Retigabine (Trobalt, Potiga) — Petition to the ATA

Dear Markku,
I apologise for being a pain in the neck or a..
But the following post from Dan got my attention and I think it's worth perusing:

I'm not the best writer or beat around the bush person so here it goes:

Markku as a leader of this board I think that your guidance, with our help of course, is absolutely critical for this idea to see a daylight.

As you know the retigabine thread has a great interest of us tinnitus sufferers and I think it's unacceptable that this drug had never been trialed for tinnitus per se.

Being available on the market is a huge bonus, it just needs to be made available off label for tinnitus.

After some testing of course. No one so far had life threatening or permanent side effects, that's promising.
Even my gp, upon checking his medical info on computer, said that this drug can help tinnitus.

Not sure what other members think about this idea but I would like to hear some opinions or suggestions.

Over 4000 signatures from this board alone is not a small number, I'm sure people are members of other forums or groups, so we are talking many more.

I can get hundreds alone from my friends and the whole dental hospital if needed
I don't think it's too much to ask.

Fire away TT members!

 

@attheedgeofscience and
@Dr. Nagler - come to my mind

With their sharp intellect and guidance we can do the right thing

Please people can you give some suggestions!

Thanks @Markku, I'm sure everyone can get hundreds of signatures from friends, family and work colleagues

 

Consider if signatures are even necessary.

If you would like to enlist the help of the ATA, then I would start by first contacting the association for their (informal) opinion. Then based on that, you can decide what next steps to take. I would not start to engage in all kinds of preliminary activities until you know where you stand; they may reject the idea regardless of how many signatures can be collected, or they may think it is brilliant straight away. In both cases, the preliminary work would be wasted.

There is nothing wrong with doing advocacy work. There is also nothing wrong with helping yourself first. If you suffer from tinnitus and have decided to the best of your ability that Trobalt would be worthwhile for you to attempt (considering whatever risks there may be), then do it!

And if your current GP won't go through with it, then find someone who will. I would, however, listen to the feedback/reasons that the GP provides as to why not (before moving on to someone else).

My suggestion.

 

@attheedgeofscience

Spot on as usual!
Who do you think would be the best person to do this preliminary talk to ATA and what is your opinion on contacting universities?

 

I have never been in touch with the ATA, but I believe they can be contacted via their homepage, of course:

http://www.ata.org/about-ata/contact-ata

Or you can ask Dr. Nagler. He would know.

I would supply them with a pubmed document such as the following:

http://www.ncbi.nlm.nih.gov/pubmed/24681057

But as always, consider what it is you are trying to achieve. If you want to help yourself, then approaching the ATA with the above information will not lead you to your goal.

 

I would also suggest getting the US military's attention on Retigabine and our petition. Other militaries that would be interested are Israeli, Russian, Chinese, etc. Autifony is also working with the US military.
But this is the next step. I think this has good potential.

 

@attheedgeofscience

This is by no means an attempt for a personal gain, this has been suggested by @dan and I just think it's plausible!

Then again, when I think bit deeper, yes it's personal as well cos I would like to get rid of this shit

 

The US military has its own so-called centre of excellence dedicated to hearing loss (probably not known to that many). I have commented on that earlier on within the following thread which also contains a small amount of advocacy I looked into:

https://www.tinnitustalk.com/threads/bta-refuses-to-fund-drug-and-stem-cell-research.6599/page-2

 

A center of excellence that knows F#$Kall about Retigabine.
Lets not dismiss any opportunity.

 

Another publication that could help to lobby about retigabine:

http://www.ncbi.nlm.nih.gov/pubmed/23716673

 

In terms of ATA, your goal would be for Dr. Jennifer Melcher, Chair of ATA's Scientific Advisory Committee, to (with the approval of ATA's Board of Directors) issue a call for research proposals to study the efficacy of Retigabine in the treatment of tinnitus.

Your petition should be sent to Cara James (ATA's Executive Director) and copied to Dr. Melcher and Thomas Lobl (Chair of ATA's Board of Directors).

The petition should be short and to the point. It should be sent to the above by @Markku as owner of Tinnitus Talk. Those signing should give their real names and cities.

The petition should contain the year of the founding of Tinnitus Talk. _____

It should not contain the number of members of Tinnitus Talk. The only relevant number in that regard is the number of people who sign.

If @attheedgeofscience would be kind enough to summarize Regitabine's mechanism of action and the rationale behind its proposed use in tinnitus in two concise sentences, that would be very helpful.

Also -

How many people on the board have tried the drug? _____

How many of those have achieved what they would consider to be substantial relief? _____

I would not cloud the issue with reference to "a little bit of relief" or the like. I would not refer to side effects in the petition.

With the above information, I would be willing to help with the wording.

Dr. Stephen Nagler

 

Noted.

 

This is all fantastic stuff - great!
But please I have a request.
Can we please not limit this to the ATA. This in effect limits it to the americans amongst us.
How abouit the (pretty useless IMHO) charity BTA as well?
This is a global problem as mentioned above. So military in many (allied to the west anyway) suffer from it.
Israel I would think would be a great place to start as every citizen (age permitting) must serve in the armed forces.
There are charities set up in many countries ''dedicated'' to T.
Many are english speakers such as South Africa or Australia and New Zealand.
But they potentially exist in many other countries such as Poland Spain Russia or any other countires from where members on the forum come.
So no problem with language then if the member can do the translation.
ideally we could direct this right across the board, and world, using social media to get so many signatures that it will provoke a talking point in the main news channels. And then keep it up so it doesnt go off the boil.

Just a quick thought:
As we know Retigabene is offered to epileptics only when other drugs have failed (I think that is correct?). Is this due to the side effect potential / strength of the drug.
If so, does this mean that it will not be chased up or investigated as a potential cure due to the already known side effects?
Or would it go straight into phase 4 study for T as it is already a known and used drug?
Apologies in advance if these are random and stupid questions.

I am willing to help in any way I can.....as are I am sure many members on this forum.
Can we get a list of potential helpers who are willing to spread this message across social media?
Or would you all say that this is not a good thing to do?
I realise that we have to get our facts right and our what we are going to say agreed and correct...
But surely more publicity is a good thing as opposed to not?

Just as an aside, programme on bbc radio five live right now.
About headphones and noise cancelling...
Not one mention of the dangers of listening too loudly as usual.
But all the facts and prices otherwise on headphones....shame...on the BBC again!
This is what I mean about lack of publicity.
Now if this campaign was going and we were getting groups signing and joining up together across the oceans, well the BBC would mention T when discussing headphones. It would become a normal follow up part of the conversation when discussing such topics, at least a health warning with the conversation reminding people to not raise the volume too high.....which means that the level of T awareness would have risen considerably...no??
And a follow up conversation on the BBC five live radio is about hearing aids whereby someone can pick up the wi fi routers with these new hearing aids.....by the way provided free by the NHS and costing much more than the most expensive headphones...he played the sounds he hears from the wi-fi....it sounds a lot like the sounds that people say they hear with T. And they are all saying how wonderful it is and how great it is to be able to hear all these sounds which are music to the ear!!
What a lost opportunity to mention T in this long programme about hearing and technology.
Sorry this last part of my post is off topic....BBC five live on while i write this....now they are playing new sounds that can be heard of fake engine noises, so they are now saying that this would be great to offer the kids while they are bored i n the car!
Or sounds that can be of explosions! Help to deal with road rage! What ever next....?

 

Yesterday was a particularly bad t day for me - the kind where you want to chop your head off. I've always thought that cinematography is a great way to alert the public. Think of Matthew McConaughey in The Dallas Buyers Club. If anyone has seen the movie, it really brings home just how desperate the first HIV infected people were, before antiretrovirals became the norm for managing patients with HIV. Plus is shows to what lengths they would go to to get their hands on anything that would prolong their lives. Desperation similar to us right?

Yes, tinnitus is not classified as life-threatening as HIV but it is life-altering and with no cure to date.

For a film, I imagined the scene of two people talking. One with t, the other without. When the t sufferer spoke, the t played through the cinema sound system over his/her voice. When the non t sufferer spoke, the incessant noise stopped. The film would obviously need a good story line. Maybe the lives of 5 t sufferers inter-twined. But i thought what better way to wake people up to our suffering then through a movie that half of it was the sound of t. The audience would come out stunned, (probably in pain) having experienced t for only 60 minutes. At the end of the film. It can say: "Did you find the noises of the 5 people disturbing? T sufferers live with this every day for their whole lives. Something can be done about this ... Enter promo for Retigabine trial or funding for advancements in medicine". Obviously something far more artistic than what i have depicted but you get my drift? Let ordinary people experience what it would be like for them to have t for just one hour. What better way to show the public than have them experience t themselves? The relief they feel when they walk out the cinema to silence...

A Dallas Buyers Club type movie but about tinnitus? What better way to advance medicine and possibly a retigabine trial and more? Any good screenplay writers, directors, producers, actors, writers out there that could make this happen?

Ok, so maybe a petition first but we have to think big. Dallas Buyers Club came after the fact which is a sad thought. What if that movie had been made before? Would there have been more funding available to fight HIV? Sir Bob Geldolfs plea to feed the starving children of Ethiopia in 1984 was met because of the terrible scenes people saw on their TV's in Africa. Again this year with Ebola. TV and film are strong channels to make it happen.

Anyway, it was just a thought. I'm all in for signing any petition to make Retgabine available to us and properly trialled and will spread the word.

 

@SteveToHeal

Well done! What a great post. Think big!
Dont sit in an armchair being cynical but get thinking.

Can we approach the large hearing aid manufacturers or shop chains - to put up petition in their shops, on their websites, or even to dare to ask them that they give a small donation to the charity (which would have to be set up) or direct to other charity already existing, the funds gathered all for T research. They can publicly proclaim that they give such donations which would attract more advertising and business.

Just as an aside, just announced in the news - a chap named as Julien Bloch (i think from USA) who wants to come into Britain who also has proclaimed violence etc...against women.
100 000 signatures gathered by social media asking that he not be allowed into the country
Result, Foreign Office has said he is not allowed in to UK

So you see, enough signatures from public and it is publicly discussed and there is action.

 

As I understand it, the idea is to get a study done the results of which will at the very least make physicians everywhere more willing to prescribe Retigabine to their patients. ATA is well-positioned to fund such a study if they can be convinced that it would be a worthwhile thing to do and if they can draw interest from respected investigators through a call for research proposals.

If you want to have separate petitions for various organizations throughout the world, I see no problem with that. Rather the problem is that - as @Markku noted above - "I've seen tinnitus petitions before, and pretty much all of them have failed. I have never seen a tinnitus petition gather more than a handful of signatures. This is the sad reality."

I'd still like to know how many people on this board have tried Retigabine in the hopes of attaining tinnitus relief and out of that group how many have achieved what they consider to be substantial relief.

Dr. Stephen Nagler

 

If we are trying to get a drug approved for tinnitus, it will require (in all places I'm familiar with) a clinical trial of some size and rigor. Such a trial can cost way, way more than ATA or any other such charity can afford. Drug trials are generally funded by the pharmaceutical firm that hold the patent or by government agencies.

As Dr. Nagler described, though, the ATA could consider requesting proposals for smaller efforts that could help lay the groundwork for a major proposal by a researcher to an agency like (in the US) NIH or DOD.

 

Jim, I think what they are talking about is a study the results of which would encourage physicians to be more willing to prescribe Retigabine for tinnitus sufferers off-label. I totally agree with you that getting Retigabine formally approved for use in tinnitus would be a much bigger deal.

Dr. Stephen Nagler

 

@Dr. Nagler
You can find here informations about people who tried or are currently trying and some informations about improvements of their tinnitus and relief they think retigabine has provided to them (however, i don't think all the people who have tried retigabine have filled those report forms) :

https://www.tinnitustalk.com/threads/retigabine-trobalt-potiga-—-user-experiences.6047/

 

Not to rain on the parade here, but I think we need to be careful about the word "TRIAL".....In many respects that can generate all sorts of connotations, expectations, requirements, obligations, red-tape, and any manner of possible bureaucratic baggage.

I agree fully with comments so far, that the goal needs to be very clearly defined and "felt out" before embarking on a petition drive strategy to fulfill that. In very simplistic terms, I think that goal is to "just" make Trobalt/Potiga less scary to doctors so they can prescribe it off label to those asking for it for potential Tinnitus relief and not 'last resort' epilepsy patients...Am I correct???
If so, this is not a "trial", this is a "label change". It's a..."Hey docs, loosen up a bit you won't get sued" change. No one is suggesting this drug be handed out without a prescription, and the fact that it is already available (in some countries) means the "it didn't kill the trial participants" approval stuff has already been done. Again, I would leave the word "Trial" out of it altogether - or at least buried innocuously or I envision 'Autifony type' time frames.

Now how one effects a "label change" is ?????? Is this an FDA thing (for USA)? Is this a GSK manufacturer thing? (And would they want to take that on if it was not in their application trials in the first place?). Is it a "muscle thing", where the public pressure is so great rules are changed? (Think Ebola). If a "muscle thing" I suspect it would need a huge response with big backing like the VA pushing it heavily (see ATEOS's link there, it is impressive what they have going regarding hearing issues)...The ATA and BTA??? I'm not sure they have the clout but those initial calls to ask are essential first steps there, as at least they have the supposed 'name recognition' credentials for the subject matter = Tinnitus.
And so on...

That link c/o @attheedgeofscience ... https://www.tinnitustalk.com/threads/bta-refuses-to-fund-drug-and-stem-cell-research.6599/ I think is highly relevant to this discussion as there is a lot of cogent information, plus methodology pros and cons voiced in there.

@SteveToHeal ...I agree that "movies" (aka 'entertainment' = sic, in our case!) are a very, very effective way of changing/addressing public perception. I can think of numerous examples, but one sticks in my mind from some time ago but it makes the point. An Indian/Apache-Native American friend of mine said to me after Kevin Costner starred in "Dances With Wolves" in 1990 [It took the USA by storm!]..."You know, I think Costner, without maybe even knowing it, did more for the Native American cause and self esteem in 2 hours than 50 years of activism, petitions, lives, and cries in the wilderness". This friend had been such an activist for decades.

On that note, I have thought and discussed with some of the mods, about choreographing and doing a modern dance/semi-improvised theater piece, with TT members from all around the world. The subject of course would be Tinnitus. The venue could be anywhere. The commitment would be real. The impact could be spread further by doing a professional-style (not hard these days) video of it and using that for "promotion" and "awareness"...Same idea as a movie really, but more intimate if performed live.
It's a stretch of an idea, but has generated thoughts of how, where, when, and a sort of "TT gathering" at some benefactor's estate (any offers???!!!) where those of us who cannot be around cities and normal conferences (too noisy), etc. would be 'sound safe'.

To conclude....Perhaps this is two threads here??? One would be the "Label Change" thing (or whatever to call it), and the other would be "More ardent Tinnitus Awareness ideas" to support that? The former seems like it may be very technical and step-by-step. Uncovering rocks, finding new rocks to uncover, making a trail of evidence, etc. The latter, more creative and 'global' so to speak.

My two cents....Best, Zimichael

 

To be honest, I am not 100% sure what "we" are trying to achieve here (since I am not the one who wrote the original post).

But here is what I will do (after an exchange earlier today with @Markku):

1) Contact one of the co-authors of a recent research paper on potassium modulators for a formal definition of the mechanism of action of Trobalt in relation to tinnitus suppression.
2) Contact GlaxoSmithKline for any view/input/feedback/consideration that they may be willing to provide on their own product. I will include recent research from this year on potassium modulators.

I have no idea how successful I will be, but as the saying goes, if you do not try, then you will never succeed.

I also do not think that this kind of work is very relevant; it is relevant, but not very relevant. The reason it - in my opinion - is not very relevant is because any doctor, anywhere in the world, can already - today - legally prescribe Trobalt for off-label purposes should they want to. And that would include tinnitus. And by the time a study such as the above might be finished, then we hopefully already have another and safer product available on the market. Or at least nearly so.

 

If by"relief" you mean never hearing severe tinnitus (that I heard every second of the day for 5 months when not in the shower- and occasionally even over the shower)- then count me in

My tinnitus reduced significantly within a couple weeks of starting retigabine - to the point of being very tolerable - I would have been thrilled if the improvement would have stopped there-- but it didn't-- I basically can't hear my tinnitus even when searching for it now, occasionally I'll hear it when plugging my ears (but not always when plugging ears)

I have no doubt that retigabine is responsible for my initial volume reduction.butto tell you the truth the continued improvement that I have seen in the past couple months-- I'm not sure if its from retigabine (because I am off of it now) or through brain plasticity being able to file away the insignificant sound that I was left with

 

Right, I would definitely count you in - and I am absolutely thrilled for you.

But one success story does not a trend make. In order for a petition to have any chance of getting attention, we would need to know how many tried the drug (even for a day or two) in the hopes of achieving relief and how many ultimately "achieved what they would consider to be substantial relief" that they attributed at least in part to the drug.

Dr. Stephen Nagler

 

Would GSK fund further trial since it's their drug?

@Dr. Nagler
Valid point but it goes back to supply issue, I'm sure many more on this board would have tried if it was readily available.

 

@Dr. Nagler from the retigabine user's thread (see link in my former post), I can count at least 8 people who had at least temporary relief and improvement of their T

Edit : around 15-16 people have tried retigabine, but it seems that most of the people who didn't have any relief were the ones who couldn't reach 600 or 900mg/day (because of supply problems - which are related to the aim of this thread - or because of side effects)

 

Sorry.....But I am more of a "data proofer" if you want to carry a stick with any weight behind it. I still think our sample size in the Retigabine trial is too small and too "young" to get serious attention in the halls of GSK, etc.

My leaning would be more towards a push on the already available, published evidence, (and we have those sources) showing the relationship of Kv7/Retigabine to potential effects on tinnitus...and then add the "evidence" of our own, in terms such as: "Preliminary informal trials by volunteer subjects are supporting this supposition to date".

 

Avoid the word, "trial." I had just skimmed this thread, and that word--as Dr. Nagler mentioned it might--implied something huge to me.