scoop.it!

Between 2005 and 2011, nearly half of all new drugs were FDA approved without demonstration of tangible benefits

Between 2005 and 2011, nearly half of all new drugs were FDA approved without demonstration of tangible benefits | Gp Issues: Science & Technology | Scoop.it

Between 2005 and 2011, nearly half of all new drug formulations in the US were approved without companies having to demonstrate a tangible benefit, such as relieving disease symptoms, extending life, or improving someone’s ability to go about normal activities.

 

What patients really want is evidence that the drug they are taking will actually improve their condition. But the FDA, the American drug regulator, doesn’t routinely consider this for new molecular entities (NMEs) – drugs that have innovative chemical structures that have never been marketed before.

 

The findings come in a new paper by Nicholas Downing of Yale University and colleagues, part of a series on the drug approval process published in the Journal of the American Medical Association (JAMA), that found there was wide variation in the quality of evidence considered by the FDA. They also found that nearly two out of five drugs approved by the FDA was brought to market after a single pivotal trial.


Via Dr. Stefan Gruenwald
The Gp Tutor's insight:

Will it get any easier for the consumer when customized medicines eventually become main stream?

more...
Carlos Garcia Pando's comment, January 23, 2014 3:35 PM
Well done! Invest in useless drugs and leave those "rare" diseases or conditions unattended.
Jose Mejia R's comment, January 24, 2014 8:52 AM
there is growing evidence that … [the FDA] has become the servant of the industry it regulates.” So sad to confirm it.
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Weekly Innovation: A Radiation Detector In Your Smartphone - NPR (blog)

Weekly Innovation: A Radiation Detector In Your Smartphone - NPR (blog) | Gp Issues: Science & Technology | Scoop.it

A Radiation Detector In Your Smartphone.

The Gp Tutor's insight:

Will this be a boon or bane for people? Will common folk be able to use the information properly?

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