CFS patients and families deliver strong message to NIH officials

[Guest guest]

SUMMARY OF SEPT 7, 2010, MEETING WITH NIH OFFICIALS AND CFS PATIENTS AND

FAMILIES

By Rivka , with help from

Contact: <bobmiller42@...>

On September 7, 2010, at 11 a.m., at the NIH campus in Bethesda, MD, a group of

9 CFS patients and their families met with high-up NIH officials. To my

knowledge, this is the first meeting of its kind in the 27 years since I was

first struck down with this illness in 1983.

The meeting was organized by long-time CFS patient . The meeting's

CFS participants (patients and family) included: Charlotte, , Sherry,

, Marielle, Bobbi, Rivka, and . A wonderful surprise addition

to the meeting was Dr. Dan , of Incline Village, NV, champion doctor of

CFS patients and co-founder of the Whittemore Institute in Reno, NV.

The meeting was held just prior to the start of the 1st International XMRV

Conference sponsored by the NIH. The NIH officials present included:

Gottesman, M.D.

Chief of NCI's Laboratory of Cell Biology

and Director of the NIH Office of Intramural Research

http://www.nih.gov/about/almanac/historical/deputy_directors.htm#gottesman

H Plotz, M.D.

Chief, Arthritis and Rheumatism Branch (NIH)

http://www.niams.nih.gov/Research/Ongoing_Research/Branch_Lab/report_individual.\

asp?id=569 & Branch_LabID=25 & email=plotzpmail (DOT) nih.gov%20 & includefile=RAG

Roland Owens, Ph.D

Assistant Director of the NIH Office of Intramural Research and Chief of the

Molecular Biology Section in the Laboratory of Molecular and Cellular Biology in

the National Institute of Diabetes and Digestive and Kidney Diseases at NIH.

http://jgh.hunter.cuny.edu/index.php/component/content/article/6-biographies/95-\

owens-roland-a-phd.html?directory=18

These are my impressions of the meeting. Any and all mistakes, such as

misrepresenting someone's words or sentiments, are all mine. And I welcome any

corrections from others.

The agenda that originally set for us went smoothly. It was for a

half hour meeting, but in the end we were given a full hour. First, had

the patients go around the large table and introduce ourselves, stating how long

we have been, or our family member has been, ill. Then he read a statement which

included points and issues he felt needed stressing. They focused on, but were

not limited to, these two key points:

1. The need for trust building

In the past, our government offices (NIH, CDC) have acted in ways that has

eroded our trust in them, from the (rather amorphous) decades of neglect to,

most recently, the highly concret fact that Judy Mikovits, the scientist who

found the link between XMRV and CFS, was excluded from the XMRV Conference line

up until patients loudly complained. said that we now need our government

to act in a way that engenders our trust in them.

2. The need for funding

Funding is needed for ME/CFS research, clinical trials, and Centers of

Excellence (including WPI).

(For the full text of 's statement, see below.)

After made his very salient, well-written points, Dr. made a

statement, and then three additional patients made theirs, each lasting about 2

minutes. (My statement is included below.) Honestly, embaressingly, I can't

recall any of them. Though I do recall feeling very proud to be on the same side

as Dr. . And I do recall feeling very moved by the patients' statements.

One woman, the mother of a long-time patient, made a strong plea for attention

to pediatric CFS issues.

After Dr. and the patients' spoke, it was Dr. Gottesman's turn.

He told us that he had talked to Dr. Francis just that morning, and that

the NIH Director wanted us to know that positive things were going to happen.

" We are on track. Things will happen. " He did mention that NIAID is currently

setting up multicentered clinical trials.

After he talked, we patients started with questions. It was a 1 hr meeting, so

there were many topics and I cannot recall all of them. They included (not

necessarily in this order):

- What power and purse strings Gottesman has as Deputy Director of Intramural

Research. He was pointedly asked, Can you make a commitment to us right now for

clinical trials? Answer: Gottesman explained that his department, Intramural

Research, means research done within the NIH, not outside the NIH. Intramural

Research is only 10% of the NIH budget. Intramural Research is where " higher

risk " research can be done (I am not sure why he brought up that point, i.e. if

it relates to us or not.) My impression was that he felt he did not have a lot

of say in deciding on clinical trials. My impression was that he was at this

meeting because wanted someone high up to meet with us, but that

did not have the time (or inclination? Or knowledge of our needs?) to match the

person we would meet with what our actual needs were. Others may have a

different impression of the situation. Gottesman did say, in so many words, that

the meeting was hastily arranged, and for the short time they had to arrange it,

it was pretty good to get someone as high up as he. In terms of funding, he did

say, " There will be more funding, and more publications. "

- Patients pointedly asked why has this illness been ignored for 2+ decades.

When Gottesman said it was due to a lack of concrete scientific, clinical and

medical findings and published papers, patients countered that there are 5000

scientific and medical studies on CFS already published.

- When Gottesman said that Alter's paper was the first evidence of something

concrete (i.e. a virus) for CFS, patients reminded him about Elaine DeFreitus

and how her viral findings were ignored and even discredited by the CDC 19 yrs

ago.

- Strangely, at least to us patients, Gottesman praised the former CFS point

person Dr. Strauss, saying that both the NIH and CFS patients lost a good

fighter for our cause when we lost Strauss. No patients nodded their heads in

agreement. Gottesman also seemed not to know about the disappointment patients

feel towards NIAID Director Fauci. So we told him we did not feel warm and fuzzy

towards him for having ghettoized us to the Office of research for women's

health (I don't recall their official name), which has no money.

- Gottesman noted how dangerous it is to take antiretrovirals when we have not

done clinical trials. And before clinical trials they need to test the meds in

vitro. We patients responded with the fact that there are already two published

studies on antiretrovirals that work to hinder XMRV in vitro. (We sent these two

studies to Gottesman via email after the meeting.) I think it was Dr.

who talked about how patients are already doing antiretrovirals. That that is

how desperate we are.

- We talked about how if XMRV or related viruses are a deadend (i.e. not a cause

of CFS, and not a cause of anything hurtful to the body), we hope their interest

in CFS does not reach a deadend, too.

- Patients discussed the pathetic name our illness was given, Chronic Fatigue

Syndrome, and how that very name has contributed to families abandoning their

sick family members because of a disbelief that they are really sick.

- Gottesman talked about how respected Dr. Alter is and how Alter's interest in

our illness and his published study will change everything for our illness.

Alter, and his paper, carry a lot of weight.

- When the NIH team (Dr. Owens) said more people were needed to go into the

field of CFS research, Dr. said there are many good doctors who are

already working on this, but not getting funding. And patients stated that the

lack of funding in general, for CFS, turns off potential researchers.

- Patients talked very concretely about how funding for CFS projects and

research are selected and allocated, and how the team who approves CFS research

grants is flawed (noting the dentists and psychologists who are included in the

team, as opposed to more immunologists and CFS experts).

- Gottesman said that for our specific concrete greivences, we need to write a

letter stating those grievances and concerns and send that to the Director

's office. He promised us that it will be addressed and forwarded to the

right person within the Director's office. (If patients are willing to send

emails to Director , we ask you to select something from the list of

points Bob raised in his statement, found below. Pick the one or two points that

you feel most effects or moves you.)

- Most importantly, Gottesman said he'd meet with us again. And I think 3 months

time was suggested. We said we'd like others involved in that meeting, perhaps

others from the NIH who we might suggest, due to our specific needs.

Any mistakes in this assessment of our meeting are all mine. There is a good

chance there are many mistakes, as it was all taken in through exhaustion,

brainfog and a poor memory.

Thanks to for organizing this meeting, to Dan for adding

the weight of his years of experience and expertice. Thanks also to the amazing

patients and family members who shared difficult stories of years lost to CFS,

and to the NIH officials who took the time to meet with us and will hopefully

meet with us again in the near future.

-- Summary by Rivka , with help from

_______

's testimony at the NIH meeting, September 7, 2010

My name is . I want to thank you for meeting with us today. We are

particularly grateful for your work Dr. Lo and for Dr. Alters as well, and the

PNAS publication.

I have had CFS for all of the 25 years that it took the NIH to get to this

point. And still, we are only at the beginning of understanding a retroviral

role in my illness.

I'd like each person with me to introduce themselves to you briefly and then I

have 5 points that I want to make on behalf of patients here and the 1-4 million

others suffering throughout the U.S.

INTROS

1. Trust Building: The PNAS paper was critical in confirming the Science study

last fall which identified a retroviral association with CFS. But the fact that

it almost wasn't published, that it took an outcry from patients and scientists,

and that the NIH almost let the CDC prevail after 25 years of failed CDC

studies, is frightening to us patients.

a. Even with the first XMRV conference sponsored by NIH, starting today, the

researchers that found the XMRV association in CFS were not going to be invited

to speak until patients protested.

b. So, we present this petition, even though the study was published, because

the 1016 patients who signed this petition, and many more will be watching the

NIH's commitment to scientific progress in CFS very closely, and you have some

trust to build as our federal health agency in this patient population.

c. We are also delivering this second petition from P.A.N.D.O.R.A. (PATIENT

ALLIANCE FOR NEUROENDOCRINEIMMUNE DISORDERS ORGANIZATION FOR RESEARCH AND

ADVOCACY) with nearly 1600 signatures requesting a meeting with Secretary

Sebelius to address the lack of funding for CFS/ME, and related illnesses.

2. Funding. NIH's record of funding CFS research is near zero. Less than $2 per

CFS patient per year. So patients are demanding that the NIH allocate at least

$100 million dollars over the next two years to researching CFS, especially the

family of retroviruses that you have now identified.

a. I've heard years of excuses at the CFSAC meetings from NIH representatives

that not enough fundable proposals make it through your process. We know that

right now you have a stimulus budget. We Say " Build it and They will come " . You

have a huge opportunity right now to attract hundreds maybe thousands of

proposals on this illness, and you need to be aggressive about it. That means

changing the process, expediting the way proposals get reviewed and studies get

funded, like you did with AIDS.

b. There are many lessons from the AIDS epidemic that you published yourselves.

[shown in the report]. One lesson is that funding early saves money in the

future and certainly could prevent the spread of a debilitating virus. The book

that gives an account of the politics behind HIV in America " And the Band Played

On " describes Dr. Don Francis then at the CDC, was turned down for $30 million

in funding when he was desperately trying to prevent the spread of AIDS in 1985.

That lack of early funding for HIV prevention cost the U.S. government $$$

Billions of Dollars later while addressing the HIV/AIDS epidemic, which we are

still fighting.

3. We would not be here if the privately funded Whittemore Institute

had not identified the connection between XMRV in cancer and the immune problems

(RNASE L defect) in CFS patients. They had to know CFS patient histories to

figure that out. That is why it is Key to have doctors like Dr. ,

Dr. Klimas, Dr. Antony Komaroff and others working with NIH researchers.

We need CFS Centers of Excellence funded by NIH – as recommended by the CFSAC

advisory committee for years. The WPI should be funded as the first one, and you

need to make others happen.

4. NIH and FDA need to drive a clinical trial process for treatments with the

end goal of making safe and accessible treatments available as soon as possible.

We are already experiencing the AIDS-effect of patients self-medicating with

very serious medications, such as antivirals and antiretrovirals, because many

of us are desperately sick and there are no alternatives for CFS patients -

none.

a. I have participated in the only clinical trial approved by the FDA for CFS,

the Ampligen (AMP-516 and AMP-511) study. I was on it 10 years ago, And I

improved, the data showed efficacy, but still the FDA denied approval. After

living in the DC area for 5 years, I had to up-root and move my 10-year old twin

sons back to Reno, so that I could access Ampligen again, but yet To This day,

I am still one of only a few patients with access to Ampligen. There is no

excuse that there is only one trial in one city in the whole country to access

the only treatment available. NIH needs to seed this process quickly, so

patients have faith that FDA trials will bring them relief. The alternative is

chaos like the early days of AIDS.

5. Lastly, children with CFS is a very troubling issue. Many recommendations

have been made by CFSAC to address the obstacles to real pediatric care and

coordination with educators and law enforcement. Children with CFS have to be

part of the science. Your PNAS study also compels us to worry about passing this

living torture to our children and spouses, and to worry whether every childhood

cold will trigger what I have. What would you do if it were your child?

While I am angry that it has taken decades to get here, I Still have Hope,

Because, We are sitting here today, just prior to the First XMRV Conference and

because the NIH has confirmed a breakthrough. Your speed and commitment will

give us our lives back.

Thank you for allowing me to speak here today.

--

________

Rivka 's testimony at the NIH meeting, September 7, 2010:

In 1983, I was 21 when I got mono and never fully recovered.

So one day I'm a straight A student leader, a mountain hiker, a global traveler,

climbing the career ladder in int'l relations -- the next day I didn't have the

strength to brush my teeth.

Two decades later, I'm still bedridden and homebound much of the time. Two

decades -- because my gov't and the medical community refused to believe my

illness was real. Instead of taking me seriously, my illness was labled

" fatigue. " The NIH ignored us, which was devastating. But the CDC did worse;

They published studies saying CFS was an inability to handle stress, was due to

childhood abuse or was an emotional imbalance. (Their most recent study saying

this came out just last month.)

Last wk, 26 yrs after I got sick, my blood was tested and, yes, I have the human

gamma retrovirus XMRV. My next step is to take dangerous anti-retroviral meds,

even though, unfortunately, clinical trials have not been conducted.

I'm still bedridden much of the time; it will take me weeks to recover from the

energy required for this meeting. But I am so glad to be here.

I am here to ask each of you, personally -- you (point or look at each NIH rep)

-- to help me and the 1-4 million Americans with CFS that I represent today.

- We want you to fund fast-track clinical trials for treatments, medications.

- We want you to fund Centers of Excellence just for this illness, starting with

the WPI in Reno, the folks who discovered this link between XMRV and CFS.

We have spent the last few decades abandoned by our gov't. Abandoned. Please do

what is right and help us. Now. Finally.

Lastly, I want to publicly thank Dr. Dan for believing us and for

dedicating his life to us.

And I want to thank my mother, who has stood by through the last 2 decades. (She

was present at the meeting.)

-- Rivka

_______

Closing Note: In a post-meeting email exchange between Deputy Director

Gottesman and CFS participant Rivka , Dr. Gottesman said he would be

forwarding Rivka's " Dear Secretary Sebelius, Dear Director " singing

video to NIH Director Francis . (Video found here:

)