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.