Petition: Stop CDC from hiring shoddy contractor for ME treatment guidelines

[Hutan]

I'm not sure if the petition page has changed recently or people are looking at something different, but I see this:

Sign this petition to demand that the CDC not issue this contract, put the project on hold, and meet with #MEAction immediately to assure us they will:

1. Create a TRANSPARENT and COLLABORATIVE approach to future guidelines for ME/CFS,
2. Not repeat the same mistakes when dealing with the challenges that still exist, and
3. Include expert practitioners, who actually work with patients, in any process that recommends treatments

I don't see any significant problem with the wording including of item #3. There are some treatments for symptoms - pain relief, sleep aids, POTS treatments - as well as correction of any identified nutrient deficiencies or thyroid issues, feeding tubes and mobility aids if required - that aren't controversial.

The petition isn't specifically calling for experimental treatments to be included - just some involvement of clinicians who regularly work with ME/CFS patients. That might mean, for example, talking with Workwell about how sensible GET is.

Edit - oh - I've seen this now on the petition page:

6) As a direct result, treatments for ME are known to the small number of expert clinicians but do not appear in the literature. No systematic review that is limited to the published literature can capture how this disease is currently treated.

Yeah, that is a problem.

 

[Hip]

I'm not comfortable with the 'are known' if we don't have any good evidence to support what is claimed to be known.

It's quite possible for doctors who treat patients day in and day out to have personal knowledge of the efficacy of those treatments; but that knowledge is not ratified and broadcast to the wider medical community until good quality clinical trials are performed.

I am not saying that every doctor who believes his treatments work is necessarily correct. Some may be fooling themselves about the efficacy. But this is why clinical trials are important.

 

[Andy]

I'm not sure if the petition page has changed recently or people are looking at something different, but I see this:




I don't see any significant problem with the wording including of item #3. There are some treatments for symptoms - pain relief, sleep aids, POTS treatments - as well as correction of any identified nutrient deficiencies or thyroid issues, feeding tubes and mobility aids if required - that aren't controversial.

The petition isn't specifically calling for experimental treatments to be included - just some involvement of clinicians who regularly work with ME/CFS patients. That might mean, for example, talking with Workwell about how sensible GET is.

Yeah, they've halved their number of points, compared to how it read earlier. As I say upthread, I didn't have issues with any of the original points except the one I quoted

6) As a direct result [of insufficient funding], treatments for ME are known to the small number of expert clinicians but do not appear in the literature. No systematic review that is limited to the published literature can capture how this disease is currently treated.

which I was worried had the potential to allow all kinds of unevidenced treatments in, desirable or not. I'm glad to see that #MEAction has had a rethink.

 

[Esther12]

It's quite possible for doctors who treat patients day in and day out to have personal knowledge of the efficacy of those treatments; but that knowledge is not ratified and broadcast to the wider medical community until good quality clinical trials are performed.

I am not saying that every doctor who believes his treatments work is necessarily correct. Some may be fooling themselves about the efficacy. But this is why clinical trials are important.

Like you say, it's possible they've found something effective, it possible they're just fooling themselves. It's impossible for us to know which, so it's not a good idea to say that it is known.

 

[Hutan]

@Andy, sorry I have confused things. I really shouldn't post when I am in a hurry.

I was quoting the MEAction link described in the initial post as 'full text'. The items 1 to 6 with the problematic #6 appear on the petition page.

 

[Andy]

@Andy, sorry I have confused things. I really shouldn't post when I am in a hurry.

I was quoting the MEAction link described in the initial post as 'full text'. The items 1 to 6 with the problematic #6 appear on the petition page.

I don't blame you, that was the page that I've been looking at as well. Hopefully then they intend to amend the petitions description.

 

[Tom Kindlon]

There were real problems with the last review done by the Pacific Northwest Evidence-based Practice Center, and I seem to remember a really poor response to criticism. I'm surprised we're only just hearing about this plan for the CDC to use them on ME/CFS again now.

I remember being irritated by this response, which seemed to try to act as if patients were frustrated with them for being too rigorous - I just skimmed through the comments submitted by Tom Kindlon and others, and to me the reviewers seemed to indicate that they just didn't know what they were doing.

"Although we cannot experience the condition as a patient would, we included patients and experts as members of our technical expert panel, and strove to attend to their areas of concern and guidance as we prepared our report. It is however, our responsibility as independent investigators to strictly report on evidence that is currently available using a pre-defined and structured systematic method."
https://effectivehealthcare.ahrq.go...chronic-fatigue_disposition-comments-2015.pdf

Yes, it was frustrating how they used the Work and Social Adjustment Scale for employment measures and didn't actually use the proper data. And then ignored the comments I made on this:

Tom Kindlon
Assistant Chairperson of the Irish ME/CFS Association

Methods

The Work and Social Adjustment Scale is not valid as an employment measure (or work impairment) and should not be used given actual employment data was reported for some studies.

Here are the questions that make up the Work and Social Adjustment Scale

Mundt JC1, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale:a simple measure of impairment in functioning.Br J Psychiatry. 2002 May;180:461-4. http://bjp.rcpsych.org/content/180/5/461.long

Work and Social Adjustment Scale

Rate each of the following questions on a 0 to 8 scale:
0 indicates no impairment at all and 8 indicates very severe impairment.

1. Because of my [disorder], my ability to work is impaired.
0 means not at all impaired and 8 means very severely impaired to the point I can't work.

2. Because of my [disorder], my home management (cleaning, tidying, shopping, cooking, looking after home or children, paying bills) is impaired.
0 means not at all impaired and 8 means very severely impaired.

3. Because of my [disorder], my social leisure activities (with other people, such as parties, bars, clubs, outings, visits, dating, home entertainment) are impaired.
0 means not at all impaired and 8 means very severely impaired.

4. Because of my [disorder], my private leisure activities (done alone, such as reading, gardening, collecting, sewing, walking alone) are impaired.
0 means not at all impaired and 8 means very severely impaired.

5. Because of my [disorder], my ability to form and maintain close relationships with others, including those I live with, is impaired.
0 means not at all impaired and 8 means very severely impaired.

Comment: Only one of these directly relates to work. This means that scores and in particular changes in scores during a trial (or between treatments) may have nothing to do with changes in employment.

Thank you for your comment. Although the work and social adjustment scale reflects more social adjustment than employment parameters, it has been recognized as one tool to use in measuring meaningful change in patients with ME/CFS.

Tom Kindlon Assistant Chairperson of the Irish ME/CFS Association
Results
The data from this paper, looking at employment outcome measures in the PACE Trial, were not used: PLoS One. 2012;7(8):e40808. doi: 10.1371/journal.pone.0040808. Epub 2012 Aug 1. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. McCrone P1, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. http://www.plosone.org/article/info:doi/10.1371/journal.pone.0040808 There are tables with various pieces of data. The authors summarise it as: “There was no clear difference between treatments in terms of lost employment.”

Response
This paper is out of scope for this review. We did not review cost-effectiveness.

 

[Barry]

"When the EPC published its report in 2014 it disastrously included recommendations for GET and CBT, and concluded that PACE was a good trial with little bias!"

I would think this alone should kick the whole thing into touch.

 

[Esther12]

Yes, it was frustrating how they used the Work and Social Adjustment Scale for employment measures and didn't actually use the proper data. And then ignored the comments I made on this:

Response
This paper is out of scope for this review. We did not review cost-effectiveness.

I saw them make a similar reply to a comment about the CBT actometer data. What matters should be whether the evidence/data referred to in a paper is within the scope of the review, not what the title of the paper is.

For them to follow that up with their smug response about needing to strictly report on evidence was pretty infuriating.

I need to stop wasting time getting irritated by stuff from years ago... but there's so much irritating stuff around!

 

[dave30th]

also, these are treatments for symptoms arising from ME, not for the ME itself. I think that's what the sentence means essentially, but it's ambiguous.

 

[Medfeb]

Yeah, they've halved their number of points, compared to how it read earlier. As I say upthread, I didn't have issues with any of the original points except the one I quoted

6) As a direct result [of insufficient funding], treatments for ME are known to the small number of expert clinicians but do not appear in the literature. No systematic review that is limited to the published literature can capture how this disease is currently treated.​

which I was worried had the potential to allow all kinds of unevidenced treatments in, desirable or not. I'm glad to see that #MEAction has had a rethink.

I agree that the ideal is randomized clinical trials, particularly blinded ones. And I appreciate the concerns that inappropriate practices could get in.

But its going to be some number of years until blinded RCTs are available. In the meantime, we have the evidence of disease experts who are using decades of experience and knowledge on disease presentation, subtypes and experience with various drugs to treat patients. Personally, I think its appropriate to use this experience to support the establishment of clinical guidance. That's what was done in both the peer-reviewed pediatric primer and in the IACFS/ME primer.

Edit: Even in there were no concerns with the performance of this group, I'm concerned that this proposal is relying on just a published literature base that is so sparse (of biomedical treatments) and so biased (with psychogenic approaches)

 

[Hip]

Like you say, it's possible they've found something effective, it possible they're just fooling themselves. It's impossible for us to know which, so it's not a good idea to say that it is known.

But it's not a good idea in my view to sweep those possibly effective treatments under the carpet just because very few medical scientists take much interest in ME/CFS clinical research.

I would like to see any guidelines on ME/CFS clinical practice admit culpability, and explicitly say that due to the lack of funding and medical interest in ME/CFS, treatments that ME/CFS specialists are using have not been properly tested in good clinical trials, and thus their efficacy remains uncertain. At least that is an accurate summation of the situation.

We should also mention the case of the Staphylococcus toxoid treatment, which was proven pretty effective in two clinical trials, and then was withdrawn from sale due to regulatory issues, a tragedy that I am sure would not have been allowed to happen in the case of any other serious diseases like multiple sclerosis, Parkinson's, etc, but since it is only ME/CFS, few people seemed to care.

Let's tell it like it is: there was a pretty good treatment for ME/CFS, but such is the disregard for ME/CFS patients, nobody thought to make a replacement product when the original was withdrawal due manufacturing regulations.

 

[Esther12]

I'm not saying that anything should be swept under the carpet, but at the same time, there are thousands of proposed treatments for ME/CFS that lack any good evidence of efficacy and we can't say that any of them are known to be effective. I'm not opposed to mentioning that there is a problem with a lack of funding for rigorous research.

We should also mention the case of the Staphylococcus toxoid treatment, which was proven pretty effective in two clinical trials, and then was withdrawn from sale due to regulatory issues, a tragedy that I am sure would not have been allowed to happen in the case of any other serious diseases like multiple sclerosis, Parkinson's, etc, but since it is only ME/CFS, few people seemed to care.

Let's tell it like it is: there was a pretty good treatment for ME/CFS, but such is the disregard for ME/CFS patients, nobody thought to make a replacement product when the original was withdrawal due manufacturing regulations.

I'd forgotten about that - I vaguely remember reading some patients talking about this, but from before I took the time to try to read medical papers. Odd that manufacturing regulations may have got in the way.

 

[Hip]

I'd forgotten about that - I vaguely remember reading some patients talking about this, but from before I took the time to try to read medical papers. Odd that manufacturing regulations may have got in the way.

Yes, odd indeed. Two years ago I tracked down and wrote to the pharmaceutical company who manufactured the original Staphylococcus toxoid vaccine, a product called "Staphypan". It took some detective work to find them, due to several changes of ownership and amalgamations. The company is now called Janssen Pharmaceuticals.

When my contact at Janssen managed to find some of the older staff who knew the background story of this vaccine and why it was discontinued, he explained to me that the product was taken off the market in 2005 because when new GMP (good manufacturing practice) rules were introduced at that time, their "old artisanal process" of making this vaccine could not be easily updated to comply with the new GMP standards.

But we know the vaccine works, so it should not have been that difficult for this company or another pharmaceutical company to invest some money to update and develop a new Staphylococcus toxoid vaccine for ME/CFS patients.

So we already have an effective ME/CFS treatment, yet there are no pharmaceutical company takers, even with the 17 million patients in the world, which would be a major revenue stream.

 

[Esther12]

Yes, odd indeed. Two years ago I tracked down and wrote to the pharmaceutical company who manufactured the original Staphylococcus toxoid vaccine, a product called "Staphypan". It took some detective work to find them, due to several changes of ownership and amalgamations. The company is now called Janssen Pharmaceuticals.

When my contact at Janssen managed to find some of the older staff who knew the background story of this vaccine and why it was discontinued, he explained to me that the product was taken off the market in 2005 because when new GMP (good manufacturing practice) rules were introduced at that time, their "old artisanal process" of making this vaccine could not be easily updated to comply with the new GMP standards.

Thanks for asking them. Did they say anything about it as a potential treatment for ME/CFS? Even if they thought it was unlikely to be a genuinely effective treatment, we're still a pretty a big market for a potential treatment, so I'd have thought a pharmaceutical company would be interested in trying to bring something to market.

 

[Hip]

Thanks for asking them. Did they say anything about it as a potential treatment for ME/CFS?

Sadly Janssen seemed pretty uninterested. I was hoping to make them realize that one of their old products, if updated, could be a worldwide blockbuster ME/CFS drug; that was the main motivation for writing to them.

The text of the original email I sent them, and details of their reply to me, in this post.

 

[alex3619]

Signed.

Very true but that isn't what #MEAction seem to be suggesting should happen - they are calling for unevidenced treatments to be included in the review.

They are not. This is a common misinterpretation of evidence based methods. Doctor experience is rank 5 evidence (on most scales) and so the lowest, but its still evidence. Right now we can add researchers to that, as most of the new findings are either not published yet or have not been independently validated.

The issue is we severely lack RCTs in ME, due to many decades of poor funding and insufficient clues, but that is about to change now that our researchers are making breakthroughs in weeks rather than decades. In EB reviews they triage to only certain kinds of things. In an under-researched field this makes it very likely that the review will be highly biased, with a big skew towards things that have found funding, which is why psychobabble was so prominent last time.

 

[alex3619]

Yeah, that is a problem.

Its a problem in a review, but not really a problem. They use off-label but otherwise standard treatments, just like in most diseases. These are not off the wall treatments. For instance there are accepted treatments for OI and nutritional deficiencies, sleep issues, and so on. They are just not clinically trialed in an RCT or major study.

 

[Milo]

also, these are treatments for symptoms arising from ME, not for the ME itself. I think that's what the sentence means essentially, but it's ambiguous.

Agreed. Symptom management is not treatment. And by symptom managment, i include both pharmaceutical, dietary and behavioral approaches. Those are not treatments.

 

[Skycloud]

As of this morning the petition letter says this (there is no no.6):

Dear Dr. Inger Damon,

We are alarmed that the CDC intends to issue a sole-source contract with the Pacific Northwest Evidence-based Practice Center (EPC) to expedite the development of federal evidence-based treatment guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME).

We demand that this contract not be issued and that the project be put on hold for the following reasons:

1) CDC has undertaken this project and the sole source contract without any discussion with or involvement of people with ME or the doctors who treat them.

2) The EPC previously conducted a systematic evidence review in 2014, but failed to account for the use of the Oxford definition and other overly broad diagnostic criteria used in many studies and which do not require a hallmark symptom of this disease—post-exertional malaise (PEM). This led to the erroneous conclusion that GET and CBT were effective treatments for people with ME.

3) The ME community made repeated attempts to engage the EPC in addressing multiple methodological concerns, but was ignored until 2016.

4) When the EPC finally reanalyzed its review in light of those criticisms two years later, it found there was insufficient evidence for the efficacy of GET and CBT. However, EPC refuses to publish this reanalysis in a peer-reviewed journal. This leaves the 2014 review publication intact, despite the EPC’s subsequent revision of the recommendations.

5) Patients are seen by a small number of expert clinicians who have decades of experience with ME. Research in ME is performed by a small group of dedicated scientists. The involvement of both are essential to the development of logical, ethical treatment recommendations for people with ME. The uneven quality of the peer-reviewed literature in this underfunded disease means that expert scientists and clinicians’ involvement is absolutely critical: they are best positioned to assess the available evidence and make recommendations. Yet CDC has not clarified how they will reach out to incorporate the knowledge and experience of those whose know the disease best.

This project must be put on hold, and the CDC must collaborate with the ME community to ensure that they address the challenges that still exist, engage the community in a transparent and collaborative process to develop the project protocol, and incorporate expert knowledge in the evidence review and in any resultant treatment guidelines.

We urge you to pause this process immediately and meet with #MEAction at your earliest convenience to discuss these concerns.

sincerely

I haven't followed all the detail of the discussion of content above, and what may have been altered (?). I haven't the energy to clarify if/how it's been changed and I'm not comfortable if a petition letter might be changed after people have signed it. The petition letter as I've quoted is 'ok enough' for me and I'll sign later in the week if that's still the case.

The CDC should include input from people who have some understanding of the disease and it's seriousness and understand the problems with the research to increase the likelihood of a decent review. If they want a decent review. I do question why they would solely (or at all) want to use the same outfit that did a bad job before and acted in bad faith by not publishing their revised review.

I don't really think the CDC will pay any attention to this petition, and I believe it's deliberate that they have made this public so near to the deadline. It's a classic way of pushing things through with as little effective opposition as possible. (And as cheaply as possible). Hope I'm wrong.