Hough Ear Institute's Hair Cell Regeneration Project

[Jurger]

Maybe we can get a reaction from @Justin De Moss on some of the questions we posed? What's been holding up Phase 2 of the pill? If it's funding, how much would you need? Do you have enough funding to start Phase 1 of your injection? What about the limitations of intratympanic drug delivery? What's Hough's view on alternative delivery methods? Are you worried you might not get a high enough concentration in the cochlea with intratympanic drug delivery? What about reaching the apex of the cochlea?

Thanks in advance.

 

[JohnAdams]

I got a response from the FDA.

Me:
"......Is there any way I can get special permission to negotiate with Hough Ear to try this medicine now? "

FDA:
"You are welcome to reach out to Hough Ear Institute to find out if they have submitted an investigational new drug (IND) application to the FDA or if they plan to. We checked www.clinicaltrials.gov but did not see any ongoing clinical trials regarding HPN-07. We also encourage you to speak with your doctor to see if they think you might be a good candidate for this therapy."

I immediately noticed that they failed to answer my question, which was in the form of yes/no.

I know very well that I am allowed to reach out to Hough Ear. I don't need government permission to ask someone a question, this isn't the Soviet Union.

Look what a dodgy response that was.

 

[Dizzyhead888]

I got a response from the FDA.

Me:
"......Is there any way I can get special permission to negotiate with Hough Ear to try this medicine now? "

FDA:
"You are welcome to reach out to Hough Ear Institute to find out if they have submitted an investigational new drug (IND) application to the FDA or if they plan to. We checked www.clinicaltrials.gov but did not see any ongoing clinical trials regarding HPN-07. We also encourage you to speak with your doctor to see if they think you might be a good candidate for this therapy."

I immediately noticed that they failed to answer my question, which was in the form of yes/no.

I know very well that I am allowed to reach out to Hough Ear. I don't need government permission to ask someone a question, this isn't the Soviet Union.

Look what a dodgy response that was.

Follow up with the same question.

So the only way to try this medication is through a formal clinical trial?

 

[FGG]

@Justin De Moss

Why not just market this pill as a supplement and make no specific claims? If it works, word of mouth will spread like wildfire.

The line between supplement and medication seems blurrier than it used to. Look at all the "Nootropics" on the market now. And why is Vinpocetine OTC in the US and a prescription in Germany? Why is Betahistine the reverse in other Western countries (I say Western because you can get substantially more OTC in Mexico and Thailand for instance)?

 

[linearb]

Look what you're arguing against. Your position is just sit down and shut up and let the process run its course and do nothing because the process is perfect.

Er, no? I'm criticizing you for not taking the time to understand the thing your railing against, because it causes your railing to seem very tone deaf.

I am suggesting that before you attack the agency/process you take the time to understand it -- both so that you understand generally what you're arguing against, instead of just making blind accusations that don't make any sense to people with a grasp on the forces at work. Secondly, if you do understand FDA process around all these things, then you'd understand what you, as an individual, can do to get around these constraints and access some of these compounds before the general public if you really want to. Seems like a better use of time than shouting at clouds.

Nowhere have I offered blind defense, or really much defense, of the FDA -- I have plenty of my own criticisms there. I have offered defense only of having a regulatory process in place, because the cases where "totally free market + pharma/chemical cos == mass casualty events" are legion. Is the current system perfect? Fuck no. It's not useful to try have a nuanced debate about how to fix or replace the FDA, with someone who seems to object to the existence of the institution at a visceral level, without actually knowing much about it.

 

[JohnAdams]

Er, no, I am suggesting that before you attack the process you take the time to understand it -- both so that you understand generally what you're arguing against, instead of just making blind accusations that don't make any sense to people with a grasp on the forces at work, as well as personally because if you do understand FDA process around all these things, then you'd understand what you, as an individual, can do to get around these constraints and access some of these compounds before the general public if you really want to.

Seems like a better use of time than shouting at clouds.

You're talking down to me like an asshole as if I don't know how any of this works.

My mom is good friends with a woman that owns a biomedical equipment developer that has moved several products to market. She has explained to me exactly how screwed up the FDA is. I also studied this is in grad school and took two classes from an instructor that develops medical products and he too explained to us very clearly that most of the FDA process serves as an artificial barrier to entry.

 

[Pawel1]

I have found a new article about current on-going pharmacological treatments for Tinnitus.
https://www.businesswire.com/news/h...ne-Insight-Report-2019-Analytical-Perspective

Below is a list with seemingly the most promising ones:

1. JB 004A
2. SPI-1005
3. OTO-313
4. OTO-203
5. BGG492A
6. NST-001
7. Neramexane mesylate
8. Cilostazol
9. Vestipitant
10. Levitra
11. AUT00063
12. AM-101

I just thought, it woud help a little bit.

 

[linearb]

I got a response from the FDA.

Look what a dodgy response that was.

This is exactly the reposnse I'd expect, because the information on what you, as an individual, need to do to get a drug fast tracked is widely available and published.

I know this, because I was considering doing this exact thing (getting an experimental drug under FDA compassionate use guidelines).

They're directing you to the facility because above and beyond all else what you're going to need is the knowledge and cooperation of the facility / MDs. Successful petitions to get access to early treatment are generally initiated through medical providers; having such cooperation is a requirement. Which is spelled out really clearly on the FDA pages that explain how to do what you're trying to do.

I've directly worked for a biomedical provider that has several products on the market now; your anecdotes don't impress me.

 

[linearb]

To be as helpful as possible, here are the current rules for expanded access:
https://www.fda.gov/news-events/public-health-focus/expanded-access

I think a strong case could be made that tinnitus meets all five of the base criteria, provided you're unable to be in a clinical trial, and provided you can get a doctor to advocate for you on the harm vs benefit question.

What you would need, @JohnAdams, if Hough is calling the shots on this test and/or has patent, is a compassionate doctor at Hough who wanted to help you. If you had that, then getting through the hoops on the FDA side is more a paperwork question than anything. If you don't have that, you're out of luck, because the process is:

1 - Talk to your licensed physician before deciding if an investigational medical product is right for you.
2 - Have your licensed physician visit FDA's Expanded Access: Information for Physicians page.
3 - Have your licensed physician contact the company to request the investigational medical product for expanded access use.
4 - For sponsor-investigator single patient expanded access requests, if the company is willing to provide the investigational medical product for treatment under expanded access, the expanded access request can be submitted to FDA.
5 - Treatment can begin once everyone agrees to expanded access to the medical product.

Notice that the FDA is just a gatekeeper here, and the real bars you have to clear are:
* get a doctor on your side to agree this is a good idea
* get the patent holder of the compound / drug to agree to let you try it.

If you can do those things, the FDA bars are fairly straightforward and paperwork based.

I do not, personally, think this is an unreasonable set of hurdles to clear to be able to consume potentially dangerous drugs pre-market, but that's just an opinion and we could certainly have all sorts of conversations about how this process should be changed. "Get rid of the process completely and let people buy whatever" is not a viewpoint I'd ever come around to, but, again, that's just an opinion.

 

[JohnAdams]

This is exactly the response I'd expect, because the information on what you, as an individual, need to do to get a drug fast tracked is widely available and published.

I know this, because I was considering doing this exact thing (getting an experimental drug under FDA compassionate use guidelines).

They're directing you to the facility because above and beyond all else what you're going to need is the knowledge and cooperation of the facility / MDs. Successful petitions to get access to early treatment are generally initiated through medical providers; having such cooperation is a requirement. Which is spelled out really clearly on the FDA pages that explain how to do what you're trying to do.

I've directly worked for a biomedical provider that has several products on the market now; your anecdotes don't impress me.

It was a yes or no question.

Here's the moment I completely win this argument:

The drugs they approve aren't even safe much of the time, yet they are testing them for safety!

How many people have tinnitus from FDA approved drugs/procedures that passed phase 1 safety trials?

"As noted by one observer, "No one has yet defined safety and efficacy. Nevertheless, distinguished panels attempt to make what are termed 'scientific assessments' in the absence of objective basing points." In practice, safety and efficacy depend strongly on individual circumstances such as age, sex, genetic makeup, and a host of other medical and personal factors that are often difficult for regulators to know."

"However, one important class of drugs that clearly suffered from post—1962 FDA regulation was the beta blockers, an innovative treatment for a variety of cardiovascular conditions. The FDA approved the first U.S. beta blocker, propranalol, in 1968—three years after it had been approved in Great Britain. In subsequent years, the FDA was criticized for delaying the introduction of other, newer beta blockers and for restricting approval of propranalol to only limited indications, against the advice of expert cardiologists.44 Finally, in November 1981, the FDA announced its approval of a new beta blocker, timolol, for an innovative indication, the prevention of second heart attacks. The FDA's action was based on a study published seven months earlier, showing that timolol could reduce mortality from second heart attacks by enough to save an estimated 6,500 to 10,000 lives per year in the United States.45 At this rate, it can be estimated that some 4,000 to 5,800 preventable deaths occurredduring the seven months required by the FDA for its purportedly expedited approval. However, as noted by Wardell, there had been clinical evidence fii,r the efficacy of beta blockers in preventing second heartattacks as early as 1974.46 The total cost of this seven-year delay could then be put at some 45,000 to 70,000 lives—several times greater than all the casualties resulting from thalidomide and other major new drug disasters."

https://web.archive.org/web/2019071...erials/files/cato-journal/1985/5/cj5n1-10.pdf

The FDA is wasting time and lives on their dumbass, super slow, approval process, that you love so much.

 

[linearb]

Government agencies are unlikely to answer "yes or no" questions through email for reasons that should be obvious.

If you want to try the Hough drug, the process is spelled out above.

Did the FDA drag its feet on beta blockers, causing mortality? I have no idea, but it sounds likely based on what you posted. Did the same FDA fast-track fen/phen with insufficient warnings, causing mortality? Yes.

When you're regulating drugs, action and inaction both have hazards associated with them.

 

[Jurger]

@JohnAdams Just ask Hough if they're willing to provide the drug, although I think you'd be a candidate for Phase 2a, which should start pretty soon.

 

[JohnAdams]

@JohnAdams Just ask Hough if they're willing to provide the drug, although I think you'd be a candidate for Phase 2a, which should start pretty soon.

They cannot, by law, give it to me outside of a clinical trial. I would also need to be near to the trial location, and I doubt that I would. I live in a shack in a swamp in Appalachia with an outhouse and hillbillies and confederate flags and Oxycontin™ everywhere.

 

[Jurger]

They cannot, by law, give it to me outside of a clinical trial. I would also need to be near to the trial location, and I doubt that I would. I live in a shack in a swamp in Appalachia with an outhouse and hillbillies and confederate flags and Oxycontin™ everywhere.

Dude, I mean permission as part of expanded use. You need your doctor, Hough and the FDA on the same page.

 

[JohnAdams]

Dude, I mean permission as part of expanded use. You need your doctor, Hough and the FDA on the same page.

But is that legal? Did I read that FDA e-mail wrong? Are they saying I could if I get everyone to agree? My primary care doctor is super cool and would definitely get on board.

 

[Jurger]

But is that legal? Did I read that FDA e-mail wrong? Are they saying I could if I get everyone to agree? My primary care doctor is super cool and would definitely get on board.

That's what expanded use is. Access to drugs that aren't approved yet, for serious diseases that don't have a treatment alternative, for patients who can't participate in a clinical trial for said drug. Your doctor, the company and FDA need to agree you can get it. I suggest you reply to the FDA asking if 'expanded use' is possible. They won't give you a yes or no, but will tell you the same thing. I suggest you get in touch with Hough to ask them if they are willing to cooperate (if your doctor and the FDA approve) and then contact your doctor for the paperwork. I think your doctor needs to formally apply.

 

[Rb86]

Let's keep this on topic. I was informed that Hough MIGHT have some important news in the next 4-8 weeks. No I don't know what that means.

 

[Piney]

Everyone has a pill and a potion to cure this ailment. It should take no money to do the trial and you only get money if it works.

 

[JohnAdams]

get a doctor on your side to agree this is a good idea

It's in the bag.

* get the patent holder of the compound / drug to agree to let you try it.

Will try.

 

[JohnAdams]

The FDA guy thought I was trying to get them to force Hough Ear to give me their medicine. Upon rewording my question, according to your excellent advice, @Jurger, I have received indication that working through my doctor and Hough Ear that I can in fact seek permission to acquire this medication under expanded use terms, so long as Hough Ear approves.

 

[Jurger]

The FDA guy thought I was trying to get them to force Hough Ear to give me their medicine. Upon rewording my question, according to your excellent advice, @Jurger, I have received indication that working through my doctor and Hough Ear that I can in fact seek permission to acquire this medication under expanded use terms, so long as Hough Ear approves.

Now the question remains: will Hough do that? I think I know the answer.

 

[Jurger]

Let's keep this on topic. I was informed that Hough MIGHT have some important news in the next 4-8 weeks. No I don't know what that means.

Where did you get that from?

 

[Hazel]

Great to see @Justin De Moss on here and answering questions directly from the community! That's a great example to other tinnitus researchers and companies.



In the meantime, @Markku and I have invited Justin to the Tinnitus Talk Podcast, and he graciously accepted. A date for recording has not been set (and we have a few other episodes in the pipeline), so it might take a while, but it should prove interesting and enlightening!

We'll use the questions posted in this thread for input to the podcast, so Justin doesn't have to answer them all here and now.

Cheers,
Hazel

 

[lymebite]

In the meantime, @Markku and I have invited Justin to Tinnitus Talk Podcast, and he graciously accepted.

That's terrific! The Tinnitus Talk Podcast is such a great vehicle to share information and raise awareness.

For anyone who has not yet done so, I would encourage all to help support the Tinnitus Talk Podcast by becoming a Podcast Patron. It is a modest cost to help defray the expenses of @Hazel and others. It took me a while to sign up but I finally did so earlier this week. Would love to start seeing everyone with "Podcast Patron" badges on their Tinnitus Talk profiles!

You can sign up at the first link, and find more info at the second link.

https://www.patreon.com/TinnitusTalk/

https://www.tinnitustalk.com/thread...come-a-patron-of-tinnitus-talk-podcast.35165/

 

[Rb86]

Where did you get that from?

From a direct email with Hough Ear Institute. This could mean quite literally anything. Best case? Phase 2 coming to fruition. That would still just be the start of the waiting game everything else is in. Feels good but doesn't mean too much.

Or it could mean something much less. Let's not do any speculation until we get the actual news.

 

[Coleoptere]

so long as Hough Ear approves.

Not sure why they should do that... They only benefit if you participate in their trials. But who knows? Better try than do nothing.

 

[JohnAdams]

Not sure why they should do that... They only benefit if you participate in their trials. But who knows? Better try than do nothing.

I don't fear failure.

 

[Auron]

I don't fear failure.

Me either. But I do fear side effects.

 

[Jurger]

Not sure why they should do that... They only benefit if you participate in their trials. But who knows? Better try than do nothing.

Well, not only for that reason. How many pills would they give @JohnAdams? They haven't figured out dosing yet. I think an expanded use request stands to have more success after Phase 2.

And with regard to not living near Oklahoma and therefore not being able to participate in the trial, since this drug is taken orally you'd basically only have to come back for tests. Depending on the trial design (eg the amount of tests) someone not living near Oklahoma might very well be able to participate.

 

[Coleoptere]

How many pills would they give @JohnAdams?

Agreed. They might guess using their lab results. But at the end he would be the first experiment.