Tuesday, August 11, 2009


Testing is the bread and butter of CFS investigation. While some believe that testing is useless and trial and error is the answer, this Patient Advocate believes in testing. This PA is in line with the approach of the sponsor of beatcfsandfms.com. This PA believes that the key to unraveling the disease is through extensive and repeated testing - and then a judicious trial and error. It can probe different areas and give direction, if not for now, for later.

For instance, my daughter does “regular” testing that includes CMP, CBC, thyroid panel with antibodies, iron panel with ferritin, A1C, vitamin D, and liver panel. Additionally my patient often does Coxsackie B, SED rate, CRP and EBV antibodies. A few of these tests are sent to special labs. For instance the Cox-B and EBV antibodies are sent to ARUP in Salt Lake City to do tests recommended by Dr. John Chia and Dr. A. Martin Lerner, respectively.

The following paragraphs are taken from notes made over a period of years. They include repetitions. Much of this task of being a Patient Advocate involves repetition.

Recently my patient has repeated a few key tests Redlabs (now know as VIP labs), in Reno, NV. Redlabs is an extension of Dr. De Meirleir’s operation in Belgium, and they provide a key service for CFS patients in America. They primarily test for RnaseL Elastase, Immunobilan, and metals sensitivity (HELP or Melissa). This is the only lab that provides such testing in the US.

My patient is housebound so a phlebotomist comes into her home to draw blood. The patient and the PA go carefully over the test instructions. The package is sent overnight to Redlabs. My job is to keep after the shipment. Sending overnight blood samples is not without problems.

The Patient Advocate calls Redlabs to find out if they have received the sample in a timely fashion. It is important that the blood sample arrived within 24 hours. In this case, after leaving several unanswered messages, the PA learns that the vials had arrived and that the work on them had started. The results will be faxed to the doctor in two weeks time. The PA duly notes this and phones back in two weeks. The NK cell and Immunobilan have been sent to the doctor. The RnaseL will take a few more days and it is suggested that the PA phone back on Friday. Meanwhile the PA goes after the doctor’s office and again has to deal with a machine. The PA wonders if anyone will pick up the message and certainly the PA has no confidence that they will call him back. Often calls to an office machine go unanswered. The job of the Patient Advocate is to keep after these offices to fax the test results.

The PA must be aggressive and be willing to irritate people with polite assistance. A particular lab might identify you as a PA and try to shut you down immediately. They are used to talking to the top dog. They don’t like little dogs. However there is information that they are allowed to release. The PA has to keep after them. Leaving messages is for the birds. They will not be returned. You just have to keep calling.

Once you identify that the tests are in a particular office, and once you get to talk to a real person, then you try to get them to fax the items to a particular number. Sometimes this goes smoothly, but often it does not go smoothly. Perhaps I am in NY doing another job that is parallel to the PA job: raising money to pay for this “research” and treatment. In NY I do not have a fax machine. Perhaps this is an oversight. Perhaps I should have purchased a mobile fax machine to carry around with me. Instead I have the fax sent to a corner store. I walk down and talk to them, telling them that I am expecting a fax. Often, when I drop by later, it still has not arrived. This can be for any number of reasons, as you can imagine. At other times I am in MN. Here too I do not have a fax machine. In MN I use my office away from home, the local Kinko. Sometimes the fax shows up, at other times, no. The majority of time I am in Haverford PA and I use the fax machine at the local college. Gail H. is very helpful with informing me of an incoming fax. The other gal, while polite, has slight interest. I have formed a friendship with Gail H, that allows her to help me out. Needless to say I pay the college nothing for the use of their fax machines, thinking instead that it is a professional service provided to me for my “academic research”.

Among many other things, the Patient Advocate will follow up with various labs to find out when the tests are complete. You might ask why is this necessary? I will tell you. It is necessary in order to get to the next stage: hassling the doctor’s offices for the results. If you did not follow up in an aggressive manner, you would never, ever, get the results. And let us remember that these tests are not cheap. The recent Redlabs work is going to cost around $1200, and the chances of insurance reimbursement are zero. Both private insurance companies and Medicare are allergic to paying for CFS/ME. This is not surprising as the United States Government medical wing, the CDC, cannot come to grips with CFS/ME. To them it doesn’t exist.

This test will confirm an elevation of RnaseL, as well as equivocal NK cell function. Additionally my patient did a repeat Immunobilan test to determine IgA and IgM for gut dysbiosis and leaky gut. The tests are done to get an angle on the viral end of things

Different situations require different solutions. Oftentimes the solutions are complicated and detailed and confusing. For instance the PA might want to get a certain blood test or two done on the patient. On the surface this might seem to be a simple task. However, it is far from being simple; it is a nightmare. The patient in this case is homebound. The patient’s case in itself is precarious. The lifeline to drawing blood is a phlebotomist from a local private services. At the beginning, the phlebotomist charged us $50 for a draw. Later she increased it to $80 for special times. Now it is $80 for all times. The phlebotomist used to have a fax, but that no longer works. Instead the phlebotomist has a cell phone that she answers when she feels like it. Often the PA does not hear back from the phlebotomist for a week. The appointment with the phlebotomist is apt to be canceled by either side. Perhaps the patient does not feel up to the draw; perhaps the appointment interferes with the patient’s boyfriend’s nap; perhaps the phlebotomist herself is sick or has taken a fall. Are you beginning to get the picture? Let me draw it out further for you. The PA lives in Philadelphia. The patient lives in St. Paul MN. There is one thousand miles between these two cities. It is a three-day drive, or a three-hour plane ride. Plane tickets need to be secured by the PA so that he can be present for the blood draw. In other words, the PA is not overly excited about spending five hundred dollars and spending a number of days MN in order to have the blood draw not take place. I can hear you now asking the obvious question. Why is it necessary that the PA be present at the blood draw?

That is a good question. Usually it is not necessary. Usually the phlebotomist takes the samples to M. Hospital, where they are processed. However this current set of tests is not the routine to M. Lab. This set of tests go to Quest in New Brighton, MN and needs a delivery boy. The Patient Advocate becomes the deliver boy. On a certain Monday I meet the phlebotomist outside of the patients’ apartment. It will be sunny, raining or snowing. Who knows? After the draw the PA will scurry up to Quest Diagnostics to give the samples to Nurse L. Quest is in New Brighton, twelve minutes away. The PA has scoped out the Quest location and knows how to get there (even though he is from Philadelphia), but will need to check for highway construction. The blood has to get there in 15 minutes. Nurse L. has helped me with these tests before. Nurse L. is a great helper, one of the best. I have called Nurse L. many times, just as I did over a year ago. I remember then riding my bike down near the river in St. Paul and hearing my cell phone; I stopped my bike at the side of the road and tried to pull it out in time to get the call. It was Nurse L. returning a call, and everything was working out, the blood was on its way to CA.

This was the second or third time that these labs go to Focus Labs in CA. The first time they were sent to the wrong lab in CA and that was a useless enterprise. This PA was interested in getting results from the lab used by Dr. Montoya.

Just this last week there have been a number of calls and emails going back and forth between Nurse L. and the Patient Advocate. Nurse L. wants to make sure that everything works out. Nurse L. informs me that she needs the doctor’s requisition ahead of time, and also the specific test information so that she can fill out the forms and have everything ready to get in the overnight mail to Focus Lab in CA. Nurse L, nor anyone at Quest has ever done these tests, so this is a new one for them I faxed Dr, T and Dr. G, hoping that one of them will come through. So far I heard from Dr. G and sent that along to nurse L. Nurse L is set. Dr. T has not responded. I think she is getting less and less interested in this case. Hopefully the patient will get better - so that she can get another doctor, a doctor who is a little more responsive and human. Everyone has their problems, but Dr. T is like Dr. Gaschet. She is afraid of the sight of blood. Anyway nurse L is set now. The phlebotomist can come at the proper time. The phlebotomist knows what vials are necessary and the PA know where Quest lab, so this test has a good chance of getting to Focus Lab in CA in good shape. The preparation takes time. Information is difficult to come by and the PA must nose it out. A few people might be slow on the uptake so the PA needs to be a little bit pushy. What is the alternative? I am paying over $500 for a ticket to MN - so this needs to happen.

You might want to ask what is this test? This time we are doing Focus lab test number 2340 – Chronic Fatigue Panel III. A certain amount of research as well as phone calls determines that this is the test to do. It includes EBV EA, EBV IgG, EBV IgM, HHV6 IgM, IgG, CMV IgG, IgM, Coxsackie B, Interferon Alpha and NK cell activity. We recently did NK cell through Redlabs - so this test is a backup of that. It is like you cannot get enough information on these items. Either that - or none of it is worth anything. Which is it? One year ago we did the EBV and HHV6 tests. Focus is the lab used by Dr. Montoya - and they tend to get higher titers than other labs. With these results the PA can make comparisons, and Dr. G can make decisions about going forward with antivirals. So that is one of the tests that we are doing. Are you interested in hearing about another one? This is fascinating isn’t it? One to the problems with being a PA is that the PA cannot get enough of this stuff. I am glad that you feel the same and want to hear more. Here it is:

In a previous paragraph I have spoken about the blood work that needs to be done and the arrangements that this process takes. Scheduling the phlebotomist is pretty easy. It is important to get a good phlebotomist, as this makes a big difference. I suppose now that you are asking, what is the big deal. The person just takes blood, what is so hard about that? Well I can tell you that it makes a big difference. Phlebotomy, like many things, is a special skill. The phlebotomist needs to be able to establish a bond of trust with the patient and reassure that patient that all is going to be well. For instance we already know that taking blood out of a patient is a stressor. In this disease almost anything is a stressor. The fact that this phlebotomist has established the trust of the patient and draws blood very easily and well is worth its weight in gold. We have a terrific phlebotomist, the strongest link in the chain.

Also the PA must press on with testing and various programs. It is the nature of the disease that not many options are viable. Very few therapies bring results, and often they are not noticeable. Very few tests shed much light on the situation, although it is possible to get a slight angle on one particular aspect or another. The bottom line though is an expensive form of disappointment.

At other times, the PA must force the situation to do tests that in their very nature can bring upset with the results. Take for instance the Translocator Protein test from Acumen labs in the UK. This test on my patient yields very depressing and discouraging results. It indicates, to the degree that it can be believed, that the functioning of the mitochondria is very poor. Certainly the condition of the patient is reflected in this test. What the exact cause is or the exact treatment is, no one knows. What is clear is that something is remedially messed up. Certain parts of this negative result are more curable than others and can be measured again.

Recently we have undertaken to repeat this test. The hope is that various parameters have improved with treatment. The symptoms of the patient meanwhile have been on a slight upward tick. As with other tests, perhaps an improvement can be sensed. On the other hand, there is no guarantee of improvement in any parameter, and the picture also might be drawn the same or worse. In a way, it seems preferable to not repeat this test and just hope for the best. However, believing that the truth holds hope, the PA forces the situation, spends the additional $1000 plus $250 expedited FedEx shipment in order to get more information -in hopes of being able to draw a more perfect picture. Certainly one would want proof that basic parameters are better - SOD, CoQ, magnesium, B12 and thyroid. Spinning off these improvements along with other therapies, one would hope that time itself would aid in the healing. So the Patient Advocate has anxieties here, about doing these tests and about fielding the results. Doing these tests disturbs the life and sleep of the PA. Just the filling out of the forms and the drawing and shipment is a big problem. Imagine finally getting the report back, and trying to sift through the results. It certainly is possible to discount the entire enterprise and hope for the best, in spite of the results.

But what about doing this test, this set of mitochondrial tests in the UK. How does it happen? How can you get blood samples from here to the UK and have legible work done on them? As usual arranging for this test takes a great deal of research, as well as a great deal of communication with folks in the UK. My patient was one of the very first USA persons to do this test in the UK. My patient has a very hip PA.

The Patient Advocate will read the results of this first test, almost two years ago now. The results made for disturbed reading not only because they were difficult to understand (the idea of the mitochondria itself is incomprehensible to the PA), but also for the problems that they announced. Two years later, the PA still reads through the detailed analysis trying to make heads or tails of this essentially very bad news. And this is only the first test. The second test was done almost a year later, and was more specific and stranger in its negativity. The upshot is that the PA wonders how much damage has been done here and is any of it correctable? The PA understands that this test goes into one disturbing area of CFS, but perhaps not an essential one. The subject is disputed. Other CFS doctors emphasize other tests. Only a small fraction of CFS patients get this mitochondrial test done. The real implication of the test is unknown. However, with this in mind, the PA is looking for two things in repeating this test. The first is confirmation of the initial results. The PA knows that tests are tests and they do need to be substantiated. The second thing that the PA is looking for is improvement in a few areas, indicating that these therapies are making inroads into the pathology of the disease. On the one hand, the PA does not want to look, or the other, the PA does want to look – dismissal, fear and hope sit side by side on this one.

Most of the other test items of CFS are vague and offer the hope or possibility of getting around something. This mitochondrial test is frightening in its specificity, and in the possibility of no change or a worsening of the test results or a broadening, without any significant dent being place on the pathological entity. Still the emphasis has to be placed on the possibility that sections and subsections can be identified and dealt with.

The PA must arrange for test kits to be sent to the patient. These might be from Vitamin Diagnostics, Diagnos-techs, Viracor, Metametrix, Genovas, LabCorp, Acumen, Biolab, Redlabs Belgium or other labs. The PA must arrange for requisitions from doctor’s for tests. The PA must chase down test results. The patient can do various tests directly. Often they are recorded online. Often the situation does not work very well and the PA must make an effort to try to retrieve the test results. At times this process can take days or weeks.

The PA has to keep all variables in mind. The PA must pour over test results and think about the implications. For instance just today the PA has been examining a test result from about a month ago. The PA looked at this test result when it came in, copied the sheets and sent them to the various doctors. At times the PA might be able to get an interpretation of them, but more often the PA is on his own, and he must nose out by himself what these tests mean. Often it is clear-cut. It is obvious when a selective IgA deficiency shows up, particularly when it is not the first time. Viral titers are another thing. The quest for a viral involvement goes on and on, with contradictory interpretations. Things come and go like in an inkblot drawing. Everything is shifting, nothing is clear. For instance take the instance of Coxsackie B. What to do with this? Does my patient have coxsackie b involvement or not. Does my patient have lyme disease involvement or not? It is difficult to tell.

Recently the patient has had a series of blood tests done. These tests are both routine and specialized. The routine tests go off to various places including ARUP labs in Salt Lake City, Utah where EBV and Coxsackie B panels are done. The EBV panel is a special kit by The PA writes up the request for the physician and faxes it to her office. In time the signed requisition ends up at the patient’s home. The patient arranges for the phlebotomist and the blood is drawn. Off it goes to various labs. In time the PA will have to go after these results. Otherwise the PA will never see them. They will just disappear into a drawer. For instance it has now been two weeks since the blood has been drawn, and there is no sign of the routine part of these tests. This part of the tests takes a few days to process. Sometimes the results are mailed to the patient’s home. At other times they have to be extracted from the physician’s office. This is the way that it is done in MN.

The other set of tests are sent to Redlabs (now VIP labs) in Reno and are reported back to a different physician. The same problem presents itself. How does one get ahold of the results? Getting the tests done themselves also takes effort. Part of the problem is that it is the Patient Advocate’s idea to have these specialized tests done. Therefore it falls upon him to get the test kits, then to have the doctor sign and fax the requisition and to make sure that the blood gets to the lab in a timely fashion - and that the lab is clear on the correct tests to be done. This all takes a great deal of time and many different phone calls, as both offices, the doctor’s office and the lab office, are partially dysfunctional. Then there is the problem of having to retrieve the results from the doctor’s office. And then there is the problem of determining what, if anything, the test results might mean.

Certain things have changed since the last Translocator Protein test of one year ago. In the first place the patient is now taking a regular dose of thyroid. A year ago this was not true. In January or February 2008 my patient got on 120 mg of Armour. In the more recent Translocator Protein test we would look for an elevation of the low levels of cristae. Low levels of cristae are associated with poor thyroid function. That could be one positive step. We have another test that indicates a higher ATP over the last year. Perhaps this test also would show betterment in ATP production? What we can make of the DNA fluorescence binding, who knows or God knows? We might look for decrease in calcium at the outer Mito membrane. At the same time as beginning Armour, my patient started the methylation protocol. Already it has shown some benefit and will continue to do so. It might help regulate this high calcium. The increase in glutathione, indicated in the Vitamin Diagnostics test, also might be helpful in getting some of these substances off the Translocator Protein function. My patient now uses nickel free cookware, so maybe the nickel will come down, and also she is doing the FIR sauna. My patient also takes a detox cocktail and the methylation protocol and Yasko protocol is seen as a detox element. We will see also whether the potassium or zinc will get better also. Getting rid of the nickel will be important. So we shall see.

It turns out that the more recent test for mitochondrial function has improved. Indeed the cristae have improved, the nickel and pbbs are gone, the ATP is functioning better and other parameters are improved. The use of the FIR sauna, the avoidance of stainless steel, the Myhill energetics, the methylation supplements, all seem to have helped to bring improvement. The question is, when will the fatigue lift?

We live in a quite amazing age, one where many sophisticated tests can be done out of the home. These do not include important tests like Echo tests, or SPECT scans, or sleep studies. It is important to do these items is the patient can get to a hospital. Once the patient becomes too sick to go out, this avenue is cut off. It is an important argument to press forward when the patient is half sick and get what information is possible. It is not a great idea to sit around and wait. This disease can get worse, and often does, in spite of rumors that it does not worsen, or is not a progressive disease. Those patients who do not give this disease its proper respect will pay the consequences. You must do things when you can. If you do not do this, the patient paints themselves in a corner.

My patient also regular does tests that measure gut ecology. These can be done through Metametrix’ GI Effects test or Genova’s CDSA or Redlabs Belgium’s microbial stool analysis. Various pathogens, parasites, candida and a host of other items can be done. These can be very important tests as can saliva tests from Diagnostechs measuring cortisol or blood tests from Vitamin Diagnostics measuring methylation, ATP and NADPH. Primary home tests can be done with organic acids and amino acids from various labs. These tests provide important information on various urinary metabolites both for diagnostic work and for tracking.

An amazing little test is the Immuknow test from Viracor which measures ATP, and is used mostly for transplant patients, to monitor treatment. Dr. Ablashi told me about this test, which is used by a few CFS patients.

There are other important tests, and you can nose them out.

The Patient Advocate and the patient have an array of home tests from which to draw. Collectively these tests provide valuable information that circles around the edges of this illness, the center of which remains unknown. In approaching this kind of testing do not expect much help from either Medicare or private insurance. Occasionally they will make a mistake and give a reimbursement, but I don’t count on it. Instead I put my mind to where I can get money to pay for these tests.

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