This. Is. Why.

Posted on October 17, 2012 by Jennie Spotila

I’m on the verge of tearing my hair out, and I suspect I’m not the only one. The American Academy of Family Physicians published a review article about CFS (paywall) on Monday, accompanied by a patient information sheet. From the very first sentence, this information sheet is a disaster. It packages harmful misinformation for family doctors to share with patients. Let’s take a look:

Chronic fatigue syndrome (CFS) is a disorder that causes you to be very tired.

NO! No it does not! A person with sleep apnea is tired. A nursing mother is tired. A perfectly healthy person studying for the bar exam is tired (ask me how I know). CFS does not make me tired. CFS causes prostration, a medical term that means a collapse from complete physical or mental exhaustion. Using the word “tired” is not only medically inaccurate, it falsely minimizes the severity of my disease and my experience.

People with CFS may have other symptoms, such as poor sleep, trouble with remembering things, pain, sore throat, tender lymph nodes, or headaches.

Can you spot what’s missing? Post-exertional malaise! The generally accepted hallmark symptom of this disease is not on the list. It is the first symptom on the Fukuda criteria list of accompanying symptoms. But it’s not listed here and not explained to the patient.

Not everyone with CFS has all of these symptoms.

I know hundreds of CFS patients. Every single one of us has experienced these symptoms for extended periods of time, if not daily, over the course of years. While it is technically correct that the Fukuda criteria do not require all of those symptoms, it is an oversimplification to simply say we don’t have all the symptoms. And of course all the other symptoms and overlapping conditions are not mentioned at all.

Childhood trauma (for example, physical or sexual abuse) may raise the risk of getting it.

I am aware of two studies that showed a higher prevalence of childhood trauma among CFS cases compared to healthy controls (this one and this one). Here’s the problem: childhood trauma may raise the risk of many disorders later in life. Without comparing the prevalence rate of trauma among other illness groups, there is no way to know if the association with CFS is unique. Are there studies comparing the incidence of childhood trauma among people who develop multiple sclerosis, rheumatoid arthritis, cancer, hepatitis, heart disease or  . . . oh, that’s right. Doing that kind of study in those illnesses might be offensive because those illnesses are real. But we can do those studies in CFS with no problem.

Two treatments can help with CFS: cognitive behavior therapy (CBT) and graded exercise therapy. With CBT, a therapist teaches you about how your thinking affects how you feel and act. With graded exercise therapy, you slowly increase your physical activity, which hopefully increases your function.

You know where this is going, right? Setting aside the arguments about whether CBT and GET studies actually show a benefit, and setting aside how this sort of statement plays right into the mental illness meme, let’s talk about GET. Will GET increase CFS patients’ functional ability? Maybe some patients, but it should be pursued with extreme caution and prejudice. As the work of the Pacific Fatigue Lab and my own exercise testing results show, the energy metabolism systems of CFS patients are severely impaired. We do not make or use energy, or recover from activity, the way other people (including other illness groups) do. Graded exercise must be undertaken very carefully because it takes very little activity to push a patient into a severe crash.

I shudder to think about how family doctors will use this information sheet, and what it will do to the patients who receive it. What is truly remarkable about it is that it bears only a passing resemblance to the full review article and the AAFP’s patient education page on CFS. But this watered down, oversimplified summary of misinformation about CFS will undoubtedly be used, and it is likely to make things worse for patients, not better.

So does anyone – journalists, doctors, policymakers, or other observers – wonder why the CFS Advisory Committee and patient advocates have been begging CDC to fully revise its website and remove the harmful content that filtered into this information sheet?

This is why.

Does anyone wonder why the CFSAC  recommended that the CDC remove its Toolkit from the CDC website?

This is why.

Does anyone wonder why an alliance of organizations and patients wrote a lengthy and heavily referenced position paper in support of that recommendation?

This is why.

Does anyone wonder why there was such vigorous disagreement at the CFSAC meeting about whether professional societies like the AAFP should be invited to participate in revising the CFS case definition?

THIS. IS. WHY.

 

 

Update November 2, 2012: Author Toni Bernhard published a great article about the AAFP patient information sheet.

Update October 31, 2012: I’ve also published a detailed analysis of the AAFP review article on CFS.

Posted in Advocacy, Commentary | Tagged , , , , , , , , , , , , , , , , , , , | 30 Comments

Blaze of Glory

Posted on October 16, 2012 by Jennie Spotila

Pacing is . . . actually, my descriptions of pacing generally involve expletives that are not appropriate for this blog, so we’ll stick with “Pacing is challenging.” One positive side effect of my pacing efforts, though, is that I am still celebrating my birthday one month after the fact.

Last week, I went out for a birthday lunch with Friend K. We’ve been friends for 22 years now, and K knew me for four years before I got sick. We went to law school and took the bar exam together, and undertook a mammoth road trip together. When I started dating my husband, K was the first friend I asked to check him out. Hanging out with K is great because she really gets the illness, and so I don’t have to talk about it but I can if I want to. She told me the latest stories about her sons, and generally made me laugh my ass off. For a few hours, I felt like a normal person having lunch with her best friend, and it was glorious.

I also went out for a birthday dinner last week with Friend M. I met M soon after I got sick, and she is another rare gem: a friend who gets it. M and her husband read a prayer at our wedding, and she is one of the most loyal and giving people I know. For my birthday, M took me to one of my favorite local restaurants for dinner and we closed that place down. The meal was sublime, but having M’s undivided attention for four hours was even better. She told me some great stories about her eight year old daughter, including the “court proceedings” in which M has been accused of posing as the tooth fairy. I felt just like the women at the table next to ours, enjoying a girls’ night out with one of my closest friends. These moments of normalcy, of interacting with the world the way I used to, are so rare and precious.

And then there was the payback. The day after that dinner, I was crashed but I didn’t care. It was totally worth the pain and post-exertional relapse. I was still high on the joy of being with my friends. But then I was crashed for two more days, and I started to question the price of normalcy.

My attempts to implement stricter pacing techniques have challenged me far more deeply than I expected. I’m questioning everything now. Before the exercise testing, I was absolutely convinced that having occasional episodes of normalcy was worth the crash days. Outings like these feed my spirit and make me so happy. But now I wonder if it’s the right thing to do. Do I have to give up the last few remnants of my healthy life in order to cope with my sick life? How do I strike the right balance between accommodating my physical limitations and hanging on to who I am? What else do I have to give up in order to live crash free?

I feel like these are deep, existential questions. For 18 years, I have sacrificed my body in order to enjoy occasional outings with my friends, to participate in CFS advocacy, and to take care of my family. If pain and crashing was the price of continuing to participate in my life, I paid it gladly. But is this the right way to balance the equation? Is having dinner with a friend worth three days in bed? Facing that consequence is not fair, and I don’t want my life to be this way. But this is my reality. I need some kind of owner’s manual to tell me how to figure this out. Do I punish my body by exceeding my physical limits? Or do I punish my soul by living within those limits? It’s a no-win situation, and I don’t know how to answer these questions any more.

Posted in Occupying | Tagged , , , , , , , , , , , , | 13 Comments

Another CFSAC Done Gone

Posted on October 6, 2012 by Jennie Spotila

The CFS Advisory Committee held its second meeting of the year on October 3-4, 2012. Last time, I organized my summary around the good, the bad, and the WTF moments. This time, I am organizing around the discussion themes. Overall, I felt this meeting was more substantive than in the past. There were even hints of introspection and data driven discussion.

Agency Updates

Assistant Secretary Dr. Howard Koh attended the opening of the meeting, and provided an update on the Department’s efforts since the last meeting. I was watching the meeting via webcast, and my feed froze during Dr. Koh’s comments. However, the portion I did see contained nothing new. Dr. Koh did not provide any details on the Ad Hoc Working Group beyond what we already know. Unlike previous meetings, he did not take questions from the members. Although he said “the committee has gotten stronger,” he did not announce the appointment of a new member to replace Dr. Rose. The committee bylaws require vacancies to be filled within 90 days, so the failure to appoint a replacement is a violation of the bylaws.

Both the FDA and Social Security Administration gave substantive presentations to the Committee. In my opinion, this was the high point of the meeting. Both Dr. Sandra Kweder (FDA) and Arthur Spencer (SSA) provided detailed information about their agencies and CFS related data. Dr. Kweder reported on the status of nine investigative new drug applications for CFS. Mr. Spencer provided disability data that the committee has been requesting for years. The overall approval rate for Social Security disability among cases where CFS is the primary diagnosis is 21%, in contrast to a national overall rate of 30%. I’m looking forward to seeing the slides from both these presentations because there was a lot of good information in them.

NIH and CDC also gave detailed updates. Dr. Susan Maier (NIH) reported that several new members were added to the Trans-NIH ME/CFS Working Group, including Dr. Harvey Alter. It’s very good news that Dr. Alter is staying involved in CFS despite the end of XMRV. Dr. Maier also provided (for the first time) data on the acceptance rates for CFS-related grant applications. The overall success rate is 25%, and in FY2012 the success rate is 18%. These rates are higher than the overall rate across NIH. Most of CDC’s report was focused on various education initiatives including CMEs offered through Medscape and CDC, as well as video of patient vignettes for the MedEd Portal that will be finished next year.

That ToolKit

CDC announced that after extensive debate, they have decided not to remove the ToolKit from the CDC’s website. Dr. Beth Unger said that they believe it should be available until it can be updated to reflect the other website revisions. Surprisingly there was little fanfare or reaction to this announcement. At its June meeting, the CFSAC had recommended that the ToolKit be removed. Dozens of patients testified in June and at this meeting that the ToolKit is harmful misinformation, and a coalition of groups and individuals submitted a detailed position paper to CDC in support of that June recommendation. Despite all that, the CDC has decided to keep the ToolKit. There was no pressure or reaction on the record from CFSAC members. No one asked why this decision was made, and no one besides Mr. Steve Krafchick pointed out that CDC is ignoring the CFSAC recommendation. CDC got off very lightly on this score, and I still can’t believe that no one raised a stink about it.

Chicken, Meet Egg

As I said above, Dr. Maier presented data on the approval rates for CFS applications to NIH. In light of that data, Dr. Gailen Marshall asked the committee why they thought NIH funding was so low. The high approval rate suggests that the problem is not NIH’s willingness to spend money but that there are few applications coming in. Dr. Mary Ann Fletcher spoke frankly about the perception in the research community that it is extremely difficult to get funding. She cited an unnamed researcher who left the field because of it, and pointed out that Dr. Nancy Klimas is quite successful in her applications for HIV and Gulf War Illness funding but not CFS. Eileen Holderman pointed out that the illness name, and particularly CDC’s definition and use of the name, dilutes our disease into simple chronic fatigue. This discussion tied in nicely with public comment by Matthew Lazell-Fairman and others that the decades of neglect and active denigration of the disease by CDC and other federal policy makers has created the climate where researchers believe they will not get funding. This circular discussion recurs at every single CFSAC meeting, but this time it led to the recommendation of creating a CFS study section at NIH.

Biomarkers

Biomarkers in CFS was a recurring theme on both days of the meeting. Dr. Jordan Dimitrikoff gave a presentation on the challenges faced by those studying Chronic Pelvic Pain Syndrome to identify biomarkers, not just for diagnosis but also to generate hypotheses about potential treatments. This is very similar to the approach of several CFIDS Association grants, in which a symptom or biomarker is queried to identify a possible drug to address that symptom or marker. Dr. Dimitrikoff acknowledged that the “true experts are the patients,” and he advocated setting aside cognitive bias to evaluate data and create learning networks. Dr. Fletcher then presented data from her research with Dr. Klimas and Dr. Gordon Broderick which identified different gene expression profile networks in CFS and Gulf War Illness patients, especially in immune pathways. This presentation complemented Dr. Dimitrikoff’s nicely, giving very specific examples of how biomarkers could lead to identifying potential drug treatments.

Discussion covered several very important points. First, that the case definitions are producing too much variability among patients. Without animal models, it is very difficult to study patients in a meaningful way without narrowing down the clinical presentation. Second, biomarkers must be distinctive in order to be useful. It is not enough to distinguish healthy controls from CFS patients. Biomarkers must distinguish between CFS and other chronic inflammatory conditions. In other words, if a biomarker cannot distinguish CFS from rheumatoid arthritis or lupus then it is of less utility than one that can. This has implications for both diagnosis and treatment trials.

Dr. Kweder’s presentation on the FDA and CFS treatment trials focused on the importance of outcome measures in order to quantify whether a treatment is having an effect. Outcome measures are not necessarily biomarkers; for example, there is no biomarker for migraines. But the more objective and quantifiable an outcome measure is, the more useful it is in clinical trials. Dr. Kweder pointed out that CFS has no single accepted case definition, no quantifiable way to measure symptoms and no biomarker for disease presence or activity. These are barriers to clinical trials, and partially to blame for the lack of trials in CFS. Dr. Kweder cited fibromyalgia, irritable bowel syndrome and depression as examples of conditions that received more clinical trials when those barriers were addressed. The FDA stakeholders’ meeting in spring 2013 will focus on identifying valid reliable outcome measures for CFS clinical trials.

There is a significant difference of opinion about whether we already have biomarkers and outcome measures for CFS. Dr. Fletcher and others cited a variety of measures already in use by researchers and clinicians. Dr. Fletcher was adamant that biomarkers did not need to be exclusive to CFS in order to be useful. Dr. Kweder said that a quantifiable biomarker or outcome measure must correlate to how the patient feels or fares. She also noted that heterogeneous conditions need larger clinical trials, so identifying subgroups can help target a treatment to those it is most like to help.

Case Definition

This is such a controversial topic, perhaps I should not expect a discussion of it to go smoothly, but the committee struggled once again to chart a way forward. Dr. Nancy Lee said that the case definition issue was discussed in at least one meeting with Secretary Sebelius, and that the Secretary was clear that the case definition must come from the medical community. Dr. Lee said that a recommendation from the committee that the Secretary endorse or adopt a specific definition will go nowhere. Dr. Marshall tried to focus discussion on designing a process that would produce a definition, but the committee quickly got snarled in the complexity of the problem.

One of the most contentious issues was whether the medical community has already endorsed a definition. Mr. Krafchick pointed out that the IACFS/ME used the 2003 Canadian Consensus Criteria in writing the Primer, and that it was the body of experts in this condition. Dr. Lee argued that the entirety of the medical community needed to endorse a definition, and Dr. Fletcher countered that this was not only unrealistic but was not a standard applied to any other illness. The root of this disagreement is the status of the IACFS/ME versus other medical societies. When the American College of Rheumatology endorsed a definition of fibromyalgia, the rest of the medical community accepted it because the ACR is a defined sub-specialty of medicine. Dr. Marshall drew a sharp distinction with the IACFS/ME, which is not a sub-specialty that offers board certification, and insisted that the American Colleges must have input into the definition in order for it to be widely accepted. This led to another vigorous argument over whether ME/CFS experts should address the definition or if non-experts should be invited to provide input and endorsement. The committee split over this, and in the end voted 5-4 (with one abstention) in favor of limiting input to the ME/CFS experts at this stage.

The other thorny question was whether to start with one of the existing definitions (Fukuda v. Canadian Consensus 2003 v. International Consensus 2011 – and different members referred to these papers by different names which made it even more confusing) or start from scratch. Dr. Dimitrikoff and Dr. Dane Cook recommended learning from definition processes in other illnesses such as lupus or IBS. Dr. Ermias Belay and Dr. Unger from CDC both advocated for a data driven process, relying on their multisite study that should be completed next year (although they did not promise a finished paper next year). This led to frustration among Dr. Fletcher, Mr. Krafchick and others about delay and the need for immediate action and leadership. After much wrangling, the committee settled on the 2003 Canadian Consensus Criteria as the starting point for a process to produce a clinical definition (see text of recommendation below).

One thing that got lost in this discussion was the role of patients. My impression from the preliminary discussion on October 3rd was that Dr. Marshall and others recognized patients as important stakeholders in this process. But the role of patients was not discussed on October 4th,  and the final text of the recommendation did not specifically include or exclude us. I don’t think it is an exaggeration to say that there will be hell to pay if patients are excluded from the process of creating a new case definition.

Committee Effectiveness

At the end of the first day, Dr. Marshall invited committee discussion on recommendations or other issues for the next day’s session. This led to a discussion of how effective the Committee is in its work. Dr. Lisa Corbin and Mr. Krafchick expressed concern about the committee’s recommendations not receiving feedback or action. Dr. Lee stated that a response to the June recommendations is still in preparation, to which Mr. Krafchick noted that 111 days had passed since that meeting. It was also clear, once again, that members are not receiving materials related to the meetings. Dr. Krafchick had not seen Assistant Secretary Koh’s letter in response to the November 2011 meeting, and was told that “it’s on the website.” Does this mean that such key documents are not sent to members, or that they are not even notified when such information is posted to the website? Members were asked to read several articles in preparation for the case definition discussion the next day (again suggesting that they were not sent in advance), but the existing CFS case definitions were not among them. To be frank, I think it is appalling that more preparation is not done for these meetings and it clearly hampers the effectiveness of discussion. I also wish that members would give more thought to the phrasing of their recommendations in advance. The editing-by-committee process at the end of each meeting is frustrating to watch, and a little more care in proposing motions might help with that.

Final Recommendations

These are the recommendations to the extent I was able to capture the language. The final version may vary slightly:

  1. CFSAC recommends that the Secretary promptly (before 12/31/12 or as soon thereafter as possible) and in consultation with CFSAC members convene at least one stakeholders (ME/CFS experts) meeting to examine the Canadian Consensus case definition (Carruthers, 2003) and its utility for diagnosis and treatment of ME/CFS.
  2. CFSAC recommends that there be a standing committee for review of ME/CFS proposals at NIH.
  3. CFSAC recommends that NIH issue an RFA of $7 to 10 million to establish outcome measures, including but not limited to biomarker discovery and validation, in ME/CFS patients. (Note: This replaced a recommendation limited to just biomarker discovery and validation passed by the committee during the same discussion.)
  4. CFSAC recommends to the Secretary that she endorse the Coalition 4 ME/CFS option 1 proposal for the ICD10-CM that was recommended at the 9/19/12 NCHS public meeting. (Note: The committee passed this recommendation despite advice from Dr. Nancy Lee (DFO) that the Secretary would not intervene in the ICD10-CM process.)
  5. CFSAC recommends that the Secretary allocate specific funds to study cluster outbreaks of ME/CFS.
  6. CFSAC recommends that the Secretary allocate funds to study the epidemiology of patients with severe ME/CFS.
  7. The members also voted unanimously to send a thank you letter to President Obama.
Posted in Advocacy, Commentary | Tagged , , , , , , , , , , , , , , , | 16 Comments

Metrics

Posted on October 3, 2012 by Jennie Spotila

I delivered the following testimony via telephone to the CFS Advisory Committee on October 3, 2012.

I would like to note something that Dr. Nancy Lee said today: “Nothing about me without me.” That’s what we’re asking for. FDA is moving in this way. We want HHS and its agencies to do so as well. Do nothing about me without me. Take our input. Leverage our expertise. We are highly motivated to assist you.

Even the newest members of this Committee have heard enough testimony from patients to recognize the despair that comes from living with a disabling, incurable disease that is barely recognized by most healthcare providers. My fellow advocates have spoken eloquently about the grinding isolation, pain and despair that they endure day after day.

But no one talks about the despair engendered by these meetings and the work of this Committee. I have heard many patients say that they don’t believe this Committee will ever help them. That there is no point in following your work because the government does not listen to your recommendations. There are patients who have abandoned the hope that this Committee will produce meaningful change. Their lives are the same, day after day, and they believe that all this Committee does is talk. After each meeting, and even today, I’ve observed a surge in frustration, disappointment and despair among my fellow advocates because another opportunity for progress has been lost.

Everyone at the table today has invested many hours in the work of this Committee. Regardless of your good intentions and engagement in these discussions, what matters to patients is meaningful change. If good intentions were all that was needed, we would have been cured long ago. Patients are looking for concrete progress, and they don’t see it here.

What do I mean by concrete progress? Performance measurement and metrics are buzzwords, but it all comes down to measuring change. Dr. Maier’s slide on the approval rates for ME/CFS proposals to NIH is an excellent example of this. Another hypothetical example is that NIH says that there are not enough ME/CFS research applications coming in to justify an RFA. But what if we could measure progress on that? First, we would need to know how many applications would be enough; that would be the goal. Then at each meeting, NIH could report on how many applications had been received in the previous six months. We could see whether the number of applications was increasing or decreasing over time, and we would know exactly how far we were from reaching the goal. This type of goal setting and progress measurement could be repeated across all the domains of this Committee. In my experience, knowing where you stand relative to a goal naturally leads to more targeted action.

But we don’t measure progress that way right now. The only goals we have are your recommendations, and the only measurements we see are the responses noted in the Recommendations Chart, which has not been updated since November of last year. And this is why we despair after each meeting – nothing is changing in our lives and we can’t identify what progress is being made, if any, through this Committee.

In the absence of metrics from your side of the table, I thought I would share with you my own metrics. I tracked a variety of things in my day-to-day life in order to share some concrete numbers with you.

  • 111 days have passed since your last meeting
  • I have been disabled for all of those days
  • I left the house a total of 21 times, typically for three hours or less
  • 5 of those outings were for healthcare visits
  • I had an additional 9 email and phone exchanges with my healthcare team
  • I paid to have groceries delivered 7 times
  • I paid to have my house cleaned 7 times
  • My doctors currently prescribe 9 different medications for me
  • I took a total of 1,554 pills since your last meeting
  • I had 4 episodes of tachycardia and near fainting
  • There were 14 days since your last meeting when I could not get out of bed
  • I could not drive a car at all
  • I could not take a walk at all
  • This Saturday is the 18th anniversary of the day I got sick. If I had given birth on October 6, 1994, that child would now be an adult.
  • ME/CFS ripped into my life 6,567 days ago. I could have spent those days building my legal career or writing books, or maybe both.
  • Instead, for 6,567 days I have endured every insult and change that ME/CFS has thrown at me.

These are my metrics and this is my charge to you: Show me progress. Show me measurable change. Make a difference so that I can stop counting how many days and how many ways ME/CFS is destroying my life.

Posted in Advocacy | Tagged , , , , , , , , , , , , | 6 Comments

Meeting This Week

Posted on October 1, 2012 by Jennie Spotila

UPDATE: You can watch the meeting via webcast OR you can call in to the meeting in listen-only mode at  1-866-761-7202. Passcode: 3117619.

 

The CFS Advisory Committee will meet on Wednesday and Thursday this week. The registration deadline for attendance and for public comment has passed, but I’ve collected some important links for you. I will be watching the meeting (and I hope you will too!) and will publish a summary on Friday.

  • The Federal Register notice for the meeting indicated:  “The meeting will be live-video streamed at www.HHS.gov/Live  . . . Listening-only audio via telephone will be available on both days. Call-in information will be posted on the CFSAC Web site.” The video link is not working, Update: the link is now working but still no call-in information has been posted yet.
  • The agenda for the meeting was posted after the deadline for comment registration had passed.
  • Public comment is scheduled for both days of the meeting, and will include comments from Lori Chapo-Kroger, Mary Dimmock, Pat Fero, Sue Jackson, Matthew Lazell-Fairman, Alexander Lopez-Majano, Denise Lopez-Majano, Jadwiga Lopez-Majano, Matthew Lopez-Majano, Billie Moore, Faith Newton, Matina Nicholson, Donna Pearson, Amy Squires, Charlotte von Salis, and me.
  • For background on how the committee functions, check out my post CFSAC Basic Facts.
  • Hopefully we will hear an update on the Department of Health and Human Services Ad Hoc Working Group.
  • I am continuing to investigate the committee’s membership background, including who nominated them and profiles of new members Dr. Adrian Casillas and Dr. Lisa Corbin.
  • One member of the committee resigned shortly after the meeting in June 2012. The committee bylaws (not currently available on the website) require a replacement be appointed within 90 days but there is no indication on the agenda that a new member will be sworn in for this meeting.
Posted in Advocacy | Tagged , , , , , , , , , | 5 Comments

Mental Illness Meme

Posted on September 25, 2012 by Jennie Spotila

When it comes to press coverage of CFS and XMRV, there is a pervasive mental illness meme that must be addressed. It goes something like this:

  1. XMRV/viruses do not cause ME/CFS. Therefore, it could be a mental illness.
  2. Patients strongly object to characterization of ME/CFS as a mental illness. A small number of patients get nasty, make threats, or make it personal.
  3. This crazy behavior by a small number of patients proves the point that ME/CFS could be a mental illness.
  4. The strong resistance by ME/CFS patients to the mental illness explanation must come from society’s belief that mental illness is not “real” or “legitimate” illness.
  5. The small number of extremists are to blame for researchers, doctors, and journalists not wanting to touch the illness with a ten foot pole.

After the publication of the Lipkin study last week, there were several articles along these lines. The meme is particularly common in the British press, including articles in The Telegraph and The Daily Mail. Predictably, the comments on these articles follow the pattern of patients strongly objecting to the mental illness meme and offering physiological evidence that refutes it, and others claiming that the absence of biological evidence proves that patients are suffering from exaggerated lethargy or a desire to avoid reality. Things generally spin out of control from there. But I think getting caught in the meme’s whirlpool misses the point; let’s pick apart the meme’s logic.

XMRV/viruses do not cause ME/CFS. Therefore, it could be a mental illness. Yes, it could. But it also might not be. The meme commentators base the entire premise on this great leap in their reasoning: A is not the cause so Z probably is. This is not logical. Eliminating one possible cause does not therefore mean that another (unrelated) possible cause is the best candidate. If someone presents at an emergency room with abdominal pain and testing rules out appendicitis, this does not mean that the pain is psychosomatic. There are at least a dozen other possible causes of the pain, and any competent doctor would proceed with testing to rule out those other possibilities. The same is true of ME/CFS: XMRV has been eliminated as the cause, but there are many more causal theories that must be pursued.

This first element of the mental illness meme is evidence of cognitive bias. The meme supporters’ bias is mental-illness-until-proven-otherwise. My bias is physiological-cause-until-proven-otherwise. I freely admit my bias but I have not, to date, seen the meme supporters own up to the bias in their own reasoning.

A small number of patients get nasty, make threats, or make it personal, and this proves that ME/CFS could be a mental illness.  Unlike some of the commenters on the mental illness meme articles, I do not dispute that this is true. Threats, harassment, stalking, and violent behavior is illegal and inexcusable. It does not matter how angry you are, or how justified you believe your anger to be. This kind of illegal behavior is wrong and counterproductive. I would like to see ME/CFS patients disavow this behavior and stand up to it when it does occur.

However, this element of the meme is illogical and over simplistic. Does the criminal behavior of a few anti-abortionists mean that all anti-abortionists endorse violence for political ends? No. Does the fact that many lung cancer patients have a history of smoking mean that all lung cancer is the result of smoking? No. A small number of patients engaging in “crazy” behavior tells us nothing about the cause of ME/CFS. The fact that only a small number of patients do this means that the vast majority of patient do not. Shouldn’t this tell us that ME/CFS is not caused by mental illness, since the vast majority of us do not engage in “crazy” or illegal behavior?

Furthermore, the meme supporters make it sound like this behavior is unique to ME/CFS. But given the proliferation of crazy online, I question whether the ME/CFS patient population has more than the normal prevalence of this behavior. I’ve seen death threats made to researchers who are working on endangered sea turtles. In the last several months, I’ve seen online harassment and threats over football and editorial cartoons. Death threats to researchers or journalists are neither new nor confined to ME/CFS.

The strong resistance by ME/CFS patients to the possible psychological origins of their illness must come from society’s belief that mental illness is not “real” or “legitimate” illness. This is another fallacy. There are many reasons for our strong resistance to the theory that ME/CFS is a mental illness: 1) There is a great deal of research that supports a physiological cause or causes; 2) Our experiences are more similar to other disabling physical illnesses such as MS than to serious mental illness such as clinical depression; 3) Research has found evidence that distinguishes CFS patients from controls with mental illness such as depression and anxiety; 4) Many patients have been dismissed by family, co-workers, and healthcare professionals as being malingering, so we are understandably sensitized to dismissal cloaked in “mental illness” language; and 5) Insurance and disability companies offer different levels of benefits for mental versus physical disorders, so patients face real harm from characterization of their illness as mental, rather than physical. This element of the meme is actually quite devious. Not only does it ignore all the evidence against the mental illness theory, but it implies that patients themselves are prejudiced against mental illness and that is why they resist the label so strongly. According to the meme supporters, we are both mentally ill AND prejudiced against mental illness.

The small number of extremists are to blame for researchers, doctors, and journalists not wanting to touch the illness with a ten foot pole. I do not doubt that the extreme behavior has tainted the entire patient population and added to the “career destroyer” reputation of the illness. But I suspect that the repetition of the stories of threats and harassment have turned it into an urban legend far larger than the actual number of incidents. Furthermore, there is a much more significant reason why researchers do not want to work on this disease: funding. The historically anemic research funding makes this a self-fulfilling prophecy – few researchers apply for funding because they believe there is no funding, and then NIH explains the low levels of funding by pointing to the small number of applications. The early years of HIV were marked by unpopular patient populations (gays and IV drug users) and dramatic protests (occupation of public offices, vandalism of public buildings with red paint), but researchers still wanted to work on the disease. As funding increased, even more researchers became involved. If the social prejudice against gays and drug users or the ACT UP protests did not deter researchers from HIV, then I find it hard to believe that a few ME/CFS patients could be responsible for the failure of researchers, doctors and journalists to engage in this area.

Despite the protests of some of its authors that they have “deep sympathy” for people with this disease, the mental illness meme in coverage of CFS is over simplistic, misleading and illogical. The meme paints a portrait of this disease with such broad strokes that there is no likeness at all; it is more Jackson Pollock than Leonardo da Vinci. But patients who fall down the rabbit hole and try to counter this meme within its own universe do not further our cause. Let’s challenge the meme at its foundation: it’s illogical reasoning rooted in cognitive bias and broad generalizations.

Update September 30, 2012: Another article has appeared in the British press. I won’t link to it because it is an unfortunate combination of misinformation and hyperbole. The article quotes an unnamed researcher as saying, “it’s safer to insult the Prophet Mohammed than to contradict the armed wing of the ME brigade.” It is true that patients are deeply offended by the kind of comments I discuss in this post, and it is quite possible that a very small number of individuals have made threats against a few doctors and researchers. See my comments on that above (executive summary: patients should stop it, and the rest of us should disavow that behavior). But it is patently ridiculous to suggest that the ME/CFS patient community is in any way similar to violent fundamentalists. As far as I am aware, ME/CFS patients have not rioted, burned flags, or killed an ambassador. The ME/CFS patient community does not have an armed wing. Such a melodramatic comment says more about the anonymous researcher and the journalist who chose to repeat this silly exaggeration than it does about ME/CFS patients.

Don’t fall for it, fellow patients! They are baiting us. They are saying stupid things to push our buttons and elicit the very responses that have been posted in comments on the articles and on Twitter. Stop delivering what they want to see on a silver platter. Don’t fight the battle on the ground they’ve chosen – let’s take the high ground. If we fight from there, we can’t lose.

Posted in Commentary | Tagged , , , , , , , , , , , | 21 Comments

Those Lipkin Samples

Posted on September 22, 2012 by Jennie Spotila

You may recall from my post on the Lipkin study that Dr. Lipkin talked about the sample cohort at the press conference on September 18th. Dr. Lipkin said that the samples would be available for other investigators and that applications to use the samples should be made through NIH. In his interview with Dr. Vincent Racaniello on This Week in Virology, Dr. Lipkin said:

We’ve been able to store sera and PBMC so that other investigators who want to do either microbiology, or genetics or proteomics will be able to access those samples through the NIH. There will be calls for proposals, and there will actually be funding associated with that.

During the interim, we offered the laboratories and the investigators and the clinical sites who were engaged with this work to put forward proposals to do something with these materials in advance of that RFA, though without any funding. Two of those groups..well, several groups applied. Two of them were selected by the entire team, and they will be receiving plasma samples that they can then study. The primary focus has been on microbiology and genetics, but I’m sure there will be other applications as well. (emphasis added)

Obviously, the availability of these samples and the possibility of funding is of great interest to the CFS community. NIH spent more money on the Lipkin study than any other CFS study in 2011, and the results came well after the XMRV question seemed settled with the retraction of the original study by Science. If the samples can be used in future studies, especially if NIH provides funding for such studies, then that will be a huge win for CFS.

I asked Dr. Susan Maier, chair of the Trans-NIH ME/CFS Working Group and ex officio representative to the CFS Advisory Committee, for additional information. She provided the following clarifications by email on September 21st:

We are very pleased that Dr. Lipkin has offered to make remaining specimens available to any ME/CFS investigator who successfully competes for NIH funding.   Dr. Lipkin and NIH program staff agreed that the NIH peer review process would offer the fairest means to decide who should have access to these samples.  Consequently, interested investigators will be advised to consider currently available and relevant NIH funding opportunities in order to pursue these samples. NIH will be issuing a notice in the NIH Guide to Grants and Contracts very soon that will elaborate upon these points.  However, it is important to note that there are no set-aside funds associated with these samples.  In addition, Dr. Lipkin’s laboratory will maintain these samples, which is standard NIH protocol. They will not be stored at NIH.

With regard to the two investigators who have already received samples, Dr. Lipkin was referring to his study collaborators.  This is separate from the process described above. (emphasis added)

So there will NOT be any set aside funding or RFA. Investigators will apply through NIH and the normal NIH peer review process, but there will be no new money. I’m not sure why conflicting statements were made by Dr. Lipkin and Dr. Maier. The last RFA from NIH for CFS research was in 2005, and the CFS Advisory Committee has recommended that NIH issue RFAs many times over the last decade. I had hoped that Dr. Lipkin was correct and that we were on the verge of securing an RFA. It appears we will continue to wait.

 

Posted in Research | Tagged , , , , , , , , , , , | 4 Comments

How Did They Get Here?

Posted on September 21, 2012 by Jennie Spotila

I’ve been following the work of the CFS Advisory Committee closely, and after the latest group of new members were appointed I wondered who had nominated them. I’ve done some research, and the answer might surprise you.

Just getting this information took some effort. I emailed the CFSAC on June 25, 2012 requesting a list identifying what individual, organization, agency, or entity nominated each of the current voting members of the CFSAC. On July 17th, the CFSAC responded:

We do not keep records on which individuals or organizations nominated the CFSAC members.  Some members nominated themselves, which is definitely permitted. (emphasis added)

I was rather surprised at the claim that the Committee did not maintain records on nominations, and in fact I found that General Records Schedule 26 requires that information on requests for approval of nominees and appointment documents for individual committee members be maintained for six years. Either the Committee staff was violating federal records requirements by not maintaining those files, or their response to my request was misleading. I did what any determined ex-lawyer would do: I filed a FOIA request on July 23rd. On September 20th, I received copies of the letters and emails that nominated the current voting members of the Committee. Here is what I found:

  • Dr. Gailen Marshall, Chairman of the CFSAC was nominated by Dr. Ronald Glaser. At the time of he submitted this nomination (September 2009), Dr. Glaser was serving as a member of the CFSAC. Dr. Marshall was appointed to the Committee on May 10, 2010.
  • Dr. Adrian Casillas was nominated by Dr. Gailen Marshall in August 2011 (while Dr. Marshall was serving as a member) and was appointed to the Committee on June 13, 2012
  • Dr. Dane Cook was nominated by the CFIDS Association in September 2009, and was appointed to the Committee on May 10, 2010.
  • Dr. Lisa Corbin was nominated by Dr. Ermias Belay of the Centers for Disease Control in August 2011. Dr. Belay first served as the ex officio representative from CDC to the CFSAC several months later in November 2011. Dr. Corbin was appointed to the CFSAC on June 13, 2012.
  • Dr. Jordan Dimitrikoff was nominated by Dr. Hope Ricciotti, Vice Chair of the Department of Obstetrics and Gynecology at Harvard Medical School in September 2010. He was appointed to the Committee on May 10, 2011.
  • Dr. Mary Ann Fletcher received multiple nominations over the course of several years. In September 2009, both Dr. Glaser (a member of the CFSAC at the time) and Dr. Fred Friedberg of the IACFS/ME submitted letters in support of her nomination. In September 2010, the Miami CFIDS Support & Advocacy Group nominated Dr. Fletcher, and two individuals also wrote in support. Finally in August 2011, the Miami group nominated her again four individuals wrote in support. Dr. Fletcher was finally appointed to the Committee on June 13, 2012.
  • Ms. Eileen Holderman was nominated by P.A.N.D.O.R.A. in September 2009 and was appointed to the Committee on May 10, 2010.
  • Mr. Steven Krafchick was also nominated by P.A.N.D.O.R.A. in September 2009 and was appointed to the Committee on July 1, 2010.
  • Dr. Susan Levine nominated herself to the Committee in September 2009 and was appointed to the Committee on May 10, 2010.
  • Dr. Ann Vincent was nominated in October 2010 by Dr. J. Michael Miller of the Centers for Disease Control. Dr. Miller was serving as the CDC’s ex officio representative to the Committee at the time. Dr. Vincent was appointed to the Committee on May 10, 2010
  • Dr. Jacqueline Rose nominated herself to the Committee in August 2011. She was appointed on June 13, 2012, but then resigned several weeks later.

I am struck by the distribution of nomination sources: two members (Dr. Vincent and Dr. Corbin) were nominated by the serving ex officio representative from CDC; two members (Dr. Marshall and Dr. Casillas) were nominated by serving voting members of the Committee; four members (Dr. Cook, Mrs. Holderman, Mr. Krafchick, and Dr. Fletcher) were nominated by CFS organizations; two members nominated themselves (Dr. Levine and Dr. Rose); and the last member (Dr. Dimitrikoff) was nominated by a colleague at Harvard. This does not look random to me. It looks more like a score card with careful selection among the different sources. Consider the 2012 appointees: one successful nomination each from CDC, a Committee member, a CFS organization, and a self-nominee.

I am concerned that most of the researchers and doctors being appointed do not have CFS as their primary focus. In nominating Dr. Vincent and Dr. Corbin, CDC highlighted their experience in integrative medicine, and both of them are directors of clinics that focus on fibromyalgia and chronic fatigue patients. Dr. Dimitrikoff is an expert in chronic pelvic pain syndrome, and his CFS experience is based on its overlap with CPPS. Dr. Marshall has treated CFS patients, but Dr. Glaser’s nomination letter said his research focus in on psychological dysfunction and immunoregulatory changes in a variety of conditions, including CFS.  I’ve previously reported on Dr. Casillas’s expertise in immunology but not focused on CFS. Only Dr. Cook and Dr. Fletcher conduct a great deal of research on CFS, and Dr. Levine treats many CFS patients. Dr. Fletcher is the only CFS expert to be appointed to the Committee since 2010.

Another trend is the decreasing success of nominations from CFS organizations. While four current Committee members were nominated by organizations, Dr. Fletcher is the only successful nominee since 2010. With the addition of three non-voting organization representatives to the Committee in the last charter revision, I am very concerned that organization nominees will have less likelihood of success.

There is a vacancy on the Committee left by Dr. Rose’s resignation. The Committee bylaws (not presently available on their website) require that a vacancy be filled by appointment within 90 days. The CFSAC has not released the actual resignation date, but the 90 days must be expiring soon if it has not already. In a letter to me, Assistant Secretary Koh stated that the 2011 nominations were being considered to fill the vacancy. Will we see a new appointment at the meeting on October 3rd?

Does the source of a nomination matter? I argue that in this context, it does. The trend in the last two years has been towards non-CFS experts, including two successful nominations from CDC. At the same time, Dr. Casillas told me that the new members received no briefing or materials in advance of their first meeting in June. Mr. Krafchick complained at that meeting that he had not received materials in advance either. In my opinion, the Committee must ensure that its membership is sufficiently educated about the issues that come before it. If non-experts are appointed, they must receive adequate preparation and briefings on the issues. Otherwise, the combination of lack of subject matter expertise and lack of advance preparation does not bode well for the work of the Committee, at least not if we hope for recommendations that address the unique scientific and social issues of CFS.

 

Posted in Advocacy | Tagged , , , , , , , , , , , | 32 Comments

Stick a Fork In It

Posted on September 18, 2012 by Jennie Spotila

After three years of controversy about the purported association between CFS and XMRV, and after two years of waiting for the definitive Lipkin study to be finished (full text of the paper is here), we have our answer. Stick a fork in it, people, because XMRV is done. There are plenty of places to get summaries (such as here and here and here, and a quite revealing interview with Dr. Lipkin here). I want to focus my analysis on the issues that come up the most in patients’ discussions about XMRV.

Did the Lipkin study use the right patients? As far as I can tell, yes. The Lipkin study used the Fukuda and Canadian Consensus Criteria, and only selected patients that had a sudden viral-like onset. Dr. Lipkin said today that this was done so that they chose subjects with a high likelihood of having an infection. The patients were selected by six clinicians around the country (to avoid any limitations based on geography): Dr. Cindy Bateman, Dr. Nancy Klimas, Dr. Anthony Komaroff, Dr. Susan Levine, Dr. Jose Montoya, and Dr. Dan Peterson. If you know anything about CFS, then you recognize these clinicians’ names. Cases were further examined for exclusionary conditions, like hepatitis, HIV, and thyroid dysfunction. Again, this was done to avoid confounding the results by introducing too many variables. Finally, cases had to demonstrate a required level of functional impairment based on responses to four clinical questionnaires. By comparison, the patients in the original Lombardi study met both the Fukuda and Canadian criteria, and presented with severe disability (Lombardi Supplemental). Those samples came from the Whittemore Peterson Institute’s national tissue repository (Lombardi), included samples from geographical diverse areas and included some cluster outbreaks. The Lombardi paper does not specify whether testing was done to exclude other infections, how long the samples had been stored prior to use in the study, or the mean length of illness. The Lipkin study appears to have done everything possible to identify a clean cohort of severely ill CFS patients who were likely to have evidence of infection, and we have much more information about this cohort than we do about the original Lombardi cohort.

Why not test the same patients as Lombardi, et. al? That’s been done. The Singh  and Levy studies both retested reported positives from WPI. The Blood Working Group study also used reported positives from WPI and Lo, et al. Those studies were all negative. Dr. Lipkin did not explicitly address this issue in the press conference, but I assume that the point was to start with a fresh cohort and try to replicate the association between these viruses and CFS.

Were the samples handled correctly? As far as I can tell, yes. Dr. Lipkin spent significant time at the press conference this morning addressing the issue of why blood was used in this study. This is important, because after the negative replication attempts began to pile up, XMRV-theory supporters began claiming that the virus could not be detected in blood, but could be found in tissues. The question was raised again this morning by both Hillary Johnson and Deborah Waroff. Dr. Lipkin and Dr. Alter both said that the reason blood was used in this study is because both the Lombardi and Lo studies found XMRV/pMLVs in blood. I’m not sure why this gets lost in discussions about XMRV. The Lombardi paper found XMRV in 67% of the CFS blood samples they analyzed. It wasn’t tissue; it wasn’t lymph; it was blood. So an attempt to confirm the Lombardi and Lo findings has to look at the blood.

For the Lipkin study, blood was drawn fresh from patients and controls between 10am and 2pm, within the same season (to control for possible communal infections and diurnal variations).  The blood was treated with EDTA (an anticoagulant) and shipped overnight to Columbia University where the coding and sample splitting was done. The Lombardi Supplemental says that blood samples were treated with sodium heparin, a different anticoagulant. There is no information provided about the time of day or time of year that samples were collected, nor the length of time samples were stored before the study. I’ve seen some claims online that the type of anticoagulant used makes a difference, but I have no information to say for sure either way.

After coding, each sample in the Lipkin study was divided into multiple aliquots. There were four testing sites (more on this in the next section): CDC, FDA, Dr. Hanson’s lab at Cornell, and Dr. Ruscetti’s lab at NIH. Each group received a double set of samples – 2 each of every patient and control. In addition, the groups received artificially spiked positive controls and known negative controls.

Did they use the right tests? Yes. Each of the four testing sites used their own assays in the Lipkin study. CDC used assays previously described in earlier papers to perform multiple rounds of PCR. FDA used a modified version of the assays described in the Lo paper to run PCR. Dr. Hanson performed PCR on samples that had first been cultured in the Ruscetti lab. Finally, the Ruscetti lab used a serologic assay that was slightly modified from what had been reported in Lombardi. Each lab used both negative and positive controls and got accurate results with those samples.  Is it a weakness that these labs did not use the precise assays used in Lombardi and Lo? I suppose one could make that argument, but the flip side is that refinements in testing should be used to produce (hopefully) better results. If the labs had been required to use the exact tests used in Lombardi, and the results were negative, it would be a fair question why they were prevented from applying what had been learned since Lombardi. With this design, each lab could use the technique that it felt was most likely to produce accurate results.

Were the positive/negative results reliable? Yes. The Lipkin study testing involved PCR of plasma, PCR of PBMCs, PCR of cultured PBMCs, and serology testing. Remember that each subject sample was not only split among the labs (so subject x was tested by each group), but each sample was sent to each location twice (so subject x was tested twice by lab A, twice by lab B, etc). In order to be counted as a positive result, the Lipkin study states: “Subjects with two positive results in the same sample type were considered positive for XMRV/pMLV.” In other words, subject x had to test positive in two plasma samples or two PBMC samples, etc. to be counted positive. The original Lombardi and Lo studies did not use this redundancy.

The results were clear: No positives were found by CDC in plasma. No positives were found by FDA in plasma or PBMCs. No positives were found by Hanson in cultured PBMCs. (Lipkin study Table 3).  Zero, zip, nada, nyet, nothing. Why do they think that PCR is reliable? Because Lombardi used PCR. This is another fact that has frequently been forgotten or swept under the rug during online discussions of XMRV. People have been claiming that you can’t find XMRV with PCR, when the original study used PCR. The Lipkin study included positive and negative controls, checks for contamination, and PCR found NOTHING (except in the positive controls).

The serology results were not clear cut. Approximately 6% of both the patients and the controls were found to be positive using a slightly modified version of the serology assay used in Lombardi. However, the Lipkin study points out that this antibody cannot be validated in a sample known to be positive for clinical XMRV infection, since there is no confirmed case of human XMRV infection. Furthermore, the antibody used may be cross-reactive, meaning it appears positive in the case of a non-XMRV infection. The CFIDS Association article on the study explains this nicely. In the paper, the authors state, “We posit that positive results represent either nonspecific or cross-reactive binding.” The fact that the same number of positives were found in both patients and controls is strongly suggestive that the result is not associated with CFS. In his interview with Nature, Dr. Lipkin said, “If you consider this in the context of the work that shows that XMRV originates in the laboratory, then I think we can probably close the door on this once and for all.”

The consensus reached by all of the study authors could not be clearer: “Our results definitively indicate that there is no relationship between CFS/ME and infection with either XMRV or pMLV.”

Where do we go from here? The Lipkin study ends as follows:

We remain committed to investigating the pathogenesis of CFS/ME and to ensuring that the focus on this complex syndrome is maintained. Studies under way include the search for known and novel pathogens and biomarkers through deep sequencing and proteomics.

There was much discussion at the press conference about the promising avenues for further inquiry, including additional pathogen discovery work, examining host response, and looking at protein and gene products. Dr. Lipkin is involved in some of that work through the Chronic Fatigue Institute. In his interview on This Week in Virology, Dr. Lipkin also said that he is professionally invested in the search for the pathogenesis of CFS.

Much was also made of the fact that the samples gathered for the Lipkin study represent an extraordinary resource for future research. The samples are stored in freezers at NIH and are available for qualified investigators. Application to use these samples must be made through NIH, and Dr. Lipkin stated that two investigators had already received samples and were working on them (although he offered no more specific information). In the TWiV interview, Dr. Lipkin said that it was the panel of investigators on this study that approved applicants for samples, but he didn’t explain how that works. He also said that there would be NIH money available for an RFA to use the samples, but this is the first I heard that. Obviously, an RFA from NIH with money attached would be big news and tremendous progress – so I hope we can get that confirmed by NIH. Finally, he said there is enough plasma stored for 50 labs to conduct studies. I think this is a huge positive outcome; more money was spent on this study by NIH than for any other CFS study in 2011. I am thrilled at the prospect that we might learn more from these samples.

Is XMRV really over? Yes. On top of the definitive statement in the paper, Dr. Mikovits and Dr. Alter firmly closed the door on XMRV/pMLV and CFS today. Dr. Alter said this study was “quite definitive.” Dr. Mikovits said the study rigorously excluded the earlier findings and that XMRV is “simply not there.” Furthermore, she said she was “100% confident in the results.” It can’t be said any plainer than that. Dr. Mikovits is on record as denying an association between XMRV/pMLVs and CFS. I’m fairly certain there will be some people who are still not convinced, but they will have to make their claims in spite of what Dr. Mikovits said herself.

What about the prostate cancer papers? That’s done, too. A study published today in PlosOne today concludes “In summary, our findings do not support any association between XMRV infection and prostate cancer, and by extension indicate that XMRV has never replicated outside of the laboratory setting. The initial discovery linking XMRV to prostate cancer in 2006 arose from laboratory contamination of clinical samples by an XMRV-infected LNCaP cell line. In turn, the LNCaP cells were most likely previously infected by 22Rv1, from which XMRV almost certainly originated through in vivo passaging of the CWR22 xenograft in mice.” Update at 8:10 pm: the original XMRV and prostate cancer study from 2006 is now retracted.

 

Posted in Commentary, Research | Tagged , , , , , , , , , , , , | 13 Comments

The News on XMRV

Posted on September 18, 2012 by Jennie Spotila

I am going to refrain from any comment on the XMRV study results announced today until I have had a chance to read the paper, listen to the press conference, and think about the whole thing for a few hours. In the mean time, here are some related materials:

Posted in Research | Tagged , , , , , , , , , | 3 Comments