Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change

by Jody Smith

The FDA held the Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change on November 15, 2012. An invitation had been issued earlier to Phoenix Rising and anyone interested in attending.

There was not much mention of ME/CFS until well into the webinar, which surprised me and left me dismayed at first. Instead, speakers talked about the origins and history of the FDA, as well as about several other severe health conditions including HIV/AIDS, cystic fibrosis and muscular dystrophy. An advocate for CF and another for MD spoke at length about the challenges that faced them in the early days of advocacy in bringing attention, funds and support to those suffering with these diseases.

The webinar was expected to be an hour long, according to the email invitation I received. At an hour and half into the webinar, mentions of ME/CFS had been few and far-between. At this point questions were taken. As I watched the time, I wondered how the waiting callers were doing. They do have ME/CFS after all, and many of us don't hold a brain-battery charge for 90 minutes or more. Would they be able to hold it together to ask their questions?

And if we were the reason for the webinar, why was our participation playing such a small part in the proceedings? I don't know how many callers were waiting, but with such a short time available to them, was everyone able to get a turn, and did they each get the time they needed?

I had recorded the webinar and listened through the two hours of the meeting again the next day. At first listen-through, I'd wondered what the point was in inviting us to listen to the problems and successes of these other groups. Somewhat reluctantly, I concluded after a second run-through that, while most of the content about ME/CFS did not appear until the last half hour, and most of that was found in the question and answer period between the speakers and callers, this webinar may prove to be a valuable resource after all.

I'm not sure what I expected, perhaps that the speakers would address the unique challenges facing those of us with ME/CFS, the invisibility and lack of respect we find in our dealings with the medical, research and drug manufacturing communities. Maybe I thought the speakers would bring us some insights into why we have been shunted aside for decades by the powers that be.

None of this occurred. But the experiences of AIDS, CF and MD advocacy may nevertheless be something we can benefit from as we work towards effective advocacy, research and treatment for ME/CFS.
Sandra L. Kweder: History of the FDA and Drug Regulation


The first speaker was Rear Admiral Sandra L. Kweder, M.D., U.S. Public Health Service, Office of New Drugs, Center for Drug Evaluation & Research, FDA. She began with an overview of the history of the FDA and drug regulation. She went into detail about how the review process for drugs works. She recommended that those of us with ME/CFS and our advocates would do well to connect with institutions that conduct drug trials, and to gain from the experience of other patient groups.

"Objective measures are limited. We don't have a marker in the blood or a marker and a muscle biopsy or something of that sort that has clearly been shown to predict the clinical course of disease. There are some that are subjective, but none are widely accepted or definitive. There is no question that the clinical trials and drug development have been constrained by these vectors," Dr. Kweder said. "Companies are likely to be reluctant to invest in developing a treatment that is surrounded by all of these uncertainties."

"There are other conditions that have had exactly these same challenges and are seeing the fruits of collaborative work between patient advocates and researchers and funders," Dr. Kweder went on to say. "Progress has been made by establishing definition of the clinical trial populations and targeted reliable measures to assess their symptoms and functioning, so I think this to me makes me very optimistic about CFS and ME."

Dr. Kweder's final word of advice was that we should get creative, and that we should learn from the experience of other advocacy groups.
Richard Klein: How to give input to the FDA


The second speaker was Richard Klein from the FDA's Office of Special Health Issues. Klein talked about how patients can give input to the FDA.

"I want to talk a little about advocacy and the role that patients play in advocating FDA and outside FDA," he said. "Traditionally it has been through advisory committee meetings through open public hearings or written submissions. We have had public policy meetings where the public is invited to speak. Public town hall meetings and written comments that are requested to the Federal Registry."

He referred to advocacy by patients with HIV/AIDS back in the '80s. He brought some light as to how the FDA works, detailing what the FDA can and cannot do. They cannot direct drug research for instance, although they can offer guidance in regards to the development of medication.

As he spoke about patient advocacy as carried out for HIV/AIDS in the early days, I was aware that this is one of the areas of real difficulty for people with ME/CFS. Many of our ill are so incapacitated that the idea of showing up in numbers and doing anything other than perhaps rolling off a cot is inconceivable.

And for whatever reason, we just don't seem to have the family members and friends often seen lifting up other health conditions. Walk-a-thons and public outcry in meetings or rallies aren't going to work for us, unless healthy people who care about us start showing up in greater numbers.

Still, it may be worth doing a little brainstorming as to new and varied ways that the bedridden and the housebound might be able to combine their voices in order to be heard. The recent email campaigns by people with ME/CFS to the FDA, to other agencies and organizations, to public figures, for instance, seem to be bearing fruit. We are of course in early days, in terms of being heard and noticed. But it is a start.

He pointed out that we "really need to work with the FDA but also researchers, Congress, which can direct funding and to a certain extent can call the shots on how research is pushed forward in a particular direction." He suggested that we need to give special attention to the pharmaceutical industry.
Mary Dwight: Learning from Cystic Fibrosis


Mary Dwight, the Vice President of Government Affairs with the Cystic Fibrosis Foundation, was the next speaker. She led us down the path taken by cystic fibrosis advocates over the years, from days of invisibility to a substantial measure of success.

Scientific research and information is the ground floor to getting anywhere. The Cystic Fibrosis Foundation ran into resistance among drug developers in much the same way we have with ME/CFS. Drug companies were not eager to develop drugs that offered no cost benefit for medications that would serve only that specific patient community. The foundation overcame this resistance by offering up venture philanthropy.

Venture philanthropy is willing to try new things, providing financial, human and intellectual capital. It may be focused on measurable returns, with progress being evaluated at certain points along the way. Venture philanthropy may involve capacity building rather than targeting program development or costs of general operation.

At one point there was some disagreement between the CFF and the FDA as to the importance of a particular drug for cystic fibrosis. The FDA's stance was that a second drug was not necessary since they had one available on the market. The foundation pointed out that the initial drug sometimes didn't work or stopped working. The FDA listened, and changed their decision about the second drug.

That, my friends, was encouragement for advocates and patients alike.

The Cystic Fibrosis Foundation put together a patient registry and care centers. From there, drug developers and patients could be brought together to perform clinical trials. Dwight said that the "patient registry really enables us to keep data that was gathered in a clinical trial against what we knew about the disease."

The foundation organized a national therapeutic network focused in one location. They created standardized research procedures, and studied design and advice from experts. Communication was stimulated, and collaboration was encouraged by the gathering of scientific consortia. Dwight said that it is up to the patient community to bring data to the FDA. It is only then that the FDA will assess this data. She encouraged ME/CFS advocates to amass "natural history" and group data for our patients.
Pat Furlong: Learning from Muscular Dystrophy


The last speaker was Pat Furlong from the Parent Project Muscular Dystrophy. She gave a history of the MD community from its early days of invisibility to a place of successful advocacy for muscular dystrophies. Like ME/CFS, for some types of muscular dystrophy there are no biomarkers. This has caused problems for MD advocates that are similar to many that we face.

Furlong said that her organization used the Cystic Fibrosis Foundation as a pattern for developing a model program. Their first step was to compile a patient registry. She detailed what she considered to be essentials for a strong program. The base would be a clinical infrastructure that included a patient registry, research networks, and a clear picture of desired endpoints.

Next would be advocacy, to bring in funds from the NIH, the DOD and the CDC, and to foster the direct engagement of regulators. Education of patients, clinical trials, and drug developers are all necessities. Clear goals and expectations are vital.

Parent Project Muscular Dystrophy's board put together a policy statement to guide towards what they wanted from the FDA in terms of advocacy. Meetings with the Center for Drug Evaluation & Research have been held concerning policy and data for the FDA.

A consulting firm is preparing a risk-benefit framework for rare diseases, for publication. The consulting firm is creating a parent survey on risk tolerance. The risk tolerance form will be submitted to the FDA. The PPMD wants to make clear to the FDA that in some situations, taking the drug is worth the risk for those with serious, life-threatening concerns. Some patients would very willingly bear those risks because the natural history has shown that some might become worse or even die if the drug was not approved by the FDA.
Questions and Answers


At this point, callers Patricia Carter, Jennifer Spotila, Marly Silverman, Courtney Miller and Hillary Johnson had an opportunity to be heard. At the end of the question and answer period, Steve Morin of the Office of Special Health Issues extended an invitation for others to submit any questions they have.

The Q & A time did not begin until we were an hour and a half into the webinar, leaving only about half an hour for those with questions. While this may have been quite frustrating for both the callers and listeners, there is the potential for more meetings to come.
What Next?


Two meetings have already been discussed for the foreseeable future. On Dec. 20 of this year, the FDA has scheduled an advisory committee meeting to discuss Ampligen, a drug that may be utilized for those with ME/CFS. Next year the FDA will have a meeting with the goal of discussing endpoints and outcome measures related to ME/CFS.

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Half-baked theory here, or more of a question, really.

On the subject of why we do not have the familial support that goes to the wall for us in terms of lobbying, writing campaigns, rallies, fund-raising, et al. .... I have read mentions here and there over the last few years about a possible correlation between ME/CFS and Aspergers/autism. I have seen it in my own family once I became aware of Aspergers syndrome.

Many of us have families that are not nurturing and supportive, many others of us have families who we know love us and who show it in many ways and yet in other, puzzling, ways we find a vacuum when it comes to understanding, empathy and a certain type of reaching out from our family members. Some of us find that talking at all about what we go through can bring any number of inappropriate reactions -- irritation, anger, or down to the milder end of the scale -- a nodding of the head as we talk about devastation as though we had just said I had a boiled egg for breakfast. Dismissal, even though done in a pleasant manner.

Is it possible that the ... absence of familial response on the scale of networking, campaigning, etc. might be due to a large proportion of Aspergers or autism in the mix?

It is a question that has crossed my mind, as I look at the (lack of) response my condition gets from my family, who are all people who love me, and who would all be astonished if I were ever able to get it through to them that I needed serious help and that they should do something about that.

 

1. Sloth - we are 'obviously' morally deficient, since most of us don't particularly look sick. There's no room for useless eaters.

2. We're not dying fast enough. Slowly dying, a little more each day, doesn't count


"jimelis, i really laughed to read this--"We're not dying fast enough." and "There's no room for useless eaters."

And I appreciated the rest of your insightful post.

 

Half-baked theory here, or more of a question, really.

On the subject of why we do not have the familial support that goes to the wall for us in terms of lobbying, writing campaigns, rallies, fund-raising, et al. .... I have read mentions here and there over the last few years about a possible correlation between ME/CFS and Aspergers/autism. I have seen it in my own family once I became aware of Aspergers syndrome.

Many of us have families that are not nurturing and supportive, many others of us have families who we know love us and who show it in many ways and yet in other, puzzling, ways we find a vacuum when it comes to understanding, empathy and a certain type of reaching out from our family members. Some of us find that talking at all about what we go through can bring any number of inappropriate reactions -- irritation, anger, or down to the milder end of the scale -- a nodding of the head as we talk about devastation as though we had just said I had a boiled egg for breakfast. Dismissal, even though done in a pleasant manner.

Is it possible that the ... absence of familial response on the scale of networking, campaigning, etc. might be due to a large proportion of Aspergers or autism in the mix?

It is a question that has crossed my mind, as I look at the (lack of) response my condition gets from my family, who are all people who love me, and who would all be astonished if I were ever able to get it through to them that I needed serious help and that they should do something about that.

Thank you for expressing this, Jody. Exactly! In some cases I see the lack of response as part of a general lack of empathy in certain individuals, but overall I understand this problem, our problem, as not having a place on the social map. Once I read a book which exposed me to a very powerful idea--that our ideas about realtiy are socially constructed much more than being factually true. The book's title was The Social Construction of Reality. It was a sophisticated look at our world by a very adept Sociologist.

Perhaps, in order to enter into the social map, we first have to enter into the imaginations of people. So, theatrical presentations--think of large puppets, film and story--this has often been how an invisible or incorrectly perceived group has been able to enter into social reality. Think of how Harriet Beecher Stowe's Uncle Tom's Cabin affected so many to become Abolitionists. For the first time, through a story, many were able to see the humanity of slaves. There are examples of other powerful books (now they would be films probably) which enabled people to "get it": Diary of Anne Frank; certain films and stories which showed the reality of Native Americans; The Gulag Archipelago; the theatrical presentations gay men rolled out to communicate their reality and plight with AIDS.

As one low-energy person trying to connect with others, including sharing my physical reality, I have come up with potent pictures and scenarios in words--a theatrical approach--to break out of the limited ordinary assumptions, and present something different. I dramatize in order to communicate. In this I am not attacking, criticizing, blaming others but including them, aiming to include them in some understanding. Imagine a big puppet show. It may seem funny but this is a lot of how people learn. We teach children this way, through stories and imaginative means.

In other words, we may need to enter the imagination first, present our realtiy there. This is not science but social science. And it employs art, theatre, literature--to make the point.

 

"I would have been lost without the software my son set up for me to record it all."

That's great. Can you tell me what you used?

When my B-12 deficiency first started it manifested as my writing hand becoming useless and I found that by using a voice recognition software, Dragon Naturally Speaking, I was able to write and send emails and documents. I don't recommend it, though. Today an app that came on our ipad is far easier and more accurate, but only does brief recordings.

 

Victronix,

I will find out from him and post it here.

 

"Is it possible that the ... absence of familial response on the scale of networking, campaigning, etc. might be due to a large proportion of Aspergers or autism in the mix?"

Yes, that's a fascinating connection to have made.

After years of supportive therapy I was able to work with my therapist to help me to engage my father enough to get him to help me out financially. Ultimately that led to my having the nutrient tests that changed my life, at that point, and I think when he saw that, it did get him more involved and understanding of how he could help.

He is somewhat Aspergers in nature, very self centered and self focused, unable to express empathy. He was convinced that his sister's schizophrenia was because "she just had too much time on her hands, never having had a job".

Perhaps if the community becomes aware that the families may have this stumbling block, concerted careful and supported efforts at direct outreach can help bring about change. For me it took years of therapy and self-help books to get to that level with myself to get past the resentment and blame to be able to present a potential constructive role to him.

Mine started with a long letter that I worked out over weeks. In response, I received a check, which was a pretty awful feeling. But that was just the beginning.

 

Thanks for reporting on this, very interesting to read (as someone who does not have ME/CFS).

I do research on PTSD and traumatic brain injury and what I've found is that the public perception is greatly influenced by things they can quantify: biological markers, images on brain scans, anything that you can show them in a picture and they understand, which cannot be done for PTSD. Consequently, grants and financial interests are increasing for traumatic brain injury, while PTSD remains struggling and patients continue to commit suicide. The role of public perception influences journalists and they repeat the same myths about PTSD being "like a ghost" and that in turn then influences readers to continue to believe the myth.

If the solution is a vaccine or surgery or a Big Pharma pill, then the funding will appear and the agencies will get on board. If the solution is complicated, then the cycle of myths and hand wringing continues and it's a real struggle to move forward.

So to some extent, the marker, whatever it is, for a diagnosis is key (the definition). Glad to see discussion on that and specific names of individuals.

"3. The FDA exists to promote the pharmaceutical industry and protect their profits. That’s why we end up with so many drugs that do nothing useful except make rich people richer."

Excellent point. And unfortunately, the US Empire is getting more corrupt by the minute, meaning that even things like the FDA will become even less functional and more prone to influence.

I think its important to continue to think outside the box. This forum is a remarkable asset. I think people lose sight of the importance of such assets relative to a pharmaceutical solution from an FDA. I was originally on a B-12 forum elsewhere, and using Fredd's protocol, and greatly improved, so stopped using it, and when I came back, it was dead -- I was really shocked, as though the rug pulled out from under me. Access to the knowledge of people from all over the world was suddenly gone! But eventually I found the trail over to this forum, where Fredd had appeared also, and was amazed at how well this forum is organized, how efficient and supportive and functional it is. I can never keep up with all the information -- and good information -- appearing on here all the time.

thanks for your reply, appreciated Aidan...blesses...

 

I don't know about radiation sickness as a cause, but I like your spirit!

Thanks very much...hate everything about the corrupt medical 'legal mafia' all part of the Iluminatii's pure corrupt b.s. 'pray I die and not get well' I will continue to expose their complete filth, wish I could tell every person to go out and donate bloods but that would be wrong but feel the only way forward is a multi million dollar lawsuit plus full public and criminal inquiries...will not try them in the medias because even our medias are completely controlled and owned by the filth but in the meantime I use facebook twitter and myspace to voice my anger...there is no doubt in my mind that simon the weasle wessely sits in the back pockets of the illuminatii's he is just another puppet but the suprise for him is forthcoming because all this time he works on bloods containing radiation and it's just a matter of time now before he takes the sickness plunge...they say in life what goes around comes around...it's way far gone into the worlds foods supplies plus fish and livestocks, it's everywhere and now Japan just made it more worse...the f.d.a. c.d.c. and n.i.h. are all puppets of the rothschild's elite scumbags and that's 100% fact...radiation planned the 'silent invisible genocide of the 21st century...ebv, xmrv comedy at its best...total disgrace to every sick child, they better pray Aidan dies...p.s. what goes around comes around...

 

Half-baked theory here, or more of a question, really.

On the subject of why we do not have the familial support that goes to the wall for us in terms of lobbying, writing campaigns, rallies, fund-raising, et al. .... I have read mentions here and there over the last few years about a possible correlation between ME/CFS and Aspergers/autism. I have seen it in my own family once I became aware of Aspergers syndrome.

Many of us have families that are not nurturing and supportive, many others of us have families who we know love us and who show it in many ways and yet in other, puzzling, ways we find a vacuum when it comes to understanding, empathy and a certain type of reaching out from our family members. Some of us find that talking at all about what we go through can bring any number of inappropriate reactions -- irritation, anger, or down to the milder end of the scale -- a nodding of the head as we talk about devastation as though we had just said I had a boiled egg for breakfast. Dismissal, even though done in a pleasant manner.

Is it possible that the ... absence of familial response on the scale of networking, campaigning, etc. might be due to a large proportion of Aspergers or autism in the mix?

It is a question that has crossed my mind, as I look at the (lack of) response my condition gets from my family, who are all people who love me, and who would all be astonished if I were ever able to get it through to them that I needed serious help and that they should do something about that.

I agree at what you wrote above but the mark on all auto immune conditions will turn out to be radiation...cfs gulf war illness and all above are just 'labels' like tags doctors pin on donkeys tails...radiation is already known by these researchers as a marker for all auto immune conditions including children with AUTISM...AIDAN G WALSH...P.S. there is no difference in non deployed, deployed gulf war illness and cfs 100% identicle 'LABELS' RADIATION WITH BROKEN CHROMOSONES AND TRANSLOCATION...IMAGINE HEALTHY ONE DAY EATING A FISH WITH RADIATION AND YOUR LIFE STOPS...A RADIOLOGICAL DISASTER THE 21ST CENTURY MEDICAL COVER-UP...

 

I think AIDS is a special case. I agree it had huge disadvantages in terms of social prejudice but in terms of advocacy it had big differences from our situation: high prevalence in the gay population initially where there was already a strong community already used to advocacy (often a geographically close one), plus a sense of urgency because people were dying. I don't know even one other person with ME in the whole country because I've never formed a social life around my illness (except for posting here online).

I think MS in the days before it was understood would be a better model for us than AIDS. Was MS advocacy actually successful at that point? I only know MS as exactly that - multiple sclerosis, presumably named once the mechanism was understood. Were MS advocates successful before that?

Many diseases have been down this road even cancer! If you want to learn more about MS you might want to read this book: http://www.nejm.org/doi/full/10.1056/NEJMbkrev0804949

The review states in part: "..The best aspect of the book is Talley's discussion of multiple sclerosis societies that are dominated by laypersons and of the differing roles of such societies in various countries as reflections of the unique social structure of each country. The National Multiple Sclerosis Society of the United States is held up as an example of a successful advocacy group, with its ability to raise public awareness, to attract useful publicity, to persuade influential persons to participate, to provide effective political pressure to change public policy, and to persistently advocate further change, while at the same time providing services and support to patients. There are lessons here for other advocacy groups..."

 

Many diseases have been down this road even cancer! If you want to learn more about MS you might want to read this book: http://www.nejm.org/doi/full/10.1056/NEJMbkrev0804949

The review states in part: "..The best aspect of the book is Talley's discussion of multiple sclerosis societies that are dominated by laypersons and of the differing roles of such societies in various countries as reflections of the unique social structure of each country. The National Multiple Sclerosis Society of the United States is held up as an example of a successful advocacy group, with its ability to raise public awareness, to attract useful publicity, to persuade influential persons to participate, to provide effective political pressure to change public policy, and to persistently advocate further change, while at the same time providing services and support to patients. There are lessons here for other advocacy groups..."

Thanks, Kelly - looks interesting.