Harriet Hall CFS: Rituximab Revisited in Science-Based Medicine

[BurnA]

That said, I think Kogelnik's actions of providing the drug outside of a trial is irresponsible. I think at the very least an open-label, trial with defined outcomes was warranted.

There is a big difference - the cost and risks of Rituximab are far higher. Surely some transparent data collection (ongoing open label trial) is not too much to ask?

This is somewhat a separate discussion but I'd like to add my opinion here.
IMO a doctor is responsible for taking care of their patients first and foremost. To prescribe a drug off label to a very sick patient carries a lot of responsibility. I don't see how this can be described as irresponsible at all. They are using their education and experience to make a massive, potentially life altering decision for a patient. That's what doctors do.

While we might all like to see more information on the use of RTX on patients, we are not entitled to this. And the cost of the drug is not a factor in this - why would it be ok to prescribe a cheap drug off label but not an expensive one? That would be irresponsible.
Don't get me wrong - I would love to see OMI publish all their data and perform registered trials but this is for my selfish reasons and for the broader good. But they don't have to do this. Whether they publicly documented all their work or not - it wouldn't change the outcome or cost for their individual patients, to whom their responsibility lies first and foremost.
Labelling them irresponsible is a step too far IMO.

 

[funkyqueen]

@funkyqueen i was intrigued so i read some comments ( i dont normally ).
It seems quite a well orchestrated campaign of comments - i dont think there could be any other explanation.

+1

From phase 2 discussion:
"Two patients experienced an allergic reaction to rituximab-infusions. In the majority of patients no infusion-related symptoms or subsequent ME/CFS worsening could be noted. In eight patients, symptom flares were observed after one or more rituximab infusions. This is infrequent in lymphoma patients receiving rituximab. Such transient worsening also occurred when a patient was B-cell depleted and had a sustained major response, and usually lasted for days to a few weeks. However, we have observed one patient included in another study (KTS-3-2010, for patients with severe or very severe ME/CFS) who experienced such transient symptom worsening lasting for almost three months. Based on pilot observations, a slow infusion rate of rituximab seems to reduce this problem, and in the presently ongoing randomized phase III study (“RituxME”) all intravenous infusions are given over approximately four to five hours infusion time. The symptom worsening seems similar to that described after infusion of normal human immunoglobulins as a therapeutic option in adolescent ME/CFS [41] and may indicate an unspecific immunoglobulin effect in these patients."

Thanks, Marky90 , for having refreshed my memory
Yep, i really believe in the fact that, the more slowly one receive this kind of infusion, the less we have probabilities to develop a side effect.. (Well, saying that, i understand me, while the side effects attributable to Ritux is not only the fact of the infusion rate)
One thing that i find surprizing, it's the " rapidity" of American's infusions ( in 4 hours). In France, for this kind of drugs, its 6h00, for the same dose, ( and, an Australian woman told me that in Australia, for a chemo/ immunosuppresive ttt, the minimum of infusion time is 8h00 ). In France, they use to give corticosteroids before this kind of infusions, not in US it seems

In my opinion it is pointless to give this person traffic on her blog and to argue with her. It won't change her mind.

I'm agree with you, Kati, i think she is ( faaaaaar) from change her mind, despite of the comments she can read, but, i think PWMEers do not have to keep silent, and let her write misinformations

 

[greeneagledown]

For what it's worth, if someone going to the Open Medicine Clinic who was interested in getting Rituximab asked Kogelnik or Kaufman to discuss their success rate with the drug before making a decision, I suspect OMC would be pretty honest with them. I doubt Kogelnik would say, "NO I'M NOT TELLING YOU HOW OUR PATIENTS HAVE DONE WITH THIS DRUG. YOU'LL JUST HAVE TO ROLL THE DICE BAHAHAHA."

 

[MeSci]

For what it's worth, if someone going to the Open Medicine Clinic who was interested in getting Rituximab asked Kogelnik or Kaufman to discuss their success rate with the drug before making a decision, I suspect OMC would be pretty honest with them. I doubt Kogelnik would say, "NO I'M NOT TELLING YOU HOW OUR PATIENTS HAVE DONE WITH THIS DRUG. YOU'LL JUST HAVE TO ROLL THE DICE BAHAHAHA."

As far as Kogelnik is concerned, not according to this thread, but maybe yes according to this one! From threads I've read about Dr Kaufman I can't imagine him being secretive or aggressive.

 

[jimells]

However I think most doctors use off-label and unproven treatments some of the time.

Especially neurologists treating migraine patients. They like to prescribe all kinds of anti-seizure medications to be taken every day, presumably for years. Some of them have been tested in RCT, some have not, and frequently the evidence is rather weak, especially considering the long list of adverse effects from these medications. Certainly those medications have not been tested properly in ME patients - but Harriet Hall is not complaining about any of that, is she? Her objections are political, pure and simple

 

[jimells]

That said, I think Kogelnik's actions of providing the drug outside of a trial is irresponsible.

What if a patient also has RA or cancer that can be treated with rituximab? It's not so simple in that case - which is why physicians are paid the big bucks to make the hard decisions that can't be made ahead of time by guideline committees and rule books.

 

[barbc56]

I just now had the time to look at Dr. Hall's previous blog mentioned and it wasn't the one I thought was being talked about. Did I miss it on this thread?

I was thinking of this blog, again written by Harriet Hall and starts out with the same MO with a patient's privacy. But to be fair, I'm not sure if the blog she was quoting was open or closed at the time she wrote this. It's now open only to members It gets a little better, relatively speaking compared to this latest blog. But still....!

The same criticisms I have for the most recent one are the same.

Part of gingergirls post I forgot to add as it makes another important point and says a lot.

I once posted something on PR re: my experience at a screening of Forgotten Plague and another website contacted me and asked my permission to re-post it. They said they would not re-post without permission, they would post it verbatim, and they would link it back to my original post on PR. They were respectful and the information they shared was nothing controversial or hurtful to anyone

If I ever wrote a blog and I can't think of why I would, I would make it private which is really sad if someone posts writes information that might be helpful to others. Maybe this should be standard internet etiquett? A case could be made for posting quotes from another OPEN site if you need to defend yourself but there are certainly shades of gray even there.

Barb

 

[jimells]

Looking at the SBM website I am also still concerned that there are other players in the background here. There is something spooky about the 'skeptics' movement.

Well let's see. Since they are skeptics, they probably know Ben Goldacre, a well-known skeptic who is also associated with Sir Simon, who is first cousin to the devil himself. Therefore We Declare Guilt By Association!

(sorry. I couldn't resist)

 

[barbc56]

Her objections are political, pure and simple

Possibly but on the whole, her objections in the two threads seem to be more about ethical and medical considerations. The former is rather ironic considering one can say her blog may also be unethical. Especially the most recent one. But the way it's written that message gets lost.

I don't think the blogs talked about here are a reflection of some of the other blogs she has written. While this might give a more balanced perspective about her style of blogging, it's certainly does not excuse the ones we are talking about here.

As an aside, do we have any updates on Whit's health?

Barb

 

[barbc56]

Well let's see. Since they are skeptics, they probably know Ben Goldacre, a well-known skeptic who is also associated with Sir Simon, who is first cousin to the devil himself. Therefore We Declare Guilt By Association!

(sorry. I couldn't resist)

I think it's quite unfair to compare guilt by association and I would say the same thing if I saw a comment like this on SBM. Why even go there?

Are people aware that James Coyne is also a contributor at SBM?

Barb

 

[BurnA]

I think it's quite unfair to compare guilt by association and I would say the same thing if I saw a comment like this on SBM. Why even go there?

Are people aware that James Coyne is also a contributor at SBM?

Barb

I laughed out load at that post @jimells - thanks !

 

[jimells]

I think it's quite unfair to compare guilt by association and I would say the same thing if I saw a comment like this on SBM. Why even go there?

Are people aware that James Coyne is also a contributor at SBM?

Barb

I'm sorry I didn't make it clear that my post was in jest. I thought for sure that comparing Sir Simon to the devil would give it away. I know nothing about this group or who they are connected to.

 

[barbc56]

I laughed out load at that post @jimells - thanks !

Then I guess it's okay for others to laugh at us and doctors that are associated with our community?

You can't have it both ways.

I've said enough for today and will go take a much needed nap!

Barb

 

[BurnA]

I'm sorry I didn't make it clear that my post was in jest. I thought for sure that comparing Sir Simon to the devil would give it away. I know nothing about this group or who they are connected to.

Then I guess it's okay for others to laugh at us and doctors that are associated with our community?

You can't have it both ways.

I've said enough for today and will go take a much needed nap!

Barb

Laughter is the best medicine I have at the moment. Please don't deny me that.

 

[barbc56]

I'm sorry I didn't make it clear that my post was in jest. I thought for sure that comparing Sir Simon to the devil would give it away. I know nothing about this group or who they are connected to.

Yeah, I kind of thought that and do have to say the latter part did made me a smirk. Maybe I just don't want to admit that!

Are we not allowed to have fun here anymore ?
Sarcasm and humour are now forbidden ?
Laughter is the best medicine I have at the moment. Please don't deny me that

Absolutely not! If I ever lose my ability to laugh Im done for. I was just worried it might be taken out of context.

So off for a nap. I think I could use a good dose of humor. It always helps.
.

Barb

 

[Snowdrop]

I think it's quite unfair to compare guilt by association and I would say the same thing if I saw a comment like this on SBM. Why even go there?

Are people aware that James Coyne is also a contributor at SBM?

Barb

James Coyne was mentioned earlier in this thread.
And as far as the guilty assoc. remark--for us it's just blowing off steam here it's not a comment meant to be taken quite so literally I think and it's not in the same position to be judged as it would be if written in a blog in my opinion.

I do appreciate your contributions here and many comments @barbc56 . But with regards to a previous comment about HH discussing medical concerns and ethics I would have to say it doesn't then follow that discussing that or any other topic means that the discussion cannot still be political in nature. There is reading things literally and at face value then there is parsing the nuance of the commentary or what has been termed at times 'reading between the lines'. Because the 'reading between the lines' is not reading what is explicitly stated does not make it any less real. Just as what a person says absolutely explicitly can be misconstrued or misunderstood because of deliberate word choices meant to allow for an ambiguous interpretation.

Parsing 'reading between the lines' and nuance is merely a skill that can be acquired and honed like any other. It's not 100% accuracy but then neither is science.

 

[ukxmrv]

I'm wondering if this is an attack on Ron Davis by using his son'?

"Someone" does a dig around about the family, finds Whit on PR and then passes the information onto this blogger to try and smear them.

 

[jimells]

There is reading things literally and at face value then there is parsing the nuance of the commentary or what has been termed at times 'reading between the lines'.

When dealing with mass media, that's usually where one finds the real story. Just like when I want to know what a doctor really thinks about my illness, I read their notes. It was interesting to see that my neuro thinks I need to see a psychiatrist, although he has never said that to my face.

 

[beaker]

For me when I read and re-read the SBM article, there are two different issues.

One is that OMI is using Rituxan on patients and there are details that ideally should be released some day such as:

Is it part of a clinical trial, how are these patients being selected, how many patients have used Rituxan, what ME/CFS symptoms did they have, what side effects did they have, how many have improved, stayed the same or gotten worse from Rituxan? How does OMI data compare with Fluge & Mella's? All of these are very legitimate questions and I support this information and knowledge being made public when the time is right b/c it will help others.

OMI is a private clinic. It's patients have the right to medical privacy. As such, they are not under any obligation to release anything.That includes the cost -- which many have brought up. It's not a cheap drug. It takes a lot of time and therefore staff hours to infuse. That's also between doctor and patient. This isn't the first expensive treatment used off label for this dx.

If they are doing a trial they wouldn't release information until publication.

BTW I am not a patient there nor affiliated.

yes, we are all curious. But if someone wants to share they will share. If not....

There has been a history of this illness of things being tried off label. I've done my share. Some in formal studies, most informally to see if it would be something worth a study. Most with bad results. I have no regret for trying. I'm glad that some doctors are willing to do that. It's 30yrs for me. I hope doctors keep trying things. I don't want to stay this way the rest of my life. What risks I take are between me and my physicians.

 

[Gingergrrl]

OMI is a private clinic. It's patients have the right to medical privacy. As such, they are not under any obligation to release anything.That includes the cost -- which many have brought up. It's not a cheap drug. It takes a lot of time and therefore staff hours to infuse. That's also between doctor and patient. This isn't the first expensive treatment used off label for this dx.

If they are doing a trial they wouldn't release information until publication.

BTW I am not a patient there nor affiliated.

yes, we are all curious. But if someone wants to share they will share. If not....

There has been a history of this illness of things being tried off label. I've done my share. Some in formal studies, most informally to see if it would be something worth a study. Most with bad results. I have no regret for trying. I'm glad that some doctors are willing to do that. It's 30yrs for me. I hope doctors keep trying things. I don't want to stay this way the rest of my life. What risks I take are between me and my physicians.

@beaker Nothing in my post stated that medical privacy should be broken or patient's names should be given out. That would be a violation of HIPAA and would be illegal. That is one of the main reason's that I was horrified that Harriet Hall disclosed personal info re: Whitney.

I was speaking of the clinical data being released, when the timing is right, as it can be of help for all of the other doctors/researchers who are studying the same thing such as Fluge & Mella and the upcoming UK studies. It can only help to share this data and it is the reason that OMI is called "Open" medicine institute as they have stated themselves.

Nothing in my prior post said that they need to publicly disclose the cost. And lastly, nothing in my post said that they should not be using Rituxan. I stated that we are all adults, we are all very ill, we have all tried things that made us sicker, and we should have the right to continue to choose treatments, including potentially dangerous ones if given proper informed consent.

I think you are attributing meaning to my words which were not there.