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P2P Spin

June 12th, 2014

spinstopsListen carefully to the agency updates at the June 16th CFS Advisory Committee meeting. Updates on the P2P Workshop and systematic evidence review may sound reasonable, but I suspect that hidden within will be some spin-doctoring to deflect our concerns about (and criticisms of) the P2P Workshop. So let’s just get it out of the way right now. Here are some possible spin arguments, and my responses.

The P2P Workshop is responsive to the CFS Advisory Committee recommendation to hold a meeting on case definition.

No, it is not. The recommendation was for a meeting to devise a clinical and research case definition. NIH has said that the P2P Workshop is expressly NOT devising a case definition.

ME/CFS experts are participating in every phase of the P2P Workshop.

Every phase except the one that really matters, and the expert participation is marginal. For example, there are twenty people on the P2P Working Group (that met in January to plan the meeting), but only five of them are ME/CFS experts. The full Working Group only meets once, if it follows the pattern of other P2P meetings. We don’t know how many experts are on the Technical Expert Panel (which helped with the protocol for the evidence review). The experts who will speak at the Workshop? Yeah, we don’t know who they are either. And the group that really matters is the P2P Panel and by design, NO experts whatsoever will be on that Panel. Ask yourself: would you have accepted an IOM committee with no ME/CFS experts on it? Then why is it ok for P2P?

Don’t worry, the P2P Panel of non-ME/CFS experts is just like a jury.

No, actually, it is nothing like a jury. For one thing, juries are selected in public, with both sides of a case having the opportunity to question potential jurors and move for their disqualification. The P2P Panel? Selected by NIH, behind closed doors, with no transparency for how they are screened for bias or preconceptions about ME/CFS. That’s like letting the prosecution choose a jury before anyone walks into the courtroom. Furthermore, this “jury” will make decisions based on an evidence base and field that is controversial, confusing, and laden with bias. No jury would ever be cast adrift in such murky waters without multiple layers of guidance and experts to assist them.

The systematic evidence review is the best methodology out there.

This may be true, although there is certainly controversy over the value of evidence reviews. But the issue is not the methodology. The issue is the study protocol that will be used to apply that methodology.  I’ve already documented the multiple concerns with the protocol, beginning with the failure to ask if the case definitions capture more than one disease. Beyond that, remember that the evidence review is the PRIMARY source of information for the Panel of non-ME/CFS experts. If the review doesn’t ask the right questions, then there is little chance that the Panel will do so at the Workshop.

The P2P Workshop will cover more than the Key Questions as stated in the evidence review protocol.

I’m hearing this already from several sources, and I have three objections. First, the draft agenda documents follow the evidence review questions very closely. And if you compare the key questions and agenda for the P2P Opioid meeting, you will see that they match. Second, even if it is true that the Workshop will cover additional questions – where are those questions? Why is there no transparency about the content of the Workshop? If there are additional topics being covered, then NIH should release that information immediately. Third, if the evidence review does not include some of the questions, then how can the Workshop adequately cover those questions in the absence of the evidence report?

The Workshop will cover ME/CFS, not medically unexplained fatigue.

Then why is the evidence review covering studies on patients with fatigue and no underlying diagnosis? Why does the draft meeting agenda describe the overview section as “Overwhelming fatigue and malaise as a public health problem”?

Our experts and the public will be able to refute anything that goes wrong in the systematic evidence report.

The calendar matters here. The evidence review, conducted and written by a contractor with no ME/CFS expertise, will be published in draft form six weeks prior to the Workshop. At the same time, the contractor will present the evidence review to the P2P Panel (also with no ME/CFS expertise) in a three hour closed door meeting. The two groups of non-experts will discuss the evidence report. Not a single expert will be in the room to point out anything that went wrong with the review. So technically, yes, the public can comment on the draft evidence report. But in reality? The non-expert Panel may never see those comments and even if they do, they will assess the comments after spending three hours discussing the non-expert report with other non-experts.

reality-marketing-no-spinOur experts will be able to provide all the necessary information at the Workshop meeting.

The speakers may have been suggested by the Working Group (only 25% of whom were ME/CFS experts), but the final agenda and speakers are selected by NIH. Each speaker has 20 minutes to talk about their assigned topic. There is time for discussion on the agenda, but we don’t know how it will work. Will the non-expert Panel control discussion with questions? Will there be an open mike that gives experts and patients an opportunity to point out everything that is wrong with the evidence report? We don’t know. Remember, the non-expert Panel takes the evidence report (which they review for 6 weeks) and the Workshop (which lasts 1.5 days and is controlled by NIH), and then they have to turn all that information around and in 24 hours produce a report with recommendations on the future directions of research, case definition, and possibly treatments.

To put this challenge in context, remember the 2011 State of the Knowledge meeting? That was a two day meeting and all the presenters were ME/CFS experts. The summary of research gaps and opportunities was presented by Dr. Suzanne Vernon with the Director of NIH, Dr. Francis Collins, in the room. And what has happened at NIH for ME/CFS research since then? An RFA? Nope. A strategic plan? Nope. Engagement with stakeholders, increase in funding, fair grant review? If a two day meeting of ME/CFS experts that provided input directly to the Director of NIH could not fix any of these problems, then a panel of non-ME/CFS experts using a flawed evidence review and 1.5 days of presentations of experts and non-experts combined will be facing a very steep climb to deliver a strong set of recommendations after 24 hours of discussion.

We should be glad NIH is paying this much attention to ME/CFS.

So any attention is good attention? No. In this case, attention in the form of bad key questions and the framing of the problem as “overwhelming fatigue or malaise” could be very damaging and counter-productive. The conclusions and report of the Panel of non-ME/CFS experts will shape NIH policy. NIH will put a media relations push behind the report. We will be stuck with it for some time to come.

Opposition to P2P is just nay saying and complaining.

As I’ve extensively documented here and in the letter to Dr. Collins, there are legitimate concerns that this process will not produce recommendations that move the field forward with the best of what science can offer. To dismiss these concerns as complaints or negativity is, quite frankly, disrespectful of the advocates who have taken the time to express them. Give my concerns a fair hearing. Then let’s talk about whether the P2P Workshop is the best way to collaborate with the ME/CFS research and clinical community. Anyone who thinks we’re whining or overreacting has not actually read the material submitted to Dr. Collins.

Don’t worry. We’re NIH and we know what we’re doing.

Even the most qualified scientist can get it wrong. Even the purest motivations can lead to mistakes. I’ve written before about the problems of mistrust and disrespect in the ME/CFS landscape. NIH should not tell us to just trust them. NIH should be demonstrating that it is safe and appropriate for us to trust them. Based on what I’ve documented about P2P thus far, they have not done so.

 

  1. Mary Dimmock
    June 12th, 2014 at 10:19 | #1

    This is very well done, Jennie.

    The number of serious issues here is stunning – especially this comment
    “But If a two day meeting of ME/CFS experts that provided input directly to the Director of NIH could not fix any of these problems, then a panel of non-ME/CFS experts using a flawed evidence review and 1.5 days of presentations of experts and non-experts combined will be facing a very steep climb to deliver a strong set of recommendations after 24 hours of discussion.”

    The other serious issue for me is the question of the scientific validity of comparing diagnostics and the benefits and harms of treatments across ME and CFS definitions when we know that those definitions do not describe a set of biologically related conditions. The failure of the evidence review to even ask if the definitions being compared represent the same disease is an insurmountable fatal flaw.

  2. Claudia Goodell
    June 12th, 2014 at 11:20 | #2

    This is the section that describes the part of the process giving me the greatest concern:

    ” The evidence review, conducted and written by a contractor with no ME/CFS expertise, will be published in draft form six weeks prior to the Workshop. At the same time, the contractor will present the evidence review to the P2P Panel (also with no ME/CFS expertise) in a three hour closed door meeting. The two groups of non-experts will discuss the evidence report. Not a single expert will be in the room to point out anything that went wrong with the review. So technically, yes, the public can comment on the draft evidence report. But in reality? The non-expert Panel may never see those comments and even if they do, they will assess the comments after spending three hours discussing the non-expert report with other non-experts.”

    and

    “…the final agenda and speakers are selected by NIH. Each speaker has 20 minutes to talk about their ASSIGNED topic. There is time for discussion on the agenda, but we don’t know how it will work. Will the non-expert Panel control discussion with questions? Will there be an open mike that gives experts and patients an opportunity to point out everything that is wrong with the evidence report? We don’t know. Remember, the non-expert Panel takes the evidence report (which they review for 6 weeks) and the Workshop (which lasts 1.5 days and is controlled by NIH), and then they have to turn all that information around and in 24 hours produce a report with recommendations on the future directions of research, case definition, and possibly treatments.

  3. rivka
    June 12th, 2014 at 11:22 | #3

    so grateful to you for all this work and the energy it took. — rivka

  4. Ess
    June 12th, 2014 at 14:29 | #4

    It’s all been SPIN from the get-go–and this is the culmination of it with the P2P arm of the IOM contract. It’s all BOGUS. The(ir) goal–HHS, NIH, CDC–has never been to ‘help’ ME/CFS patients.

    This exercise is completely ludicrous–and it is just what TPTB do–put forth funding (marginally so) for psyche projects and fatigue across the board for ME/CFS–which is what the IOM contract and P2P are all about–none of this has anything to do with the complex biological disease of ME/CFS.

    It is completely BOGUS. It is a further exercise in SPIN and B.S.

  5. Ess
    June 12th, 2014 at 18:13 | #5

    More . . . P2P–Pathway to Prevention of getting to the biological truths of ME/CFS and, therefore, prevention of effective treatments for the millions of people worldwide with ME/CFS–our lives stolen from us–not only from the debilitating disease of ME/CFS–but from TPTB–i.e., HHS, NIH and CDC in the U.S.–in cahoots with contracting to the psychobabblers in the UK–Wessely, Sharpe and White–to ‘psychiatrize’ ME/CFS as a psychological disease and as broad-based ‘fatigue.’ These are all lies and everyone knows it; ME/CFS is a complex debilitating ongoing disease.

    Pathway to Prevention–as such described above — there is not now nor will there be a stoppage to preventing the ongoing spread of ME/CFS and associated lymphomas–same infecting agents implicated–and this is only the ‘tip of the iceberg.’

  6. Anne
    June 13th, 2014 at 06:20 | #6

    Jennie- You might as well call me the Nurse who is now the ROWDY Patient!

    I waited like everyone else, hoping by now, thinking we would have treatment like the HIV AIDS patients and I too, like many others, spent 6 figures on off label meds for over 10 years, thinking, well no problem, we will have meds, get treated, and get back to work.

    I was mistaken like the rest of us who did that as we all ended up broke!

    I was also quiet, because I was watching. But now, its time for the Medical People with this illness to come out and advocate, because we know how to speak their language.

    Not that the advocates didn’t, advocates did a great job. The medical people know all of the legalities that these agencies have basically gotten away with, pulled the rug over our heads with, and gave us that lip service, which will be an asset to the advocacy cause because of all of the injustice done.

    Well! No more lip service from these people! We are done with their lip service!!

    And, we need to watch some of our own “so called” experts!
    Im sure that is no secret, just to make a note of it!

    The P2P for ME Review, is as NEGLIGENT as the 1994 Fukuda Definition.
    This time, we can NOT let this go!
    That Fukuda Definition has kept us in a 30 year hell because of the deceptive way it was written.

    The P2P for ME Review is clear negligence, has major bioethical violations, and non disclosure issues regarding those Non Medical lay people who are supposed to be the jury!

    Quite frankly, patients aren’t criminals, they do not stand in front of juries!!! That’s basically going back to a Dr Mengele style study were the patients did not get a fair trial.

    What makes NIH Negligent regarding the P2P, is they hired a group to write that review, who had no idea what they were doing, they did not have the review proof read and certainly did not check their work, If they did, they would’ve clearly seen, that GET should not be used because of the 3 VO2 Max research studies that were done by 3 different research teams in 3 different centers, and published before this review, And all had the same results- basically saying GET is harmful to ME patients as ME patients do not recover normally from post exertional activity, but abnormally and much longer.

    I am stating it that way, because I am looking at this through RN eyes (I had to put the nurse cap back on for this and start thinking like an RN again), and through RN eyes, it is absolutely, clearly negligent, with bioethical violations, and WILL BE HARMFUL TO ME PATIENTS, ME PATIENTS WILL CONTINUE TO SUFFER THE SAME HARM!

    Remember, Malpractice cases are won because of irreversible damage! It has to be irreversible damage otherwise everyone would be suing for something.

    If as an RN, if I worked in a center were patients came for GET therapy, and saw that a patient had ME, and didn’t question the doctors orders, double check the data since it was new data to see if it was correct data, and didn’t stop the patients from doing that GET therapy- Then the patient would crash, go home, go to bed, never get out, and become permanently disabled, irreversible damage because of that GET therapy….

    I then would get sued, everyone who worked in the center would get sued including the doctor. It does not matter what that GOVT criteria says, if the patient suffers irreversible damage, becomes disabled, that would be equate to a medication error doing the same thing. Not only I would get sued, but I would be reported to the nursing board who would revolk my license because of the patient becoming permanently disabled from that therapy or treatment.

    This type of case, wouldn’t even go to court, the malpractice lawyers would get their lawyers to settle out of court because of the amount of evidence there is regarding the harm of GET therapy as their lawyers would want to keep this quiet, so no one is embarrassed!

    I know someone who that has happened to, a top notch nurse with 30+ years experience, and it was a mistake involving a decimal point being in the wrong spot of the dosage calculation, one spot over, for a new IV drug, that the pharmacist should’ve calculated. But because the pharmacist didn’t calculate the drug, because the pharmacist trusted this particular nurse who made that unfortunate accidental error, resulting in the patients death! She not only got sued, she actually resigned because she was beside herself, never recovered from that. She also turned in her RN license, she didn’t fight it,

    Well, if we allow this P2P for ME to proceed, we will not only going back 30 years to Incline Village, but we will going back another 40 years to Auschwitz Germany. Auschwitz Germany is where Dr Mengele set up his patient experimentation and eugenics clinic. Mengele was judge and jury, Patients did not get a fair trial as I mentioned above!

    P2P for ME is noting but a modern day version of Dr Mengele’s work! No question about that!

    We need to Request a Bioethics Review- from the @NIHClinicalCntr Christine Grady RN Chief of Bioethics, AKA Dr Fauci’s wife as well as one from another known bioethics person or bioethics group.

    No one should fret about it being Dr Fauci’s wife! Because she has malpractice insurance, and NIH covers her for Malpractice. She is also licensed by the State Board of Nursing in Maryland where the NIH is. She has no choice as she is an RN, and she has to look at ALL of the evidence! She HAS to admit there will be patient harm when she sees the evidence!

    It can become a very very uncomfortable situation, for her, for NIH, and for Dr Fauci, if we have to report her to the State Board of Nursing, as well as every nursing org in the country, and to every bioethics person in the country- they all are on twitter- very very easy find them!
    So, she would have more than one place to deal with!

    No more nonsense, no more psychobabble, no more lipservice, no more pulling the rug over our heads,
    ANE NO MORE SHAM DEFINTIONS WITH SHAM SYMPTOMS!
    WE MEAN BUSINESS!!!!!

    I will say this, this is the first time, this past year, that I have seen all of the patients do something, everyone is participating in some way in the 20 years I have been getting treatment. Even if they think what they are doing is something small, it all adds up, and its great!

    We can do this!!! :)

    • Jennie Spotila
      June 13th, 2014 at 08:14 | #7

      I know I’ve said this before in another context, but I will point out again that there are readers of this blog who lost family members in the Holocaust. I would greatly appreciate it if everyone could avoid drawing parallels to Auschwitz, Dr. Mengele, etc. out of respect for the other readers of this blog. This should be a safe place for people to read and comment on the issues. Thank you to everyone for your cooperation.

  7. Chris Heppner
    June 13th, 2014 at 13:59 | #8

    Jennie, this is a terrific piece–many thanks again. The case against EBM as used in this context is very strong, and we have the evidence of earlier EBM studies of CFS to back this up. But what can we do other than protest? You and others have written good letters to NIH, now Solve CFS has also written a critique–do you think anyone at NIH is really listening? Wouldn’t it be great to get Snowden to leak internal memos and documents about the setting up of this crazy scheme?

    But thank you again for researching this and laying it all out for us to see.
    Chris

    • Jennie Spotila
      June 13th, 2014 at 16:43 | #9

      Is anyone at NIH listening? Oh I wish I knew.

  8. Gabby
    June 13th, 2014 at 19:22 | #10

    They might be listening but, are they hearing?

  9. kathy d.
    June 13th, 2014 at 23:39 | #11

    Thanks for your excellent post, as usual, the points and responses. For those of us with ME/CFS brain fog, it is incredibly helpful to see this — and of course, it makes a lot of sense.

    Thank you also for your comment about the Holocaust. While I didn’t lose relatives in Europe, part of my family fled anti-Semitic pogroms in Russia, and as a child I knew adults who had been in camps.

    Those of us with ME/CFS are misunderstood, mistreated, demeaned, ignored and a lot more. But all of that is not equatable with the horrific anti-human crimes committed against Jewish, Roma, Polish, and many more peoples, including children, many with disabilities. These were crimes that most of us would never even think of.

  10. Ren
    June 17th, 2014 at 14:27 | #12

    There seems to be an ongoing and very serious bio-ethics discussion among some doctors, researchers, lawyers, academics, advocates, etc which does accuse governments of crimes, including human rights abuses, against people who are ill, including people with ME/CFS:

    “It is rare for citizens to try to take their government to court, and even more so for a Western European government to be taken to the International Criminal Court (ICC) in The Hague… It is alleged that the austerity measures introduced by Greece’s government constitute peacetime genocide and crimes against humanity… The social impact is stark, with the number of suicides estimated to have doubled… ‘they [the elderly] too are dying because they don’t have medication…’”

    “‘Genocide involves intent. Surely you can’t be suggesting that the Greek government actually intended these consequences?’”

    “Tanya replies: ‘To substantiate how something is done intentionally you must show that not only did they know of the consequences but they were willing to have the consequences,’ she says.”

    “‘And we can prove they knew the extent, they knew the severity and not only were they completely fine with it, but they actively opposed all other solutions.’”

    http://www.bbc.com/news/world-europe-17811153

    [Greek] Officials have denied that vulnerable groups…have been denied access to health care…

    However, the scientific literature presents a different picture. In view of this detailed body of evidence for the harmful effects of austerity on health, the failure of public recognition of the issue by successive Greek Governments and international agencies is remarkable.

    Indeed, the predominant response has been denial that any serious difficulties exist, although this response is not unique to Greece; the Spanish Government has been equally reluctant to concede the harm caused by its policies…

    This dismissal meets the criteria for denialism, which refuses to acknowledge, and indeed attempts to discredit, scientific research…”

    http://www.enetenglish.gr/resources/article-files/piis0140673613622916.pdf

    “It has become socially acceptable to ridicule, demonise and denigrate the disabled, both in public and in the mass media…It is the aim of this group [a UK, persons w/ disabilities advocacy group] to monitor these resurgent and deeply troubling developments and campaign against unacceptable attacks on the dignity of the sick or disabled human being, whenever and wherever they arise…”

    http://blacktrianglecampaign.org/about/

    “…[Danish] counties are shoving somaticaly-ill patients into functional disorders [aka mental disorders, according to a Danish source], because there are treatment options within psychiatry and the citizens are then stuck with the lowest level of social welfare so the counties save money on expensive flex-jobs and early disability pensions… She (Karina Hansen) has been incarcerated, forcibly treated, forcefully detained…by the psychiatrists… The treatment Karina is given…is contraindicative to the WHO guidelines and to human rights.

    Her fate is known all over the country and has resulted in the fact that no one with the diagnosis of ME dares to let themselves be hospitalized out of fear of being detained by the research clinic as lab rats…” – Danish physician Stig Gerdes

    https://www.facebook.com/JusticeForKarinaHansen

    Danish lawyer Keld Parsberg compares Danish patient “treatment” for functional disorders, as propagated by Per Fink, to be akin to tactics used in the McCarthy-period and that of the USSR legal courts.

    http://forums.phoenixrising.me/index.php?entries/per-fink-hated-part-i-vi.1602/

    “In 2001, the American Journal of Bioethics published an article by Warren T Reich [Professor Emeritus of Bioethics] from Georgetown University who reported on an inquiry into ideas that were used to justify the shift of medical ethos… Reich…considers the evidence in relation to the current ethos of care of the sick and the manipulation of that care:

    “To develop an adequate ethic for the healthcare professions, we need to look more deeply into the sentiments and commitments of healthcare professionals…namely, physicians’ attitudes and the state’s attitudes towards care… Major responsibility for medical care shifts to the state, while the rationale for receiving care depends more and more on the individual’s contributions to the state….”

    http://www.investinme.org/Documents/Library/magical-medicine.pdf

    While modest strides in ME/CFS care continue to be made in Sweden, in 2012 the Swedish government said the Swedish health authorities would not investigate negligence, etc related to ME/CFS bc there weren’t enough people with this illness for the State to spend money on it.

    http://www.svd.se/opinion/brannpunkt/en-vardskandal-i-det-tysta_6938371.svd

    Consider as well – rationed hospital beds, emergency rooms, ambulances, ambulance services, wait times resulting in deaths and severe injury, suicide, elderly neglect, etc.

    I never doubt that my health, my life, my family’s future was rationed away in order to fund a “more worthy” social end, to feed academic egos, and line someone’s pockets. There seems to be an epidemic of healthcare brutality.

  11. Ess
    June 17th, 2014 at 22:55 | #13

    @Ren
    This is very serious, indeed, and not to be dismissed and/or taken lightly. Thank you for providing this information and these additional examples, Ren; you are good at fact finding.

    In first world countries in the 21st century . . . this arrogance and abuse of power is very very frightening. There is an element of toxic distorted mentality/mindset at work in destruction and erosion of human rights AND human lives. Speaking up results in intimidation, threats, bullying and dismissal as to being on committees, etc. if you speak up against–in truth. These ‘goals’ of TPTB are bringing out the absolute worst in human behaviour towards human kind. This is NOT acceptable; it is far from acceptable.

    AND–we are right in the midst of some this distorted mindset and MALtreatment–30+ years held captive/prisoner with ME/CFS as a patient community with NO meaningful treatments; our lives rotting away–and they/HHS et al have amped up oppression and discrimination against/towards this illness–towards citizens with ME/CFS– by ramming in the IOM contract and the P2P. And they want/EXPECT us to smile and go along with this destruction of our lives. If the tables were turned–what would THEY do? I think they’d fight for their lives!!

    Remember–the ME/CFS Experts and Researchers advised against this–STOP the IOM. They know, like we do, how wrong this IOM contract and P2P is–how against the truth this is–how destructive to human life.

    This is treachery at work here. Let us not fall for guilt trips and manipulations with HHS’ agenda–and the people delivering it; EYES WIDE OPEN.

    Denial and inaction (on our) part will only allow this oppression against a very seriously ill community to continue and take over–and all the while the disease continues to spread–this is a travesty of the worst kind. It IS criminal!

  12. Anne
    June 17th, 2014 at 23:51 | #14

    @Ren
    You can take you government to court and you can win too.
    I know a lawyer who has done it and won the cases.

    I do believe we will see that happen in this case because
    there is proof of harm!

    That P2P is the most negligent thing I have ever seen.
    I know, I have actually been an RN since 1985, I knew it was negligent as soon as I read
    it and I have actually been corresponding with an ARHQ person about it since
    the day it was published online May 2nd 2014.

    More medical people with this illness need to come out of the woodwork,
    because we know how to speak the language.

    Let me be quite frank,
    these people that have been assigned by NIH, etc.. to anything regarding our illness,
    are not too intelligent and if you look up their curriculum vitaes, some of them do
    not even have hands on experience with patients, they went right to the lab to
    do research.

    Every university that has a medical school has a bioethics department,
    they do reviews and consultations and most of them have people on call 24/7.

    This “spin” they think they are doing, isn’t going to spin forever, the turntable
    is going to stop.

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