NIH grant goes to Lombardi

[since]

http://grants.nih.gov/grants/new_investigators/QsandAs.htm#1596http://grants.nih.gov/grants/new_investigators/QsandAs.htm#1596

You have posted the FAQ for a specific grant, the "Pathway to Independence Award", which is designed for new investigators. What is your point?

[In Vitro Infidelium]

  I wonder why you suggest a patient would only make a judgment based on assumptions and not research record.

I didn't make that suggestion - I posed the question: 'who does know whether or not Lombardi has the "creative expertise required" ?'  - the point being that there isn't any readily available data on which to make such a determination. It's not issue about whether someone has the right - that issue comes down to the contractual relationship between donor and recipient. As I pointed out at post 12 above - I don't know enough about the US legislation, but the UK legal provision gives an absolute right for the donor to withdraw at any time and for the samples to be destroyed. There were, and I believe under some circumstances remain, allowances for researchers to seek waivers against withdrawl once a study has passed a certain stage, but the standard amongst t all UK public institutions is set at: the right to withdraw/sample destruction at any time. The reasons for this strict system have been played out in the UK media over several years. 

I feel you've seized a little to quickly upon an opportunity to attack those in the ME/CFS community you perceive to be acting contrary to you own ideal of acceptable conduct. A lot of patients on these forums have been left in limbo by the WPI on occasions - in many cases financially. That you feel you can sum up the solitary moral course in this situation as 'solidarity to the end' is baffling.

Attack ? I really don't understand,  all I've done is set out a pragmatic approach to an unwanted situation.  I first wrote blog posts about what was wrong with WPI over a year ago - and (amusingly) ended up on the hate list of super evul villains pilloried on this very forum because of what I wrote. I haven't invoked a moral position at all, I think that patients should be free to make whatever decision they are inclined take, but it is surely not unreasonable to pose questions about effectiveness of actions and likely outcomes. For M.E/CFS affected people  to be taken seriously, requires that we are seen to act with consistency and reason, and within some degree of collective responsibility. Actions that appear to those individuals and institutions that we wish to influence, to be capricious or baseless or unreasonable have the effect of reducing our collective credibility. In the case of WPI, if it is really in the best interests of M.E/CFS research, that the WPI be excluded from US governemental gant programmes - that case needs to be made with clarity. Giving an institution that has demonstrated a poor appreciation of patient intertersts, the chance to 'blame' patients for the failing of research, because of the caprcious behaviour of patients doesn't seem to me to be the smartest move available.

I've heard the argument about how M.E patients should act ad nauseam. It doesn't lead anywhere, there are millions of patients worldwide, the potential for millions of imperfect opinions, emotional reactions, factual errors, you name it. We are as imperfect as everyone else. Similarly, as with any other community online, we can be polluted with imposters. There will always be a terrible quote amongst millions of patients for the likes of Trine Tsouderous and whomever else to pounce on at a moments notice to fit the slant of any article.

Millions of patients maybe, but online posting in English, there's a couple of hundred, I don't think it's a great burden to ask people posting in public about issues that affect the image of M.E/CFS advocacy to think before they post - and as to imposters, it's an ad hominem that's been levelled against me often because "I don't come across as a sufferer".  But none of that is relevant to the point I was making, which was not about forum civility but the real world act of withdrawing samples from a research project. What I'm suggesting is that people think about all the effects that such an action may have, and to consider the alternatives. There is no way I would ever have supported research at WPI by donating samples, there was simply never a point at which I trusted the organisation - but having begun the process of supporting the research it is really important that everyone understand what the outcome might be from a 'donor strike'. If a strong evidence backed justification for such a 'strike' can be articulated then the action may be a pragmatic option - otherwise M.E/CFS advocacy is left open to charges of capriciousness and worse. 

IVI 

[In Vitro Infidelium]

Well this gives information regarding the rules as they pertain to any conflicts of interest for Research Institutions or their PI's.  The one following the link is regarding any financial conflicts of interest? Not sure how VIPdx and Wingfield would play into this.  But I would think it would be a huge conflict of interest especially now with what is going on in the media.  Just exactly what  and who's funds were used for what?  Inquiring taxpayers what to know.

http://grants.nih.gov/grants/policy/coifaq.htm#255

That is certainly a more apposite base for challenge of WPI fitness as a grant recipient, than the previously posted doc. and for anyone motivated to do so, worth raising questions with the relevant authority as to how the provisions of the regulations have been applied to the WPI so far, particularly in respect of the WPI relationship to Wingfield/Redlabs/VIPdx. However, there are some rather prominent 'bureacratic' get outs in the regulations and it may well be that everything that should have been reported was reported - and having been reported, the regulations were satisfied. An obvious limitation of the regulations is that they only apply to 'investigators' not management, so while the 'white coats' have to account for their interests, the sharp suits don't.

IVI

[Robyn]

So the US study participants know they can remove themselves from the grant study at anytime.  There were no waivers in place.  Those were the rules.

[Robyn]

Well there is this too:

http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch4.htm

NIH grants are subject to requirements intended to ensure that recipient organizations handle their Federal awards responsibly. Grantees are required to adopt and enforce policies that minimize the opportunity for improper financial gain on the part of the organization, its employees, and organizations and individuals whom they may collaborate, and that limit the potential for research results to be tainted by possible financial or other gain. In addition, NIH grantees are expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research.

And this:

NIH intends to uphold high ethical, health, and safety standards in both the conduct of the research it funds and the expenditure of public funds by its grantees. The public policy requirements specified in this section set many of those standards. The signature of the AOR on the application certifies that the organization complies, or intends to comply, with all applicable policies, certifications and assurances referenced (and, in some cases, included) in the application instructions. The policies, certifications and assurances listed in this section may or may not be applicable to the project, program, or type of applicant organization. Requirements/objectives are listed in alphabetical order.

As noted in this section, some requirements may necessitate the submission of a separate document (e.g., human subjects assurance, IRB certification, civil rights assurance). Applicants and grantees should take particular note of these requirements (for example, see specific sections on Human Subjects Protections and Civil Rights Protections), the absence or inadequacy of which may delay an award or render an applicant ineligible for award.


The grantee is responsible for: 1) establishing and maintaining the necessary processes to monitor its compliance and that of its employees, consortium participants, and contractors with these requirements; 2) taking appropriate action to meet the stated objectives; and, 3) informing NIH of any problems or concerns.

If a grant is awarded on the basis of false or misrepresented information, or if a grantee does not comply with these public policy requirements, NIH may take any necessary and appropriate action, including using any of the remedies described in Administrative Requirements—Enforcement Actions or other available legal remedies.

"What about human protection?  They've lost patient information and sample's! If that's not a human subjects protection violation I don't know what is"

[Wildaisy]

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. vlombardi@wpinstitute.org. This is after all, tax payer money.

http://www.cfschronicles.com/blog.html


I have written to Dr. Lombardi.  Please feel free to use any or all of my email as you compose your own email to Dr. Lombardi.  Here is what I wrote.

Re: 

Project Number:  5R01AI078234-03

Title:  NEW STRATEGIES TO DECIPHER THE PATHOPHYSIOLOGY OF CHRONIC FATIGUE SYNDROME


   As an M.E. patient and a U.S. taxpayer whose taxpayer funds are being used for this grant, I have some questions:

1.  Will this grant be used to study the connection of  any retrovirus with "Chronic Fatigue Syndrome"?

 2.  If retroviruses will not be pursued, then what viruses, genetic factors or biomarkers will be pursued?


I eagerly await your response.

Patricia Carter, Esq.
Orlando, Florida

cc:  cbeisel@niaid.nih.gov
         njmoody@geisinger.edu
                  Barbara.McGarey@nih.hhs.gov
         Edgar.Swindell@hhs.gov
                 Elizabeth.Fischmann@hhs.gov
      Naomi.Miske@hhs.gov

[Tango]

You have posted the FAQ for a specific grant, the "Pathway to Independence Award", which is designed for new investigators. What is your point?

It's the wrong link of course.  Will have to find the right one.  You can try if you like.

The point is that if they had initially applied with a post doc they would have had no chance.

There is a points system.

Lombardi does not meet the definition of a PI

[Superjump]

"It's pretty galling for those of us who cautioned any involvement with WPI, to now see some of those who supported the hype apparently not willing to 'suck it up' and see the thing through, irrespective of any wider fall out."

I got the impression from that statement the value judgement had already preceded the possibility that people had legitimate reasons to withdraw from the study.  Also I took 'whatever that is' in the sarcastic tone it's usually spoken with. If you had asked me, what do you mean by the words it would have seemed less contentious from the outset. The whole post wreaked of a supercilious tone. Otherwise you might of said misguided instead of bloody stupid. If you honestly believe you haven't invoked a moral position at all, then from my point of view, that is deluded. To be galled by a poorly defined group of people of whom you can hardly claim to have the full spectrum of their opinions and reasons for their actions so early on tells me the judgement has preceded the investigation.

I posed the question: 'who does know whether or not Lombardi has the "creative expertise required" ?'  - the point being that there isn't any readily available data on which to make such a determination.

That is an assumption rather than a fact. Like I admitted myself, I wasn't placed to judge Lombardi, but just looking at the information closest to hand and comparing Lombardi's CV with Mikovits CV. Mikovits has decades of retroviral experience that Lombardi doesn't. I wouldn't presume that folk around here didn't know even more than that. If Mikovits has or had led more projects as a creative lead and achieved good results in the past. Knowing that ones donations are going to pedigreed researcher with a history in the field can play a part in the decision to donate blood or money. Value for money with ME research considering the paucity of it is an important factor.

All this is by the by, if like I happily conceded, the outcome of withdrawal is the biggest waste of patient resources. It's a consideration worth looking at, but it's just that, a consideration. I wonder if some patients who withdrew were hoping the WPI would stop litigating Mikovits so she can focus on finishing her studies with Lipkin. Maybe they even hoped the patient displeasure would compel the WPI to resolve conflicts and take Mikovits back initially.

These are not things that are easily decided.

I'm not sure why you think there are only a couple hundred patients posting online, if you spread yourself across the various social networks I would assume there are many many more. I dare say I've encountered or read comments by more than that number over the years and have far from seen it all.

I'm sorry to hear you have been attacked on this forum, I've seen it happen before so I wont try to pretend it hasn't happened. In this context I reference the possible imposter because if journalists can use anonymous quotes from online forums, then a vehicle for creating colour for their stories exists. Often the tone in an article appears to have been decided upon before any ink stained the page, a testament to the long standing prejudices towards ME. You only need a journalist who is friends with a psychiatrist who gives them 'advice' to perpetuate such prejudices to masses of people.

I can't help speculating that value of patient conduct is a limited and difficult commodity - it is an unrealistic expectation. A lot of people who get involved online with ME will have gone through the same agonising process. Trusting their doctors, trying their hardest to get better, only to find the treatments have made them more ill and being instructed it is all in their head. Every time someone goes through that system and ends up online because it's the only place their health allows them to exist, all of the hurt, uncertainty and anger comes with that. While the paradigms for ME treatment, particularly like those we have in the UK continue to exist, that conveyor belt is set to provide a steady supply. I feel patients are put in a position where it is very difficult to know what to believe, whilst burning multiple sources of trust in the process. When you're burned by authoritative people and institutions, authority everywhere starts to sound a lot less believable.

I grew up being fixed by doctors so trusted them without reservation. When I got ill, my family and friends would say, get well soon, sends cards all that sort of thing. To go from that situation to, "You're not ill, do some exercise." is tough. Personally I blamed myself for years. It took some personal tests of willpower to convince myself that I had something that wasn't merely an issue that required effort. I've no doubt said some dumb things online from time to time, so it stands to reason the next person who shares my experience could end up in exactly the same place.

[Firestormm]

Of course now science insider have provided more information on the qualification of Lombardi and approved his role as PI: http://www.mecfsforums.com/index.php/topic,11355.0.html

'NIAID staff members visited WPI on 15 December and assessed the qualifications of researcher Vincent Lombardi, a co-author of the retracted paper who still works at the institute. NIAID officially approved Lombardi as the new principal investigator yesterday, noting that he had the “technical expertise and experience directly applicable to the studies in Aim 2 of the grant,” which focuses on genetic susceptibility to the disease and dysregulation of the immune system. Aim 1 was to identify and confirm novel viruses linked to CFS.'

There was a bit more on Prohealth: http://www.prohealth.com/library/showarticle.cfm?libid=16806 which included a link to Lombardi's profile: http://www.wpinstitute.org/research/research_profiles.html

This was interesting from science insider:

'The National Institutes of Health, NIAID’s parent organization, in 2010 spent about $6 million on research for CFS, an amount patient advocates contend is inadequate for a disease that afflicts an estimated 1 million to 4 million Americans alone. WPI’s relatively rare investigator-initiated grant to study CFS began in September 2009, the month before the controversial Science report was published, and ends in August 2014.'

It underlined for me at least the size of the grant in relation to total spend and how 'fortunate' WPI were to be allocated the funding in the first place.

I have yet to get to grips with the detail of this grant and what it actually entails - project for coming weeks I think.

Edit:

As I said above I haven't got to grips with this research detail, but if it is retroviral knowledge and experience that Mikovits is seen to have and Lombardi not, are such skills even necessary for this grant/this stage of the grant I wonder?

[Superjump]

As I said above I haven't got to grips with this research detail, but if it is retroviral knowledge and experience that Mikovits is seen to have and Lombardi not, are such skills even necessary for this grant/this stage of the grant I wonder?

I don't have an answer for that, but the role of PI would seem a bit redundant in a lot of cases if one could merely design a study, propose it to a grant issuer, and leave the work to be completed autonomously.

I've not read a science paper recently that didn't include some creative inferences. Conclusions are often drawn from the results of a study. A good PI at the forefront would stand to learn a lot more from the results, whilst possibly discovering another important line of inquiry mid-experiment.  In any creative project, a large proportion of it exists in the mind of person conducting it.

I'd rather like to think that the onus is much greater on proving that the quality of the PI didn't matter.

Of course, I would rather that, because it suits my vanity, haha.

[Tango]

LOL  Where is Lombardi's on going record, experience and training?    He is only at the very start of his career, which personally I think he should leave. 

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

http://grants.nih.gov/grants/peer_review_process.htm#scoring

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria, and additional review criteria (as applicable for the project proposed).

http://grants.nih.gov/grants/peer_review_process.htm#scoring

The grant was awarded for very specific criteria.  That cannot be fulfilled using Lombardi.

If the Whittemore's care about their own daughter they will get that money to Judy before all the drugs making her well are taken away from her.   

[Tango]

As I said above I haven't got to grips with this research detail, but if it is retroviral knowledge and experience that Mikovits is seen to have and Lombardi not, are such skills even necessary for this grant/this stage of the grant I wonder?

If you have to ask that you have no clue what you are talking about. 

Some people will say and do anything to pretend the NIH is not laughing at patients with this tactic.

It underlined for me at least the size of the grant in relation to total spend and how 'fortunate' WPI were to be allocated the funding in the first place.

So what?  It was meant for retrovirus research that is beyond doubt proven to be part of ME and better than seeing over 75% of the funding fed into useless fluff with CDC labels.

[Tango]

This is a list of positions.  Lombardi should be the forth one.

Dr Mikovits would have too much experience to go on this list.

DEFINITIONS FOR RESEARCH ASSOCIATE, POSTDOCTORAL FELLOW, POSTDOCTORAL RESEARCH ASSOCIATE AND RELATED CLASSIFICATIONS

Research Associate - (Job Code 098063) – Must have a Ph.D. or equivalent doctorate degree in specific field. One year experience in research specialization. Expected to be “long-term or “career” employee, rather than a “temporary” appointment (but there is no security of employment, and like other staff members the individual may be terminated.) Makes a career of assisting faculty in the faculty member’s research – not doing own research. Treated as regular benefits eligible staff employee, and follows all staff employee policies and procedures. Must be paid at least the minimum salary required for exempt employees under state law. Object code is subject to fringe benefits.

Senior Research Associate - (Job Code 098060) – Must have a Ph.D. or equivalent doctorate degree in specific field. Three years experience in research specialization. Serves as a senior researcher with expertise in field. More professional and distinct than Research Associate. Employee pursues further research. Must be paid at least the minimum salary required for exempt employees under state law. Object code is subject to fringe benefits.

Research Scientist – (Job Code 098028) – Must have a Ph.D. or equivalent doctorate degree in specific field. Five years experience in research specialization. Serves as a key research scientist who is recognized as a national authority on topics in specialized field. Acts more independently and with a greater degree of freedom than senior research associate. The research is more specialized and complex than at the senior research level requiring a greater degree of expertise. Employee may not be interested in pursuing a faculty appointment at the University. Must be paid at least the minimum salary required for exempt employees under state law. Object code is subject to fringe benefits.

Postdoctoral Research Associate – (Job Code 098067) – Must have a Ph.D. or equivalent doctoral degree in an appropriate field within five years of initial appointment. Postdoctoral Research Associates are “research trainees” for the purpose of enhancing and developing research competencies. Temporary, fixed-term employee. Appointment is for a year at a time, and may be renewed on a yearly basis, up to a maximum of five years on the recommendation of the faculty mentor and at the discretion of the dean. Treated as regular benefits eligible staff employee, except for tuition assistance.

 

http://www.usc.edu/dept/personnel/comp/researchassociatedefinitions.pdf

[Tango]

It's pretty galling for those of us who cautioned any involvement with WPI, to now see some of those who supported the hype apparently not willing to 'suck it up' and see the thing through, irrespective of any wider fall out. As patients we really need to ensure we are not seen as the 'bad guys' in the WPI debacle - if the WPI is to get a 'patient vote of no confidence' then it needs to be on the basis of solid reasoning, not an emotive response, no matter how justified the emotion may be.

The justified hype is around MRVs and the lead authors on Lombardi et al.  The WPI were the funding bunnies who now are as galling as the NIH.

I posed the question: 'who does know whether or not Lombardi has the "creative expertise required" ?'  - the point being that there isn't any readily available data on which to make such a determination.

Actually there is as you can now read above.  It is whether he is an acomplished scientist.  Allowing his lab to be contaminated by plasmids and mycoplasmia, deviating from a clinically validated protocol and using incorrect reagents would strongly suggest that he is not.   

It is time for orthodox scientific investigation and not whatever approach creativity conjures up!

[In Vitro Infidelium]

Actually there is as you can now read above.  It is whether he is an acomplished scientist.  Allowing his lab to be contaminated by plasmids and mycoplasmia, deviating from a clinically validated protocol and using incorrect reagents would strongly suggest that he is not.

So it was all Lombardi's fault and Mikovits was just a victim of Lombardi's incompetence ? Surely the PI has to have some shared responsibility ? Or is that what you are saying that Lombardi and Mikovits 'failed' ? Not that other scientists have suggested there was any 'failing' in terms of 'contamination' - everyone in 'the field' accepts that the reagents were the likely source and everyone in retrovirology had been way too cavalier about the issue - XMRV being a wake up call.