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NIH protocol (chronic orthostatic intolerance)


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I received a form letter yesterday from NIH detailing the difficulty evaluating patients under this protocol and how I have been placed in the "hold" pile at this point in time. Needless to say, I am disappointed as I had been pre-qualified for the study, and apparently many others were as well. I am still hopeful that some answers will be found to help us deal with this "often debilitating, frustrating, multi-system disorders" Martha

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Guest tearose

How frustrating Martha! I am sorry for the delay. What can you do in the meantime?

Since you don't know what really is the hold up, will you start looking into other alternatives?

I guess when I hear something like this it makes me wonder if there is something with the research project itself they must reconsider...I'd hate for you to wait only to find they decide to stop the study. Maybe I'm just being skeptical?

good wishes, tearose

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I applied there 2 weeks ago and the only program they have now is one using hypnosis, biofeedback, and placing your hand in ice water. It is only for ncs. So if you are not a fainter, there is NO research being done there for other ans problems. And for this program they were only picking 35 people. That would explain the back up issues and the protocol I guess. I haven't fainted....yet. I have pretty much given up ever getting anywhere, so won't be applying anywhere anymore. It's not worth the disappointment to constantly get turned down. morgan

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Ernie, in the letter many issues are alluded to including limited resources (money, space, reports, volume of correspondence), complexity of the disorders, safety issues with temporrily discontinuing treatment before and during the study,lack of a therapeutic trial, and competition with other protocols.

Tearose, your thought that the study may be discontinued also crossed my mind. I hope not because NIH is such a reputable research facility. Martha

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The main reason that NIH is probably putting people on hold is because they oly get 1 spot per week for the Pet scan maachine. Which is the main part of the study. Even without that part of it they can hardjy handel moe then 2 at the most 3 people per week because they need at least 2 people for each test. The staff that does the testing for POTS is made up basically 0Courtney doing the lab work, Sandra the research nurse without her hadly nothing can get going). Dr. Basil- doing an internship- Dr. Goldstein the neurocardiologis, Teresa the secretary and maybe 1 to 3 student helpers. When they do a tilt test it takes at leaast 3 people and about 3 hours to do no including getting the blood test results and doing the evaluation. Pet scans take the whole day.

So, to answewr your question -they have too many people withouot enough staff to do all the protocals they have going. you see- in someprotocals the see patients ever 1 to2 years. so, they have to fit the old ones with the new ones. they basically have gotten over their heads.

The reason i know this and the people is i have been the last 2 years bu will not be going back till next year because of space.

I pretty sure i am right about this.

Kathleen

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I wrote my friend at NIH and she sent me the letter that they are sending out about the protocol on POTS. She also told me that they are just too overwhelmed because -

We get normally 2 maybe most 3 PETS per month and that is split between all protocols and we can only do 2 maybe 3 patients per month. PD, MSA, and PAF always has priority thus leaving POTS way behind.

They do have an extreme small staff- that is very true. As the point about PD- Paarkinson's Disease- MSA - Multi System Atropy and PAF being Dr.gldstei's primary work - my PD part of me has to agree with that- he has found some very important findings on PD. Also,i do have to put his work on MSA in front of my concerns of PD and POTS -because that can be fatal.

Iknowthis is not what you wanted to read but i know if Dr. goldstein had a bigger staff -he would and could domore - we need to write the headofNIH and ask for more funding for POTS then Dr. Goldsteincould do more.

Dr. Goldstien's letter

i am writing to let you know that I have decided to put a ?hold? on further accruals into NIH Clinical Protocol 03-N-0314, ?Clinical Laboratory Evaluation of Chronic Orthostatic Intolerance.?

The main reason for this decision is that we have been overwhelmed by requests from patients and referring physicians for patient evaluations under this protocol, and sadly our small Section simply doesn?t have the resources to see all the patients, even though most qualify for inclusion in the study. Our contact roster already exceeds 50 patients, not counting self-referrals in numerous e-mail requests. We have the capability of studying perhaps 1 patient per month completely in the protocol, with adequate attention to arrangements for travel, medications adjustments, consent, scheduling procedures, record-keeping, confidentiality, adverse events reporting, reports to oversight committees, and correspondence with the patients and referring physicians, all on top of the actual testing and laboratory assays. Attempting to prioritize patients has also proven extremely difficult and very time-consuming. The decision making has usually been based on reviews of voluminous records rather than on in-person screening?a less than ideal option.

As you know, the disorders under study in this protocol are highly complex. Adding to this complexity, patients with chronic orthostatic intolerance typically take numerous drugs, which affect the scientific results, and it is difficult to predict when temporarily discontinuing treatments will be safe. By any measure this protocol is also complex, involving multiple procedures and drug tests, and yet it does not entail a clinical therapeutic trial, so that participants may not benefit personally. In light of the fact that we have other complex but worthwhile protocols, we have had to make some hard choices about which patients to study, under which protocols.

I do hope and expect to continue this protocol, which has great potential for improving understanding of mechanisms of chronic orthostatic intolerance and therefore for improving treatments for often debilitating, frustrating, multi-system disorders. We will keep you on our patient contact roster and will review the situation again later in the spring.

Kathleen

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Let me explain alittl better -some of the things in his letter-

As you know, the disorders under study in this protocol are highly complex. Adding to this complexity, patients with chronic orthostatic intolerance typically take numerous drugs, which affect the scientific results, and it is difficult to predict when temporarily discontinuing treatments will be safe.

They have to be taken off some medication a week to 2 prior to going to NIH-which could be difficult.

By any measure this protocol is also complex, involving multiple procedures and drug tests, and yet it does not entail a clinical therapeutic trial, so that participants may not benefit personally.

they inject you with different chemicals to see how POTS and OI reacts to it -but this is only to get results -the information will not make our immediate life better but for PDand MSA they often can get some information that can make a difference right away.

In light of the fact that we have other complex but worthwhile protocols, we have had to make some hard choices about which patients to study, under which protocols

i am in a PD study at NIH- that is why i know this.

Kathleen

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I am gad you gave us the clarification because I was sure that there were studying another disoder like PD instead of POSTS.

I can only imagine how diificult a choice it is to make when having so many patients and so few ressources.

We will have to clone Dr Golstein and his team also!

Ernie

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