NIH Sidesteps Critical Problems with the ME/CFS Study

[duncan]

Yes, @jamie.

The Lyme studies are relevant. They are possibly suggestive of how the NIH has acted, and continues to act.

Incidentally, the four RCTs could be interpreted as just three, and at least two of those three did show improvement.

Still, there were inescapable flaws, and an apparent willingness to ignore the outcries of patient advocacies. The arguable result may be upwards of 60,000 Lyme patients each year who remain ill after conventional therapy fails them, many of whom are shunned by insurance carriers and medical establishments.

The ME/CFS community would be unwise to imagine that it is insulated from the same sort of shenanigans.

 

[Valentijn]

Walitt, Saligan, and Gill are obviously completely inappropriate choices by the NIH. They have blatantly psychosomatic views of ME/CFS, and cannot be trusted to select patients appropriately nor to treat them appropriately.

The bigger threat is probably Hallett and his team members (Maurer and Horovitz), since they have a somewhat more subtle approach than the psychobabblers mentioned above, and Hallett has more seniority and presumed support from Maurer and Horovitz. They are almost certainly the driving force behind the FMD control group, which is thankfully gone, but I have no doubt that will do whatever they can to create or twist the data in a manner which supports their theories.

But the biggest threat is methodological flaws. There needs to be statistical power, and that means 1 control group, not 3.

 

[Nielk]

The blog written by MEadvocacy is a detailed account of the problems with the NIH study and with the way NIH communicates with the patient community.

It outlines problems with the ever changing criteria, the biased investigators and advisor, miscommunication by NIH and the community mistrust as well as additional problems with the design of the study. Each section enumerates the problems followed by corresponding ways that NIH can correct those problems.

One problem for example is Dr. Unger, virologist at the CDC. She has had a biased view of ME/CFS and was an author of the Reeves' criteria. She went on to do dubious studies on "CFS" like the one about childhood abuse causing "CFS" and the one that states that maladaptive coping styles of "CFS" patients contribute to the pathogenesis and maintenance of the disease. Dr. Unger is on the executive advisory committee for the NIH extramural study.

Excerpt:

"Dr. Elizabeth Unger, CDC virologist, focused many of her studies and presentations on fatigue and the mind/body theory as she explained in this CFSAC video clip (posted by advocate Khaly Castle). As co-author of the Reeves' criteria, Dr. Unger explained in this video how her agency applies the criteria when asked by Eileen Holderman, former CFSAC Member, how CDC plans to reconcile the case definition issue. In the NIH study, Dr. Unger has been assigned to the executive committee and charged with reviewing diagnostic validity of the patient cohort. At the February 16th CDC Grand Rounds, Unger promoted graded exercise therapy (GET) and cognitive behavioral therapy (CBT), which is also promoted by the PACE Trial, for which ME experts have warned against as causing harm to patients.

Below are just a few studies Unger has been involved in:

• Acute Psychosocial Stress-Mediated Changes in the Expression and Methylation of Perforin in Chronic Fatigue Syndrome.
  
  
• Coping styles in people with chronic fatigue syndrome identified from the general population of Wichita, KS.
  
  
• Early Adverse Experience and Rihttp://www.meaction.net/2016/03/31/meadvocacy-nih-sidesteps-critical-problems-with-the-mecfs-study/sk for Chronic Fatigue Syndrome"

 

[Undisclosed]

This thread is being closed briefly for moderation purposes.

Please note, we have removed a large number of posts that were either off-topic or rule breaches or both. The off-topic posts were related to private emails sent to the NIH etc. These posts are not going to remain deleted. There are some rule breaches that need to be moderated. A new thread with the remaining deleted/edited posts will be started later today so the very interesting conversation can continue.

Please stick to the topic of this thread -- discussion about how to make the NIH study better which will affect all of us.

 

[Undisclosed]

The new split thread can be found at the following link: http://forums.phoenixrising.me/inde...ls-to-the-nih-good-or-bad-split-thread.43866/