NIH grant goes to Lombardi

[Wildaisy]

http://projectreporter.nih.gov/project_info_description.cfm?aid=8144303&icde=0

Project Number:

5R01AI078234-03 

Contact PI / Project Leader:

LOMBARDI, VINCENT C

Title:

NEW STRATEGIES TO DECIPHER THE PATHOPHYSIOLOGY OF CHRONIC FATIGUE SYNDROME

Awardee Organization:

WHITTEMORE PETERSON INSTITUTE

Abstract Text:



DESCRIPTION (provided by applicant):  Chronic Fatigue Syndrome (CFS) is a complex disease estimated to affect between 0.5%-2% of the population in the Western world. Its pathogenesis is thought to involve both inherited and environmental (including viral) components, as with other chronic inflammatory diseases such as, multiple sclerosis, rheumatoid arthritis, and atherosclerosis. Consistent with this chronic inflammatory context, CFS patients are known to have a shortened life-span and are at risk for developing lymphoma. We hypothesize that chronic inflammatory stimulation from active and recurrent infections of multiple viruses on a susceptible host genetic background leads to the pathogenesis characterized by CFS. The overall goal of this research project is to define these viral and host parameters in European and American cohorts of CFS patients that correlate with distinct disease phenotypes, including the development of mantle cell lymphoma (MCL) in a subgroup of the American cohort. In Aim 1) we will identify and confirm novel viral infections in European and American CFS patient cohorts. 1.1) we will use two complementary methods for detection of novel virus mRNA: massive parallel signature sequencing (MPSS) and a custom DNA microarray. 1.2) Quantitative polymerase chain reaction Q-PCR will be used for confirmation of virus gene expression. 1.3) immortalized cell lines will be developed to isolate virus and elucidate links between virus and host cell gene expression. In Aim 2), we will elucidate genetic factors of susceptibility and the dysregulation of the host defense system. Specifically, we will determine: 2.1) PBMC gene expression of 88 human genes previously confirmed as being differentially expressed in CFS 2.2) serum chemokine and cytokine profiles using multiplex suspension antibody arrays on a Luminex platform 2.3) HLA, KIR genotypes and whole genome SNP profiles 2.4) Defects in the type I Interferon signaling pathway. In each subaim both cohorts will be compared to normal and disease controls using specimens of serum and PBMC taken at multiple time-points from individual patients and taken from our unique and extensive sample repository. This study will provide information necessary for development of treatment and diagnostic strategies for distinct subgroups of CFS patients, and may identify novel virus associations, genetic signatures and biomarkers, which can predict the development of MCL, thus enabling use of preventive therapeutics. PUBLIC HEALTH RELEVANCE: The proposed research will provide significant insight into the disease mechanisms of Chronic Fatigue Syndrome so accurate testing and specific treatments can be developed with a goal of curing the disease and preventing life-threatening complications. 

Public Health Relevance Statement:

PROJECT NARRATIVE The proposed research will provide significant insight into the disease mechanisms of Chronic Fatigue Syndrome so accurate testing and specific treatments can be developed with a goal of curing the disease and preventing life-threatening complications. 

Project Terms:

Acute; Affect; American; Antibodies; Atherosclerosis; biomarker; body system; Cell Culture Techniques; Cell Line; Cells; Centers for Disease Control and Prevention (U.S.); chemokine; Chronic; Chronic Fatigue Syndrome; cohort; Complex; Custom; cytokine; Data; Data Analyses; Data Set; Defect; Detection; Development; Diagnostic; Disease; disease phenotype; disorder control; DNA Microarray Chip; DNA Sequence Rearrangement; European; follow-up; Functional disorder; Gene Expression; Genes; Genetic; genetic association; Genome; Genotype; Goals; Health; Host Defense; Human; immortalized cell; Immune; Immune response; Individual; Infection; Inflammatory; Inherited; insight; Interferon Type I; latent infection; Life; Link; Longevity; Lymphoma; Malignant lymphoma, lymphocytic, intermediate differentiation, diffuse; Messenger RNA; Methods; Multiple Sclerosis; Neurologic; novel; novel virus; Pathogenesis; Patients; Peripheral Blood Mononuclear Cell; Phenotype; Plasma; Play; Polymerase Chain Reaction; Population; Predisposition; prevent; Preventive; Process; Recurrence; repository; Research; Research Project Grants; Rheumatoid Arthritis; Risk; Role; Sampling; Serum; Signal Pathway; Signal Transduction; Source; Specimen; Stratification; Subgroup; Suspension substance; Suspensions; System; Testing; Therapeutic; therapy development; Time; transmission process; Variant; Viral; Virus; virus culture; Virus Diseases; Western World

[Wildaisy]

The overall goal of this research project is to define these viral and host parameters in European and American cohorts of CFS patients that correlate with distinct disease phenotypes, including the development of mantle cell lymphoma (MCL) in a subgroup of the American cohort.

I wonder when the IRB was given for this project?

I wonder who the subjects of this research are?  Obviously, they need both US and European patients as research subjects.

If you have questions, you may contact:

 E-mail to:  info@wpinstitute.org
                           cbeisel@niaid.nih.gov
                           Christopher E. Beisel Ph.D. NIH Grant Coordinator

                           njmoody@geisinger.edu
                           Nancy Moody, MA, Human Research Protection, IRB Administrator  AHRQ


See also:  http://www.mecfsforums.com/index.php/topic,11255.0.html

If you're interested, you can see Lombardi's curriculum vitae here:

http://www.wpinstitute.org/research/docs/vinny_cv.pdf 

[Wildaisy]

I question this action by the NIH.  Here is what I wrote:

Re: 

 

Project Number:

5R01AI078234-03 

Contact PI / Project Leader:

LOMBARDI, VINCENT C

Title:

NEW STRATEGIES TO DECIPHER THE PATHOPHYSIOLOGY OF CHRONIC FATIGUE SYNDROME

Awardee Organization:

WHITTEMORE PETERSON INSTITUTE
 
 Dear Dr. Beisel:
 
 I note with dismay that this grant has been awarded to the Whittemore Peterson Institute, whose founder and CEO is currently being sued for embezzlement:
 
 http://www.rgj.com/assets/pdf/J7184397127.PDF     
 
 Also, the person who has now been appointed PI is totally unqualified and inexperienced:
 
 See:  http://www.wpinstitute.org/research/docs/vinny_cv.pdf 
 
 As a person who has been suffering with Myalgic Encephalomyelitis (M.E.), sometimes called Chronic Fatigue Syndrome, I question the wisdom and the propriety of this action by the NIH.  When was this grant given to the Whittemore Peterson Instiute with V. Lombardi as P.I.?
 
 Does the fact that the Whittemores now appear to have ties to organized crime give the NIH pause to reconsider this decision?
 
 With so very little research money being spent by the U.S. government on this illness, it is doubly disappointing to see such action as this.
 
 Please answer my questions.
 
 Sincerely,
 Patricia Carter, Esq.
 
 

Contacts - RE: NIH Grant to WPI/Lombardi:  http://www.mecfsforums.com/index.php/topic,11339.msg131291.html#new

[Thegodofpleasure]

This is old information and the award of the grant will not be reversed in the light of recent revelations about the Whittemore's.
Any implied criticism of the NIH for doing what we, the patient community, were encouraging them to do at the time, is therefore unhelpful.

Some of the other studies listed under the "similar projects" tab are surely of far more interest to us and the HIH should be applauded for funding them:

http://projectreporter.nih.gov/project_info_Like.cfm?aid=8144303&icde=0 

[In Vitro Infidelium]

This is old information and the award of the grant will not be reversed in the light of recent revelations about the Whittemore's.
 

This is actually a very recent report. What it does, is to confirm that a grant that had been awarded in the 2011 funding year, to the WPI with Dr Mikovits as primary investigator, has been awarded with Dr Lombardi as PI in place of Dr Mikovits. This was a specific process reported at the time of Mikovits' departure. The NIAID has a five year commitment in principle to support work at the WPI, with actual funding confirmed on an annual basis. The report therefore confirms the NIAID's confidence in the WPI to be able to continue research under Lombardi's rather than Mikovits' leadership.

Whether the further two years worth of funding that would be due in September 2012 and September 2013 is actually granted will depend on assessment of the project so far, and quite possibly other factors. The WPI will have to show that it is a stable entity and it would be foolish to think that the current legal claims do not have profound implications for the WPI, not only are WPI board members but also WPI employees - not least Dr Lombardi - potentially material to the unfolding litigation. The award decision on the 2011 grant was no doubt taken before the Seeno/Whittemore affair blew up, but the potential involvement of Redlabs/VIPdx in the litigation process, may place Dr Lombardi in a challenging position given that his employers (Wingfield) at Redlabs have alleged his current employer (WPI) was a benefit of fraud, and that the president of WPI was complicit in fraud. 

IVI

[Thegodofpleasure]

The project details state:

Award Notice Date:   5-AUG-2011

That's six months ago.

Judy Mikovits was fired at the end of September.

The project reporter info therefore merely reflects the fact that Lombardi was the Head of Research at WPI at the time - J.M. having already been moved sideways to become Head of Translational Research.

I'm sure that the NIH will take other factors into account when considering further awards in future years ........ but we really must let them make that decision.  If they then get it wrong then we would have cause to jump up and down.

[Firestormm]

Any implied criticism of the NIH for doing what we, the patient community, were encouraging them to do at the time, is therefore unhelpful.

I would certainly concur with the above GOP if you mean to say that only Mikovits was thought capable of doing this research - whatever the specifics of it to date have been.

Although this may be I suppose an administrative alteration to the paperwork reflecting Lombardi's new position and we shouldn't read too much into it.

As to the effect of the recent litigation? Who knows? Literally. As has been confirmed to me - this stuff happens a lot in the States and heck it may not even result in any successful prosecutions let alone 'bankruptcies' or whatever.

If I lived in the US (heaven help those resident there  ) then I wouldn't be petitioning the NIH to remove the grant from WPI at this precise moment.

That Harvey and Annette have been involved with some shady activities appears to have some legs at the moment - but to what extent all this could effect WPI is a little too soon to call I would suggest.

Smoke and fire? Maybe but peeps could just as easily say the same about Mikovits perhaps...

[Firestormm]

From a comment posted on Khaly's blog (http://www.mecfsforums.com/index.php/topic,11336.0/topicseen.html) that I have seen before but think pertinent perhaps here (in relation to the roles played by Lombardi and Mikovits on the Lombardi et al. paper:

'“In the life sciences, first listing is usually given to the researcher who did most of the work, both physical and intellectual, and last billing goes to the mentor or person who guided the project and whose grant money paid for the project – the PI.”
http://scienceblogs.com/effectmeasure/2007/11/authorship_on_scientific_paper.php''

Perhaps I am reading too much into people's objections to the name change on this research, I don't know (but judging from the comments on that blog - perhaps not). I mean Lombardi was appointed head of research and whilst he was heading up VIPdx too (which as IVI points out could be relevant to any court case), he is qualified presumably to head-up this research.

It's important I think that the research continues rather than be pulled, and from my understanding, Lombardi being PI instead of Mikovits (who is not there anyway) makes not a jot of difference.

Then again if WPI are implicated in whatever charges are decided by the court - criminal and/or civil - the NIH will base any decision it makes in relation to this research on that I would guess. Could the research be transferred to another institution in the worse case event? I suppose it could - there must be some precedent even if not in exactly the same circumstances. Could Lombardi take this research to another institution? Probably, if another institute was willing to allow him their labs and staff - I should think he and the grant would be welcome.

[Robyn]

Dr. Mikovits name was still listed on the grant as of this date:

Award Notice Date:   5-AUG-2011

The money was then allocated in September.  Now given the current events we've been witnessing in the media. The NIH needs to take a hard look at the ethical implications of their decision.  I've listed some contact information that patients can contact regarding this.  This is taxpayer money and I for one do not feel comfortable with my money going to this institute.  Until this matter is resolved the grant funding should be put on hold.

Contacts - RE: NIH Grant to WPI/Lombardi:  http://www.mecfsforums.com/index.php/topic,11339.msg131291.html#new

[In Vitro Infidelium]

Dr. Mikovits name was still listed on the grant as of this date:

As recorded here: http://www.researchgrantdatabase.com/g/5R01AI078234-03/NEW-STRATEGIES-TO-DECIPHER-THE-PATHOPHYSIOLOGY-OF-CHRONIC-FATIGUE-SYNDROME/

A pertinent issue is raised here http://www.nature.com/news/embattled-scientist-in-theft-probe-1.9505

Shortly after her dismissal, Mikovits told Nature that she planned to continue her research at another institution, supported by a grant of roughly $1.5 million from the US National Institute of Allergy and Infectious Diseases (NIAID) that she won while at the WPI. But such R01 grants are awarded to institutions, not individuals: when a principal investigator (PI) leaves, the institution is allowed to choose whether to keep the grant and name a new PI, or transfer the grant to the original holder’s new institution. Both actions require approval from the funding agency. The NIAID would not comment on the grant, which runs to August 2014.

The reporter data is current, not six months old and demonstrates that the NIAID has approved Lombardi in the role of PI. In practical terms work using the grant will have already begun and while it's certainly up to participants in any continuing study whether they wish to withdraw or not, it is unlikely that a request to have blinded samples withdrawn at this stage would be viewed with much sympathy - samples are usually taken with a signed waver regarding future ownership or accruing rights.  The only effect of withdrawl at this stage may well be that individuals never get any feedback on what their individual results were (if there was provision for this to happen ?).

In the longer term however addressing  concerns regarding due dilligence on the part of the NIAID in awarding future grant installments - 2012 and 2013, in the light of matters raised in litigation between the Seeno and Whittemore families might well be an appropriate action for US citizens concerned about how their taxes are being used. The question put to the NIAID though might be best posed in terms of 'can research at WPI be guaranteed of appropriate quality supported by best financial practice ?' rather than - 'this institution isn't trustworthy, cut the grant now'.  Who knows what Lombardi may achieve, and the grant spec is precisely what many people have asked CFS researh to be about. If the WPI could be saved - then that is the least worst option and worth taking on that basis. I would suggest though that continuing Government support at the WPI be contingent in changes to the Board, with both UofN and external science qualified representatives being full board members. 

[Tango]

Why did the NIH take funding from the person in charge of the research who is qualified and give it to Lombardi who doesn't meet the requirements to be a PI of an NIH funded study?

The money should be with Mikovits or is the NIH taking the proverbial. 

Now remind me what methods Lombardi uses for MRV research?  Oh yes the method in the blood study that was not from Lombardi et al. and the method from ViPDx that Annette said is not the same method as used in the research lab.  that's a good way to bury research isn't it?  Unproven methods.

[Firestormm]

As has been said above, the funding was with the institution and not the lead researcher:

'...such R01 grants are awarded to institutions, not individuals: when a principal investigator (PI) leaves, the institution is allowed to choose whether to keep the grant and name a new PI, or transfer the grant to the original holder’s new institution...'

[Tango]

As has been said above, the funding was with the institution and not the lead researcher:

'...such R01 grants are awarded to institutions, not individuals: when a principal investigator (PI) leaves, the institution is allowed to choose whether to keep the grant and name a new PI, or transfer the grant to the original holder’s new institution...'

As I said, the WPI do not have a lead researcher (PI) and the NIH knowns full well this will cause problems for further MRV research. 

[Robyn]

I actually had some contact info wrong.  Seems Nancy Moody works at the University of Reno.  Participants need to direct questions to her regarding there protected information.  I know I never signed any waiver. Participants need to find out if their private information is still being used in ANY way.  Any participants that may not have pulled from the study (or any that have) need to contact her regarding their HIPPA rights and what is happening with their protected information.  Also inquire if a new IRB was issued to Lombardi.

Biomedical Research / Exemptions
Nancy Moody, JD, MA, Director
(775) 327-2367
NMoody@unr.edu

[In Vitro Infidelium]

As I said, the WPI do not have a lead researcher (PI) and the NIH knowns full well this will cause problems for further MRV research.

I have no idea what the NIH does or doesn't know 'full well' - but the definition of PI is simply a matter of nomination by the applicant. Where there is a change in the PI during the grant allocation process or period of grant payment, then the grantor reviews the status of the organisation and if it approves of the new arrangement then the grant is paid/secured. The NIAID have clearly accepted WPI's nomination of Lombardi as PI for the study the NIAID is funding. Whether this was a sound move will be demonstrated by the quality of any published research. Refusing the grant on the basis that Vincent Lombardi isn't Judy Mikovits was never going to be an argument that the NIAID was going to take seriously.

IVI