Vote of No Confidence 02/08/2012
Vote of No Confidence In the fall of 2006, as I scanned for information on ME/CFS research, I stumbled on a burgeoning institute called the Whittemore Peterson Institute. The institute was to be housed at the University of Nevada at Reno medical campus as part of their efforts to create the Center for Molecular Medicine. The WPI would take over the second and third floors of a building attached to the CMM. It would offer a translational clinic, an onsite lab, quality scientific research, and was backed by both state and private funding. On my second visit to their web site, I saw a biography of Dr. Judy Mikovits as their new Research Director. Her links to the NCI and ample publications were impressive, yet confusing. Cancer? What did this have to do with CFS? (I had just started more serious research into CFS after wifi and a laptop offered the online world to me from bed. I had a lot to learn.) Still, the idea of a center of excellence for ME/CFS excited me. I began calling it my CFS Mecca. At that time, I was reeling from a bad relapse that left me in severe pain, mostly in bed, or on the couch, PEM after even a few minutes of caring for my then 2 year-old triplets, and paying our part-time babysitter overtime to take on extra hours. I had already missed out on too many “firsts” with my kids, like their first sled ride that winter. I had been sick since November of 1995 and pushed to have as normal a life as possible. As a moderately severe case with occasional semi-remission from my worst symptoms, I was lucky to be able to do so. But, pushing to have children was one step too much for what my body could tolerate. Motherhood, age and lack of any noteworthy basic medical care despite seeing several doctors, left me desperate for a solution. As any patient with an invisible, incurable disease knows, desperation can blind even the most pessimistic of patients. It is my opinion that anyone knowingly preying on patient desperation should be promptly shot on the spot. For the next three years I would occasionally Google to see if the institute would get off the ground. It seemed stalled at points. Not enough private funding. The Whittemores were to come up with $5 million privately. In 2008, I saw an advertisement for their fundraising gala. I told my mother some day I would like to go to one. I tried to plan for the 2009 event, but was too sick and broke to attend. In October of 2009, the Science paper burst on the scene with a bang. As I told David Tuller of the New York Times, I said out loud, “BINGO! This is it.” To me, a low-level retrovirus made sense and how wonderful that it came from an institute that was working so hard for us, who understood the severity of the disease through their daughter’s struggles. I offered up my help in any way I could through their FB page. I worked hard with others to promote WPI to friends and family. Fundraised through joint FB efforts. Sent small donations as our budget would allow. Advocacy became easier with a single-minded goal to help Judy Mikovits and her team continue their scientific research and for WPI to open a translational clinic that would provide effective treatment. I would say hindsight is 20/20, but the details are still blurry as to what happened to the dream we all shared. One thing is very clear to me though. I do not have confidence that WPI is running their business in a professional, responsible manner. I vote no confidence in the Whittemores, and in turn, no confidence in their assessment of Vince Lombardi’s abilities. NIH RENAMES PRINCIPAL INVESTIGATOR ON WPI GRANT AS VINCE LOMBARDI What do we know about Vince Lombardi? For the most part, he has remained quiet and uninvolved in patient affairs. An article in Science Magazine focused on his late entry into science and his business experience. Vincent Lombardi, who would soon play a prominent role in the XMRV saga, co-founded the new lab [RedLabs] and served as its director of operations. …Lombardi was a late bloomer in science. In 1990, while he worked as a securities trader in Lake Tahoe, he decided to pursue an under-graduate degree at a local school. As part of a biostatistics class, he worked with Peterson, analyzing immune parameters of CFS patients. After his graduation in 1995, he ran investment companies and also worked as a marketing director for a pawnbroker business. He went on to pursue a Ph.D., first studying RNase L but switching to peptides in the tobacco hornworm, which he completed at the University of Nevada, Reno, 2 years after starting RedLabs USA. Science Mag His integrity, commitment to patient welfare, and his ability to bring strong collaborators to the ME/CFS arena has yet to be seen. His CV is unremarkable, but apparently adequate enough for the NIH coordinator, Christopher Beisel, to feel comfortable handing over $300K a year to him. This is his first chance to work as a Principal Investigator on any project. So far, he has been unable to secure a grant on his own according to the NIH Project Reporter. Since, for now at least, this grant has fallen into his incredibly fortunate lap, I would like to know exactly what Vince Lombardi has planned for this grant. I feel it is fair for patients who gave their time, health, money and blood to WPI research to request that the study design(s) be spelled out for us more clearly, especially since WPI seems to no longer support a retroviral etiology. If retroviruses will not be pursued, then what viruses, genetic factors or biomarkers will be pursued in the long list of items mentioned in the grant abstract? Ask Vince Lombardi and see if he responds. vclombardi@gmail.com. This is after all, tax payer money. (Update: 2/9/12 - Science Insider reports that Lombardi will work on Aim 2 of the grant which includes genetic susceptibility and immune dysregulation.) Even if Lombardi was a brilliant scientist, I have too many reservations at this point regarding the business aspect of WPI to continue my involvement with them in any way. For months I had heard whispers from friends who visited Reno, or had read news articles from Nevada, of the Whittemores' connection to “the mob”. I shrugged making the excuse that many wealthy politicians would be suspect of that, but it didn’t make it so. But, it turns out selling your soul to the devil is still an option. Faust would be proud. WHITTEMORES VS SEENOS The most recent news of the Whittemores finds them at odds with Harvey’s business partners, the Seeno brothers. Talk about being blinded by desperation. How could it have escaped my attention that Harvey Whittemore was in business with a billionaire group from California known for organized crime and part of an ongoing investigation by the FBI since 2010? The Seenos are suing both Harvey and Annette Whittemore for embezzling money from the Wingfield group, where supposedly the Seenos invested $44 million to save the crumbling business after Harvey went “broke” in 2008. But, Harvey had a history with the Seenos years before the Wingfield group. Jill Lufrano of the Daily Sparks Tribune writes that “In early 2004, the Whittemores sold half of their ownership interest in various companies, including Argus Media, Inc., Wild West Sound Company, Inc., Redlabs U.S.A., Inc., Dr. Pepper/7-Up Bottling Company of the West, Coyote Springs Water Corporation and Coyote Springs Land Development corporation to Thomas Seeno’s Company, TNSS, LLC.” Daily Sparks Tribune The Whittemores countersued the Seenos claiming they are mafia-related, sent a burly guy named Ray to reclaim property directly from their home as well as cash from a safe, and threatened bodily harm to them. Through their lawyer they wrote, ‘“These allegations are false. We will take any and all steps necessary to preserve the reputation for integrity that we have built in this state for over 40 years.”’ Daily Sparks Tribune I hate to think of any of my friends, current or former, being threatened in this way. But, perhaps being a rich lobbyist/politician/lawyer precludes a person from understanding what integrity is in the first place. Integrity to me would mean choosing one’s business partners much more carefully than selling half of your assets to a long established organized crime family. There can be no claim of naivite on Harvey Whittemore’s part either in my opinion. As Francis McCabe points out “Whittemore once was considered the most powerful legislative lobbyist in Nevada and one of the nation's top gaming attorneys. He represented the Nevada Resort Association, an organization of the state's top casinos, individual casinos and 100 businesses. He had worked as managing partner for Lionel, Sawyer and Collins' Reno office for many years. He now operates a small law office in Reno.” Las Vegas Review Journal How could a grant be handed over to people willing to be involved with the Seenos? And how can patients ever again trust that they are handling money honestly? It is a clear waste of tax payer money to hand over $300K to the Whittemores. I have withdrawn my consent to be involved in any study at WPI (see below) in large part because of the enlightening news of the Whittemores' involvement with the Seenos, but also because I do not like to be part of a brand new PI’s project. I tend to hate teaching hospitals as well. I like experience. I will also write to Dr. Beisel and his superior to request reconsideration based on the current legal scandal. I was considering writing to Chase Giving and Vivant as well, but I have a hard time lately finding anyone willing to support WPI fundraising anyway. In fact, it seems all support, even among doctors initially interested, has been partially lost at WPI. MUSICAL CHAIRS At one point, there was ample interest among doctors and advocates in WPI. During this time, permission was given for their support and roles in the institute to be published on their site. However, at this time, to my knowledge, many of those doctors you see listed, as well as a couple staff, are MIA. I find it unethical to continue using their names when they have no involvement in the institute at all. But, titles and names are how things are run. One of the worst missteps was giving Vince Lombardi the title of 'Clinical Lab Director'. The terms 'laboratory director' and 'clinical director' are not interchangeable from a regulatory point of view. The regulatory term is 'laboratory director'. 'Clinical Lab Director' is a cross between these two titles, although it might have occurred as a way to differentiate between the research and clinical labs. The laboratory director of VIPdx is, and has been, Sanford Barsky. His name is on every record I have for lab results from VIPdx since 2010. He electronically signed off on each one. In November 2011, an acquaintance began correspondence with the Nevada State Health Division regarding VIPdx and UNEVX's HGRV/XMRV tests. In the course of this correspondence, it was confirmed by Vickie Estes (Supervisor for the Medical Laboratory Services for the Bureau of Health Care Quality and Compliance) that “Unevyx is not licensed to perform XMRV testing to date. Dr. Vincent Lombardi is not now nor has ever been serving as the laboratory director for VIP.” Once Vickie Estes knew of this innacuracy, she contacted VIPdx who, subsequently, removed Lombardi's statement about the validity of XMRV tests (written in his capacity as Clinical Lab Director) and, later, took down the site altogether. It may have been a minor oversight for Annette to create an inappropriate title, but for me, it is another instance of serious neglect to protocol. The search for the real laboratory director lead to some questions about Sanford Barsky, MD. Turns out he has had his own issues with scandals. During his tenure at Ohio State Medical Center as Chair of Pathology, Dr. Gerard Nuovo informed him that up to 30% of female patients were receiving surgeries at OSMC based on misinterpreted Pap smear tests. They were told they had HPV. For his efforts, Dr. Nuovo was removed from his position and replaced with a junior pathologist by Barsky. (Read the full article here) Not only did Barsky allow continued surgeries and misinterpreted Pap smears to continue, he was accused of scientific fraud. Bob Fitrakis of Freepress writes, “At question is whether Barsky submitted research data that was passed off as new that had been duplicated and doctored from his own previous publications.” Freepress.org (see video at the end of this link for details regarding recycled images by Barsky – video is very fast) Despite repeatedly informing his superiors of unnecessary surgical procedures and possible scientific fraud with federal money, the whistleblower, Nuovo, was fired for bringing "frivolous charges" against Barsky after Barsky had already moved to his new home as the Chair of the Pathology Department at the University of Nevada and Nevada Cancer Institute’s Chief of Pathology. One of his responsibilities is to oversee the WPI lab. As laboratory director of VIP/UNEVX, it would be his responsibility to make sure all testing is accurate and ethical. Where has he been? Vince Lombardi was the only one defending his work on the HGRV serology test. The more I learned, the more I became uncomfortable with every facet of WPI and the University of Nevada's involvement with them. Patient Support Patient support had been declining for some time for WPI. The number one reason I heard from patients over the last 18 months was lack of communication by Annette Whittemore and poor office management at the front desk. Globally, patients, doctors and interested parties wrote in to the info@wpinstitute.org email looking for information. I know of one doctor who was ignored on a regular basis despite trying in every way to get an answer back from Annette Whittemore, including phone calls and having her personal email address. I had patient advocates come to me assuming the WPI Patient Advocate of the Year would be able to help them get in contact with Annette regarding what they felt were important issues, but I had to tell them my emails were rarely replied to as well and any forwarding of their messages became useless. I told them what I was repeatedly told. Annette was too swamped by daily institute responsibilities to respond to all the thousands of emails she was receiving. My heart went out to her. It’s not an easy task. It’s a nightmare. However, after a point, I realized that not having any organized way to address the email overflow was just the tip of the iceberg when it came to the institute’s overall disorganization. There was an excuse for everything that was making patients impatient. At a certain point, business is business, and excuses are not acceptable. But, it seemed everything was put on the back burner, patient communication most of all. Despite this, most patients continued fundraising in support of the research. Their lives still rested on the hope they placed in Judy Mikovits. Judy’s name became synonymous with hope because we all knew the answer to our prayers was in the science. The clinic had yet to open well past the timeline promised. Patient concerns were left unaddressed and the government scientists were poised to slam the door shut on retroviral studies. Patient hope hung by a thread the summer of 2011. Then Judy Mikovits was fired, sued and thrown into jail. The remaining patient support that I was aware of was lost at that point, not because we lost confidence in Judy because of the accusations, but because we consider this a wrongful firing, resulting in lack of scientific expertise at WPI. My wish would have been that a third party negotiator might have been brought in to settle any disputes. I would have donated another amount just to fund that. As I see it, even if I could overlook the WPI connection with the Seenos, there is nothing left for me at WPI. The scientist I trusted is gone, and the clinic was not opened in the planned capacity. Instead of a WPI-run translational clinic, which was apparently "too costly" to create, they chose to move the Sierra Medical Group into the building with Dr. Cyrus Pourzan who among other interests claims to be able to resolve autoimmune and viral issues and cure allergies and chronic sinusitis. Dr. Pourzan may be a good doctor and perhaps even helpful for some patients. However, I steer clear of any doctor who would tell me he is able to resolve autoimmune issues. I’ve heard too many promises from ME/CFS doctors around the world who feel they have the answers, yet a quick inventory of how many patients have been “cured” or even significantly helped is quite low. The other option is Dr. Fredericks, an endocrinologist who was not treating ME/CFS patients prior to joining WPI. While that is not a big strike against him, I have an excellent endocrinologist and don’t need another one. Moving On As mentioned previously, I have withdrawn my consent to have any blood tested at WPI. If you would like to do the same and are currently part of WPI research, I have attached links, my letter, and the response from WPI below. Included is a link to a blog from a friend and patient involved in the UK study. When she asked to withdraw her consent, she was informed that the consent and blood were missing. Her experience in resolving this issue has been less than satisfactory. It’s time to move on, hopefully, a little wiser and more cautious next time around. I don’t regret my enthusiasm or support. I could only go on what I knew at the time. But despite the threat of lawyers reading this blog, or possible harassment by email or text asking how I could betray them, I find it is time to cut loose and fly free. I was bound too long by my need to see WPI succeed despite my reservations. I simply held my breath and hoped we wouldn’t crash. I have to say at this point, I’m glad airbags were invented because this has been one insane ride. ****************************************************************************************** “The WPI Loses Blood and Consent Form by Chris Douglas” ****************************************************************************************** *This letter is taken in part from a fellow patient’s email. She used an example from ME/CFS Forums. Dear Ms. Jones, As a participant in the NIH study at the Whittemore Peterson Institute, I am requesting to be removed from the NEW STRATEGIES TO DECIPHER THE PATHOPHYSIOLOGY OF CHRONIC FATIGUE SYNDROME research grant studies. The consent form I signed states I may remove myself at any time and I am choosing to do so now. Please destroy all data and samples that would identify me as a participant to assure my privacy will be protected. Please send a receipt "reply all" e-mail that you have received this notification and that all actions of removing my information, data and samples have been destroyed. In addition, any consents signed by Heidi Bauer for VIP/UNEVX testing that might indicate permission for research on those samples is hereby withdrawn as well. All samples in any part of WPI are to be destroyed. No results from any testing done previous to this letter are permitted for use in any publication. Thank you. Heidi Bauer Christopher Beisel – grant coordinator cbeisel@niaid.nih.gov Nancy Moody – U of Nevada IRB contact - nmoody@unr.edu Kellen Jones-Monick – Office Manger/Study Coordinator – kjones@wpinstitute.org Reply: Dear Ms. Bauer, Whittemore Peterson Institute (“WPI”) is in receipt of your email dated February 6, 2012. WPI confirms your withdrawal from the study entitled New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome. Your blood sample will be destroyed, but your consent document cannot be destroyed because it is a study record that must be maintained for grant and regulatory purposes. WPI will continue to protect your privacy and confidentiality according to the approved protocol for the study. Best regards, Kellen Jones Study Coordinator CommentsShelley Lauer 02/08/2012 3:08pm
Heidi, so glad to see you back in the blogosphere! Excellent piece, and not only do our stories/experiences parallel each other, so do our opinions on the whole mess. And mess is too small a word. I'll be back when I think of the one I'm trying to find! ;-) John 02/08/2012 3:41pm
I don't care who does the research. I just want answers. Withdrawing from one or more studies at this stage looks to me like a waste of resources - time and money that has already been invested. MASSIMO 02/08/2012 5:22pm
Loved it Heidi!! Thanks for your articles!!! ;-) Karen 02/08/2012 5:48pm
It will be a waste if anymore taxpayer money is sent there. Lombardi is not qualified and the institute has lost patient samples and information. They have also not been responding to participant inquiries for months now. The only qualified scientist that helped make the discovery was fired. It is her research and she knows how to conduct the studies. Any government money sent there now is out the window, if you expect Lombardi or this institute to conduct this research. I see this as blatant conflicts of interest and ethics issues, as well as possible IRB violations. The government officials are also not responding to patient inquiries because they know they've screwed up. Now we have to wait and see just how badly. 02/09/2012 1:39am
You are right, Heidi. It is time to move on. There is nothing worthwhile left at WPI. They have now joined the ranks of those organizations which seek to keep M.E. sufferers sick in order to obtain profit for themselves. It is time for us to focus on the positive--including the Lipkin study, the work being done by the Mt. Sinai group, Dr. Montoya's work, Dr. Cheney and Dr. DeMeirler's work with GcMAF and MAF314, the work being done on Rituxan, and I am still hoping that Dr. Mikovits will be able to continue her work too. 02/09/2012 2:13am
In this article, Heidi suggests asking Dr. Lombardi some questions.This is what I wrote; please feel free to use any and all of my email if you compose an email to Dr. Lombardi. Mary 02/09/2012 12:23pm
There are many facts that are incorrect in this blog. Perhaps someone should actually write to the investigators and the doctors in question. A family is behind this institute. A family with children, grandchildren, nieces, nephews, in laws, and you are hurting them needlessly. All the Whittemore's ever wanted to do was help Andrea they could have. They set out to help 17,000,000 sufferers not just their daughter. ann 02/10/2012 4:25pm
http://www.reviewjournal.com/lvrj_home/2006/May-20-Sat-2006/news/7512507.html Jil 02/09/2012 2:48pm
Mary, Judy helped Andrea, but she is only one patient. What about the rest? Heidi Bauer 02/10/2012 2:40am
Jil, He really was not the laboratory director. He would need to be the laboratory director or clinical director. It's inaccurate to try to make him both. The person in charge of overseeing validity should be Sanford Barsky who is the laboratory director for VIPdx/UNEVX. As I understand it, Barsky would be responsible for saying if a lab test is valid or not. Lombardi trying to validate and defend his own test is ridiculous. If the test was valid, there should be a statement from Barsky addressing how they went about making sure that the same person creating the test (Lombardi) is not the same one validating it. We have heard nothing from him and have a response from Vickie Estes saying the test was is not licensed and Lombardi has never been the laboratory director. He overstepped what he was allowed to claim in this respect. Heidi Bauer 02/10/2012 9:05am
Edit - I'm sorry. I wanted to clarify that Vickie Estes says only that UNEVX was not licensed to sell the test. Tony Mach 02/10/2012 8:09am
"Desperation can blind even the most pessimistic of patients" Tony Mach 02/10/2012 8:24am
AFAIK Dr. Mikovits held a position there – but please check that for yourself. Tony Mach 02/10/2012 8:25am
AFAIK Dr. Mikovits held a position there at VIPdx. ann 02/10/2012 4:18pm
Karen 02/10/2012 5:57pm
Dr. Mikovits never held a position at VIPdx. Lombardi was the one that oversaw the testing going on there. Dr. Mikovits was in charge of the Research lab only. Incidently Lomardi also had a title of Research Director as one of his apparently many titles. So when he made the statement as the Clinical Director for VIPdx, that the Research Director had approved of the VIP dx test, he was talking about himself. The Whittemore's owned the VIPdx lab and Dr. Mikovits had nothing to do with it. Her employers did so get your facts straight Mach. 02/11/2012 5:53am
The complexities of the Whittemore/Seeno business arragements are easy to get confused - the Daily Sparks Tribune quote includes an error - the Wingfield business actually dates to 2004/2005 and involves the various listed businesses, including Redlabs/VIPdx. So from 2005 Redlabs was part owned by the Seenos, and by 2010 they held a majority share of all the Wingfield business. Rivka 02/11/2012 10:19pm
heidi, great work researching and writing this piece. like you did, i'll be withdrawing from the study also. -- rivka Angela 03/03/2012 2:45am
"But, pushing to have children was one step too much for what my body could tolerate." Heidi 03/03/2012 4:14pm
Hi Angela. Dan Wilson 05/05/2012 2:37pm
You can file a complaint as well with: Leave a Reply | Heidi BauerI have battled ME/CFS for almost 17 years. I became an advocate in late 2008 hoping to learn how to prevent my children from becoming ill. Since then I have had a crash course in politics and science, and the politics of science. This truly is a journey to discovery. ArchivesCategories |
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