Topic: Getting grant money for Lyme? Better pay attention!
Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
Ouuuuuuu... It's those pesky "conflicts-of -interest" policies again boys and girls.
It appears the Office of Inspector General and USDHHS is cracking down on those who get NIH grants for research, and are looking into money messes and private companies.
Wonder if Barbour, Wormser, Hu, Steere, Schwartz, Bockenstedt, Schutzer, Marconi, Shapiro, and the others with recent Lyme related grants will be affected?
The Institutions where they work may have some problems too.. big ones.
U.S. Dept of Health and Human Services Office of Inspector General
01-10-2011 Institutional Conflicts of Interest at NIH Grantees
Summary There are no Federal requirements that grantee institutions identify, report, and manage actual or potential institutional conflicts.
An institutional conflict may arise when an institution's own financial interests (e.g., royalties, equity, stockholdings, and gifts) or those of its senior officials pose risks of undue influence on decisions involving the institution's research.
We surveyed 250 grantee institutions to determine whether they have developed any policies and procedures regarding institutional financial interests and conflicts.
We requested information on any institutional financial interests related to NIH grants awarded in fiscal year (FY) 2008. A total of 156 institutions responded, for a response rate of 62 percent.
We found that although not required for institutional financial interests, 70 of 156 responding NIH grantee institutions have written policies and procedures addressing these interests.
Fifty-nine of the seventy institutions with written policies and procedures regarding institutional financial interests have defined, in writing, what constitutes an institutional financial interest.
The three most common definitions are: (1) institutional officials' individual financial interests, (2) equity held by the institution in publicly held entities, and (3) equity held by the institution in nonpublicly held entities.
We also found that although not required for institutional conflicts, 69 of 156 responding NIH grantee institutions have written policies and procedures addressing these conflicts.
Fifty-nine of these institutions have defined, in writing, what constitutes an institutional conflict.
These institutions typically defined institutional conflicts as financial interests that could affect the research, decisionmaking, loyalty, or objectivity of either the institution or individuals.
Grantee institutions that have written polices and procedures were more likely to identify conflicts (15 of 69 institutions) compared to those that do not (3 of 87 institutions).
Eighteen institutions identified at least 38 institutional conflicts related to NIH research grants in FY 2008. The most common type of conflict was institutions' holding equity in nonpublicly held companies.
For institutions that identified institutional conflicts, the strategy most often used to address them was disclosure.
NIH should require grantee institutions to identify, report, and address institutional conflicts in a consistent and uniform manner.
It is important that NIH know of the existence of such conflicts so it can ensure that the related research is free from any intended or unintended bias.
Therefore, we recommend that NIH promulgate regulations that address institutional financial conflicts of interest.
Until regulations are promulgated, NIH should encourage grantee institutions to develop policies and procedures regarding institutional financial interests and conflicts.
In response to our report, NIH stated that it is reviewing public comments to finalize regulations regarding financial conflicts of interest and, therefore, it neither concurs nor nonconcurs with our recommendation.
However, in the May 21, 2010, Notice of Proposed Rulemaking regarding financial conflicts of interest, NIH proposed regulatory changes that focus only on researchers' conflicts.
The proposed regulations do not address institutional conflicts.
Therefore, OIG continues to recommend that NIH include institutional conflicts in regulations addressing financial conflicts of interest.
Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
If you want to see who is sucking down the grant research money- your taxpayers dollars- here is a list for recent Lyme grants. (note- more than one page)
BTW- If anyone can find anyone on the list who is actually looking for a "cure" and not grabbing big bucks just to add to their own resources or to develop another vaccine, which is the big excitement in duck land now...
Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
And Rocky Mountain Spotted Fever... after many many moons some are still are sucking down research money to make a vaccine.. and NO vaccine has come to light ... not even close.
And what is he still doing looking at Lyme when he knows it has been decided that there is no such thing as "chronic Lyme disease" and acute Lyme is easy to diagnose and easy to cure?
Abstract Text:
DESCRIPTION (provided by applicant): Lyme disease, which is caused by the tick-borne spirochete Borrelia burgdorferi, can usually be treated successfully with 2-4 week courses of oral or intravenous antibiotic therapy.
However, approximately 10% of patients with Lyme arthritis have persistent synovial inflammation despite such courses of therapy. To explain antibiotic-refractory Lyme arthritis after 2-3 month courses of oral and IV antibiotics, the competing hypotheses of persistent infection or infection-induced autoimmunity have been proposed.
In the absence of an animal model, clinical correlations in human patients are required to address these hypotheses.
To date, most patients with antibiotic-refractory Lyme arthritis have had negative PCR results for B. burgdorferi DNA in joint fluid after antibiotic treatment; they have had HLA-DRB molecules that bind the OspA163-i75 epitope of the spirochete, particularly the DRB1*0401, 0404 and 0101 molecules, and T cell reactivity with this epitope.
Our goals in the next grant cycle include an assessment of antibody responses to lipid and carbohydrate antigens of B. burgdorferi to determine whether a decline in one of these responses after antibiotic therapy might serve as a practical surrogate marker for spirochetal killing in Lyme disease.
The precursor frequencies of T cells specific for OspA163-i75 or implicated autoantigens will be determined in both the infectious and post-antibiotic periods of the illness, the clonal characteristics of these cells will be delineated, and the numbers and function of T regulatory cells will be determined during active arthritis through arthritis resolution.
To broaden the search for candidate autoantigens beyond those identified by sequence homology with the OspA-,63-175 epitope, B cell epitopes of putative autoantigens will be sought using patient sera to screen a large array of expressed human proteins, and T cell epitopes will be sought using patient synovial tissue as a source of naturally processed MHC complexes from which peptides will be eluted and identified using tandem mass spectrometry.
The knowledge gained from these studies is likely to aid in more accurate diagnosis and more effective treatment of antibiotic-refractory Lyme arthritis.
Of greater general importance, antibiotic-refractory Lyme arthritis, which shares similar HLA associations with rheumatoid arthritis, may serve as a model of infection-induced autoimmunity.
Furthermore, this work brings us closer to the long-term goal of direct comparisons of antigens in Lyme arthritis and rheumatoid arthritis synovia.
"And what is he still doing looking at Lyme when he knows it has been decided that there is no such thing as "chronic Lyme disease" and acute Lyme is easy to diagnose and easy to cure?"
Because he is looking to further substantiate an autoimmune cause for those patients still suffering from symptoms after initial antibiotic treatment. If he's looking at MHC complexes (involved in transplant rejections, which is an autoimmune reaction of epic self-not self proportions) and is looking to compare post-antibiotic Lyme arthritis to rheumatoid arthritis, this is the direction he's taking: It's not persistent infection, it's an autoimmune disorder.
Regarding the vaccines:
The IDSA is going whole hog making vaccines. They are profitable, and new antibiotic R & D is not. The problem with this is obvious for society, whether one mentions Lyme or not: MRSA and other opportunistic infections are going to continue to rise without adequate treatment and new antibiotics to kill them.
posted
TC, do those who get grants have to show what they did with the money, or show what results they got from their research? Publicly?
Camp Other, I saw Steere's early papers - he stated very clearly that Lyme is a relapsing illness, since it's a spirochetal illness. So did others. He and the others reversed their opinions prior to the vaccine.
We do find spirochetes in people post-abx treatment. It is a medical, scientific fact.
Posts: 13116 | From San Francisco | Registered: May 2006
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Camp Other
Unregistered
posted
Robin123,
I know what Steere said, I've read those publications and he's made an about-face. He has yet to prove to anyone that it was with good reason. I was just laying out what he is trying to do now - there is money in vaccine development. And the thing is, the government (for good and for ill) has now backed off on funding more new antibiotic R & D when it is needed for all kinds of reasons.
I know spirochetes have been found in people post-abx. But this news isn't getting into the media, or where it is, it's coming from patients. Even if it is true, I think it would have a lot more weight if the researchers who published that work themselves made sure it got represented in the media. Directly. Not through some PR filter.
And I'm talking about other people who aren't Steere... how about Barthold? How about Brorson? How about other researchers who want to get down to the bottom of this as much as patients do?
I think this would help all who are suffering a great deal. People with the scientific cred have to speak up about it; we've all been citing a lot lately and it's apparently not enough. Maybe this would be.
Offhand, do you know how many of those spirochetes were found intact during autopsies versus live spirochetes in living human hosts? Because if we could separate those out and list those, it'd be helpful. PCR detection reports and live cultures from already treated hosts... I need to look them up, but if you know already, that would help. Thanks!
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Camp Other, I know that Alan McDonald found spirochetes in seven out of ten brains from people who died of Alzheimer's.
There's quite a list of researchers with the kind of info you're referring to. I have a feeling the media is suppressing the info.
There's a good pamphlet by Dr S and Lorraine Johnson, "The Treatment of Lyme disease: a medicolegal assessment," that lists a lot of the research.
And probably more lists are out there too. It's a matter of getting through the media blockade, I think.
Posts: 13116 | From San Francisco | Registered: May 2006
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Camp Other
Unregistered
posted
I know about Barthold's studies and MacDonald's.
How many links are there to studies on recovering live spirochetes from living human hosts? Not autopsies, and not mice?
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onbam
Unregistered
posted
Another site besides lymecryme.com that has a lot of research is actionlyme.org...you just have to wade through a lot to find it.
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Camp, what about darkfield microscopy? I think people see ketes that way in their blood.
Posts: 13116 | From San Francisco | Registered: May 2006
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Bartxxxx is, surprisingly, still on the scientific advisory board of American Lyme Disease Foundation (ALDF) (astroturf, bumsteerite). He seems to be very careful about what he says, which he needs to be to keep getting funded. NIH funding is totally controlled by the IDSA group. In fact, we should probably not mention him by name here in a favorable light.
Regarding examination of blood, the problem is that Bb doesn't spend much time in the blood. This is why PCR isn't usually helpful in diagnosis.
Thanks for the grant info, Tincup - fascinating!
And, nice to meet you, Camp, I like your blog!
Lorima
Posts: 74 | From MA | Registered: May 2007
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Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
You are welcome Lorima.
Yes, sad to see that money going down the drain... or shall I say directly into undeserving pockets.
True, you can use darkfield microscopy and the right stains to find live spirochetes. But this is usually far more easily done when it's early infection and in the blood.
Finding the dormant ones or persisting ones means getting into the collagen and taking a biopsy - not something people generally do.
Lorima,
Barthold is on the ADLF site? I didn't know. Hm. Thanks for pointing that out - I will check it out.
I don't know what to make of this, given his research and some of the things I heard him say at the IOM in October. That and I think he is ALSO on the LDF site, too. Weird.
Funny thing is, you find out later on that people you don't think are willing to listen or care about the issues sometimes are. They get tired of their own research being simplified and misinterpreted. This happened with Volkman's research - he's retired now and has helped CALDA and written letters pointing out the IDSA's errors.
I'm cautiously watching this and seeing what happens.
And Lorima, you are right about the PCR - doesn't usually help.
Thanks for the compliment on the blog... Actually, funny thing is right now someone has been discussing the mouse infectivity test with me in comments recently (a 14 comment run now!) who knows a fair bit about the issues involved. Might want to check that out, under my TED video posting on quorum sensing (how bacteria "talk" to each other).
onbam,
Thanks for the link, I'll check it out.
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And what are all these EXPERTS DOING GETTING GRANT $$$ when
There is no such thing as "chronic Lyme disease" Get grants to PROVE IT= clear goal here
Lyme is easy to diagnose and easy to cure? Get grants to study what they dont know -- but OI thought THEY knew all about lyme disease.. and its no big deal...
Looks by the research going on ITS CLEAR that they have NO IDEA about this complex bacteria. In fact I would expect little or no breakthrough results after all this $$ being spent.
-------------------- Positive 10 bands WB IGG & IGM + Babesia + Bartonolla and NOW RMSF 3/5/09 all at Quest
posted
And what are all these EXPERTS DOING GETTING GRANT $$$ when ;;;
There is no such thing as "chronic Lyme disease" Get grants to PROVE IT= clear goal here
Lyme is easy to diagnose and easy to cure? Get grants to study what they dont know -- but OI thought THEY knew all about lyme disease.. and its no big deal...
Looks by the research going on ITS CLEAR that they have NO IDEA about this complex bacteria. In fact I would expect little or no breakthrough results after all this $$ being spent.
-------------------- Positive 10 bands WB IGG & IGM + Babesia + Bartonolla and NOW RMSF 3/5/09 all at Quest
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