More money and what’s really important

Every CFS patient with federally sponsored health insurance has experienced firsthand that it is very poor coverage for anything but the most mainstream care. However, now all of a sudden, some expect the WPI to provide boutique care for what Medicaid will pay. And cure everybody of an incurable disease. On the first visit.

Let’s see what mainstream medicine has to offer. Here are the Mayo Clinic guidelines for CFS: link. That’s what Medicare will pay for, and they say right there that they think IVIG and antivirals don’t work, so that finishes the discussion of expensive treatments. There were comments yesterday that there are a few CFS doctors that accept Medicare. If that’s true, then what’s the problem? My mail indicates that the best known CFS/Lyme doctors do not accept Medicare, let alone Medicaid, or they have other ways of generating income. But if they do take it, then there’s less of a problem if we can’t. And we can’t for now – not won’t or don’t want to.

It is impossible to budget without knowing in advance the percentage of federally insured patients that will want to be seen, but it is likely to be high. Medicare will pay if you need a million dollars worth of ICU care, but they won’t pay a few hundred dollars for you to be seen by a doctor that has the time to listen and think about a complex history. I have no interest in discussing the state of the health care system. We all know up close and personal how bad it’s gotten. It would be better if doctors worked for love instead of money like Mother Theresa, but apparently there aren’t many that do, or the clinic would already be up and running.

I’m certainly not going to touch whether doctors are worth what they expect to be paid or not. I do think everybody needs to remember that whatever a doctor’s fees, he or she doesn’t take it all home. There are many expenses involved in running a medical practice, including but not limited to malpractice and other insurance, rent or maintenance on the space, salaries, supplies, accounting and legal fees.

As for whether the WPI should have a clinic that treats a volume of patients, or just be doing a few clinical trials, that decision has already been made. Annette Whittemore’s vision of translational medicine included treating patients from the beginning. Bench to bedside to bench. The clinic exists. It is a very large space, capable of seeing a large volume of patients. There are many patients asking to be seen. In an amazing display of synchronicity, all of my professional and many personal experiences are a piece of what’s needed to organize it. Although there are many ways in which I am the right man for the job, I’m also sick and that is far from ideal, but no CFS/neuro-immune disease knowledgeable doctors have stepped up to the plate. So it seems to be my fate. I appreciate all the support from the community that I am receiving. I will do my best not to disappoint.

What are we going to offer that’s different? Medical decision making will be influenced by continuous interaction with the research lab and physicians around the world. We’re going to keep track of a large number of patients, so there is an opportunity to contribute to the greater good of the community. We are going to have doctors who are not wedded to their particular black box protocol and who are willing to consider all therapeutic options for each individual they care for, whichever neuro-immune disease cohort you fall into. We can’t offer a magic bullet that doesn’t exist, but we will be looking for one, and if we find it, you won’t have to come to Reno to hear about it. We’re going to offer quality care; that’s not unique, but there’s precious little of it to go around. We’re going to treat some patients for free as soon as we can. That unfortunately is pretty much unheard of.

There will be no solicitation of any kind. There will be no products pushed or sold. Nobody who has any questions about our motives need come. This is a unique endeavor. No one has helped us before, so we are going to help ourselves. Of course I hope that the ME/CFS community is behind us. I have no illusions about being able to be all things to all people. The harsh realities of practicing medicine preclude that, but we will do our best to serve our patients and the larger community as well.


“I can make more generals, but horses cost money.
Abraham Lincoln

As expected, there are many comments and letters this morning about money. Many ask that reconsideration be given to accepting insurance assignment. I have promised transparency and money is always one of the hardest things to talk about openly, but here goes.

For a number of excellent legal reasons, the institute and the medical practice are separate entities. There is NO money to float the expenses of the clinic while waiting for collections. So if there is no cash coming in immediately, we can’t open. It’s that simple. We have no subsidy. We may be able to revisit accepting insurance later, but for now, if it isn’t fee for service, there will be no clinic. I wanted to accept insurance. Everyone at the WPI wanted to accept insurance. It isn’t possible at this time.

The idea that the institute should fund large scale clinical trials is not realistic, since the government has no interest in funding XMRV research and the drug companies won’t go to work until the detection/causation issues are worked out. The funds actually need to flow the other way, from the clinic to the institute. The reality is that the patients are going to need to fund the research. Not fair, but true. So yes, once again, the patients get screwed. Money has a way of highlighting difficult reality.

People have asked if we could charge a higher copay for Medicare/Medicaid patients. It is illegal to balance bill federal insurance. Also accepting Medicare/Medicaid is an all or nothing proposition. You have to play completely by their rules or opt out all together. They don’t allow a middle ground. The government thinks a 20 minute visit is adequate, particularly since there is no treatment. We are not going to fix the system; it is broken and cannot be fixed in it’s current form.

I am assuming that everyone realizes that paying the provider is only part of paying the bills. Even if I could figure out how to fund the startup, and even if we used PAs instead of doctors on the frontline, the numbers don’t come close to working out. Personally I prefer PAs, because in general I don’t like doctors and, as a group, PAs tend to be more compassionate and detail oriented than doctors. However a physician is still necessary to supervise and bill for PA services. Also insurance won’t pay for anything telephonic and that will likely be a significant part of follow-up care. Mid-level practitioners would make it possible for ongoing care at a distance to be less expensive.

There is clearly a huge need for a consultation service for patients who can’t leave home. It is illegal to prescribe for a patient that has not been physically seen within a period of time, as it should be, but we will interface with local doctors to help encourage appropriate care. Eventually, we would like to partner in some way with like-minded local physicians to become satellites of sorts. Care needs to be available everywhere. All suggestions will be considered.

Lots of mail about how to get cheaper doctors from overseas or other kinds of discounted help. People have made suggestions such as using PAs for poor people and doctors for rich people. I can tell you clearly now, nothing like that is going to happen. The providers will be of the highest caliber or we will not open. There will not be two tiered care. I am unwilling to deal with the administrative difficulties of a sliding scale. But there will be a wait list for free care. The physician group will donate a percentage of time to patients who cannot afford to be seen – percentage to be determined when we have some real numbers to look at. We will ask that patients who can afford it donate for patients who cannot pay. Any ideas about how to fund for this group of patients is appreciated.

Rest assured that I too have lived the downwardly mobile life of a CFS patient. When I left practice, we had substantial savings that is now gone, having spent an unbelievable amount of money on $500/hr doctors and uncovered IV antibiotics for two people. I am determined not to do that to others. I hereby promise that nobody is going to get rich on the budget I’m putting together. Salaries will be fair, but we are looking for people for whom it is more than a job. The purpose of the clinic is to treat individual patients, but because of the translational medical approach that will be engendered by existing in concert with the research lab, there is a bigger purpose as well.

There will be no attempt made to “entice” patients to travel to Reno in order to make money, as someone put it in an email. Success would mean no need for patients to travel. Time will tell whether we offer anything new and different or not. I share the dismay of many as to how ineffective prior attempts at improving outcomes have been. One of the most upsetting things to absorb from the epidemiological study that is my mail is that the patients who have avoided doctors and expensive treatments have generally done better than many who have pursued endless aggressive experimental treatments. My impression is that the chronic Lyme patients are sicker and have more pain than the CFS group. That may have something to do with Borrelia burgdorferi infection, or it may have more to do with all the antibiotics these patients have been exposed to. Which doesn’t mean that antibiotics aren’t an essential part of treatment for some. As I’ve said before, I am not against the use of antibiotics, any more than I am for the use of antiretrovirals. I am for what works that doesn’t harm. I am in favor of making all treatment options available and tracking response in collaboration with the research lab. The goal is to develop a coherent approach to treatment that is finally informed by research and understanding the nature of the disease.

Back to work

I’ve accepted the position of Director of Clinical Services for the WPI, or the Center for Neuro-Immune Disease as the clinic will be called. I am currently recruiting in earnest. Physicians, nurses, PAs, practice manager. We are planning to open in May, but that is of course completely dependent upon finding the right doctors. A few good men or women. If you are out there reading this, please get in touch. It’s a phenomenal opportunity to be part of something unique from inception. The space is amazing and Judy’s lab is down the hall. I’m still too sick to rely upon this body to see patients scheduled a long way in advance, but I have a background in Emergency Department administration, physician recruiting and management. And I know the enemy intimately. In fact, all of my experience, as a doctor, a patient and the mother of a patient, seems a part.

I see it as a primary care emergency. There are already a huge number of patients on an interest list, even though a trip to Reno is a daunting proposition for most. My mail is full of tales of unbelievable neglect by the medical profession and the care that has been rendered has often been more harmful than helpful in hindsight. Most are lacking a local physician with even a basic understanding of their illness. Whatever care they have had has been idiosyncratic, hit or miss. Whole families need to be hooked in to appropriate care. CFS parents with autistic kids. There’s never been a systematic approach to either illness.

Since many patients will be traveling to be seen, and many have never had a chance to tell their story to a doctor who wasn’t trying to escape from the room, first visits will be two hours, revisits an hour. For those needing long distance follow-up by Skype or phone, it will be available with your physician or physician extender. Continuity of provider will be a goal, but there will be continuity of care that will allow transitioning easily to a new doctor if there is no chemistry or if there is staff turnover. We are forming a Physician Working Group to help us think about a decision tree. Consensus is too much to expect, but I’m sure we will learn a lot and it will shape the thinking of our doctors. Patients should be able to expect a uniformity of approach, but not a cookie cutter protocol.

I’ve looked hard at accepting insurance and unfortunately have concluded that it isn’t possible to offer quality care to this group of patients at current reimbursement rates. Medicare/Medicaid simply won’t pay the bills. Private insurance generally doesn’t cover out of state care anyway and patients are going to come from overseas. Any way we structure it will be unfair to somebody. Whatever fair physician fee we will need to charge, the travel costs will be the biggest chunk anyway. I have read rumors on the internet that range from the WPI is going to see patients for free to it’s going to cost some crazy amount. It looks like it will have to be a cash practice, hourly fee to be set, but I can say for sure it will be at the lower end of the CFS/Lyme/alternative doctor fee scale. We will provide a superbill and documentation to support a claim. Fully operational, the clinic should generate income that will be donated back to the WPI and the research, percentage of gross to be announced at year end. We intend to have a fund for patients who otherwise cannot access care as soon as we are in the black.

When I started this blog, it was pretty much of a personal rant from the perspective of a disabled doctor. I have a bigger responsibility now, but I want to continue to share my experience openly. One of the many unusual things about the people running the show at the WPI is the clarity of their intention to help. A major intention of mine is to end any feelings that there is something worth knowing that is secret. Secrecy in the face of a public health emergency is a travesty. Anything but collaboration to ameliorate the unbelievable suffering is intolerable. Going forward, what we learn will be incorporated into the thinking of mainstream physicians everywhere so that care will be available locally. At this point the treatment options worth considering are limited. With a large patient volume and a group of physicians sharing with each other and with the scientific team, it should be possible to look at these options systematically.

Down the road, I’d like to be able to offer comprehensive care, including an extended stay to begin rehab, though it’s just a twinkle in my eye at this point. We will offer the opportunity to be seen on more than one day during a trip. We’ve traveled for care to be seen for an hour and it’s a miserable experience. There’s a wonderful opportunity in Reno for someone to take on a Ronald McDonald type house, if you are out there reading this.

We are in the special position of being a startup, so we’re going paperless. I’m looking at Electronic Medical Record systems now. We will be able to search charts horizontally, by medication or other intervention, symptom, particular abnormal lab result, pretty much anything we want. Many who write want to help in some way and there will be collective value in contributing to our database. The doctors on the frontline will be sharing with the best and most experienced clinicians and scientific minds from around the world; they will know what the current options are and how to think about them for a given individual. My vision is to create what I needed fifteen years ago when I first became ill, and again seven years ago when it happened to Ali and my husband. We were never even diagnosed properly due to the incredible ignorance surrounding this disease. We are going to change all that.

Leaving for Reno again on Monday night. I’ll do the wheelchair thing and use oxygen in the plane this time. Pace myself while I’m there. Grumble. Grumble.

10 months

I was pretty sick when I wrote my end of the year post. Right after I wrote it, I came down with an upper respiratory infection that I am still recovering from. The rest of my family now have it too. I’m not back to where I was a month ago, but I am approaching function again. This episode has reminded me of how grateful I am not to feel like that all the time anymore.

My Hard Truths post hit some readers like a wet blanket. In particular, there are some patients who are noticeably improved after a couple of months of treatment and already feel that antiretrovirals are worth it for them. Ali, who was the skeptic when we began, has been reminding me of how much better we are than when we started. I was most definitely writing from a place of personal disappointment, having gotten so close to where I need to be for productivity. Perhaps I was feeling the need to say something to moderate the enthusiasm I expressed months ago, since it clearly is not a slam dunk, at least for patients who have been sick for a long time. Perhaps I was expressing my frustration that this far into it, the science has not progressed enough to enable adequate assessment of what the drugs are doing, but neither Ali nor I have any thought of stopping them.

We do unfortunately find ourselves back in that place of “fiddling around the edges” as a friend put it in an email. My New Year’s resolution was to get serious about supplements again (I have difficulty swallowing pills), in the hopes that it will be more productive now that we are healthier. In the early years of my illness supplements and botanicals were more noticeably effective than they have been in recent years; maybe they will be again. I have been struck by the fact that any intervention mentioned, no matter how benign, seems to have made somebody worse, including supplements. Personally, I have never found a supplement to be anything worse than useless.

It still seems intuitively obvious to me that preventing infection of new cells is a good idea. The drugs we are taking, that have tested against XMRV in vitro, interfere with early stage replication events only. They do nothing to prevent provirus from producing viral product and fueling persistent immune activation. The HIV model continues to fit very well, complemented by what we know about simple animal retroviruses. Here are a couple of good papers about HIV that also shed light on the downstream effects of XMRV/HMRV’s:
Antioxidant protection from HIV-1 gp120-induced neuroglial toxicity. Walsh
HIV-1 viral proteins gp120 and Tat induce oxidative stress in brain endothelial cells. Price
Another MLV paper that fits our evolving model:
Activation of Transcription Factor Nrf-2 and Its Downstream Targets in Response to Moloney Murine Leukemia Virus ts1-Induced Thiol Depletion and Oxidative Stress in Astrocytes. Qiang
Here is an interesting, well referenced paper (unpublished):
HIV infection in children – neurodevelopmental (autistic) outcomes and clinical pathologies – and their correlations to idiopathic autism. Lozac

My opinion is still that patients have the right to consider antiretrovirals as one of their treatment options. My goal here is certainly not to aid the considerable forces that want to shut down that option in any way, but to have it be an informed decision in light of the anecdotal evidence that we do have. It bears repeating here that doctors do this every day with less evidence and much more dangerous drugs than the drugs under consideration here. What must be said is that the response to antiretrovirals has been mixed, though there has been some success. It does not appear that anyone has been harmed. I still believe that there are compelling reasons to consider antiretrovirals for certain, but certainly not all, X+ CFS patients.

There continues to be tangible progress towards making the WPI’s vision of collaborative science and medicine a reality. There were lots of curve balls in 2010, but it’s a new year, if not a whole new ballgame. We are gaining momentum. A team is assembling. We finally know how to think about the disease. A coherent approach to treatment is within reach at last. There is a rapidly evolving framework for considering the needs and best options for an individual patient. We have an unprecedented opportunity for scientists and doctors to work together to move our understanding ahead as quickly as possible: understanding to translate into clinical successes. The obstacles are considerable, but failure is unthinkable. Breaking new trail is never easy, but was there ever a group of patients who needed new trail more desperately?

Do not go where the path may lead, go instead where there is no path and leave a trail.
~ Ralph Waldo Emerson

Letter from Annette Whittemore

January 1, 2011
XMRV: A Human Retrovirus with Unknown Pathogenic Potential, Not a Lab Contaminant
The recent proclamation that “XMRV is not the cause of CFS,” came from an individual who did laboratory experiments to show how PCR experiments can become contaminated. These results have nothing to do with the reality of a disease or the methods used by those who have detected XMRV in the blood and tissue of patients found to be infected.    The positive studies, which cannot be explained away by PCR experiments, are those which have used multiple methods to show that XMRV is a live replicating gamma retrovirus in human blood and tissue samples using the gold standard methods of viral isolation and antibody testing, in addition to PCR. Unsupported conclusions, such as the one offered by the Wellcome Trust spokesman, often create sensational headlines but do little to move science forward. Authors of the positive XMRV studies have been extremely careful not to claim causality, realizing that more scientific research is required to make such a statement. However, one fact still remains clear. Not one of the negative studies changes the results of the scientific research done by Lombardi et al., Lo et al., Urisman et al., and Schlaberg et al.
The WPI-led scientific study, which rigorously ruled out contamination, revealed high associations of gamma retroviruses with physician-diagnosed CFS patients, using four different methods of detection. Recent commentary associated with the negative research papers on XMRV, which used only one testing method, claimed that these studies proved that XMRV was not the cause of human disease. On the contrary, what the authors of the “contamination studies” confirmed is something that most experienced scientists already know; there are risks associated with using PCR if one does not properly control for contamination. They cannot conclude that other research groups had the same problems or that “XMRV is not the cause of CFS”.
Most significantly, the recent Retrovirology publications failed to address the most important pieces of scientific evidence of human infection in the previous XMRV studies, including the fact that XMRV positive patients produce human antibodies to gamma retroviruses, XMRV integrates into human tissues, and infectious virus has been cultured from the blood of hundreds of patients with a diagnosis of Chronic Fatigue Syndrome and M.E. Humans do not make antibody responses to mouse DNA sequences from contaminated lab experiments. The Retrovirology studies only point out that XMRV research cannot be done in a mouse laboratory without extreme caution and should not rely solely on PCR methods.
Many researchers realize that the question of gamma retroviruses and human disease cannot and should not be dismissed lightly. Retroviruses integrate into their host’s DNA causing life long infection. Human retroviruses, such as HIV and HTLV-1, are causative for immune deficiencies, neurological disease and cancer. Animal studies involving XMRV demonstrate that the virus moves quickly away from the blood to various organs within the body, such as the spleen, lymph nodes, GI tract, and reproductive organs. This helps to explain why the virus is difficult to detect in blood even as it replicates in the tissues of those infected.    Other studies using mouse models of Murine Leukemia Virus infection, a close relative of XMRV, have shown significant tissue involvement soon after infection, resulting in many physical symptoms of disease including cognitive deficits and immune deficiencies, symptoms which are well documented in patients with XMRV associated diseases.
Many anxious patients have asked, “Where do we go from here?” and “Is this the end of XMRV research?” The answer to the second question is an unequivocal “no.” As to the first question, a quick check of the status of ongoing research in various labs confirms that the research groups who have been working on XMRV over the past year are still hard at work developing better assays to check the world’s blood supply for the new retrovirus, finding correlates of immune dysfunction, engaging in animal studies, extending their findings to other groups of patients, and in general, enthusiastically continuing their research. They understand that novel scientific discoveries, which threaten current dogma, will continue to be challenged until the evidence can no longer be denied. For instance, there are still those few who question the fact that HIV is the cause of AIDS.    It took Nobel Prize winner, Dr. Barry Marshall, 17 years and three trials in which he infected and then cured himself of H-Pylori associated ulcers, before the medical world would accept the fact that the bacterium causes the disease. Today we are engaged in a new battle to prove that human gamma retroviral infections, such as XMRV, are underlying pathogens in neuro-immune diseases and untold cancers.
It is clear that more research must be done to clarify the role of gamma retroviruses in human disease. However, when a pathogen such as XMRV is found in over 80% of those tested with the same diagnosis, causality is clearly a reasonable hypothesis that begs further scientific and medical research. It is a known fact that important questions of causality can often be answered through well designed clinical trials. For those who have suffered for years from these debilitating diseases, novel drug trials cannot begin soon enough.

WPI’s collaborative research projects are revealing the infectious and inflammatory nature of neuro-immune diseases, providing strong evidence against the use of CBT and exercise therapy as rational “treatments” for those who are ill. Such knowledge underscores the urgent need for much more private and federal funding of biological research to provide diagnostic tests and effective drug therapies for the millions who are ill, stop the spread of infectious retrovirus(es), and end the devastating cycle of disease.

Annette Whittemore
Whittemore Peterson Institute

Link to original letter

Reentry Phenomena: Part 7

by Ali Deckoff-Jones

      As the New Year dawns, I find myself feeling hopeful. When I look back on the past year, I can see that I took many small steps forward, each one a progression towards being back in the real world. This is a huge change, because for so long the only way that I could get through the days was to come to a state of acceptance of my limitations. I learned to appreciate the small pleasures – things as minor as reading a good book or watching my favorite TV show – because I truly believed that was all I was ever going to get out of my life. I oscillated between overwhelming depression, because I felt that my life would never be meaningful, and acceptance of the fact that I had to keep living, regardless. Now, as I look forward on a fresh new year, I no longer imagine myself locked away at home, never allowed the chance to chase my dreams.

      In November, I set a huge goal for myself: write 50,000 words in 30 days. On November 29th, I crossed the finish line, finishing off my project with 50,103 words. The novel needs a tremendous amount of work and re-writing, but the fact that I was able to finish at all seems nothing short of a miracle. I wrote an average of 1,666 words each day, which took a solid hour and a half. It is amazing to me that I was able to commit to such regular mental exertion, and for the prolonged period of 30 days, but that wasn’t even my biggest success that month.

      Every week, I met up with local writers who were also participating in NaNoWriMo, so that we could cheer each other on. Going out was hard, as I suffered from regular episodes of dysautonomia and never felt truly ‘well,’ but the push was worth it because I got to socialize with other writers my age and remember what it is like to be out in the real world. I never felt ‘normal’ exactly, but, for a time, I was distracted from my illness and able to meet people outside of my family sphere.

      One of the new friendships that I made quickly developed into something more, and, for the first time in over four years, I entered a romantic relationship with someone local. At the time, I knew that it would be short-term, because he would be moving mid-December, but the chance to feel connected to someone new was a wonderful opportunity. He was amazingly understanding of my limitations and the realities of my illness, and never made me feel less-than because I was sick.

      For many years, I had given up on the idea that I would ever meet someone. I felt that it was unlikely that anyone existed who could deal with my illness, and even if they did exist, I wouldn’t want to drag them down with me. But he helped me realize that someone might actually want to be with me, despite my illness: that I might actually be worth the extra trouble.

      I have let my illness define me for so long, but now I am starting to see the person I have become separately from my CFS. I am a person living with illness, yes, but I am a person first and foremost.

      Of course, despite these massive gains, I am still a CFS patient, and as we all know any big push leads to a crash. By the time my boyfriend left mid-December, I could feel myself going downhill. I spent the second half of December in a post-exertional malaise fog, and am just now starting to turn the corner. The crash itself was not severe – mostly just an increase in fatigue, coupled with some inflammatory symptoms (mild-depression, irritability and skin-inflammation). I was still free from the overwhelming pain and malaise that was my constant before I started the ARVs.

      For me at least, it seems that the ARVs are slowly helping me along the road towards better health. They are not a cure-all by any stretch, but I believe that they are the reason for my steps forward, and that I am better than I would be without them. The improvements may be slow, but any improvement in quality of life is worth it to me. While my pain and fatigue are much decreased, some symptoms seem harder to budge, like my dysautonomia, poor circulation and the post-exertional malaise. It may be that some symptoms will take years to dissipate, as the infected cells in my body slowly die off, and are replaced with healthy cells. Or it could be that I will have to wait for XMRV-specific drugs, before I will see the large-scale improvements I am looking for.

      Either way, I will keep enjoying the small improvements that I have been afforded. The uphill trend is not steady, but rather, for every two steps forward I take one step back. As long as the steps forward outnumber the steps back, I will remain hopeful.