Llewellyn King's Dec 15, 2012 article on the Stamford Advocate on the FDA approval meeting of Ampligen dated Dec 20, 2012. 

Llewellyn King host and producer of
the "White House Chronicles" on PBS

Llewellyn King, host and producer of the "White House Chronicles" on PBS wrote an article at the Stamford Advocate regarding the FDA potential approval of Ampligen (Hemisphererx Biopharma) during today's FDA Arthritis Committee review of the Hemisphere Biopharma submission to the FDA to approve Ampligen to treat myalgic encephalomyelitis (ME), which is also known in the U.S. as chronic fatigue syndrome (CFS). 

In his article you will find the positions of Drs. Andrea Kogelnick, Dan Peterson, Derek Endler and personal assessments of ME/CFS patients who clearly benefit while on Ampligen and the downward spiral once they are off the drug. 

According to Llewellyn King "When patient activists face the government in various hearings, it is painfully asymmetrical, it seems to me. The sick tell sad stories of suffering, loss of love as well as health, while the government people talk abstractly about patient loads, international disease definitions, allocation of resources and appear self-important rather than appalled at the suffering that passes before them.

The patients turn to the government for recognition, but the government turns them into a statistic."

Read more: http://www.stamfordadvocate.com/local/article/FDA-to-rule-on-Lazarus-drug-4121250.php#ixzz2FbyRM2kQ

FDA Review of Ampligen Happening Right Now at the Arthritis Advisory

As I type this I am listening to Dr. Lucinda Bateman followed by Robert Miller, a patient advocate colleague of mine of many years. He is a living proof of how Ampligen works for many ME/CFS patients.  The direct link to watch the entire event is:
https://collaboration.fda.gov/aac122012/

Tina Tidmore will be proudly representing PANDORA and the new team of PANDORA led by Lori Chapo-Kroger, the new president of this outstanding organization.  As a founder of PANDORA, and as I have been advocating tirelessly for a drug to be approved for ME/CFS for more than a decade, my heart and my soul are once again being tested today.

I am posting below the entire comment by Dr. Kenneth Friedman's to the FDA committee regarding the reasons why Ampligen should be approved by the FDA today. No more waiting! No more excuses! The time is now! ONE VOICE, ONE COMMUNITY, ONE CAUSE (TM). 

Written testimony of Kenneth J. Friedman, Ph.D.
Submitted December 6, 2012
For the FDA Arthritis Advisory Committee Meeting of December 20, 2012 NDA 22151

Kenneth Friedman, PhD

The announcement by the Food and Drug Administration that its Arthritis Advisory Committee is meeting on December 20, 2012 to discuss the new drug application for Ampligen, for the treatment of patients with Chronic Fatigue Syndrome, sends the wrong message to those ignorant of Chronic Fatigue Syndrome (CFS) and raises the eyebrows of those with even glancing knowledge of the illness. Those ignorant of Chronic Fatigue Syndrome might assume that the illness must be related to arthritis. Why else would the Arthritis Advisory Committee be considering the application of a drug dealing with CFS? While CFS is a multisystem illness, and there are at least four current case definitions by which to diagnose the illness, not one of those case definitions lists arthritis, or arthritis-like symptoms, as one of the features of this illness. The decision to place the fate of Ampligen and CFS patients, some of whom have been successfully treated with Ampligen, in the hands of the Arthritis Advisory Committee must have alternative reasoning.

Those of us who have even a glancing knowledge of CFS, know that CFS has been treated like the plague-ridden buttocks of chronic diseases. Neither the National Institutes of Health or the Centers for Disease Control and Prevention (CDC) will conduct a proper epidemiological study to estimate or confirm actual number of patients who have CFS in the United States. Indeed, the CDC, who changes case definitions of the illness apparently on whim, has varied the number of patients from 800,000 to 4 million – a more than fourfold difference – without any concern for the accuracy of its numbers. But upon the assumption that there are 1 million CFS patients in the United States, you would think that the National Institutes of Health (NIH) would have a program dedicated to researching the illness within the walls of at least one of its institutes. Not so. There is not one, research laboratory within the entire NIH studying CFS. And as for the CDC, despite its having a laboratory devoted to CFS research in its Chronic Viral Diseases Branch, there are no recent studies emanating from it dealing with the etiology or pathophysiology of the illness. Hence, our concern is that the FDA is following the lead of its sister agencies of choosing to ignore, or worse, undermine, its responsibilities to CFS patients and those who attempt to assist them.

While the FDA announcement speaks of this application as being “new,” in fact, it is not. The manufacturer of Ampligen, a small pharmaceutical company named Hemispherx, has appeared before the FDA before, only to be turned away and ordered to perform more clinical studies. Without the resources of a large pharmaceutical company, it has conducted clinical trials to the best of its ability in a patient-cost-recovery program. If the object of clinical trials is to prove drug efficacy, the trials have done so: some CFS patients when given Ampligen, improve dramatically. Take their Ampligen away, they relapse. Reinstitute the Ampligen, they improve again. Not all CFS patients improve, but if the CDC can vary its estimate of the number of CFS patients by varying its CFS case definition, the fact that not all patients improve suggests that the case definition of CFS needs to be improved, or that subsets of CFS patients exist, and that Ampligen works on a specific subset or, perhaps, even several subsets.

The second consideration of the FDA in determining whether or not to award approval of Ampligen use for CFS patients is the drug’s safety when administered. To our knowledge, CFS patients either improve on Ampligen or they do not. We have not heard of any patient dying as a consequence of Ampligen administration. We have not heard of any severe or life-threatening reaction to the administration of Ampligen. If there are adverse reactions to Ampligen, we must presume them to be minor. Given the risk-benefit ratio of Ampligen administration, the patients have spoken: Many have moved themselves and their families to geographically disparate regions of the country in order to gain access to treatment. Without the treatment, they languish in bed; unable to care for themselves much less interact with their families.

So why then is the Ampligen application before the Arthritis Advisory Committee? Two possible reasons come to mind: (1) The FDA does not have an advisory committee better equipped to deal with this application, or (2) The prejudice against CFS, its research and its treatment is so large, that the FDA feels that the application would have a less prejudicial review before an irrelevant advisory committee rather than a committee more familiar with CFS. Perhaps, the FDA, like the NIH, does not have an existing advisory committee with the appropriate expertise to competently process CFS applications and considers the formation of such an advisory committee too costly. The National Institutes of Health has been notorious for having inappropriate reviewers sit in judgment of extramural, CFS research applications only to reject those applications for specious reasons generated by ignorance. Institutional and peer prejudice against CFS, CFS research, and the brave investigators who attempt to investigate this illness have been called to this nation’s attention at the NIH, Chronic Fatigue Syndrome State of Knowledge Workshop (http://www.vtcfids.org/images/Elephants%20in%20the%20Room%20As%20Delivered.pdf). The failure of the federal government to act on the deliberate closure of CFS laboratories at universities and the termination of CFS researchers has led to yet another closure of a university research and clinical laboratory dedicated to CFS within recent months - proving the pervasive, poisoned environment for CFS treatment and research within the United States. How could the attitudes and culture which cause and permit universities, literally from coast-to-coast, to close CFS laboratories and prevent their faculties from engaging in CFS-related scholarly activity not infiltrate federal advisory committees?

Quite possibly, the timidity of the FDA to approve the use of Ampligen for CFS patients, as well as its timidity in the approval of a variety of other applications under its consideration, is a response to lessons learned in the past. When the FDA received the application to market thalidomide in the United States, after it had been marketed by 14 pharmaceutical companies in 46 different countries, it was considered to be a rather straightforward application. However, little was known about its side effects, and the drug affected experimental animals differently than humans. The FDA delayed approval. Subsequently, reports from Australia and West Germany indicated that thalidomide was associated with cases of human limb deformities and other congenital abnormalities. The drug was removed from all world markets and the application for approval in the United States was withdrawn. A national health crisis had been averted by stringent and slow adherence to FDA, drug approval rules.

However, subsequent to its initial removal from the market, thalidomide has been shown to be an effective therapeutic agent in leprosy, tuberculosis, sepsis, and cancer. Thalidomide may be useful in

the treatment of macular degeneration, in combating lesions in the mouths and esophagi of AIDS patients, and in the treatment of multiple myeloma. Consequently, in 1998, the FDA approved the use of thalidomide for the treatment of leprosy under a program (System for Thalidomide Education and Prescribing Safety [STEPS]) with severe restrictions and limitations. The message: Even for thalidomide, the FDA has weighed the risks vs. the benefits, and has decided to cautiously approve thalidomide.1
There is no evidence to suggest that Ampligen is a thalidomide. There is no evidence to suggest that are as severe, potential side effects to the use of Ampligen as there are to thalidomide. Yet, for some CFS patients, the consequences of being denied Ampligen therapy are as severe and possibly worse than living with the side effects of thalidomide.2 Some CFS patients without Ampligen have no lives whereas with Ampligen they do. If the FDA can approve thalidomide for patient use in the United States, can there be any reason not to approve Ampligen?
1 http://www.nyu.edu/classes/jaeger/thalidomide.htm 2 http://ffdn.se/web/england-1/


Dr. Friedman's credentials are impeccable. As a former expert member of the CFS Advisory Committee under the authority of the U.S. Secretary of Health, Dr. Friedman has the knowledge, the expertise and the experience to comment on why Ampligen must be approved for ME/CFS treatments.

So far the questions are being pertinent from the FDA panel to the individuals representing Hemisphere Biopharma and the stakeholders who are there present as well. I had to take a quick break from watching the event and when I came back Dr. Bateman was answering a question on the issue of Cognitive Behavior Therapy (CBT). Her response (not verbatim) was that CBT is not a medical treatment but a coping mechanism tool for patients whose lives are in disarray due to the illness challenges. 

If you are a ME/CFS patient or a loved one or a caregiver, please contact the FDA and let your voice be heard:

Contact Information

• Yvette Waples, PharmD
  Center for Drug Evaluation and Research
  Food and Drug Administration
  10903 New Hampshire Avenue
  WO31-2417
  Silver Spring, MD 20993-0002
  Phone: 301-796-9001
  Fax: 301-847-8533
  E-mail: AAC@fda.hhs.gov

• FDA Advisory Committee Information Line
  1-800-741-8138 (301-443-0572 in the Washington DC area)
  Please call the Information Line for up-to-date information on this meeting

Here is the link to the calendar information on Dec 20, 2012 (today's meeting), which will end at 5 pm this afternoon.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm

ONE VOICE, ONE COMMUNITY, ONE CAUSE (TM). 

"Us and Them" is Phasing Out

(Last guest blog from Tina Tidmore about the June CFSAC meeting.)

I've watched local, state and national politics, as well as the first "Survivor" show to see how people gain power to win against those who disagree. The ones who have extreme views tend to be the loudest and get the most attention. They pull at those closer to the middle to bring them to the extreme view. As they pull, the bring the people in the middle away from those with opposing views. The end result is two opposing groups who are angry and throwing stones at each other. It becomes a power struggle of who can get the most support and they try to squash the opponent by shear force.

In these situations, I notice that the majority is often in the middle on the issue. But they don't have strong feelings, so they are silent. What's missing is the dialogue. If the ones who are close to the middle on both sides start talking with each other, then they may find they almost agree. But the power struggle prevents this dialogue, where a solution and movement takes place.

In the history of the CFSAC meetings, the patients were on the other side of the table, creating an "us" feeling. (Exception is the one patient advocate on the committee.) The committee members, were "them." So we had an "us" and "them" set up.

The June 2012 meeting was different. The CFSAC administrators arranged for a dialogue from teenager patients and committee members. Talking to each other is better than throwing stones. Although, a few stones may be needed to get their attention. But openness is needed to listening with the heart. And if the person is in defensive mode, they aren't being open.

They got another patient advocate on the committee, a doctor who is an anesthesiologist.

They are working on the by-laws for organization reps to be on the committee, to be included in the discussions of the committee. (This may prevent the urge to yell out during the meeting.) This is great.

While it's great to have more patients participating in the committee discussion instead of just preaching, pleading or hurling at them, care should be taken to not become dependent on government agencies to do their work. The organizations must keep independence so they never become beholden to the government, even in a partnership agreement. They must always be advocates whether they are in the peanut gallery or sitting with CFSAC members as part of the committee. They must never fear losing power or position and fail to speak. This would be a betrayal. But it doesn't have to be on the outside. Advocacy does not mean adversarial. Advocacy can be done while sitting and talking with those who disagree.

If you see ME/CFS patients or organizations reps talking to some who you disagree with, don't think it is because they agree with them. Think they are trying to persuade them in a less formal way.

The CFSAC administration is also trying to get ME/CFS out of the fringe. The researchers and clinicians, evidently, are not mainstream enough to have credibility among others. The suggestion is to get representatives of physician organizations involved in the process for forming new criteria. We faced another conundrum: to get the new definition accepted, need to bring these associations of ignorant, possibly biased clinicians, to the table to be part of the discussion and the decision. But, they may mess it up if they have any say in the process.

The idea discussed at the June 14 meeting is to educate them first. Then have them be included in the process. Scary, isn't it. But, as long as ME/CFS researchers and clinicians are considered "out there" by their peers, then we won't change these associations and the physicians who are members. We must include these associations if we are to get ME/CFS mainstreamed. We must remove the "us" and "them" attitude and actions. We need to get them to carry our message for us, for our clinicians and researchers do not have the credibility as the leaders of these associations. I really appreciate the FDA ex-officio bringing this out in the June 14 meeting.

A wise ME/CFS patient explained a common way change happens.
1) Folks get mad and take to the streets with their demands.
2) They go too far and demonstrations turn violent
3) After the mess is cleaned up by authorities, the suits (more moderate and professional-acting folks in the movement) meet with the opposition to work out the changes.

This is what I have seen at the June CFSAC meeting. It's good we are now past stage 1, 2 and now are at stage 3.

Another thing I learned for sure from this CFSAC meeting is that I definitely have a southern accent. All doubts have been removed. I was reminded of it often. So, whether by radio interviews or at CFSAC meetings, I will use my southern drawl to persuade. And if I have to, I will publicly and boldly correct the ignorant and the biased - bless their little hearts.

The Train is Moving

(Another guest blog from Tina Tidmore)

For years, the CFSAC seemed to be stuck in stagnation. Ex-officios seemed not too interested, nor did they appear creative. Committee members felt much frustration. The hardest part is getting the train to move from inertia. A lot of fuel is needed to move such dead weight into action.

However, two years ago, the XMRV claims provided the fuel that got that CFSAC train going. It's slow, as it leaves the station. The question is, who will answer the call "All aboard"? So, what movement is being shown in the government agencies as revealed in the June 13 CFSAC meeting?

• The FDA has 8 applications. Two are from private companies and the others are from investigators.
• Lipkin study on XMRV will be published within a few weeks as a "white paper" and then as a peer-reviewed paper.
• Some CFSAC members also criticized the CDC toolkit.
• CDC has made some changes to their website and will be doing more. They will be adding a section on pediatrics.
•  The CDC is looking for ways to continue a dialogue with patient organizations. They have met with many in the last year.
• The CDC participated in a pathogen study, found nothing, although it was just plasma.They recognize that it is not conclusive on the pathogen question. They are working with 7 well-known ME/CFS physicians to do research on their patients. They discovered an abnormal response in the brain of ME/CFS patients in research that was presented as abstract at a conference.
• CDC is creating a CME course for clinical care that will be finished on June 20 and one on CFS and sleep that will be available on July 8. They worked with some well-known ME/CFS physicians to do this. The CDC will be working with the Center for Advance Professional Education company to come up with a curriculum for medical school.
• The Assistant Secretary of Health Dr. Howard Koh is wanting to improve communication with patient organizations and have their representatives on the committee.
• The FDA has centralized where the CFS applications go and have educated those who review them. They received the CDC toolkit, but they also received the IACFS/ME Physician Primer.
• Koh arranged for an ad hoc committee of government agency reps. to have meetings on what they can do for the patients with this illness. A national webinar and a national patient registry have been discussed in those meetings.
• Live videostream of the meetings returned, despite the continued financial cuts in the DHHS.  

Besides these progress reports, a new arrangement happened where a panel of patients had a dialogue with the committee. The committee members could ask these teenagers and a parent of an ME/CFS patient questions and the panelists could ask the committee members questions. As far as I can remember, this is a first and shows an openness to patient concerns instead of defensive posturing.

We all were very concerned with the new members, especially with the loyal and vocal Dr. Nancy Klimas, Dr. Chris Snell and Dr. Lenny Jason all leaving at the same time. However, these new members got a crash course today with a wonderful look at the biological findings in ME/CFS pediatric patients, as described by Dr. Peter Rowe. And they got to know the extreme injustice and suffering - not only from the disease but from an ignorant and uncaring system - as revealed in the moving testimony of some of the young ones and their parents. From some of their comments, I have concern about one, but the others are on board. That one, I think will come around. So, those who understand the illness are still in the majority. And they are speaking up too.

Tears flowed when the mother spoke of her daughters and the struggle to get the accurate diagnosis, and then find out the proper treatment and also make sure they get an education. As one slap in the face after another, or one injustice after another, the woman sitting to might right said, "Oh my God." And the woman sitting to my left said, "Oh God." Back and forth they went as the family's tragedy was told in all its gory details. Certainly, while we hear these stories again every time, CFSAC members must be reminded that this is not play. We are dealing with life and death here. The new ones need to know this and the old ones need to be reminded at every meeting.

Additionally, many patient organizations and patients signed a joint letter of concern with four primary objectives and a request to meet with Sec. Sebelius, Dr. Howard Koh and Dr. Nancy Lee. They can no longer say, "But the patients are divided in what they want." Not true. These many patients and organizations found areas where they agree and are pushing for that.

Importantly, the CFSAC members are considering endorsing the IACFS/ME Physician Primer and recommend it be distributed. How wonderful! Attorney Steve Krafchick asked, "Why invent a new toolkit when you have a primer?" Krafchick said the CDC physician toolkit is very superficial and the treatment section can be taken out.

For years, the CFSAC seemed to be stuck in stagnation. Ex-officios seemed not too interested, nor did they appear creative. Committee members felt much frustration. The hardest part is getting the train to move from inertia. A lot of fuel is needed to move such dead weight into action. 

However, two years ago, the XMRV claims provided the fuel that got that CFSAC train going. It's slow, as it leaves the station. The question is, who will answer the call "All aboard"? So, what movement is being shown in the government agencies as revealed in the June 13 CFSAC meeting?

• The FDA has 8 applications. Two are from private companies and the others are from investigators.
• Lipkin study on XMRV will be published within a few weeks as a "white paper" and then as a peer-reviewed paper.
• Some CFSAC members also criticized the CDC toolkit.
• CDC has made some changes to their website and will be doing more. They will be adding a section on pediatrics.
•  The CDC is looking for ways to continue a dialogue with patient organizations. They have met with many in the last year.
• They participated in a pathogen study, found nothing, although it was just plasma.They recognize that is it not conclusive on the pathogen question. They are working with 7 well-known ME/CFS physicians to do research on their patients. They discovered an abnormal response in the brain of ME/CFS patients in research that was presented as abstract at a conference.
• CDC is creating a CME course for clinical care that will be finished on June 20 and one on CFS and sleep that will be available on July 8. They worked with some well-known ME/CFS physicians to do this. the CDC will be working with the Center for Advance Professional Education company to come up with a curriculum for medical school.
• The Assistant Secretary of Health Dr. Howard Koh is wanting to improve communication with patient organizations and have their representatives on the committee.
• The FDA has centralized where the CFS applications go and have educated those who review them. They received the CDC toolkit, but they also received the IACFS/ME Physician Primer.
• Koh arranged for an ad hoc committee of government agency reps. to have meetings on what they can do for the patients with this illness. A national webinar and a national patient registry have been discussed in those meetings.
• Live videostream of the meetings returned, despite the continued financial cuts in the DHHS.  

Besides these progress reports, a new arrangement happened where a panel of patients had a dialogue with the committee. The committee members could ask these teenagers and a parent of an ME/CFS patient questions and they could ask the committee members questions. As far as I can remember, this is a first and shows an openness to patient concerns instead of defensive posturing. 

We all were very concerned with the new members, especially with the loyal and vocal Dr. Nancy Klimas, Dr. Chris Snell and Dr. Lenny Jason all leaving at the same time. However, these new members got a crash course today with a wonderful look at the biological findings in ME/CFS pediatric patients, as described by Dr. Peter Rowe. And they got to know the extreme injustice and suffering - not only from the disease but from an ignorant and uncaring system - as revealed in the moving testimony of some of the young ones and their parents. 

Tears flowed when the mother spoke of her daughters and the struggle to get the accurate diagnosis, and then find out the proper treatment and also make sure they get an education. As one slap in the face after another, or one injustice after another, the woman sitting to might right said, "Oh my God." And the woman sitting to my left said, "Oh God." Back and forth they want as the family's tragedy was told in all its gory details. Certainly, while we hear these stories again every time, CFSAC members must be reminded that this is not play. We are dealing with life and death here. They need to know that even in America, the sick are being mistreated and they must stop it. These stories give them the motivation to act with courage.

In acting with courage, they will be imitating some of the patients themselves. As the first one on this day, first time for her to give testimony, spoke boldly, even shocking some in the audience. This slender and petite woman, did not shrink back or filter her words. Her trembling from the situation only showed how great her passion and courage was to stand up and declare a wrong has been committed.

The fears of the new members seem to be unnecessary as seen from some of their comments. During the breaks, I got to speak to some. One of the new members told me he thinks he might need to call some of his former ME/CFS patients to suggest helpful treatments he learned at the meeting. They get it, or they are getting it.

Even Dr. Gaillen Marshall, the new chair, made a striking opening remark. He acknowledged the concerns some had in his being in the chair's seat. He said he sees holistic, integrative and personalized care as being applicable to this disease. "Most diseases are syndromes," said Marshall. He said cancer, diabetes and others are one disease, but with subgroups. "Not all have the same symptoms, even if they are the same disease," Marshall said. While other diseases have seen much progress, ME/CFS patients are still waiting, still asking. After the very profound and deep comments from Matthew Lopez-Majano, Marshall said that they will not grow to be old and have the same disability as they do now with the disease. "There is a light at the end of the tunnel," he said.

Also, new in this meeting, many patient organizations and patients signed a joint letter of concern with four primary objectives and a request to meet with Sec. Sebelius, Dr. Howard Koh and Dr. Nancy Lee. They can no longer say, "But the patients are divided in what they want." Not true. These many patients and organizations found areas where they agree and are pushing for that. 

Importantly, the CFSAC members are considering endorsing the IACFS/ME Physician Primer and recommend it be distributed. How wonderful! Attorney Steve Krafchick asked, "Why invent a new toolkit when you have a primer?" Krafchick said the CDC physician toolkit is very superficial and the treatment section can be taken out.

As this train starts to move. We must acknowledge that action is being taken. But that does not mean we don't need to give more fuel. It is still slow. We want - the situation demands - that the train move much faster. So, patients must still push for more improvements. But, as it moves, it will get easier and easier and the momentum will begin to help it along. To all, patients, organizations and government agencies and the CFSAC, have you answered the call. Are you on board?

You Are Not Alone

(from Tina Tidmore, guest blogger)

As I sit in a hotel room, listening to 12 other people discuss their experiences with ME/CFS, I can't help but think of the other group of patients in cyberspace. The young people here share their stories of dealing with school, ignorant physicians and the joys of finally finding someone who can help. "That's just like what happened to me," is a phrase that shows a connection and an understanding that patients experience only with other patients.

Hearing a 16-year-old talk about ATP and coxsackie virus shows that ME/CFS is really its own world, with its own language and its own citizens and celebrities. Stories of different doctors and their treatments actually shows we are really like a family. Dr. Dennis Mangan, formerly of the NIH, said the ME/CFS researchers and patients together are like a family, maybe a dysfunctional one, but still a family.

Here in this room, we have no dysfunction. We have laughter, understanding, patience (and patients) and a camaraderie. Not only do we have the patients sharing with each other, we have parents who share their own trials and victories. One mother tells her story and breaks down in tears. Quickly, another mother comes to hug her. Ten minutes later, loud laughter fills the room. And we even have a little bit of strategy talk. It's like a large group of people who just discovered others of their kind.

What is most interesting to me is that these names who are attending are not the same names I see in the ME/CFS cyberworld. I asked some, why don't I see you on the message boards, Facebook, talking to other ME/CFS patients online. One young man said he has seen some improvements in his health. He still wants to help the cause, but for his own emotional, and therefore his physical health, he had to disconnect himself from the day to day drain. The ME/CFS cyberworld can be very demanding, even caustic.

I certainly understand that. After many battle scars, I left from doing government, crime and corruption coverage for the local newspaper. I told the publisher I was not ready for pasture, but I emotionally and physically could not be on the front lines any more. Evidently, the same thing can happen with ME/CFS advocates. We must protect our health first. And we should appreciate anything anyone does because we know it comes with a prices.

I also hear some of the young people who say that while they want to advocate for other young ME/CFS patients, they need to fill their time between the CFSAC meetings actually thinking about and doing (as they can) things that are not disease-centric. These young people want a life of school, friends, and more. So, as they can, if they can, their precious little energy is spent on living.

I posed the question of why there is such a difference in the ME/CFS cyberworld, with people daily looking for and commenting on the littlest nugget of news on the disease. The consensus is that some of  our disease brothers and sisters have lost much of their life. Their friends and jobs and more have all disappeared. All they have is their computer screen, their window into the rest of the world, a world they can not participate in, only comment on. Frustrated, they want it to change. But without the creativity that some have found to do something constructive online, it only leads to anger. Thankfully, it seems to be less than it was a year or two ago. But that anger is still there.

My lesson from tonight's gathering in this hotel suite, and from what we see in the ME/CFS cyberworld, is that we must protect our emotional and physical health. If that means we are part-time advocates, then so be it.

Tonight, all of us - those in the ME/CFS cyberworld and all those who fight the battle at the CFSAC - can go to bed and rest with the peaceful knowledge that we are not alone.

Affordable Care Act, Supreme Court, May Awareness Month 2012

The U.S. Supreme Court has heard by now both arguments regarding the Affordable Care Act. Many disabled individuals with NEIDs have both Medicare and Medicaid covering their healthcare (dual eligibility).  The arguments for and against the Medicaid mandate expansion to the states about the ACA (Affordable Care Act) were presented by the U.S. Solicitor General Donald Verrilli Jr, and the opposing counsel by Paul Clement. Medscape has been providing daily recaps of the Supreme Court's proceedings regarding the ACA. Florida is the lead state joined by 25 other states. For many experts, the personal or individual mandate that requires the young, the old, the health and the sick to sign up for healthcare benefits creating a large pool is crucial to the affordability of the program. Other experts representing opposing point of view, are saying that the mandate is unconstitutional and therefore if the mandate is found unconstitutional the entire ACA program needs to be scraped.

Many experts have noted that this mandate was for many years embraced and promoted by the Heritage Foundation, a conservative think tank that embraces and promotes conservative values in the U.S. political arena. Many experts also have noted that a similar mandate is already in place in Massachusetts. It was signed by President hopeful and former Governor Mitt Romney. The program in Massachusetts is viewed by a large majority of experts who have been analyzing the program as extremely successful and has kept the affordability of developing the program in check. 

PANDORA recommends to our members to become educated on these important issues. The ACA has answered some of the concerns patients have had to deal with for a couple of decades. No more pre-exisiting conditions, no more caps on life-time coverage. If one is disabled and cannot afford insurance one can join a special insurance pool. Children up to 26 years old can also be kept on the same insurance medical plan of their parents regardless of going to college or not. 

This new access to medical insurance through ACA has in fact neutralized some of the harsh reality that the overall patient NeuroEndocrineImmune diseases (NEIDs) community faces.  The NEIDs patient community has been consistently and often penalized by the medical, scientific and government ignorance of how NEIDs are to be treated. There is also a lack of serious concern leading to a complete lack of priority from the Department of Health and Human Services in the past 3 decades, with no difference whether there is a Democrat or a Republican in the White House or a Congress that is either to the right or to the left of our political spectrum. The harmful effect trickles down to the National Institute of Health, CDC, and other federal government agencies that complement care and quality of life for U.S. citizens are minimal in terms of addressing 3 decades of abandonment and lack of political will from our government officials to fix these serious problems.  

The lack of priority by our federal government regarding NEIDs, then trickles down to the state, municipal and county levels. It crosses over academia causing lack of interest in the science of NEIDS. The lack of physician training and robust scientific research prevents even the basic level of medical care to be provided to NEIDs patients in every state.  The cost of ignorance is higher than the cost of treatments that would benefit the overall NEIDs patient population in the U.S. 

As a citizen of this great country I urge you to learn about the issues and make your voice count.

You owe to yourself to win your future. Neither PANDORA, nor you, and nor I can change the past. However we can change the future. Join us as an Advocate Extraordinaire™ during May Awareness Month in 2012.  Speak up and stand up for the NeuroEndocrineImmune disease you are stricken with loudly and clearly. Support PANDORA and the other hardworking organization serving the NEIDs community in the state where you live and create change. Join the member organizations of the Coalition 4 ME/CFS and the Coalition 4 Fibromyalgia and they will show you how we can all work together across state boundaries toward a comprehensive national policy that will benefit our entire community. 

All of our collective voices, as ONE Community, One Voice, One Cause!™