Tests for Efficacy of Infusions

[monks]

My doctor, who is an allergist/immunologist, wants me to get a cognitive assessment prior to starting infusions then 6 months in to test if it's working. Not a psych eval, to see how my brain functions.  

During my initial consultation, I said I had brain fog, which could be from a number of things and not from low immunoglobulins.

Nowhere can I find anywhere that this is valid or even useful so I'm looking for specific information to give to him showing him he's totally wrong and then to show him what is used.

All I can find is people's experience but nothing in writing.  I need something in writing from a creditable source, if there is something.

I would bark like a dog if he asked, if that was the only way to to get treatment, but this makes zero sense to me and is a waste of my time and energy, especially considering I'm so sick from Chronic Fatigue Syndrome.

Thanks for the help.

Monk

[s162216]

Apr 17, 2015 19:38:47 GMT monks said:

My doctor, who is an allergist/immunologist, wants me to get a cognitive assessment prior to starting infusions then 6 months in to test if it's working. Not a psych eval, to see how my brain functions.  

During my initial consultation, I said I had brain fog, which could be from a number of things and not from low immunoglobulins.

Nowhere can I find anywhere that this is valid or even useful so I'm looking for specific information to give to him showing him he's totally wrong and then to show him what is used.

All I can find is people's experience but nothing in writing.  I need something in writing from a creditable source, if there is something.

I would bark like a dog if he asked, if that was the only way to to get treatment, but this makes zero sense to me and is a waste of my time and energy, especially considering I'm so sick from Chronic Fatigue Syndrome.

Thanks for the help.

Monk

Hi Monk and welcome to the forum,

I can't think of any reason as to why your immunologist would want you to have a cognitive assessment prior to getting IgG infusions. IgG infusions efficacy is measured by how the number of infections suffered is reduced and also the serum trough levels, so I really don't see the reason.

Speculating, the fact that he want you to have another assessment in 6 months to see if it is 'working' makes me (being from a scientific background) think that they could be doing this as a research project, but if they are and have not informed you then they're seriously breaking ethical research laws by not getting your consent to take part. I personally would bluntly ask why he wants you to have such an assessment when none of the major professional organisations for clinical immunologists say that one is needed.

I don't know where you're from, but if your in the UK then for a professional opinion I would contact Primary Immunodeficiency UK (PID UK, who are the patient support organisation in the UK, go to , or if in the USA then I would contact the Immune Deficiency Foundation (www.primaryimmune.org). We do also have details of other national support organisations on this forum under the Useful Links section.

I hope you manage to get to the bottom of this and receive your immunoglobulins as its pointless for you to have essential treatment delayed because of a dubious requirement that nobody else appears to require.

Sam (admin).

-- Sent from my Palm Pre3 using Forums

[monks]

Hi Sam, Thanks for responding. I'm puzzled because it makes zero sense. Since I posted this I found a few links for the criteria from 2 different insurance companies. They want clinical evidence. And I plan to confront him like you said. No one in the world uses this is a criteria? I spoke to my PCP for a minute about this and I think he thinks its nuts too. I don't know what my being able to figure out how long it takes a car going 25 mph to travel 87 miles has to do with this?

My difficulty getting DX'd has to do with my not having had infections in the classic sense. I've never been on ABX. I do have some but doctors don't understand Chlamydia pneumonia and Mycoplasma Pneumonia.

I'm in the US and because of my insurance I have to see someone in my plan. The first doc I saw (he's my 2nd opinion) "treatment" was more pneumococcal vaccines. This guy is an allergist/Immulogist and does a lot of asthma research. He is not a Clinical Immunologist.  I tried to get a referral the the one near me, really good one, and they won't go for it.

I've contacted the PID association here so I'll see what they say. My treatment has already been delayed (think he forgot about me) so who knows. I've been trying to get diagnosed for years so another month won't matter.

Thank.

[monks]

@the Boss. Ok I just got home from the Allergist (because that's what he is) and he is stuck on this cognitive testing. He told me because I haven't had infections (atypical presentation) he needs to find some way to show that I am getting some benefit from this, even though the symptoms he is stuck on are from my other illness ME/CFS. I had showed him some stuff I found which was more Subjective Day to Day Living stuff and he said See, this is what I want to do. No it's not what you want to do.

He says I've had no other infections but won't test me for 2 I think I have and have responded to ABX. He Is more annoyed that I got some antibiotics that I took and they helped me and at one point just said well I'm just an allergist.

He said my numbers weren't that bad so I didn't need that many antibodies but then he said IVIG which I know will be too much for me. I am getting the feeling he is just not that familiar with this and has no clue.

The bottom-line is he told me that unless I do this assessment he will not go ahead with my getting immunoglobulin. My decision is do I do what he wants which is really going to screw me up with my ME/CFS or contact an agency affiliated with my insurance and say he's withholding treatment unless I get this testing.

[hlh]

Hi Monks,

Please forgive me for my ignorance, but what is your Immunodeficiency? Is your doctor having a hard time getting coverage for your IVIg for your diagnosis?

Here's my two cents...

This is definitely an unusual request. But it is actually kind of interesting to me. Is one of your main complaints fatigue? Do you have difficulty concentrating and with some challenging mental processing tasks? It is very common when you are tired/fatigued to have some cognitive problems. From what I know about Immunodeficiencies, many folks are tired and have some improvement in their chronic fatigue with their IVIG treatment. So actually, maybe it isn't a bad idea at all to do this cognitive testing to try to quantify your improvement. If your fatigue improves with IVIG, then your thinking may too. I would certainly keep a good sleep diary as well, to see if you sleep less and/or better after treatment. That may be another way to quantify improvement.

Our doctor led us to believe that my father also had to have a way of quantifying whether a 6 month trial of IVIG helped, or his insurance may refuse to continue paying for it. Traditionally this is done by counting infections pre and post, as you say, but maybe since you don't have ?infections (confused by what you posted about this) your insurance may be demanding some sort of test.

But FYI - cognitive testing isn't a big deal at all. A few hours... no math problems at all! My Dad has had it multiple times. Totally painless.

And by the way - I'm not sure what you meant by "more pneumococcal vaccines" that your prior Immunologist recommended, but studies have shown that the Prevnar pneumonia vaccine is probably more effective in many of us than the Pneumovax. In the US, the recommendations are now for those who need the pneumonia vaccine should get both Prevnar and Pneumovax. And before my Dad started IVIg his immunologist checked his Pneumovax antibody level periodically to see if he needed another "booster".

And finally, if there is a really good Immunologist near you, why not go see him once and pay out of pocket or the additional co-pay for being out of network? I tell you... this might be the best money you can spend. They will charge you a reduced rate if you tell them it is out of pocket, and they can send their recommendations to your current Immunologist. Just be very organized with gathering your medical records, lab tests, and questions so that the visit will be very efficient.

It's tricky... I totally sympathize the difficulty trying to find a decent doctor that will work with you. It took my Dad 5 years and 4 doctors before he got to his current, decent one. But also.... my Dad would definitely not take IVIg unless he absolutely had to. He delayed it for many years until this year having a flurry of 7 infections. It certainly is great if you can avoid the inconvenience, expense and possible serious side effects of this treatment. Hopefully you'll be able to figure out with your doctor what's right for you.

[monks]

Here's the bottom line. I've had ME/CFS/Seids for over 20 years. That is the cause of 99% of my issues. I know what to do, and how to approach things.

The sole reason he wants to do this is because I have an atypical presentation without multiple infections, that I was treated for. I do however have multiple infections.

He has no knowledge or interest in my many other issues and in fact refused to run labs to test for these infections.

If all it took was getting to someone else I would have done that a year ago. I am at the mercy of my insurance unless I pay out of pocket. The appointment itself is nothing compared to the treatment..

I am changing focus right now and going to see an Infectious Disease doctor for my other issues then I'll get an advocate to appeal this.

I appreciate everyone's time. I'm done with this for now.

sacfs.asn.au/download/consensus_overview_me_cfs.pdf

[s162216]

monks the reason why he and/or the insurance company may be reluctant to provide you with IVIG is because there is little to no clinical evidence that it actually is beneficial in helping those who have CFS. Are you trying to get IVIG based on that, or are you actually getting repeated infections that require antibiotic treatment as you're unlikely to get approved for it unless they think it will be beneficial?

In the UK for example the NHS groups conditions as to the clinical evidence for IVIG's efficacy, and CFS is on the "black" list i.e where it will not be funded except in extremely exceptional cases due to a lack of clinical evidence of it being beneficial. Partially this is because of the extremely high cost (about £35 a gram!), but also as it is from donated blood plasma it is a finite resource, and every few years there is actually a shortage of it so in the UK those who have no other treatment options (like those with PID such as CVID) will get it as priority over those who have other possible treatment options.

IVIG itself is certainly not a universal placenta: being a blood product it does carry an extremely small risk of transferring infectious organisms (to put it in perspective, the last time anything was known to have been transmitted through IVIG in the UK was in 1993 and afterwards everything was massively tightened up to prevent it from happening again), plus there being the chance of side effects like with any drug.

Good luck with your doctors etc, I hope you can come to a solution with them.

Sam.

[hlh]

Thanks for this additional information, but I'm still confused. Do you have an Immuodeficiency?

"The sole reason he wants to do this is because I have an atypical presentation without multiple infections, that I was treated for. I do however have multiple infections."

This statement doesn't make sense. An atypical presentation of what? And with infections or without infections?

I think we don't know your history well enough, but that's ok. It can be exhausting having to rehash everything. But I believe Sam is correct about the one diagnosis you say you have - CFS. CFS is not an eligible diagnosis for treatment with IVIg. There have been clinical trials done already to show that it doesn't work for CFS and has a high incidence of side effects.

www.ncbi.nlm.nih.gov/pubmed/2239975

But I think you know that.

So honestly, if your doctor is willing to advocate for you to get IVIg even if you don't have a qualifying diagnosis, and all you need to do is cognitive testing, then you already have an amazing advocate. I would totally go along with doing the cognitive testing and then do a trial if it looks like your insurance will then pay for it. You have to realize that the placebo effect is very real, and since IVIG costs a small fortune they really cannot use it for non-proven diagnoses without showing that it benefits you somehow..

I'm sorry this has been a long road for you. Please understand that we are trying to help you. Good luck.