What Is Going on Here? Why Are We Not Allowed to Consent to Paying and Trying Experimental Drugs?

Discussion in 'General Chat' started by JohnAdams, Sep 29, 2019.

    1. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      The two hair cell regeneration drugs being tested in Europe and America have both passed the safety phases of their clinical trials. A very believable anecdote from one of a trial participants has indicated that they do in fact help with tinnitus and hyperacusis. There is not one good reason why we shouldn't be able to consent to paying for and using these drugs right now. There are 0 reasons why we should be prohibited from trying these drugs. ZERO. Fuck this shit. People are SUFFERING. Holy shit! The BTA and ATA and <others> need to be helping us get access to try these things. Wtf is going on here?
       
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    2. Pawel1
      Wishful

      Pawel1 Member

      Tinnitus Since:
      January 2016
      Cause of Tinnitus:
      Loud Music
      Realistically speaking, is it even possible that we could try those drugs, while they are still doing studies? Doesn't really make sense to me, to be honest. But, I don't want to wait for another 10 years, for the cure. Let's start a big Facebook tinnitus campaign. I will even donate my money!
       
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    3. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      It's not possible to try them. The companies in question would never agree to giving them out without proper due diligence (which includes the completion of clinical trials, regulatory approval by the FDA / EMA, etc.)

      JohnAdams is just bonkers, I'd like to see him try get these drugs... He's all talk. Guy is useless as a fart.
       
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    4. Pawel1
      Wishful

      Pawel1 Member

      Tinnitus Since:
      January 2016
      Cause of Tinnitus:
      Loud Music
      Oh, c'mon... I'll buy myself a Snickers then... Just to forget about this.
       
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    5. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      Yes, they have both passed their safety trials.
      We live in societies that have abortion up to the 3rd trimester. We can get breast implants, to ridiculous sizes. We can have our penises surgically altered to sorta look like a vagina. We can give teenagers hormone blocking drugs to try and alter their sex phenotype expression. We can smoke cigarettes. We can buy sports motorcycles. We can do MMA fights. We can skydive. We can do mountain climbing.

      Is there any good reason why, knowing these things have passed their safety trials, not hurry up, and get to the point where we can pay to have them injected into us? Ring Relief doesn't fucking work, but they can sell it to us over the counter, and it is safe. What's the reason?

      Here is the answer folks. Big pharma has lobbied and used the revolving door between government and corporations to create a situation where entry into this market is an artificial barrier to entry. There is such huge money involved in the medical industry that they cannot tolerate any type of disruption whatsoever.

      Think about it, if you were a preferred stock holder in one of these big pharma corporations, and you knew legalizing marijuana would crash one or more of your products, wouldn't you pay big money to hedge the risk from that through trying to influence regulatory policy? It is the same thing as also lobbying to slow down the approval process.
       
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    6. Striveon

      Striveon Member

      Tinnitus Since:
      08/2018
      Cause of Tinnitus:
      Unknown
      I thought I read somewhere an article that Trump signed to allow drugs on clinical trials to be tried by those suffering?
       
    7. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      The main ingredients can be bought by any research lab. Neither Audion nor Frequency Therapeutics owns a patent to the active ingredients to their drugs. In the case of Frequency Therapeutics, they have a propriety combination that also divides supporting cells. Which is good. We could get a willing ENT or otolaryngologist to do it but they can't because the drugs aren't approved to be injected into humans.

      Here is the Audion drug, for sale, right here:
      https://adisinsight.springer.com/drugs/800049561

      You have to resort to insults because you have so much faith in the system that any questioning or criticism of it causes you great fear deep down inside. The idea that evil and greed could ever conspire to manipulate the system just fills you with so much dread that you would probably have to reevaluate your perception of the world in a way that would require a level of introspection that you have never had and a level of hope that you know died with you when you were a little child. You are now what is colloquially known as an NPC.
       
    8. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      Yes but that is limited to terminal illnesses I believe.
       
    9. Striveon

      Striveon Member

      Tinnitus Since:
      08/2018
      Cause of Tinnitus:
      Unknown
      Well that's just shitty :(
       
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    10. Bill Bauer
      No Mood

      Bill Bauer Member Hall of Fame

      Tinnitus Since:
      February, 2017
      Cause of Tinnitus:
      Acoustic Trauma
      Greed has nothing to do with it. Lack of competition is the culprit. If the existing antitrust laws were to be enforced, "greed" would motivate new treatments to be developed.
       
    11. Earing
      No Mood

      Earing Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      noise
      Farts are actually very useful. Got cramps? Farting will cure them. Want to test to see if your girlfriend is serious about you? Crack a few farts on the couch and see what she does. If she stays, she will be by your side through almost anything. If she leaves, good riddance. Need some room on a crowded subway train. A good fart will clear the area, leaving you to stew alone in your success.
       
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    12. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      Nonsense. When lobbyists push for regulations that protect the company's profits over the well being of people, then that is 100% greed.
       
    13. Bill Bauer
      No Mood

      Bill Bauer Member Hall of Fame

      Tinnitus Since:
      February, 2017
      Cause of Tinnitus:
      Acoustic Trauma
      So is a company developing and bringing to market a lifesaving drug - 100% greed. Greed is human nature, and it happens to be the part of human nature that gave rise to civilization. The harm done by the lobbyists is caused by the political system that allows this sort of thing to go on.
       
    14. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      No. But when a company sends lobbyists to congress to promote regulations that give their company an advantage, which does in fact happen, then that is greed.
       
    15. all to gain

      all to gain Member

      Tinnitus Since:
      June 2019
      Cause of Tinnitus:
      dirty drugs
      Why should they rush? There will always be plenty of tinnitus sufferers to treat.

      We are just left with the carrot dangling in front of ours noses, but we can't quite grasp a hold of it.

      It sucks big time!!!
       
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    16. Bill Bauer
      No Mood

      Bill Bauer Member Hall of Fame

      Tinnitus Since:
      February, 2017
      Cause of Tinnitus:
      Acoustic Trauma
      Why do you say "no"? Do you have any arguments to back this up?

      If something is legal, then the company is doing the right thing by taking advantage of it. If that something is detrimental to society, just make it illegal - problem solved. Solving the problem the other way - by changing the human nature is harder and as a result it is going to be less effective.
       
    17. Bill Bauer
      No Mood

      Bill Bauer Member Hall of Fame

      Tinnitus Since:
      February, 2017
      Cause of Tinnitus:
      Acoustic Trauma
      If they don't hurry up, other companies will get a chance to get their product to market, establish themselves, and get a larger market share.
       
    18. all to gain

      all to gain Member

      Tinnitus Since:
      June 2019
      Cause of Tinnitus:
      dirty drugs
      Very true.
       
    19. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      Elon Musk can design and build an interplanetary space ship that can land vertically and be ready for humans faster than they can inject humans with a medicine and see how well it works. That's backwards.
       
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    20. Skity

      Skity Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Noise trauma / TMJ
      This is true not only for tinnitus, and this is absurd.

      There are terminally ill patients who aren't allowed to participate in trials because they are still "unsafe", this dude has 4 days to live, WHAT'S THE WORSE THAT CAN HAPPEN?
       
    21. linearb
      Psychedelic

      linearb Member Benefactor Hall of Fame

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      temporarily banished from this plane of existence.
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      1999
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      karma
      ....because the second this was allowed, Pharma companies would instantly start resorting to the sketchiest, most barely-legal schemes you can imagine to get probably-snake-oil drugs into people's hands?

      I think that "preventing pharmaceutical companies from selling drugs that haven't fully cleared regulatory hurdles to desperate people" is a good goal, mostly because the pharma cos themselves are so obviously crooked and completely untrustworty; just in the time I've been dealing with tinnitus, we've had massive fabrication of the safety and efficiency of SSRIs by the industry, all the Vioxx nonsense, and, oh yeah, millions of people dying in an opioid epidemic that was 100% deliberately designed and executed for profit by a single bad-faith pharmaco with millions to burn.

      This is why we can't have nice things. If you wanna go test random noncommercial compounds, it's pretty easy to get stuff custom synth'd in china, and then if you have a friend with a GC/MS in the states and have access to a reference GC/MS for whatever you are trying to custom synth, assuring purity is reasonably straightforward. I know this because I've actually done it in two cases, though for things which were much more boring and better documented than what you're talking about. Hell, you get your weird drugs and send me a few milligrams, I'll drive over to boston and hang out and smoke fancy hash for a day while my friend runs labs on it :-P
       
    22. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      They can test the drugs for efficacy and safety without it taking so long.
      upload_2019-10-1_9-26-49.png upload_2019-10-1_9-26-57.png upload_2019-10-1_9-27-5.png upload_2019-10-1_9-27-24.png
      Okay.

      You're not going to convince me that they need more than another year to prove that this drug either works or it doesn't.

      It takes 3 months from injection time to measure the outcomes. Why do they need 9 months to show up at the FDA and ask themselves every day "are we sure?" over and over and over again.
       
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    23. linearb
      Psychedelic

      linearb Member Benefactor Hall of Fame

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      temporarily banished from this plane of existence.
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      1999
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      karma
      Seems to me like you don't know too much about how clinical trials work, why these things take as long as they do, why it is as hard and expensive as it is to get equivocal data, etc. These ideas are very clearly laid out a lot of places.

      One big thing that makes me personally very wary of messing with any new "ear" drugs -- anything which has the potential to help tinnitus, almost certainly has the potential to make it worse. This is true of the bimodal tech, but less worrying there because the effect is pretty conclusively short-lived. The long term effects of drugs are a lot harder to predict.

      https://www.cancer.org/treatment/tr...t-you-need-to-know/clinical-trial-basics.html

      https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

      https://www.forbes.com/sites/alison...ical-trials-before-you-need-one/#23265a65f1a6

      Like I said above, though, if you want to go lab rat yourself, literally the only thing stopping you is some money, some emails to Chinese labs, and a friend with a GC/MS. Go hog wild!

      All of the stuff in your images are scams, notably, none of them are products that required FDA oversight. So, if you want your "drugs" to basically just be snake oil scams too, yes let's neuter the FDA, and return to the era of Bayer selling Heroin as a pediatric cough medicine, the pharmacos would love it

      FVNb3Njl.jpg
       
    24. AUTHOR
      AUTHOR
      JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      There is not one good reason why a 3 month trial needs to take 12 months to verify all of the data. You're just assuming that everything is perfect the way it is in the system and that's a farce. The examples you give are from 100 years ago, just like all these cry babies that are still bitching about racism and using slavery and the KKK as examples.
       
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    25. linearb
      Psychedelic

      linearb Member Benefactor Hall of Fame

      Location:
      temporarily banished from this plane of existence.
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      karma
      welp, if you can't talk about FDA timelines without making inappropriate comments about utterly unrelated issues, good day to you, sir.

      as for "crybabies".... get gud?
       
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    26. Selah1281

      Selah1281 Member Benefactor

      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Unknown
      So the bimodal devices are continuous use or periodic use indefinitely?

      Is this what Dr Shore stated to you?

      what about people like ClareB and kelpiemsp who said they’ve been cured?
       
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    27. all to gain

      all to gain Member

      Tinnitus Since:
      June 2019
      Cause of Tinnitus:
      dirty drugs
      Man, this is a scary thought. All the hope has gone out of me now.
       
    28. linearb
      Psychedelic

      linearb Member Benefactor Hall of Fame

      Location:
      temporarily banished from this plane of existence.
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      1999
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      karma
      This is what Dr Shore's lab technicians told me, and this was also my own experience using the device.

      The thing kelpiemsp used is not identical to the thing I use; additionally, it seems reasonable to assume that these devices will have somewhat different effects on different people. I have no opinion on the subjective experience of other people.

      I believe @kelpiemsp withdrew from benzodiazepines over the same general period of time; that's potentially a complicating factor, since benzos are well known to interact with tinnitus in various ways. However, that is entirely my own speculation; we don't have nearly enough data to speak rationally and predictively about any of this yet.
       
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    29. Selah1281

      Selah1281 Member Benefactor

      Tinnitus Since:
      06/2019
      Cause of Tinnitus:
      Unknown
      Yes I understand @kelpiemsp was in the University of Minnesota trial and it’s a different device and @Clare B was I believe in the Neuromod trial.

      In the Neuromod thread @GlennS was saying he got the impression Lenire was a one and done treatment. I didn’t get the same impression with pricing for replacement tongue tips and talk of potential future software upgrades.

      How long did the effects of the UMich device last for you after your last treatment?

      Interesting that he was in a trial and withdrawing from Benzos. I was specifically told I couldn’t be in a UMich trial because of clonazepam use in the past six months. Were you using clonazepam at the time of your trial experience since it was prior to this latest round? Just wondering if they changed the requirements.
       
    30. linearb
      Psychedelic

      linearb Member Benefactor Hall of Fame

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      Not long at all. Days. Was noticing tone bursts within ~48hrs.

      I was using PRN diazepam at the time, but very little of it. I do have the sense the requirements got tighter for phase-II which sort of makes sense, as Phase-I is "can we convince ourselves as researchers that this works at all?" and phase-II is "can we convince the FDA this works safely and efficiently?" That's a simplification, but there's a grain of truth in it. The phase-I was relatively tiny, there were only 20 or so of us. Also I was traveling from far away, something they prohibited in phase-II.
       
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