Author Topic: Important Announcement About the Rutgers / NORD Study  (Read 37620 times)

Quantum

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Important Announcement About the Rutgers / NORD Study
« on: March 26, 2017, 09:17:01 PM »

Poiscenter moderators team has a very disappointing announcement to make. Following an unfortunate string of events, the current Rutgers study on POIS, and on the effect of transcutaneous vagal nerve stimulation on POIS,  had been stopped early last year, and will not be completed.   In early 2016, a complaint had been made by a participant to the Institutional Review Board (IRB) about the study, and the POIS study had been suspended by the IRB for a 10-months investigation.  Around late February/early March, the IRB finally issued its report, and the complaint was deemed unfounded, so the research project could have go ahead.  However, unexpectedly, Dr Barry Komisaruk has just announced a few days ago that he has decided to terminate his POIS project.

Here some more details about what happened and what is the current situation :

- On August 2015, the Rutgers study began, with a few participants

- Eight months later, around April 2016,  the study had been stopped dead in its track by a complaint to the Institutional Review Board (IRB) from one of the early participants.  Both the reason for the complaint and the identity of the complainant are confidential, so we do not have this information, and never will.  Poiscenter had not been informed at all of the situation, and the IRB asked Dr Komisaruk for secrecy about the fact that a complaint had been made, and about the study being suspended for a ten-months investigation.

- After April 2016, Poiscenter had stopped to receive any interim reports and any information about the study, and the moderators team did not know anything more than you about what was going on.  Demo had sent countless communications to NORD and to Dr Komisaruk, but absolutely no information was given to us.

- When we saw that the last interim report, which was due for September 2106, never came, Demo intensified his communications to NORD and to Dr Komisaruk in order to know why this report had never been transmitted to us.

- A few months ago, around November 2016, thanks to Demo's persistence, we finally learned that there had been a complaint months before, and that the study had been totally stopped since then, and that an investigation by the IRB had been going on, and that we had to wait for the IRB conclusions.   We were shocked and saddened, and were also very frustrated of not being able to share this information on the forum, because we were asked by NORD and IRB to not make this public, including not posting anything about it on the forum.   We suppose that the fact we heard anything at all about this complaint was a kind of leak, as we had been kept totally outside of the process for months.

- Around late February/early March, the IRB report about the complaint had finally been issued, and the complaint had been deemed unfounded.  The POIS study had the green light to go on, but probably with some requirements from the IRB about modifying the protocol, to prevent any other problems ( we don't have any other information regarding this).  At that point, we were waiting to hear from Dr K, in order to share all of this story, and, as we were hoping, the good news that the study was resuming.   

- In a dramatic turn of events, a few weeks after IRB decision had been known, Dr Komisaruk has announced this past week, through a letter to NORD, that he has decided to terminate his POIS study, and will reimburse the received funds to NORD, so that Poiscenter funds will be available for another team, in order to start a new POIS study  ( see below for his letter of withdrawal, and the reasons he gives for it )

- NORD is as shocked as we are about Dr Komisaruk's decision, but they will place us on their new list of RFP ( Requests for Proposal) this April, so another research team will be awarded our money by the end of 2017, for a totally new project  ( yes, we are back to square one)

Here is Dr Barry Komisaruk's letter to NORD, announcing that he will not go on with his research on POIS:

Quote from: Dr Barry Komisaruk
"Dear demo,
I just sent the following email to Catherine Blansfield of NORD.
Barry"
 
 
Dear Catherine,
 
The IRB investigation into the claim by one of the participants in our POIS project has concluded that his claim of an adverse event related to his participation was “unfounded”.
However, the IRB expressed concern that some of the prospective participants have significant underlying clinical issues. As an academic researcher, I am not prepared to address such clinical issues. Consequently, in order to avoid future such problems, I have decided to terminate the POIS project.
 
I recognize that the project was “crowd-funded” and am deeply moved and impressed with the seriousness of purpose and commitment of the contributors.  I encourage their seeking solution to the debilitating problem of POIS, but regret that I will not be able to perform the proposed research.
 
Therefore, I have instructed the Rutgers University Grants and Management office to return, as soon as possible, the entire amount of funds that the contributors, through NORD, have provided for my project, which according to that office has been $15,500.00 to date (the originally committed funds totaled $31,000.00).  I hope that the contributors will be able to support other research with the returned, plus thus far uncommitted by NORD, funds, to eventually understand and cure POIS.
 
I thank you, the contributors, and NORD for the wonderful support that you have provided, and wish you the very best of future success.
 
Sincerely,
Barry
 
Barry R. Komisaruk, Ph.D.
Distinguished Professor, Psychology
Rutgers Univ Bd of Gov Distinguished Service Professor
Adjunct Professor, Radiology
Rutgers University - Newark
Smith Hall, Rm 327a
101 Warren Street
Newark, NJ 07102


There is nothing we can do about all of this.  We have to accept the situation, and understand that Dr. K. made a difficult clinical decision -- one he truly believes is in the best interest of POIS sufferers.  Now, we have to look forward for the new research project with a new research team. 

We don't know yet if we will be able to get any raw data from what has been done in the few early months of work, like the results from the survey done with forum members.  Considering the situation, we should keep our expectations at a low level about recovering anything from the aborted Rutgers project.

We know that all of this sounds unreal, and needless to say that no such scenario ever happened before in a study founded through NORD.  Our administrators, Demo, Daveman and Stef, are speechless about all this, and we know that this announcement will cause a lot of emotional reactions. There is no easy way to share this, and we are still digesting these recent events ourselves.

The positive side is that we get a fresh, new start, and no money is lost in the process.   We hope that the new project will run smoothly and will bring interesting results for the understanding and treatment of POIS.  What happened with this research project have shown that it is a very complex undertaking, and although due to highly unusual events this study failed, thanks to NORD, we are still in a position to complete a viable study properly. It confirms the importance of having a professional medical entity assisting with the analysis of program applicants and all others aspects of the study, and although it is a slow process, it is necessary to assure a complete and viable study.

Also, we have learned some lessons which will help in the filtering of future participants.  We are sure NORD will be very careful when reviewing the process which will allow participants in the new study to come.

We will readily share any new information as it becomes available, now that the “secrecy” problem is over.

Sincerely,

Quantum,

on behalf of the whole Poiscenter moderators team.
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Nas

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #1 on: March 26, 2017, 10:00:26 PM »
Terrible, absolutely terrible. Somewhere in this, someone must've made a terrible, terrible mistake that may cause POIS sufferers to wait an extra 3 years for a new study to be published. And believe me, 3 years is ALOT for a POIS sufferer. Adding to that, that all of Dr.K's work has gone in vain instead of getting published and at least sharing what ever information he gathered, it's not like we know alot about this illness.
This probably what I'd describe as a huge mismanagement that led to a failuer.
I expect that the new team would start off where Dr.K stopped and that the new team would stay in contact with Dr.K and his team or else. This is treason to all of the doners and sufferers of this illness, I'm sorry if I sound so harsh but this is only the reality of this situation, nothing else.

Disaster

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #2 on: March 27, 2017, 01:20:24 AM »
I have to say that I am not surprised.  I live in NJ and have had POIS for over 25 years now and I would have made the perfect participant. I reached out to both Barry and his assistant over 20x and they were very unprofessional with communicating or getting back to me so that I could participate.  That was definitely a red flag. So I looked into their backgrounds and personally I think they were the wrong people for this kind of research.  We need real top level Medical researchers not PhDs. This is not a Psychological illness this is a true medical illness. Any study they would have published would not have helped our cause or found anything of medical use to cure what we have.

Personally I would like to get involved with finding a replacement. And I think we need more money then $15,000. Even for a proper blood sampling study we would need $30,000. on the good side we have very limited amount of potential patients to study but that's also bad in finding proof of the cause. I think we need to approach either Male Sex Problem doctors like doctors who deal with Erectile Disfunction or we need to focus on possible causes. Dr. Waldinger thinks POIS is Autoimmune like celiac disease, so approaching doctors have studied sexual dysfunction in Autoimmune patients may be a good place to start, next doctors who study rare autoimmune illnesses.  From my own testing And anectodal accounts I believe that blood pressure issues while arroused and after O play a significant role in physical symptoms, so special cardiologist might take on a study. On the emotional/cognitive side most people believe hormones and other chemicals released are one culprit, so Special endochronologist might do a study of 20 or so hormones, before, during and after O and compare to a placebo.

The point is there are a lot of medical avenues to approach. The avenues the Rutgers people were heading down was so weak. Plus they have no experience with what they were testing. If we thought the autonomic nervous system was involved (which I don't believe it is) then the proper researcher for be from a true autonomic lab like Mayo Clinic, Cleveland Clinic or Vanderbilt (the 3 top Autonomic neurological labs in the country).

I hope you all include me in the next hunt for a proper research team.
POIS sufferer for over 3 decades. Has progressively gotten worse over the years and I became completely disabled around 2011. My case of POIS is very severe.

Quantum

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #3 on: March 27, 2017, 07:07:20 AM »
Terrible, absolutely terrible. Somewhere in this, someone must've made a terrible, terrible mistake that may cause POIS sufferers to wait an extra 3 years for a new study to be published. And believe me, 3 years is ALOT for a POIS sufferer. Adding to that, that all of Dr.K's work has gone in vain instead of getting published and at least sharing what ever information he gathered, it's not like we know alot about this illness.
This probably what I'd describe as a huge mismanagement that led to a failuer.
I expect that the new team would start off where Dr.K stopped and that the new team would stay in contact with Dr.K and his team or else. This is treason to all of the doners and sufferers of this illness, I'm sorry if I sound so harsh but this is only the reality of this situation, nothing else.

Yes, it is indeed a sad news. 

The new project will be a completely new project, so I do not think there will be any data "recycled" or any contact with Dr K.  The approach could be totally different, and I think it will not be linked to the vagus nerve neither, because the grant is open to all kind of approaches. 

The complaint have been managed according to state-of-the-art procedure, like usually in any scientific study that is done under supervision.  But like in any of these studies, participants are allowed to make a complaint.  This is out of the control of the Chief Researcher, and of any supervising board.

I personally think that what we have to learn from this, is that the next research will need very elaborated screening process, including a clear assessment of already existing pathologies other than POIS, before being accepted as participants,
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Quantum

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #4 on: March 27, 2017, 07:30:55 AM »
I have to say that I am not surprised.  I live in NJ and have had POIS for over 25 years now and I would have made the perfect participant. I reached out to both Barry and his assistant over 20x and they were very unprofessional with communicating or getting back to me so that I could participate.  That was definitely a red flag. So I looked into their backgrounds and personally I think they were the wrong people for this kind of research.  We need real top level Medical researchers not PhDs. This is not a Psychological illness this is a true medical illness. Any study they would have published would not have helped our cause or found anything of medical use to cure what we have.

Personally I would like to get involved with finding a replacement. And I think we need more money then $15,000. Even for a proper blood sampling study we would need $30,000. on the good side we have very limited amount of potential patients to study but that's also bad in finding proof of the cause. I think we need to approach either Male Sex Problem doctors like doctors who deal with Erectile Disfunction or we need to focus on possible causes. Dr. Waldinger thinks POIS is Autoimmune like celiac disease, so approaching doctors have studied sexual dysfunction in Autoimmune patients may be a good place to start, next doctors who study rare autoimmune illnesses.  From my own testing And anectodal accounts I believe that blood pressure issues while arroused and after O play a significant role in physical symptoms, so special cardiologist might take on a study. On the emotional/cognitive side most people believe hormones and other chemicals released are one culprit, so Special endochronologist might do a study of 20 or so hormones, before, during and after O and compare to a placebo.

The point is there are a lot of medical avenues to approach. The avenues the Rutgers people were heading down was so weak. Plus they have no experience with what they were testing. If we thought the autonomic nervous system was involved (which I don't believe it is) then the proper researcher for be from a true autonomic lab like Mayo Clinic, Cleveland Clinic or Vanderbilt (the 3 top Autonomic neurological labs in the country).

I hope you all include me in the next hunt for a proper research team.


Hi Disaster,

A few short points before I am leaving for work:


- Definitively, from IRB concerns about the prospective POIS participants having significant underlying clinical issues, I think it will be clear for NORD as it is for us that the next research team should include physicians, not only PhD that have no clinical expertise.  I totally agree with you on that.

- your suggestions are interesting.  I wasn't there in 2014, and don't know how much of an influence, as fund raisers, we have on the choice of team NORD will make among those who have proposed projects for a POIS study, but we will have more information on that on the weeks to come.

- It is not $15 000 that we have, but the original $31 000.  that is not a huge amount, in the world of medical research, but that is what is needed to be part of NORD RFP program, and this allow us to benefit from the very professional supervision of NORD.  With what happened, we see that such a solid supervision is essential - Poiscenter could not choose a research time directly, on its own, and handle this kind of situation if it arises, we do not have the resources and qualifications to do so.  NORD provides all of that,  at a low overall cost, research included.

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POISse

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #5 on: March 27, 2017, 08:15:18 AM »
I am extremely sad to read this. Not only we expected a lot from the study but for those of us who truly believed in the vagus nerve theory it is a disaster. How can't we have access to the raw data at least? This is outrageous. The reimbursment of the funds is not the exact price that the people of this forum paid. The time lost is an opportunity cost for all of us, years we could have allocated to another research. This is a breach of contract and could lead to a legal action. I believe we are entitled to more than "I'm sorry I quit". If we don't fight this decision we can say that we've lost years. I didn't participated in the funding because I wasn't an active member at that time but I will help in fighting this decision if the forum members agree on this.

Daveman

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #6 on: March 27, 2017, 10:06:34 AM »
Fortunately we have not lost our money, and have the opportunity to start new. By "start new", my first reaction was to take our money and take over the project ourselves. One of the biggest problems in the process of doing controlled medical studies, is the hermeticism. At least if we were doing it ourselves the time factor would be less of a problem as we could see where things were going.

That being said, we chose NORD and the controlled medical study route because we need true educated evaluation of our problem in a scientific manner. We are not experts, despite living and feeling POIS, and we can't have influence in the process. Normally expert studies devise surveys and procedures to extract, in an orderly fashion, any valuable information that we can offer.

Also, so many things can fail. As we have seen. Without professional control of the project, we would likely fail with them. Fortunately that has not happened in this case. (We still have our money)

So if we were to initiate a study on our own, it would behoove us to have some professional advisory group (like NORD). Also, NORD fits its programs into "grant packages", which are usually much less expensive than it would be if we were to undertake a study of our own.

In short any endeavor that we may try to undertake on our own would be QUITE A BIT more expensive than the NORD program. Would I dare to estimate 5 to 10 time more expensive if it were to be done properly.

I think on NORDs side, the only "fault" they had, was to require so much of our pressure to be on top of Rutgers' advance.

Continuing with NORD, practically speaking is the smoothest option. Returning the funds to us is practically impossible, legally quite complex; the funds came from over 600 individual donations, often by anonymous donors, so any return would have to be done through a representative entity that we devise, and which can show that the donors are in accord.

If we could get organized and raise another $200,000, it might be possible to initiate a parallel study of our own or at least have funds prepared for any more sophisticated extensions of what may be learned in this next study.
WITHOUT RESEARCH THERE WILL BE NO CURE!
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sameer7777

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #7 on: March 27, 2017, 10:11:18 AM »
It's sad we are still standing back to zero  ....!!!
pls don't expose me.
AFTER SEX/MASTERBATION (FLU LIKE SYMPTOMS)
1)BACK NECK PAIN GOES TO DOWN SPINE
2)NERVES LIKE SQUEEZED OUT
3)MORNING FEET NERVES PAIN
4)NASAL INFLAMMATION
5)BRAIN FOG
6)DEPRESSION
7)HIGH SUGAR LEVELS (TRIED INSULIN FOR 1 YEAR MAKE ME MORE SICK

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #8 on: March 27, 2017, 10:57:10 AM »



...for those of us who truly believed in the vagus nerve theory it is a disaster.



It's sad we are still standing back to zero  ....!!!



Yes it is sad, Sameer.

And POISse, we still do have - - from Dr Komisaruk, a world-renowned orgasm expert who gave us the benefit of his thinking about POIS in-depth -- the vagus nerve theory and tVNS to explore...but only in our own way :( And there is always a possibility that we can, if interested as forum members, to even hire another expert (after all we successfully "crowd-funded"/raised approx $35,000 amongst ourselves before at this forum for the Rutgers study!).

And even with $zero$, COLM_2, for example as a solo-effort, has begun experimenting (alone) and I think has some positive results to share!

He will be reporting here at the forum about it soon.

Also, I know at least one other forum member is also very serious about modifying an expensive tVNS device -- similar to one used at Rutgers -- for POIS. Maybe Dr Komisaruk can advise us, I already asked him.

Don't give up hope, guys!



« Last Edit: March 27, 2017, 02:25:20 PM by demografx »
10 years of significant POIS-reduction, treatment consisting of daily (365 days/year) testosterone patches.

TRT must be checked out carefully with your doctor due to fertility, cardiac and other risks.

40+ years of severe 4-days-POIS, married, raised a family, started/ran a business

sameer7777

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #9 on: March 27, 2017, 10:59:53 AM »
Oh OK we hope so let's see Thankyou for the reply
pls don't expose me.
AFTER SEX/MASTERBATION (FLU LIKE SYMPTOMS)
1)BACK NECK PAIN GOES TO DOWN SPINE
2)NERVES LIKE SQUEEZED OUT
3)MORNING FEET NERVES PAIN
4)NASAL INFLAMMATION
5)BRAIN FOG
6)DEPRESSION
7)HIGH SUGAR LEVELS (TRIED INSULIN FOR 1 YEAR MAKE ME MORE SICK

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #10 on: March 27, 2017, 11:07:25 AM »

Oh OK we hope so let's see. Thank you for the reply.


Sure.
« Last Edit: March 27, 2017, 11:18:27 AM by demografx »
10 years of significant POIS-reduction, treatment consisting of daily (365 days/year) testosterone patches.

TRT must be checked out carefully with your doctor due to fertility, cardiac and other risks.

40+ years of severe 4-days-POIS, married, raised a family, started/ran a business

LAPOISSE

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #11 on: March 27, 2017, 11:44:02 AM »
This is quite unbelievable ;

I really don't understand the reason they gave us. What is an "underlining clinical issue" ? Is it connected to POIS ? if it is, it can help so they have to tell us, no discussion... if its not, I dont see the reason for stopping the study if one participant has some independent health problem . They just can't say "You lose 3 years, we are quitting without giving any reason"

NORD also totally screwed up in my opinion ; They are supposed to have some control and expectation considering that they choose Dr K. When I read the answer they gave us following my request for some more infos I'm highly dubious about the seriousness of NORD :

 " The delay with this project is not due to apathy, but rather the great care being taken to ensure that the research is conducted according to the highest scientific and ethical standards.  I hope that that will be evident in the future progress reports, but I recognize that this does not necessarily make the wait any easier "

Are you kidding ? Do you ever talked to Dr K or you don't have any clue of what going on and just give us a bullshit automatic answer. We gave NORD our trust, we deserve a bit more than that.

If it was just me I would withdraw the money from NORD and directly give it to the only researcher that have some experience about POIS : Dr W. NORD process is unbelievably slow and apparently inefficient ;1 year just to investigate about the complaint one participant made : its unreal... I understand the medical standard regarding some drugs approval for selling but For POIS research its not adapted ; We just need some guys with a good medical knowledge that perform 172839 tests on a representative group of people to find a biological marker of POIS and hopefully describe what going wrong ; and they need 6 month for that ; Dr K used 3 years to re-write in fancy term the POIS wikipedia page that already exist Something we could have done ourselves in a month. I think that if we don"t start wide by controlling everything we'll probably face dead end after dead end ; One guy look at vagus nerve, the other at BP, an other at allergies, etc.

I knew it will be a long way to understand what POIS is but not going forward at all is depressing.

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #12 on: March 27, 2017, 12:38:57 PM »
What is an "underlining [sic] clinical issue"? Is it connected to POIS?

I interpret "underlying clinical issue" as a psychiatric issue, e.g., paranoia, severe depression, severe anxiety. This is what I think (my opinion) led Rutgers to believe what it was that caused our POIS forum member (and might have possibly led
future Rutgers-study POISers) to complain that he was "damaged" by Dr K's study.

This is unprecedented: it never happened before in the history of NORD or Rutgers!

And I think this is what caused Dr Komisaruk, who is an academic researcher, not a qualified MD such as a psychiatrist, to say that he is not equipped to deal with these issues in his research. And this is also why I think Daveman and others have stressed that it is important to have a medical entity -- not just a PhD -- screen participants for "underlying clinical issues" in a new POIS study.

I can understand why it would take Rutgers this long to prove that our POISer's claim of "damage" was unfounded. It probably required a lot of back and forth beteeen Rutgers investigators and our forum member's doctors, and maybe even involving lawyers on both sides. But we don't really know, because so much was done in strict confidence, possibly because of potential litigation.


« Last Edit: March 29, 2017, 11:30:49 PM by demografx »
10 years of significant POIS-reduction, treatment consisting of daily (365 days/year) testosterone patches.

TRT must be checked out carefully with your doctor due to fertility, cardiac and other risks.

40+ years of severe 4-days-POIS, married, raised a family, started/ran a business

trusttheprocess

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #13 on: March 27, 2017, 03:59:52 PM »
This is quite unbelievable ;

I really don't understand the reason they gave us. What is an "underlining clinical issue" ? Is it connected to POIS ? if it is, it can help so they have to tell us, no discussion... if its not, I dont see the reason for stopping the study if one participant has some independent health problem . They just can't say "You lose 3 years, we are quitting without giving any reason"

NORD also totally screwed up in my opinion ; They are supposed to have some control and expectation considering that they choose Dr K. When I read the answer they gave us following my request for some more infos I'm highly dubious about the seriousness of NORD :

 " The delay with this project is not due to apathy, but rather the great care being taken to ensure that the research is conducted according to the highest scientific and ethical standards.  I hope that that will be evident in the future progress reports, but I recognize that this does not necessarily make the wait any easier "

Are you kidding ? Do you ever talked to Dr K or you don't have any clue of what going on and just give us a bullshit automatic answer. We gave NORD our trust, we deserve a bit more than that.

If it was just me I would withdraw the money from NORD and directly give it to the only researcher that have some experience about POIS : Dr W. NORD process is unbelievably slow and apparently inefficient ;1 year just to investigate about the complaint one participant made : its unreal... I understand the medical standard regarding some drugs approval for selling but For POIS research its not adapted ; We just need some guys with a good medical knowledge that perform 172839 tests on a representative group of people to find a biological marker of POIS and hopefully describe what going wrong ; and they need 6 month for that ; Dr K used 3 years to re-write in fancy term the POIS wikipedia page that already exist Something we could have done ourselves in a month. I think that if we don"t start wide by controlling everything we'll probably face dead end after dead end ; One guy look at vagus nerve, the other at BP, an other at allergies, etc.

I knew it will be a long way to understand what POIS is but not going forward at all is depressing.

I'm with LAPOISSE, my first reaction to hearing this news was more confusion than anger.  This sudden ending of the study and expectation of not receiving raw data makes absolutely no sense to me, and immediately raised the following questions in my mind.

1) I don't believe the "underlying clinical issue" was psychiatric issues as demografx suggests, this is to be expected with POIS, as a great deal of POIS symptoms can be considered psychiatric issues.  If the "underlying clinical issue" was in fact psychiatric issues, then this should have been addressed with the lengthy approval process, as stimulating cranial nerves intimately connected with the heart has inherent medical risks.  If the approval committee did not foresee this, then why not add another MD after the investigation was completed?  Instead, another PhD researcher was added.

2) Since NORD investigated the complaint through it's IRB, this suggests a study participant went behind Dr. K's back and reported it to NORD, which would obviously slow or stop the study.  No POIS member would do this in their right mind unless they believed Dr. K was subjecting them to unethical or dangerous testing procedures.  I don't believe this to be the case either, as the study progressed very slowly, with the only real progress that was communicated throughout the 2 year study was the POIS survey symptoms and the lowered HRV findings.  Furthermore, we were assured the delays were to ensure unethical or dangerous procedures were not being used (see LAPOISSE's post above for the exact words).

3) Why the strict confidence surrounding the investigation and the "underlying clinical issue"?  I understand the need for confidence in regards to the identify of the person who filed the complaint and findings of the study, but why after dropping such a bombshell on us could they not even give us the complaint that led to the investigation?  Also why weren't we informed of the investigation initially, and when we finally were informed why did NORD and the IRB not allow Demo and Quantum to share the news of the ongoing investigation?  Correct me if I'm wrong, but we were continually told the final interim report was still coming.  Was there really the need for such a high level of secrecy surrounding the investigation that even the people in charge of communicating with us did not know of the pending investigation and suspension of the study, something that went on for 10 months?  Also why did it take so long to investigate the complaint?

4) Further red flags in the study raised by disaster, "I have to say that I am not surprised.  I live in NJ and have had POIS for over 25 years now and I would have made the perfect participant. I reached out to both Barry and his assistant over 20x and they were very unprofessional with communicating or getting back to me so that I could participate.  That was definitely a red flag. So I looked into their backgrounds and personally I think they were the wrong people for this kind of research.  We need real top level Medical researchers not PhDs. This is not a Psychological illness this is a true medical illness. Any study they would have published would not have helped our cause or found anything of medical use to cure what we have."

5) Why would Dr. K abandon 3 years of research into POIS, and the $31,000 payment he would have received at the end of the study when he was so close?  The investigation concluded the claim was unfounded, and merely raised concerns, which he could've addressed by adding medical personnel to the study.  I could understand if he was in the early stages of the study, but all he had left was one interim report and the final study.  Raising further questions, according to Quantum "needless to say that no such scenario ever happened before in a study founded through NORD."

I have a theory that could explain the total failure of this study and the questions I raised, but my post is already getting pretty long, and the more important issue at hand is the future direction of POIS studies and POIS forum.  After years of research into POIS, I have come to the same conclusion as Dr. K, that the only viable option for achieving the level of POIS relief we seek with minimal side effects is without a doubt tVNS.  I think POIS forum needs to double down on our efforts to investigate this.  First, I think we should pursue legal action as POISse suggests so that we don't lose years of research on, in my opinion, the only viable POIS cure (for raw data of the study we funded, and against Dr. K for breach of contract).  Second, as I suggested almost a year ago under a different account, I think we need to cautiously test tVNS devices ourselves.  If you want something done right you must do it yourself, and although doctors may never fully accept POIS as a serious medical condition if we pursue this option, at least we will hopefully have a working treatment.  Finally, if NORD and Dr. K are not forthcoming with data from the study, I would hope study participants will come forward with any and all information you learned during the study now that the study is over, since the confidentiality regarding the progress of the study is no longer a concern.

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #14 on: March 27, 2017, 04:09:14 PM »
This is not a reply to the above post, just a clarification of IRB (#2 above), which is part of Rutgers, not NORD.


« Last Edit: March 27, 2017, 04:11:49 PM by demografx »
10 years of significant POIS-reduction, treatment consisting of daily (365 days/year) testosterone patches.

TRT must be checked out carefully with your doctor due to fertility, cardiac and other risks.

40+ years of severe 4-days-POIS, married, raised a family, started/ran a business

Daveman

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #15 on: March 27, 2017, 05:58:08 PM »
We are and always have been free to study "other things" in parallel. Of course, as "trustheprocess" says, that may mean that we have no official medical recognition in the end. That of course wouldn't matter much if any treatment found by that means was effective and safe for a large majority of our members.

I think if we want to continue with tVNS investigations, there are low cost options available, limiting our investment exposure in case the treatment doesn't work.

I wouldn't at all be surprised if vagus nerve problems aren't secondary in any case, responding to primary auto-immune causes. Still, ifthis line of investigation can find a remedy of some kind, all the better.

But we always have to remember, semen injections (I guess which have been dropped as a remedy) are dangerous. The use of a tVNS machine can be dangerous, we have fought for years and years to stop the desperate attempt to find a cure by potentially sacrificing our life and health.

This forum was founded as a means of promoting a safe medical research environment for the resolution of the POIS delema.

So we face another setback, but the research will go on. If we want to do studies in parallel, that option is always open. But to do it properly, we need appropriate medical researchers and some controlling entity.

This costs money. Much more than we are paying now.

WITHOUT RESEARCH THERE WILL BE NO CURE!
Sessions 5 to 9 days, mostly Flu-like, joints, digestion problems, light cognitive.
Niacin has changed my lif though, now 1 day MAX.
Somewhere in this interaction with Niacin is the answer!

Jimmy

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #16 on: March 27, 2017, 07:33:14 PM »
Im worried that the new research program with nord will take the same long process as the old one.

Im with starting new donation program which i believe can result in good amount of money to support new research program with other medical organization.

Lets start a survey to see who is willing to participate in a new donation program.

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #17 on: March 27, 2017, 08:55:44 PM »
I'm worried that the new research program with NORD will take the same long process as the old one.
Good point, Jimmy, but the POISCenter admin/mods team does not see another way out with NORD: they simply have no mechanism in place to refund the Grant donations. We're lucky to not lose it completely! And we don't have the funds OR the staffing to fight this legally.

But, as you & Daveman point out, we're free to fund parallel projects.


« Last Edit: March 27, 2017, 08:59:10 PM by demografx »
10 years of significant POIS-reduction, treatment consisting of daily (365 days/year) testosterone patches.

TRT must be checked out carefully with your doctor due to fertility, cardiac and other risks.

40+ years of severe 4-days-POIS, married, raised a family, started/ran a business

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #18 on: March 27, 2017, 09:05:40 PM »

This [parallel study path] costs money. Much more than we are paying now.


Excellent point, Daveman! And again, we don't have the staffing to manage the process. We would have to hire overseers, with medical credentials.


« Last Edit: March 27, 2017, 10:24:17 PM by demografx »
10 years of significant POIS-reduction, treatment consisting of daily (365 days/year) testosterone patches.

TRT must be checked out carefully with your doctor due to fertility, cardiac and other risks.

40+ years of severe 4-days-POIS, married, raised a family, started/ran a business

POISse

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #19 on: March 28, 2017, 05:38:29 AM »
All participants in the funding could ask for a class action in order to motivate a legal firm to take our case. We could also ask for a pro bono case to a top legal firm, since there are a lot of people suffering, and because is the first time in the history of Nord that it happens. People would be touched by our story.

I am only suggesting this because it matters that we know the real reason behind all this. We have to say that it matters to us. The investigation concluded the claim was unfounded so why would someone abandon 3 years of research and 30k without any valid reason ? The first 3 reports were practically empty shells, everyone on the forum agree on this, so Dr K could have done it one more time and the case would have be closed. We are all aware that there is no guarantee of results in research, but there was a guarantee of reporting.

If Dr. K wants to abandon the research so be it, but he must share his findings.

I understand that recovering the money is better than nothing, but we should ask for the datas in compensation for this and for the years we've lost waiting.

Only if we get this, the new research will start somewhere after square one, and that will be the true victory.