MORE SEX & Borrelia!

[Guest guest]

Friends/colleagues:

This post contains two parts: (1) summary of ability, sorted by sex of the

subject, of different screening tests to successfully pick up CDC-defined

Lyme cases (data from Feder's paper); (2) implications of clear findings of

SEX BIAS to call HALT to the use of the CDC surveillance criteria for Lyme

disease (logical goal).

SUMMARY OF SCREENING TEST RESULTS BY SEX OF SUBJECT (FASCINATING!!)

To summarize in a more succinct manner from my earlier post (i.e., see,

PLEASE READ! Feder, Borrelia & SEX) here are some fascinating statistics.

Keep in mind that the authors (Feder, Gerber, Luger, and --- an all guy

line up, I should point out...yes, equal opportunity in medicine is

bullshit...) tell us that ALL of the 32 patients " fulfilled the Lyme disease

national surveillance case definition of the Centers for Disease Control. "

There are 18 females, 14 males. 72% of the females reported EMs, 57% of the

males.

FOCUS IS THE SEX BIAS OF THE SCREENING TESTS FOR LYME DISEASE

IgG titer (positive = 1:320 or greater) missed 45% (8/18) of the females, 14%

(2/14) of the males.

IgM ELISA missed 78% (14/18) of the females; (13/14) 93% of the males.

IgG western blot (positve = 5 positive bands) missed 56% (10/18) of the

females, 21% (3/14) of the males.

IgM western blot (positive = 41 band, plus one among bands 18, 25, 31, 34)

missed 78% (14/18) of the females, 93% (13/14) of the males.

IgG titer + IgM ELISA missed 28% (5/18) of the females, 7% (1/14) of the

males.

IgG titer + IgG western blot missed 39% (7/18) of the females, 7% (1/14) of

the males.

IgG titer + IgM ELISA + IgG western blot missed 22% (4/18) females, 0% males

(0/14).

IgG titer + IgM ELISA + IgG western blot + IgM western blot missed 17% (3/18)

females, 0% (0/14) of the males.

SO, 17% (3/18) OF ALL FEMALE PATIENTS WITH CDC SURVEILLANCE CRITERIA LYME

DISEASE DID NOT HAVE A POSITIVE TEST ON ANY OF THE FOUR TESTS !!!! COMPARED

TO 0% OF THE MALES !!!

IF ONLY AN IgG TITER + IgG WESTERN BLOT IS USED (NOT AN UNUSUAL REGIMEN IN

DOCTORS' OFFICES), THIS MISSED 39% OF WOMEN (COMPARED TO 7% OF MEN) !!!!

IF A WOMAN WANDERS INTO A DOCTOR'S OFFICE WITH RECENT SX OF LYME (NO EM) AND

HER DOCTOR ORDERS JUST A LYME IgG TITER, FEDER'S DATA ON WOMEN WITH

DOCUMENTED CDC-DEFINED LYME DISEASE SUGGESTS THAT 45% WILL HAVE A NEGATIVE

TEST!!! (COMPARED TO 14% OF THE GUYS). AND, TYPICALLY, THESE WOMEN ARE LUCKY

THEY GET EVEN THAT. MANY DOCTORS WILL NOT EVEN TEST FOR IT.

FEDER'S DATA SUGGEST THAT EVEN IF A FEMALE PATIENT IS LUCKY ENOUGH TO WALK

INTO A DOCTOR'S OFFICE WHO IS WILLING TO DRAW OUT ALL THE BIG GUNS AND ORDER

EVERYTHING (AND RISK HAVING THE MEDICAL BOARD BREATH DOWN HIS/HER NECK FOR

ORDERING EXCESSIVE AND INAPPROPRIATE TESTS), 17% OF FEMALE PATIENTS WITH BONA

FIDE DISEASE MAY STILL NOT OBTAIN A " POSITIVE " TEST AND TREATMENT FOR THE

DISEASE BECAUSE *ALL* OF THESE TESTS ARE SEX BIASED, PARTICULARLY BIASED

AGAINST ACHIEVING POSITIVE TEST RESULTS IN THE FEMALE POPULATION WITH ACTIVE

LYME DISEASE. (NOTE THAT *ALL* OF THESE TESTS SHOWED SIGNIFICANT DIFFERENCES

BASED UPON SEX AS DEMONSTRATED BY FEDER'S DATA.)

SECOND PART: SEX BIAS IN LABORATORY TESTS AND THE CDC SURVEILLANCE CRITERIA

The destructiveness of the CDC surveillance criteria has been noted for

years. For at least the past 10 years, the Senate Committee on Labor & Health

has been calling on the CDC to change its criteria. Nothing happens.

Sex is incendiary. This might be enough to burn down the house. It's not as

incendiary as charges of race bias, but it might just be enough. If other

papers support interpretations of the data as can be ferretted out from

Feder's old publication, this could be enough. Clean. Simple.

Reminds me of strategies for bringing down the death penalty. Proving the

death penalty is arbitrarily enforced and used to kill innocent people is

enough to halt state killings. DNA evidence shows innocent people are killed.

That's enough. You don't have to get to the deeper, divisive questions. What?

Even Bush has called a moratorium?

Note that Feder's data suggests that the CDC criteria (as far as lab tests

go) is not fixable. Even if you routinely ordered ALL 4 tests simultaneously,

this regimen still missed 3/18 women with CDC-defined LD. This suggests that

there can be NO lab criteria for the diagnosis of Lyme disease. Heck, we all

knew that ...

If anyone has off-hand knowledge of other papers to re-analyze in this

fashion, let me know. Thanks.

Lynn Shepler, MD, JD

Addendum:

Note that if the tests were constructed with more of an emphasis on findings

in the IgM, males would be disadvantaged. In Feder's data, males were much

less likely to test positive on the IgM western blot or to test positive on

the IgM ELISA. If we lived in a world where you had to have a positive IgM

western blot to get treated, few guys would make the grade.