Attention Non-Americans: A Protest Against the FDA

Discussion in 'General Chat' started by JohnAdams, Nov 9, 2018.

    1. JohnAdams
      Murderous

      JohnAdams Member Benefactor Hall of Fame

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      I'm advocating a protest against the FDA to quit being stupid and hurry up.

      If you're not an American then you're stupid to defend the unconstitutional powers of the FDA. If you think they have our best interests in mind then you're really ignorant. The USA is a very complicated nation and we have many evil interests guiding our governmental processes.

      Frequency Therapeutics is an American company under American governance, so if you're not living here and don't understand the dynamics of our laws and our history please just keep your opinion to yourself.
       
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    2. another sean
      Studious

      another sean Member Benefactor

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      What did I miss?
       
    3. AUTHOR
      AUTHOR
      JohnAdams
      Murderous

      JohnAdams Member Benefactor Hall of Fame

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      I've been trying to rally support on this forum to essentially draw attention to the fact that the FDA is holding back progress in the advancement of new technology, namely FX-322. The FDA has proven itself to be an impediment in the past.

      Certain people have heavily criticized me for my efforts and some of them aren't even in America and act as if the process is immutable and there's something wrong with me for what I'm saying. I'm inviting them to keep their ignorant opinions to themselves.
       
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    4. sirhand
      Badass

      sirhand Member

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      If you are American, vote Republicans to stop overbearing regulations from impeding progress.
       
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    5. Ed209

      Ed209 Member Podcast Patron Benefactor Ambassador Hall of Fame

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      Are you aware there was a $1.8m report in 2006, by the Institute of Medicine, that found major problems with the FDA’s process for ensuring the safety of drugs in the US?

      The FDA produced a report of their own to address the issues which can be found here:

      https://www.fda.gov/downloads/Drugs...ormationforPatientsandProviders/UCM171627.pdf

      I suggest reading it all, but I’ll post an excerpt below:

      New drugs, devices, and diagnostics present the greatest opportunity currently available to improve healthcare and the way medicine is practiced; but all medical products pose potential risks. The FDA is challenged to make sure that it consistently balances access and innovation against the steps taken to improve our approach to safety issues. The Agency’s efforts to improve drug safety must not dampen the process of medical innovation that could itself enable safer approaches to drug development and drug use. Stimulating the development of products that can be used safely and effectively by patients suffering from unmet medical needs is important. Safety and innovation, as well as efficiency in drug development, do not necessarily conflict but are dependent on one another. A more modern, efficient, and risk-based drug development process will improve FDA’s ability to detect safety-related problems earlier. FDA will not achieve enhanced safety programs without also pursuing innovation in the way that drugs are developed.
      The emerging science of safety also offers a way to partially solve a fundamental dilemma: the trade off between safety and access. A clear example of this trade off occurs when FDA, after analysis of adverse events, considers whether to withdraw a drug from the market for safety reasons. While withdrawal of the drug would avoid further adverse events, it would also deprive patients for whom the drug is effective of its benefits. If, however, new science enables us to determine that the adverse events are restricted to a small, identifiable segment of the population, public health could be improved by making the drug available to others who could benefit without undue risk.
      The new science of safety, by its very nature, will require an interdisciplinary team approach to assessment, incorporating experts in genetics, cell biology, and other basic sciences with clinical pharmacologists, clinicians, statisticians, epidemiologists, and informatics experts. We agree with the IOM that adequately incorporating the input from these various experts will require a much more formalized, semi-quantitative approach to benefit and risk analyses and continuing reorganization of regulatory processes. We regard improving our approaches to risk and benefit analysis to be one of the important facets of the science of safety that urgently requires additional development.


      There’s more info here:

      http://nationalacademies.org/hmd/Re...the-Public/Change-Drug-Safety-Policy-FDA.aspx

      Again, I encourage activism, but I’m not sure what you want people to do at this stage?

      FX-322 is in the very early stages and has to go through a vigorous process. A few people off a forum will not be able to change the regulations. It is an unknown drug in early development.

      If the data from phase IIa, in a few years, is promising, you could launch a campaign to try and get it fast-tracked. However, if it’s a drug that looks to be safe and efficacious then it will likely achieve this status organically. Until then it’s a waiting game.

      At this stage nobody will listen to you, including Frequency Therapeutics.
       
      Last edited: Nov 9, 2018
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    6. another sean
      Studious

      another sean Member Benefactor

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      This kinda reminds me of the South Park episode Die, Hippie Die where all the hippies try to fight back against the corporations and the most they ever do is organize a festival and play louder music.

       
    7. Alue
      No Mood

      Alue Member

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      It's not that simple. The Bush administration halted stem cell research for nearly a decade. Neither party is great.
       
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    8. Tex

      Tex Member

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      I agree 100% with the vote Republican part. But there really are two sides to the FDA bashing.

      I have bashed the FDA a lot myself. Then I think about all the people in this country that scream lawsuit over everything, and I mean everything. Also, think about all the horrific drugs that have been approved.

      If the drug companies fear lawsuits over every single side effect possible, then we will never get anywhere.
       

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