Volkman's critique of IDSA guidelines

[ahhclem]

Sure looks like to me that Steere and company got "spanked" by one of their own.

David Volkman, Ph.D., M.D. , Emeritus Professor of Medicine and Pediatrics SUNY, Stony Brook, NY has written a letter to the new IDSA panelists debunking much of the old guidelines.

http://www.lymedisease.org/news/lymepolicywonk/82.html

from CALDA Lyme Policy Wonk blog:

David Volkman, Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook, and previously Senior Investigator with the National Institute of Allergies and Infectious Diseases, has submitted the attached letter to the IDSA pursuant to its document submission process. He has performed both clinical and bench research in Lyme disease since 1985. Given his impeccable credentials, outlined in the first paragraph of his letter, his submission should carry considerable weight with the panel. Among other things, he points to the suppression of research and stifling of the types of investigative inquiry necessary to begin to address pressing issues for Lyme patients—the need for better testing, the need to acknowledge persistence and start looking for treatment protocols that help patients get better, the need to keep surveillance definitions outside the arena of patient diagnosis, the need to acknowledge the usefulness of PCR testing, and the need to avoid prophylaxis regimens that may promote chronic Lyme. His letter smells a little bit like “courage” to me—a pretty rare commodity these days.

There is a .pdf link to Volkman's entire letter, complete with references, at the bottom of the article.

[edited for a typo, despite previewing first]

[cave76]

Thanks for posting that------ I'd read it somewhere else also. I hope some good comes of that stance, like others joining in.

[kitty9309]

I sent Dr. Volkman a thank you e-mail. Actually got a response (don't know if it is an automatic response).

"Thanks for your kind remarks. The proper diagnosis and approach to possible borreliosis is well known, the problem seems to be the deceptive recommendations of the IDSA designated "experts."

Sincerely,
David Volkman, Ph.D., M.D.
Emeritus Professor of Medicine and Pediatrics
SUNY, Stony Brook, NY
"

I searched his name and can only find stuff from early 90's.

When did he jump ship and change sides???

Why did he???

[hv808ct]

Well, at least some of the comments coming into the IDSA regarding the guidelines review are from credible and rational sources.

David Volkman, Ph.D., M.D., Emeritus Professor of Medicine and Pediatrics, SUNY, Stony Brook, NY, fired off a referenced, 10-page letter about the guidelines and the authors of those guidelines.

He makes some good points.

I wouldn’t presume to argue with him about the immunology of natural infections or the proper treatment of human patients, but I think his reliance on the clinical outcomes of 17 patients from 1988, and the white-footed mouse as a model of human infection are serious weaknesses.

He writes that there is “…both animal and human evidence of persistent borreliosis following inadequately treated LD….” The critical word in that sentence is “inadequately.” I don’t think anyone would argue that “inadequate” treatment of any infection would not encourage persistent or chronic infection.

Commenting further about those 17 patients, he writes, “…all lacked detectable antibodies against borrelia. Although early antibiotic treatment abrogated antibody responses, it did not eradicate infection. When retreated, most of these chronic patients markedly improved within a month of completing a course of intravenous ceftriaxone, consistent with their problems being due to persistent, ongoing occult infection; although borrelia was not isolated in most cases….”

The issue of abrogated antibody responses and seronegative Lyme is interesting, but not exclusive to Lyme disease. Stopping any infection with effective antimicrobials should also truncate an immune response to that infection. I suppose the absence of antibody in an infection (i.e., seronegativity) only becomes an issue when one is relying on serology for a diagnosis.

Volkman also suggests that, “IDSA committee members deny the possibility of persistent seronegative Lyme disease.” I think all they deny is that pumping expensive antibiotics into symptomatic people on an open-ended schedule is somehow beneficial.

Volkman’s answer to the serology dilemma seems to be PCR. Maybe. I’m not sure. It’s sensitive and specific: just like a good diagnostic should be. But what does it tell you about infection, disease, and immunity? I’m sure if someone subjected me to enough PCR they could possibly find M. tuberculosis, MRSA, N. meningitidis, S. pyogenes, and measles. I don’t have TB, a staph or strep infection, meningitis or the measles. I might have DNA to these bugs, but there’s a big difference between being “colonized” and being “infected.” Should I be treated anyway just because a PCR assay says I have bug X?

As for the lowly white-footed mouse, I don’t think it’s a very credible model of natural infection in humans. Mice don’t show much morbidity and seem to clear their borrelial infections. I guess they’ve had a few million generations to evolve and adapt to ticks and B. burgdorferi since its arrival from Europe some 15,000 years ago.

Regarding financial conflicts and conflicts of interest, I wish Volkman had spent some time pointing out those kinds of conflicts among Lyme advocacy organizations, A.G. Blumenthal, Lyme specialty labs, and the many cash-and-carry private practice physicians who make a nice living off of the ignorant, the gullible, and the desperate. Fortunately, some of them are now in jail.

Just today, one of these online Lyme patients complained about how much his Lyme Literate MD was costing him. He wrote, “My first visit was $450 for 1 1/2 hours. The lab testing was approximately $1600.” (Two weeks ago, I had a complete physical, hematology and blood chemistry, EKG, PPD, chest film, and a well-deserved colonoscopy. Out-of-pocket cost was zero. But then I have good insurance and I don’t see quacks.)

So Volkman could have spent a few paragraphs talking about these for-profit LLMDs; their ties to i.v. infusion companies and diagnostic labs with “unusual” Lyme tests; their patient trolling at Lyme advocacy meetings; their memberships on Lyme advisory boards; their partnerships in Lyme clinics; their hawking of nutritional supplements and quack treatments; and, of course, their lack of published evidence and peer-review to back up their practices and claims.

Last year, Volkman wrote, “Although the use of repeated courses of antibiotics for a putative borrelia infection is unsupported and may cause serious morbidity, persons with evidence of previously inadequately treated Lyme disease may be seronegative and may benefit from adequate antibiotic therapy.” (My emphasis.)

Well, yes, I don’t thing anyone would disagree. But he’s describing a minority of patients. The majority of patients get bit, get sick, test seropositive, and respond to antibiotics.

[minitails2]

Ah, Mr. McSweegan, you're back.

[ahhclem]

There are many compassionate docs who see that their patients are still ill after being treated by "guidelines" and are honestly torn as to what to do. Volkman's letter is a very credible resource to be handed out to them and help them to wake up and start thinking critically for themselves as to what is really going on.

[Spanky]

"hv808ct":

Regarding financial conflicts and conflicts of interest, I wish Volkman had spent some time pointing out those kinds of conflicts among Lyme advocacy organizations, A.G. Blumenthal, Lyme specialty labs, and the many cash-and-carry private practice physicians who make a nice living off of the ignorant, the gullible, and the desperate. Fortunately, some of them are now in jail.

Just today, one of these online Lyme patients complained about how much his Lyme Literate MD was costing him. He wrote, “My first visit was $450 for 1 1/2 hours. The lab testing was approximately $1600.” (Two weeks ago, I had a complete physical, hematology and blood chemistry, EKG, PPD, chest film, and a well-deserved colonoscopy. Out-of-pocket cost was zero. But then I have good insurance and I don’t see quacks.)

So Volkman could have spent a few paragraphs talking about these for-profit LLMDs; their ties to i.v. infusion companies and diagnostic labs with “unusual” Lyme tests; their patient trolling at Lyme advocacy meetings; their memberships on Lyme advisory boards; their partnerships in Lyme clinics; their hawking of nutritional supplements and quack treatments; and, of course, their lack of published evidence and peer-review to back up their practices and claims.

Yes.

Watching this "debate" (using the term loosely) unfold for a number of years now, one of the things that never seems to amaze is the degree to which Lyme patient "advocates" (using that loosely, also), are completely unwilling or unable to admit the degree to which "LLMD"s have a vested financial stake in the issue...

...and by aligning themselves so noticably and publicly with those with such an obvious stake...that they call their own motivations and credibility into question.

The aggressive cult-like tactics that these same groups employ in an exteremely unsophisticated and often just plain ridiculous manner...actually hurt and harm the legitimate issues of Lyme patients.

In my opinion, even in the unlikely event that this whole "antitrust" business (using that term incorrectly)...'Blumenthal's not-so-excellent Lyme adventure'...produces anything in the way of benefit to anyone, whatever...

...it still was, and is, an inappropriate use and abuse of power and NOT the appropriate or even an intelligent way to address the issues...or the legitimate forum or method by which to present those issues....and ultimately produced nothing whatever to justify the initial antitrust claim.

See also:

http://annalsofneurology.wordpress.com/ ... rs-debate/

Us vs. Them

Patient groups, who were represented on the ILADS guidelines-development committee by Pat Smith of the Lyme Disease Association, routinely cite the ILADS guidelines as evidence that prolonged antibiotic treatment for chronic symptoms is a reasonable approach to care in the hands of the right doctor. Others charge that the ILADS treatment parameters are being used to justify antibiotic therapy for nebulous symptoms that cannot be definitively linked to Lyme infection.

“Reimbursement is high for antibiotic infusion. There are a number of physicians in the country - primarily family physicians - who have made themselves ‘Lyme disease experts’ and treat chronic Lyme with antibiotics,” said Roos of Indiana University. “Every patient deserves to be thoroughly evaluated, but they should not be in the hands of these ‘Lyme clinics. They should go to academic medical centers and see neuro-infectious disease specialists who have no financial interest in them having Lyme.”

Lyme researcher David Volkman, an emeritus professor at the State University of New York at Stony Brook, has a unique perspective on the whole Lyme debate: he is solidly in the middle. In fact, he said: “I think I am despised by both groups.”

[Joe Ham]

If Blumenthal's action was so off the wall (unfounded) then why did IDSA settle by agreeing to review and possibly rewrite the Guidelines with fresh authors?

And if it was intended by IDSA to be a rubber-stamp operation then why the extended "comment period"?

http://www.lymeneteurope.org/forum/view ... f=7&t=2531

[Spanky]

"

Joe Ham":

If Blumenthal's action was so off the wall (unfounded) then why did IDSA settle by agreeing to review and possibly rewrite the Guidelines with fresh authors?

Well, I'm not sure what you are driving at there...but if you are implying, as has been done in many other comments posted online...that the IDSA must have settled because there was some sort of exposure or something that they were fearful of...that simply doesn't follow, in my opinion.

There are all sorts of reasons why sane people decide to settle rather than pursue something to an ultimate decision, verdict.

Cost and negative PR for instance, weighed against what possible good could come of it, for one, I would think. I really don't know. I don't speak for the IDSA (contrary to what some have suggested elsewhere).

The notion that they must have settled because they were somehow "guilty" is just...naive and silly. Not worth talking about.

And, if you read the terms of the agreement...you will clearly see that the IDSA admitted nothing, whatever.

But what I am saying is that this was the wrong and improper vehicle. There was no legal basis for an antitrust "investigation". In my opinion.

A Congressional committee, for instance, has subpoeana power and the ability to call witnesses. That' probably would have been a better, less aggressive route.

And if it was intended by IDSA to be a rubber-stamp operation then why the extended "comment period"?

Well, why not?

The IDSA settled the thing on terms very favorable to them. Good deal for them. Smart. And a settlement allowed Blumenthal to back away from what he must have realized, finally, was a looming political embarrassment, if not disaster.

Look at it another way...if you can get what you want in settlement...then why proceed to trial?

Any change in the Guidelines requires a 3/4 vote. That virtually guarantees, barring some miracle, that the Guidelines will remain virtually intact.

By settling on those terms, and having a neutral panel affirm the Guidelines, the questions raised by opposing voices will have now a powerful rebuttal.

Whatever taint may be associated with them because of Blumenthal's claim of conflict will be removed. They will have been independently ratified on terms that Blumenthal agreed to.

So, I would guess that the review panel would want to bend over backwards to make sure that the process is viewed as affording every appearance of fairness, openess and opportunity for the public to have input and participation.

Don't you think?

(And...to my experience, it oftentimes is the case that some "grassroots" types ("slacktivists", some call them) really use these public comment sessions for their own organizing agendas, rather than any substantive impact they actually may have. In this case, there is probably some ass-covering yet to be done by those that launched this and then proclaimed it as "an important victory")..

[Fin24]

I would guess that the review panel would want to bend over backwards to make sure that the process is viewed as affording every appearance of fairness, openess and opportunity for the public to have input and participation.

and therein lies MY concerns from the getgo--no true additional input or re-evaluation of anything and simply APPEARANCES of such

there are parallels : inside job hiring; academic position assignments, sometimes even grants application acceptances.

an APPEARANCE of fairness when in fact there is none and when there doesnt have to be any due to lacks of accountability and oversight as well as an " acceptability" of the status quo

when all say " well thats the way its done what are ya gonna do" and move on.

I also agree that we all are hurt by the "I know you are but what am I" tactics of pointing fingers at conflicted interests and qualifications for treating an illness.There are those making money on both sides and both trying to claim " expert" status.and not all for noble reasons either

why is this one disease so damn politicized??Is anyone battling over long term therapy for TB or some other infections that can and do persist? I think once we really figure out the bottom line--the real reasons for the politicizing of Lyme( and its NOT the sanctity of the practices of medicine or drug costs or even public health concerns of this I am sure)--and then disarm the explosives of political matters, we may have a chance at progress.

I cant help but think if someone -anyone -has the ability to simply advance the information and science and shares all of the pos and neg information we can come to some sort of treatment concensus--just like they were able to with many other diseases.Shut the mouths of IDSA and shut the mouths of LDA and JUST DO THE WORK.and accept the outcomes of that work-

You dont see this with anything else- Even diseases that remain nebulous--and even diseases that remain hwith indefinite or multiple treatment options ( like cancers--they all dont have definitive absolute protocols guaranteed to improve outcomes)--if those illnesses are allowed to have Drs decide whats best along with their patients then why not with Lyme??

why is THIS disease being hijacked by one group that is dictating protocols that arent based upon definitives?? Youve got to ask "why" before you ask "how" and even before you try to fight the "how"

has anyone gotten any closer to the answers??


IMO there are going to be "baddies" in any group large enough and with enough at stake- so now that Lyme community has reached critical mass there are going to be those trying to make as much money off of it as fast as they can. Is this right?? hell no--but it will exist

There are now a number of ID Drs jumping IDSA ship and swimming into the waters of trying to help treat those with Lyme still ill despite IDSA guidelined treatments. And among them there are those who are starting to see that there is more to this illness. And again there are those few others who see dollar signs. rather than keep up the attitude of hv808ct of muddying the waters with yet another " hah those Lyme drs are all money grubbers" why cant we embrace the possibility that while SOME IDSA are arrogant SOB's who couldnt care any less if they tried and SOME so called ILADS drs are hoping to get rich off the Lyme mother Lode, that this is NOT the point

what IS the point is that there are VOLUMES of good solid scientific evidence proving that we arent doing the best we can for many with Lyme
and we ought to knock off the squabbling and finger pointing and get down to DO what it takes to figure it out