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A patient responds to NIH request for input

With respect to ME/CFS, the NIH has a long history of asking for such advice and then ignoring it

Recently the NIH issued a Request for Information (RFI) to help identify research areas and topics to be included in strategies to advance research efforts on ME/CFS. Unfortunately, with respect to ME/CFS, the NIH has a long history of asking for such advice and then ignoring it.

Patient advocate Gabby Klein appraises the current issues between the NIH and ME patients rather succinctly in her response to the government agency below. — Russell Logan

For the past three decades, ME stakeholders including patients, advocates, medical experts and CFSAC members have given countless recommendations as to what should be studied to enable scientific progress for the disease.

This was done in the form of working groups, CFSAC meetings, written and oral communications from patients, advocates and medical professionals. None of these recommendations were acted upon. Instead, we have seen the creation of yet more NIH working groups.

So now, yet again, we are being asked for our input. In all honesty, the time for more words is long over. While NIH is busy talking more and more brave ME patients are dying prematurely from this disease and new patients are being diagnosed every day. The urgency is dire – we need action now!

Emerging needs and opportunities that should be considered as new ME/CFS research strategies are developed

  • Replications of past significant studies. There are over five thousand peer reviewed scientific studies that have been published in journals on ME. They have not had a major impact because most were small due to funding restrictions and in need of large scale replications. These include studies showing disruption of the immune system and neurological deficits. Biomarker studies such as two-day CPET exercise testing. low NK cell function and Rnase-L enzyme dysfunction. These studies need to be replicated in a grand scale.
  • Studying patients from the Lake Tahoe, Nevada outbreak. These patients were at ground zero. After all, it was following this outbreak that this disease was re-defined and re-named. Since then, because of the poor name and criteria, the patient cohort has become muddied and have included many who do not suffer from ME.
  • Pharmaceutical studies on currently used treatments. These include Ampligen, Rituximab, low dose low dose Naltexone (LDN), anti-virals and IVIG therapy.

Challenges or barriers to progress in research on ME/CFS

  • Lack of NIH funding. This is and has been the greatest barrier in meaningful research for this disease. It has resulted in few and especially small scale studies without any replications. We need an increase of $243,000,o00 just to get us on par with similarly burdened diseases. This is not taking into account that our need is even greater than those other diseases since we currently have no officially accepted biomarkers nor any FDA approved treatments. Without an increase of this scale, we have no hope of advancing science to the level that is needed to bring hope for a treatment or cure to ME patients.
  • Use of the wrong cohort. Using the government constructed criteria such as Oxford, Reeves and Fukuda has been an impediment to scientific advances. These criteria are overly broad and include people who do not have the ME. They include patients that actually suffer from other illness or patients who just suffer from ‘fatigue’. We have strict criteria developed by our international ME experts, the CCC and ICC – we should use them.
  • Studies based on psychiatric and somatization theories. Studies based on these misguided theories are not only a waste of time and money, they have been the cause of harm to patients. Some have been permanently damaged based on these studies. (PACE). See above for what should be studied.
  • Rejection by NIH of applications for impactful biomedical studies. Among many other respectful ME experts, scientific giants such as Dr. Lipkin and Dr. Davis have had their proposals rejected. The NIH employees who evaluate study proposals for research in ME are not knowledgeable about the disease and therefore are not capable to make a fair and accurate decision on which study proposals to accept. ME experts should be evaluating these applications

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FEATURE PHOTO: Rapid Riffle Shuffle in a Poker Game by Todd Klassy

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Written by Gabby Klein

Wife, mother, artist and advocate fighting for the rights of ME patients. In 2003, my career in insurance management came to an end when I became disabled with myalgic encephalomyelitis.

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  1. I wrote to the NIH informing them that they very well know what the original object and purpose of the syndrome is, and to feign ignorance is deliberate negligence.
    Of course they did not respond.
    I had absolutely no expectation that they would.
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    “Studying patients from the Lake Tahoe, Nevada outbreak. These patients were at ground zero. After all, it was following this outbreak that this disease was re-defined and re-named. Since then, because of the poor name and criteria, the patient cohort has become muddied and have included many who do not suffer from ME.”

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