Retigabine (Trobalt, Potiga) — Petition to the ATA

[valeri]

This is a public forum. The information here is available for all to share and distribute.


I am honestly not sure what you mean. Are you referring to the paper by professor Moore or the statistics? Or are you referring to the fact that the data collected in the trial was done via the Internet? Or are you referring to the file format of the statitics? Or something else?

Is it "formal" enought to be presented as a statistical data?

 

[attheedgeofscience]

Is it "formal" enought to be presented as a statistical data?

By definition, everything done here is non-formal. This is a public forum. The statistics were compiled by non-professionals (= me). And the trial was conducted in a very non-clinical setting, so-to-speak.

Still... Team Trobalt managed to develop contacts with researchers and - with the help of TRI - have submitted a manuscript to a recognized journal of pharmacology.

The data is what it is. And so is the format. You - and GSK - will have to make do with it because... that's all there is!

Alternatively, you could refer GSK to the User Experiences Section URL (which is where the raw data is located). Still, this is non-clinical data all the same...

www.tinnitustalk.com/threads/retigabine-trobalt-potiga-%E2%80%94-user-experiences.6047/

 

[valeri]

@attheedgeofscience

Thank you!
Helpful as usual

 

[Danny Boy]

I don't think the ATA will care about trobalt, as if it helps treat tinnitus, they won't make any money, GSK will. And GSK doesn't care as they have Autifony.

 

[valeri]

@attheedgeofscience

Jacob do you have any links to statistics related to army forces and tinnitus.
Any related to Australia? I know it's probably negligible compared to U.S. army but I don't have any luck in finding any data.
Just trying to gather some info then I will contact one person (former soldier) here to see if he can help somehow.
Thanks!

 

[attheedgeofscience]

Jacob do you have any links to statistics related to army forces and tinnitus.

For the US armed forces, there is a pile of info and statistics via this post of mine from earlier on:

tinnitustalk.com/threads/retigabine-trobalt-potiga-%E2%80%94-petition-to-the-ata.6896/page-5#post-81128

(see the pdf-attachment for the link above).

Or you can go straight to the US Army's Hearing Centre of Excellence:

http://hearing.health.mil/

About the Australian armed forces, I would need to check on that (I don't immediately have any links/info in my head, I must admit).

 

[attheedgeofscience]

Any related to Australia?

I found this article which has some statistics in it:

www.theaustralian.com.au/news/health-science/defence-ignores-silent-service-hearing-loss/story-e6frg8y6-1225863770971

 

[valeri]

@attheedgeofscience

Regarding the latest update from team trobalt, why is it so hard for prof and researches to run a proper trial on trobalt?
I mean the drug is here, there is an evidence it's working so why all this beat around the bush?
One would expect gsk and anyone interested in tinnitus cure to be jumping the vagon and taking it a step further.

Thanks!

 

[attheedgeofscience]

Regarding the latest update from team trobalt, why is it so hard for prof and researches to run a proper trial on trobalt?

Because the world is not a perfect place; because Trobalt has side-effects; because Trobalt was brought to the market for other reasons; because it costs money; because there are ethical reasons in relation to running a trial.

Let's do a comparison. The American (=National) Rifle Association has some 5 million members and +$250M revenues. Compare that with the ATA which has well... let's not even mention the numbers, because... there is no point. What does have a point is that there are at least 5 million chronic tinnitus sufferers (or more) in the US. But for some reason, tinnitus research and curative aspects just do not seem to have the same appeal as guns (in this instance - and in this example). Not also forgetting that the US DoD is handing out some $1B in hearing disabilities per year to its veterans. That fact in itself should be an incentive for making an effort.

Let me give you another example. Something I am more familiar with. The first stem cell treatments using Mesenchymal stem cells were conducted already 10 years ago in China (www.sinostemcells.com). These types of stem cells have the potential to cure/treat a number of "incurable" diseases - examples being: eczema, allergies, autoimmune disorders - which would include e.g. MS, arthritis, diseases of the eye - not to mention improvements with conditions involving paralysis (most recently complete paralysis of the spine - a condition which remains incurable due scar tissue formation that occurs after injury, but which can now to some degree be overcome using grafting techniques in a "proof of concept" scenario). I have myself felt first-hand the effects of stem-cells (I have been through two separate stem cell treatments). While I did go for stem cell treatments due to tinnitus, I did also - as it happens - have other conditions as well: life-long eczema and a chronic auto-immune eye disease. Both were cured not just 20, 30 or 50% - they were cured 100%. When a person gets cured of "something" 100% after 30 years (of eczema, in my case), that individual knows they are dealing with something pretty powerful. And so, you would think that everyone would immediately investigate further. Right? As I say, the world is not perfect. And that's already 10 years ago...

Returning to Trobalt, specifically, I think it was (very) interesting in the beginning of the thread created by Mpt. I still maintain that it is interesting. I also maintain that Mpt's testimony was accurate and sincere. He did end up cured. Unfortunately, we do not seem to have been able to replicate the same outcomes (even with volunteers going as high as 1200 mg/day; Mpt only went up to 900 mg/day). Ideally, we therefore need to understand what was "different" in Mpt's case. Was it because of his recent onset of tinnitus (i.e. 6 months or so)? Was it because he had already seen improvements because of two rounds of steroids (which is unusual - and prone to side-effects)? Was it because of his specific onset (i.e. ear-syringing)?

What the Tinnitus Research Initiative has offered the tinnitus community is that they will publish the outcome of an Internet based trial of Trobalt in a recognized pharmacological journal. This can be done as a series of case studies. I have already highlighted the problems faced (i.e. lack of willingness of participants to volunteer their data in a timely manner). Without proper data, who would risk funding a trial where the evidence of success is non-visible in its early stages?

attheedgeofscience
15/APR/2015.

 

[attheedgeofscience]

@attheedgeofscience

Regarding the latest update from team trobalt, why is it so hard for prof and researches to run a proper trial on trobalt?
I mean the drug is here, there is an evidence it's working so why all this beat around the bush?
One would expect gsk and anyone interested in tinnitus cure to be jumping the vagon and taking it a step further.

Thanks!

In addition to my response, above, there is one thing that you (and others) can do if you wish. A "thing" which potentially could be quite useful. I noticed that the Message From Team Trobalt...

www.tinnitustalk.com/threads/team-trobalt-update-%E2%80%94-april-9-2015.9064/#post-105730

...has at this point in time received no fewer than 40 positive ratings! To put that into perspective, I should mention that TinnitusTalk has now passed the 100,000-mark in terms of number of posts:

However, you will not find a single post on the entire forum which has received more positive ratings than the post that was alerted to you yesterday! Guaranteed.

So what can you (and others) do to contribute? Well, you can go to...

https://twitter.com/tinnitustalk
https://www.facebook.com/TinnitusHub
https://www.facebook.com/TinnitusTalk

...and either share, rate, and/or re-tweet the post via those platforms (see below)

Facebook:

Twitter:

Thanks.

attheedgeofscience
15/APR/2015.

 

[sakrt]

@attheedgeofscience

Regarding the latest update from team trobalt, why is it so hard for prof and researches to run a proper trial on trobalt?
I mean the drug is here, there is an evidence it's working so why all this beat around the bush?
One would expect gsk and anyone interested in tinnitus cure to be jumping the vagon and taking it a step further.

Thanks!

Valeri: I agree with you. It's ALL political. Competition and money between pharmaceutical companies. ALL drugs have side-effects - some worse than others. Even more disgusting are the ones placed on the market without approval - from Pfizer. There are ethical protocols for clinical trial studies. Researchers/ doctors CANNOT divulge any info. about their research to outsiders who attempt to inquire of it. Think about it - do you think they'd actually blab to an unknown individual on the phone or email, of ANY significant new data before publication? They just repeat what's already on their website. or else they will be held in contempt for sharing confidential info. Their drug may not even be approved. (Test subjects are required to sign confidentiality contracts as well).
In regards to (young) military veterans who are currently suffering from "T" and baby-boomers - whom are a big market today. They are currently the main focus for pharmaceutical co. to creating a short-term drug/device to make a fast buck, even though there are similar drugs already on the market, as you said - Trobalt. However, even this drug has not yet been further evaluated. Why?
Political and money - it's already on the market: The End.
Announcements of new drugs is enticing but also can be misleading. I sense from your posts, you'd find better answers from the majority of people on other threads, who can provide you with direct info. from their own experience(s) of taking the actual drug(s) themselves (including Trobalt), rather than hearsay gobbledegook from reps and investors of one not yet approved.
If this drug is approved, we then shall learn from actual customers of it's success (or horror).

 

[Danny Boy]

Valeri: I agree with you. It's ALL political. Competition and money between pharmaceutical companies. ALL drugs have side-effects - some worse than others. Even more disgusting are the ones placed on the market without approval - from Pfizer. There are ethical protocols for clinical trial studies. Researchers/ doctors CANNOT divulge any info. about their study to outsiders who attempt to inquire of it during research. Think about it - will they actually tell an unknown individual confidential info. before publication? They just repeat what's already on their website - or else they will be held in contempt for sharing confidential info. Their drug may not even be approved.
In regards to (young) military veterans who are currently suffering from "T" and baby-boomers - whom are a big market today. They are currently the main focus for pharmaceutical co. to creating a short-term drug to make a fast buck, even though something similar is already on the market, as you said - Trobalt. However, even this drug has not yet been further evaluated. Why?
Political and money - it's already on the market: The End.
Announcements of new drug creations is enticing but also can be misleading. I sense from your posts, you'd find better answers from the majority of people on other threads, who can provide you with direct info. from their own experience(s) from taking the drug(s) themselves, rather than hearsay gobbledegook from reps and investors of one not yet approved.
Till this drug is approved, we then shall learn from actual customers of it's success (or horror).

Pfizer isn't doing anything for tinnitus, sadly, as they are the second biggest pharmaceutical company in the world. Odd how a spin-off GSK company is working for a cure. From what I can tell Dr. Charles Large has bought patents from GSK to create his new drug. So hopefully he's doing this to win a nobel prize and to be remembered in history.

 

[NiNyu]

The American (=National) Rifle Association has some 5 million members and +$250M revenues.

What does have a point is that there are at least 5 million chronic tinnitus sufferers (or more) in the US. But for some reason, tinnitus research and curative aspects just do not seem to have the same appeal as guns..

T doesn't exist for most people. It's not even contagious or life-threatening thus nobody cares. Furthermore, pharmaceutical companies are not interested in a cure. They want something to sell you for a lifetime. It's all money business. Next!

 

[Brianna]

T doesn't exist for most people. It's not even contagious or life-threatening thus nobody cares. Furthermore, pharmaceutical companies are not interested in a cure. They want something to sell you for a lifetime. It's all money business. Next!

Hey hey hey, you. I keep wanting to not pad stuff here to be a bit euphemistic and hopeful for some. We've got to stop agreeing. But I had a thought (a few):
1. I am trying to migrate to organic, as organic and non-GMO as that can be. Toxic pesticides and some known neurotoxins are in what we eat normally. neurotoxins affect the nervous system, so attempting to move away from Monsanto, et al . Seems like a decent attempt. Due to Monsanto's great control, while I am reaching for organic, winds blow toxins ... I may still consume those. I still drink an occasional diet xxx and know aspartame is in it and what it did from me when I drank a lot of it.
2. In my early to late adult life, just before my last job ended, I had an endless stream of:
a) highlighting my hair (the fumes were horrible) b) straightening my hair (once in high school) c) getting a perm of all things. Then I had my nails done with acrylic and who knows what else.
3. I lived 15 miles from Indian Point Nuclear Power Plant in NY. Studies were being done using kids teeth that had fallen out to check for toxicity.
4. I live probably < 10 miles from a coal plant on the French Broad River. I know the city water is high in chlorine and that's not good.
5. Add to that the scripts given, surgeries done, etc.
6. Then, commute to NYC and go through what used to be the World Trade Center to get to work (or just ride the subway system on a hot summer day). Remember (or not) Guiliani telling everyone shortly after 9/11, to come to NYC - everything's fine. We knew it was bs then and proven years later with first responders dying off.

Anddd ... the list is endless. We all use hair products. Sodium laurel sulfite has been identified as a known carcinogen. I don't know what else is in it but it's likely not good.

I don't know how in the heck one detoxes from a lifetime of toxins.

But yeah, we've pretty much been saying the T community isn't worth it - looking for not a cure but something to help with it without doing damage to our bodies. The hearing-impaired community wasn't worth it. This stuff is nuts.

From what I can tell Dr. Charles Large has bought patents from GSK to create his new drug. So hopefully he's doing this to win a nobel prize and to be remembered in history.

The endless optimist and knight on his continuing quest. I remember you said you'd like to get England back on the map (and it was never off the map ). Your optimism is something that would be worth bottling and selling. I'll buy the first bottle.

 

[valeri]

Email I received from GSK:

"Thank you for your email relating to Retigabine. GSK values any feedback provided by our customers. We have forwarded your suggestion to the appropriate department within GSK for consideration."

Now we sit and wait for some reply from the "appropriate department".

 

[Rog]

Now we sit and wait for some reply from the "appropriate department".

I will be in bed...

 

[Calories]

This is my last hope! If this fails, I will be pushed to modulate all potassium things in my body with KCN!

 

[attheedgeofscience]

It's all money business.

It's always about money. For any business! For instance, have you ever heard about a car salesman who wakes up in morning and says to himself: "Hmmmm... today I am going to sell all my cars at a price of 10% below the break-even rate - just for the hell of it!"?

I haven't...

Businesses exist to make a profit. Maximum profit, in fact. This concept along with the basic supply-demand curve are the two "axioms" of economics on which pretty much all "economic theory of the firm" is based. The will (and need) to survive applies to any and all businesses. There have been academic scholars who have tried to frame the purpose of a business in other terms, but all those theories eventually failed.

Furthermore, pharmaceutical companies are not interested in a cure.

Another concept straight from business school: in a competitive market place (i.e. non-socialist state), businesses have to compete with each other and as long as there is not a monopoly within the specific market segment, businesses will have to take into consideration the quality and the pricing of their product. If they don't, some other business will come along and run them into the ground (= market competition). Market competition is therefore a natural way to ensure that the consumer is left in the best possible position regarding the goods produced (in this case, medication). This also applies to the pharmaceutical industry which easily qualifies as a market segment in which there is strong competition because:

1. There are many players on the market forcing them to compete with one another (hell, even the newly emerged neuro-otology sub-field has some +10 players in total)
2. The quality of the "product" is important i.e. suppose, as an example, if OTO-311 were to be found superior to AM-101, then that would leave Otonomy with an advantage over Auris Medical (which they - AM- obviously would try to prevent by ensuring their own product is best). "Superior" in this case would refer to parameters such as: pricing, side-effects, delivery mechanism, and efficacy. And these are the parameters on which pharmaceuticals compete with each other - believe it or not (although, I am pretty sure you do not...).

They want something to sell you for a lifetime.

Right. So that would explain why both OTO-311 and AM-101 are one-off treatments...

Like all businesses, pharmaceuticals aim to maximize their profits. However, the way they do that is not by selling untested products as @sakrt has implied ad nauseam on this forum, nor is it done by engaging in a "conspiracy" to create a product required to be taken for life, as you (and others) tend to imply (again, ad nauseam). No, what pharmas do is to engage in off-label promotion of their existing product base. This allows them to take their already developed product and make more revenue by offering it to another patient group (for which the medication could be considered effective e.g. Aspirin is a painkiller, but can also be used for purposes such as reducing inflammation or thinning of the blood).

From time-to-time, I read about scientists being worried of so-called super-bugs. These cause infections for which they - the scientists - worry that there will be no effective treatment (i.e. drug resistant). Medical professionals sometimes call it a threat to humanity that must be solved with great urgency. Turns out they were wrong. Since the invention of the Internet, it has become painfully obvious that the most immediate threat to humanity is the amount of stupidity displayed by certain inhabitants of planet Earth. If in doubt, one needs look no further than some of the messages posted within this thread.

attheedgeofscience
16/APR/2015.

 

[Calories]

Adding to what @attheedgeofscience said. Remember once there were only medication for Diabetes, now we have insulin, now further research is on for an oral insulin. More over stem cells are being researched to make pancreas secrete insulin.

If Pharmas were only interested in tablets, why did a wise guy think further, it is business too, create a new U.S.P and get new business. Even if some one finds a medicine for temporary relief for tinnitus, then it creates a U.S.P for a new company to create a permanent cure.

But, till then... We all will have to suffer

 

[valeri]

Msg from GSK:


"I can confirm that your email has been received by the relevant department,
They wish to inform you that at this point in time GSK has no plans to develop Retigabine for tinnitus.
Once again, thank you for the information you have provided. GSK values any feedback provided by our customers."

No surprises there I guess

 

[Danny Boy]

Msg from GSK:


"I can confirm that your email has been received by the relevant department,
They wish to inform you that at this point in time GSK has no plans to develop Retigabine for tinnitus.
Once again, thank you for the information you have provided. GSK values any feedback provided by our customers."

No surprises there I guess

GSK already sold patents to Autifony so I'm guessing they'd be reluctant to create or reapply this for tinnitus..I could be wrong though.

 

[nills]

Msg from GSK:


"I can confirm that your email has been received by the relevant department,
They wish to inform you that at this point in time GSK has no plans to develop Retigabine for tinnitus.
Once again, thank you for the information you have provided. GSK values any feedback provided by our customers."

No surprises there I guess

There are several other companies already researching similar compounds and analogs so it isn`t a surprise GSK isn`t going to clean up their problem child.

 

[Mark662]

Autifony is a "spin out" from GSK, so maybe they will re evaluate their position if AUT063 turns out to be ineffective.

 

[valeri]

@attheedgeofscience

Just reflecting on what was written in another thread, any chance of getting China interested in further investigation in Retigabine?
Being worlds superpower I wouldn't be surprised if some answeres would come from there.
Southeast university of ninjang is involved in some research with Salvi, but I don't think it's got to do with anything "real" like retigabine.
What are your thoughts on this?
Thanks!

 

[attheedgeofscience]

What are your thoughts on this?

Thank you for your message. I have read the article by Dr. Richard Salvi (re: Nanjing University, China) and which can be found elsewhere on this forum. My understanding of the article is that the joint focus area of the universities involved is related to imaging studies (as in "where is tinnitus activity located within the brain"). This would be similar to what the TINNET initiative is pursuing in their EU-wide study (remember that TRI is behind TINNET - and TRI is assisting Team Trobalt):

Source: http://tinnet.tinnitusresearch.net/index.php/tinnitus-working-groups/tinnitus-neuroimaging.html

In addition, I took note of the following quote within the article which featured Prof. Salvi:

"Other research has shown this activity, but what is novel about the current study is the amygdala pops up. This is the part of the brain that assigns emotion to our perceptions," says Salvi. "Many patients report the onset of tinnitus after experiencing significant stress or anxiety. We think it's not just the hearing loss that's essential. There are other emotional factors working together with the auditory factors."

Source: www.buffalo.edu/news/releases/2015/05/020.html

The above finding (re: significant stress/anxiety) is a specific trigger I recall being mentioned by Prof. Jeanmonod when I went to to see him (see my full day consultation which can be found elsewhere on the forum). There does indeed seem to be a two-fold trigger of tinnitus in some cases: 1) hearing loss (= loss of auditory input to the brain) and 2) an emotional event occurring subsequently.

When it comes to tinnitus, my interests lie purely with the pharmacological- or treatment- angle (not the diagnostic angle). In terms of possible treatments, therefore, I do not think that the "China-option" is particularly interesting (given their focus area mentioned in the study).

What I can say is that I remain engaged with various researchers constantly. Not a week goes by without me having written or received an e-mail from a member of the tinnitus research community. As an example, just today, I was in contact with a researcher who wrote the following:

I guess we are currently at a point were we have to convince others. We have to convince medical doctors to try Retigabine; we have to convince other researchers to study the effects of Retigabine (or similar agents); we have to convince investors or funding institutions to finance a study on Retigabine. And we will need good arguments for that.

Pharmacological treatments also "offer" the option to explore certain possibilities further - example:

www.tinnitustalk.com/threads/new-study-on-trobalt-maxipost-in-relation-to-shl-induced-tinnitus.9505/

I do not have a background within the academic circles. I will therefore continue (only) to contribute to the areas where I feel I can add value e.g. tracking down clinical trial information, establishing connections with CEOs, liaising with researchers, and being part of awareness-campaigns. In this respect, I will try to contact yet another pharma working on potassium channel modulators: http://knoppbio.com and I will also try to follow-up with a source of mine in relation to the AUT-63 trial.

attheedgeofscience
19/MAY/2015.

 

[attheedgeofscience]

Update on the Manuscript Collaboration Between Tinnitus Talk and Tinnitus Research Initiative

As some of you may know, in the Fall of 2014, a group of members of Tinnitus Talk started reporting their experiences with Trobalt (Retigabine) as an off-label physician prescription.

This led to a few members of Tinnitus Talk forming a group which has since come to be known as "Team Trobalt" for the past year. Our self-appointed task was to try to establish - in a scientific setting - the beneficial results that some members had experienced from taking Trobalt. A first step in this direction was to create interest within academic circles in relation to the potential relationship between Kv-channel openers and the treatment of symptoms of tinnitus. This first step has now been achieved with the publication by the Tinnitus Research Initiative, titled:

"Potassium channels as promising new targets for pharmacologic treatment of tinnitus: Can internet-based "crowd sensing" initiated by patients speed up the transition from bench to bedside?"

Indeed Tinnitus Talk is mentioned within the manuscript - see page 7. As a former member of [USERGROUP=11]@Team Trobalt[/USERGROUP], and on behalf of [USERGROUP=11]@Team Trobalt[/USERGROUP], we are very proud to have come this far.

Please take a moment to reflect on the journey that has led us to this point by having a quick read through this thread. Please also take a moment to download the manuscript which we have asked the authors to make available - in full - on the ResearchGate website (see link below).

Please also note that so far no formal relationship between Trobalt and the reduction of symptoms of tinnitus has been established in humans. We are not advocating the usage of Trobalt or any other drug. We are simply updating the forum on the significant first step we have achieved: the publication of a manuscript by the Tinnitus Research Initiative in relation to Kv-channel openers.

attheedgeofscience
15/DEC/2015.


The full text manuscript can be found @

www.researchgate.net/publication/284728150_Potassium_channels_as_promising_new_targets_for_pharmacologic_treatment_of_tinnitus_Can_internet-based_crowd_sensing_initiated_by_patients_speed_up_the_transition_from_bench_to_bedside

Please also take a moment to rate/share/comment the related update on Facebook!

 

[dochoppy]

congrats to whoever was involved in getting this manuscript brought to life. Very strong work, I am very impressed, this is real progress.

 

[hoper]

 

[attheedgeofscience]

Update on the Facebook "Virality" of the Recently Released Research Paper by The Tinnitus Research Initiative

The update which was released approximately a week ago has been a huge success. Below the statistics for the number of "reads" of the manuscript (a combined "read score" of almost 5,000). It is quite easy to see when the news of the research paper kicked in...

The research paper can still be found here (we kindly asked if the authors would upload it so as to be available in full):

www.researchgate.net/publication/284728150_Potassium_channels_as_promising_new_targets_for_pharmacologic_treatment_of_tinnitus_Can_internet-based_crowd_sensing_initiated_by_patients_speed_up_the_transition_from_bench_to_bedside

The Facebook-update regarding the manuscript can be found here: