Hough Ear Institute's Hair Cell Regeneration Project

Yeah, it's completely ridiculous. Helping us get out hands on such a thing should be a priority for advocacy groups like the ATA and the BTA but they are all complete losers and hard headed as well. It's almost like they are purposefully looking away from anything that could treat us.

 

Write the FDA and politely ask if we can work with Hough Ear to try and get early access to this drug since it has passed phase 1 and is safe.

druginfo@fda.hhs.gov

Make the subject line "Hough Ear Institute/Tinnitus".

Do it.

 

Done.

 

Would this potentially screw up Phase 2 testing, though? Maybe a workaround could be an airtight NDA.

 

Yeah I don't even know if Hough Ear would want such a thing. This is just maddening that something that is safe is restricted for us to try ourselves. We're being told by a scientist that it can treat tinnitus. It's like who is the person stopping us from having this? There surely is someone at the FDA that has the authority to allow us to have this treatment.

 

Hearing related disorders are literally ruining countless lives and it is totally heartbreaking to think there could already be a treatment... we just can't access it .

 

What's worse is that we could organize to make ourselves heard at the FDA but half of this community sits around moping that there will never be a cure or that it's hardwired into our brains and can't be cured.

 

There will be a cure, but I reckon I will be dead before it appears.

 

I’ll bite: how?

 

No idea. All write letters to the same people at the same time? Raise money and send Hazel or someone to lobby for us?

 

Let’s start with people to write. Who do we include and based on which criteria? Researchers? ENT association board members? Politicians? Companies?

 

Hough Ear? Maybe we should start with Dr. De Moss and see what he thinks?

 

I think we should have two goals in mind when taking action:

1. Accelerating testing/research, meaning:
a. funding
b. bitching to decision makers hearing loss and/or tinnitus is crap and should have priority, not to mention carries significant societal costs

2. expanded use programs for potential hearing loss drugs that have made it past a phase 2a trial, when there should be a pretty clear picture of safety, efficacy and dosing

 

And funding and expanded use programs should be a quid pro quo. If you get $100K from a hearing loss and tinnitus patient organization, expanded use should be on the table. Tired of these guys getting public money to do their research and fund their labs and then say “see you in 12 years when this is past Phase 3 and I’m a millionaire”.

 

I agree with all these points.

I think if we had a unified message/request for these letters beyond just that we are suffering and we want people to do something about it, it would be stronger. I don't think many people would brainstorm solutions for us unless they were suffering themselves or close to people who are but they might listen to specific suggestions.

 

No, I can't. It would be unethical. Not to mention put the research in jeopardy, the researchers and their reputations, etc. It would do no one any good if we got shut down.

I have to let the process take its course, just like you.

 

Do you only need funding to conduct phase 2 trials? Can we raise the necessary amount and become volunteers ourselves? How much are we talking about?

 

I asked this when I was in OKC. Could I kick start enough funds and then be in a trial? They said it's not ethical to recruit that way. But I could sign up to receive notice of recruitment which i did (sign up, haven't received a notice).

 

FGG I am not convinced you are human, your IQ is way too high. I am sure you are the first wave of an alien super race.

I could be wrong... usually am.

 

Send a check to me... and then I’ll deliver it to them on your behalf.

 

Thank you but I am nothing like that at all. I just have a medical background and am utterly obsessed with trying to learn everything I can to try and get my life back. I used to be so joyful.

I learn so much from everyone here. I'm so glad this place exists.

 

Wow. I sure have missed a lot. This is pretty cool.

 

Expanded use is not just a case of the company signing off on using their not (yet) approved drug. The FDA also requires there aren’t any alternatives and that you can’t participate in a clinical trial. We’d also have to contact the FDA (and the EMA) to ask how this is related to hearing loss drugs.

 

i know, I was just joking... you will have joy again... guaranteed.

 

Yah man, stop hiding out, we missed you dude... welcome back.

 

ChrisBoyMonkey made a letter template... perhaps somebody who’s good at writing could create a template we could all use en mass.... just a suggestion.

 

How do we phosphorylate our GSK3 in our supporting cells in our cochleas without giving ourselves cancer? I know inhibiting notch and also stimulating EGFR can do it but that's kinda risky to do systemically.

I know also that taking a drug orally or through IV, which is about our only option DIY to attempting this but the BLB is a problem. You can use mannitol to increase permeability up to 2X but that carries risks as well causing more damage through ototoxic compounds in our blood.

 

Sounds interesting, I've been given a bit of hope. I've been taking some time off of Tinnitus Talk and this year seems to have a lot going for it. It's still brutally painful every single day, I'm not sure how I'll be able to pay for my life next week let alone wait 5-10 years for a better treatment... but with this and Frequency Therapeutics, Lenire and Susan Shore's updates, I'm excited to see what's in store for 2020. Where will we be by next November? How much closer to a cure?

Very exciting.

 

A lot of respect for your work. Personally, if there was a pill that wasn't the cure to tinnitus but helped reduce it.. however I'd have to wait 2-3 years for it or more, I'd put aside all ethics and just swallow it. I'd take the risks. But that's me.

 

Considering that this treatment has been stuck in trial purgatory for years, looks to me like the process itself is unethical.

Why should we have to wait 5 more years to try this? We shouldn't. Our government is failing us. You should be allowed to resume testing this TODAY.

There is not one good reason whatsoever why you shouldn't be allowed to do that.

What I want to know is EXACTLY why you can't. What s the specific reason you cannot begin recruiting right now? What is holding this up?

I'm so sick of these mysteries.