Still going uphill. Ali has surpassed me physically, to my great joy. There are moments when we both find it hard to contain the new found energy. We are also each having our own difficulties reintegrating into life again. There has been so much lost; in moments it is very hard to come to terms with where we are now, rather than dwelling on what might have been. But I can tell you with certainty that all of these lazy, crazy, faking patients will get up at the first possible moment with a burning desire to do something, anything that has a positive effect on the world. Nobody wants to be a burden. I can remember a time, not so long ago, when I thought that my husband would be better off if I died. It is going to be breathtaking to behold so many chronically ill people recover, whether it’s now with these three drugs, which I think is likely to be the case for at least some patients, or a little later, when the drug companies finally get to work on it.
The disease is a relapsing, remitting process on it’s own. Many people who get sick for the first time, get well within a year or two. However, it is rare for patients who have been sick for several years unremittingly, to get better enough to return to nearly full function. We are both now over 80 KPS points; we were at about 40 points when we quit Lyme treatment a year ago and at about 50 points when we started HAART 6 months ago. (Karnofsky performance status). It is unlikely that we are some kind of rare exceptions. We are the only patients I know of so far on three drugs for any length of time (since May). There are a few who have been taking one or two drugs for several months who are somewhat better or not better. There is a single case report on this blog of a teenager who is much better on two drugs (comments in HAART post of Aug 22). I encourage anyone else trying antiretrovirals to get in touch with me or share here.
I read things suggesting that we are the tip of the iceberg, but as far as I can tell, we are only a small handful of people. Only a very few doctors brave and compassionate enough to help. There’s an attitude that these patients don’t die, so what’s the hurry? It took fifteen years with HIV, so everyone should be patient now. But since something has been learned in the last twenty-five years, it seems to me that this time, all that experience could be brought to bear to speed up the process a bit.
I just watched a YouTube video of Dr. John Coffin at the XMRV conference yesterday, expressing his opinions about off-label use of antiretrovirals. The only thing that he said of importance was that the disease remits on it’s own, but that only makes clinical trials all the more pressing, so that we don’t rely on anecdotes. Now! Not in a couple of years when the scientists say that they have proven causation. The patients are so willing to be part of the experiment, trapped in purgatory. But the scientists are worried. Don’t mean to single out Dr. Coffin; he’s in good company. But what a bunch of fuddy duddies, practicing medicine without licenses. And their basis for opinion is what? Wish they could all spend a few hours in a CFS body. Bet they’d take a few pills and see what happens. Spend a day living with the agony of a child you can’t help, can’t comfort. It’s intolerable. So many people. While these scientists pontificate. It’s an emergency!
It’s amazing to me how respectful the patients are as a whole. There is a certain wisdom and acceptance of reality not seen in most patient groups. Nobody expects a thing. It’s been too long. We’ve become too patient. No one knows better than I do the meaning of the word can’t. It will be incumbent on those of us who recover some measure of function to fight for the others.
Tonight is the WPI fundraiser. Please donate whatever you can.
>Give me the antidote and turn me into an anecdote! I'll make a book of all the other anecdotes,Dr.Coffin,while you are gathering statistics.I don't just have CFS;now I'm old with CFS.How much longer can I wait? Karen Hart
>As Karen wrote, many of us are entering our 'older years'. My worst nightmare in the years I've been sick was to be old with CFS. Which is what I'm facing, and older means the higher chances of other illnesses.
If I were to get better I assume it would a very emotional period of adjustment. Might be some good feelings mixed with some pain, as you wrote for all the lost years.
Watching the Q&A I felt like only Judy Mikovits understands the stakes for us patients.
It was very hard to watch Dr. Stoye slap down Mindy Kitei when she asked an important question.
There are secondary gains to having CFS but they're not what the idiot docs think of when they psychologize us. It's the many ways we've learned to make a limited life tolerable. To find the tiniest of silver linings in a day when one is too weak to get dressed.
I was curious when at the Q&A when Hillary asked Judy about clinical trials and (I think that was the question) and Judy clammed up, which spoke volumes
There is absolutely no excuse for delays. I live in a neighborhood with many HIV positive gay men — some are friends — and since the drug cocktails they are mostly living healthy productive joyful lives while I remain invalided and invisible.
michael
>So pleased to see you mention reintegration issues. I've been thinking about those myself now that treatment is getting so close. My common sense tells me that you don't just pick up where you left off after 27 years of sickness compounded by neglect by society. What about the grief of lost life and, for women at least, the loss of opportunity to have children.
>I am new to this blog but I think it is fantastic, I am XMRV+ also and waiting for the WPI clinic to open up. So what comes next after your symptoms are resolved do you have to stay on the HAART protocol forever to contain the infection? What do HIV patients do?
>My understanding is that if one has a retroviral disease one is on drugs for a lifetime. It's the case with HIV positive folks.
Of course, science could advance to figuring out how to rid the body of a retroviral disease, but I think that's long ways away. I'd be more than happy to be on drugs indefinitely to get my life back.
michael
>Very experimental drug that removes HIV from the DNA of infected cells:
http://en.wikipedia.org/wiki/Tre_recombinase
>Thank you so much for doing this and reporting this. You have no idea what it means to me to read about your progress.
Eelco from The Netherlands
>Well, clinical trials seem like they'll be slower in coming than I had hoped. I think I'm going to ask my gay friends to toss me a few of their drugs to try out.:)
I think I'm going to change my life goals and work. I had to think about that a couple of years ago when I got quite well. This illness has taught me a lot.
>Thank you so much for your dedication to sharing your experience with all of us who are ill. And thanks to the other people who posted comments here. It helps so much to know that I am not alone even though I wouldn't wish this disease on anyone.
>I just want to say thank you, for sharing your progress with us.
Jannik from Norway.
>I have not heard one good reason for why a clinical trial cannot start immediately. If you have patients already diagnosed with the retrovirus, and they have no true existence, then what is stopping them? Do they not want to know if this is causing ME?
I say, get moving scientist, they is no reason to delay. Don't take another 5 years from patients.
>I also want to express thanks for sharing your process and medical insights. Also thank you for compiling the list of Essential Readings. My doctor is eager for information and this list has been a great resource for me to refer her to.
>I'm coming up for my 50th birthday and over 28 years of being seriouslt ill with ME, XMRV+ and no remission in all that time.
There will be thousands of us in my position. Growing old with the disease.
We are offering ourselves as guinea pigs as we have nothing to lose.
As we have never had a remission or any improvement we are ideal to test on.
XMRV+
>Thanks a lot for the reports.
I agree, about clinical trials. I heard in the Q&A plenty of opinionating and speechifying – where was the actual hard-core quantitative cost/risk/benefit analysis at? I was basically expecting these benevolent and technically gifted wisards to get all mathematically-economically hot & heavy 'just any second now', but no – they seemed almost content to intuit stuff, which is not really how Misters Copernicus and Bacon laid it out for us back in the times! I don't know, maybe they did an analysis earlier in the workshop – but why then, no allusion to its numerical results?
The cost of a serious trial is what, around a million bucks, or five, I'm not sure. The benefit (of doing it early) is that, say, there's (conservatively) a 30% chance that about 10 million Westerners and NE Asians (at least; some people from other countries will also be able to afford treatment) get 50% of their lives back, one year earlier than they would if we wait another year to start a trial. So the expected number of life-years gained is 10M * 0.5 * 0.3 = 1.5 million life years. You non-mathematical folks can see the principle without much trouble: if you have a 25% chance of receiving $400, then you have an 'expectation' or 'expected value' of reiciving $100. If it costs $1 to play a game and there's a 50% chance of winning $2 (otherwise nothing), then the expected payoff of playing is $0. If you play 1,000 times, you will probably break even, more or less.
Now, assuming we can get into a brutally unsentimental mood, a year of human life is worth about $50,000, because that's what the Dutch or Canadian governments will pay to medically secure one, instead of doing something else useful with the money. Therefore, 1.5M life-years are worth about $75 billion dollars. Or, 'something like that' – something 5x, 8x different at most, if the reader does not like the exact parameters fixed by me. What's 8x more or less? It don't matter, because its still a zillion times more than the cost of the trial, one way or another.
That's just the value of the joy of life. There are also concrete economic benefits. We can say that about 1.5M Americans have the illness (roughly 1% of working-age persons) and estimate their economic productivity to average 1/3 of that of healthy normals. If there is a 0.3 chance that they all get 50% better, then they add on average another 1/3 of normal productivity. The expected gain then is 0.3 * 1% * the $13T US GDP/annum = $39 billion IN THE USA ALONE.
[…]
>[…]
Now, we have allowed a 0.7 chance that the trial turns out to be nothing but a waste of effort, so that's 0.7 * a million, or five million – whatever it is. Doesn't really compare to a probabilistic expectation of $75 billion in increased Western/NE-Asian happiness, plus a $39 billion economic bonus, not of joy, but of concrete, solid goods an services (whose purpose, in economic theory, is of course to create happiness) distributed to the total US population (mostly – long story). And remember, all these estimates have *already allowed* probabilistically for a 0.7 (=70%) chance that the trial shows that treatment is useless!
There is also a probabilistic expectation of harm to the people in the trial, of course. But the analysis works out similarly to the money analysis. Philosophically it is a little different, as generally we would much rather detract 1% from the well-being of 90 people than subtract 90% from the well-being of one person. The small potential waste of money in doing the trial does not sap the finances of one person or 100 people, but rather comes from US taxpayers in general (actually, it really comes out of less interesting things NIH is doing with money it already has). Nevertheless, we will easily find that this risk is worth it. For one thing, lots of people are already assuming the risk anyway, voluntarily! And no doubt, many more would like to. That's because they intuit that the risk/benefit/cost analysis works out aptly for them to take the medications. So, by doing the trial, we are not really adding any risk to persons, that those persons don't already strongly desire to assume on their own account.
Also, this virus has been found in about 7 different labs! Don't forget NCI and CC. When we weigh that against the labs who didn't find it, we cannot say that it is definitely there, but it is really hard to say that there's less than a 50% concrete chance that it is – that's what matters. Further, even if it is there we don't know if it is causal – but we can't really deny a 50% concrete chance that it is, since there are many diseases and many microbes in this world but none provides a precedent for so many people with the same disease having the same virus as a harmless or near-harmless secondary effect of the disease. These are some of the reasons we made the conservative estimate that the trial is only about 30% likely to show a large benefit.
SO DO THE TRIAL ALREADY, YOU SLY DOGS! – oh, uh, excuse me – I believe, ladies and gentleman, that a conservative analysis tends to strongly favor a clinical trial being initiated as soon as possible – the expected benefit of not waiting another year quite substantially outweighs the expectation of costs. Thank you.
>I disagree with all the above posts. I agree a compassionate doctor can be moved to prescribe ARVs offlabel and that a bedridden patient who wishes to be dead should try to find such a doctor if they think the drugs will do them no permanent harm.
OTOH, how do you expect science to proceed until Ian Lipkin figures out why the studies are contradictory, until blood collection and testing are standardized, until viral loads can be measured, and until the pharmaceuticals start testing new drugs or HIV drugs that got shelved, on MLV's? How exactly do you expect the system to move ahead so that testing can be accurate, viral loads can be accurately measured, and drugs can come onto the market (three is very few drugs–HIV patients have around 30 I believe), that will be covered by insurance?
It can't be done. I am not upset with the scientists. Science proceeds in a certain specific way and that's the only way good science proceeds. Three drugs would be a very poor clinical trial as likely a good portion of the patients in the pilot study wouldn't tolerate all three. The trial would fail just on that measure, most likely.
I appreciated Ali's posts as she was specific about what she could do (a short walk and stretching exercises, though I'd love to know if a short walk was on an even grade and 10 minutes or 30 minutes). I don't know what general improvement means. I have no clue. I just have to take it that both Ali and Jamie feel a lot better, but the picture is too vague for me to understand. And that's another reason a clinical trial needs to be done properly, with actual measures of viral load correlated with actual measures of improvement. Self reporting is just too vague for me, anyway.
Best to all, suffering is no fun, whatever form it comes in.
>I should also add, that though I have no "right" to request it, I would appreciate a complete picture of what Jamie and Ali are doing medically–all the regular and alternative medical interventions. They are on more than ARVs. This would give me a complete picture, and perhaps help others.
>Physician Apathy Toward Patient Suffering Is The Embodiment of Harm.
I’m XMRV+ and have been on the same protocol (AZT + Viread + Isentress) as Jamie & Ali for just over a month. The refusal of so many physicians to utilize this therapy confounds and angers me.
Science has revealed which ARVs are most likely to be effective against XMRV. Compassionate medicine dictates that physicians temper this data with the patient’s quality of life and goals (among other things). Physicians who divorce this objective scientific data from subjective considerations aren’t practicing the noble art of medicine but rather some pedantic brand of science not suited for the clinic.
Unfortunately, much of the chronically-fatigued, XMRV+ population has lowered its expectations of physicians and grown accustomed to suffering. Our suffering is sufficiently profound, in fact, that many would risk our lives for a chance to improve. Meantime, so many apathetic physicians continue perpetuating a profound waste of human potential—their own and their patient’s. Such apathy toward patient suffering is the embodiment of harm.
Thankfully, my physician values her role as a compassionate healer. She embraced ARVs as the first potentially-curative treatment for my chronic illness. We discussed the risks, but she knew that my decline had been severe enough that almost no treatment would pose too significant a risk at this point. ANYONE paying attention would know this. Interestingly, the ubiquitous “concern” about ARV use has been absent during the last 20 years that myriad physicians prescribed me dozens of off-label, palliative medications. Those medications certainly caused me permanent harm, but the choice to use them was a calculated risk, as is ARV therapy. It’s that simple.
>You really hit the nail on the head by saying (the PhD researchers) are "practicing medicine without a license". These researchers are doing fantastic work, but leave clinical medicine to the clinicians.
Dr. B
>One of the saddest days of my life was the day I turned 35 and I realized I'd lived more of my life very ill with CFS than I had as a healthy individual. At this point I cannot remember what feeling healthy fealt like.
Personally I am not at a point where I am ready to try antiretrovirals. But I support those who are very ill and want to try them now. For some there is no time to wait and for those most severely ill it is a chance in some cases to save a life.
>@ Jill Neimark
I certainly agree with you that prescribing ARVs off-label is a dangerous thing to do. Although I also understand the desperate patients who want to get better. Personally I rather wait for the science to evolve, I have this disease now for many years and wouldn't take a gamble with potentially dangerous drugs. Better be safe than sorry.
But what pricks me in your story is that you're saying self-reporting is to vague. While I definetly agree with you, I'm amazed you think clinical trials are a bad thing. You couldn't be more wrong, a clinical trial would solve the 'vague self-reporting'!
You're assuming clinical trials would be a waste because as likely a big proportion can't handle these drugs. How do you know? I hope you're not basing that on 'vague self-reporting' either? Because nobody knows answer yet and that's more reason to start clinical trials.
Your last point is pretty moot too, because (IMHO) it doesn't matter if we can't measure viral load yet. In the ends all that matters is if people recover on these drugs. While there's no way yet to determine that by bloodtests, that doesn't matter, if people recover the drugs work! Is it that important, patient wise, to know the exact MoAs of the recovery? NO, all that matters is getting better!
Greets from the Netherlands
>the clinical trials could at least measure inflammatory markers to see if they change on ARV's. its true that this would not necessarily prove causation by XMRV, but it is something. they have tried antivirals of all kinds for MS, for example, without identifying a pathogen.
the problem lies in the fact that researchers do not see us as a dying group as they did with HIV. if they only knew.
it really amazes me though, how complacent they seem, knowing this is spreading right now, and via saliva too!
>Bravada Jones….i would love it if you could post your progress on the meds on one of the CFS forums (phoenix rising or http://www.mecfsforums.com/index.php)…so many people would appreciate it.
thanks
>Hi there, Netherlands. First, I didn't say ARVs were dangerous. I said that I felt if a doctor was moved by compassion to prescribe ARVs offlabel to an appropriately bedbound and perhaps suicidal patient, then I certainly could understand and even advocate it. In fact, I asked Dr D-J to assist someone I know, if she could, whom I was convinced would be XMRV positive (and who turned out to be). Her symptom profile just seemed to shout it out.
I'm not so convinced that I would be (though if a cheap universally approved test for all MLV's comes out, which it will eventually, I may test; but only if I feel there is a drug I'd like to take, and the only one that vaguely interests me at the moment is Ampligen)…
As for clinical trials, science would not be science nor reliable if it did not follow certain strict standards. I personally call the progress this year *breathtaking*!!! Alter made all the difference, as his reputation and his good science should have and did. That doesn't mean Judy Mikovits and WPI aren't heroes for getting the whole ball rolling, but good science is a community effort and there are GOLD standards. You can't just get a clinical trial up and running in an afternoon. You can conclude nothing from early and poor science. In the end, the whole world benefits from science properly done and sorry but it takes time. I have the greatest respect for scientists, and if they rush the process, they can make dire mistakes. Better not to rush the process. Let them do what they must. Top scientists are on this now. It is very exciting, even if MLV's turn out to be an important co-factor, and virulence switched on by other important pathogens (something very key to investigate, as treatment protocols would be different than if MLV's all by themselves were the alpha and omega of treatment).
Self reporting is too vague. It's interesting, and sometimes has led me in good directions, but I can't discern enough from "still going uphill."
I wish everybody the best, but to ask the scientists to rush their process is to ask them to abandon their process, and then to have unreliable results. Again, that doesn't mean a compassionate doctor shouldn't treat offlabel if he/she feels it is the best choice for a patient requesting it.
>PS to clarify–since I can't edit comments–by asking (by email ) Dr. D-J to assist someone, I did not mean practice medicine, just put them in touch for information purposes.
>thank you so much for sharing
>I was 50 when I got this "syndrome". Now I am 63. I would like a chance to talk with my wife and children and grandchildren, while actually thinking, you know? Even a few months would be better than dying in here, so far from this room and this world.
>Hey bravada,
Yes can you please report on how you're doing? Dr. D-J mentioned above that she and Ali are the only two she knows of on all three drugs, and I find that very interesting given that any doctor with understanding of AIDS and willing to treat us with ARVs would likely be worried about decreasing future resistance. It would be interesting to know how the other patients on all 3 drugs are doing.
>There has been a discussion going on on Phoenix Rising on why, based on what we know so far about MLVs, HAART by itself is unlikely to be successful for this particular brand of retrovirus. Discussion focuses on the cell's internal restriction enzyme systems to flush it out of our reservoirs (which cut the proviral DNA while protect the host genome), immune modulation to deal with cytokine storms and other immune dysfunction (ampligen, IVIG), and HAART to stop what replication does occur, as a logical 3-step approach to treatment.
http://www.forums.aboutmecfs.org/showthread.php?7403-Eradicating-reservoirs-of-HGRV
>@ Bravada Jones:
Yes, compassion's missing in the equation for ME / CFS / Fibromyalgia patients. Doctors are sitting on the sidelines waiting for guarantees as so many SUFFER. For some people it makes no sense to wait for drug studies or until they're bedridden or suicidal to start HAART. The treatment has a better chance of success if the patient isn't at death's door. It's called personal autonomy. Congratulations on being an informed, proactive patient.
>Got it as teenager, now 50s. We all have different presentations. But I live much better, just knowing the specifics of having the virus and all the other stuff. Soon others can go to WPI and really know that they have something. All of this feels like a cure after so many years of not knowing anything. A real treatment for many will come soon … and the we can watch the reputations be ruined of the quacks in high places.
>Brain is too fuzzy to say much but THANKS.
>I am only in my early 30s. I would be willing to take the 3 ARVs if I could get them and inexpensively enough. I worry that it will take years for insurance to cover them.
>Jamie: Both yourself and your daughter have a wonderful writing style and express so well the many issues we face. Have you considered submitting at least a written presentation for the upcoming CFSAC? Deadline I believe is next week.
>Hi Jamie. I hope I haven't missed your mentioning it on your blog, but I will be interested in seeing what happens in terms of the markers for underlying immune dysfunction (e.g. NKC activation, helper/suppressor ratio, Rnase-L and LMW Rnase-L) that are common in ME/CFS. That would be possibly helpful in figuring out whether the XMRV activation is the cause of those dysfunctions, or whether they are underlying issues that are contributing to the virus being such a problem for us. In general, THANK YOU for making your experience public. People with this disease are really sick, and it's time for them to start having options to get better. Best, Lisa
>Greetings….& Thank u Jamie, for putting u'r self 'out' there & speaking the Truth !
HAS ANYONE HERE,BEEN TOLD,THEY "WILL DIE SOON"?
WELL,I HAVE !
From an awesome dr, w/palliative care,who KNEW,
about 'this-these' illnesses,from,"Loosing 3
patients already" !
I am XMRV pos +….thanks,…to Dr Judy w/WPI.
I am very sick, w/over 25 yrs or sooo…of "NOT, HAVING A LIFE" !
I can barely write now,think ! or be on the computer.
BUT…..I have a dear friend, who is doing the 'research' for me…
" TO INSIST !!….THAT I HAVE,'MY RIGHTS',
TO BE ON THIS,REF.TO HERE,…TREATMENT." !!!
So, I state here, "Any One,Have any Idea's.?
..What to Join the Club ? " :)
W / "Blessing's and Light",
angel-on-duty,
14thetruth@gmail.com
>The issues with doing clinical trials now from a scientific standpoint seem to be the following:
1) We don't have a good way to objectively measure viral load or markers of infection to see if they are improving. Symptom improvement is the most important measure, but its not everything.
2) Its possible that if the clinical trial failed, it could set us back – not because the virus wasn't responsible for the illness, but because people mistakenly thought that it wasn't because the drugs picked for the trial were not the correct drugs – or because the correct drugs weren't developed yet.
3) There is a chance that even if people improve on the current drugs, they may become resistant and might not be able to be salvaged with newer drugs. This happened with HIV in the beginning, and its how they learned that more than one drug is needed.
All of those things being said – if someone has such a low quality of life that they want to try the drugs based on current knowledge and risks, they should be able to do so. Unfortunately, CFS is such an awful disease that many, if not all, patient probably fall into that category.
Potential upsides of taking these drugs outside of trials include:
1) Improvement in symptoms.
2) If you luck out and happen to pick the right combination of therapy before its "proven" by trials, you might fare better having treated the infection earlier than those who wait for the trials.
3) Anecdotal knowledge about treatments/failures/adverse effects can be tabulated loosely in some cases.
4) If people improve consistently (albeit anecdotally) it might encourage faster research and faster development of more clinical trials.
>5) Improvement on ARVs would put the final nail in the coffin of those who still irrationally think ME/CFS is an illness of psychological origin. (As if response to ampligen, symptoms history and onset, and lack of response to any known psych treatment were not enough over the years).
>Jamie, thank you for yet another great (and inspiring) post. 80 points on the KPS is no small change!
I wondered if you had thoughts on the SMART Study of ART drugs in AIDS. As I understand it, the study was designed to figure out if AIDS patients could delay starting the drugs with appropriately high immune markers, or take treatment breaks. The purpose of this was concern over the side effects and safety profile of the drugs. What they found was that patients were having progressive symptoms when they stopped the drugs — often symptoms that had been attributed to the drugs themselves. In other words, the conclusion in part was that it might be dangerous to not start the drugs as soon as possible and stay on them continuously.
I tend to think there is a moral in that for ME/CFS patients. Yes, the drugs are potentially scary/harmful, but what danger are doctors doing when they allow this illness to progress, since it clearly is progressive for many of us? What is *not* taking the drugs doing to many of us?
Also, AZT seems to be from my research the main drug of the three that penetrates the blood brain barrier, but it's also toxic to the mitochondria, which are damaged already for many of us. You seem in favor of treating with all three drugs, but what about AZT for the mito toxic patient?
Peggy
>It is very heartbreaking to read your blog. Also it's very positive to read how you are doing after/during the antivirals.
I don't have the right words, too tired right now.
I wish both of you all the best!
A ME-mom from the Netherlands with also a sick child (toddler)