“Have a good walk with Daddy, pumpkin,” I say to my 11-month old baby girl earlier today. I giver her and my husband a kiss and go back into the house. As is the case on many Saturdays, it’s a not-so-good day for me. Weekends are particularly challenging because the nanny only works during the week, although my husband does much more than his fair share. It breaks my heart, but I cannot take care of my daughter for more than a couple of hours without a break or help because of the toll that takes on me physically. If the weather allows, my husband takes our daughter on long walks on Saturdays and Sundays, so that I can lie down and take a nap or just rest. There is no sun in the Northern California sky today, but luckily, it’s not raining, so they are off for their special time together. I am about to head for the bedroom, but decide to take a quick look at Facebook, which, besides email, is usually the only way for me to stay in touch with my friends. A link posted by XMRV Global Action catches my attention. I know I shouldn’t—my aching body screams for rest—but I can’t resist and start reading the linked article, “Studies Fail to Reveal Cause of Chronic Fatigue Syndrome” by Dov Michaeli, MD, PhD. After I am done reading, I know there is no way I will be able to fall asleep. I am shocked.
Dr. Michaeli set out to “show you how science works” by discussing the inconsistent findings of various studies regarding XMRV in ME/CFS. Dr. Michaeli started by talking about the 2009 Lombardi et al. study, which found XMRV in 68 out of 101 ME/CFS patients (68%) versus 3.7% in healthy controls. He mentioned “a bunch of other papers [that] found no trace of the virus DNA either in patients [n]or control blood and concludes, “It turns out that [the Lombardi study] was a simple case of contamination.” Just like that, he completely dismissed the findings of the Lombardi study without even mentioning that none of the subsequent studies that haven’t been able to find XMRV in ME/CFS patients have used the same methods as the Lombardi study.
How about the study performed by the National Institutes of Health (NIH), the FDA and Harvard Medical School, which found MLV, a virus related to XMRV, in 86.5% of ME/CFS patients versus 6.8% in healthy controls? Dr. Michaeli neglected to mention that paper altogether. He did, however, mention “a report published by CDC investigators and colleagues in July 2010 [that] found not evidence of [XMRV] antibodies.” He commented, “I cannot think of an easy explanation for this discrepancy.” Why would somebody whose proclaimed goal it is to explain science to his readers selectively report on the evidence and choose to leave out one piece of the puzzle altogether? I cannot think of any easy explanation for this oversight.
Let’s see what Dr. Michaeli has to say about the study by Singh et al. published just last week. This latest study also didn’t find any evidence of XMRV in ME/CFS. Dr. Michaeli agreed with Dr. Singh that it is time “to move on” and give up on XMRV in ME/CFS. According to Dr. Michaeli, Singh et al. “obviously were focused on eliminating any possible post hoc argument that their method of analysis was different from the original [Lombardi] paper.” He further opined that “Singh and her colleagues went out of their way to ensure that there was no rational way to question their results.” But wait a minute, didn’t the Singh paper say that they used many of the same techniques as in the original [Lombardi] study?” [emphasis added] It does look as if the Singh at al. study came closer to replicating the Lombardi study than prior studies, but, based on the language in the Singh paper, the Singh study didn’t use all of the Lombardi methods and was, thus, not a true replication study. But one would never know that, reading Dr. Michaeli’s piece. (Update, May 16, 2011: See “Response to Shin et al” by the International M.E. Association, which explains in great detail all the ways in which the Singh study was flawed.)
How about Dr. Lipkin’s note to Vince Racaniello in response to the Singh study? Dr. Lipkin said, “We have a plethora of explanations for how CFS/XMRV/MLV studies could go awry. However, we don’t have evidence that they have. Absent an appropriately powered study representing blinded analyses by Mikovit[s] [Lombardi study] and Lo/Alter [NIH study] of samples from well characterized subjects using their reagents, protocols and people, all we have is more confusion. I remain agnostic. We won’t have answers until the end of 2011….” Sounds like Dr. Lipkin, a renowned ME/CFS researcher, is not convinced yet that there is no connection between XMRV and ME/CFS. If there is no rational way to question the Singh study, as Dr. Michaeli said, does that mean that Dr. Lipkin is “irrational?”
Dr. Michaeli calls out Dr. Mikovits, the lead researcher on the Lombardi study, for defending the Lombardi study’s findings. He calls Dr. Mikovits’ stance a “surprising attitude from a scientist who is supposed to look unflinchingly at the data, personal bias notwithstanding.” In that spirit, I can’t help but find Dr. Michaeli’s one-sided coverage of the XMRV studies surprising for a medical doctor who is supposed to report on the state of the research in a balanced way. Just to clarify, I don’t know if there is a link between XMRV and MR/CFS. But I don’t think we’ve seen any convincing evidence that no such connection exists contrary to what Dr. Michaeli wants his readers to believe.
Until that point in the article, Dr. Michaeli has merely reported on the XMRV controversy in an unbalanced way. That was not very scientific, but at least it wasn’t personal. However, comparing patients—who in the absence of conclusive evidence are not ready to give up on XMRV—to birthers and deathers, as he did towards the end of his opinion piece, is highly offensive. And the comparison doesn’t even make sense. Birthers and deathers cling to indefensible views to further their own political interests. If XMRV is a dead end, how would insisting on the XMRV theory further ME/CFS patients’ interests? It would just prolong finding a treatment that does work. Why would they “cling,” as Dr. Michaeli calls it, to the XMRV theory if that could delay their getting help?
ME/CFS patients are very sick. Nevertheless, they have been abandoned by the government and the medical community for decades. What if the research community prematurely gives up on XMRV—something Dr. Michaeli is pushing for—only to find out decades from now that Lombardi et al. were on the right track? Why does Dr. Michaeli not want to wait for conclusive evidence? And why does he judge ME/CFS patients who have tested positive for XMRV for taking antiretrovirals, which he calls “worse than useless—it is dangerous?” I don’t want to downplay the potential side effects of retroviral medication. These are very serious drugs. But questioning ME/CFS patients’ rationality shows ignorance about how severely ill those patients are. Does Dr. Michaeli really believe anybody would take this kind of medication without carefully weighing the pros and cons?
Mindy Kitei said it best in her testimony at the Chronic Fatigue Syndrome Advisory Committee meeting on May 11, 2011, ”Have You No Sense of Decency?:
“Researchers in government and at universities, as well as the CFIDS Association, admonish desperate patients that taking anti-retroviral drugs is medically indefensible. When the healthy reprove the sick that they’re impatient and reckless and foolish and need to wait for treatment, I say there is no treatment, and where are the drug trials? Thirty years and not one approved drug and none in the offing.
ME patients should have the same freedom to try medications that AIDS patients had in the early days. The AIDS patients became their own advocates because there was no one advocating for them. The same holds true for ME patients now. Patients are gravely ill, and they have the right to treatment. To say that they don’t—that’s what is medically indefensible.”
Maybe Dr. Michaeli’s stance on the British PACE study explains why he judges ME/CFS patients harshly for their desperate decision to try and get better. He said that “CFS is not all in your head,” but his endorsement of the PACE study surely could lead one to think that he doesn’t really believe in his own statement. He astonishingly called the PACE study “an excellent study showing that psychotherapy coupled with graded exercise is the most effective of all therapeutic modalities in clinical use.” Wow! What about the fact that the patients in the PACE trial who did improve did so only marginally? What about the fact that the flawed recruiting criteria for PACE resulted in many or maybe even most participants being fatigued due to depression and other conditions, but not due to ME/CFS? What about the fact that Peter While, the chief investigator of the PACE study, is Chief Medical Officer of Scottish Provident, an insurance company that stands to lose a fortune if ME/CFS patients in the UK were to be classified as having a physical, as opposed to a psychological, illness? Dr. Michaeli didn’t mention any of these or the other issues of the PACE study. Perpetuating the myth that PACE was a scientific study and that cognitive behavioral therapy and graded exercise therapy are valid treatments for ME/CFS—when, in fact, they are harming ME/CFS patients by worsening their condition in sometimes irreversible ways—that’s what I call dangerous!