ME/CFS Alert: Episode 77 - Dr. Derek Enlander

[Dolphin]

Published on 9 Mar 2016

I haven't watched this myself so far but saw it described elsewhere as follows:

An interesting interview with Dr. Derek Enlander. At approx 18 mins in he talks about a study currently being undertaken in Mt. Sinai to replicate the GET part of PACE with 100 patients. So far 65% of that cohort have been harmed by GET This study, when published, will I believe be very significant in terms of debunking PACE

 

[taniaaust1]

wow this is great that this study is being done with proper ME/CFS patients using the canadian criteria. A big thanks to those patients who are putting themselves at risk by partaking in this study.

 

[Kati]

Dr Enlander had tough words for drs who were using Rituximab as ouptpatients, that patients could die. This is actually misinformation.

I was a chemo nurse up to the time I got sick and even lymphoma patients received all of their chemo as outpatients and their chemo drugs, which include 4 different drugs plus the Rituximab, was all done as outpatient. Moreover over my 8 years spent in oncology which included bone marrow transplant, I have never seen any patients dying as a result of Rituximab, or any chemo for that matter. Forever the most part, cancer patients die of disease progression, and second to that would be infection, mostly secondary to a failing immune system from disease progression.

 

[user9876]

Dr Enlander had tough words for drs who were using Rituximab as ouptpatients, that patients could die. This is actually misinformation.

I was a chemo nurse up to the time I got sick and even lymphoma patients received all of their chemo as outpatients and their chemo drugs, which include 4 different drugs plus the Rituximab, was all done as outpatient. Moreover over my 8 years spent in oncology which included bone marrow transplant, I have never seen any patients dying as a result of Rituximab, or any chemo for that matter. Forever the most part, cancer patients die of disease progression, and second to that would be infection, mostly secondary to a failing immune system from disease progression.

In the UK or at least my local BMT unit they insist that their patients are no more than a 40 min (perhaps an hour) drive away from the unit (or an outpost unit). They have flats for patients to stay in where this is difficult. They also do a lot of monitoring even as out patients.

One of the things that worried me about some people getting Rituxumab is where people were traveling long distances to get an infusion.

 

[Sean]

An interesting interview with Dr. Derek Enlander. At approx 18 mins in he talks about a study currently being undertaken in Mt. Sinai to replicate the GET part of PACE with 100 patients. So far 65% of that cohort have been harmed by GET This study, when published, will I believe be very significant in terms of debunking PACE

Double wow!

This could be very interesting.

 

[BurnA]

Double wow!

This could be very interesting.

While the results, if as described above, will be immensely beneficial for the patient community, it seems awful that patients have to be harmed to prove something we already know. I hope they haven't been harmed too much.

If this was a pharmocological trial and 65% of patients were harmed you could imagine the outcry.

 

[olliec]

I think this is an update on an existing (slow?) study? Enlander told me about it at least two years ago, and also mentions it here in 2013 http://phoenixrising.me/archives/16404

 

[alex3619]

He actually says 65% have been hindered or harmed.

 

[jimells]

He actually says 65% have been hindered or harmed.

And they didn't stop the study? For some reason I have the impression that medical ethics would require an end to research with this level of harm.

 

[ScottTriGuy]

And they didn't stop the study? For some reason I have the impression that medical ethics would require an end to research with this level of harm.

Yeah, ethically how are they not stopping the study/harm.

 

[Comet]

An interesting interview with Dr. Derek Enlander. At approx 18 mins in he talks about a study currently being undertaken in Mt. Sinai to replicate the GET part of PACE with 100 patients. So far 65% of that cohort have been harmed by GET This study, when published, will I believe be very significant in terms of debunking PACE

Huge thank you to all the patients enduring this for us. They are making ME/CFS history. Hopefully this study, when published, will stand up to scrutiny.

 

[Jonathan Edwards]

In the UK or at least my local BMT unit they insist that their patients are no more than a 40 min (perhaps an hour) drive away from the unit (or an outpost unit). They have flats for patients to stay in where this is difficult. They also do a lot of monitoring even as out patients.

One of the things that worried me about some people getting Rituxumab is where people were traveling long distances to get an infusion.

This seems odd to me. As Kati says, the risks of post-infusion reactions are very small. By the time a patient has finished their first infusion they have been exposed to IV drug for about five hours. If they were to get hypersensitivity reactions those would have shown themselves long before. The only issue I am aware of is post-infusion pneumonitis but this can occur many days after infusion so staying overnight is not much help. I think things are likely to be different for leukaemia or lymphoma patients receiving other drugs as well.

It is a pity that Dr Enlander clearly does not know much about rituximab, and is prepared to make comments that are unhelpful. I have to say I am also not very impressed by the account of another GET trial. Unless the design is very clever it will be just as uninterpretable as PACE, being unblinded. It also does seem very odd that a trial should continue if 65% of patients have been deemed to have adverse effects.

 

[Snowdrop]

My first thought was that if 65% are being harmed then you would think that they'd stop the trial. Why is this allowed to continue?
I would love definitive proof that we are being harmed but if as J Edwards says the results are not open to clear interpretation then there is not even a greater purpose for this.

 

[Bob]

Dr Enlander says @ 20.30 that 65% of participants have been "hindered, if not hurt" after exercise. (He doesn't say 65% were "harmed", unless he discusses it elsewhere in the video and uses different wording.)

This doesn't necessarily mean that 65% deteriorate or report adverse effects when exposed to exercise, but it may mean that any improvements are not as great as the control group. We don't know what it means until published.

@Dolphin, just bringing your attention to this, in case you wanted to know: your opening post says that 65% have been "harmed".

 

[Bob]

I would love definitive proof that we are being harmed but if as J Edwards says the results are not open to clear interpretation then there is not even a greater purpose for this.

I think J Edwards means that none of these types of studies are interpretable because they are open-label and use self-report measures, so they can't provide reliable evidence.

But if Dr Enlander is using some objective measures (e.g. actigraphy or biological tests) then that may be very be helpful evidence. Also, whatever we think of these studies, agencies like IOM, CDC, Cochrane and NICE seem to love them, so the study may be very helpful to present as evidence to any such agency.

I hope the exercise study has a robust methodology, as far as is possible for this type of study, and replicates PACE by using incremental exposure to exercise.

 

[BurnA]

Having watched the video one thing that struck me was there doesn't seem to be any collaboration or joined up thinking in the US ( at least that he was involved in) . I thought his answer to this was very strange "perhaps they're jealous" although i'll give him the benefit of the doubt as he didn't really finish his answer.

He was at pains to point out that the exercise test was simple, I hope that doesn't mean too simple to draw any conclusions.

 

[BurnA]

Alex points out that Dr Enlander says that 65% of participants have been "hindered or harmed" after GET. This doesn't necessarily mean that 65% deteriorate or report adverse effects when exposed to GET, but it may mean that any improvements are not as fast as the control group. We don't know what it means until published.

Also, whatever we think of these studies, agencies like IOM, CDC, Cochrane and NICE seem to love them

Hindered or Hurt is the exact wording.
The impression is that's exactly what he means, no hidden meaning about slow improvement.

The IOM CDC NICE etc love these studies when it suits them, I wonder how much they like them when the don't like the findings ?
Reminds me of the criticism Fluge and Mellas open label trial got by the people who supported PACE. Eh...

ETA bob has the correct verified wording above !

 

[user9876]

This seems odd to me. As Kati says, the risks of post-infusion reactions are very small. By the time a patient has finished their first infusion they have been exposed to IV drug for about five hours. If they were to get hypersensitivity reactions those would have shown themselves long before. The only issue I am aware of is post-infusion pneumonitis but this can occur many days after infusion so staying overnight is not much help. I think things are likely to be different for leukaemia or lymphoma patients receiving other drugs as well.

I was initially commenting on Kati's comments about chemo therapy being done in a day hospital where they are but with a great deal of care.

But It has got me wondering about what the follow ups that would happen when giving someone with Rituximab. I assume they would still go to regular clinics and see a doctor and have various blood tests at regular intervals? Also access to the clinic via phone if there are new/unusual symptoms? I'm guessing this is important if say the NHS were to roll out Rituximab for ME what would be required in terms of general follow up?

It is a pity that Dr Enlander clearly does not know much about rituximab, and is prepared to make comments that are unhelpful. I have to say I am also not very impressed by the account of another GET trial. Unless the design is very clever it will be just as uninterpretable as PACE, being unblinded. It also does seem very odd that a trial should continue if 65% of patients have been deemed to have adverse effects.

I believe he is doing a lot of testing around the exercise protocols including lots of blood tests both immediately afterwards and 3 days afterwards. So I think it could bring some interesting results.

 

[Bob]

Hindered or Hurt is the exact wording.
The impression is that's exactly what he means, no hidden meaning about slow improvement.

Actually we both got his wording wrong. (I've corrected my post now.) What he actually says is: "hindered, if not hurt". Watch at 20mins, 30secs.

Edit: or does he discuss this twice and use different wording?

 

[Bob]

The IOM CDC NICE etc love these studies when it suits them, I wonder how much they like them when the don't like the findings ?
Reminds me of the criticism Fluge and Mellas open label trial got by the people who supported PACE. Eh...

Yep, that's why I hope Dr Enlander's study has a robust methodology, otherwise it will be ignored and rebutted.