International experts speak out against the IOM contract to determine clinical diagnostic criteria

1. In my opinion, the CFIDS is not an organization that represents the ME/CFS community. I've been reluctant to say anything to date but must step in memory of Tom Hennessy RIP whose phone in memorial service is today at 4:00pm EDT. 1:00pm PDT. He would have spoken out concerning this issue.
2. The huge salaries the corporate executives receive is appalling when there is very little funding for ME/CFS research from this organization. This in of itself, raises a Red flag with me.
3. Their rating with Charity Navigator is only 2 stars and their financial rating of 39.70 is another big flag http://www.charitynavigator.org/index.cfm?bay=search.summary&orgid=6512
4. What have they accomplished over the last twenty years or more?
5. Their lack of using scarce resources for critical research is big in my books
6. Their lack of timely and proactive communication with the ME patient community is another. Their web site has outdated information and current information is seriously lacking.
7. I am puzzled on what they accomplish in their day to day operations. It took me only 2 days to get a researcher on board, fund research on a major discovery back in 2009.
8. There is no accountability, no review process based on their performace. Having been a management consultant within worldwide organizations of Fortune 100 companies at the excutive level, I do have a bit of insight into this matter.

Tom Hennessy was very forthright in stating advocacy issues and problems concerning efforts with lobbying Congress, in an interview he gave to Cort Johnson on here. Tom being his usual self told it like it is and his account is accurate. As you know, there are powerful forces arrayed against the ME/CFS and similar patient communities from the health, medical, disability insurance industry and the APA. His father was a lobbyist for Getty Oil so he had first hand knowledge and expertise on how things were run on the 'Hill'

As I stated in an earlier post, Congress is in sequester. Funds are tight. The National Debt is at an all time high. Top research labs across America are facing extreme shortages in funding for critical research projects.

To educate the patient community on how things are really run in Congress, I will make a few things clear. I had a close relative who was at the highest level of a former Presidential administration for eight years afterwards he was a lobbyist on the 'Hill'. If someone came to him with a specific request, all he had to do is make one phone call. The head of whichever department he called would jump into action to make sure his order was carried out.

The influence to get bills proposed, bills supported and passed are unfortunately based on how much money and how much influence special interest groups can provide Congressional members for their relection campaigns. These members are wined and dined, taken on special junkets to get the ear of members of Congress to press for legislation that will benefit their particular interest group or oppose legislation or funding that would be detrimental to their interests. Favors are called in on behalf of these groups. There are hundreds of lobbyists for each interest group working full time for their cause. Many were members of Congress who have many friends in Congress.

This is how the system works. The special interests groups arrayed against various patient communities are formidable. Hundreds of millions of dollars are spent per annum on Congressional lobbying by these groups. www.opensecrets.org

Unfortunately, the ME/CFS communities do not have the funds to lobby Congress successfully for their cause. Behind the scenes, the system is in place on how DHHS will treat this illness. The CFSAC annual meeting is more or less a HSS dog and pony show. All one has to do is look at the demeanor, attitude and questions asked by these officials and the acomplishments of the board over the last few decades.

The action of HHS to award a contract to define the criteria of this illness by esteem members and representatives of the IOM, is ludicious. We have seen the IOM results of the treatment criteria on the GWI to know the outcome for ME/CFS. It is disheartening at best, considering the fact that the veteran organization consisted of a very powerful lobbying group.

Based on his knowledge and experience, Tom knew the best formula or strategy to counteract the lobbyists and special interest groups on the 'Hill'. It was to form a broadbase coalition group to represent those patient communities that have a difficult time in obtaining research grants. Mikovits attempted to tie these groups together. I believe that the correct strategy to use is to form a broad based coalition among chronic, neuroendocrine, and autoimmune patient communties.

I also believe that future funding will have to be provided by donations from private foundations and patient organizations.

Eco

Yes Ecoclimber , we need a broad based coalition for very specific goals. I was going to blog on this, but all my blogs have been on hold till more of my brain comes back online. Such a group would not try to do everything for every disease, but would focus on common elements. It would give us more numbers, more power, more money, and more people who can think and act without going into a meltdown. If such a group had an online information source that was comprehensive and accurate, it would then counter spin from organizations like the SMC.

I know Debbie and Glen Hutchins are very busy with their non profit organization trying to raise funds for CFS, since they are directly effected by this disease.

I know they are well versed in the disease and they obviously (or was) of considerable financial wealth. I wonder if they would be interested in being our voice on Capital Hill and present the funding that they have put for forth privately and what it has been able to achieve with what Dr. Lipkin and group has already found which is an obvious constant immune and inflammation attack on our bodies. Hopefully this would help in obtaining additional federal funding.

What information that Dr. Lpkin and the CFI can get in front of this IOM group, if we can't stop it might prove to be a good thing in their conferences to develop a disease definition. I know Dr. Lipkins name was on letter sent to Ms. Sebillus.

Just a thought that took me 2 hours to write this little bit and I'm sure the wording is probably wrong, but put parts of it in your own words and a lot more may possibly come out of it.

I appreciate all of you very much and I don't think I would still be alive if it wasn't for all of you. Thanks

Thank you for spending your valuable energy writing this post.
Dr. Lipkin was NOT one of the signatories of the letter though. Maybe you left out the "not" I do stuff like that all the time. No worries either way.

It would be nice if doctors who are and/or have been involved in ME/CFS and did not sign because they were not contacted in time/able to reply in time, or were not contacted to sign for whatever reason, would follow up as Dr. Lilly Chu did -- w/ a letter of their own supporting the position of the other physicians. ( See thread "CFIDS Association asking expert signatories....." for her letter.
If you know how to contact any doctors and/or researchers ( no matter how big or little their involvement w/ ME/CFS ) who did not sign to ask them to write a letter -- even just a couple sentences stating their support -- that would be wonderful.

I'm not sure what the time line is on this IOC endeavor is, but it would be nice if CFI and Dr. Lipkin could publish at least the portion of the studies that indicate cytokine and chemokine activity that indicates immune system and inflammatory systems being constantly active with a unique indication of change at approximately the 3 year mark. While there is a change it doesn't indicate a change towards healing and the activated immune system is still in place along with activated inflammatory system. My professional opinion would lead me to encourage not using treatments such as biofeedback, acupuncture, St. John’s wort, aerobic exercise, motivational interviewing, and multimodal therapies As this could in turn harm the patient instead of help them. The 2 day exercise test that has been used to establish PEM has already proven the effect on energy within the mitochondria continues to wane long after completion of the first day of exercise, therefore making use of a 1 day exercise test a complete waist of funding money, but also the patients and researchers time. A decision to use a 1 day study when the support for the 2 day study is supported by the patients shows a total lack of managerial and supervisory skills.

Did Dr. Lipkin make any statements as to when they were going to test the house/bedbound patients samples. I know he said they had came up with a way to get the samples by use of "house nurse" if that's the right words. I would be real interested to see what their various samples turn up.

I sure wish Dr. Lipkin would have signed the letter, but he is busy. I'm also concerned about the funding getting to them with the government shutdown in place!?

It's been posted elsewhere, but is well worth a read:

Jennie Spotila's latest blog with the Statement Of Work from HHS to IOM detailing the Contract.

HHS and IOM contract - New Strategies
The main lesson from all of this is the American political system (and European political systems) is based on money, campaign contributions, lobbying and wealth centred networks. This sets the agenda and pre-determines all outcomes. The proof of this lies in the fact that our emails, letters and phone calls to Congressmen and Senators and to the HHS Secretary and to NIH and CDC were ignored and fobbed off. It is now very obvious that HHS Secretary Sebelius has been briefed for the last few weeks and months by "advisors". The agenda of these "advisors" is not entirely clear yet. But extrapolation from the Gulf War committee of the IOM gives us some clues. It strongly suggests, but does not conclusively prove, that these "advisors" desire a certain outcome. One which reduces payment liabilities for health insurance companies (to ME patients), reduces government payments for diagnostics and treatments (for ME patients) through Obama-care, reduces government disability payments, maintains the income and bonuses of psychiatrists and psychologists, maintains their somatic syndromes nonsense, increases profits for big (psychiatric) drug companies, and one which continues the lie first formulated by Dr. Straus and then continued by Dr. Reeves of CFS being a so called "fatigue illness", thus preserving the reputation of the NIH and CDC and preserving the careers and status of those in the NIH and CDC. Self interest at every level.

To achieve their desired outcome these "advisors" have conducted their affairs in secret behind the backs of CFSAC and patients and ME / CFS organisations. They then lied about the IOM contract. The "advisors" have adopted a divide and conquer approach ; this was successfully used to build empires in the past. This divide and conquer approach works as follows. They will recruit 1 or 2 ME doctors / researchers and enlist 1 or 2 representatives of one or two big ME organisations in the USA. They will form a small minority on the IOM panel. The IOM will use them to claim that the IOM is inclusive and open to the views of patients, when in reality they will be used as traitors,. The others on the panel will be carefully selected and will all be "yes men" and be told informally that their careers will depend on supporting the "right outcome". The IOM will claim that these people are "independent". They will represent a few fields including immunology, neurology, psychology, psychiatry and physiotherapy and primary care nurses.

The "investigation" itself will be guided carefully by IOM. This guidance will proceed in a certain direction - psychiatry based. As part of their "investigation" they will look to Britain and see whats happening there. The NICE clinics will be examined. CBT and GET will be included in the IOM's "analysis". They will ignore the scientific evidence into the biological causes of ME / CFS and claim there is contradictory evidence, no biomarkers, and no replication studies to verify anything. The "investigation" will presume that there are no biological treatments for ME / CFS and especially no "evidence based" treatments based on double blind placebo controlled trials. How convenient for them that NIH and CDC refused research funding in this area and the FDA blocked certain medicines for ME / CFS. From this they will decide that nothing can be done for ME / CFS patients and that CBT and GET offer the best way to "manage symptoms". The new definition will be a regurgitation of the Fukuda criteria with some some vague language about possible (though not proven) immune dysfunctions, possible (though not proven) infections at some stage of the illness and possible subgroups, with recommendations for further research, which of course will not be funded. The final outcome, which was determined before the investigation began, will be much the same as the vague, psychology centred "multi-system illness" invented for Gulf war syndrome.

The objectives of Secretary Sebelius' "advisors" will be achieved ; this being
an outcome which reduces payment liabilities for health insurance companies (to ME patients), reduces government payments for diagnostics and treatments (for ME patients) through Obama-care, reduces government disability payments, maintains the income and bonuses of psychiatrists and psychologists, maintains their somatic syndromes nonsense, increases profits for big (psychiatric) drug companies, and one which continues the lie first formulated by Dr. Straus and then continued by Dr. Reeves of CFS being a so called "fatigue illness", thus preserving the reputation of the NIH and CDC and preserving the careers and status of those in the NIH and CDC. Self interest at every level.

(Show this to Dr. Lucinda Bateman)

Hermes, this is superbly written and to me totally convincing--many thanks. I can only add a reminder of the statements that Dr. Unger at the CDC apparently made, to the effect that GE was "non-negotiable," and her point blank refusal to consider a two day exercise test, which might make GE look rather unconvincing. I wonder if anyone told her off for almost blowing the cover off?

I can also add a remotely analogous situation here in Canada that is still ongoing; Health Canada, a government bureaucracy, "regulates" the level of permissable RF and EMF emissions via something called Safety Code 6, which is up for a mandated review. So they announce with fanfares that the task will be given to an "independent" entity, the Royal Society of Canada, "because they have stringent conflict of interest policies." They, like the OIM, are to be the cover. It turns out that the committee first chosen by the RSC contains several members who appear on Health Canada videos defending the status quo, and decrying or denying that there is any research showing damaging biological effects below the thermal level--totally untrue. A fuss was raised, and as of now 3 members, including the chair, have stepped down and been replaced. A Freedom of Information request also revealed that Health Canada intended to control the committee very tightly, providing their own very limited choice of documents to be considered, and so on. Despite the embarrassments we caused them, I have no doubt at all that the "fix is in," and that the result will be a simple endorsement of the appallingly lax current "regulated" allowance. There is too much money at stake in the cell phone and "smart" meter businesses to allow the mere ill health of a few hundred thousand humans to interfere.

I suspect that there are many of these "indpendent" and rather mysterious organizations that exist largely to give a cover of independent verification to prearranged decisions. I have the highest regard for Lucinda Bateman--wish I had access to her as my doctor--but fear she may have been misled; I can only hope that her good will and expertise will have a positive effect on the IOM deliberations. Chris

This is something I am worried about. Should the CDC not use a 2 day CPET test, our best test, should the IOM produce a report similar to what it did for GWS despite all our advocacy, then we need to get behind backing our researchers with independent funding. At that point only the advancement of the science will help.

So why does the CDC refuse to use a 2 day CPET? Their stated reasons are blatantly ludicrous.

However if we can stop or mitigate these HHS failures, then we might have restored some reason into this whole process.

I totally agree!

Not exactly sure I understood all your points. But I will say that Fukuda, Reeves, Oxford and NICE are doing a huge amount of damage every day. CCC is obviously vastly superior to all of them, especially the latter three which are just laughable. This is why HHS must adopt CCC immediately. Of course, CCC can and should be improved on, but for now, lets please focus on getting CCC adopted ASAP.

I would also ask that anyone who is a patient of or knows anyone who writes journal articles, whether reviews or on their original research, please ask them to use CCC (in addition to, if they want, Fukuda).

Thanks for considering.

Wonderfully said!

Right!

And I'll add that:
- there is zero funding for Rituximab trials, or even inexpensive studies on the link between rare cancers and ME!

- the CFSAC meeting this fall has been switched to a tele- or video- conference and had the time for the meeting cut in half supposedly because of budget cuts. I am actually in favor of videoconferencing (at least some of the time) since it eliminates travel time and expenses, however, cutting the meeting in half is unacceptable- they can't even afford a few more hours of videoconferencing and yet they can afford this insane IOM contract?

And we don't know, it could be more. I searched for cost of IOM reports. The only record I could find was of the nine reports done on GWI up to August 2002, which averaged $1.826M each. (Plus a report on geographic differences in health care which cost $8.5M)

And Im very curious why these reports cost so much if the committee members volunteer all their time, the IOM is a non-profit with a development department and a $62M donated endowment and they sell the reports for around $40 in hard copy (though you can download for free). Of course there is staff and other overhead and panelists' expenses are covered, but still $1-1.8M seems very excessive.

I certainly agree we need more research on biomarkers. And good evidence of some exist now, perhaps to the point of including in a definition. However, we need the damage caused by Fukuda, Reeves and Oxford ended NOW, which means adopting CCC immediately and then working on improving with biomarkers.

The fact is, HHS IS the enemy because they made themselves the enemy by consistently persecuting us over three decades. That doesn't mean we shouldn't engage with it and it doesn't mean there aren't a minority of people there who are working in good faith for/with us.

Eco, great post. I totally agree- except for the last sentence.

I thinks it will help us to unite as much as possible, both within the ME community and with others similarly situated to ourselves such as GWI, Lyme, etc. patients.

I think we do need to engage private foundations more, just like CAA does to get almost all of its funds. Also, in soliciting private individuals, pleas for medical research are the best, I think. When it comes to patient contributions, however, I strongly feel that all of our money should be going to lobbying congress (and parliament, if it works the same in the UK). We, as patients, with our great disability, will never be able to adequately fund research on our own. However, Congress is able to get NIH to spend the hundreds of millions we need per year on biomed research and congress is also able to whip CDC's CFS program into shape so it helps us, rather than greatly damages us. ALL else can and will flow from that.

Current trends in the US government lead me to suspect that rather than moving toward a model and treatment of ME and CFS that would benefit us, the government is moving to a contain and manage model (and this is a cyclical process). This is being driven, again only suspicion, by hardline economic ideas that do not solve problems, just limit them in the short term. They then try to contain the problems for as long as possible. With us that has been half a century.

Here is something I posted elsewhere recently:

The US government has ALWAYS had a contain and manage model when it came/comes to mecfs. We had brain scans showing punctate lesions similar to those of AIDS patients, MS patients and those with Alzheimers, way back in the early 90s. To me, the only question that remains is WHY? What are they trying to hide or avoid?

In the 80s, Japan called this illness the Low Natural Killer Cell Disease.

Dr Peterson has been using low VO2Max scores and Natural Killer cell tests to diagnose for decades.

Various doctors and researchers have shown mitochondrial damage, immune system damage, unusual response to exercise, etc, etc, etc.

All this physical evidence has been around long enough for anyone who is truly interested in the science to understand that this is not a psychosomatic illness. And yet the CDC has used money sent to the Viral and Rickettsial Diseases branch to fund fake research purporting to prove the illness is caused by childhood sexual abuse and/or inappropriate response to stress, two ideas that are preposterous on the face of it. Why would any scientist interested in the scientific answers that are needed spend scarce resources on bogus research like this unless they had been ordered to do so by those above them in the chain of command? (I suspect this is the reason Dennis Mangan didn't last long at HHS. He is/was too principled to do the bidding of the hidden hand so he had to retire early and is now on our side as a private citizen.)

Sending this illness to the Women's Health closet is another example of how they have tried to marginalize and disappear this illness. Pretending it only happens to women when it is plain to see it affects men and children as well is just another tactic used to dismiss the reality and substitute the myths the US government has dedicated its power and money to.

There are a lot of dots to be connected over the last 30-some years. They add up a continued effort to misinform, disinform, denigrate, ignore, disappear and/or bully patients and researchers who don't go along with the program. Any one of these dots might be thought to be simple stupidity, sexism or economically motivated, by itself. But the dots make a pattern that implies malice, not just stupidity or lack of understanding.

That our real experts (there are no "outside experts") have spoken up is hugely important. They are taking real chances with their futures in research and in medicine. The least we can do is stand up for them and stand behind them.

Management strategies are not new. What is new is the degree that this one might go. These things are cyclical. During economic crises many in government go looking for targets to slash costs. There was GWS, and now its us. This may not stop with a new definition, or just new treatment recommendations like do nothing, get therapy, exercise, and refuse tests. The US could easily go down the same path as the UK, ignore the science, promote their own unproven ideas, and deny even more to patients. The situation in the US, or anywhere for that matter, is not good for ME patients. It could be about to get a whole lot worse.

The other thing is this is business as usual. The US has been in economic decline for three to four decades now. In large part I think this is because of economic policy. They slash budgets for the wrong things, privatize the wrong things, and fail to invest in things that will make a difference. Its not just me saying that, I read commentary to this effect quite often now, sometimes from leading economic academics.

Its not just the US though. Our new Prime Minister is planning to do things that I think will damage Australia's long term interests. This is driven by two things. Debt and misplaced and disproved economic dogma. Four decades of economic dogma will not die just because its pushing the world toward global economic ruin.

The US is a special case right now due to extreme government debt. There are forces to push budget slashing. They don't care particularly about disabled people, and will slash the budgets that we and others need for research into cures. They also resist changes to healthcare that will deal with rising costs, and refuse to deal with excessive military spending, or to raise taxes. The US is its own worst enemy, and its the American people who suffer most.

Rising disability and health costs are not contained by denial. That leads to medical and social debt, and hence other costs to society and government. Any problems that are getting worse and not being addressed will cost more and more over time. Eventually there will be crises that cannot be denied, covered-up or dismissed. The cost for fixing them then may be very much more than the cost of doing something now.

We have indeed been ignored for nearly four decades now. It started in 1970, in the UK, with an academic hypothesis that ME was mass hysteria. The US followed through the 80s culminating in the definition of CFS in 1988. The CDC then pursued this further, and the Oxford definition was created. Around two decades of research using the Oxford definition has sidelined real advances, and given us no treatments that cure or increase objective functional capacity.

Psychiatry is one of the sacred institutions. It needs an overhaul and to be dragged into the 21st century. Yet I don't think this is going to happen, not universally.

We do need to support our researchers though. We also need to support, and be supported by, other groups that have been targeted or are likely to be targeted.

Very well written and sadly all too true. Beyond ME/CFS are incredible challenges to global economy and "healthy" societies --- re: social policies, government corruption and policies that undermine the original intent of their respective constitutions, public apathy ( if it doesn't effect someone directly they are less and less likely to get involved or even care. ) , and on and on. It can really get me down.
But how can I dive in and help w/ all that when I am chained to my bed ?
There is too much short term investment for votes , then in long term investment that will make a difference.
For our health ( get these people well and back to work is better than paying disability -- if one only views economically)
and an investment in basic science opens up avenues for so much well being of the entire planet.
medicine, climate changes, social policy, hunger, agriculture, pollution, energy, etc....
Invest in us will also help other illnesses down the road, just as we benefit from research into medical research that has come before.
It's all about votes and power and greed.
what happened to integrity ?

But then I come here, or find other groups of people on the net. Strangers who are hungry to do good deeds.
They are out there. It warms my heart when I hear of it or witness it. And I have many times.
If we could only bottle that.