Breaking news. The entire WPI research program has been closed by the institute’s CEO, and the facility is now locked down. It’s former principle investigator, Dr. Judy Mikovits, is in active discussions concerning institutions to which she may move to continue her grant-funded research. The institutions must remain unidentified, for obvious reasons, but it’s important for patients to know that she remains committed to continuing this critical work.
So now, on top of everything else, a divorce at the WPI. Yet to come are all the things that can happen in such messy situations. Meanwhile, there is no Mikovits-led research at the WPI or any research institution at the moment. An enormous loss of possibility. I’ve done a lot of soul searching about whether to write this blog or not. My motivation for writing all along has been to make things better, to inform, alleviate isolation, share ideas that I hoped would be useful. This is different. Writing this entry, I feel like I’ll be taking away hope, which is anathema to me. But at this time, withholding the information I have would be dishonest. I don’t know what else to do, except tell it the way I see it.
Here is the reality and the context for why I write this particular blog entry: My email inbox is filled with so much pain and confusion, as patients try to figure out what the BWG study means to them. I feel it is my obligation to both these patients and the larger community to share my opinions. I think what the BWG results mean is that all the XMRV/HGRV testing done at VIP Dx has been and is now null and void. Keep in mind that Dr. Mikovits works at the WPI research lab, which is a separate lab from the clinical, commercially-oriented VIP Dx lab. She believes that she has reproduced her original work many times and found evidence of infection in the patients who were previously found XMRV positive. But she never found any single patient positive on every date tested by every assay. So there has been an assumption that there were false negatives in the WPI research lab for some time. Another important thing to keep in mind is that WPI routinely used several tests on each sample, whereas VIP Dx used different, more limited testing, on the samples they received, testing that apparently was never truly validated against WPI methods or performed with appropriate controls. I personally don’t know why this was the case or how it happened. Obviously the decision to sell a test was a very poor one, hindsight being 20/20. It left the institute with a difficult conflict of interest.
I have watched this whole thing unfold and kept quiet because I hoped that management at the WPI would come to their senses, before it was too late. They have not, so I now feel obligated to share what I know.
Dr. Mikovits is a personal friend of mine. We’ve spent time together in Reno. We were excited about our collaboration. We still speak and email regularly. Because I know her so well, I can tell you first hand that she never thinks of or spares herself, and instead gives her all to the research and the patients who need it so badly. She has been criticized for the unorthodox step she took of allowing patients to gain access to her, a step that was life-saving for some, though it turned her into the ME/CFS hotline.
In terms of the BWG: I was told that the BWG specimens were being run in both the WPI research lab and the VIP Dx clinical lab. Though the labs were kept separate, and cooperation between the two labs was already very troubled, Dr. Mikovits believed that VIP Dx would succeed, and everything would be doubly validated.
When the results of the BWG were uncoded and revealed to all nine labs (but not yet made public), in early August, WPI was left in a bad place. Dr. Mikovits says that at that time she asked WPI management to stop offering the XMRV test at VIP Dx. But the testing was not stopped. Why?
Then, when the BWG results were finally made public on September 22, Dr. Mikovits was quoted as saying, “VIPdx lab will NOT continue XMRV-testing because it hasn’t been shown to be reproducible in [the] BloodWorkingGroup”. Shortly after she said this, cooperation between the two labs ceased completely and the research lab was closed. Why?
It is important to know that Dr. Mikovits stands by her work at the WPI research lab, which is all she can vouch for. She cannot account for what happened at VIP Dx. It was in a different location, under different leadership: Dr. Lombardi was in charge at VIP Dx.
Now it appears the WPI research program is getting thrown under the bus, but VIP Dx is still up and running, now minus XMRV testing. None of this means that we don’t have HGRV’s, or that some of the work that came out of the Mikovits-led research lab wasn’t correct. What it does mean is that there is no validated test for clinical, commercial use. And it means we are now at risk of losing all the gains we’ve made because of poor managerial decisions.
My next blog will be to repost Dr. Mikovits’ slides from Ottawa, this time with her comments and a summary from me, making the case for HGRV’s. Culture contamination with VP62 doesn’t explain away her findings. She was finding variants of XMRV. The serology test used in the BWG and published in Lombardi et al is picking up something that is at least very close to, if not antibodies to, MLV proteins. Someone needs to find out what those proteins are. There were electron micrographs from patients showing retroviruses. Pictures. Frank Ruscetti has been studying retroviruses since the beginning of the field and he believes he has been looking at something real. And there have been clinical responses to antiretrovirals, including ours, that are hard to explain away, other than that they are doing what they are supposed to do, inhibiting the replication of retroviruses. Please read Dr. Snyderman’s posts and comments again: A Reason For Hope.
As sometimes happens with divorce, we now find ourselves in a position where we have to take sides. The science, not the institution, is the child that must be protected somehow in the ensuing custody fight.
For the record. As we descend back into darkness… I wrote the below text a few weeks ago, but didn’t post it. I have confronted these issues directly with WPI management and not gotten an adequate response.
If you tell the truth, you don’t have to remember anything.
~ Mark Twain
I’ve been quiet about my own personal experiences at the WPI, figuring things would unfold on their own, without disclosure from me. But something is happening that I can’t just let pass, It is this belief patients have that, could they only get to Reno and be treated at WPI, it would all be better. This dynamic is too painful to watch in silence. It hits a nerve. When my daughter got sick with “Chronic Lyme Disease,” I felt that there was information other doctors had that might help her. The memory of that feeling, of being unable to help my child, thinking that there was something to know that I didn’t know, and the poor decisions that desperate feeling led to, is driving this next disclosure of mine. Keep in mind that most of what I know about that is happening on the clinical side at the WPI now is hearsay. He said, she said. Eventually, it will all come out in the wash. But as a physician, I feel the medical carrot being dangled before the public needs comment.
I recently watched Annette Whittemore on Nevada Newsmakers imply that there is new treatment available at the WPI that is producing miraculous results. Due to patient confidences, I can only impart my reaction, not prove my case with details. But her comments were over the top, an advertisement, cobbled together from little pieces of reality, but not reality. There is one doctor working independently in the clinic space, downstairs from the WPI. He is a lovely doctor, an experienced endocrinologist with an interest in CFS. He would have made a wonderful addition to a multidisciplinary team. Does he know something that nobody else knows regarding how to treat CFS? No. There is no treatment being offered in Reno that isn’t mentioned on my blog. No secret knowledge. Nothing you need to be an insider to find out.
It has been really tough for me to decide what, if anything, to say about this next topic. Given that I promised to be truthful here, saying nothing seems almost a lie of omission. If I say something, I sound bitter, which maybe I am. And if I say nothing, I sound incompetent, which I am not. A no win situation. But the truth is, I was well on my way to getting the WPI clinic going as envisioned from day one: A team of like-minded doctors sharing ideas and generating a large patient database, an integral part of a WPI translational research institute. It would have generated enough income to support the research program. But the plug was pulled, inexplicably. A very poor decision.
The ways in which I was mismanaged and completely constrained by ineffective micromanaging when I was working at the WPI, and now this insanity, shutting down the research program, establishes a pattern of behavior. Although it is sad, the party is over, and needs to be. They were, and are, in over their heads. They started with the best of intentions. We will always owe them a debt of gratitude for the spark of genius and the increased awareness they have brought to our disease. But now, the work needs to be done by someone with the resources to do it right. They have risen to their level of incompetence. It doesn’t matter to us who wins, gets the money or what their personalities are like, as long as the research continues. We need it to happen. The WPI is now an obstacle to progress.
Tonight’s song: Square One by Tom Petty