NORD Interim Report for POIS Study

[demografx]

National Organization for Rare Disorders

On May 25, 2016, at 7:54 AM, Jacqueline Kraska/NORD  wrote:

Hi Demo,

I've attached a document that outlines the role of sponsors [Rutgers University is the sponsor of our POIS study] and PI's [ Dr Komisaruk is our PI (Principal Investigator) ] - just in case it's helpful:

BW
Jacqui

Hope you can all read this PDF ok...
demo




This means that the sponsor is essentially responsible for all
operational aspects of the clinical trials it sponsors.

[demografx]

Re: above attachment from NORD:

On May 25, 2016, at 6:04 PM, Jacqueline Kraska/NORD wrote:

Hi Demo,

The same roles and responsibilities for PI and Sponsor apply to all clinical research, whether clinical trial or not. The conditions that are listed purely regarding trials are not applicable though.

Kind regards,
Jacqui

[demografx]

On May 26, 2016, at 11:31 AM, Jacqui Kraska/NORD wrote:

Hi demo, I think you can ignore as regardless of drug, device, investigation the roles and responsibilities remain the same.
BW
Jacqui

[demografx]

Hi Demo,

I hope you can help me with another question; when the study is completed at the end of September. It I expect will need to be peer review before being published. When the study is complete prior to peer review will the 12 participators who used the tVNS devices be allowed to share their experiences?

I'm looking forward to hearing about this almost as much as the publishing of the final paper. If you don't could you clarify with Prof K?

I hope this is not too much to ask!

Thanks FloppyB




FB, I forwarded your post to Dr Komisaruk, now awaiting his reply.

Excellent question.

[demografx]

(From a NORD [Washington, D.C.] legislative tracking advisory in my mailbox today).

They're advocating on behalf of rare disorder groups -- like POIS.

www.rarediseases.org

[demografx]

This is NORD's "motto"

It could be our forum's motto as well!

[demografx]

Hi Demo,

I hope you can help me with another question; when the study is completed at the end of September. It I expect will need to be peer review before being published. When the study is complete prior to peer review will the 12 participators who used the tVNS devices be allowed to share their experiences?

I'm looking forward to hearing about this almost as much as the publishing of the final paper. If you don't could you clarify with Prof K?

I hope this is not too much to ask!

Thanks FloppyB




FB, I forwarded your post to Dr Komisaruk, now awaiting his reply.

Excellent question.

Just my educated guess, but no informational response yet to our previous - and FB's current above - tVNS and fMRI questions...tells me that public confidentiality (vs NORD's MAC - who may well have all the information we're looking for) about our scientific progress is paramount.

If the tVNS and/or fMRI progress info is publicly disclosed now, the "newsworthiness" of Rutgers' POIS study might lose its 'breakthrough' appeal to a scientific publisher (e.g., JAMA) in definitively finding POIS medical-validation as a disorder, and then treatment success of course -- which we are all most anxious to hear about.    ASAP!

I witnessed Dr Waldinger in 2011 go through much pre-publication confidentiality anxiety with our forum.

Keep in mind, if word gets out, it could get picked up by magazines, newspapers, TV, radio, or worse, by tabloids. The last thing someone like JAMA wants is...secondhand medical news. And perhaps inaccurate medical news. Not many publications have rigorous editorial standards. So the truth can get sloppy.

That said, I hope I'm wrong. I want us to see what's going on!

[demografx]

I showed the above post to Jacqueline Kraska @ NORD and she replied interestingly with the following:

On Jun 1, 2016, at 10:04 AM, Jacqueline Kraska wrote:

Hi Demo,

With regards to the posting, I may be interpreting this wrong, but scientific reports are different than publications which would be peer reviewed. The PI does need to provide NORD with a final scientific report to obtain the rest of the funding, which MAC will review for approval. The PI does not necessarily have to publish results.... often research leads on to further research which eventually leads to publications. In order to publish the PI would need to submit to publications and be accepted - that is they think it is worthy etc. of publication.

All the best,
Jacqui

[joelawerence]

I showed the above post to Jacqueline Kraska @ NORD and she replied interestingly with the following:

On Jun 1, 2016, at 10:04 AM, Jacqueline Kraska wrote:

Hi Demo,

With regards to the posting, I may be interpreting this wrong, but scientific reports are different than publications which would be peer reviewed. The PI does need to provide NORD with a final scientific report to obtain the rest of the funding, which MAC will review for approval. The PI does not necessarily have to publish results.... often research leads on to further research which eventually leads to publications. In order to publish the PI would need to submit to publications and be accepted - that is they think it is worthy etc. of publication.

All the best,
Jacqui

Very interesting reply. So if the research is not published, what other means is there for us to know the full results?

One positive is that there may be additional funding sanctioned if the NORD team is satisfied with the research.

[demografx]

Thanks, joelawerence.

Again, only my guess, but I would think that - - instead of a glorious published initial effort -- further research (beyond this current vagal dystonia "opener") is Good News.

Why?

It means someone -- like a tVNS manufacturer -- might fund the next stage...without our hard-earned dollars.

And if this happens it means we're on the right POIS-treatment track!

So if that's true: who's stopping us from responsibly -- see warnings in link -- experimenting with tVNS ourselves and our own doctors?
http://poiscenter.com/forums/index.php?topic=2294.0

[demografx]

•On Thu, May 26, 2016 at 8:38 PM, demografx wrote:

Jacqui, sorry to keep asking, but is Rutgers' testing of tVNS on POISers considered a "clinical trial" ?

•On Jun 1, 2016, at 12:55 PM, Jacqueline Kraska/NORD wrote:

Hi Demo,

I don't think I ever answered your question here.

Yes it would be considered a clinical trial.

Please see link to WHO's definition: http://www.who.int/topics/clinical_trials/en/ I find the Q&A section helpful.

BW
Jacqui

[Quantum]

Just my educated guess, but no informational response yet to our previous - and FB's current above - tVNS and fMRI questions...tells me that public confidentiality (vs NORD's MAC - who may well have all the information we're looking for) about our scientific progress is paramount.

If the tVNS and/or fMRI progress info is publicly disclosed now, the "newsworthiness" of Rutgers' POIS study might lose its 'breakthrough' appeal to a scientific publisher (e.g., JAMA) in definitively finding POIS medical-validation as a disorder, and then treatment success of course -- which we are all most anxious to hear about.    ASAP!

I witnessed Dr Waldinger in 2011 go through much pre-publication confidentiality anxiety with our forum.

Keep in mind, if word gets out, it could get picked up by magazines, newspapers, TV, radio, or worse, by tabloids. The last thing someone like JAMA wants is...secondhand medical news. And perhaps inaccurate medical news. Not many publications have rigorous editorial standards. So the truth can get sloppy.

That said, I hope I'm wrong. I want us to see what's going on!

I fully agree with your words, Demo.  Scientific research is very competitive, and have its own culture.  Secrecy till publication is part of this culture.  There is also a competition between the different academic institutions and research teams, for reputation, hierarchical status, visibility, not unlike competition in the sport world, or political scene, or almost any field of human activity. It would be naive to think that a research on our own rare disorder would escape those cultural rules. 

[demografx]

Thanks, Quantum. Very instructive!

BTW, the worldwide publicity value on "orgasm" seems to be high, judging from all the high profile links (prestige media/publications) we've seen here, perhaps making any "POIS" reporting more valuable.

If nothing else, the public NORD reports could be submitted - by us, even today (I see no restriction!)  - to the media, if we want lots of published POIS "news" to show our doctors.

The competitive aspect that you pointed out would I think tie in somehow to all this valuable mass-publicity (post-study results-publication).

[demografx]

Re-posted from above. Editing included below.

"Thanks, joelawerence.

Again, only my guess, but I would think that - - instead of a glorious published initial effort -- further research (beyond this current vagal dystonia "opener") is Good News.

Why?

It means someone -- like a tVNS manufacturer -- might fund the next stage...without our hard-earned dollars.

And if this happens it means we're on the right POIS-treatment track!

So if that's true: who's stopping us from responsibly -- see warnings in link -- experimenting with tVNS ourselves and our own doctors?
http://poiscenter.com/forums/index.php?topic=2294.0 "

[demografx]

So if the research is not published...

Dr Komisaruk wrote in NORD's Interim POIS Report #3:
"We plan to publish these [Report 3?] findings, which we trust will raise awareness of this distressing condition."

[Defsync]

Do you guys think - in either your laymen or formalized educated POV - that POIS will be 'curable', or for a better suitable word of progressive insights - be treatable by the end of the decade? I'm really looking for at least 2020 to have some line of formalized treatment.
...


POIS is a rare condition, so research for it will not go fast.  It is not a disease like cancer, diabetes, depression, or cardiovascular problems, that attracts billions of dollars of research found each years.  Remember that health is a "business" like any other.  Investors want a good ROI (Return on Investment) for the bucks they put in.  If you have the choice between investing in a very rare condition, or investing in a condition that has epidemic proportion, like diabetes, or cancer, what would YOU do with your money?   Same thing for the Government - If you pay for a public network of health services - hospitals, clinics, .... - you will invest funds where they will help the most people you have to provide care for, in order to lower your health system budget.  In many cases, follow the money, and you will find answers to many questions.

However, and that is our chance, their is other kind of "investors" for rare disorders.  First, those who are suffering from this rare disorder, and that is what made this current Rutgers study possible.  Also, their is interest from the part of world-class specialists of a very specific field - in this case, sexual dysfunctions.  If you are a world-class researcher in this field, it may become redundant to make yet another study on premature ejaculation - there are already so many!  There comes a time that you, or some of your PhD candidates, want something fresh, some uncharted territory to explore, and take a chance at becoming the first to make a breakthrough in a rare condition.  That is an "investment" in a career path.  So, prominent figures like Dr Waldinger or Dr Kamisaruk, and the team surrounding them, will be interested in conducting studies about a rare disorder like POIS.

If you feel that this is not enough, don't forget that POIS can benefit from research on other health problems.  MrRaba has already cited research done for CFS/ME,  that could lead to interesting results for POIS.  Personally, all that I have learned about the IDO and TDO enzymes upregulating in immune reactions, that I believe explains a part of what causes POIS, come from millions of dollars of researches done for two "blockbusters" conditions,  cancer and depression.  Those two has attracted many millions of dollars of research money on the study of the kynurenine pathways, something impossible for a rare condition.  Just check the amazing numbers of study about this that can be found on NCBI/PUBMED for that, 7027 full-text journal articles if you type "IDO",   over 4000 if you type "kynurenine".  And this is not a mainstream subject in research for those 2 conditions.  POIS can benefit from what is learned in studies for other conditions, so count on that too.

It doesn't matter. You have rarer diseases and (or) congenital diseases with, presumably, a far less and selectively small amount of people that get more spotlight and research than our syndrome; there are millions - I repeat: millions - of doctors and (or) medical researchers / scientists world-wide. You would think 14 years would be more than enough time to mathematically increases the chances of getting at least 20 scientists to take interest, let alone just one's you can count on one hand.

14 years since its formal inception and just what? 1-3 researchers out of millions of others? Why we have to rely on a forum to actually discuss treatments through the dangerous, informal process of Trial and Error? It doesn't matter if it was just 1 case. It makes absolutely no sense.

For something as medically unorthodox and original in premise - people suffering from neurological and systemic changes in their body post-orgasm and this is STILL not well talked about? Are you effing kidding me? Even Dr. House himself would salivate at the unique originality and mysteriousness of this condition with much delight.

I'm sorry but I don't buy the money / resource excuse just as much as I don't buy the capital of scientific curiosity as a form of financial value; this is something that should've been long studied and researched on since the early 00's. Hand in hand with Chronic Fatigue Syndrome and Dysautonomia.

By the way and how slow research is going with the inexplicable lack of spotlight - I can't conceivably see this being treated until mid-to-late of the 21st century, and that's being generous. And quite frankly, as a 44 year old I neither have the time nor the inclination anymore to bother with a cure if we have to wait that long. We still can't cure CFS effectively and we spend millions if not billions on that. Just imagine how much we spend on this 'POIS' and just imagine the chronology. Laughable. 

Waldinger's vagus nerve theory is a shot in the dark but it's our golden ticket to possible success - if his theory later proves to be successful in the next year or so that's our chance; but if nothing suffices out of that theory in particular...we're literally back at square one.  And no, forum theories don't count. Because there's simply too little researchers egging in on this thing and I have extreme doubt that it'll get cured until most of us are either in our Seniors or dead. He's literally our only hope. without him or the fate of his research, I cannot conceivably see this thing being cured until the later half of the end of the century.

 Dont give your money to research in the united states. Health is a business. HERE. elsewhere? sure. but not anywhere in the same ballpark. and in europe doctors have channels of discussion that are generally squashed in this country. if the only doctor to unequivocally do the research paper that got us on the map was overseas, why would  anyone think its a good idea to put research money behind an organization in the united states? And also, the christian scare still reigns in this country. Men masturbating for research, in the united states,  is going to meet with harsh pushback.

still demografx has gone beyond superman levels to get this to work tho. he has sacrificed more than anyone else here. and for the most part knows what he is doing. =P

formal inception was 2010, not 14 years ago. 6 then? if you want to know why this isnt being talked about everywhere, well..... idk, blame me? im probly the number one person who would know how to utilize the internet to spread awareness like wildfire, but until the dying parent im taking care of passes, im not willing to sacrifice my privacy getting this involved.

[demografx]

Just received a vacation note from Jacqui Kraska complimenting our forum on being so active.

[Quantum]

Hi Pentrazamine,

I hear your frustration, especially in the following:

It's either you guys are really incompetent and aren't trying hard enough or, for whatever conspiratorial reason, scientists just simply aren't interested in a never-before-seen sexual disorder cross-cutting the immune system.

In both cases, it's inexcusable. And by how slow things are going, it'll be countless decades. I'm talking 30-50 years not just a meager 20 years.  which, for some of us, is equivalent to no cure at all.

I do not know exactly who are the "you guys" that you think may be incompetent, but anyway, this was not in line with the forum rule of being nice. I would like to open you to the fact that, from my point of you, you are part of those "you guys" that heve POIS as a challenge and do whatever they can to solve the POIS problem and lower its cost on their life. So, what are YOU ready to do in order to help with this ?

I don't mind someone who keeps a healthy criticism, and I agree that pharmaceutical interests won't see POIS as an interesting investment leading to a blockbuster drug.  That being said, it is to each and everyone of us to raise awareness and do whatever we can to help progress toward an understanding of POIS, and eventually, relief and treatment.   The funds that have been raised by this forum and has led to the current Rutgers study is a tremendous example of what can be done, even if POIS is a rare condition.   This will help raising POIS awareness in mainstream medical research as well.

Keeping this forum active, being supportive with other members,  is another way to help.  A dead forum, or a negative one, won't attract anybody, and won't help the POIS cause at all.  See, as a great example, how Demo is positive and have been animating this forum for years, with lively graphics and dedication, despite his own health issues.  I can assure you this forum wouldn't have been kept alive if it was't for his and other administrators presence ( Daveman and Stef)  I have been founders of another forum, and let me tell you, an inactive forum can die rather quickly, but life attracts life.  And, I am sure of it, poiscenter is the best place to go on the net for POIS info and for support, and, or sure, for updates on the current Rutgers study.

Do you have any intention of adding a new POIS video on Youtube, for example, or do anything else ?  Any action is welcomed, as small as it may seems. 

If you don't stand up, you don't stand a chance! 

Hang, on, Pentrazemine.  I have been having POIS for about 38 years now, so for at least as long as you have. There are hard times, for sure, but then better times can come.  It is sure that I have gotten better these later years, from both what I have learned by myself through the years, and what I have found here since I have found this forum.  Even 10% relief is 10% relief, so try and see what could help you ( be consistent and scientific in your approach, and you will find at least some partial relief, among all what have been mentioned by members here... it is to soon to hope for a complete, scientific and definitive solution for now.)

[Pentrazemine]

you're right. i apologize if i sounded rude and not nice, i have nothing but the up-most respect for what you guys have been doing. it's just i'm very frustrated that the odds of a cure are slim to none given there's no incentive in a cure. so this has made me very war-weary.  i was just venting on you guys at the expense of my own anger over all of us living with this condition.

[Quantum]

you're right. i apologize if i sounded rude and not nice, i have nothing but the up-most respect for what you guys have been doing. it's just i'm very frustrated that the odds of a cure are slim to none given there's no incentive in a cure. so this has made me very war-weary.  i was just venting on you guys at the expense of my own anger over all of us living with this condition.

Thanks for your answer, Pentra ! 

I wish you to find at least some way to relief your symptoms, and increase your quality of life.  Any level of relief is a step in the right direction ! 

And, above anything, keep the hope alive, quantum leaps happen !  For example, great advances in other medical fields, like gene therapy or stem cells or depression treatment or auto-immune diseases, can lead to something useful for POIS.