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

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.

 

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

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.

 

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.

 

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.

 

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:

 

"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.

 

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!

 

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.

 

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)

 

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.

 

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.

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.

 

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.

 

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.

 

Signed.

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.

 

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.

 

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

 

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

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.