Survey: FDA Proposed Regulation of Lyme Tests

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
duncan
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Joined: Wed 5 Sep 2012 18:48

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Thu 13 Nov 2014 13:48

Whoa, hold on there VM. What you wrote about the nature of the studies on Henry's little list is misleading at best, imo. You seem to imply there is a substantial number of studies that specifically target Late Stage Lyme, or NB, or PTLDS. That is simply not correct. How did you put it? "...many of them mention 'chronic Lyme', persistence, PTLDS, and antibody-refractive Lyme arthritis."

Because a study may "mention" a topic, does not mean the study revolves around or focuses in on that subject.

So you have the Tulane monkey study for NB. Please note that does not involve human subjects.

And you have Steere's pet project on refractory Lyme arthritis, which I'm guessing is more or less him trying to explain away why one of the few clearly visible signs of Late Stage Lyme won't resolve the way it's supposed to after IDSA-recommended treatment.

This list stands as clear testimony in support of what I opined yesterday. As far as I can see, there is little to no meaningful research being conducted by the NIH on Late Stage Lyme,or on NB. As for PTLDS/Chronic Lyme, the only one I could find worthy of discussion is the one I alluded to the other day that was launched in the late '90's. And as for treatment studies, well....

This needs to be fully appreciated before it can be remedied.

phyfe
Posts: 167
Joined: Sat 15 Sep 2012 19:28

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by phyfe » Fri 14 Nov 2014 16:47

I thought this article (sent to me by a friend) would be interesting for all to read. It outlines the sad state of funding for TBD research in the United States.

http://www.keepmecurrent.com/current/ne ... 10598.html
Dr. Peter Rand, the senior investigator at the Vector-borne Disease Laboratory in Scarborough, who originally established the Maine Lyme Disease Research Lab 26 years ago, called the reduction in the federal support of research “appalling,” and said, “in the case of vector-borne disease research, prevention and education, a major infusion (of cash) is needed.”
Here's another interesting little tidbit for you all:

In 2014 our "friends" at the NIH are spending approximated $70 million dollars on studying Adolescent Sexual Activity while only allocating $24 million to research on Lyme.

And the list goes on and on!
Last edited by phyfe on Fri 14 Nov 2014 17:07, edited 1 time in total.

Lorima
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Lorima » Fri 14 Nov 2014 18:11

How much, or little, money the NIH puts into clinical LD research is irrelevant, as long as the dominant assumptions (which pass as "known facts" in medical culture) about the disease are wrong. All the research that gets funded will necessarily be designed, and then interpreted, in accordance with these fake facts, and hence the results will be largely meaningless. Somebody may manage to get something done that is real and useful despite this, but I think the odds are against it.

I think that accurate molecular, cell biology, and even some animal studies are still possible under the current regime, and one can never predict when such studies might make possible a clinical breakthrough of some kind, if some dark horse researcher is clever enough to both make a discovery, and dodge around the IDSA-faithful defenders in order to make it widely known and accepted. I think animal studies are likely to be even more stingily funded than molecular studies, partly because they don't have the "coolness factor" that molecular manipulation still carries, but also because there is a feeling that everything that needs to be done, has been. For example, there are probably a lot of medical people who feel that Wormser and colleagues' whole-mouse culture proves something. (While I feel that sending a known camp-follower like Wormser to find something that he and his colleagues vehemently assert doesn't exist, is a fool's errand.)

Doing meaningful research on LD requires investigators capable of independent thought, rigorous science, and the ability to negotiate a hostile research environment. This isn't trivial; these abilities, while not impossible for one person to host, have many areas where they work against each other. It's hard enough to do good science when there is a supportive culture for it. We shouldn't expect a large supply of researchers capable of pulling it off in an environment like this, in any generation. As far as I can see, the number of people who have done this in the past, with regard to LD, can be counted on the fingers of one hand. I presume the medical establishment generally picks off aspirants at the grant review stage, as quickly as they arise. I presume most of this happens simply because the grant reviewer makes an intuitive judgment that the proposals are implausible (in light of current "knowledge") and unlikely to bear fruit, not as a conscious effort to enforce current dogma. Current medical dogma on any subject is self-reinforcing, just as real science, in contrast, is self-correcting.)

Nicole Baumgarth's lab's recent article on the peculiar immune response to Bb in the mouse is welcome, and useful. I have long regarded the frequently seen failure of normal Ig class-switching (from IgM to IgG) to be one of the more intriguing features of LD biology, as well as being highy relevant to the failure of the current mandated LD diagnostic protocol. Baumgarth is in the academic lineage of Stephen Barthold, who has been one of the most successful researchers so far to challenge the LD dogma. He and Baumgarth are DVM/PhDs, and settled in a department focused on veterinary rather than human medical issues. This keep them somewhat protected from direct interference in their research, but perhaps also marginalizes their research, in the eyes of academic medicine, which is regrettably subject to influence by a hierarchy of prestige, rather than merit. Barthold left Yale for UC Davis, which probably was necessary, to pursue his insights. But Yale (Bockenstedt, for example) trumps UC Davis among conventional medical academics, regardless of the relative quality of the work.

There are exceptions to the dominance of academic institutional prestige; for example, after leaving his Yale fellowship, Steere was at the lower-tier Tufts before joining MGH, but was still considered the world expert due to being credited as the discoverer of the disease. And Wormser is still at NYMC, but presumably due to his loyal and energetic service in promoting Steere's views, became prominent as go-to ID authority (Steere being a rheumatologist); and hence the IDSA LD guidelines' first author. Still, notice how one of our IDSA apologists reflexively referred to Harvard and Yale as the go-to institutions to validate any LD-related claim. That's the automatic default option, even though in this particular controversy it is absurd.

Sorry if all this contradicts anyone's naive faith in the purity of science and modern medicine (or conversely, seems like belaboring the obvious). It's not comfortable; just how it is, as nearly as I can discern. Certainly, I had no idea medical science was so corruptible, 10 years ago. I can't blame people for initially being shocked and disbelieving, when they encounter a long-term, unfixable mess like this, propagated by the most trusted institutions. For people who center their belief system on science and technological progress, the shock must be almost existential. On the other hand, I do have to wonder about all the seemingly intelligent people who are excessively slow to recognize what's gone on here, and what it implies about the fragility of (at least medical) science, even when they've personally encountered all the pieces of the puzzle, and spent time thinking about it. Could it simply be that we're reluctant to give up a modern version of religious faith?
Last edited by Lorima on Sat 15 Nov 2014 0:10, edited 1 time in total.
"I have to understand the world, you see."
Richard Feynman

hv808ct
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by hv808ct » Fri 14 Nov 2014 21:40

Re: Survey: FDA Proposed Regulation of Lyme Tests
Postby Lorima » Fri 14 Nov 2014
I love the sweeping, conspiratorial narrative that makes up so much of the LymeLand psychology. But maybe once in a while we could try to pin some actual names, places, dates, etc. to some of the statements that get tossed about as “common fact”. For example:

fake facts

How can a fact be fake? And what “facts” are assumed—in LymeLand—to be “fake”?

IDSA-faithful defenders

Who are these guys? Just the 9,000 dues-paying members of the IDSA or some smaller subset? Could we get some names, please?

hostile research environment

Where is this environment? Academia in general? NIH in particular? The Republican House?

the number of people who have done this in the past, with regard to LD, can be counted on the fingers of one hand.

So I imagine they can be named. And they are…..?

I presume the medical establishment generally picks off aspirants at the grant review stage, as quickly as they arise. I presume most of this happens simply because the grant reviewer makes an intuitive judgment that the proposals are implausible…

That’s a lot of presuming. You could just look up the members of the NIH IRGs that routinely review LD-related grant applications. I believe you’ll find that while some reviewers are Lyme or related researchers, most are not. They’re just good researchers or good ID people. More importantly, you cannot rely on “intuitive judgment” in front of 20 other reviewers and expect them to take you seriously. You need to lay out reasons and facts for wanting to fund—or not fund—a particular application.

Current medical dogma on any subject is self-reinforcing, just as real science, in contrast, is self-correcting.)

Since science-based medicine is science-based it too should self-correct through the process of scientific enquiry, experimentation, observation, etc.

This keep them somewhat protected from direct interference in their research

“Direct interference” by whom? Names, please, besides that of the dean.

Barthold left Yale for UC Davis, which probably was necessary, to pursue his insights.

Or it could be the native Californian and graduate of UC Davis wanted to go home, and to become the inaugural director of the UC Davis Center for Comparative Medicine.

I do have to wonder about all the seemingly intelligent people who are excessively slow to recognize what's gone on here

Just what is going on here? Perhaps I’m slow or only seemingly intelligent, but I’m not aware of any plots or conspiracies here or there. Then again, I am slowing down……..

duncan
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Fri 14 Nov 2014 22:30

I always get a kick out of the tendency of researchers and clinicians, who, when absolutely clueless as to the underlying disease process staring them right in the face, take refuge in trying to hide behind psychology - a discipline they know even less about.

This is an even sweeter moment for me, as they appear to be (at least a little) on the receiving end of some psychoanalysis themselves. Certainly some cogent and logical analysis. I love the irony, and I think I can almost feel the uncomfortable squirming in the word choice in the post above by hv808ct.

I have found this to be characteristic of certain big brand academians, as well as some individuals in organizations like the NIH and CDC. Brings to mind the Woody Allen adage: "Those who can't do, teach. Those who can't teach, go work for government health agencies." I may have gotten that last part wrong. ;)

I will let Lorima discuss her own post - if she even feels the need or inclination. I just had to point out the "sweeping" irony.

The merits of examining a dysfunctional psychology peculiar to a segment of the medical community - one that serves as the underpinning of resistance to progress on several TBD fronts - are many and obvious. That such resistance even exists is an outrageous affront to Scientific ideals, as well as basic human core values. The resistance to innovation springing from labs outside the small cast of usual subjects is reflective of this tragedy.

Oh, hv808ct, that concern you have about being "only seemingly intelligent"? Well, it needn't be. That's just my opinion, and not part of any conspiracy.

Lorima
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Lorima » Sat 15 Nov 2014 0:32

hv808ct,
My post was written for people on this forum who know the history of the Lyme research fiasco in some detail. There's no need for us to spell out this history in detail, every time we talk about it; whole books have been written about it. I suggest Edlow's Bull's-Eye for the academic view, and Weintraub's Cure Unknown for the journalist/patient view. Weintraub is far better referenced, if you'd like to check the original sources yourself.

Since you apparently can't see that it has been a fiasco, I guess you couldn't be expected to understand how and why the multiple scientific gaffes occurred. Or else you're being disingenuous. Either way, I don't see any benefit to spelling it out for you. Read those books, if you've really forgotten what happened, or don't understand what was wrong with it, and if you care. Otherwise, continue as you have been.
"I have to understand the world, you see."
Richard Feynman

hv808ct
Posts: 256
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by hv808ct » Sat 15 Nov 2014 16:55

by Lorima » Sat 15 Nov 2014 1:32
hv808ct,
My post was written for people on this forum who know the history of the Lyme research fiasco in some detail.
… I don't see any benefit to spelling it out for you….
Yes, that’s the standard response among conspiracy theorists when asked about basic facts underlying the conspiracy: ignore them or accuse them of being disingenuous, or better yet, being part of the conspiracy. Frankly, laying out the storyline—including names, institutions, dollars, etc., might be good practice for building a more compelling and convincing conspiracy, and that would help attract more recruits and believers, wouldn’t it?

Anyway, I’m reasonably familiar with the history and science of LD in the U.S. I’ve been involved in these issues, off and on, since the 1990s. As for the fiasco you speak of, I guess you’re not referring to Willy Burgdorfer sitting silent as a Teutonic Buddha while investigators at Yale and Stony Brook spent years wandering down blind alleys trying to figure out what was going on in Lyme, Ct. and Shelter Island, NY. Being from central Europe and familiar with the German medical literature, he could have said, “You know, we have something like this arthritic/dermatologic presentation in Europe that appears to be tick-borne and bacterial because it responses nicely to penicillin.” But he didn’t and instead the notion of a “new” and “mysterious” illness emerged subsequently in the press, and encouraged various nuts to start running around New England claiming it was killing kids, dogs and cats, and everyone should be afraid. So yes, I suppose you could blame people like Burgdorfer and the LDF group for the emergence of a “fiasco” called the public’s perception of Lyme disease.

As for books on the subject, you can read the trash cobbled together by quacks and crooks and housewives or go to the experts:

Lyme Disease: An Evidence-Based Approach, by John Jay Halperin, ed.
Lyme Disease: The Ecology of a Complex System, by Richard Ostfeld
Tick-Borne Diseases of Humans, by Jesse L. Goodman and David T. Dennis
Making Sense of Illness: Science, Society and Disease, by Robert A. Aronowitz
Biography of a Germ, by Arno Karlen

And let’s not forget Harrison’s or Mandell, and maybe some recent journal reviews by Lantos, Feder, Kraemer, or Auwaerter.

Or just stick with mythology. No messy facts or cruel realities to deal with.

Lorima
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Joined: Mon 29 Oct 2007 20:47

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Lorima » Sat 15 Nov 2014 17:01

BTW, the last paragraph of my post above
http://www.lymeneteurope.org/forum/view ... 318#p40313
wasn't meant to refer only to the medical establishment and their collaborators. Although I do think the problem is more monolithic within medicine, perhaps due to the authoritarian and standardized nature of the training there, I think it's a problem among most highly mainstream-educated people in our culture.

When we Lyme patients and caregivers had to choose between faith in the medical/scientific authorities and our own or our family's live, we had to do our own research, and then (reluctantly at first) question our default faith in the pronouncements of the dominant medical authorities. At least, we have questioned, with regard to LD - though some of us have gone on to look at other medical fields, to see if the same scientific errors and fragility obtain. The news is not wonderful, as John Ioannidis, the Cochrane Collaboration, the IOM, and many others have been saying for quite a while.

There is something about having to come up with an answer, whether or not it is a true answer, that causes medicine to short-cut the scientific process in favor of arbitrary policy decisions, rather often. It's easy to see how the job of doctoring is made much quicker, easier, and more uniform, by applying a set of simplified decision algorithms to each case. Fifteen-minute, or even half-hour, appointment intervals wouldn't be possible without them. Yet real biological science usually can't be reverse-engineered to provide such simplified algorithms. So the algorithms are created...some other way. "Science-based medicine" is, in many instances, an Orwellian locution. If you poke around a little in the literature of one of these fields where arbitrary decision rules have been generated for the clinician's convenience, it often falls apart surprisingly quickly, from a scientific viewpoint. But it remains highly durable as a social construct and business opportunity.

If we hadn't had to deconstruct one of these arbitrary disease models in self-defense, who knows, we might be almost as credulous toward the medical academic and government 'experts' as hv808ct and Henry (though I hope with less sarcasm and pretense of certainty). To give the benefit of that doubt, is why I used "we" in the last sentence of my post, instead of "them."
"I have to understand the world, you see."
Richard Feynman

Lorima
Posts: 914
Joined: Mon 29 Oct 2007 20:47

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Lorima » Sat 15 Nov 2014 17:40

hv, I just read your last post. I think the highly emotional tone of it, does all that is needed to discredit it.

By the way, the authors of the books I recommended are

1) a professor of Public Health at Harvard (Edlow's Bull's-Eye and
2) a professsional science journalist (Weintraub, Cure Unknown.

Your bizarre rant about the sources I suggested is either irrational venting, or designed to mislead the uninformed.

If it's the latter, I'm not sure who you think might be favorably impressed by this kind of communication.
"I have to understand the world, you see."
Richard Feynman

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Sat 15 Nov 2014 17:56

One doesn't have to endure hv808ct's revisionist history to realize something is very wrong with the way mainstream medicine is approaching Lyme today. The emphasis is on diagnostics for acute cases, and on prevention.

There is merit to these areas of research. What I find is unconscionable is the lack of meaningful research investments into alleviating the plight of victims of Late Stage Lyme, Late Stage NeuroBorreliosis due to Bb sensu stricto, and even that political construct, PTLDS.

I don't have to conjure conspiracies to take a snapshot of the Lyme research landscape as of 2014 and see, clearly, that it is pretty much barren, at least in terms of substantive projects for those sick for longer than a month or two(unless they are fortunate enough to have a pair of arthritic knees). To look for accountability is not to succumb to conspiracy theories. It is saying there are people who have made decisions, and those who continue to make decisions today, that are leaving grotesquely high numbers of people sick with TBD's to fend for themselves.

It is all the more unfortunate when efforts to encourage innovation are snuffed out in the name of the very population who are being effectively disenfranchised from the medical community.

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