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The Marshall Protocol Study Site > ABOUT THE MARSHALL PROTOCOL > ANNOUNCEMENTS AND NEWS > An update on the NIH, Dr. Elias Zerhouni, James P. Kiley of NHLBI


An update on the NIH, Dr. Elias Zerhouni, James P. Kiley of NHLBI
 Moderated by: Dr Trevor Marshall  

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scooker48
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 Posted: Fri Sep 30th, 2005 15:48

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I send a huge THANK YOU to the entire Research Team and everyone who participated in the meeting yesterday. 

I have guarded optimism about the requested meeting.  It would obviously be great for the MP, cut they might easily deny the request.  When will we know?

Sherry



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Aussie Barb
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 Posted: Fri Sep 30th, 2005 18:58

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see info re opening PDF files

see also Topic: Press Release about FDA application to go out on Monday



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♥Barb♥: Dx Inflammation - Endocrine Imbalance 2003| Depression| 24+ years not Dx| MP Aug04-Aug2010| barbliv @ hotmail.com | ABC of MP| Barb's Story|
Dr Trevor Marshall
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 Posted: Sat Oct 1st, 2005 17:40

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Sherry,
First, thank you for your special help with our efforts :) :)

We will probably have sense of what follow-up there will be sometime during this coming week. I will be working the phones to make sure that I touch bases with all the players.

What had the greatest impact was that there were 8 'representatives' of the Foundation at the NIH, and that they had each come from seperate states, some having flown in. That clearly communicated our sense of purpose, and it was not lost on Dr Zerhouni's staff. Dr Zerhouni himself did not attend the meeting, it was with his senior staff, and senior staff from the NHLBI (Dr Zerhouni was pre-occupied with the awards presentation), but each of us met him (briefly, in the hallway), and shook his hand.

..Trevor..

LeAnne
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 Posted: Sat Oct 1st, 2005 18:16

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.Dr. Marshall,

Did you get a sense that they were truly open minded and truly wanting to understand and inquire information about the MP, or is this just a way for them to be able to say that they did take the time to listen? I know through our letters and contacts, that we have all begged them to listen to us. I am just wondering if they really want to listen or if they want to get us off their back.

LeAnne

Last edited on Sat Oct 1st, 2005 18:48 by LeAnne



____________________
Neuro-Sarcoidosis/lungs, spleen, nervous system, skin lesions, 125D66, MP 8/05, Ph1 3/06, Ph3 7/06, NoIRs, low lux home, cover up, 25D9 Sep07
Dr Trevor Marshall
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 Posted: Sat Oct 1st, 2005 19:09

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LeAnne,
I got the impression they would rather not have to cope with radical change in medicine right now. But I will continue to plug away this week and see if we can turn their uncertainty into a desire to help. But from this day forward Dr Zerhouni has no deniability. He cannot say "I didn't know."


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 Posted: Sat Oct 1st, 2005 20:36

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I want to extend deep appreciation to Trevor, Meg, and Belinda for their wisdom and energy in preparing for this recent event.  I was fortunate to be a witness in the forefront of yet another milestone for our health and wellness.  The presence and input of the patients were important, but the preliminary efforts leading to all of this have been extraordinary.  Only time will tell, but I believe we will soon be receiving some positive communication from the NIH, as it appeared to me that most of those attending were interested in helping to meet our goals and needs.  Their attention to Trevor and to the MP community was definitely noted!

Trevor and his team diligently work on many levels simultaneously, mostly unbeknownst to only their family.  We are greatly indebted to Trevor for his research and ingenious findings and to the board and moderators for sharing their knowledge through patience and perseverance. 

Congratulations also to Trevor for his success with the FDA filing! 

Carole 



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Dr Trevor Marshall
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 Posted: Sat Oct 1st, 2005 21:56

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Carole,
I want to extend my thanks to you, and all the others who helped out with this event. I haven't named the folks who travelled to the NIH individually, because we try to maintain folks' anonymity as much as possible. But I welcome their perspectives here, as, I am sure, do the members.

Without you all being present Meg, Belinda and I would never have been taken seriously. Now we will need your help as we try to impress upon the NIH folks that they need to "walk the walk" as well as "talk the talk." I think Dr Allen will be contacting you all by email, and appreciate your ongoing support to keep pressure on TPTB :)

..Trevor..

wytnez
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 Posted: Sat Oct 1st, 2005 23:31

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Trevor, Belinda, Meg and all who attended this milestone event on behalf of all sufferers of chronic diseases......I extend a heartfelt thank you!  I am so happy that you are working with the FDA to get the only treatment mandated to treat chronic diseases.  I am in the process of finding out who covers the health section in my city paper and would love to enlist the help of the GNP who is following me on giving them her documented proof of my progress. 

Once again a big    

Saj 



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Barney
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 Posted: Mon Oct 3rd, 2005 12:52

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HI ALL!!  BARNEY HERE!!

WOW, WHAT A TRIP!!!

SORRY IT HAS TAKEN ME SO LONG TO WRITE AND LET YOU ALL KNOW WHAT HAPPENED, ESPECIALLY TO ALL THOSE WHO SENT ME 'PEP' PM'S, BUT HAD TO REST.

WE STARTED OUT WITH A MEETING AROUND THE DINNER TABLE AT THE HOLIDAY INN RESTAURANT. WE WERE GIVEN A COPY OF THE PRESS RELEASE AND SOME OTHER PAPERS THAT DR. MARSHALL WANTED US TO SEE.

WE DISCUSSED, BUT CAME UP WITH NO REAL PLAN, EXCEPT WE WOULD MORE THAN LIKELY USE THE BANNERS WE HAD MADE. ACTUALLY WE DECIDED TO PLAY IT BY EAR MOSTLY, WHICH IS WHAT REALLY HAPPENED.

THIS IS MY STORY, AND I AM SURE I WILL MISS SOME OF THE THINGS THAT HAPPENED, SO FORGIVE ME IF I MISS TELLING ANYTHING.

WE GOT UP AT 530AM TO GET READY FOR THE DAY. THE HOTEL SERVED A NICE BUFFET WHERE WE WOULD MEET AT ABOUT 630AM FOR BREAKFAST AND A MEETING FOR WHAT WE COULD EXPECT FOR THE DAY.

WE RODE THE SUBWAY TO THE NIH (MY FIRST SUBWAY RIDE, WHAT AN EXPERIENCE). WE WERE CHECKED THRU SECURITY AND GIVEN OUR BADGES. WE WENT DIRECTLY TO THE BUILDING FOR THE PIONEER AWARDS. WE SCOPED IT OUT AS TO WHERE TO SIT TO BE OUT OF THE WAY OF THE AWARDS AND THE CAMERA. WE DID NOT WANT TO DISTURB THE AWARDS OR THE FILMING. WE SAT IN THE REAR OVER TOWARDS THE RIGHT AND WE PATIENTS HELD UP VARIOUS BANNERS. A LADY (ANN) CAME IN AND ASKED US WHAT WE WERE DOING AND WE ADVISED HER THAT WE WOULD LIKE TO BE HEARD BY DR. ZERHOUNI. WE KEPT HOLDING THE BANNERS UP AND IT WAS BEGINNING TO GET A LOT OF LOOKS. SHE THEN CAME IN AND WROTE DOWN WHAT THEY SAID. I COULD NOT CONTAIN MYSELF. I HAD HAND OUTS (ABOUT MY LIFE AND JOURNEY ON MP), SO I GRABBED ONE AND ASKED MEG TO LET ME OUT. I WENT INTO THE LOBBY AND ASKED ANN TO READ THIS. TURNS OUT SHE WAS IN THE COMMUNICATIONS DEPARTMENT AND HER ASSOCIATE WAS WITH HER. I EXPLAINED WHY I WAS THERE AND SHE WANTED MORE INFO SO I WENT BACK INSIDE TO GET DR M AND BELINDA. THE HEAD OF COMMUNICATIONS FOR THE NIH JOINED US ALONG WITH 5 CAMPUS POLICEMAN/WOMAN. AS WE EXPLAINED (ESPECIALLY DR M/BELINDA), THE POLICEMAN DISAPPEARED ONE BY ONE, SEEING THAT WE WERE QUIET 'PROTESTORS' (AS THEY LABELED US). I ASKED IF ANN WOULD LIKE US TO REMOVE THE BANNERS. SHE SAID THAT WAS OUR 1ST AMENDMENT CONSTITUTIONAL RIGHT AND SHE HAD NO RIGHT TO TELL US TO TAKE THEM DOWN. I TOLD HER WE WOULD AND SHE SAID SHE WOULD TRY TO GET US A MEETING SET UP. I WAS TELLING THEM I WAS DYING (WITHOUT MP) BECAUSE THEY HAD EVERYONE (THE DOCTORS) CONVINCED THAT SARC GOES AWAY AND I TOLD HER THAT WAS NOT TRUE. I BECAME SO EMOTIONAL THAT ALL OF A SUDDEN (OUT OF THE CLEAR BLUE SKY) I BROKE INTO TEARS AND HAD TO LEAVE THAT DISCUSSION. AS I PASSED THE YOUNG LAD POLICE OFFICER, YOU COULD SEE SHE WAS ABOUT TO BREAK INTO TEARS AS SHE ACKNOWLEDGED MY PAIN.

THE REST WAS IN BUILDING 1 WITH 6 HIGH RANKING NIH AND NIHLB AND THEIR COMMUNICATIONS DEPT, WHERE WE TOLD THEM OUR PLACES OF RESIDENCE (THEY WERE VERY IMPRESSED THAT AS PATIENTS, WE CAME FROM ALL OVER THE US). DR MARSHALL AND BELINDA DID A GREAT JOB OF TRYING TO GET OUR POINTS ACROSS AND WE PATIENTS PUSHED THE POINT THAT WERE IT NOT FOR MP, WE WERE DYING AND THAT SARC DOES NOT GO AWAY AND WE WANTED THEM TO STOP TELLING THE WORLD THAT SARC DOES GO AWAY. AT THE END OF THE MEETING, CAROL BROKE INTO TEARS JUST AS I HAD AND NEITHER OF US COULD EXPLAIN IT, EXCEPT THAT IT JUST CAME OVER US. 

WE ACCOMPLISHED THE BEGINNING, AND NOW ALL OF YOU MPers NEED TO JOIN THE 8 OF US WHO WENT AND DO WHATEVER IT TAKES TO GET OUR STORY OUT.

BARNEY



____________________
Sarcoidosis, asthma, fibromyalga, diabetes, left kidney only. Started MP 1/1/05. Benicar only since 9/2007. 11/11/12 had a heart attack, 1 81mg asprin, diabetes blamed for this. Heart is regenerating new veins to replace the ones that died. Doing great.
rainbowcatcher
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 Posted: Mon Oct 3rd, 2005 13:59

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Dear Barney,

We truly understand those tears & you have every right to shed them! You have been through hell to get here (both of you) & finally someone was listening to you; anyone who has a heart would have felt the same. We are very proud of you all!

A HEARTFELT THANK-YOU TO EVERYONE WHO ATTENDED!

"We can do it!" (quote barney)

:dude: RB :cool:



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jillian
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 Posted: Wed Oct 5th, 2005 19:08

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Is there an anticipated timeframe for how long it takes for the FDA to 'approve' the three applications? Is confidence high that they WILL actually approve the applications? (After seeing what's happened the past couple of years with the MP and TPTB, I've gotten very pessimistic...)

'til later,

Jillian from North Dakota



____________________
PulSarc79,FMS,CFIDS,etc,disabled93. AvoidD/Noirs Aug02. Oct02: 1,25D=42 NTfrzen; Apr05:25D=10. P1 Oct05-Feb06; ModP2C Feb-Nov06; P2 Nov14-Dec06; ModP2BSS Jan-Mar07; ModP2CBSS Mar07-Oct08. P2 Nov08-Apr09. Temporary MP break May09-Dec09.
Dr Trevor Marshall
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 Posted: Wed Oct 5th, 2005 19:21

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Jillian,
The MP has actually been accepted very fast by TPTB. If you compare Barry Marshall's work, from the 1982 discovery to the FDA decision in 1994, we have done very well so far.

I am continually told by TPTB at the NIH that one of the major hurdles we have to jump is that we just want things to move too fast.

If I was sitting in a cushy job in a University then I wouldn't care how many patients died while we were getting the Phase 3 trials organized properly, would I? One has to understand the conventional frame-of-reference before one can appreciate the magnitude of our task:)

As for when the NIH will make the next move, well, things happened today (behind the scenes). Small things, but finite, I believe...

..Trevor..

jillian
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 Posted: Wed Oct 5th, 2005 19:50

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Trevor,

Thank you for your answer and, as always, your continuted support.

Count my pessimism to pre-MP Th1 inflammation! (only pre-MP a couple more days, can't wait to see what emotional herxes I get :D.) Your optimism is good enough for me!

'til later,

Jillian



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PulSarc79,FMS,CFIDS,etc,disabled93. AvoidD/Noirs Aug02. Oct02: 1,25D=42 NTfrzen; Apr05:25D=10. P1 Oct05-Feb06; ModP2C Feb-Nov06; P2 Nov14-Dec06; ModP2BSS Jan-Mar07; ModP2CBSS Mar07-Oct08. P2 Nov08-Apr09. Temporary MP break May09-Dec09.
Frans
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 Posted: Wed Oct 5th, 2005 20:06

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Dr Trevor Marshall wrote: As for when the NIH will make the next move, well, things happened today (behind the scenes). Small things, but finite, I believe...

..Trevor..

Dr Marshall,

Every step is a step closer to the end-goal, MP for everyone who (desperately) needs it!

Sincerely, Frans



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Ival
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 Posted: Tue Oct 11th, 2005 05:34

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HI

Sorry it has taken me so long to post on this but I type with one finger and I have been so busy since I have gotten back.


I went to Bethesda because I could not believe that I'm getting well on a protocol that I found on the Internet and then went to Chicago to explore further. I had to see for myself that the NIH cannot comprehend what is actually happening. I believe the meeting definitely open the door but I'm still not sure how much they understood.  

The meeting started with them pretty much trying to scare Trevor by telling him they thought they had already settle this with them. And that he could be sued because he was practicing medicine without a license he pretty much said that with a low tone of voice. I'm gonna say that doctor Roth is the one that did most of the talking but I could be wrong on the name. Then when he saw that Trevor was going to continue with this he said that the best he could remember was all the paperwork that he had from before was not published in peer review papers, he could not say that officially because it did not have the paperwork in front of him.


That is when Trevor showed how well he is he jumped straight out of the chair and spun around it was one of the best memories I have of the meeting. 

Then doctor Roth pretty much tried to explain to us how much money has already been spent on this disease by doing the study and we should be excited about that and some estrogen study that they were working on to.


Every time he tried to get off the subject Trevor, Belinda , and Meg would not let him that was really impressing to me how dedicated they are to get this out to the public.

Everybody at the meeting got to talk to them tell their names and where we were from and how we were getting well but nobody actually ask me what disease I had come to think of it. I saw most of the patient's eyes swelling up while they were talking when it came to my turn I wanted to talk for an hour but I could hear my voice cracking with emotion and I did not want to sound like an idiot so a pretty much just stop talking.

They kept acting like it was alternative medicine that we were taken some vitamins and some bat wings and mixing them together and Blogging on the Internet and getting well.


Trevor, Belinda, and Meg did an excellent job explaining the protocol to them and it was not alternative medicine. It seemed to me that he was using the state of the science meetings to scare Dr, Marshall off that they were going to be expensive and there was no way he could even be ready for such a task.

I think it overwhelmed him when Trevor came back to that is an excellent idea and I have all my doctors and scientists ready when can we start because I have not been able to talk to any of your doctors and scientists.

That is when it looked to me that he just started going through the motions to be nice until we left. After the meeting was over in the hallway he asked Trevor to please not use the word cure and that made me think that we did get a lot across. Trevor told him he was using the word curative in all his papers which I thought was real professional and seemed like a good compromise. The best thing about going was being around the group it just made me proud it was a feeling that I haven't felt before it was great. They saw 8 people this time by this time next year if nothing is done they probably could see 8 hundred wouldn't that be great. This is some of the things that come to mind and my opinion of how the three days went.

Ival



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 Posted: Tue Oct 11th, 2005 08:01

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Meg may report more about the trip to Bethesda, but this is what she posted earlier:
Belinda


"My impression of the NIH meeting was that they were trying to 'handle' us. The PR people moderating the meeting had no background information and did not ask for any. They seemed to rely on the short (surely biased) briefing they must have gotten from the Heart, Lung and Blood Institute (NHLBI) folks.

Dr. Roth, the NHLBI Deputy Director, insisted that the Marshall Protocol was "unproven", that we needed to do a study and that we could apply for an NIH grant. When told that two Pioneer Award grant applications that fit perfectly into the desription of the new NIH Director's Roadmap initiative to help novel scientific studies, was rejected, Dr. Roth said that the appplications must have been inferior or the study not nearly as important as those that were accepted because they were reviewed by their "experts". Nevermind that all last years' recipients were 'pioneers' in well-established research facilities and few, in any of the studies, had any groundbreaking potential.

This representative of NHLBI, the institute that is responsible for sarcoidosis, said it is our responsibility to prove to them with a randomized, placebo-controlled, double-blind study that the Marshall pathogenesis is correct. While Dr. Roth admitted that we might be right, he said there was nothing the NHLBI or the NIH could do to help. He made it clear with his body language, tone of voice and attitude that we were wasting his time. The NIH, the nation's premiere research system, spends $28 billion tax dollars per year. This immense bureaucracy's focus, however, is on managing diseases, not finding cures. The system, IMO, is seriously flawed and will not be easily changed because too many careers and too much money is at stake.

It appears that there is no avenue at the NIH for promoting the study of a medical breakthrough that doesn't come from within their academic network.

But we will continue to push for scientific accuracy in the information about sarcoidosis that the NIH posts on its website because its director, Dr. Zerhouni, said NIH information must be impeccable. We made it clear that the unsubstantiated myths they are publishing were confusing our doctors, hindering our diagnoses and making it difficult for the average doctor to recognize the potential of the only cure available. Two other NHLBI employees were present and they voiced interest in helping us accomplish this goal.

Our suggestions that the NIH call a 'state of the science' conference about sarcoidosis so that we could meet with their experts met with some approval. Perhaps because the responsibility for convening such a conference lies with the Office of Rare Disease and it was a welcome change of subject."

Meg

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 Posted: Tue Oct 11th, 2005 09:08

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I thought that NIH and NHLBI is for making sick people life more easy, and what i am hearing right now is they are making more troubles instead solving or trying to help solve troubles.
What are they for if they can`t do anything.
Institution which can do nothing is not needed or need to be reformed.
It is radicullous that Dr Marshall developed cure for disease and now He has to deal with administration, politics and other stuff that should not concern His mind and are others people job who seems to not fit to their duties
I have read Your`s raports with great intrest :)



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 Posted: Tue Oct 11th, 2005 09:51

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The people at NIH all seemed to have the same question: “Why are you here?”

Why would a group of people resort to holding up banners at the Pioneer Awards? Barney had a good answer (paraphrasing): “Because we want your attention – we want you to listen to us, and we especially want you to understand what life was like battling a terrible disease before this treatment developed by Dr. Marshall because he understood what causes the disease. We want action too, because we are only a sampling of other patients who are recovering using this treatment.”

There were still puzzled looks, so I explained that patients like Barney believe that someone like Dr. Marshall, who has built on the work of many other researchers and added his own discoveries to devise a treatment that is an effective intervention for such a disabling chronic disease as sarcoidosis -- when this treatment has literally turned their life around -- people like Barney seem to be saying that they believe that Dr. Marshall is the TRUE PIONEER. Who else has delivered something that has gone so directly to the bedside to assist suffering patients?

In the later meeting with NIH/NHLBI representatives, there was some clarification of a few misunderstandings. But it was obvious there’s still a lot to be learned about who Dr. Marshall is, what has been accomplished and the significance of his discoveries.

Most impressive to the NIH/NHLBI staff was the fact that there were so many people in that room who had come from all over the U.S. to talk about the MP. The staff seemed to be contemplating what could have motivated people to travel to Bethesda to speak so passionately about a combination of medications and lifestyle modifications. Why?

This is obviously not what NIH/NHLBI is used to hearing. They are used to patients lobbying (with passion) for more research to find a cure. How often, though, does someone like Ival tell them, “What I just don’t understand is why in the world someone isn’t beating down the door to investigate this treatment, because my recovery has been simply amazing.”

Perhaps the only time they hear talk like that is when people talk about herbs, over the countter potions and creams. Yet the patients had explained that heir own physicians were managing this new therapy, writing the prescriptions and watching their progress with a combination of bewilderment and satisfaction.

The meeting closed with a short list of action items and reassurances there would be follow-ups. I have no doubt that the presence of patients, their heartfelt explanations of how they came to try the Marshall Protocol and what had happened to them when they did is the one thing that made a difference in Bethesda.

The fact is that your letters were not answered either because NIH either did not think you were real or they did not think answering you was important. These are the things NIH/NHLBI doesn’t understand, in my opinion:

1. The science behind Dr. Marshall’s discoveries.
2. The significance of Dr. Marshall’s explanation of the etiology of chronic Th1 disease.
3. The impact of the explanation of the etiology of Th1 disease on treatment.
4. How treatment based on an understanding of Th1 disease etiology affects patients, their lives, the community and the economy.
5. How the current system of academia-linked investigator-driven research fails.

The patients who went to Bethesda are each and all wonderful people. They pled your case logically and passionately. I hope NIH/NHLBI is beginning to understand why they went there, because as time flows on IF there is no progress at NIH, there will only be more people asking why someone at NIH isn’t listening to Dr. Marshall and beating down the door to learm more about the etiology of Th1 disease.

Belinda

LeAnne
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 Posted: Tue Oct 11th, 2005 11:21

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What is the next step?

What can we do to help?

When is the next meeting that the NIH will hold on sarcoidosis?

If they want to see proof, than they need to see proof. We all need to band together, save our money, and prepare to attend. If we can organize a meeting with fifty or more MP patients, it would make a huge statement. The key to this would be to organize it. I know there are people all over the world who are on this protocol. It would take planning, time, and money. Is this something that would be possible to organize?

Another thought would be holding our own meeting, and asking Dr. Kiley,Dr Roth, Zerhouni, and other key players to attend. If we did this, they would be on our turf, and we would be in control of the meeting.

Again, what should the next step be?

LeAnne



____________________
Neuro-Sarcoidosis/lungs, spleen, nervous system, skin lesions, 125D66, MP 8/05, Ph1 3/06, Ph3 7/06, NoIRs, low lux home, cover up, 25D9 Sep07
k1075
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 Posted: Tue Oct 11th, 2005 15:01

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Hello to all,

I attended the meeting at the NIH and can officially say that although the members of the NIH seemed to me to be very defensive regarding their handling of we MPers.... I believe the door has been opened for them to take Dr. Marshall more seriously.

It did seem that they had a preconceived notion that we were advocating some type of alternative medicine, and I believe Dr. Marshall, Belinda, and Meg did an excellent job of explaining that we are not just taking herbal medication and meditating...but that this is a real "curative" protocol. 

There did not seem to be to be any scientists or doctors in the meeting, so it was very difficult to get across the science to them.  We were basically meeting with the PR people and the deputy director, who I believe is a lawyer.

I do think we drove home the need for new information to be put out regarding Sarcoidosis and the ramifications of misinformation.

Barney did an excellent job of scaring them when she said that she had a friend with Sarcoidosis who has been donating blood for 20 years because she didn't know it was contagious. You should have seen the look on the deputy director's face when she said that! I think it was comments like this which really got their attention.

I do believe that they listened to us, whether we were actually HEARD or not remains to be seen, but at the very least I do sincerely believe that we GOT THEIR ATTENTION, and hopefully that will open the door for Dr. Marshall in the future.  I definitely believe the trip was worth every minute and that possibly it is a solid beginning............



____________________
DX: Sarc- mediastinal lymph node biopsy 07/22/04, Uveitis. Began Phase I 08/13/04; Phase II 11/29/04: Phase III (second try) 03/05/07.
08/12/04: D 1,25- 43.6. 12/18/04: D 1,25- 39
10/15/05: 25D-11; 1,25D-31.
4/28/09: 25D-7; 1,25D-14

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