Sunday, September 30, 2012

Really? The FDA said that? FDA considers CFS to be a serious or life-threatening condition.

FDA considers CFS to be a serious or life-threatening condition.

I was skimming various blogs and found this blog post. I'll post one paragraph (I broke it up for easier reading but kept the bullet point markers) she wrote but the entire post is worth reading. It looks like an excellent blog:

  • FDA considers CFS to be a serious or life-threatening condition. This means that drug applications can qualify for the Accelerated Approval Process. Accelerated Approval brings drugs to market after shorter clinical trials, and additional studies are done after that approval. This is how many HIV drugs have been approved, as well as drugs for cancer and other condition.

  • FDA will offer a webinar on “Excellence in Advocacy” in November 2012. The purpose of the webinar is to show advocates how they can speed the development and approval of treatments through engagement of researchers and pharmaceutical companies. I find it a little ironic that FDA will be telling us how to be better advocates, but I think this will be an important session. FDA has been through this process with HIV and other serious conditions; they must have a perspective on what works and what does not.

  • Ampligen will be considered for approval at a public meeting on December 20, 2012.This meeting will feature an FDA panel, as well as public comments from clinicians, patients and others.

  • FDA will hold the 1.5 to 2 day stakeholder meeting in the spring of 2013. This meeting will bring together other federal agencies, researchers, clinicians, pharmaceutical companies and patients. It emerged during the call that a major goal of the meeting will be identifying consensus endpoints. In this context, endpoints are the reliable quantitative measures that will be used in clinical trials to evaluate whether a treatment is working.

  • FDA takes no position on the name issue of ME v. CFS. What they focus on is whether a treatment improves patient condition. They are using the term ME/CFS as a framework for that process but take no position on lumping vs. splitting in defining the illness.

  • There are currently 8 open applications for new drugs to treat CFS. Dr. Teresa Michele stated that many of those applications are for nutritional supplements, with small early trials. FDA expects that agreement on measurable endpoints will speed and increase research into other treatments.

So I went to the FDA's website:

Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS)

FDA will be planning a series of activities focused on drug development to treat the symptoms of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) in order to explore:
  • The burden of disease that impacts the quality of life for ME and CFS patients;
  • The quantitative outcome measures or endpoints that determine if disease symptoms improve with intervention; and
  • How drug efficacy should be clinically tested based on these endpoints or measurements.
Please send correspondence regarding ME and CFS to
Please Note: The list of activities will be updated as each activity is announced.
Teleconference between FDA and Patients/Patient Advocates – September 13, 2012
Additional Resources:

Yesterday a friend posted this article from prohealth on facebook (which is what started me off on my quest for more info). An excerpt from the article:

She [Sandra Kweder MD] quickly demolished any concerns about whether the FDA believes chronic fatigue syndrome is a ‘serious and life-threatening disorder’ - stating that the agency considers ME/CFS on a par with cancer, diabetes, epilepsy, heart failure and other serious diseases.

This was an important statement, given that ‘serious and life-threatening’ is a key criterion in the FDA’s decisions on drugs selected for expedited review.

Let’s take a brief look at the options this designation may open up in future consideration of drugs for chronic fatigue syndrome:
Fast track – Drugs on Fast track status are accorded more frequent meetings with the FDA and are eligible for 'accelerated approval'; and the application can be submitted in pieces rather than all at once.

Accelerated Approval - The FDA can conditionally approve a drug before it has final confirmation of its effectiveness, thereby allowing the drug company to get the drug out to the patients more quickly and giving it the opportunity to raise funds for the final studies. This is particularly important for small drug companies with limited financial resources, such as Ampligen maker Hemispherx.

Priority Review - The FDA will aim to review the drug in six months instead of 10 months.
The FDA's designation of ME/CFS as a ‘serious and life-threatening disorder’ should make it more difficult for the NIH and CDC to justify spending such small sums on ME/CFS, and it gives ME/CFS advocates another plank they can use to promote their cause in the federal arena.

Saturday, September 29, 2012

Cognitive Moments

I'm going through a major bout with insomnia which has increased my cognitive deficits. Yesterday, though crashed, I had to go to the store to get a few items that I can't run out of. For example, I have a lot of difficulty with swallowing (even swallowing saliva at times has gotten tricky-its like my swallowing muscles stop working which is quite unnerving) so I have to crush all my medications and put them in either yogurt or applesauce. I was out of both.

I make it through the store by leaning on the grocery cart whenever I had a woozy moment.

I finally arrive at the checkout counter. As I'm waiting the man behind me and I start talking. Another checker comes over asking about Sherry Brandy which led to more discussion amongst us as none of us had ever heard of Sherry Brandy.

In the meantime the checker had rung up and bagged my grocery items. I walk out of the store leaning on the cart.

When I arrive at my car I'm putting the bags (3) in the trunk when I hear a woman in the background trying to catch someone's attention.

I hear her yelling "Ma'am, would you mind coming back in and paying for your groceries please?"

As I'm hearing this I'm thinking "I guess someone tried to steal some groceries! Well, they got caught!"

I turn around to return the grocery cart and I see her waving at ME! "Maam?" she says, "Would you mind returning to the store please?"

Horrified I go back into the store with her. At the same time I'm trying to suppress this giggle that I innocently walked out of the store because I forgot to pay.

It turns out she thought the man behind me and I were together so she charged my items to him. : )

I tried to joke about it with them by saying "shoot-it almost worked!" but they didn't find it as humorous as I did.

The other moment wasn't funny. I got approved for Medi-Cal. The worker contacted me and asked me for receipts and addresses about where I send my Medicare payments. I was also paying about $60 per month to stay on cobra benefits so I could still have vision and dental coverage.

I assumed it meant they would be paying the premiums as that is one of the things Medi-Cal does. So I thought I had gotten a break so I didn't pay the premiums for anything last month.

It turns out I was only approved for share of cost Medi-Cal so I ended up almost losing my Medicare Part D drug coverage. I got a letter from them saying I owed $216.

I think that worked out okay. I'll find out on Monday when I call.

I did, however, lose my dental and vision coverage because of my cognitive moment. Oh, well c'est la vie...

Friday, September 28, 2012

What I Wake Up to Each Day

Waking up to my reality each day is  difficult. I'll list the issues lest I continue to be accused of being too negative and thus not worthy of interacting with (PWME's have a different attitude).

Yes-I'm angry and discouraged. I'm angry that I'm dealing with all of this stuff alone. That because of the stigma of the label of this disease I do not qualify for assistance. I don't like feeling helpless.

Here's the issues I wake up to each day:

1. Isolation-no friends. No one to talk to. No one. Can't afford therapy

2. No money. I'm going to be out of savings by April or May if the money keeps going like this. I need clothes, shoes, socks, more blankets, food, pajamas, a robe, flannel sheets (I slept on some last night and had bad night sweats but the water just sort of sat on the sheets and it was so uncomfortable I ended up taking them off the bed at 5 a.m. this morning. I don't think the sheets will work for me as long as I have these night sweats. That's why I'm awake after 4 hours sleep.

     -over $5000 went towards pet care
    -over $1200 went towards car repairs
    -$1500 worth of medical bills-(welcome to Medicare)
    -$1200 more worth of medical bills sitting on my desk that I cannot pay
    -I need new glasses but can't afford them

3. Once my money runs out I can only afford $500 rent and that's with a food budget of $200. Food these days is more like $400 per month.

4. I'm angry that over 50% of my SSDI check is spent on Medicare premiums, and a damn student loan that's killing me.

     -I cannot discharge this loan.

     -My Medicare drug coverage plan won't be offered next year so I have to find a new plan which takes tons of research because its so confusing.

     -the premiums for drug coverage have increased, and the plans currently being offered are going to cost me double what I paid last year so I have to figure out which medications I can go without.
5. The money I have leftover to live on leaves my quality of life poor, my choices for housing poor.

6. I can no longer afford supplements, or treatments for my ME/CFS other than what's paid for by Medicare. Ha! As if there was any treatment from the medical community.

7. No way to earn more money because I'm too ill. If I were healthy I would be working my ass off right now to meet my expenses.

8. I'm trying to get on Section 8 wait lists. Unfortunately all but one county so far is full. Applications open up rarely and when they do it's just to get on a wait list. That's what opens up-the wait list not an actual place to live.

9. Managing this illness is challenging as we all know. I fear getting worse because I can't afford treatment.

     -I'm trying to find a doctor who takes Medicare. I'm continuing to have bleeding under the skin. I also have a skin cancer on my arm that needs removing but there's no way I'm paying the amount of money it will take.

10. I feel like an utter failure about the money. It's not my fault. I didn't plan on those expenses. I fear the judgment of various people regarding it. Luckily they won't have to worry about being saddled with my care.

11. I do not qualify for food  stamps or any other aid because I make too much money. Yeah right.

     -again its that damn student loan. It doesn't show up on my credit nor can I provide proof that I'm responsible for a student loan because my name isn't on it. My ex's name is on it so I get zero credit and I get denied aid because I can't prove I'm paying it so in the eyes of the government I have that extra $302 when in reality I don't.

12. I also dont' qualify for any type of credit card because my name is on the house deed so it looks like I have mortgage payment. Crazy right?

13. I have to find a new place to live. I don't want to. I'm too tired. I'm tired of moving, of being in transition. I desperately need to feel settled. It's discouraging looking for housing because the rents are high due to the housing market, and the roommate rentals that are open do not want anyone who is disabled.

14. So when do I have any money or energy leftover to socialize or do the things that feed my soul?

15. I would love to be comforted. I would love to break down and cry with a friend and talk about how scared and alone I feel.

17. I'm getting worse physically due to the constant stress and the fact that I'm doing too much for what my body can handle.  I don't know what I can cut out. I'm back to being in bed most of the time.

18. I fear the choices I will be forced to make as a result of all this.

Wednesday, September 26, 2012

In Honor of Rich Van Konynenburg

This morning I woke up to find the following email. It had been forwarded to me by a mutual friend and was also posted on various message boards, yahoo groups, and other places where Rich was active:

This post is from Rich's wife. There is no easy way to say this, and this message is very difficult for me to write.
Rich died early this morning. It appears that he suffered a massive heart attack in his sleep. He did not have a history of heart disease, so this was sudden and quite unexpected. It doesn't seem possible to me that Rich is gone. I am at a loss to express how profoundly I will miss him (I already do!). 
I am trying to figure out how to begin notifying everyone who will want to know. Please feel free to repost this message on any forum or group where people who interacted with Rich will want to know of his passing.
Diana Van Konynenburg

I'm in shock, stunned. I've been rattled all day. How can Rich be gone?

He was such a wonderful man and a gift to the ME/CFS community. He was kind, generous, a gifted researcher, and a source of compassion and wisdom during rough times. He was dedicated to finding a way to help us.

He and my dad both worked (and retired) at Lawrence Livermore Lab. I remember communicating with him about it. He was generous in answering emails even though he was busy.

His protocol helped bring many people from bedbound back to functional or even working. Rich was humble. Despite ample evidence that the methylation cycle is involved in ME/CFS Rich never suffered from hubris. In fact when it was clear the methylation protocol wasn't working for some people (I was one) he went back to the drawing board to try to figure out why.

For me it was because my body couldn't (can't) clear a massive low grade chronic infection. Rich never got defensive. He didn't view questions like 'why isn't this working for me' as a threat but more as a mystery. He sincerely wanted to help us have a better quality of life and he worked tirelessly at it.

During rough times on message boards Rich would come in and calm everything down. In fact during very tense conversations I began to watch for Rich to comment. When he did the tone of the conversations would inevitably shift.

He was like a collective Father figure to the ME/CFS community. A community that has suffered from stigma, scorn, and horrible neglect by the medical system. Having Rich around eased that burden somehow.

But he also had something rarely found in a healthy person.

His faith and spirituality gave him an uncanny ability to walk in someone else's shoes.

He understood what it was like to live like this. He knew how much we suffered. and he knew we weren't exaggerating, being dramatic, or whining. He knew without a doubt how sick we are.

I remember emailing him a couple years ago and in my email I said he felt like an Angel for us. He wrote back and said he wouldn't go THAT far.

Now he is that Angel.

I cannot imagine what his wife and family are going through. My thoughts and prayers are with them. The ME/CFS community stands beside them just as Rich stood by us and we weep with them knowing what a deep loss to thousands (and more) of people this is and knowing that Diana and the rest of his family are suffering a loss so heart breaks for them.

Wednesday, September 19, 2012

Oops! Forgot the Title!

I'm laying here listening to a most beautiful piece of music. After being approved for SSDI in 2010 I treated myself to a really expensive set of headphones ($300). Music and visual images of beauty are moving as well as inspiring to me. It was well worth the expense at the time. I'm grateful I did it because now I can't afford shit.

It's been a difficult month-no surprises there. After much reflection and tears I made the heartbreaking decision to give Chelsea to the owners of the rescue organization on the condition that she not be adopted out again. I haven't been able to write about it, or talk about it until the past few days. Chelsea needed more care than I could provide. Her quality of life wasn't good.

Now she's with the people she bonded with and who saved her life 3 years ago. They love Chelsea, have a beautiful house, beautiful land. And she'll have access to free weekly vet care. The owner of Homeward Bound said "I will keep Chelsea with me until she takes her last breath". So Chelsea is home and has a much better quality of life. Heck her quality of life is way better than mine is.

I have the usual me/cfs stuff going on. Daily low grade fevers starting in the afternoon. I'm having unusually bad fatigue of a different type. I'm wondering if I'm anemic. I've been having more bleeding episodes (today included) so I've started searching for a surgeon. I've been at the maximum level of hydrocortisone and still bleeding which sucks.

My weight is the lowest its been since before high school. When I saw the GI doctor last month they weighed me. I was expecting to have gained weight so I was surprised to see that I'd lost 6 pounds. I don't have a clue as to how to put weight on anymore.

I'm looking for a hematologist or immunologist to treat my immune deficiency. I can't afford to buy the supplements my doctor wants me to take. I'm supposed to be taking Researched Nutitionals Tranfer Factors LymPlus and Transfer Factor PlasMyc. They cost about $85 each. I'm almost out of them. I'm also taking Colustrum but can no longer afford that either.

I'm concerned about not being able to take immune support supplements anymore. They don't improve my functioning but they prevent me from getting worse. The treatment I need is IVIG or... hmmm....I can't remember the name of the other one. I found a better link for CVID (Common Variable Immune Deficiency)-I wonder if a lot of us aren't misdiagnosed. This paper talks about how it can lead to chronic infections (obviously), inflammation, autoimmune conditions, lymphoma....sound familiar?

The fact that I'm having night sweats, daily low grade fevers, weight loss, lack of appetite, fatigue, chills, etc...says that I need more intensive treatment. I feel like I'm slowly losing my battle to maintain this level of functioning. But I'm fighting for every ounce of functioning I can squeeze out of this body.

People have probably heard about the results of the Lipkin study concluding no link between me/cfs and xmrv/pmlv. Again, no surprise there. For anyone interested in reading about it here are a couple links: Lipkin and Columbia (youtube video of press conference).

Even though deep down I know there isn't a single cause for ME/CFS I was still hoping for one because then it would be easier to treat. Lipkin believes in the perfect storm theory. I think he may have even used that term in the press conference. It's a term I've used to describe the events leading up to me getting sick. From the article on prohealth:

Instead of a single cause, Lipkin pointed to "the three strikes theory” which suggests that genes, environment and timing all conspire to create ME/CFS - and referred to animal studies showing that early events can set the stage for problems years later.

While leaving the viral question open, Lipkin suggested the body’s response to viruses may play a larger role than the viruses themselves. People with ME/CFS could be reacting abnormally to normal levels of a virus; or a virus could kick off a chronic response and then completely disappear - leaving a dysregulated system behind. 

One focus in the future will be to analyze proteins in the blood to find aberrant pathways that can be targeted by drug therapies. In this scenario, which may be the quickest to produce results, the ultimate cause of the disorder is bypassed, at least early on, in an effort to uncover problems that drug therapies can attack. 
The results of the Norway study along with all this are pointing to problems with B cells (to put it quite simply) at least for a subset of us. I know I'm in the infectious/immune subset of ME/CFS patients.

My blood was in that study. I'm eager to get the results of the gene expression and pathogen study that Stanford is also doing on me/cfs patients. We had to do a follow up questionnaire recently.

I had to stop Cymbalta because it completely set me back as far as bleeding and my colon. It's bad again. I'm desperately looking for a good psychiatrist. The depression is back.

But its the isolation that is killing my spirit. It's brutally lonely.

I've been trying to find some way to meet people within my narrow energy envelope. It hasn't worked out so well so far. I'm hoping and praying that tonight I can show up to a study group on finding meaning, myth, and the sacred. It starts tonight and meets only 1x per month. I've been wanting to find some sort of meaning in the midst of all that has happened these past 5-6 years.

There's a lot more to write but I'll stop here...wishing you all much peace