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'Cures' bill raises safety concerns for experts 6/7/15 Washington Examiner

Discussion in 'Other Health News and Research' started by *GG*, Jun 7, 2015.

  1. *GG*

    *GG* Senior Member

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    Medical devices and drugs could reach your hands faster if a massive House bill is approved, but leading experts question whether they will be safe.

    Two medical experts are concerned several provisions in the bipartisan 21st Century Cures Act may unnecessarily speed up product approvals at the expense of thorough reviews for safety and effectiveness.

    "Changing the Food and Drug Administration's standards to get more drugs on the market is inherently risky to patients," Dr. Aaron S. Kesselheim, associate professor of medicine with Harvard Medical School, told the Washington Examiner.

    Kesselheim, with Harvard professor Dr. Jerome Avorn, wrote an editorial in the New England Journal of Medicine that criticizes parts of the measure.

    The bill was unanimously approved by the House Energy and Commerce Committee last month and awaits a vote from the full chamber. That vote could happen as early as next month, Committee Chairman Rep. Fred Upton, R-Mich., and Rep. Diana DeGette, D-Colo., told the Examiner.

    cont'd

    http://www.washingtonexaminer.com/cures-bill-raises-safety-concerns-for-experts/article/2565734
     
  2. Snow Leopard

    Snow Leopard Hibernating

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    What does this actually mean?

    Is it pharma money grab or something else?
     
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  3. *GG*

    *GG* Senior Member

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    Since it is being brought to us by the US gov't, probably not much for the money spent! LOL

    Like Pharma wants to CURE disease, then they would have fewer customers!

    I think only time will tell, some of the implications is probably letting dying patients try drugs that are in the pipeline. Seems reasonable to me!

    GG
     
  4. sarah darwins

    sarah darwins I told you I was ill

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    Well, that's confusing. From the article:

    I had always understood something like the later to be the case — ie. it takes many years and vast sums of money to get a new drug to market. If Kesselheim and Avorn are correct, the drug companies may have been fibbing just a teeny bit. Who knew?

    It would be nice to get the truth of this.
     
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  5. barbc56

    barbc56 Senior Member

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    @sarah darwins

    I could be wrong but I think the approval times are after all the years of studies, ect.
     
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  6. WillowJ

    WillowJ คภภเє ɠรค๓թєl

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    New money (for research for unmet needs?) at least sounds like good news.

    "All facets of healthcare innovation"? Who is and is not included in that? I also feel confused.
     
  7. alex3619

    alex3619 Senior Member

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    That has usually been an accepted practice though I think there are a lot of hurdles which are country and possibly even state dependent. If you are dying then some chance might be better than no chance.
     
  8. *GG*

    *GG* Senior Member

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    No, I don't think it is an accepted practice. I remember of a young married couple, the wife had Cancer, if I recall correctly, and had less than a year to live. She died and never received the drug that was in the pipeline, that might have helped.

    GG
     
  9. alex3619

    alex3619 Senior Member

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    That comes down to hurdles and barriers. It is probably something that is widely done, but it isn't easy to do. Furthermore by the time you figure out all the barriers and how to work around them you could be dead. To complicate matters its often the case that the drug companies require patients to enroll as test subjects. Its not just given without strings. You might also have to pay for the treatment, which will not be covered by insurance.

    Take Ampligen for example. Lots of patients were on that outside of existing trials organized trials, and probably still are. Maybe someone still getting Ampligen can comment.
     
  10. Denise

    Denise Senior Member

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  11. sarah darwins

    sarah darwins I told you I was ill

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    OK, I think I understand. So there are two different things here — the development time and the official approval process. It sounds a bit like this bill is aimed at lowering the bar in the second part. I have no idea if that's a good thing or a bad thing. Or both.
     
  12. *GG*

    *GG* Senior Member

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    LOL, I would say less time for approval is better, bureaucracies kill more people than they help!

    GG
     

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