The LDA is wrong about the IDSA Guidelines

At least, I think so, in several signifigant respects.

Here's the operative portion of text:
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Press Release Source: Lyme Disease Association


Statement from Pat Smith, President, Lyme Disease Association
Tuesday October 10, 10:32 am ET
New IDSA Guidelines Forbid Doctors From Using Clinical Discretion in
Diagnosing Lyme Disease


JACKSON, N.J., Oct. 10 /PRNewswire/ --


"In a nutshell, the reckless new IDSA guidelines forbid doctors from
using clinical discretion in determining whether or not patients have
Lyme disease. Instead, they require that doctors either see a
characteristic rash known to occur in about half the patients, or that
patients register positive on the two tests recommended by the Centers
for Disease Control & Prevention (CDC) -- tests known to miss up to
half the patients. At any stage of disease, as many as half the
patients may remain undiagnosed".
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1. "Clinical discretion"

Notice the words: "forbid doctors from using clinical discretion" in
determining whether patients have Lyme disease...

Presumably, what is intended here is nothing less than that these
guidelines somehow overturn the CDC's longstanding directives that the
diagnosis of Lyme disease is primarily a clinical diagnosis.

But do they? How could they? And remember that these are not only
G-U-I-D-E-L-N-E-S, and therefore, NOT mandatory, but also that, to a
great extent, the very same "expert panel" members who are advising the
IDSA are also the "experts" that advise the CDC in regard to the same
issues!

But the simple fact...apparently overlooked by the LDA, is that the
guidelines explicitly acknowledge the clinical nature of Lyme disease
diagnosis in the GUIDELINES themselves. Right there in the beginning,
where they placed it so the LDA could see it:

"It is important to realize that guidelines cannot always account for
individual variation among patients. They are not intended to supplant
physician judgment with respect to particular patients or special
clinical situations".

I mean, any questions, there? Isn't that pretty straightforward? See
that..."not intended to supplant physician judgment"?

And, if you don't understand that, how that statement by the IDSA
relates to "clinical discretion", then compare that to the statement of
Paul Mead, speaking on behalf of the CDC:

" For this reason, CDC has stated repeatedly that the surveillance case
definition is not a substitute for sound clinical judgment. Given other
compelling evidence, a physician may choose to treat a patient for Lyme
disease when their condition does not meet the case definition".

What does a "clinical diagnosis" entail?

A diagnosis based on observation of the signs and symptoms of a
disease.

So, on the issue of the "reckless" GUIDELINES forbidding "clinical
discretion"...the fact is, that the clear, plain and ordinary language
of the GUIDELINES says just the OPPOSITE.

The LDA is just WRONG, in my opinion.

2. Rash or CDC +?

Apparently, the LDA has interpreted the GUIDELINES to require a patient
to have either an EM rash or be judged seropositive in accord with the
CDC surveillance criteria.

"Instead, they require that doctors either see a
characteristic rash known to occur in about half the patients, or that
patients register positive on the two tests recommended by the Centers
for Disease Control & Prevention (CDC) -- "

It would seem that the LDA is suggesting ,(and, as has been suggested
here by some other observers here), that an EM rash is the ONLY
acceptable indicator of a clinical diagnosis according to the
GUIDELINES, and that in the absence of an EM rash, the doctor must
confirm his diagnosis through the ELISA/Blot analysis in accord with
CDC surveillance standards (presumably before commencing treatment, if
I am following what the LDA suggests). (And there seems to be an
implication that patients will not receive treatment in the absence of
either of these two factors).

I suspect, (although am certainly not sure) that this is coming from a
misreading of this (admittedly awkwardly-worded) statement in the
executive summary portion of the GUIDELINES:

"Clinical findings are sufficient for the diagnosis of erythema
migrans, but clinical findings alone are not sufficient for diagnosis
of extracutaneous manifestations of Lyme disease or for diagnosis of
HGA or babesiosis. Diagnostic testing performed in laboratories with
excellent quality-control procedures is required for confirmation of
extracutaneous Lyme disease, HGA, and babesiosis".

What I understand that to mean is that an EM ALONE, by itself...is
sufficient to render an appropriate clinical diagnosis of Lyme disease.

But I do NOT understand that to mean that an EM is the ONLY appropriate
indicator of a clinical diagnosis. In other words, my understanding has
always been that a physician may reach an appropriate clinical
diagnosis by observing an array of signs and symptoms, (in combination,
perhaps), and exercising his sound clinical judgment...including
serology...(but that for REPORTING requirements, the CDC surveillance
criteria must "confirm" the diagnosis).

This is what the CDC has been saying for years, and it is what Lyme
advocates USUALLY insist upon...that a physician can reach an
appropriate diagnosis in the absence of "positive" serology.

Again, from Dr. Mead's testimony:

"A clinical diagnosis is made for the purpose of treating an individual
patient and should consider the many details associated with that
patient's illness. Surveillance case definitions are created for the
purpose of standardization, not patient care; they exist so that health
officials can reasonably compare the number and distribution of "cases"
over space and time. Whereas physicians appropriately err on the side
of over-diagnosis, thereby assuring they don't miss a case,
surveillance case definitions appropriately err on the side of
specificity, thereby assuring that they do not inadvertently capture
illnesses due to other conditions".

And again, if I am understanding the LDA's apparent insistence that the
EM is the only appropriate indicator of a "clinical diagnosis"...look
at the clear language of the GUIDELINES:

"Clinical manifestations most often involve the skin, joints, nervous
system, and heart. Extracutaneous manifestations are less commonly seen
than in earlier years. Early cutaneous infection with B. burgdorferi is
called erythema migrans, which is the most common clinical
manifestation of Lyme disease".

So, what does a "clinical diagnosis" really mean in the context of Lyme
disease? If I understand the concept properly (and it has been
suggested that I do NOT)...there really is no way to answer that
question except on a case-by-case basis, depending on the facts and
circumstances of each individual case.

But I would urge that those those who seem to want to suggest that it
has some specific meaning, other than its ordinary and customary
meaning, when applied to Lyme disease, that they should consider if it
is really they who are now attempting to apply rigid and inflexible
diagnostic criteria.

There is freedom and flexibility in ambiguity, in other words.

For practical concerns, I would suggest you really need to realize that
what you are talking about is whether a person with a history of
tickbite, (no EM) symptoms suggesting infection and consistent with
documented clinical manifestaions, with a positive ELISA...(that's why
the blot would usually be taken)...should be treated in the absence of
a CONFIRMATORY Western Blot, interpreted in accord with CDC
Surveillance criteria.

That would be the usual situation where this consideration would apply,
if I understand properly.

Now, the clear meaning of the medical literture as I have previously
understood it (or thought I had) was that a "negative" western blot
should be interpreted to suugest a POSSIBILITY that the positive ELISA
might be a "false positive". But that should NOT end the inquiry or
"rule out" Lyme as a diagnosis. (And repeat testing to see if the
results are consistent should probably be performed, as well as
differential diagnoses).

In other words, iwhile a "negative" western blot might suggest to the
physician that Lyme might NOT be the cause of the patient's complaints,
after ruling out other possible causes of a "false positive"
result...the physician may well return to the Lyme diagnosis, and
render an appropriate clinical judgment and decide to commence
treatment...even in the absence of a "confirmatory" blot.

I think that is what they mean by "sound clinical judgment".

My answer...clearly, YES. That's an enirely appropriate diagnosis and
treatment...but it is NOT CONFIRMED. (And therefore, not reportable).

In any event, from a patient perspective, it would seem to me that the
critical thing from a patient perspective is whether in a
non-"confirmed", but suspected case, whether the physician then renders
treatment to the patient.

It would seem as though thte LDA is suggesting that the physician is
somehow mandated NOT to do so under these GUIDELINES...and I simply
cannot find justification for that assertion.

I am NOT trying to be argumentative here and am merely trying to
understand this issue.

If I am wrong...(it happens)...then I would SINCERELY appreciate anyone
who would like to tell how I am wrong.

But please, telling me that "I am not a scientist" is NOT helpful...(I
KNOW this)...nor is telling me that I have "reading comprehension"
problems without explaining why.

Please try to be specific?

Okay?

(Anyone want to talk about something other than who said what about
McSweegan's unit)?

.

Relevant Pages

  • Allen Steere NIH funding history
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    (sci.med.diseases.lyme)
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    (alt.support.mult-sclerosis)
  • Battle lines have been drawn over new clinical guidelines
    ... new clinical guidelines on spotting and treating Lyme disease. ... Infectious Disease Society of America are the "best that science has to ... cause the painful illness -- extends much past this period in patients ...
    (sci.med.diseases.lyme)
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