Home > Advocacy > CFSAC Testimony May 2013

CFSAC Testimony May 2013

May 22nd, 2013

I submitted two versions of testimony to the May 22-23, 2013 CFS Advisory Committee meeting. My written testimony can be viewed here.  What follows is the testimony I delivered by telephone this morning:

My name is Jennifer Spotila, and I thank my fellow advocates for being there in my stead. My comments today differ from the written testimony I submitted last week, because there is new information that I must bring to your attention.

First, the FDA Drug Development Workshop put an exclamation point on the need for more research in order to accelerate the identification of effective treatments for this disease. Unfortunately, not only is our government failing to fund research commensurate with the burden of illness, but funding is decreasing at an alarming rate.

Last year, NIH projected that it would spend $6 million on ME/CFS in 2012. But when I totaled the spending for the grants linked to the ME/CFS category in NIH’s Estimates of Funding for Various Research, Condition and Disease Categories, I found that NIH actually spent just over $4.5 million. This is a decrease of almost $2 million or nearly 30% from 2011 spending.

Let me repeat that for emphasis. NIH funding for ME/CFS research in 2012 dropped by nearly 30%.

But it is worse than that. Three of those grants are unrelated to ME/CFS. These grants comprise 18% of the 2012 total. If we remove those grants, the total spent by NIH drops to just under $3.7 million.

Let me repeat that for emphasis. NIH funding for ME/CFS research in 2012 was just under $3.7 million.

Whether you use NIH’s total of $4.5 million, or you use my adjusted totals to remove unrelated grants, this is an unacceptable drop of nearly 30% from 2011 funding levels. Is this what the Obama Promise looks like? NIH funding for ME/CFS research is at its lowest level since 2008. Do I really need to repeat that for emphasis?

We are not alone in seeing a decline in funding from 2012. Of the 235 disease categories listed on the NIH site, close to 30% show a decrease from 2011 (although only 11 other categories saw a decrease of 20% or more). But this means that almost 70% saw an increase in funding, so I do not accept the excuse that times are tough.

Dr. Maier has said many times that there are not enough applications coming in. She is right. Approximately 20 ME/CFS applications were submitted to NIH last year. Obviously, such a low number of proposals will not get the job done. At the same time, NIH has invested set aside funds for other conditions in order to stimulate research. For example, the MAPP initiative for chronic pelvic pain that you have heard about at prior meetings started with $40 million in funding set aside by NIH. The RFA process exists to promote and encourage research into areas of need.

To be perfectly frank, I am tired of the chicken and egg debate of which comes first, the money or the larger number of proposals. Here’s a novel idea: do both at once. Advocates, organizations, and researchers should do everything in their power to encourage more proposals, and NIH should pony up dedicated funding. Try both and see what happens.

How can we be positive about change, as Dr. Jones said this morning, in light of these numbers? This is a crisis situation. I do not accept a 30% drop in funding. I do not accept plummeting backwards to 2008 funding levels.

The second issue I must bring to your attention is the High Priority Recommendations List that you will be asked to approve this afternoon. Less than 30 minutes has been allocated for this discussion, and my information is that you will be voting on the original list as drafted in January 2012. I am sorry to say that this is patently ridiculous. If you allow this, you will be approving a list that is 18 months old, that includes none of your recommendations from 2012, and that includes two recommendations that have already been completed. Furthermore, the wording of several recommendations have been altered from the original versions, and you will be making this decision without hearing any of the public comment scheduled for tomorrow.

If you go along with this, you are telling the patient community that designating high priority recommendations is a formality not worthy of meaningful discussion or even the slightest effort to produce a current, up to date list. I ask you, Committee members, to move this discussion to Thursday afternoon so that you can devote the attention and consideration that this document deserves. If you do not, then I ask you to vote NO and not approve the list in its January 2012 form. We deserve more than formalities. Thank you.

 

  1. Rivka
    May 22nd, 2013 at 17:01 | #1

    GREAT stuff. thank you for saying all this. what type of response was there? any?

    • Jennie Spotila
      May 22nd, 2013 at 18:24 | #2

      Actually – and I was surprised – they announced after lunch that they would move the Priority Recommendations discussion to Thursday afternoon! It also sounds like there will be discussion of more than just that original list.

  2. Gloria
    May 22nd, 2013 at 17:39 | #3

    Well said! Until when we have to wait?

  3. Melissa
    May 22nd, 2013 at 19:04 | #4

    I was surprised they moved the Priority Recommendations discussion to Thursday as well. Well done, Jennie.

  4. May 22nd, 2013 at 20:07 | #5

    I testified once. It was a big waste of time. The one upside was that I got my testimony on video, so that I could send it to the Press. It has gotten me published 14x on 4 continents now.

    Why do patients keep trying to work with the system, as though it’s something logical, rational, and humane? If the government wanted CFS & ME to be fixed, it would have done so 20 years ago.

    Government-funding will never solve a government-censored illness. The solution to CFS & ME lie in private money, and non-government funded science.

    As for the FDA, just google “Who owns the FDA?” and you will understand why this insanity has become our reality. FDA has no plans of helping CFSers. They never have, and they never will. You want proof? Just read Chapter 8 of this book (WRITTEN IN 1993!) about Ampligen –> http://fms-help.com/aids.htm

    I submit that this video should be the new *theme video* for the CFS & ME community:

    “HEY LOOK KIDS…. THERE’S BIG BEN, THERE’S PARLIAMENT AGAIN. (1-minute)””

    http://www.youtube.com/watch?v=iAgX6qlJEMc

    BUCK THE SYSTEM. STOP FUELING IT!

    RESISTENCE, REVOLT, & REVOLUTION ARE HISTORY’S ONLY PROVEN SOLUTIONS!

  5. LC
    May 22nd, 2013 at 21:49 | #6

    @lemonfoundation

    It’s important to try to engage where/ when we can because

    1) Never refuse a seat at the table when you’re offerred one. You at least then have a CHANCE of doing something and government can’t say, “Look, we tried to help but they refused.”

    2) Like Jennie, I have had my suggestions taken into account. Although the CDC website is far from perfect, they did make changes based partly on comments various people submitted.

    3) It could be worse. Without testimony and engagement by patients, researchers, and clinicians, we could be in the same situation as the United Kingdom, where graded exercise therapy and cognitive behavioral therapy are the only covered treatments. It’s easy to say there’s not enough change but it ‘s hard to see what was potentially prevented.

    4) Documentation. Even if nothing happens now, documenting what the government did wrong or ignored and having it posted on a government website means they can’t deny they didn’t know what was going on. It’s also a good way to refer media to a testimony — “Look, it’s on the gov’t website!” If it isn’t documented, it didn’t happen.

    Also, engaging with the gov’t doesn’t mean you can’t do other non-gov’t related activities.

    Finally, as someone who has done research with and without government support, government support is still very important. Most foundations/ private money cannot support the multi-year projects that researchers want to do, even if foundations play a role in providing initial funding. Also, private money often comes with more strings attached than government money. There is a role for both. It should be noted that contrary to pharma and other claims, the majority of drug breakthroughs are still primarily funded by government. Drug companies moslty only get involved when a drug has been well-developed enough by government money in academic labs to warrant pharma to step in. I have no illusions pharma is in it to help people; they’re in a business to make money. If people are helped along the way, that is secondary good.

  6. May 22nd, 2013 at 23:36 | #7

    LC :@lemonfoundation
    It’s important to try to engage where/ when we can because
    1) Never refuse a seat at the table when you’re offerred one. You at least then have a CHANCE of doing something and government can’t say, “Look, we tried to help but they refused.”.

    I could not disagree more; The government can keep their seat and their money too. Because both are 100% useless to the patients.

    As I stated in my federal testimony last year:

    “Over the past 9 years, after opening my private foundation, I got the White House to open an investigation, Senator John Kerry to forward my case to the head of the CDC, and the U.S. Global AIDS Coordinator to forward my case to the NIH/NIAID.

    Amongst other things, my blood has been to the CDC-Atlanta (twice) and to the Washington-DC pathology labs. I have sat on conference call with the American Red Cross. Facilitated by the United Nations, I have been out of the USA (twice now) to meet with a Nobelist and his colleagues to provide blood samples.”

    “INSANITY IS DOING THE SAME THING OVER AND OVER AGAIN, AND EXPECTING DIFFERENT RESULTS.” Einstein

    When will CFSers learn to stop acting like *the system* is logical, rational, and humane and instead start marching/rolling in the streets ACT-UP/OCCUPY style?!

    “THE PEOPLE UNITED WILL NEVER BE DEFEATED!”

    • Jennie Spotila
      May 23rd, 2013 at 08:15 | #8

      When I did more reading into the HIV/AIDS movement, instead of relying on my personal and flawed memories of that time, I was very surprised to learn that for every person in an ACT UP protest there was at least one other person walking the halls of Congress or joining meetings at FDA. If those people had not been there, the movement’s overall success would not have been as great.

      This is why I have invested the time and energy into the FDA Patient Rep program. We need people to work in the system while others push the system.

      Readers of this blog know I am a vociferous critic of CFSAC. But what really worries me is how bad things would be without it. What would happen if NIH and CDC did not have to justify themselves on the record twice a year?

  7. floydguy
    May 23rd, 2013 at 08:31 | #9

    What was your take on Unger’s statement that they were only looking at doing a one day exercise test? I find it hard to believe that she is considering that unless:

    - CDC is trying to scuttle proper testing
    - Clinicians are saying we can’t do a 2 day exercise test for thousands (millions?) of patients to make a “proper” diagnosis
    - Insurance companies are saying we won’t pay for that
    - Medicare is saying we won’t pay for that (despite what they say about being cost agnostic)
    - Unger still doesn’t get it; she thinks a one day test with a new improved questionnaire will be “close enough”

    I don’t think we should let that go quietly in the night until it’s clear what the reason are.

    • Jennie Spotila
      May 23rd, 2013 at 08:53 | #10

      I was flabbergasted by that discussion. How could she have never talked to Chris Snell? She just saw his presentation at the FDA meeting! And her statement that the clinicians in the study didn’t want to do it seemed weird because Staci Stevens does testing in Kogelnik and Peterson’s offices. I think most of your proposed explanations could be factors, including reimbursement and the lack of need for two day testing for these specialists to diagnose. But I emailed Chris Snell last night to give him a head’s up about the conversation, and I’m sure that I’m not the only one!

  8. floydguy
    May 23rd, 2013 at 09:08 | #11

    Thanks for sending the note to Chris Snell. I don’t know much about FOIA but I wonder whether it might be possible to get CDC notes about the interactions with these clinicians or maybe other things?

    I totally agree with you about CFSAC. As you can guess, I am not a fan either but it does force Unger et al to show and at times be uncomfortable. There is a possibility that they may slip up and reveal what’s really going on or what they’re really thinking. I think it should be encouraged to have more rough and tumble direct questioning and discussion. A lot of the other things going on like the endless Medicare presentation should be reduced or eliminated.

    • Jennie Spotila
      May 23rd, 2013 at 11:12 | #12

      I think the notes of discussions with clinicians would probably be withheld under FOIA under the internal advice exception. It might be easier (and certainly faster) to talk to the clinicians about it.

  9. LC
    May 23rd, 2013 at 12:45 | #13

    @floydguy

    Insurance and Medicare should not be involved, cost-wise, in most medical studies. When researchers ask for money, the cost of all testing should be taken into account and not have to be paid for by insurance and Medicare. The exception is that if the patient develops a problem during a study, say a heart attack that is unrelated to the trial, their insurance or Medicare will need to cover them the same as if they had a heart attack and was not in a study. This is federal law. If the study does not cover specific testing or other costs, that is usually told to patients up front, like the “cost recovery” trial for Ampligen, where patients have to pay for Ampligen themselves.

    It’s also possible they were worried about the adverse effects of exercise testing and whether subjects would be put off by it but I wouldn’t be too sure about that given CDC’s questionable understanding of PEM. In fact, Dr. Snell’s group have shown that many people affected by CFS and able to do it want to do exercise testing to get a sense of their illness.

    RE: Jennie’s point about HIV activists. The reason why the psychiatry manual DSM hasn’t listed homosexuality as a “deviant disorder” that needs treatment since the 1970s (it did pre 1970s) is because while people were protesting about it outside of the psychological circle, a group of gay psychologists within the American Psychological Association worked for years to overturn it. So there’s a need for “inside” and “outside” voices.

    RE: Medicare. That talk is important for the many, many CFS patients that rely on Medicare, Medicaid, and even private health insurance to cover their testing and treatment. Private health insurance is influenced by Medicare. There are many tests and treatments that are helpful but not covered by insurance. This means that even if the doctor orders a test or treatment, patients can’t get it due to cost. Knowing the process of how Medicare makes decisions means clinicians, researchers, and patient advocacy groups can work together to get coverage for appropriate testing and treatment.

  10. May 23rd, 2013 at 15:41 | #14

    Jennie Spotila :When I did more reading into the HIV/AIDS movement, instead of relying on my personal and flawed memories of that time, I was very surprised to learn that for every person in an ACT UP protest there was at least one other person walking the halls of Congress or joining meetings at FDA. …Readers of this blog know I am a vociferous critic of CFSAC. But what really worries me is how bad things would be without it. What would happen if NIH and CDC did not have to justify themselves on the record twice a year?

    CFSers’ have a lot to learn about what needs to be happening (in the streets and in the govt meetings), because the last two decades (i.e., since the Gulf War) have not proven successful from any advocacy efforts.

    Two award-winning documentaries:

    http://surviveaplague.com/
    http://houseofnumbers.com (90 min: http://youtube.com/watch?v=BwgmzbnckII)

    I got my public library to buy copies of both to put in their general circulation. I like when our tax dollars actually buys something beneficial to humanity.

    P.s. – I am living proof HIV is not the cause of AIDS, which is why Luc Montagnier has been so interested in my blood. I blogged for several years about my plight.

  11. floydguy
    May 23rd, 2013 at 16:37 | #15

    Jennie Spotila :
    I think the notes of discussions with clinicians would probably be withheld under FOIA under the internal advice exception. It might be easier (and certainly faster) to talk to the clinicians about it.

    Maybe but I am not sure I trust all Clinicians.

  12. floydguy
    May 23rd, 2013 at 17:37 | #16

    @LC

    If 2 day exercise tests became critical for research purposes, it seems entirely possible that it would become important for clinical diagnosis – at least for a while. It’s easy to see people saying we can’t have a two day test costing thousands of dollars as a screen for ME.

    It seems like an exemption for extremely ill people should be possible. Perhaps with extensive documentation, other lab testing, personal letters and evidence that they are strictly housebound. For others, I think they should have to deal with an exercise if they want to get an official diagnosis – assuming that the 2 day test is proven to be the ultimate marker.

    re: Medicare

    There are lot of things that are important but it seems that discussion could take place mostly offline. The problem as was stated in the meeting is the diagnosis of “CFS” not the testing itself. I am well aware of the issues as I end up paying out of pocket for a lot. I’d prefer the focus be on root cause issues rather than getting into endless debate over how NKC function and 40 other important tests should be covered.

    The other reality is that there are only a handful of MDs who do these tests anyway so a majority of the people can’t get them done even if they were approved by insurance. My experience is that it is best not seeing an MD that doesn’t know what they’re doing. They’ll likely prescribe something that makes your condition significantly worse.

    Out of the estimated 1MM with “CFS” how many are on Medicare?

    The way forward is to get at root cause and prove there is a “real” disease not figuring out the best ways to sneak around getting various tests approved – that quite honestly don’t have a lot of science or evidence that can be done with the results. So for example I have really low NKC function. I can take Inosine on my own but can’t take Ampligen so at the end of the day what is the point? Outside a handful of people in the ME world nobody gives a hoot that I have low NKC function.

  13. Dr. Dave Hatfield
    May 27th, 2013 at 02:02 | #17

    lemonfound said “CFSers’ have a lot to learn about what needs to be happening (in the streets and in the govt meetings), because the last two decades (i.e., since the Gulf War) have not proven successful from any advocacy efforts.”

    If you consider Gulf War Illness one of the CFS/ME diseases, which most do, advocacy efforts from both outside and inside, as those have been described in this discussion have been extremely successful in many regards. Laws have been passed forcing the VA to recognize GWI as a service-connected illness, to make it so that people with the illness showing up years after the war or their service has ended can still prove service connection, laws that have added specific diseases and the description of undiagnosed illnesses with any of a number of different symptoms (similar to those many CFS/ME patients express), and much more.

    Public awareness campaigns through the press have been successful in drawing attention to the problems, and working directly with VA and Congress have added to those successes. One without the other would not have been as successful, I don’t believe. Capturing both kept pressure on Congress to do what needed to be done. In the end, only working the ‘outside’ piece will never get laws passed or make the bureaucrats move. There has to be some inside work done to make those things happen as well.

    Dave

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