Author Topic: Important Announcement About the Rutgers / NORD Study  (Read 37708 times)

Limejuice

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #40 on: March 31, 2017, 11:57:23 AM »
I think b_jim was referring to the POIS research patient and not the Dr.

b_jim brings up a very important question. However, considering the complaint was 'unfounded' after an investigation I would assume a liability document was signed.

My question is why did the investigation take 10 months?

And how will NORD and future researchers better vet applicants?
« Last Edit: March 31, 2017, 12:15:06 PM by Limejuice »

LAPOISSE

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #41 on: March 31, 2017, 12:19:48 PM »
Of course bjim is right...we should try not to be to too naive here...all that sound like a big excuse for something else that they dont wanna say...bottom line is in the real world no entity wich has been contracted can waste 3 years of the time if a group of person -suffering-and step out without a compensation...tell the story of our research to anyone, he will understand easily that there is something wrong.
A complaint of one guy is not a sufficient reason to abandon everything at the moment they are supose to deliver the result.if they cant deal with some "clininical issue", they should have said it long time ago and as bjim mentionned they are covered for it...

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #42 on: March 31, 2017, 02:03:50 PM »
Interesting thoughts come up, but I still say let's move forward to new ground. We don't have to give up any decent ideas about the past, but let's not let them get in the way of POIS progress.

We can't go back to a Rutgers study tomorrow.
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 #43 on: March 31, 2017, 03:57:41 PM »
I understand what you say Demo but still, it would be a shame if we dont get anything from that time we dedicate to Rutgers.Going back to zero means we 'll get a new team in maybe one year and some results maybe in 3 others years. We cant get absolutly nothing, just a 3 sentences answers and a good luck...we have all been waiting month after month..its not like the study has just began...they must have some results..other than questionnaire or some usefull info..im sure the nature of the clinical issue is usefull(they aparently feared that it will happen again so its part of the syndrome) and as long as the identity of the person is not reaveled I dont see a confidentiality breach...this behavior toward us is in my opinion just unacaptable. Of course if you feel its OK with you, lets not try to get the most of what we can get and wait an other 3 years

Going less Crazy

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #44 on: March 31, 2017, 06:07:34 PM »
I didn't read much into this but I'd bet he didn't find much of anything with the research, thus discontinuing it after the complaint and wasting more of our time.  So maybe we can find a different avenue for research.  We should get ALL of the results given to us though, even if there was nothing.
My POIS managed with Diet (@ diet that 100% manages my pois)Believe my POIS stems from inflammation in the gut. O = neuro POIS from inflammation from the gut

Current supps: microdose of zyrtec and gaia liquid olive leaf extract for sleep. Micro astragalus and 1tsp ev olive oil for energy .

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #45 on: March 31, 2017, 06:48:08 PM »
You all saw my letter to Dr K above (page 3), asking for more info. What more can you all suggest to do? It is obvious that he needs to clear anything released with IRB. And since he refunded our money, how much obligation does he really have? I only see data completed on just 2 patients, is that meaningful enough for us to fight for?


« Last Edit: March 31, 2017, 06:54:38 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 #46 on: March 31, 2017, 08:30:48 PM »
...I'd bet he didn't find much of anything with the research...
What led you to that conclusion?
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 #47 on: March 31, 2017, 08:34:32 PM »
Another random thought: I would imagine that the 10-month delay made it much more difficult to find new volunteers after almost a year since the "old" volunteers were waiting.
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

b_jim

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #48 on: March 31, 2017, 11:06:13 PM »
He didn't sign a document to accept potential risks during the study ?

=> Yes, I meant the injured patient.

It's not something rare for a patient following a scientific study to have side effects.
And then, the doctors are protected by a document signed by the patient explaining the possible causes are accepted.
Of course, I probably forget something. I didn't read the study details.
Taurine = Anti-Pois
Suffering from lyme disease

Going less Crazy

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #49 on: March 31, 2017, 11:07:59 PM »
just i feel like if he was onto something he would have continued with the research.  it was his personal decision to discontinue?
My POIS managed with Diet (@ diet that 100% manages my pois)Believe my POIS stems from inflammation in the gut. O = neuro POIS from inflammation from the gut

Current supps: microdose of zyrtec and gaia liquid olive leaf extract for sleep. Micro astragalus and 1tsp ev olive oil for energy .

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #50 on: March 31, 2017, 11:31:47 PM »
Yes, it was his personal decision. But the IRB set the stage with their conclusion that our POISer-complainer had "underlying clinical issues." So my guess is that the IRB wasn't very surprised with his decision. But...we could play guessing games all weekend about this.
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

Quantum

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #51 on: April 01, 2017, 12:12:44 PM »
Hi b_jim, Limejuice, LaPoisse, GLC, and everyone,

Everybody would like to know more precisely what happens, and have more details, for sure.  But we do not have those information, and we will not be given answers to our questions, because the process of a complaint is confidential.

I think complainant surely had signed a document about potential risks.  But that does not take away the power to make a complaint ( that would against ethical research), and one of this participant did use this power, and the IRB had to follow the rules, to receive and consider the complaint,  and make an inquiry according to their own protocol.   Why ten months ?  What was the reason for the complaint? Why this... ? When that...?, And so on... We don't know, we have not been told anything more than what we have shared with you.  We only have been told at the end the the complaint had been deemed unfounded.   

From there, we have to turn toward the new study, and learn from this, and work toward a better screening of participants, meaning:  having less "psychological vulnerability", being more willing to accept that a research protocol implies RISKS.   I think for now, it is important to make it clear, that the POIS sufferers that will choose to take part in the future study will have to accept the risks that comes with this choice.  We all agree that life with POIS is not easy,  We don't know why, sometime, our POIS gets more severe, or less severe.  We don't know much, so, how this complainant could have thought that it is the study that made him worst?  This worsening could have happened anyway, that's something to consider. Only the anxiety link to being part of the study could explain this!  We have to be clear, POIS is something quite severe and abnormal, and may have a complex relation with other illnesses, be they psychological comorbidities, or else, so we have to accept this. If you can't, and cannot accept that, even if POIS really manifest in the physical body, that at least a part of POIS may be of psychological origin,well, at least, accept that it can be the case in other POIS sufferers, and the study is for every POIS sufferers, not only for you, and must be aware of this.  And this includes the possibility that many members are really hard case of psychological disturbance, apart from having POIS.  I, for one, like I have already mentioned often, had psychological issues like severe anxiety and emotional instability before POIS and apart from POIS. I do not beleive that is is "All In our Heads", no, but a part of it, and surely some aggravating factors, can.

So, those who will accept to participate in the future study, in my own opinion, will need to have a clear sense of commitment to the POIS community, a sense that they do not go there just for themselves, they do care that the study goes through, whatever they have to personally accept as effects or apparent worsening of their POIS. They should be aware of their own situation, health-wise, in particular on the psychological level and about resistance to stress.  On top of that, any one choosing to enter the study should make it clear that it is an experimental study, and refrain from having ANY expectations about results !  If you enter the study because you find life unbearable with POIS and think this is your last chance to get better, don't enter the study !  Do the POIS community a favor and stay home, and let those who are more stable and have a more realistic perspective enter the study.

I think it is more important to make this clear than to make guesses at the details of how the Rutgers study fiasco happened.



You are 100% responsible for what you do with anything I post on this forum and of any consequence it could have for you.  Forum rule: ""Do not use POISCenter as a substitute for, or to give, medical advice" Read the remaining part at http://poiscenter.com/forums/index.php?topic=1.msg10259#msg10259

Limejuice

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #52 on: April 01, 2017, 01:49:29 PM »
Thanks Quantum. I completely agree with the purpose of the study and who the stakeholders are. In 2012 I donated at least $1000 towards this like many others did.

I just want to make sure we know the causes of the issues that halted this study so we can learn from any mistakes made to have a more beneficial future study. I think everyone here has the same intent. If I asked a question it wasn't to sir trouble or create an issue - it was gather information so we can make the right decisions moving forward.

The information poiscenter's been give leaves much ambiguity and any clarify will help us. Thanks to our team for asking NORD and Dr K these tough questions!

Edit - I just want to add that there aren't many research organizations available with the budget we have so we don't want to burn bridges with NORD but it's also important to ask the tough questions so we can be as helpful to the process as possible. Demo, Quantum and the team have been good at this!

« Last Edit: April 01, 2017, 02:12:46 PM by Limejuice »

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #53 on: April 01, 2017, 02:18:14 PM »
Thank you very much, Limejuice.
Demo
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 #54 on: April 01, 2017, 02:30:18 PM »
As long as we're speculating, I wouldn't be surprised if there wasn't a nasty, money hungry lawyer or counselor aiding & abetting our POISer-complainer. Especially since it took him 8 months to register the complaint :(

I only bring this up because of the EXTRA care in screening suggested. This event is so rare I would hate to see us go through the added time and expense if not necessary.

We can't screen for poor motives on the part of POISer friends/family advisors.

Keep in mind, for better or worse, we are in a litigious society.

I'm NOT making any direct accusations, but we are all devastated...and in the absence of real, true facts...looking for all possible answers!

Rutgers POISer: if you're reading this, please tell us it's NOT true. You can PM me in utmost confidence.



« Last Edit: April 02, 2017, 10:40:46 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

COLM_2

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #55 on: April 01, 2017, 06:06:08 PM »
Hello,

I have posted on a six month trial of VNS that I wanted to share on the site.

http://poiscenter.com/forums/index.php?topic=2387.msg20829#new

Regards,
Colm
Formerly user COLM (previous username accidentally deleted). Few decades with POIS.

Quantum

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #56 on: April 01, 2017, 10:06:33 PM »
Thanks Quantum. I completely agree with the purpose of the study and who the stakeholders are. In 2012 I donated at least $1000 towards this like many others did.

I just want to make sure we know the causes of the issues that halted this study so we can learn from any mistakes made to have a more beneficial future study. I think everyone here has the same intent. If I asked a question it wasn't to sir trouble or create an issue - it was gather information so we can make the right decisions moving forward.

The information poiscenter's been give leaves much ambiguity and any clarify will help us. Thanks to our team for asking NORD and Dr K these tough questions!

Edit - I just want to add that there aren't many research organizations available with the budget we have so we don't want to burn bridges with NORD but it's also important to ask the tough questions so we can be as helpful to the process as possible. Demo, Quantum and the team have been good at this!


Thanks for your comments, Limejuice.

I fully understand that people would like to know more about what happened, and you do not do that in order to "stir trouble or create an issue".   However, knowing that we won't receive any additional information from NORD about the complaint, we try to encourage the members to look forward for the new study.   If we ever manage to get some tiny pieces of new information, we will share them, but don't have too much expectations.   And even in that case, it would be very general information, nothing specific for sure.


You are right in saying that there are not many opportunities to get a full study, complete with Board Review, for only $33 000.   It is still a very good choice to stick with NORD.

As for the complete reasons causing the discontinuation of the Rutgers study and the way to prevent a recurrence, I feel we will have to trust NORD to help in this process, because they won't disclose any information linked to the complaint.   We have to deduce what has to be improved, like the screening, and in particular the screening about the other health conditions the potential participants may have.  We now also know, through Dr K letter to NORD, that it will be necessary to have doctors on the next research team, that can take care of the clinical aspects of the study ( I would like to emphasize that, if Dr K had not forwarded to Demo his letter to NORD, we would know even less than we do now ).

We do not know what are those "underlying clinical conditions" that have been identified by the IRB or by NORD, and which need to be addressed, but NORD have this information, so they will act accordingly.  We have no choice but to put trust in the NORD team in this regard.

Keep in mind that the next research team that will propose a study plan will not have this information neither when they will present a POIS project.  It will be through NORD review process with the chosen team that they will be asked to adjust their protocol and, for example, establish what NORD will judge acceptable as a screening process, and may ask to add some exclusion criteria  ( I don't know how it's done, I just make hypothesis , here).  So, even if we were to ask NORD for details, we will not be able to help - It is NORD that is responsible for bringing the regulatory environment, and that will interact directly with the chosen research team.  Maybe, in the coming months, we may get some information, from Demo dedicated communications with NORD, about what they intend to ask for as requirements, that will ensure that the same kind of problem will not happen again.  But it will still be NORD that will have the responsibility to make sure that these new requirements are met, and there will not be much that we will be able to do, because we will not interact directly with the research team, at least not about what is concerning their study procedures.  We do not have the necessary qualifications and the experience to do so.  NORD has, and I think we can trust them that they will be extra-careful, considering what happened with the first POIS study project.

You are 100% responsible for what you do with anything I post on this forum and of any consequence it could have for you.  Forum rule: ""Do not use POISCenter as a substitute for, or to give, medical advice" Read the remaining part at http://poiscenter.com/forums/index.php?topic=1.msg10259#msg10259

demografx

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #57 on: April 02, 2017, 12:27:04 AM »
Hello,

I have posted on a six month trial of VNS that I wanted to share on the site.

http://poiscenter.com/forums/index.php?topic=2387.msg20828#msg20828


Regards,
Colm

This is incredibly helpful and timely, Colm!!

It shows that we have "not lost all" in our association with Dr Komisaruk!

Best,
Demo




« Last Edit: April 02, 2017, 12:42:05 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

COLM_2

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #58 on: April 02, 2017, 01:23:58 AM »
Thank you Demo & Quantum & Demo,

Just wanted to mention some other things about the VNS evaluation linked above.

I am not endorsing this product or saying it WILL work for others.

Please, if you are taking any medication that helps with depression, please be careful if you were starting to use this or any device like this.

Also, note that I am wondering what if Bioelectronics developments were a core part of our path to wellbeing? What if we had a safe VNS device that more specifically targets nerves related to POIS symptoms? A lot of what ifs, and no one knows for certain. We have no valid evidence, just personal experiences. I don't know would this focus help us even more? Possibly. But again, please do NOT take any risks with VNS devices. For all I know, I could keel over next week  and shuffle off this mortal coil :-)

Colm
« Last Edit: April 02, 2017, 04:30:14 AM by COLM_2 »
Formerly user COLM (previous username accidentally deleted). Few decades with POIS.

Shep

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Re: Important Announcement About the Rutgers / NORD Study
« Reply #59 on: April 02, 2017, 06:01:07 AM »
Dr Komisaruk most likely stumbled upon a dead end in the theory of a vagus nerve or found something serious in what could not understand the power of its capabilities or knowledge.
My IRB opinion is a cover.
I can not advise you. I'm a new person here, but it's not a good idea to spoil relations with NORD.
« Last Edit: April 02, 2017, 06:17:35 AM by Shep »