In Part one I presented information about the clinical validation and licensing of the XMRV tests sold by REDLABS to patients (1).  Part two begins with Phase III of the Blood working group (BWG), publication on those results on the 22nd of September 2011, returns to the tests sold by REDLABS and finally ends with the firing of Dr Judy Mikovits on the 29th September 2011.


Part two of my presentation is quite long, but I would urge everyone to read it.

 
[Note: REDLABS is not R.E.D. Laboratories in Belgium. The Belgium lab is not related to this presentation]


PART 2: Blood doesn't come cheap (the butchers bill)


The results of the BWG were on the surface, a mess (2). Too few people had been tested and the results were scattered amongst patients, controls and labs. Dr Ruscetti openly said he disagreed with the interpretation of the results (3) and in contrast others have continued to find the ME retroviruses (4,5,6). Later a closer inspection of the BWG paper had revealed a catalogue of flaws that rendered the results void. These were the main issues.

 

  • All the assays in the Blood working group used VP62 to optimise their assays, but this strain has never been detected in a human by any lab so it should not have been used.
  • Controls had not been pre-screened by all labs using all methods.
  • Only the three lab technician control samples were screened with all methods prior to blinding.
  • None of the 12 control peripheral blood mononuclear cells (PBMCs) were screened prior to blinding. This is the most sensitive assay, so none of the controls have been recorded as negative before blinding.
  • No preservative or Trizol was used for storage of the PBMCs during processing. This would have degraded the RNA and defeated Dr Mikovits test.
  • Patients were taking medications that could produce false negatives.
  • A portion of collection tubes had been in the CDC lab with 22Rv1 cells.
  • The time allotted for serology and culturing was massively reduced from what had been used in Lombardi et al.
  • The WPI was not given the opportunity to complete virus culture testing. Although there were samples provided to several commercial companies who had been added to the study.
  • The amount of blood draw was too little.
  • The NCI-Ruscetti did no PCR and the WPI no serology.
  • Only 14 CFS patients were tested, and 15 controls. 
  • Only 6 patients had been tested in Lombardi et al.
  • The positive serology results from Dr Ruscetti, the NCI co-author of Lombardi et al. (2009), must also be accepted as evidence of a retroviral infection, as the test has only ever been shown to react to exogenous MLVs.   
  • The WPI/Mikovits and NCI/Ruscetti have never had an assay capable of detecting MRVs in plasma or whole blood.

 

Seven days after the publication of the BWG results, on Thursday 29th September 2011, Annette Whittemore summarily fired Dr Mikovits, while she stood outside her rented home in Nevada, and closed down the Whittemore Peterson Institute (WPI) research program (7,8). This was kept from patients until Dr Jamie Deckoff-Jones revealed the shocking news on the following Monday, in what was a blog intended to share her opinion of the BWG results (8). As Dr Deckoff-Jones explained, testing for the BWG had been split between the Mikovits research lab and the commercial lab where Dr Vincent Lombardi was given responsibility for overseeing XMRV testing.   


 

“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.”

(Dr Jamie Deckoff –Jones, MD, Square One, X Rx, 3 October 2011) (8)

 

This was a surprise, for Dr Mikovits had no authority or oversight over any activity taking place in the clinical lab (AKA commercial lab, REDLABS trading as VIP Dx). Why then was the commercial lab conducting testing for the BWG study? Why had the NIH allowed REDLABS, an independent company with a vested interest, to take part in the BWG? Did REDLABS hope to clinically validate their tests? Had Dr Mikovits wanted them to use this opportunity to clinically validate their tests? 


Mikovits has stated that she had requested for the best part of two years to see the evidence for REDLABS tests sold to patients (7), was this why she wanted REDLABS included in the BWG study, if she did want them included? Dr Deckoff-Jones stated that Dr Mikovits believed they would succeed. An opportunity to have several labs confirming the existence of the ME retroviruses may have been Dr Mikovits reason for wanting REDLABS inclusion in the study. Alternatively the BWG may have wanted another lab to take part to take the number of labs participating to an even ten.


Within days of the Dr Deckoff-Jones article appearing, the WPI had hurriedly arranged for Annette Whittemore to answer questions on the WPI Facebook page, under the page name 'Whittemore Peterson Institute', with Kellen
Jones-Monick and Andrea Whittemore moderating (9). Much was said in the exchanges that followed, but perhaps the most significant comment related to the REDLABS tests and the BWG.
 

“Whittemore Peterson Institute

Many of you have questions regarding the blood working group. The purpose of this phase of the BWG study was to determine if current assays could reproducibly detect XMRV/MLV in blood samples. "They concluded that these results indicate that current assays do not reproducibly detect XMRV/MLV in blood samples and that blood donor screening is not warranted."

It is important to note that the results reported in the blood working were not based on the testing methods that are used in the clinical laboratory.”

(Annette Whittemore, WPI Q & A, 7th October 2011) (9)


 

If the results in the Blood working group were not the tests used by REDLABS, what happened to the results produced by the REDLABS group led by Dr Lombardi? Why were the results of the commercial lab not published? This was the chance to validate the commercial tests in the eyes of the world. Why was publication of the REDLABS results avoided? What was wrong? Dr Mikovits was quoted as having said that the REDLABS (trading as VIP Dx) tests were not reproducible in the BWG. 

 

 

“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.”

(Dr Jamie Deckoff –Jones, MD, Square One, X Rx, 3 October 2011) (8)


 

The results from REDLABS must have therefore been uncoded and known to all the participating labs and the authorities. Dr Lombardi's name is also not on the BWG paper (2), but his team clearly participated. So how could testing performed at REDLABS for the BWG, that was shown to not be "reproducible", have vanished? 


The aim of Phase III of the BWG was to assess clinical sensitivity and specificity of the assays (10), was this anything to do with the failure to report the REDLABS data? These are serious questions that demand the truth, the whole truth and nothing but the truth from Annette Whittemore, the management team of WPI, Dr Lombardi, the man in control of REDLABS, Harvey Whittemore, and the organisers of the BWG.


It is also peculiar that the BWG had ever portrayed Phase III as being capable of clinical validation when only 45 clinical samples in total were to be screened (10), and only 30 were in fact screened (2). True clinical validation would require hundreds of samples (11). Therefore none of the tests from the others participating labs could have been said to be clinically validated, but did any of the members of the BWG see any clinical validation data for the tests used by REDLABS?  


Regardless of how REDLABS (trading as VIP Dx) came to be conducting tests for the BWG, by July 2011 Dr Mikovits had expected REDLABS to stop selling tests to patients.  


 

“In the summer of 2011, Mikovits and her young lab assistant, Max Pfost, began poring through their notebooks, trying to find where such a contaminant might have entered their process.

 

In July, she says, she found it—an entry from March 2009 indicating that a culture of the XMRV virus had been placed into the same incubator with the rest of the lab’s blood samples. Mikovits says she was out of town the day this occurred.

 

In July 2011 she told Harvey Whittemore of the potential contamination, she says, and expected that the VIP Dx lab would cease testing patients for the XMRV virus. “I just kept saying, stop it, stop it, stop it. We have to sort this out,” Mikovits says. According to Mikovits, the testing did not stop. And after a tense summer, she was fired in September.” 

 

(Casey Schwartz, The Daily Beast, 23 July 2011) (12)

 

As recounted in her interview with Casey Schwartz of The Daily Beast, Dr Mikovits and lab assistant Max Pfost had discovered a potential source of contamination, but what samples could have been contaminated? How did it relate to REDLABS? And why did Harvey Whittemore ignore her advice that testing be stopped at REDLABS? 


In addition, Dr Mikovits had also said that she had no confidence in Dr Lombardi’s ability to carry out testing and that he had been unwilling to take her direction as Research Director (7). Therefore again we must ask why the NIH had invited REDLABS, an independent company with a vested interest, to take part in the BWG? Had Dr Mikovits objected to their participation or ask for their inclusion?


Annette Whittemore had, during the Facebook Q & A, stated that REDLABS (trading as VIP Dx) were offering clinically validated tests. 

 

 

“Regarding XMRV testing at VIP Dx. All tests offered by VIP Dx laboratory are clinically validated. If you have further questions about the tests please send your questions to info@VIPdx”

 

(Annette Whittemore, WPI Q & A, 7th October 2011) (9)

 

 

Yet, by the 7th October 2011 when this statement was made, REDLABS were no longer selling XMRV tests to patients, so this comment cannot relate to those tests. They had in fact stopped offering clinical tests by the 6th June that year, but were continuing to test samples for XMRV they had already received payment for (13). The question therefore remains, were the XMRV tests sold by REDLABS clinically validated? 

 

As of June 6, 2011, VIP Dx will no longer be accepting samples for any clinical tests.

 

If you are interested in the specialty clinical testing once offered by VIP Dx, please visit the website of UNEVX at www.unevx.com.

 

If you currently have tests pending with VIP Dx, those tests will be completed and reported by VIP Dx according to the current testing and reporting schedule.

 

If you have any questions regarding tests that you have pending at VIP Dx, please contact customer service at 775-351-1890 or info@vipdx.com (info@vipdx.com).

 

(VIP Dx statement, 6 June 2011) (13)

 

What had prompted them to stop offering commercial testing for XMRV at REDLABS? Had they found anything was wrong with their tests? If they did find the tests were wrong, how were they wrong and when did they discover this? They had stopped offering the tests before Dr Mikovits says she found evidence of a potential contaminant (12) and it was before the results of Phase III of the Blood working group were known, as samples had only been distributed to the participating labs for that study sometime around the middle of May 2011 (14) and results were not known until sometime after August 4th, as that same week Dr. Michael P. Busch, director of the Blood Systems Research Institute, had started to break the codes for the Phase III study of the BWG (15). Patients were also being directed to a separate clinical laboratory, UNEVX, for specialty clinical testing once offered by REDLABS (13). REDLABS were also happy to continue testing those samples that they had received payment for (13).  

 

 

PATIENT INVESTIGATIONS

 

After the Q & A with Annette Whittemore on the WPI Facebook page (9), some patients took up her offer to email questions to Marguerite Ross about the REDLABS XMRV tests. Marguerite Ross is the Director of Marketing & Client Relations for REDLABS and the separate lab called UNEVX (16). The following response was included in one particular email exchange with a patient who was trying to discover if the tests sold were clinically validated.

 

 

“The protocols used by Unevx and/or VIP Dx are proprietary.”

 

(EMAIL: Marguerite Ross, October 2011)

 

 

The patients then asked Marguerite Ross to provide the full details of the test, such as the reagents and cycling conditions, so that they could compare them to the methods used in Lombardi et al. (2009). The following short response was received from Marguerite Ross.

 

 

“NO.”

 

(EMAIL: Marguerite Ross, October 2011)

  

 

Marguerite Ross was also unable to confirm the tests currently in use at REDLABS were clinically validated. If the tests were those used in Lombardi et al. (2009), then those tests are in the public domain and cannot be a commercial secret (17,18). If the tests are different, then questions about evidence for clinical validation still remain. Concern was further increased by a comment by an unnamed WPI representative on their Facebook page on the 14 October 2011, under a statement from Dr Vincent Lombardi.

 

 

“Andy thank you for your kind words of support for the Whittemore Peterson Institute. As we understand it VIPdx is no longer offering XMRV testing due to recent developments. The clinical laboratory of WPI has also decided not to begin testing. There is a misconception regarding what a clinically validated test is. In order for a test to be clinically validated its performance characteristics are determined regarding precision,linearity, and interference. Therefore, a clinically validated test can in fact be validated with plasmid,or recombinant construct or even an actual virus such as 22Rv1. We have high regards for the Miller lab. If you have futher questions please contact Vincent Lombardi Interim Research Director at the WPI and please say hello to Dr. Miller.”

 

(Whittemore Peterson Institute comment on Facebook, 14 October 2011) (19)

 

 

The method described above by the WPI would not even be suitable for determining analytical sensitivity let alone clinical sensitivity. Guidance from the FDA for the manufacture of HIV tests (11) states that for validating analytical sensitivity a dilution series of at least 10 distinct HIV positive clinical specimens from different individuals should be tested. Clinical sensitivity and specificity testing needs at least 200 clinical positives. Tests to determine analytical specificity for diagnostic purposes should be validated by testing a minimum of 500 blood or plasma donors. In short, a laboratory would not be given a license to test for HIV without providing data regarding analytical sensitivity and specificity and crucially clinical (sometimes called diagnostic) sensitivity and specificity. It is possible to determine the theoretical limit of detection using a plasmid or a virus in a cell line, but that is only a preliminary step in the journey towards clinical validation.

 

If the REDLABS (trading as VIP Dx) tests were validated according to the methods outlined in that statement (19), then the tests were not in fact clinically validated. Without establishing the clinical sensitivity the tests are not clinically validated. Based on this communication by the WPI (19), REDLABS (trading as VIP Dx), a company wholly controlled by Harvey Whittemore (20), may well have sold XMRV diagnostic tests to patients that had not been clinically validated. 

 

Dr Mikovits has always been adamant that in her research lab 22Rv1 cells had never been present, and was clearly under the impression they have never been in the State of Nevada (21,22). Dr Mikovits lab had also continued to test for contamination at every stage (17) and so was not concerned by Dr Coffin and Dr Pathak’s suggestion that 22Rv1 could have accounted for the positive results in her research (23). Therefore why was WPI now under the impression that the use of 22Rv1, which is not a patient sample, could be used as a positive control? Why were the WPI, with Dr Lombardi now as their Director of Basic Research (24), happy to say that a plasmid, which would not replicate the conditions of an integrated virus, could be used to clinically validate a test? 

 

Another patient, Mr Chris Douglas, who had been a part of the WPI’s UK research study and had sent his own samples to REDLABS for testing, took the matter further and managed to uncover several more troubling pieces of information, which were recorded this year in his blog for ‘CFS Untied’.

 

 

“Next, I contacted the State of Nevada Health Board Bureau of Health care Quality and Compliance which also handles Clinical Laboratory Improvement Amendments (CLIA).

 

During the ensuing correspondence, and contrary to VIPdx’s statement to me, it emerged that “Vincent Lombardi is not the laboratory director, nor has he served in that regulatory capacity” and “they took this off their website today, it is incorrect.”

 

[The regulatory Laboratory Director (i.e. the person who represents the lab for regulatory purposes) was/is Sanford Barsky who, in February 2012, CFS Chronicles found to be accused of scientific fraud.”

 

 

XMRV testing is for both the culture and the serology tests…” and that “…ALL of the tests we run are validated and inspected by the State of Nevada,”

 

I asked to see the “validation data”, requested details about “the State of Nevada” and reiterated my question about why a “clinically validated” test (or tests) was withdrawn.

 

VIPdx replied that “The State does not “hold” this information. It is a proprietary record of the laboratory. They inspect but do not keep our records. Our validation records and test protocols are proprietary intellectual property of the laboratory.”

 

Again, I requested “more tangible evidence of the scientific validity of the two XMRV tests” and an explanation of how they “…have been validated, particularly given that there was no previously established benchmark against which to compare them.

 

I received no further replies from VIPdx.

 

(Chris Douglas, CFS Untied, 30 April 2012) (25)

 

 

Although the Nevada Health Board was correct to say to Mr Douglas that Dr Lombardi had no regulatory capacity as the laboratory director at REDLABS, he was given regulatory control of providing technical assistance and oversight of their XMRV testing on behalf of WPIs interests (26). Therefore he should be able to answer questions regarding the validation status of the tests sold to patients and used in the blood study. So why is Dr Lombardi silent on these matters?

 

Once again REDLABS (trading as VIP Dx) have told a patient that their tests are proprietary (25), but if they are, they cannot be the tests use in Lombardi et al. (17) for which details are published and in the public domain. REDLABS have also said that the Nevada Health Board inspect but do not keep their records (25). So what records has the Nevada Health Board kept regarding the tests sold by REDLABS? And does REDLABS have any record that would show the tests they have been using were clinically validated? Have they in fact ever provided the Nevada Health Board with records to prove they have clinically validated their XMRV tests? Is anyone at the Nevada Health Board even qualified to determine if these tests were clinically validated? Who actually gave approval? Could the Governor of Nevada grant a licence? Did the Governor of Nevada ever receive a phone call from Harvey Whittemore or any of his associates about these tests?


 

QUESTIONS FOR WPI AND THE BWG


These events raise some very serious questions regarding the licensing of the XMRV tests and those responsible for their performance at REDLABS, namely Dr Lombardi, his bosses and the State of Nevada Health Board Bureau of Health care Quality. They also raise hard questions for the WPI and those in charge of the BWG, regarding the missing tests performed by REDLABS for that study.  Namely, why were the results of Phase III testing at REDLABS not included in the published BWG study and were the tests at REDLABS clinically validated? To sell tests to patients you have to clinically validate a test before it is licensed. Is there therefore any connection between the failure to report testing results in the BWG and the absence of publicly available clinical validation data for the REDLABS tests? Why has nobody connected to REDLABS been able to confirm that the REDLABS (trading as VIP Dx) tests had been clinically validated?


Why did the BWG allow a commercial lab to have any influence over scientific research into a retroviral association with ME anyway? Did Dr Mikovits want REDLABS to perform testing for the BWG or did she not want REDLABS to not take part? The extent of REDLABS involvement in the BWG must now be fully disclosed and open to scrutiny by the public. The public also has a right to know if REDLABS had anything to do with the collection processing or prescreening of the patient and control samples for the BWG. If someone did not want the REDLABS test results published, then it would be disturbing if that same lab had been responsible for any of those stages considering the flaws that have been discovered in the published paper.  


An explanation for the involvement of Abbott laboratories (molecular and diagnostic labs), another company with several patents for XMRV tests, and the involvement of the company Gen-Probe, also need to be given by the BWG (2,27,28,29,30,31). Who decided that at the last minute that commercial companies, who had not participated in the first two stage of the BWG, would be allowed to participate in testing for Phase III? Is there any way that these patents could make money if the human infection was said to not exist?

 

THE DAILY BEAST INTERVIEW

Answers to these questions became even more paramount to patients interests after Casey Schwartz of The Daily Beast interviewed Dr Mikovits last month (12). 

 

 

“In the summer of 2011, Mikovits and her young lab assistant, Max Pfost, began poring through their notebooks, trying to find where such a contaminant might have entered their process.

 

In July, she says, she found it—an entry from March 2009 indicating that a culture of the XMRV virus had been placed into the same incubator with the rest of the lab’s blood samples. Mikovits says she was out of town the day this occurred.

 

In July 2011 she told Harvey Whittemore of the potential contamination, she says, and expected that the VIP Dx lab would cease testing patients for the XMRV virus. “I just kept saying, stop it, stop it, stop it. We have to sort this out,” Mikovits says. According to Mikovits, the testing did not stop. And after a tense summer, she was fired in September.” 

 

(Casey Schwartz, The Daily Beast, 23 July 2011) (12)

 

 

Why would an entry in a notebook from March 2009 relate to the XMRV tests sold by REDLABS to patients? Does the entry in the notebook and the XMRV tests sold to patients relate to Harvey Whittemore not taking Dr Mikovits advice to stop selling tests? Was there any connection therefore between Dr Mikovits sacking, the issue of Dr Mikovit's notebooks, this entry in a notebook from March 2009, and the XMRV tests sold by REDLABS? 


There is no longer a criminal investigation into the notebooks (32), so why do the police continue to hold them? (12) Should Dr Mikovits notebooks not be given back into Dr Mikovits possession so that she can continue her research? Dr Mikovits was the principle investigator and was responsible for protecting that research and the notebooks. So on who's behalf are the police keeping these notebooks?

 

Max Pfost had also phoned Dr Mikovits the day after she was fired and told her that her work at WPI had been rifled through (12). Had someone been looking for the notebook from March 2009? Did this person not know where Dr Mikovits kept her research notebooks? Did they take any notebooks? Who had made the entry in that notebook? This was after the majority of the experiments for Lombardi et al. had been done, so what samples for what research had been infected? What happened to the XMRV culture and where did it come from? If the placing of an XMRV culture with patient samples was a deliberate act, what had been the motive for potentially contaminating the samples? Had Dr Mikovits and Max Pfost therefore discovered evidence of a potential crime and or the identity of the person who contaminated patient samples with XMRV infected cells?

 

 

Dennis Jones, lawyer for Judy Mikovits, also said the reason she was fired by the institute was because she “discovered a series of improper, unethical and possibly illegal acts” by the Whittemores and their lab director.

 

For those reasons, Jones said, Washoe District Judge Brent Adams’ rulings should be thrown out."


(
Martha Bellisle, Reno Gazette-Journal, 23 April 2012) (33)

 

 

Annette Whittemore during the Q & A with patients on the 7th October 2011 had made the following comment regarding the research notebooks when asked if she would be giving them back to Dr Mikovits.

 

 

Whittemore Peterson Institute

@Joan Clarksdale: We have offered Judy access to any necessary materials she needs to answer the concerns of the journal Science. WPI is not in possession of Judy's notebooks.


(Annette Whittemore,
WPI Q & A, 7th October 2011) (34)

 

 

Whittemore Peterson Institute

Dr.Mikovits took her notebooks out of her office.


(Annette Whittemore,
WPI Q & A, 7th October 2011) (35)

 

 

Yet in Max Pfosts first affidavit taken by a WPI employee, Kellen Monick, Max claims he took notebooks from WPI on the 30th October (day after Dr Mikovits was fired), but that Dr Mikovits flew back to Reno on the 16th October to retrieve the notebooks (36). So why had Annette Whittemore on the 7th October, when Max is claiming he had the notebooks, claimed Dr Mikovits took her notebooks out of her office? Who had witnessed this event?

 

The offer of access to any necessary materials also seems strange if Annette thought Dr Mikovits she had taken the research notebooks and that WPI owned them. Why give her access? What necessary materials were they offering?

 

It had been claimed that Dr Mikovits was fired because she had taken cell lines that belong to Dr Lombardi (7). Dr Lombardi however was responsible for XMRV testing at REDLABS (trading at VIP Dx), but that lab is located on Fox Avenue several miles from WPI research lab, which is located on the University of Nevada campus in Reno (37,38). Soon after Dr Mikovits was fired patients were also reporting that when they had phoned REDLABS (trading as VIP Dx), using the VIP Dx phone number, 775-351-1890, that was associated with the Fox Avenue address for VIP Dx (37), to ask questions about the clinical validation evidence for the XMRV tests they had been selling, that the phone was being answer by UNEVX (39,40).

 

 

WPI is not responding to patients regarding the validity of the VIPdx tests. They are sidestepping these questions. They are telling patients to contact VIPdx and when you call VIPdx guess who answers? UNEVX. They are telling patients that neither they or UNEVX are responsible for answering the questions. This is a mis-representation. If UNEVX is aswering the phone for VIPdx they should answer the question. All this is being done to confuse the patients that had their testing done at VIPdx. Why won’t they answer these patients who have paid for the testing? Call VIP at (775) 351-1890 and see who answers. Bye the way here is the info on who is the Director for both business entities:

Marguerite Ross, Director Marketing & Client Relations VIP Dx

Marguerite Ross, Director Marketing & Client Relations UNEVX Clinical Laboratory

 

(Rios, Let No Man Cast Asunder…., Sciencevsantiscience, 9 October 2011) (39)

 

 

UNEVX is a separate company to REDLABS (trading as VIP Dx) that is wholly controlled by Annette Whitemore (42). Also, like REDLABS several of the same people are affiliated to UNEVX. Sanford H Barsky is the UNEVX Laboratory Medical Director, Marguerite Ross, is the Director of Client Relations, and Dr Vincent C Lombardi is the Director of Operations (41). UNEVX were also for a time offering XMRV tests (43), but had by 4th October 2011 stopped offering these tests (7). In addition Dr Lombardi had also put out a statement on behalf of REDLABS (trading as VIP Dx) on the 14 October 2011 on the VIP Dx website (44), and UNEVX also filed articles of incorporation on the 6/2/2010 (42,45). Therefore both labs were in operation simultaneously, using the same personnel and contact details.

 

Max Pfost had said that the cell lines had been delivered to the WPI lab from Japan, and were addressed to Dr Lombardi (36). Why would Dr Lombardi order cell lines and have them sent to Dr Mikovits research lab at WPI? Why would he be doing any work that Dr Mikovits would not be aware of, and when he was only a Director of Basic Research? REDLABS (trading as VIP Dx) was also not a research lab. So why would Dr Lombardi have needed to order cell lines? Were these cell lines not already available at either the WPI research lab or REDLABS?

 

It is now time for all of those involved to answer all these questions. If the tests sold by REDLABS (trading as VIP Dx) and UNEVX have not been clinically validated then all money collected for those tests should be immediately returned to patients, as you cannot license a test unless it is clinically validated. To assist in this the BWG should immediately release all testing data produced by REDLABS (trading as VIP Dx) for the Phase III study. The cost to the health of the ME population and the wider public is at stake and any delay is an unacceptable risk.  

 
 

REFERENCES

 

  1. Anonymous. 8 August 2011. XMRV testing: The REDLABS, trading as VIP Dx, WPI connection. PART 1: AN XMRV TEST FOR SALE. 8 August 2012. http://me-advocacy.com/XMRV_testing_REDLABS.html
  2. Simmons et al. 2011. Failure to Confirm XMRV/MLVs in the Blood of Patients with Chronic Fatigue Syndrome: A Multi-Laboratory Study. Science. 334 (6057), 814-817. http://www.sciencemag.org/content/334/6057/814
  3. Jon Cohen and Martin Enserink. 23 September 2011. False Positive. Science. 333, 1694-1701. http://www.sciencemag.org/content/333/6050/1694.full.pdf?sid=17d901ca-6d08-4081-9697-120a2e2f1aa8
  4. Lo et al. 2010. Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors. PNAS. 107 (36), 15874-15879. http://www.pnas.org/content/early/2010/08/16/1006901107.abstract
  5. Lee et al. 2012. Sensitivity of PCR Assays for Murine Gammaretroviruses and Mouse Contamination in Human Blood Samples. PLoS ONE. 7 (5), e37482. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0037482
  6. Paolucci et al. 2012. Xenotropic and polytropic murine leukemia virus-related sequences are not detected in the majority of patients with chronic fatigue syndrome. New Microbiol. 35 (3), 341-344. http://www.newmicrobiologica.org/PUB/allegati_pdf/2012/3/341.pdf
  7. Jon Cohen. 4 October 2011. Chronic Fatigue Syndrome Researcher Fired Amidst New Controversy. Science Insider. http://news.sciencemag.org/scienceinsider/2011/10/xmrv-researcher-fired.html?rss=1&utm_source=dlvr.it&utm_medium=twitter
  8. Dr Jamie Deckoff-Jones MD. 3 October 2011. Square One. X Rx. http://www.x-rx.net/blog/2011/10/square-one.html
  9. Annette Whittemore. 7 October 2011. Q & A on WPI Facebook page. https://www.facebook.com/note.php?note_id=10150346044661797
  10. Slides presented by the Blood XMRV working group. 7-8 September 2010. 1st XMRV conference. Bethesda, USA. http://regist2.virology-education.com/1XMRV/docs/30_Simmons.pdf
  11. FDA.1999. Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2. http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucm077067.htm
  12. Casey Schwartz. 23 July 2012. How Research into Chronic Fatigue Syndrome Turned into an Ugly Fight. The Daily Beast. http://www.thedailybeast.com/articles/2012/07/23/how-research-into-chronic-fatigue-syndrome-turned-into-an-ugly-fight.html
  13. REDLABS (trading as VIP Dx) no longer accepting samples for clinical tests. 6 June 2011. www.vipdx.com. http://www.mecfsforums.com/index.php/topic,7746.0.html
  14. Slides: Results of the Blood XMRV Scientific Research Working Group Study. 14 October 2011. CFIDS Association webinar. http://www.cfids.org/xmrv/srwg-webinar-oct2011.pdf
  15. Mindy Kitei. 4 August 2011. Breaking the codes. CFS Central. http://www.cfscentral.com/2011/08/breaking-codes.html
  16. Marguerite Ross profile on LinkedIn. (Access date 13 August 2011) http://www.linkedin.com/pub/marguerite-ross/5/707/804
  17. Lombardi et al. 2009. Detection of an Infectious Retrovirus, XMRV, in Blood Cells of Patients with Chronic Fatigue Syndrome. 326, (5952), 585-589. http://www.sciencemag.org/content/326/5952/585
  18. Mikovits invented WPI patent. 2010. (WO2010148323) DIAGNOSIS AND TREATMENT OF DISEASES OR DISORDERS ASSOCIATED WITH XENOTROPIC MURINE LEUKEMIA VIRUS-RELATED VIRUS. http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2010148323&recNum=2&office=&queryString=FP%3A%28xmrv%29&prevFilter=%26fq=PAF_M%3A%22WHITTEMORE+PETERSON+INSTITUTE+FOR+NEURO-IMMUNE+DISEASE%22&sortOption=Pub+Date+Desc&maxRec=2
  19. Comment by the WPI on the WPI Facebook page under a statement from Dr Vincent Lomardi. 14 October 2011. https://www.facebook.com/notes/xmrv-global-action/from-wpi-vipdx-and-wpi-no-longer-offering-xmrv-testing/10150356171906797
  20. Harvey Whittemore, REDLABS USA INC. http://nvsos.gov/sosentitysearch/CorpDetails.aspx?lx8nvq=3HqeF%252fFCg2b8fQKoG
  21. Dr Judy Mikovits. 29 March 2011. Webinar: Disease Associations of XMRV and MLV-Related Viruses. Pathogens in the Blood Supply. The New York Academy of Sciences. http://www.nyas.org/Events/Detail.aspx?cid=0918b8d8-9a46-4334-b194-23ade9c2a7aa
  22. Dr Judy Mikovits. 29 March 2011. Webinar: Disease Associations of XMRV and MLV-Related Viruses. Pathogens in the Blood Supply. The New York Academy of Sciences. 1min 19sec. http://www.mecfsforums.com/wiki/22Rv1_%26_Du145_cell_lines
  23. Pathak et al. 1 March 2011. Paper # 91LB. MRV Probably Originated through Recombination between 2 Endogenous Murine Retroviruses during in vivo Passage of a Human Prostate Cancer Xenograft. CROI. http://www.retroconference.org/2011/Abstracts/42508.htm
  24. WPI press release stating that Dr Mikovits was now the Director of Translational Research and Dr Lombardi was now the Director of Basic Research. 24 March 2011. WPI. http://www.wpinstitute.org/news/docs/DirTransRes.pdf
  25. Mr Chris Douglas. 30 April 2011. Misopathy Over Disclosure–Proof of VIPdx Test Validity Still Not Forthcoming. CFS Untied. http://cfsuntied.com/blog2/2012/04/30/misopathy-over-disclosureproof-of-vipdx-test-validity-still-not-forthcoming/
  26. Frankie Vigil, R&R Partners for Whittemore Peterson Institute.14 January 2010. WPI. http://wpinstitute.org/news/docs/WPI_pressrel_011410.pdf
  27. Abbott laboratories XMRV patent. (EP2448960) MARKERS OF XMRV INFECTION AND USES THEREOF  http://patentscope.wipo.int/search/en/detail.jsf?docId=EP45947506&recNum=2&office=&queryString=FP%3A%28xmrv%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=21
  28. Abbott laboratories XMRV patent. (EP2449381) MARKERS OF XMRV INFECTION AND USES THEREOF http://patentscope.wipo.int/search/en/detail.jsf?docId=EP45947974&recNum=3&office=&queryString=FP%3A%28xmrv%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=21
  29. Abbott laboratories XMRV patent. (WO2012024518) MOLECULAR DETECTION OF XMRV INFECTION http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012024518&recNum=5&office=&queryString=FP%3A%28xmrv%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=21
  30. Abbott laboratories XMRV patent. (WO2012024513) MOLECULAR DETECTION OF XMRV INFECTION http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012024513&recNum=6&office=&queryString=FP%3A%28xmrv%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=21
  31. GenProbe Incorporated XMRV patent. (WO2012030856) COMPOSITIONS, METHODS AND REACTION MIXTURES FOR THE DETECTION OF XENOTROPIC MURINE LEUKEMIA VIRUS-RELATED VIRUS http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012030856&recNum=4&office=&queryString=FP%3A%28xmrv%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=21
  32. Ewan Callaway. 14 January 2012. Criminal case against chronic fatigue syndrome researcher dropped. Nature News blogs. http://blogs.nature.com/news/2012/06/criminal-case-against-chronic-fatigue-syndrome-researcher-dropped.html
  33. Martha Bellisle. 23 April 2012. Fired Whittemore Peterson Institute researcher claims justice system flawed. Reno Gazette-Journal. www.rgj.com. http://www.rgj.com/article/20120423/NEWS/304230038/Fired-Whittemore-Peterson-Institute-researcher-claims-justice-system-flawed
  34. Annette Whittemore is happy to answer your questions. 7 October 2011. Mecfsforums. Page 4. http://www.mecfsforums.com/index.php/topic,9825.45.html
  35. Annette Whittemore is happy to answer your questions. 7 October 2011. Mecfsforums. Page 6. http://www.mecfsforums.com/index.php/topic,9825.75.html
  36. Exhibit 1: Affidavit of Max Pfost. 16 November 2011. WPI. http://www.wpinstitute.org/news/docs/Exh1-ReplyISOMotionforPreliminaryInjunction.pdf
  37. Address of VIP Dx. http://laikaspoetnik.files.wordpress.com/2010/04/test_rqn_feb_2010.pdf
  38. Address of the WPI. http://www.wpinstitute.org/about/about_contact.html
  39. Rios. 9 October 2011. Let No Man Cast Asunder…., Sciencevsantiscience. http://sciencevsantiscience.wordpress.com/2011/10/09/let-no-man-cast-asunder/
  40. Robyn. 9 October 2011. Marguerite Ross refused to confirm tests used in ViP Dx are Lombardi et. Mecfsforums. Reply 36. http://www.mecfsforums.com/index.php/topic,9839.msg117196.html#msg117196
  41. Main staff members of UNEVX. http://unevx.com/about/
  42. Annette Whittemore, UNEVX Inc. http://nvsos.gov/SOSEntitySearch/CorpDetails.aspx?lx8nvq=BlnqHf7ro%252b%252bx6x%252fFy72jGQ%253d%253d&nt7=0
  43. Jeannette (Sick and Tired). 17 August 2011. UNEVX’s XMRV test takes longer than initially announced. ThoughtsaboutME.com http://thoughtsaboutme.com/2011/08/17/unevxs-xmrv-test-takes-longer-than-initially-announced/
  44. Statement of Vincent Lombardi, Phd, Clinical Lab Director, VIP Dx, 14 October 2011. http://niceguidelines.blogspot.co.uk/2011/10/statement-by-vincent-lombardi.html
  45. UNEVX inc. Articles of incorporations file date.  http://nvsos.gov/sosentitysearch/corpActions.aspx?lx8nvq=BlnqHf7ro%252b%252bx6x%252fFy72jGQ%253d%253d&CorpName=UNEVX+INC.


Anonymous
15 June 2012
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