Harriet Hall CFS: Rituximab Revisited in Science-Based Medicine

[Nielk]

That is a very good point. A modest percentage of people with ME get worse every year, even though they keep their activity levels down. It then follows as likely that a certain percentage with ME who dont respond, will get worse.

And what do we learn in school?
Correlation does not imply causation.

One thing we do know though: About 25 % of the patients taking rtx goes through a transient worsening, that can last weeks, even months.

This logic should apply as well to self reported results of improvements. Since this disease ebbs and flows, there are automatic periods of worsening and improvements.

 

[barbc56]

I think it's premature to offer patients a drug that is still being investigated unless it's a clinical trial. However, wasn't Kogelnik doing some kind of study?

Prescribing Rituximab, or for that matter any medication before studies have finished might muddy the waters when it comes to getting accurate information about the pros and cons of using Rituximab as a treatment and who will benefit from it. There are ethical considerations If someone is prescribing it and making money from doing this.

Dr. Hall has written some very good blogs. This one might not be one of them, but I need to read it more closely. I think her point of saying to wait is valid.

It's a complicated situational and there are no easy answers. But, I think it's best to tread lightly until studies are finished.

Barb

 

[worldbackwards]

I'm not particularly of the opinion that Rituximab will come to anything (I've been here too many times and don't tend to get my hopes up), but I did resent the bizarre tone of the article, part 'we can't draw any conclusions' mixed with a hefty dose of 'WON'T SOMEBODY THINK OF THE CHILDREN FOR GOD'S SAKE!'.

If there is somebody watching over the forum and feeding this kind of material to science writers, I suspect that they are not all that interested in acting on the behalf of patients. There have been lengthy threads here discussing the pros and cons of this treatment and the risks due to the lack of evidence prior to the end of trials. Many patients' lives are bad enough for them to legitimately feel like a risk was worth taking for them; that is their own business and a judgement for them alone.

Given that in the UK, state sponsored treatment is having severely disabling outcomes that no-one outside the community seems too bothered about, one questions whether the concerns of the source for this story might be better placed in stopping harms being done by that treatment on a daily basis. Which makes me question whether those reporting these concerns are more interested in protecting the status quo from interloping treatments than helping patients.

 

[Marky90]

It`s premature obviously, but if one does nothing one also run the risk of the disease progressing. And it seems like very severe ME-patients generally respond worse. That`s one of the reasons I`m gonna pay for it. I have seen to many dafoe-stories, to go about naive with this insidious disease.

 

[Cheshire]

I'm not shocked by the fact this article says one has to be cautionary towards Rituximab.

But the tone of the article (someone told me that...), the fact that the control group trial of Rituximab is not mentionned, the use of PR posts to built the case of Whitney without his family's version, all this seems quite biased.

 

[BurnA]

Comment under the article:

Doesn't this patient realise that rtx helps save cancer patients lives and free ra patients from pain? Regardless of how an individual may or may not respond, rtx is on balance a wonderful drug.

 

[barbc56]

Assuming that the unknown patients did get worse, how does anyone "know' it was the Rituximab and not the natural progression of the patient's illness? No matter what I do or don't do, my illness is gradually getting worse. I can maybe affect the speed of the decline, but not stop or reverse it

Yes and that's the problem of studying any condition that waxes/ wanes or progresses one way or another. It becomes even more complicated to study and unfortunately may take even longer to get the results. I think this also makes waiting until further studies are done even more important.

Frustrating.

Barb

ETA I was also disappointed about the quotes from here when it could have been easily said in more general terms. Certainly PR isn't the only forum that discusses this subject. It seems less than professional and only detracted from her point. If she doesn't know why even say this?

 

[Sidereal]

I'm not particularly of the opinion that Rituximab will come to anything (I've been here too many times and don't tend to get my hopes up), but I did resent the bizarre tone of the article, part 'we can't draw any conclusions' mixed with a hefty dose of 'WON'T SOMEBODY THINK OF THE CHILDREN FOR GOD'S SAKE!'.

This is what bothers me about this blog post too. I don't think RTX will end up being useful for most of us and I'm not interested in defending Kogelnik/OMI but the tone of this article suggests that she thinks we're crazy to try off-label treatments and need to be protected from ourselves. Like this illness isn't severe enough to merit 'dangerous' treatments. The way she describes Dafoe's progressive illness, it's like she can't conceive of ME/CFS getting that bad, it must be something else like a viral reactivation from the drug.

 

[BurnA]

Regarding the article, it's gutter journalism - there is no other word for it. The author wants to spin a story so she reports only the facts she wants to and speculates the rest to sound sensational. Awful stuff.
To make it worse she tries to sound like she is writing with the patients best interests in mind.
And how could she mention Whitney Dafoe without knowing the full story - does she think she knows more about this disease and rtx than Whitney and his family? awful awful awful.

 

[adreno]

I have never been impressed by her blog. I'm not impressed with this piece either.

 

[jimells]

It's amazing how quickly, and with so little factual information, the commenters are ready to lynch Dr Kogelnik. For me, that website is a good place to stay away from.

 

[lansbergen]

I said it is not for me and that still stands but I agree with what worldbackwards wrote here.

Many patients' lives are bad enough for them to legitimately feel like a risk was worth taking for them; that is their own business and a judgement for them alone.

 

[MeSci]

It's amazing how quickly, and with so little factual information, the commenters are ready to lynch Dr Kogelnik. For me, that website is a good place to stay away from.

Having now seen her other post linked to in the first post in this thread, especially the crap about 'psychological factors' and 'deconditioning', I am strongly in agreement.

 

[MeSci]

I said it is not for me and that still stands but I agree with what worldbackwards wrote here.

I agree - as long they are fully informed of the potential pros and cons.

 

[barbc56]

I just reread the blog and have to say, however you feel about this subject, the blog is very poorly constructed.

I find it extremely disappointing that the blog uses anecdotal reports then makes conclusions drawn from them as well as citing outdated information on a blog where critical thinking skills are emphasized. If another site used this type of reasoning it would (and should) be fair game for criticism.

While I haven't read all the comments as there are now 90 plus, so far they are much more insightful than the blog. I just hope the comments won't degrade.

This was cited in the comments and it looks interesting.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/#__abstractid883651title

However much I want to continue this I've reached my reading limit for the day so apologies if I've missed something.

One thing mentioned in the blog that was worth reading was the quote from Fluge and Mella.

We do not encourage the use of rituximab for ME/CFS outside of approved clinical trials, and this is especially important for the group with very severe disease.

Maybe that was all that was needed to be said and the blog should have stopped there.

Barb

ETA
One more point from the comments that made me realize I hadn't make clear in my above post is that off label use comes in degrees. Some may be medically plausible. Some like Rituximab where the side effects are potentially more dangerous and less is known about the mechanisms behind me/cfs, at least to me, are a different story.

How that line is drawn ethically and legally, I haven't a clue. Maybe the article about the use of off lable prescribing will help.

If anyone has other citations about the subject of off label use of prescription medications, I think it would be very helpful. But maybe continued in another thread?

 

[snowathlete]

I think it's premature to offer patients a drug that is still being investigated unless it's a clinical trial. However, wasn't Kogelnik doing some kind of study?

Prescribing Rituximab, or for that matter any medication before studies have finished might muddy the waters when it comes to getting accurate information about the pros and cons of using Rituximab as a treatment and who will benefit from it. There are ethical considerations If someone is prescribing it and making money from doing this.

Dr. Hall has written some very good blogs. This one might not be one of them, but I need to read it more closely. I think her point of saying to wait is valid.

It's a complicated situational and there are no easy answers. But, I think it's best to tread lightly until studies are finished.

Barb

I agree with her point that we need to wait for trial results. That has to be the formal line, though I understand some ppl may not feel they can risk waiting, we don't know how effective and safe it is until we have more results, despite promising indications so far. But some patients may die or become far more debilitated before its authorised so I can understand some patients making a logical choice to risk it.

But to back that point up with scaremongering hearsay rather than real science? It's the sort of thing I come across on low quality personal blogs by uninformed writers who don't understand science.

I am also concerned that she quoted posts from a seriously ill patient (who couldn't even write coherently as he was so sick) seemingly without any attempt to check facts with him. The fact he is so sick may mean he is not in a position to consent to being used as a story on such a well read site, and likely isn't in a position to correct factual errors, and so I find that potentially unethical and quite disturbing.

 

[funkyqueen]

That is a very good point. A modest percentage of people with ME get worse every year, even though they keep their activity levels down. It then follows as likely that a certain percentage with ME who dont respond, will get worse.

And what do we learn in school?
Correlation does not imply causation.

One thing we do know though: About 25 % of the patients taking rtx goes through a transient worsening, that can last weeks, even months.

@Marky90 , i'll be very curious to read more about those 25% of PWMEers... Do you have some links, pls ?

 

[Jonathan Edwards]

I'd like to hear what @Jonathan Edwards thinks/knows about this.

This seems to be a very intriguing piece of psychopathology. I read the article and then looked for a Harriet Hall on Google. I came up with a Wikipedia article that seems to fit:
Harriet A. Hall (born July 2, 1945) is an American retired family physician, former U.S. Air Force flight surgeon and skeptic who writes about alternative medicine and quackery forSkeptic and Skeptical Inquirer.

The picture of Dr Hall I guess tells the story. Her article purports to be 'Science Based Medicine' and yet it is apparent early on that Dr Hall has little idea of constructing a scientific argument and prefers gossip, including revealing people's avatar names on websites. She loves to distress people unnecessarily. Her account is, as commenters have said, grossly unbalanced and poorly informed. She has made a laughing stock of herself amongst her colleagues.

Those of us involved in the science agree that treating people with ME/CFS with rituximab outside controlled trials is not to be encouraged. However, if I had not decided that treating patients with rituximab outside controlled trials in RA was acceptable, the drug would not be licensed for RA. To pick on a medical co-professional as she has done smacks of a serious confusion of motives. The Crucible comes to mind. A visit to a psychotherapist might even be in order. Could be another case of difficult potty training.

Science Based Medicine? - blaaaaggghhh.

Presumably someone will show her this.

 

[Kati]

In a field where there is
- very little clinical trials available,
- where government funding is abysmal,
- where research grant reviewers are biased (with the example of Dr Lipkin review of his grant application)
- 'chronically fatigued' patients are thought to be malingering,
- most physicians cannot more the difference between chronic fatigue ( the symptom) and myalgic encephalomyelitis (the disease),
- where most physicians prefer to not accept patients with ME through their door,
- pharma not interested in doing drug development or support much clinical trials


One has to understand the position of one physician to provide treatment with an off-label drug. HIV doctors gave AZT before it was even approved. It is a physician judgement to offer access and patient to consent to, with its risks and possible benefits.

Until we have a research network and structure that offers large access to clinical trials with drugs that have a potential to make a difference, single physicians will make a judgement for themselves on how best to help a patient with a disease which has poor prospects of recovery.

I am thankful for Dr K for offering this opportunity.

 

[Marky90]

@Marky90 , i'll be very curious to read more about those 25% of PWMEers... Do you have some links, pls ?

It`s stated in either the phase 1- or phase 2 study. Can`t remember which In the phase 1 paper there is a graph showing the transient worsenings in the responders.