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.
Thank you Jennie for being brave in documenting the facts.
Spot on. I would add that facts are actually neutral – its how they are used or interpreted that is not neutral. No amount of stomping and hollering changes facts – or in some cases opinions for that matter.
Dr. Wessely is wed to a hypothesis. Dr. Mikovits was wed to a hypothesis. Refusing to allow factual refutation of a hypothesis appears to be a two-way street.
The post of Ms Spotila is IMO typically inaccurate and representative of the biases displayed by her and her kind.Hypotheses are based on empirical measurements.Wesselly is wedded to a belief ,Anyone who knows anything about PCR will know that the PCR systems used by Ruscetti and mikovits were far more sophisticated than the one used by Silverman having a far greater power to detect XMRV env if present in their samples.They could not do so therefore as Silverman could the contamination occured in his lab. It really isnt difficult.If anyone is wedded to a belief its the CAA and their backers. The belief that a distinct clinical entity can be diagnosed on the presence of fatigue and a few minor symptom a la fukuda is tantamount to a belief in magic. Now I wonder if you will be brave enough to post this.Now anyone who does not know the difference between a belief and a scientific hypothesis like Kelly latta above is simply demonstrating their ignorance and IMOdoing patients all over the world a huge disservice
I allowed this comment through, but must remind commenters that I do not allow personal attacks on this blog. Please confine your comments to the substance of posts. Personal attacks on me/commenters/others will be deleted.
Dr. Ian Lipkin had nothing but glowing praise for Dr. Judy Mikovits in his interview with *Nature News & Comment* on September 18, 2012.
Dr. Lipkin said, “I feel very badly for Mikovits, [her co-author] Ruscetti and Harvey Alter [a hematologist at the NIH Clinical Center in Bethesda, Maryland, who led one of the CFS studies]. Mikovits in particular — she has lost everything. She can be wrong but she’s not a criminal. She has been honest in a respectful, forceful way and said that we have to conclude that we were wrong. You can imagine how difficult it must be, and I think she should be applauded. Lots of people wouldn’t have the balls to do that. She has come across as a scientist who really believes in the importance of truth.”
I share Dr. Lipkin’s positive view of Dr. Mikovits. She is a fine scientist and good person who was driven into bankruptcy by Annette Whittemore and her husband Harvey, a convicted felon.
Personally, I don’t have a problem with Dr. Mikovits’ comment in the FDA docket, and I don’t quite understand what all the fuss is about. I’m glad that Dr. Mikovits is continuing her hard work on behalf of patients. I look forward to reading her forthcoming book: http://www.amazon.com/Plague-Scientists-Intrepid-Retroviruses-Syndrome/dp/1626365652/ref=sr_1_1?ie=UTF8&qid=1375217480&sr=8-1&keywords=mikovits+heckenlively
One wonders why this is being resurrected at this time. I fail to see how this helps move things forward. Clearly the CAA is not a fan of Judy Mikovits – everybody is clear on that. This narrative seems to be a big middle finger to certain parts of the community. It’s very disappointing that Ms. Spotila has sunk to driving a wedge into an already fractured “community”. But I suppose it’s much easier to kick Mikovits while she’s writhing on the ground than analyze the total ineffectiveness/ineptitude of the CAA and friends at CFSAC and the CDC.
Note: I had to delete this comment as it contained personal attacks on me and accusations against an organization.
Hi Floyd,
I just wanted to beg to differ with you about Dr. Mikovits currently “writhing on the ground.” On the contrary–she’s doing just great! If anyone would like to follow her current research and consulting projects, (She’s working with many clinicians, including Dr. Derek Enlander, Dr. Eric Gordon, Dr. Chitra Bhakta, Dr. Michael Snyderman, and Dr. Jamie Deckoff-Jones.), please visit and/or like the following page on Facebook:
https://www.facebook.com/pages/Support-Dr-Judy-Mikovits/101589063330685?ref=profile
You can also find reports from some of the many conferences Dr. Mikovits has been to recently. These include:
United Mitochondrial Disease Foundation Symposium in Newport Beach, California, June, 2013
American Society of Clinical Oncology Conference in Chicago, Illinois, June, 2013
FDA Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) meeting in Bethesda, Maryland, April, 2013
GcMAF Immunology Conference in Frankfurt, Germany, April 2013
Physician’s Round Table Conference, in Tampa, Florida, January 2013, January 2012
Newry International M.E. Conference, Newry & Mourne ME/Fibromyalgia Support Group, in Newry, Northern Ireland, November 2012
Academy of Nutritional Medicine Conference in London, England, November 2012
Sue Vogan’s In Short Order Radio Show Interview, November 2012, and July 2013
ILADS Lyme Disease Conference in Boston, Massachusetts, November 2012
In short, Dr. Mikovits is still quite busy, active, and working to help patients! I also want to give a big shout out to Lilly Meehan and Robyn Erland for starting and maintaining this page. 🙂
Jenny,
Maybe Dr Mikovits heard another comment or there is some history between the researchers that would explain how she responded?
I’ve been at meetings and heard comments that have never made it into any public record of that day but still felt that I needed to respond. There may have been an “elephant” in that room and the report may not be adequate.
My own feeling is that she is responding to something she has heard and it doesn’t seen inappropriate to me at all.
There is a strong feeling as well with ME patients that Silverman got off lightly after the “debacle” and that Mikovits was the one unfairly singled out for criticism.
You may feel differently but patients have their own opinions here and we don’t all agree.
At the end of the day I’d like to see other doctors pick up the work that Dr Mikovits started and look at least for evidence of Retroviral activity in a cohort of epidemic ME patients.
The fact that all these years later, no one has done that is the real story.
Jennie,
First let me thank you for all you do to help all the ME/CFS patients wade through much of what is happening in the ME/CFS scientific community, and for all your efforts to encourage patients to participate in a positive and effective manner when an opportunity arises (i.e. the FDA Drug Development meeting).
Second, let me remind anyone who so casually and cowardly criticizes Jennie from behind a computer screen that all the work Jennie has done for us over many years (years she has been plagued with the same illness as most of you), all this she has done as a VOLUNTEER. So instead of undermining the ME/CFS community by lobbing biting comments at her and anyone else, maybe a more productive choice would be to use that time to contribute something positive to our shared situation, as Jennie has so selflessly done.
Ask yourself what you have done to support the ME/CFS community.
On reading Regan’s comments it would certainly seem that Dr. Mikovit’s is sticking by the ME/CFS patient community, working hard on their behalf. I am thankful to her.
[I deleted the remainder of the comment as it was a personal attack on me. Disagreement is permitted on this site. Name calling is not.]
I sent this to Jennie privately (give or take a few words for context, etc.), mostly because I didn’t realize how easy it was to post here on the blog. 🙂 In light of her most recent post, however, I decided to post it publicly as well.
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Great post! The last few paragraphs were what really spoke to me—the part about the community’s reaction during the XMRV debates (back when they were still debates and not a debacle). It’s good to see others out there who look at the facts rather than the hype/spin coming from the radicals. Thank you.
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In addition to that post, I’d just like to say that the biggest problem I see in this community is much the same one Jennie talks about: people who form opinions without bothering to wait for the facts, or in some cases, even look at the facts available. Science is slow, and we need to wait for verification of findings rather than jumping on the latest bandwagon to come along. I said that during the XMRV debates and was roundly thumped for daring to doubt the good word of Dr. Mikovitz. In truth, I didn’t “doubt”, I just withheld any judgement at all until there was some level of verification. We all saw how that turned out.
In the end, we are a very marginalized group, true enough, but it does nobody any good at all when there are people making threats against the very scientists who are doing their damnedest to figure out what’s going on. If they get off on what we think is the wrong track, so be it. We never know where that wrong track might lead, especially since we don’t even know what the right track is.
Let’s work WITH the scientists and WITH each other; it’s far more productive. What’s more, doing so doesn’t further the belief in some quarters that we’re a bunch of nutjobs with massive psychological issues, which is what the radicals in the community have done all too well.