Lightning Book Review: How To Wake Up

Posted on August 19, 2013 by Jennie Spotila

It’s time to debut a new sometime feature on the blog: Lightning Book Review, quick reviews of about 500 words to give you my bottom line opinion. Our debut is Toni Bernhard’s new book, How To Wake Up, officially released next month. Toni provided me with an advance copy of the book for this review, and I’m working on a longer piece to explore some issues more deeply with her.  For now, here’s my Lightning Book Review:

How To Wake Up (HTWU) differs from Toni Bernhard‘s first book, How To Be Sick (HTBS) in a few ways, but the most significant difference is the intended audience. HTBS was focused on people with chronic illness, but HTWU is aimed at anyone interested in trying to find more peace and contentment in his or her life. You do not have to be a Buddhist to follow Toni’s advice (I’m not), but this book does provide a nice introduction to Buddhist principles.

The first part of the book explores the three life experiences that all humans share: we are subject to impermanence and change; there is no fixed unchanging self; and we will encounter suffering. The second part of the book focuses on cultivating wisdom, mindfulness and open-heartedness – the key mental states that can help us deal with the three life experiences.

Toni’s tone throughout the book is gentle and practical. She shares what she has learned, and encourages the reader to try some of the practices she suggests. Toni’s writing feels like a friend reaching across the table to pat your hand and offer advice. There is no preaching or judgment here. HTWU is structured like a path, with each chapter building on those that came before. In contrast to HTBS, this book’s practices are arranged around spiritual principles, rather than specific situations like loneliness or pain. That being said, many of the practices and techniques can be used to cope with aspects of chronic illness, or indeed, any kind of suffering.

One aspect that I found very appealing is Toni’s emphasis on the fact that everyone – even the Buddhist masters – must practice. Every day, every hour, can bring new challenges and mental habits are deeply entrenched. Those practices, such as choiceless awareness meditation or sequential sensory mindfulness, are simple (but not easy!) and intended to be helpful.The reader can adopt an experimental approach, trying the practices that appeal and noting whether it helps or not. Everyone is different, and this is not intended to be one size fits all advice. Patience and compassion for yourself is the first step, and no one becomes an expert or finishes this process.

Life is difficult, and everyone faces pain and loss. Toni says the goal is to engage life as it really is. Wishing for life to be different only increases our suffering. We have to acknowledge how things really are, and then find a path to Let It Be. This is not letting go of negative feelings in some kind of “I’m ok with this/it doesn’t matter” way. Letting it be is acknowledging your pain or difficulty, and finding peace with its presence in your life. Depending on your perspective, this may sound like a lot of woo. But I did not find it to be unreasonable or trippy.

In my own personal experience, the greatest challenge of living with ME/CFS has always been finding the path to emotional equanimity. I am already in enough pain and have endured enough loss. Finding a way to be calm and still find joy in life has been the true struggle. I found many suggestions in How To Wake Up that may help me do that.

 Bottom line: Recommended

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Hypersensitive

Posted on August 13, 2013 by Jennie Spotila

pillbottleFDA recently issued a warning about the risk of rare but serious skin reactions to acetaminophen. Widely known by the brand name Tylenol, acetaminophen is an active ingredient in many prescription and over-the-counter medicines for pain, headaches, migraine, cold and flu. ME/CFS patients may be using Tylenol or other prescription medications containing acetaminophen, such as Tylenol with codeine, Percocet and Vicodin. A list of prescription medications containing acetaminophen can be found here.

The risk of liver damage associated with acetaminophen has been known for many years, but the risk of skin reactions was found during a review of FDA’s Adverse Events Reporting System. The conditions include Stevens-Johnson Syndrome, toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). These conditions are truly serious, may require hospitalization and can result in death.  Trust me, you don’t want to Google for images of these skin reactions – they are gruesome.

I thought that skin reactions to medications only occurred when you first took them, like an allergic reaction. But I had my own frightening experience when I developed hypersensitivity to a pain medication several years ago.

I had been taking this medication (not related to acetaminophen) for several years, and it was wonderful for my pain. While on vacation, I developed a spreading skin reaction. It was more than a rash; my skin grew bright red in large raised patches that burned, and even felt warm to the touch. They seemed to start on my abdomen and spread out towards my limbs over the course of a day. I was feverish, achy, and felt like I was in a full-blown crash (which was possible anyway because of being on vacation). It was unlike anything I had experienced, and I was scared.

Given the experiences of many other ME/CFS patients, I knew it would be best to avoid an emergency room if possible. I didn’t want to risk being dismissed or disbelieved, and even the best emergency room care would come with many hours of waiting and noise. Instead, we relied on the hotel house doctor who diagnosed the rash as a medication hypersensitivity reaction. I had never heard of this, but you can develop drug hypersensitivity at any point during the use of a medication. He prescribed steroids to stop the reaction, told me to discontinue the drug, and prescribed an opioid medication to prevent me from experiencing withdrawal from the original medication. It took more than a day for the steroids to stop the reaction, and even longer for my skin to return to normal. I consulted with my regular healthcare team after returning home, and I was advised to never take that original medication again because of the serious risks of hypersensitivity reactions. Even a single dose of the medication would trigger the same painful reaction. The loss of that single pain medication from my regimen started me on a year-long search for the right combination of drugs to adequately manage my pain.

If you use any products containing acetaminophen, be careful not to exceed the daily recommended dose limits (from all products combined). Be watchful for skin reactions, even if you have taken the medication for some time. If a skin reaction occurs, do not delay in seeking medical treatment. Some of these types of reactions can cause disfigurement or even death.

Like many ME/CFS patients, I take multiple medications for pain management and other symptoms. Taking acetaminophen seems so innocuous and low-risk, but all of our medications come with risk. We have to be knowledgeable about our meds, their risks, and watch for any changes in our bodies. Almost all ME/CFS patients are sensitive to medications, even in small doses, so be sure to report any unusual side effects or reactions to your healthcare team right away. I waited a full day before seeing a doctor, and I was very sick and miserable as a result. If it happens to me again, I won’t wait!

 

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Need to Reality

Posted on August 5, 2013 by Jennie Spotila

One of the key moments of the April FDA meeting on drug development for ME/CFS was when Bernard Munos said that ME/CFS patients will have to collect and pool their data to attract the interest of big pharma. Many advocates were dismayed by that comment. How can we collect our data? We have no resources. We’re too sick!

Enter PCORI. The Patient Centered Outcomes Research Institute was created by the Affordable Care Act, and is a non-profit organization funded by the federal government. Their budget is huge: $320 million for FY 2013 alone. And they fund research, lots of it. In May 2013, PCORI issued a funding announcement for patient-powered research networks and it could not have come at a better time. Up to $1 million per project is available to help fund data infrastructure to collect and pool electronic data from patients in order to facilitate clinical outcomes research, which is exactly what Munos told us was needed.

Two different ME/CFS projects were proposed, one led by the CFIDS Association and one led by the Open Medicine Institute. In full disclosure, I was one of many advocates consulted by the CFIDS Association in preparing their Letter of Intent, but I have no formal affiliation with the project. Both projects were supported by multiple patient organizations. Neither the CFIDS Association nor OMI were willing to tell me on the record if they were invited to submit a full proposal.

Both organizations already have the beginnings of patient centered research networks. The CFIDS Association has a nascent research network through the SolveCFS BioBank. For the PCORI proposal, the CFIDS Association went big and partnered with Patients Like Me, one of the largest patient-powered research networks in the country. Patients Like Me has almost 10,000 patients in the ME/CFS community on its site, and has the big data expertise to create systems to capture both clinical data/electronic health records and patient reported outcomes. OMI has been building its own online patient data system. They recently received a grant to build a “new personalized medicine infrastructure.”

PCORI has set aggressive goals for the projects it funds under this opportunity. During the 18 month period of grant, funded projects must achieve the following: Membership must reach 0.5% of the US population with the condition; patient-reported data must be collected from at least 80% of the participating cohort, patients must be fully involved in network governance, and data must be standardized and suitable for sharing with other infrastructure members.

These patient-powered research networks are not just big databases sitting in server rooms. Patients themselves must be in control of the data and governance of the network. This would be a first in the ME/CFS community: none of the existing biobanks and databases are governed by patients. Traditionally, the non-profits and researchers have determined the features of these databases and how they will be used. But PCORI is requiring direct governance by the network participants themselves. This will be a unique challenge for either proposal. Getting back to the advocates’ reaction to Munos, we’re too sick! So few of us have the capacity to serve on steering committees and boards of directors, and those that have capacity are already involved (often in multiple contexts). A proposal from the Association or OMI will have to think beyond traditional forms of governance in order to collect the input and opinions of the network membership.

Another challenge will be privacy and confidentiality. Patients Like Me pools anonymized data and sells it to partners, and OMI is a for-profit health practice. Participants in either network should pay attention to the consent agreements and understand exactly what will be done with their data. PCORI networks will collect more than just demographic data. Other collected data will include patient-reported outcomes instruments and electronic health records. Managing and protecting the privacy of participants will be one of the challenges for network governance.

So what’s next? Full proposals for PCORI funding are due September 27, 2013 and funding would begin in January 2014. Let’s hope that at least one of the ME/CFS proposals is successful. One million dollars would go a long way towards building what Munos said we needed: a patient-powered network of data that can be shared with researchers and form the basis of treatment trials and biomarker identification. If there is any disease cohort that needs this kind of jumpstart funding, it is the ME/CFS community.

Update August 13, 2013: The CFIDS Association announced on its Facebook page that it has been invited to submit a full application. Dr. Suzanne Vernon said in an email to me, “The CFIDS Association partnered with 10 organizations and were invited to submit a full application to compete for $12 million that will fund 18 patient-powered research networks.  Our full application is due the end of September and organizations are notified of awards in December.  I am hopeful we will have a very competitive application!”

 

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Answering Attacks

Posted on July 31, 2013 by Jennie Spotila

When I posted about the “truthiness” I saw in a comment by Dr. Mikovits, I expected criticism. I’ve heard from folks in the comments, on Twitter and Facebook, and by email. I think some of the points and questions raised are worth addressing directly.

Why bring this up now?

I didn’t raise this issue out of the blue. Dr. Mikovits posted a comment to the FDA docket and it appeared on July 25th. I posted about it on July 29th. There was nothing to the timing besides that sequence – her post appeared, and I wrote about it here.

You’re driving a wedge into the community.

No, I’m not. I am speaking honestly about a deep divide that already exists. The online patient community became polarized very quickly between those who believed the XMRV finding was correct and those who did not (or had doubts). The fights were nasty, and we’re seeing some spillover in the comments on my blog post. We did not just discuss the science during that time. Aspersions were cast by both sides, including accusations of bias and ulterior motives, and this is continuing today. These exchanges were (and are) quite toxic, and this environment drove many people out of online participation. I’ve received several direct messages since I put up my blog post that were supportive, but the individuals were unwilling to post publicly.

I am not trying to increase the toxicity at all. My sense of the community is that everyone would like to just move on, and forget the details of what happened. I understand that desire. I am playing the unfortunate role of pointing out the elephant in the room, and I know many people would like to pretend the elephant isn’t there. But the only way to avoid stepping in all the elephant poo is to admit it is in the room and deal with it.

It was all Dr. Silverman’s fault.

First of all, that’s not accurate. Second, my post detailed some of the steps Dr. Silverman took to correct his mistake. I admire him for doing so.

Dr. Mikovits got a raw deal, and admitted there was a mistake.

Yes, Dr. Mikovits said at the September 18, 2012 press conference on the Lipkin study that XMRV was “simply not there” and that she was “100% confident in the results.” I give her a great deal of credit for doing so. It’s never easy to admit a mistake, and Dr. Mikovits did so publicly and after three years of defending her original results. That must have been very difficult, but she did it and that is a good thing. The point I made in my earlier post was that the evidence was there well before September 2012.

The WPI-Mikovits implosion and the resulting legal cases were shocking. Just when I thought things could not get more wild, they got wilder. It’s a huge mess and I have no idea who is right and who is wrong. Usually, these kinds of fiascoes involve right and wrong on both sides, and if I had to guess I would say that is the case here.

You are a mouthpiece for the CAA, and they’re evil so you are too.

I am not a mouthpiece for the CFIDS Association. I have no formal relationship with the organization anymore. Opinions and views expressed on this blog are my own, unless otherwise noted. My views are similar to those of multiple organizations and individual advocates, but I am not trying to represent anyone but myself. At some point, it may be relevant for me to talk about an “inside” view of XMRV and the CFIDS Association, as I was on the Board from 2009 to 2011, but I don’t think it’s pertinent today.

There is evidence that ME/CFS patients (and other patient cohorts) are infected with gammaretroviruses.

There is no published data supporting the assertion that ME/CFS patients are infected with gammaretroviruses. All the papers showing such data were retracted by the end of 2011. There may be unpublished data, but it needs to be published in a peer reviewed journal before it can be considered valid. I don’t follow the literature for other patient cohorts very closely, so I can’t say for certain whether data has been published on that point.

Let’s just move on.

“Those who cannot remember the past are condemned to repeat it” – George Santayana

 

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Facts, Not Spin

Posted on July 29, 2013 by Jennie Spotila

I need to speak out about something, in part because I’m afraid no one else will. I’ve been following the comments posted in the FDA docket on ME/CFS, and I came across this comment from Dr. Judy Mikovits:

During the 2 minute public comments at the April meeting, a comment was made about the XMRV debacle in CFS. This comment highlights the political bias against this patient community as the mistake of XMRV was made by Robert Silverman and Joe DeRisi in their 2005 prostate cancer research. Yet their mistake was used to brutally attack the ME/CFS patient community, its researchers and physicians. This should NEVER happen again.

This comment is rife with spin and inaccuracies. I could fall down the rabbit hole of the XMRV saga to refute this and re-tell the story accurately, but I’ll confine my comments to what Dr. Mikovits actually said in this statement.

“. . . a comment was made about the XMRV debacle in CFS. This comment highlights the political bias against this patient community . . .”

I checked the transcript of the FDA meeting. The only statement that matches what Dr. Mikovits said is this quote from Dr. Kalns: “And I don’t want to step on any toes or get anybody ruffled, and I am very cognizant of the XMRV debacle.” (FDA Transcript, April 25, 2013, p. 187). That’s it. That’s all he said. There is no political bias in that statement against the patient community or anyone else. Dr. Kalns’ comment was not even about XMRV; he was looking for collaborators who could provide saliva samples from ME/CFS patients. In fact, at the entire two day meeting, there were only two references to XMRV and neither one contained anything negative against the patient community.

” . . . the mistake of XMRV was made by Robert Silverman and Joe DeRisi in their 2005 prostate cancer research.”

Technically, yes, Dr. Robert Silverman made a mistake. But in 2005, no one knew that XMRV was a lab recombinant virus. Dr. Silverman found XMRV in prostate cancer samples and published that data in 2006, just as Dr. Mikovits found XMRV in ME/CFS blood samples and published that data in 2009. It was not until 2011 that it was conclusively shown that XMRV originated in the lab and had contaminated both sets of samples. The problem is not that Silverman or Mikovits published data later shown to be mistaken. What matters is how each scientist reacted as the negative evidence accumulated.

In May 2011, Science published data showing that XMRV was actually a recombinant of two different mouse viruses that occurred during the serial passage of human prostate cancer cells in mice. Science also issued an Editorial Expression of Concern (more on that in a second). We now know that Dr. Silverman actively looked for contamination in his samples from the ME/CFS study, and in September 2011 he voluntarily retracted that data from Mikovits’ original paper. But Dr. Silverman did not stop there. He published two more papers reexamining the original premise of XMRV in prostate cancer tissue. First, he showed that there was no XMRV present in the original prostate cancer tumor that eventually gave rise to the retrovirus. Next, he showed that there was no XMRV present in a number of other prostate cancer samples and conclusively refuted his original claim that XMRV was associated with prostate cancer.

Dr. Mikovits, on the other hand, had a very different reaction to the unraveling of XMRV. Science’s Editorial Expression of Concern in May 2011 said that, “the association between XMRV and CFS described by Lombardi et al. likely reflects contamination of laboratories and research reagents with the virus.” Apparently, Science had asked the authors to voluntarily retract the paper in a May 26, 2011 letter, and Mikovits refused, calling it “an extremely premature action.” When Silverman asked Science to retract his data in September 2011, the other co-authors on the paper told Science that they had verified their own samples were free of contamination but were unwilling to provide that data for verification. Science editor Bruce Alberts later revealed that Science sought agreement from all the authors for a full retraction. Wrangling over the wording of that retraction went on for months. Ultimately, Alberts said “they simply had been ‘spun’ by the authors too many times for too long,” and so Science unilaterally retracted the paper on December 23, 2011. Mikovits did not publicly agree that there was no XMRV in ME/CFS patients until the Lipkin study was published in September 2012.

The mistake of XMRV was not in Silverman’s or Mikovits’ original papers. The mistake of XMRV was Dr. Mikovits’ stubborn refusal to see that the recombinant data made it virtually impossible for her original data to be correct. If she had impartially reexamined her data in light of those findings and the findings of the Blood Working Group, I think she could have agreed to retract the paper in September 2011 (if not earlier).

“Yet their mistake was used to brutally attack the ME/CFS patient community, its researchers and physicians.”

No one attacked ME/CFS patients/researchers/physicians because Silverman reported finding XMRV in prostate cancer. No one attacked us because Mikovits reported finding XMRV in ME/CFS patients. In fact, for the first few months after the Lombardi paper was published, there was great interest and support from experts like Dr. John Coffin, Dr. Jonathan Stoye, and Dr. Dusty Miller. Even the federal government (with the exception of Dr. William Reeves at CDC) demonstrated proper initiative by creating two task forces to address the safety of the blood supply.

The attacks came later, but in my opinion those attacks were partially in reaction to the behavior of Dr. Mikovits and other members of the ME/CFS community. Dr. Mikovits and WPI engaged in rather public feuds with Dr. Myra McClure (more here) and Dr. Frank van Kuppeveld about their methods and results. Dr. Simon Wessely and others began speaking out about death threats allegedly received from ME/CFS patients (a few examples here, here and here). But the worst attacks were within the ME/CFS community: patient on researcher, doctor on researcher, researcher on patient, patient on patient. If you participated in any of the online communities during that time, then you know that we were at least as brutal to each other as anyone outside the community was to us.

“This should NEVER happen again.”

It shouldn’t, but it will. There will be another splashy result, another paper that seems to change everything. There will be a renewed flood of interest in the disease and the research finding. And detractors and true believers will emerge from every corner and the fight will be on. I hope it won’t be as bloody a fight as XMRV, but we need to be ready for it.

And that’s why I’m speaking out now. We have to deal in facts, not spin. We have to remember what really happened with XMRV if we are to avoid repeating some of our mistakes. One of the most damaging outcomes from XMRV is the reinforcement of the belief that ME/CFS patients do not support good science, that we throw our support behind individuals and organizations instead of results, and that we behave badly when those individuals or organizations are being criticized. Our credibility was damaged, regardless of which side we were on or how we participated in the controversy.

My hope is that we will learn from this, but to do so we have to be honest about it. I can’t stay silent in the face of this kind of spin. Spin quickly turns to legend, and then becomes accepted as fact. This is very dangerous because if we believe the hype instead of the facts, we will lose sight of the truth. The truth is that since the Lipkin study results were published in September 2012, there has been a growing tendency in our community to downplay what happened. Dr. Mikovits has been increasingly seen as a victim of WPI, rather than as one of the primary players in the controversy and the long winding road to resolution. I don’t think any single person is to blame here, and I do not have a personal ax to grind. But to blame the “XMRV debacle” on Dr. Silverman and others outside the ME/CFS community is incorrect and incomplete. Many mistakes were made by many people. The only way we can learn from this and do better next time is to see and remember those mistakes accurately, not as we might wish them to be.

 

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Drug and FDA News, July 2013

Posted on July 25, 2013 by Jennie Spotila

The big BIG reminder for the ME/CFS community is that the public comment docket on drug development for ME/CFS will close on August 2, 2013. As of this morning, there are only 201 comments! That’s disappointing, given that FDA said it received 750 comments regarding Ampligen. We should not let this opportunity slip by! Remember that you can submit written comments (including attaching a document) or a link to a YouTube video. Take a minute and submit your comment now.

Other FDA new items of interest:

  • FDA is hosting a webinar on Draft Guidance to Industry on Developing Drugs for Rheumatoid Arthritis this morning at 11am. The webinar will be archived for later viewing. I’ll be watching to see what I can learn about FDA’s process of developing guidance for industry, since FDA has committed to doing so for ME/CFS.
  • FDA is hosting a public meeting for patients, caregivers, and advocates on Demystifying FDA: An Exploration of Drug Development. The meeting is all day on September 10th in Washington, DC and it will be webcast. You do need to register in order to watch the webcast. The agenda has not been posted yet, but this should be a very educational meeting.
  • One of the most common pain relievers is acetaminophen, available both by prescription and over the counter. FDA recently cautioned consumers about the dangers of taking too much acetaminophen. Before I found a pain management specialist, I took ibuprofen and acetaminophen over the counter for my pain and probably took too much on occasion since my pain was not being adequately treated. Just because something is OTC does not mean you can take large doses. And given the fact that ME/CFS patients take many drugs off label, we have to be especially careful about dosing and combination.

 

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How To Be Sick (Giveaway!)

Posted on July 15, 2013 by Jennie Spotila

I have been a fan of Toni Bernhard’s book How To Be Sick since it first came out in 2010. There is now an audiobook version available, which is fantastic for people who are too sick to read, and we have FIVE free copies to give away!

If you are not familiar with How To Be Sick, I highly recommend it. I reviewed the book in 2010, and since then it has become a reference book that I turn to again and again. Toni writes with such compassion about her own experiences, and gives the gentlest advice. Like anyone with chronic illness, I struggle with guilt, anger, grief, envy, and a host of other negative emotions. It is such a heavy burden to carry, heavier than the physical suffering of ME/CFS. I am blessed to have strong support from family and friends, and I have developed a steadfast spiritual faith as well. I view life as a learning experience, but despite all of these emotional and spiritual tools I still sink into that quicksand of emotional suffering.

How To Be Sick has helped me start coping with that burden. Toni recommends many spiritual practices, but two that have helped me the most are weather practice and compassion. Weather practice reminds me that emotions and moods are ephemeral, and that unpleasant emotions will change, just like the weather. The harder practice for me is to direct compassion towards myself and my body. I can be brutal to myself with blame and reprimands. Toni’s advice has helped me start to give myself the same compassion that I would offer to a loved one. These practices cultivate acceptance of reality (we are sick) without surrendering hope. Although both Toni and I have ME/CFS, one of the great strengths of the book is that its tools are helpful to people with any chronic illness and their caregivers – the advice is is truly universal!

Now Toni’s book is available as an audio recording (find it at Audible or Amazon). I will be buying a copy for those times when I am too sick to read. I also anticipate that listening to Toni’s advice (read by Deon Vozov) will help me hear and internalize it better. Thanks to Toni, you have a chance to win a copy of the recording through Audible.

To enter the giveaway: Leave a comment right here on this blog post telling me whether you have tried listening to audiobooks instead of reading. FIVE winners will be chosen at random from among the comments.

Notes: US residents only at this time (we’re checking to see if international is ok). You are eligible regardless of where you live (Thanks Audible!). Be sure to provide your email so I can contact you if you win. Entries will be accepted through 11:59 pm Eastern, July 21, 2013. Winners will be announced on July 22, 2013.

Five comments were selected at random using a random number generator. The five winners are Susan Sahler (#2), Kathryn (#8), Mona Neikirk (#23), Nancy Lanzalotto (#32), and Valerie Free (#46). You have been sent an email with instructions to receive your book.

Thank you to everyone who visited the blog and left a comment! And a huge thanks to Toni for making this giveaway possible, and allowing me to help out!

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Data Queen

Posted on July 10, 2013 by Jennie Spotila

One of the biggest weapons I have in the fight against ME/CFS is data. I keep track of my activities, medications, sleep, and symptoms daily, and over time that data can be very powerful.

I’ve blogged extensively about wearing a heart rate monitor, and I wear it almost every day. The beeping when my heart rate goes too high is an immediate and valuable signal to everyone around me that I need to rest, or just stop for the day. I’ve developed a good sense of the kinds of activities that trigger the alarm. Climbing a flight of stairs is ok, but not too fast. Pulling a couple weeds is ok, but more than five minutes of weeding (even sitting down) is too much. Making jam is possible, but with plenty of breaks.

In January, I added a Fitbit to the mix. There are many types of Quantified Self devices, and I think ME/CFS patients can use them to gain better control over their own self-care, and contribute to research at the same time. My Fitbit tracks the number of steps I take each day, and the number of stairs that I climb. You can also use it to track your sleep, although I don’t bother with that. As I said at the FDA meeting, having the Fitbit pedometer data helps me track how physically active I can be. The recommendation for healthy people is to take 10,000 steps each day. My biggest day so far this year was 3,360 steps. So my maximum effort is still only 33% of what a healthy person should do. My worst day was 337 steps, only 10% of my biggest day. That’s an extraordinary range between good and bad, but my overall average is about 2,000 steps per day.

Think of what we can do with this kind of data. Right now, I’m trying to determine what my safe maximum steps might be. Let’s assume that 2,000 steps is my safe max. If I’m running behind on a particular day with only 1,500 steps near bedtime, I can be a little more active. The reverse is also true. If I hit 1,500 steps at 11am, then I have to really slow down for the day. Tracking steps can also help me monitor any progress or increase in my capacity. And in a clinical trial, tracking patients’ daily steps would be a much better way to measure physical capacity and improvement than a questionnaire or single walking test.

The other tracking “device” I use is plain old pen and paper. For years, I have kept a daily log of how much I slept, my activity (both quantity and type of activity), my symptoms and my medications. You can download a copy. My doctor reviews my logs at each visit, and at the end of the year I calculate my weekly averages. I’ve kept these logs for fifteen years. Imagine how valuable this kind of longitudinal data could be for researchers! It’s also been helpful in my ongoing disability claim, because I can document my activity and symptoms levels over time.

It takes a little bit of discipline to fill out the log sheet every day and remember to sync my Fitbit. It also takes time and some data aggregation to be able to spot trends, set goals, and identify factors that help or hurt. It’s not a perfect system. My biggest need is a way to track cognitive effort beyond hours spent on the computer. A Fitbit for the brain would be excellent! But with a little effort, I am able to collect data that helps me and could help researchers in the future. What would be fantastic is if we had a way to capture all this data electronically and then analyze it all together. I suspect it is only a matter of time before those tools exist.

 

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Two Is Better Than One

Posted on July 3, 2013 by Jennie Spotila

My confidence in two-day cardiopulmonary exercise testing (CPET) is pretty obvious on this blog. A new study from ME/CFS experts Dr. Chris Snell, Staci Stevens, Dr. Todd Davenport, and Dr. Mark VanNess supplies hard data that shows how important a two-day maximal CPET is for diagnosis and documenting ME/CFS. The Physical Therapy Journal has made the author manuscript available (behind a paywall), and so that version I review here is not necessarily the final version that will be published by the journal.

The purpose of this study was to establish whether the objective measurements in CPET could distinguish patients with CFS from healthy controls. The study enrolled 51 female CFS patients and 10 female sedentary controls. The CFS patients were diagnosed using the Fukuda criteria, and they also reported symptom exacerbation after activity. All subjects completed two maximal effort CPETs conducted 24 hours apart. Unfortunately, the study did not include testing for post-exercise gene expression (like the Light study). No evaluation or follow up is reported, so we do not know how long it took the subjects to recover from the testing.

In Test 1, the CFS patients did not perform as well as controls. Multiple measurements were lower in the CFS group, including VO2max, peak workload, and workload at the anaerobic threshold. However, only the peak workload difference was statistically significant. In Test 2, the differences were quite dramatic. The controls performed the same or even better on the second test. But the CFS patients demonstrated a drop in VO2max, oxygen consumption at the anaerobic threshold, peak workload, and workload at the anaerobic threshold. The mean for the last value – workload at the anaerobic threshold – dropped by more than 50%. Respiratory measurements prove that all subjects gave a maximal effort in both tests, so the reduction is not due to lack of effort.

So what does this mean? The inability of people with CFS to reproduce their CPET results on day two is extraordinary. The authors state that it “could be utilized diagnostically as an objective indicator of abnormal post-exertional response, and possibly even a biomarker for this condition.” In fact, statistical analysis of the results correctly classified CFS patients and controls with 95.1% accuracy.

Healthy individuals stay below the anaerobic threshold most of the time. But this study showed that for many CFS patients, even activities of daily living require them to push past their anaerobic thresholds. My own test results demonstrated the same impairment. This could explain not only our limitations on good days, but why those limitations shrink during post-exertional malaise.

This study demonstrates the importance of using a two-day test protocol. While there were differences between patients and controls on the first day, only the CFS patients demonstrated a dramatic drop in performance on the second day. This significant reduction in performance appears to be unique to CFS. A recent study in patients with sarcoidosis (an inflammatory condition) failed to find any difference in CPET results between patients and controls, despite using a two day protocol.

One of the questions this paper cannot answer is: why? What do these results tell us about the underlying cause? The authors say, “It is very possible that a synergy of small effects across multiple systems is responsible for the poor exercise performance of the individuals with CFS in this study.” The results are consistent with reduced oxygen carrying capacity, possibly due to low blood volume, cardiac abnormalities, or autonomic dysfunction.

The conclusion of the paper is worth quoting at length:

In conclusion, a serial CPET protocol with measurement of expired gases demonstrates efficacy in distinguishing between individuals with CFS and sedentary, but otherwise healthy controls. As in the only other studies identified employing a dual CPET paradigm with measurement of expired gases, individuals with CFS showed a decrease in performance on the second test that was not seen in controls. This functional deficit may provide an objective indication of PEM. Despite considerable patient heterogeneity with respect to illness duration and type of onset, analysis of data from the second test was able to correctly classify 49 out of 51 individuals with CFS and 9 out of 10 controls. Non-invasive biomarkers for CFS do not currently exist. Physical therapists may consider the use of CPET performance measures to differentiate between individuals with CFS and otherwise non-disabled sedentary persons. Work efficiency (i.e. oxygen consumption and work output) at the ventilatory/anaerobic threshold appears to have diagnostic potential for CFS. (emphasis added)

This paper had a long journey to publication. The manuscript was submitted in October 2011, but was not accepted until June 2013. I hope its publication will lead to wider use of the two day maximal CPET protocol, particularly in research like the CDC’s multisite study. The suffering and agony of a two day test can be severe, as my own experience shows. But an objective way to diagnose CFS has held this field back for thirty years. If the two day CPET can provide objective diagnosis, then I say let’s go full speed ahead.

 

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Heart Rate and Beta Blockers

Posted on July 2, 2013 by Jennie Spotila

Beta blockers are routinely prescribed to ME/CFS patients who have orthostatic intolerance. But because of the medication’s effects on heart rate, it can be challenging to incorporate heart rate monitoring into the picture. After some uncertainty, I have managed to do it and would like to share what I learned.

I’ve blogged extensively about using a heart rate monitor to help me pace my activities. For many months, I kept the monitor set at 95 beats per minute, my anaerobic threshold on the second day of my exercise test. By wearing the monitor constantly, I captured multiple episodes of elevated heart rate accompanied by dizziness, nausea and sweating. And I was frustrated that my alarm would sound when I climbed a single flight of stairs or took a shower.

I received conflicting advice from two ME/CFS experts. One advised reducing my activity level further in order to avoid setting off the alarm. The other suggested taking beta blockers to steady and lower my heart rate. The first expert’s concern with beta blockers is that it would lower my heart rate, but not affect my anaerobic threshold. That expert was worried that if my heart rate monitor did not go off as frequently, I would naturally increase my activity level and risk overdoing it.

After thinking about it, and listening to other patients’ experiences, I decided to give beta blockers a try. I kept my heart rate monitor set for 95 beats per minute, and knew I would have to be very cognizant of my perceived level of exertion in order to avoid overdoing it. Several months later, I give two thumbs up to beta blockers!

The first thing I noticed on the beta blocker was that my heart rate dropped, as expected. Before the medication, I would exceed 95 beats per minute every time I climbed a flight of stairs. On the medication, I rarely exceed 90 bpm. After showering, my heart rate dropped from 98 bpm to 80 bpm. On average, I think my heart rate is about 10 beats per minute lower on the medication.

Those awful tachycardia episodes of elevated heart rate, nausea, etc have virtually disappeared. And it is so much easier to get up in the morning. Every day it was a struggle for me to get up, think clearly, and start moving around. I frequently felt a little nauseous, and I always felt like I was carrying 50 pounds on my shoulders just to get up and to the bathroom. With the beta blockers, that has become much easier. I don’t feel good in the morning, but I can get up without nausea and can start thinking about the day ahead. It is not the huge act of will and stubbornness that it used to be to just get out of bed.

Am I overdoing it? Am I crashing more as a result of masking the measure of my anaerobic threshold? That is more difficult to say. I am still crashing, and still ending the day (crash or not) in a puddle of pain and exhaustion. But there have been some unusual circumstances. Illnesses in my family have taken a severe physical and emotional toll on me. At the same time, I’ve been unusually active in this blog, advocacy efforts and FDA-related activities. So of course I am crashing, and that’s never pretty. I really can’t say for certain if the beta blockers have helped extend my capacity (like they did for Sue Jackson) or made me made me more vulnerable to overdoing it. But the worst-case scenario that Expert One worried about – that artificially lowering my heart rate would lead to more crashes – also does not seem to have occurred.

Beta blockers, like all medications, are not side effect free. I was concerned about some symptoms I have been experiencing and whether they might be a result of the beta blockers. Under my doctor’s advice, I stopped the beta blockers for a week. My heart rate shot back up within a day, and the “side effect” did not dissipate. I was happy to restart the medication after that week-long experiment.

For me, beta blockers have helped with the tachycardia and orthostatic intolerance symptoms. I’m not sure it has extended my limitations, but it hasn’t really hurt either. As with everything in ME/CFS, your individual experience may differ from mine. But it is possible to use a heart rate monitor while on beta blockers. Just remember that your anaerobic threshold hasn’t changed, so you will have to rely on your perceived exertion as well as the monitor alarm to pace your activities.

 

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