Brainstorm on Political Lobbying and Regulatory Change

[JohnAdams]

So these new therapies you mention John - the FX-322, gamma secretase targeted inhibitor etc - which companies are producing them? Are they small start ups, healthcare giants, spin outs from unis or from big companies? It's relevant to the thread I think re lobbying.

Well the active ingredients have been around for some time and are available to purchase from lab supply companies. I believe that the first people to figure out that they could regenerate cochlear stem cells was Hellar Lab at Stanford University. I think Frequency Therapeutics is a spin off from that group. There is also Regain, which is also using gamma-secretase inhibitors, and Otonomy and Decibel Therapeutics.

Frequency Therapeutics is technically a small start up but they are rapidly increasing their value and are about to IPO.

 

[Daniel Lion]

I've been writing letters, to various organizations, politicians, rich people, newspapers, anybody I can think of. I am committing to three a week.

I just did my third, and will keep going. You never know, somebody may be interested and donate to our cause.

 

[mrbrightside614]

I'll echo what others are saying in this thread in stressing the importance of synchronicity when mailing letters to politicians of all levels.

I think we should draft some kind of standardized petition to get a lot of responses/support. Local organizing and partnering with VA's after this would be a strong start. I am located in the northeast Ohio area.

 

[mrbrightside614]

Does anyone have a lot of followers on Twitter? Maybe we could make a short (1-2 min video) touching on the talking points of:

1) Prevalence of the condition
a. General population
b. Vets
c. Musicians

2) Highly variable perception of the condition—underline that many of the afflicted maintain mild forms that do not speak to moderate to severe forms that:
a. Stifle concentration
b. Stifle social relationships (ability to hold conversations; ability to enter even the "safest" of public spaces)
c. Stifle perception of music
d. Preoccupy thought
e. Disrupt sleep, regardless of the severity of the condition
f. Often require medications to perform activities of daily living and help get to sleep

3) Comorbidities associated with the condition
a. Anxiety
b. Depression & suicidality
4) Underline the NEED for RESEARCH MONEY
5) (possibly) a crowdfunding source drop

Of course we would need an agreed upon source to contribute this money to make sure it's going into hands that we feel are driving the field towards a CURE and not CBT/TRT/other sources of psychobabble stagnation.

 

[Contrast]

Never advocate research on depression and anxiety or anything to do with pallative care. It's a waste of time on money that could be going towards biomedical research like studying the etiology of a disease! The etiology of most diseases are not truly known including the various types of tinnitus and hyperacusis. If we don't speak up this trend will continue.


As long as pain killers are cheaper them biomedical research we will not get anywhere.

 

[mrbrightside614]

Never advocate research on depression and anxiety or anything to do with pallative care. It's a waste of time on money that could be going towards biomedical research like studying the etiology of a disease! The etiology of most diseases are not truly known including the various types of tinnitus and hyperacusis. If we don't speak up this trend will continue.

As long as pain killers are cheaper them biomedical research we will not get anywhere.

I wasn't suggesting to address tinnitus's downstream consequences of depression and anxiety in isolation, but that tinnitus can lead to said disabling psychological manifestations. By stressing its comorbidities you better illustrate the immediacy of treatment need.

 

[mrbrightside614]

ALRIGHT I HAVE AN IDEA.

I have not seen this formerly introduced before, so apologies if this is not a new approach.

The SINGLE BIGGEST group of tinnitus/hearing loss sufferers are veterans.

Why don't we try to build a formal/informal partnership with the VA? America is WAY into nationalism and patriotism. They would be the most powerful ally to affect political and medical change in this country.

I am based out of northeast Ohio. My idea is this:

We get tinnitus talk members to call every county in their states' veterans service office. This resource is found here, for Ohioans.
http://dvs.ohio.gov/main/county-veterans-service-offices.html
We tell them to direct their response to ONE REPRESENTATIVE PER STATE, so that each office is not overwhelmed by the wide outreach.

We explain to them that we want to form a partnership that can benefit tinnitus and hearing loss sufferers state- and nationwide. We explain our agenda as follows:

1. Recognition of acoustic trauma is a legitimate medical emergency. This needs to be more widely known and therapies not only need to be more widely available but become common practice (through known effective therapies such as intratympanic dexamethasone injections)

2. Raise awareness of the most ototoxic substances that can exacerbate hearing loss and tinnitus (don't get too carried away here—just the main culprits such as aspirin, certain antibiotics etc.)

3. The importance of advances in PRP/stem cell therapy that are devoid of attention in the medical community; stress that the stem cells can be extracted from the patients' own various forms of tissue so that there are no valid ethical concerns. They can then be distilled down into growth factors that can then be used to revitalize/rescue damaged hair cells with localized administration. (Need further technical input/a write-up script from more informed members @JohnAdams perhaps) Inform them that while the extraction may be performed by one expert (biochemist?) the administration would be performed by ENT's.

4. Raise awareness on current novel therapies that are soon to be released such as FX-322 and Susan Shore's device.

5. Intention to petition the Department of Defense (or whatever regulatory agency pays out to veterans) to allocate more of their budget towards hearing loss/tinnitus etiology research and novel therapies. Stress the fact that we are NO LONGER SETTLING FOR OUTDATED PALLIATIVE SOLUTIONS SUCH AS CBT, HEARING AIDS AND MASKERS, AND ARE SEEKING LONG-TERM SOLUTIONS SUCH AS HEARING REGENERATION AND NEUROMODULATION.

6. Explain advances in physical technology that can be used to mitigate the risk of ear drum perforation such as those nanoneedles (source? I know someone knows what I'm talking about)

I really want to emphasize the HEAPS of promising research that we've just been sitting on for years as a country that we've failed to let materialize into meaningful therapy for countless sufferers. Really pull on the heart strings.

Finally, we explain that we want to hold a statewide conference wherein leaders and constituents of veterans affair committees are invited to join in a select group of hearing loss/tinnitus sufferers. Explain that we want to effectively disseminate our agenda and petition to each county's constituents (possibly build an online site to collect signatures?) so that we can affect this political and medical change. Send the petition to Robert Wilkie to progress a discussion/conference at a national lecel
https://en.m.wikipedia.org/wiki/Robert_Wilkie

I wrote this on my phone, so this surely needs extensive refinement and input, but I really think this is our best chance to build numbers and rally as a cause.

@Markku @Jack Straw @Hazel @TuxedoCat

Please tag people in this thread that could help focus and refine this strategy. I'm no expert in community organizing. But these are numbers that we need. We have to produce a polished, rehearsed script for all TT members to call their state's county offices, and establish TT leaders from respective states to receive the responses.

 

[Markku]

ALRIGHT I HAVE AN IDEA.

I have not seen this formerly introduced before, so apologies if this is not a new approach.

Hey

Read @TuxedoCat's previous messages in this same thread.

I, Hazel, TuxedoCat and ChrisBoyMonkey have been planning the VA angle for many months now; and TuxedoCat is soon due to give a presentation to the Disabled Veterans of America.

@ChrisBoyMonkey has also been very helpful in getting us contacts.

I like your thinking a lot, mrbrightside614. You should join one of our conference calls to discuss more. We'll be in touch with you soon.

We need more people like yourself who actually might have the determination to do something, instead of just talking the talk.

 

[mrbrightside614]

Hey

Read @TuxedoCat's previous messages in this same thread.

I, Hazel, TuxedoCat and ChrisBoyMonkey have been planning the VA angle for many months now; and TuxedoCat is soon due to give a presentation to the Disabled Veterans of America.

@ChrisBoyMonkey has also been very helpful in getting us contacts.

I like your thinking a lot, mrbrightside614. You should join one of our conference calls to discuss more. We'll be in touch with you soon.

We need more people like yourself who actually might have the determination to do something, instead of just talking the talk.

Can't believe I've missed this! I've read every treatment and success story thread front to back, but apparently not this one. I'd love to be a part of this.

 

[Hazel]

Can't believe I've missed this! I've read every treatment and success story thread front to back, but apparently not this one. I'd love to be a part of this.

I like your attitude! @Markku and I are actually due to have a call with @TuxedoCat tomorrow. We'll discuss your ideas and get back to you soon with a proposal on how we can all work together on this

 

[TuxedoCat]

@Markku, @Hazel, @mrbrightside614

If you've been watching the ATA's Facebook Page you'll notice that the NIDCD will be putting together a new strategic plan and ATA says that it will inform us when the comment period opens. NIDCD has a new director who, apparently, is keen to have patient input. If we can put together a strategy to get members of the Veterans Associations to respond when the comment period opens and also at other strategic points along the budget process in the US, it could be powerful.

I'm not sure yet how the Department of Defense puts together a research strategy or their process for getting funding from Congress, but I will be looking at this more. If you come across anything, please let us know. We need reach into this process as well and again the Veterans Associations could be a powerful influence there.

I'm looking forward to the possibilities - we need people around the US that can be organized as a team and actually get out there and help.


TC

 

[Ed209]

@Markku, @Hazel, @mrbrightside614

If you've been watching the ATA's Facebook Page you'll notice that the NIDCD will be putting together a new strategic plan and ATA says that it will inform us when the comment period opens. NIDCD has a new director who, apparently, is keen to have patient input. If we can put together a strategy to get members of the Veterans Associations to respond when the comment period opens and also at other strategic points along the budget process in the US, it could be powerful.

I'm not sure yet how the Department of Defense puts together a research strategy or their process for getting funding from Congress, but I will be looking at this more. If you come across anything, please let us know. We need reach into this process as well and again the Veterans Associations could be a powerful influence there.

I'm looking forward to the possibilities - we need people around the US that can be organized as a team and actually get out there and help.


TC

This is the kind of awesomeness that's required. Huge props to all of you.

 

[mrbrightside614]

@Markku, @Hazel, @mrbrightside614

If you've been watching the ATA's Facebook Page you'll notice that the NIDCD will be putting together a new strategic plan and ATA says that it will inform us when the comment period opens. NIDCD has a new director who, apparently, is keen to have patient input. If we can put together a strategy to get members of the Veterans Associations to respond when the comment period opens and also at other strategic points along the budget process in the US, it could be powerful.

I'm not sure yet how the Department of Defense puts together a research strategy or their process for getting funding from Congress, but I will be looking at this more. If you come across anything, please let us know. We need reach into this process as well and again the Veterans Associations could be a powerful influence there.

I'm looking forward to the possibilities - we need people around the US that can be organized as a team and actually get out there and help.

TC

Do we have any estimation of when the comment period might open/how long it might last? Going back to your point emphasizing the importance of synchronicity/timing of input, I could call the county offices in Ohio and tell them when the period is to begin/end.

Do we know if this be just open-ended input or will it be guided by prompts?

I think preparing some prompts for people to reflect on before finalizing their comments could lead to more constructive input.

 

[JohnAdams]

I think that a good place for us to focus is on the Hough Ear Institute and Frequency Therapeutics. It would be great to formally, as a community, designate an ambassador and reach out to them and try and work out a process for tinnitus patients to pay out of our own pockets to try their therapies under expanded use policies.

 

[Markku]

I think that a good place for us to focus is on the Hough Ear Institute and Frequency Therapeutics. It would be great to formally, as a community, designate an ambassador and reach out to them and try and work out a process for tinnitus patients to pay out of our own pockets to try their therapies under expanded use policies.

It looks like you just volunteered yourself for the job. Seriously, you are more than smart enough and spend a lot of time on this forum, so why not take the extra step? As long as you can remain diplomatic of course

It's possible they won't/can't play ball, but there's absolutely no harm in trying.

Although, with regards to Hough Ear Institute, we're interviewing them pretty soon, and @Hazel could ask this from them as well (if it's not yet part of the topics to be discussed). Frequency Therapeutics have not so far communicated with us.

 

[mrbrightside614]

I think that a good place for us to focus is on the Hough Ear Institute and Frequency Therapeutics. It would be great to formally, as a community, designate an ambassador and reach out to them and try and work out a process for tinnitus patients to pay out of our own pockets to try their therapies under expanded use policies.

This would be nice but from what I've gathered Frequency isn't particularly interested in even opening up a dialogue with us, let alone granting us special permissions to early treatment. I would think there would be ethical and legal considerations that would preclude a company from doing so, especially at the expense of the patient, but I could be wrong. I suppose it couldn't hurt to try.

 

[JohnAdams]

It looks like you just volunteered yourself for the job. Seriously, you are more than smart enough and spend a lot of time on this forum, so why not take the extra step? As long as you can remain diplomatic of course

I feel like this:

 

[JohnAdams]

This would be nice but from what I've gathered Frequency isn't particularly interested in even opening up a dialogue with us, let alone granting us special permissions to early treatment. I would think there would be ethical and legal considerations that would preclude a company from doing so, especially at the expense of the patient, but I could be wrong. I suppose it couldn't hurt to try.

They've got a lot riding on their company goals. I think they want to play it 100% safe and I agree that it would probably be futile, at this point, to reach out to them before they publish their secondary outcome measures relating to tinnitus. After that, if they present tinnitus improvement data, especially if it shows no adverse events, then they'd morally almost have to grant expanded use exceptions.

 

[mrbrightside614]

They've got a lot riding on their company goals. I think they want to play it 100% safe and I agree that it would probably be futile, at this point, to reach out to them before they publish their secondary outcome measures relating to tinnitus. After that, if they present tinnitus improvement data, especially if it shows no adverse events, then they'd morally almost have to grant expanded use exceptions.

The only problem is I don't even know how to quantify tinnitus severity. It's obviously not indicated from current audiograms and may not even be evident in extended audiograms. MML is as subjective as any of the THI handicap responses, so I hope this doesn't become a roadblock in expanded application. I haven't read their methods and procedures, if that's even available atm. Hopefully they could take patients at their word when they say "WOW MY TINNITUS IS BETTER" and let the other stats take a hike.

 

[mrbrightside614]

Does anyone think publishing a research review illustrating the immediate need of steroidal therapies in the event of acoustic shock would be worth the time and effort spent? This topic is worthy of a review in and of itself. Since I'm still involved with my masters program at UA, I could reach out to my professor who taught the Research to Informed Practice course to see what we could do about getting published. I think justifying ourselves with at least one scholarly publication could help our legitimacy as a movement in the eyes of the medical community.

This is high on my tinnitus priority list because if we actually get fixed by novel treatments, there would certainly be some portion of me bracing for another event that rekindles the tinnitus flame.

 

[TuxedoCat]

Do we have any estimation of when the comment period might open/how long it might last? Going back to your point emphasizing the importance of synchronicity/timing of input, I could call the county offices in Ohio and tell them when the period is to begin/end.

We don't have this information just yet. Markku, Hazel and I had a Skype call yesterday and it's in the works.

You have good ideas, but I just want to understand how it is that the VA will respond to the service offices. The service offices are run by local government and they will usually act to help veterans and their families access VA benefits that for which they are eligible. For example, my dad served 5 years during WWII, after he passed my mom needed help and moved into assisted living. Because she was a widow of a veteran who served during war time, she was eligible for little known VA benefits called Aid and Attendance. My local, county service office helped me with the paperwork and even submitted it for me. They were of great help, but would they have access to the decision makers who are involved with research funding? Right now, I think that's a real long shot, but am happy to be convinced otherwise.

As far as I can tell, the DoD, the VA and NIH all sponsor tinnitus research, but I need to get a handle on how and how much.

We can discuss more when we have the call in January.

Best Wishes for the Holidays,
TC

 

[mrbrightside614]

We don't have this information just yet. Markku, Hazel and I had a Skype call yesterday and it's in the works.

You have good ideas, but I just want to understand how it is that the VA will respond to the service offices. The service offices are run by local government and they will usually act to help veterans and their families access VA benefits that for which they are eligible. For example, my dad served 5 years during WWII, after he passed my mom needed help and moved into assisted living. Because she was a widow of a veteran who served during war time, she was eligible for little known VA benefits called Aid and Attendance. My local, county service office helped me with the paperwork and even submitted it for me. They were of great help, but would they have access to the decision makers who are involved with research funding? Right now, I think that's a real long shot, but am happy to be convinced otherwise.

As far as I can tell, the DoD, the VA and NIH all sponsor tinnitus research, but I need to get a handle on how and how much.

We can discuss more when we have the call in January.

Best Wishes for the Holidays,
TC

I have no experience in community organizing, so my approach was just based on contact accessibility. If we could skip the county office middlemen and forward our concerns in unison to the applicable state/national offices, that would likely be preferable. I think there is a small likelihood that reaching out to local offices first could better sprout a grassroots movement, but this is entirely speculation. I have no clue how seriously we will be taken at any level.

My idea would be to capture as many veteran bodies in as many locations as possible to circulate a pamphlet/petition that includes:

1. Mission statement including:

a. Desire to form a coalition because of mutual interest. Maybe entitle the form "Hearing Loss and Tinnitus Initiative" + something that inspires a feeling of empowerment & solidarity in case it just gets marked spam by cursory glance.

b. Short statistical breakdown of the prevalence of the condition (I have very specific stats with scholarly references regarding tinnitus to provide at the end of the form—if someone could do hearing loss stats in terms of profundity as it relates to U.S./vets/worldwide that'd be great).

c. Emphasis of the fact that we are no longer tolerating palliative treatments and the inability for ENTs to adapt to 21st century modalities that could rescue future hearing loss/tinnitus sufferers upon traumatic exposures. Stress the fact that we are no longer accepting proverbial band-aids for what has been taken from us.

d. How we can help each other—explain the overall lack of funding and poor allocation of resources regarding novel tinnitus treatments. This is where the conference call would really help to develop a strategy concerning how our alliance would be directed.

Do we lobby for more tinnitus/hearing loss research funding?

Do we demand a committee within the DoD or whatever other regulatory agencies govern tinnitus/hearing loss research to guarantee a voice in how funding is allocated to veterans?

Do we try to loosen the reigns on the restrictions of clinical trials to open up more experimental groups for veterans and tinnitus sufferers? (This one is an extreme stretch IMO)

Do we try to reach out to all leaders of similar organizations (ATA/BTA/NIDCD and other organizations @lcj provided) to unify and strengthen our voices?

2. Cite a place to collect online signatures for the backing of our agenda. Obviously our agenda has to be refined by this conference call

3. Outline the dates when the NIDCD is opening up their comment box or whatever. Include a list of prompts (that can be borrowed from items of THI/a research paper I did this semester concerning the domains of tinnitus) to guide participants in regards to how exactly their hearing loss/tinnitus affects them.

4. Section to inform sufferers of the state of current research regarding the prevention (steroids etc) and treatment of tinnitus and hearing loss (FX-322, Shore, Thanos).

5. Section to inform sufferers where to donate—I'd be EXTREMELY choosy of who to include here and keep it very brief—maybe 3-5 sources max.

5. Contact information for relevant Tinnitus Talk staff. I don't think we should include any other contacts because the VA is the first demo we're trying to capture and we're not really formally aligned with anyone else yet.

 

[TuxedoCat]

Do we have any estimation of when the comment period might open/how long it might last? Going back to your point emphasizing the importance of synchronicity/timing of input, I could call the county offices in Ohio and tell them when the period is to begin/end.

Hi Mr Bright-

It occurs to me that you might want to get in touch with your local services office and try to get a sense if they can be of help in influencing the tinnitus research agenda at the VA. You can tell them this is in the very early phases and we don't have a plan complete with timings, but that you just want to get a sense of the possibilities. And, you can ask them if they have seen many tinnitus cases. The individual that helped me with my mom's situation a few years ago was very nice and sincerely wanted to help. He knew how to navigate the VA bureaucracy and was helpful with wordings on the paperwork because he knew what the VA would be looking for. So, you may encounter the same if you do make contact and an inquiry.

Let us know if you do find out anything before we talk in a couple of weeks.

All the Best, TC

 

[mrbrightside614]

Hi Mr Bright-

It occurs to me that you might want to get in touch with your local services office and try to get a sense if they can be of help in influencing the tinnitus research agenda at the VA. You can tell them this is in the very early phases and we don't have a plan complete with timings, but that you just want to get a sense of the possibilities. And, you can ask them if they have seen many tinnitus cases. The individual that helped me with my mom's situation a few years ago was very nice and sincerely wanted to help. He knew how to navigate the VA bureaucracy and was helpful with wordings on the paperwork because he knew what the VA would be looking for. So, you may encounter the same if you do make contact and an inquiry.

Let us know if you do find out anything before we talk in a couple of weeks.

All the Best, TC

Got it. I'll reach out today.

 

[TuxedoCat]

@mrbrightside614

Love it! I'm really looking forward to talking with you.

TC