How to Participate in the FDA Drug Development Workshop

(Reposted with permission from author Mary Dimmock)

On April 25-26, 2013, the FDA is holding a workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to CFS and ME. This meeting is expected to attract not only patients and ME/CFS expert clinicians, but also other groups including pharmaceutical companies and the FDA. This is an unprecedented opportunity for us to get the attention and interest of the pharmaceutical industry and to bring a patient perspective to the development and review of drugs for ME/CFS.

Day 1 of the workshop will give patients the opportunity to share the symptoms and signs that they experience, their experience with treatments and how this disease affects their quality of life. This is being conducted as part of the Patient-Focused Drug Development Initiative, an FDA effort to incorporate the patient experience into the drug approval process by better understanding the patients’ perspective on the severity of their disease and the effectiveness of available treatments. ME/CFS has been chosen as one of the 20 diseases for which such a workshop will be conducted and will be the first of the 20 to go! For a disease like ME/CFS whose impact is poorly understood by those outside the community, this first day will provide the critical insights needed for discussions on the second day of the FDA workshop but just as importantly will also ensure that the drug approval process better incorporates the patient perspective going forward. 

Day 2 of the workshop will include a scientific workshop on how to best facilitate and expedite the development of safe and effective drug therapies for the signs and symptoms related to ME/CFS. Presentations will include:

• Lessons learned from previous studies
• The role of drug repurposing
• Pathways to expediting drug therapies
• Appropriate clinical trial design in CFS and ME
• Outcome measures to assess efficacy
• Potential valid endpoint measurements of symptom improvement.

The Importance of both Symptoms and Biological Abnormalities 

Obviously, it is critical that FDA and the pharmaceutical companies understand the symptoms you experience and the impact of those symptoms on your quality of life. But it is just as essential that they also understand the biological abnormalities that are associated with ME/CFS – biological abnormalities that are already being measured through lab tests and other testing. Some examples include:

• Neurological impairment seen in symptoms like sleep dysfunction, headaches and sensory disturbances and that can be measured in lab tests like SPECT scans or MRI.
• Cognitive dysfunction seen in symptoms like impaired memory and processing speed and that can be measured through various cognitive performance tests.
• Immunological dysfunction seen in cytokines abnormalities, high viral titers, RNASE-L abnormality and low natural killer cells. 
• Autonomic dysfunction and orthostatic intolerance causes symptoms like dizziness, racing heart and feeling sick when stand for long periods and that can be measured by tests like tilt table tests, heart rate and blood pressure monitoring and blood volume.
• Post exertional malaise and low anaerobic threshold that cause a relapse after mental or physical exertion and documented by cardiopulmonary exercise testing.

By understanding both the symptoms and the related biological pathologies and associated abnormalities, pharmaceutical companies will be in a better position to identify opportunities to subgroup patients and potentially repurpose existing drugs that might treat ME/CFS. This is especially critical in a disease like ME/CFS which is too often described simply in terms of “fatigue not improved by rest”, is assumed to be due to depression, deconditioning or is thought to be simply another name for chronic fatigue. 

To ensure that the pharmaceutical companies understand this biology, a group of ME/CFS organizations and advocates submitted a joint letter to the FDA to ask for assurance that a brief overview of the biology and abnormalities of ME/CFS will be summarized right at the beginning of the meeting. The letter that was sent can be found at https://dl.dropbox.com/u/89158245/LetterFDAWorkshopMar18.pdf

Take Action

So what can you do to make sure the FDA and the pharmaceutical companies understand how ME/CFS has affected you and what you have experienced with treatments? There are a number of opportunities for you to participate and to provide comments. 

1. Register to attend the meeting and optionally provide comments

Here’s what you need to do:

• To attend in person, register first-come, first-serve at http://mecfsmeeting.eventbrite.com by April 8. You will be asked to provide your name and business, organization, or personal affiliation as applies (e.g., industry, government, patient). When you register, you will need to indicate that you wish to provide comments as outlined next. 

• There are three opportunities to present comments at the meeting: 
• You can request to be part of an initial panel discussion on the topics listed below.

If you wish to be considered to present comments part of initial panel discussions, you will need to indicate the topic that you wish to address when you register. Then, you will need to send a brief summary of your response to the topic(s) you selected to ME-CFS-Meeting@fda.hhs.gov. The deadline to send the summary of your comments is April 8.  You will be notified before the meeting if you will be on a panel. 

• You can participate in open moderated discussion following the panel discussions on the topics listed below. 

You do not need to register to provide comments or have prepared testimony for this part of the discussion. A moderator will recognize participants to comment when they raise their hands.  

• You can request to provide comments on other topics as part of the open comment period at the end of the day

If you want to do this, you will need to register as above. In addition, you will need to send a brief summary of your comments for the open public comment session to ME-CFS-Meeting@fda.hhs.gov. The deadline to submit the summary of your comments is April 8.  

• Suggestions for those providing comments: For those who wish to provide comments, either as part of the panel or as part of the ‘open discussion’, the following information will be useful:
• The suggested topics include:
• Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
• Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and M

The questions that the FDA is asking on each of these topics are listed below. You are also given the option to suggest a topic when you register. 

• In addition to the questions that the FDA asked, please provide comments about your lab/test abnormalities - linked to symptoms and dysfunction where possible – and indicate how those abnormalities changed as a result of treatment if known. Examples include:
• Abnormal VO2Max as a result of PENE/PEM
• Abnormal tilt test as indicative of orthostatic intolerance
• High inflammatory cytokines indicative of immunological issues
• Cognitive issues seen in impaired working memory and slow processing speed tested by cognitive performance testing
• Other suggestions: 
• Comments should be concise and to the point. Avoid jargon. Speak about your personal experience and how this disease has affected you. 
• For some people, the term biomarker may imply that the biomarker has been “validated”. It is better to use the term abnormalities or test abnormalities to avoid this confusion. 
• Given that the time for comments may need to be shortened, it would be good for you to have both a 1-2 minute version and a 3-4 minute version. 
• Provide comments by proxy: If you cannot attend but wish to provide comments, you can have a proxy provide them for you. You will need to register to do this. 

1. Participate in the FDA meeting remotely

• The meeting will also be webcast at http://mecfsmeeting.eventbrite.com. See http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm for additional information about joining the meeting.

1. Respond to two different surveys that are collecting information for the meeting. 

• Both surveys are collecting information a) disease symptoms and daily impacts that matter most to patients and b) patient perspectives on current approaches to treating ME/CFS. 

• Dr. Leonard Jason and his team and Dr. Lily Chu have created an online survey that uses checkboxes to collect information on symptoms, impact on daily life, treatments being used and the effect of treatments. For those who live outside the U.S., ignore questions about the U.S. region. The link to Dr. Jason’s and Dr. Chu’s survey is here. 
• The CFIDS Association of America (CAA) has taken the questions from the FDA workshop agenda and turned them into an online questionnaire where you can type answers into text boxes. The link to the survey is here. 
• Both surveys are open to everyone no matter where you live. Your responses will be anonymous and confidential. 
• Please try to answer both questionnaires.
• Although the surveys may not ask for it specifically, don’t forget to also include comments as above about your lab abnormalities - linked to symptoms and disease dysfunction where possible – and indicate how those abnormalities changed as a result of treatment if known. Examples are given above in #1.

1. Provide comments directly to the FDA now

• Go here and submit comments now by clicking on the ‘Comment Now!” box in the upper right corner of the page. 
• You can also submit written comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include the docket number, which is “FDA-2012-N-0962-0004”.
• The Docket is open until August 2, 2013. 

• The FDA is encouraging patients to provide answers to the questions asked in the Federal Register. But again, don’t forget to also include information about the biological abnormalities – linked to symptoms where possible – and indicate how those abnormalities changed as a result of treatment if known. Examples are given in above.

Get more information

You can get additional information from the following sources:

• The FDA maintains this webpage that lists information on its efforts regarding ME/CFS. 
• The Federal Register Notice for the April 25-26 FDA workshop can be found here. 
• The FDA has also provided a set of FAQs here about the meeting, which provide additional information. 
• A description of the Patient-Focused Drug Development Initiative can be found here. 

Details on the questions that the FDA would like asked on the two topics. 

Remember to also provide information on the biological abnormalities associated with these symptoms and the known neurological, immunological and energy production dysfunction and how treatments have affected these biological abnormalities. Examples are given above in #1. 

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

1. What are the most significant symptoms that you experience resulting from your condition? (Examples may include prolonged exhaustion, confusion, muscle pain, heat or cold intolerance.)
2. What are the most negative impacts on your daily life that result from your condition and its symptoms? (Examples may include difficulty with specific activities, such as sleeping through the night.)

1. How does the condition affect your daily life on the best days and worst days?
2. What changes have you had to make in your life because of your condition?

Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and ME

1. What treatments are you currently using to help treat your condition or its symptoms? (Examples may include FDA-approved medicines, over-the- counter products, and other therapies, including non-drug therapies such as activity limitations.)
1. What specific symptoms do your treatments address?
2. How has your treatment regimen changed over time and why?
2. How well does your current treatment regimen treat the most significant symptoms of your disease?
1. Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.
2. How well have these treatments worked for you as your condition has changed over time?
3. What are the most significant downsides of these treatments (for example, specific side effects)?

Rivka's "How To" Guide for ME/CFS Demonstrations

I'm posting the following on behalf of my friend and fellow advocate, Rivka Solomon.  Read on: Rivka covers everything you need to know to put on a successful demonstration!

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Feel free to distribute widely

Taking a Stand: 

A "How To" Guide and "To Do" Checklist for ME/CFS Demonstrations

By Rivka

Email: Rivka (at) ThatTakesOvaries (dot) org

April 12, 2012

So you want to take a stand and make a stink -- do something more visible to help your ME/CFS community? Good for you. Consider organizing a demonstration (demo) to advocate for people with ME/CFS. Consider going public, alone or with others, in your call for more respect, more attention and, most importantly, increased government funding for research and treatments. 

Organizing a demo is both easy and a bunch of work. Do keep in mind this reality check: After all the energy output, you could have a mild or significant relapse. Yet also keep in mind that you will have raised public and perhaps government awareness about a devastating disability, and thus you will have done something important for the world and for your community. In the end, you will feel good about having done it. And you will have the gratitude of those who are too disabled to take this type of public stand that we all know needs to happen in cities and counties all over the globe in order for things to change -- most especially in front of national and government health care institutions, such as, in the U.S., in front of the regional headquarters of the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). 

Below is a simplified, preliminary -- and certainly incomplete -- checklist to consider as you organize your demonstration. It does not go into great detail, but skims over the basics, including, deciding the location of your demo, deciding the tone, reaching out to others, permits and arrests, reaching out to media and more.

Remember, you can always do a mini-demo as a solo person with a single sign. In some cases, this may be a heck of a lot easier on your health, and it could still have an impact, especially if you get media attention or put it on YouTube and email the link to your national and government health care institutions.

I have included video links of my own past public and bedridden demos below this checklist. Some were solo and some were group demos.

== Checklist for ME/CFS Demos ==

Location 

a.  You will likely want to be somewhere public, where there are passers-by, and/or where media can get to or where they may already be present.

b.  Ideas: City or federal building, health care building, blood giving location, outside (or inside?) a health-oriented meeting, perhaps at a meeting or talk that includes a noted government official.

Tone

a.  Decide how animated, flamboyant, cartoony do you want to be. Do you want to be dressed in business suits, jeans or more attention-getting costumes with some type of theme? 

b.  Will you have signs or a banner? Will they be colorful, upbeat and playful, or serious? Home made or printed?

c.  Will do you something very attention-grabbing, such as a lie-in with sleeping bags, pillows, blankets?

Attendance

If you want others to attend, reach out to local ME/CFS groups.

a.  Ask: Will they join the demo? If yes, they will likely want to join the decision-making, too (i.e. location and tone).

b.  Ask: If not, will they at least help you get the word out for the demo in an email blast you write up that they distribute to their members?

c.  Have the email include all the important information, such as when and where and why you are demonstrating. Be prepared to have your name and email distributed around the web. So don't include your name or email or phone number if you don't want that. (Get a new email address just for this demo?)

Young people

Young people and young adults with ME/CFS, or the kids of parents with ME/CFS, who attend your demo may get more sympathy from the media, government officials and the public.

a.  Contact national ME/CFS groups (e.g. contact Denise at SpeakUpAboutME@gmail.com, or contact the young adult online group called kickHeal) to see if they know any youth in your area that you can invite.

b.  Contact local families with kids who have ME/CFS. 

c.  Ask local ME/CFS groups if they know young people with ME/CFS.

Permits

If you want everything to be legal, find out in advance what is needed in terms of permits.

a.  Ask city police what permits are needed to hold a demo with 1-25 people (or whatever you think it will be), at these locations: 

- on the sidewalk in front of the target location

- on the sidewalk across the street of the target location

- both in front of and across the street of the local federal building 

(note: at a federal site, like the Capitol Hill HHS headquarters, also call and ask Home Land Security and Capitol Hill police and any other federal police they suggest, to ask about permits. It may be that you have to contact the head of security for that particular department or building. In fact, that could be the quickest route to finding out what permit you may or may not need, and where you can protest legally.) (Note: across the street is likely not federal property.)

b.  Consider telling the police/security that it will be a demo of people who are disabled and who have been ignored by the government. This may win you some sympathy and extra flexibility. Or not. 

c.  Find out from the police/security folks of the building the rules of how close you can be to a federal building, and what is not allowed (e.g. I found out that sticks for holding signs are not allowed in front of the White House in Washington DC, and that you have to keep moving, and can't sit still).

d. Another idea is to *not* find out about permits and just do your demo without permits. It could cause a bigger splash if you surprise the security team, or not -- no one really knows. It is not likely they will arrest you, even if you need a permit but don't have one. It is more likely they'd just ask you to leave. And then you can just decide to leave. This could make for a short demo, though. Nothing is known for sure.

Arrest

First, you should know that I really know nothing about getting arrested as a result of demonstrating. With that in mind, here are some thoughts. I have been told that it is unlikely you will get arrested, period, no matter where you demonstration, because the police and security would first give you an opportunity to simply leave. After all, they don’t want the bad press of arresting disabled people. Thus, once warned, you can always leave. But if you don’t care about arrest, or if you think it will help with publicity if you are indeed arrested, then:

a.  Find out what could happen if you are arrested; really find out, as I have no idea. Will you go to jail, or simply get a ticket? Will you have to go to court later? Pay a big fine?

b.  Have a lawyer ready to help you if you are arrested.

c.  Have bail ready.

d.  Will you need your medications while in jail? How will you get them? 

e.  Find out ADA (Americans with Disabilities Act) regulations in terms of disabled folks on U.S. jails.

f.  Get educated: Read up online about getting arrested as a result of demonstrating. 

Government buildings

If you decide to hold your demo at a government building, there are special considerations:

a.  Find out who runs that office (i.e. in the USA, the local HHS or CDC regional office), and also who is in charge of public relations there.

- ask for a meeting with one or both, for the day of your demo

- have talking points and a letter ready to give them if you meet. Have this ready even if you don't get confirmation ahead of time about a face-to-face meeting (you still may ending up meeting them or just leaving the info for them at the front desk)

- include in the letter why you are there protesting and what you want (e.g. more government funding for research into the cause of ME/CFS and treatments and clinical trials now)

- ask them to relay this message to their higher ups, their bosses. Ask them to promise they will do this, all the way to the very top

b.  When you ask for a meeting, and/or once you secure a meeting, decide if you want to tell them about yr demo in advance or not. There might be pros and cons to letting them know you will be demonstrating that day, and pros and cons to not telling them until you are actually there with your sign. 

c.  In the USA, there are 10 HHS regional offices (http://www.hhs.gov/about/regionmap.html) in Boston, MA; New York; Philadelphia, PA; Atlanta, GA; Chicago, IL; Dallas, TX; Kansas City, KS; Denver, CO; San Francisco, CA; Seattle, WA. Plus, there are 10 CDC satellite offices in Anchorage, AK; Cincinnati, OH; Fort Collins, CO; Hyattsville, MD; Morgantown, WV; Pittsburgh, PA; Research Triangle Park, NC; Puerto Rico; Spokane, WA; Washington, DC. 

d.  Each of these above listed government sites is just calling for a small group of 1 to 5+ ME/CFS patients and their families to stand in front, on the sidewalk, demanding to be heard -- even for just 15 minutes. Each head of security of each site will be mandated to let their national headquarters know that there was a person there that day, holding a sign in front, protesting HHS/CDC's policies and lack of funding for ME/CFS. Eventually, with enough mini-protests, this will impact U.S. health care policy.

e.  There may be special considerations in terms of where you can demonstrate at a government building. See section above called "Permits" for more info. 

Media outreach

a.  Send out a short but appealing press release. Could send to print, radio and TV media. Send it via email, and also call all local newspapers and radio (you could ask me for a sample press release I used in the past). Pitch to a variety of press/media, such as health reporters, living reporters, city desks. Simply call the newspaper's main number and ask who covers those beats/sections, and who is the editor of each section. Pitch to both the individual reporter and their boss, the section editor. 

b.  Try to pitch to reporters and editors "live" (via phone), or leave your animated pitch on their voicemail. In other words, don't just rely on emailing your pitch, but do email it, too.

c.  Make sure you have a compelling story. For example, I wrote: "For much of the past 20 years, I have been bedridden or homebound with an illness that 1 million Americans have, but that gets almost no government funding for research." And, "We are a mother and daughter team protesting together in hopes to secure funding for the sick daughter who has spent much of the past 20 years bedridden or homebound, along with almost 1 million other Americans."

d.  Have a local angle: Tell them you are from the area.

e.  Include in the press release why you are there protesting and what you want (e.g. more government funding for research into the causes of ME/CFS, and treatments and clinical trials now!).

f.  If you don't reach reporters (phone or email), keep trying up to 3 times. They are busy and I have sometimes gotten a "Yes, I'd like to write an article about this," on the 3rd try. After 3 tries, you may want to give up or be considered a pest and a bother -- which is, we know, not the end of the world. The squeaky wheel gets the most attention.

g.  Consider a teleconference. It is when you have a press conference via phone; the press calls in to ask questions of a panel of patients, family members, expert doctors or whomever you decide to have present. This will take some organizing and work.

h.  Remember: Once you do a media interview, or have the media present at your demo, you will have no control over what, in the end, they say or write about you and no control over the spin they give the piece. It could be positive or negative. And please know this one thing now, before your interview (if you do have one), they will likely misquote you; they almost always do. 

Invite others

You can reach out to other groups to invite them to join your demo. This is a big task. Plus, be ready for rejection.

a.  ADA groups

b.  HIV/AIDS

c.  Autism groups

d.  Compassionate healthies, like the local Rotary Club, women's sewing circle, etc.

Prepare a one-pager 

a.  Have a one-pager to give the government official you meet with -- or don’t get to meet with, but you will then leave the letter/one-pager for them at the front desk.

b.  The same or similar one pager can be given to passers-by (for educating the public), the press, and for mailing to the government officials later. Or write up a smaller, colorful card for passers-by.

c.  This same or similar one-pager can be your prepared speech, if you want to give one to the public, the press or videotape for a video.

d.  Include in the one-pager why you are there protesting and what you want (e.g. more government funding for research into the causes of ME/CFS, and treatments and clinical trials now!).

Banners/signs with compelling messages

a.  Not much to say here except be creative!

b.  Below is a link to how I made a 25 foot banner (I bought paints, paint brushes and a large bolt of cloth all at once, at a local fabric store). I knew I would not have a lot of people at my demo, but I still wanted to take up a lot of space and get a lot of attention -- hence the 25 foot banner.

Accommodating people with disabilities

a.  Consider doing what the wise organizers of the 2010 London protest did: organize vans to pick up folks from their homes and bring them to your demo.

b.  Consider having folding chairs, wheelchairs and cots there for folks to sit and rest. Decide if these wheelchairs and cots will be a good or bad thing in terms of PR (public relations) and the media.

Media drawing tactics

This was discussed already above, but once again, consider all media drawing tactics, and if you want to do them or not.

a.  Using a huge banner you make or have made.

b.  Die-in or lie-in with pillows and pajamas? (If so, be ready for risking arrest).

c.  Blocking doors (again, be ready for risking arrest).

d.  Disrupting a meeting with a government official.

Videotape 

Videotape your demo so that you can get it on YouTube and the ME/CFS community can see it and be inspired.

a.  If possible, have at least two video cameras (Flip cameras are cheap and easy to use) and two camera people, in case one camera fails or one person does not show up. Have a still-camera or phone, too, for still photos. 

b.  Videotape the images and audio you want. You will likely want to include your homemade signs but also the official sign that includes the actual name of the building you are in front of (e.g. Red Cross, HHS, CDC, any government name). Also, include in the video the people who came who have agreed to be videotaped, and your own prepared or spontaneous speech. Videotape the speech and all images at least twice, since audio or lighting or something will likely fail in one of them. I speak from experience.

c.  Edit the video to be less than 5 minutes long, and put it on YouTube.

d.  Send a link to the video to government officials and press.

e.  Contact any ME/CFS blogs or forums and ask if they want to post a link to your video.

Write up

a.  Write up a short description of the demo, written in your own words, and distribute it to the ME/CFS community. This will inspire others to go out and lead demos of their own.

b.  Include in your write-up a link to your video and to any media attention you got.

That is it! Remember, your demonstration will make a difference, it will have an impact. 

If not you, who? If not now, when?

* * *

The below videos are related to my ME/CFS demos and activism in 2010-2011. I hope they may inspire others to demonstrate, too.

August 13-14, 2010

Video:  http://www.youtube.com/watch?v=ME764z_4vEY

(5 min: Serious video of my one-women protest in front of Health and Human Services (HHS) and Red Cross Nat'l Headquarters. It was successful in that I was told this video inspired a bigger and more impressive patient demonstration in London:  http://www.youtube.com/watch?v=cdA4_feLkV4)

Description of HHS protest found here: 

http://peggymunson.blogspot.com/2010/08/my-awesome-friend-rivka-staged-one.html

September 6, 2010

Video:  http://www.youtube.com/watch?v=8t1Xqp1LDxM

(5 min: Comedic singing "Clinical trials now!" bedridden video with me and my family.)

October 3, 2010

Video:  http://www.youtube.com/watch?v=z5eLRxtQLok

(5 min: Comedic video pressuring the Nat'l Institutes of Health -- the resulting campaign was a success, but unfortunately it was stopped to early for significant results.)

November 29, 2010

Video:  http://www.youtube.com/watch?v=1DSzTCYPAvs

(5 min: Comedic street theater video pressuring the Red Cross to ban ME/CFS blood donations -- the resulting campaign, which included a diverse group effort of a variety of tactics and approaches, not just mine, was a success.)

Write up: http://www.prohealth.com/library/showarticle.cfm?libid=15764

April/May 2011

Video:  http://www.youtube.com/watch?v=dcxtgyVuXYI

(5 min: making the 25 foot banner for ME/CFS protests)

May 10, 2011

Video: http://www.youtube.com/watch?v=_elj8mcd9Ak

(5 min: I was told this was an historic, first-ever ME/CFS protest in front of the Dept of Health and Human Services in Washington DC, on Capitol Hill. ME/CFS patients from around USA)

Description of protest found here:

http://cfspatientadvocate.blogspot.com/2011/05/hhs-demonstration-may-10-2011.html

May 25, 2011

Video: http://www.youtube.com/watch?v=hqwg5ZkmURk 

(6 min: Demo at Health and Human Services in San Fran, CA. ME/CFS patients from S.F.) 

Description of protest found here:

http://twenty-years-and-counting.blogspot.com/2011/05/mecfs-demo-in-san-francisco-success.html

Petition Our Keepers: Be Heard From Your Home or Bed!

Do you have something to say to our keepers?  Those who have kept us in virtual chains, in our homes, in our beds?  Without knowledgable doctors and social support?

If the answer is "Yes, but...I don't know what to say, I can't think,  I can't write!" here's an easy solution.

Click to petition senior federal officials in charge of ME and CFS policy and add your name.  Some of them will be at the CFSAC meeting on November 8 and 9.   When you sign, an email will be sent to a half dozen people who have the power to change our lives, from Secretary Sebelius to NIAID Director Fauci.

Imagine being bugged daily with emails!  And all you have to do is sign.  Only your signature is shared with the recipients.  There's even an option to hide your signature and still be counted (but really, don't you want those emails sent with one click?)

The text of the emails is simple and to the point:


Greetings,

I just signed the following petition addressed to: Kathleen Sebelius.

Apologize for not responding appropriately to the ME/CFS epidemic.

Bjørn Guldvog, Deputy Director General of the Norwegian Directorate of Health, recently made the following statement in response to a published study indicating the cancer drug Rituximab may be an effective treatment for ME/CFS:

"I think that we have not cared for people with ME to a great enough extent. I think it is correct to say that we have not established proper health care services for these people, and I regret that."

Follow the Norwegian Health Minister's example.

In addition, we ask that you:

1.  Double the current NIH funding for extramural research  annually until it achieves parity with funding for similarly debilitating chronic diseases like Multiple Sclerosis.  Priority should be given to research on biomarkers and potential pathogens as well as clinical trials.

2.  Take down information on the CDC's CFS website stating testing for pathogens and biomarkers is "experimental and theoretical" and that GET and CBT are appropriate treatments.

Sincerely,

[Your Name]

Simple, right?

So come on and sign!  And don't forget to share the petition with others who are likely to sign.

http://www.change.org/petitions/apologize-for-not-responding-appropriately-to-the-mecfs-epidemic

Let your voice be heard!

The Final Betrayal

 (reposted with permission)

The Final Betrayal

by Danny Ze-dog on Friday, June 10, 2011 at 3:39pm

I'm too sick at the moment to start my own blog, and even if I had one I wouldn't be able to say what I'd really like to the way I'd like to.  But in light of months of following the scientific (and anti-scientific) developments in the XMRV story, and given that it is XMRV Blog Week, I feel the need to say something.  So here it is.

I don't know for certain whether XMRV and any related MRVs cause ME/CFS, or are co-causes or co-factors, but neither does any other scientist.  I don't know what role it plays in ME/CFS, but neither does any other scientist.

I know this: I will not spend the rest of my life sick or die young because some researchers and research journals made a political decision to "close the door" on the MRV-CFS association before it was appropriately investigated.  I want a true replication study NOW.

I want 'science' journals to stop publishing negative studies by authors who haven't used clinically validated assays to detect XMRV.  I want 'scientists' to stop claiming that non-replication studies ARE replication studies.  I want any researcher, journal editor, or 'science blogger'  who claims that true replication isn't necessary in science to be forced to seek alternative forms of employment.  I want an investigation by the Department of Health and Human Services into why the NIH's tiny CFS grant review panel has turned down a series of grant applications by the WPI.

I want at least one sliver of justice for millions of sick people who have had none.  If nothing else, we should have the benefit of supposedly dispassionate, objective science.  We were raised to believe that science is the backbone of modern civilization, and the last pure thing left in a world rife with politics.  If we cannot even get THAT without political interference, then even the highest court of appeal is corrupt.  

For well over two decades we have trusted that, at some point, the system that was ostensibly built for us will finally work in our favor.  At what point do we decide as a community that it clearly will not?  And at what point will we protest en masse that our rights as citizens and as human beings are being denied by medical, "healthcare", political, and scientific establishments?

The most blatant recent example, and the most immediately crucial issue, is the organized attempt to bury XMRV-CFS research.  With whatever energy we have, we need to fight to stop that from happening.  NOW.  We need to let those who would bury it, or let it be buried, know that we will not tolerate this.  We need to let 'advocacy' organizations know that they should either support us in this endeavor or stop posing as advocates and get the hell out of the way.  We need to strategize ways that we as patients and their carers can have a real impact on the scientific institutions and policy-makers that are normally walled off from us, and on the media that increasingly serves only as a mouthpiece for the 'official sources' with the best media connections.  If the high-profile discovery of a potentially pathogenic gammaretrovirus that may infect at least 4% of the population can be whitewashed from the memory of science and history, so can - and will - that of any other pathogen, be it HHV-6, Lyme, or anything else.  This isn't just an issue for people who support the XMRV hypothesis - it is an issue for everyone who wants good science to be done on this disease, now or ever.     

ME/CFS Demo in San Francisco a Success!

Here is Rivka's report on the recent San Francisco demonstration:
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ME/CFS Demo in San Francisco, CA, USA

at the Dept of Health and Human Services
May 25, 2011

Contact: Rivka (at) ThatTakesOvaries (dot) org

Video of demo: http://www.youtube.com/watch?v=hqwg5ZkmURk

PRENOTE: A second small yet successful demonstration for the rights of people with ME/CFS was just held. A key goal of these mini-demos is to inspire more of the same; we hope you (those who are able) will hold a mini-demo, too. Only 1-5 people are needed to pull one off, get some press attention and make some waves. Make your own signs, or we can send you our pre-made 25-foot banner. All 3 goals of this Mini-Demo Strategy are found below.

WHO CAME:  On May 25, 2011, an ME/CFS public demonstration was held in front of the U.S. Department of Health and Human Services (HHS) Region 9 headquarters, in San Francisco, California. Despite the rain, eleven people came: two people with ME/CFS, Susan Kreutzer and Andy Au; three family members (mother, mother-in-law, spouse), including the protest co-organizer, Bobbi Ausubel; and six able-bodied friends. The multicultural group included people of Asian, Latino and Caucacasin decent, gay and straight, young adult and seniors. The people with ME/CFS came in spite of all the obstacles and barriers this illness throws in their way.

SETTING UP:  At 1:30 pm, the protesters positioned themselves on the busy, highly trafficked sidewalk in front of HHS Region 9, also known as the Federal Building. They unfurled a 25-foot banner that read: "Obama, Sebelius, HHS: Shame on you for abandoning 1 million sick and disabled Americans with ME/CFS and XMRV (Chronic Fatigue Syndrome and a newly discovered retrovirus). Clinical trials now!" (This banner was first used on May 10th at HHS national headquarters in Washington DC: http://cfspatientadvocate.blogspot.com/2011/05/hhs-demonstration-may-10-2011.html).

SECURITY:  Security came out immediately in the form of one person. He appeared to be the Head of Security of for the Federal Building/HHS. Bobbi told him what they were doing and how she had been told by the city police that they could be on the sidewalk without a permit, as long as they didn't have a loudspeaker. The security officer agreed, took some of the demonstrators' literature and went back inside. It was all very relaxed.

PRESS:  The protest co-organizers, Bobbi and Rivka, a mother/daughter team, had spent the days prior reaching out to the press. Success! The New York Times reporter who has covered ME/CFS in the past came "to say hi" (no article expected, but good to keep relations going) and a San Francisco Chronicle reporter and cameraperson came as well. The resulting article is found here: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/05/26/BANA1JL1AH.DTL Though this article was disappointing in the usual ways, its publication was still good news, as the SF Chronicle is one of the largest papers in the region. Plus, the reporter said she hoped to do an additional story on kids with ME/CFS. And to our knowledge, this is the first time an ME/CFS protest has made news in the U.S.

ACTIONS:  Standing in front of HHS with the banner for 1 hour, the protesters videotaped prepared and spontaneous statements (see resulting video), handed out flyers to passers-by and in a surprise action sang the song, "Clinical trials now!" (Also seen in this 2010 video: http://www.youtube.com/watch?v=8t1Xqp1LDxM).

HHS MEETING:  Also surprising, after the demonstration, there was a group meeting for a half hour with Eric Alborg, Regional Outreach Specialist of HHS's Region 9. His boss, who was out of the country, is Herb Schultz, the Regional Director of Region 9. In the hierarchy, Alborg is positioned directly under Schutlz. (Alborg's job main is to implement the new health care program.) Alborg had thought he'd be meeting with just one person, Bobbi, and had not known about the demo in advance. But after checking with someone (we don't know who), he agreeded to meet with the whole group, that is, the two protesters who have ME/CFS and their three family members. Alborg was open to listening and wanted to know why the protesters were there. People talked about the concerns and needs of people with ME/CFS (funding and clinical trials!). The demonstrators put the struggle regarding ME/CFS in the context of HIV/AIDS, linking the possible retrovirus connection (XMRV). This discussion made sense since HIV is historically a key issue in San Francisco, due to a large and politically active gay community. The protesters emphasized to Alborg that HHS should have an understanding of the politics of all this, due to HIV/AIDS. They also told him that the information about this demo, and the meeting with him, would not be limited to the small group he was presently gathered with, but would be rapidly disseminated all around the globe via the internet, and that ME/CFS was an issue that was not going to go away.

Alborg's suggestion to the protesters: 1) Call/lobby local institutions and legislators; 2) build coalitions with groups with other disabilities and chronic illnesses -- groups that have already-established power and influence. (Though he did not say it, one protester went away thinking HIV/AIDS and Autism groups).

Bobbi gave Alborg copies of a letter she had written with her own personal statement on top, followed by a list of basic needs/demands from our ME/CFS community. Bobbi's letters were addressed to HHS Secretary Sebelius, NIH Director Collins, NIAID Director Fauci and Schultz (Head of HHS Region 9). Alborg promised to make sure the letters were given to each.

OUTCOME:  Protesters reported leaving the demonstration and HHS meeting feeling great; like they had done something important, both personally and politically.

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Note from Bobbi, demonstration co-organizer

== Personal statement, given to HHS officials ==

I am the mother of a daughter with the illness Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, or ME/CFS, which has very severely limited my daughter's ability to lead a simple work and social life for over 20 harsh years. I have been her primary support. Much of the time she has been so sick she is often homebound or bedridden with disabling symptoms, not just "fatigue"!  Our family's life activities and resources are centered around the health needs of this daughter (and sister) we love. We expect more support from our government by way of research and clinical trials for this disabling disease that affects more than a million Americans. Most people with ME/CFS are too ill to be standing outside HHS today for a demonstration.  Those of us gathered here are speaking for all who are ill, and we demand to have more research and clinical trials now.

BAusubel (at) yahoo (dot) com

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Note from Rivka, demonstration co-organizer

== The Goals of Our Mini-Demo Strategy ==

It is my hope that ME/CFS patients will rise up and hold a number of these small mini-demos around the country, at HHS and CDC regional offices, of which there are 20. Demonstrators can use our banner, which we'd ship to them, or they can make their own signs. The 3-part goal of this strategy is to:

1. Get on HHS's radar (get ME/CFS and XMRV patients on HHS's radar).
2. Get press attention (get the patients' perspective in the press).
3. Get the ME/CFS community used to images of people with ME/CFS demonstrating and protesting. Once they are accustomed to these images they won't be as timid or trepidations about going out and doing it themselves (the ones who are able, of course).

Rivka (at) ThatTakesOvaries (dot) org