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Volume: 4
Issue: 18
Date: 20-Dec-96


Table of Contents:

I.    LYMENET: LymeNet Search Server Debuts on the Web
II.   LYMENET: Lyme Disease and the Eye
III.  LYMENET: Great Imitator Party report
IV.   EDITORIAL: NIH Contracts and the "Universal Fudge Factor"
V.    About The LymeNet Newsletter


Newsletter:

***********************************************************************
*                  The National Lyme Disease Network                  *
*                         LymeNet Newsletter                          *
***********************************************************************


IDX#                Volume 4 - Number 18 - 12/20/96
IDX#                            INDEX
IDX#
IDX#  I.    LYMENET: LymeNet Search Server Debuts on the Web
IDX#  II.   LYMENET: Lyme Disease and the Eye
IDX#  III.  LYMENET: Great Imitator Party report
IDX#  IV.   EDITORIAL: NIH Contracts and the "Universal Fudge Factor"
IDX#  V.    About The LymeNet Newsletter
IDX#



I.    LYMENET: LymeNet Search Server Debuts on the Web
------------------------------------------------------
Sender: Marc C. Gabriel, Editor In Chief <a229@lehigh.edu>


The LymeNet Search Server is now available on the World Wide Web.
The implementation of this system realizes another major goal of
the Lyme Disease Network.


The server is designed to allow individuals, physicians and
researchers to locate scientific and medical writings on specific
topics related to Lyme disease.  It currently contains over 3,500
references, most of which contain abstracts of the writings.  The
server will be updated monthly.


"Way back in 1992 we discussed the option of having an electronic Lyme
reference library," notes Bill Stolow, President of the Lyme Disease
Network of New Jersey, Inc.  "With the LymeNet Search Server, we have
taken a major leap in that direction.  This is yet another step in the
evolution to make the LymeNet the definitive information source for
Lyme disease."


To use the system, point your web browser to:  

                      http://search.lymenet.org/

LymeNet Newsletter Contributing Editor Frank Demarest spent
considerable time creating the computer scripts required to display
the abstracts in a proper format.  The system was in development for
two months.  


The Lyme Disease Network, which operates the LymeNet information
servers, relies entirely on individual donations to sustain their
operation.  If you find the LymeNet resources useful and would like to
contribute to their continued operation and development, please
consider a donation.  For more information, write to Bill Stolow at:
bill_stolow@lymenet.org  or visit the LymeNet Home Page at:


                       http://www.lymenet.org/


=====*=====


II.   LYMENET: Lyme Disease and the Eye
---------------------------------------
Sender: Phyllis S. Tysenhouse <ptyzen@gems.vcu.edu>


The following material was presented on September 28, 1996, at the
Conference, "Lyme Disease: The Current Issues", Dayton, Ohio, by
Lou Chorich, MD.  He is a Vitreo-Retinal Fellow at the Ohio State
University Medical School.  This is based on notes I took at the
conference, so I regret any omissions or errors that may have
slipped in.


Lyme disease is a challenge for ophthalmologists who may recognize
Lyme-related problems in any or all parts of the eye.  Ocular
inflammation is called "uveitis", which is derived from the Latin
word, uvea, meaning grape.  Lyme disease can cause conjunctivitis,
or "pink eye".  Uveitis may affect the anterior, intermediate, or
posterior portions of the eye.  Light sensitivity occurs if there
is much inflammation of the iris, the colored portion of the eye that
regulates the size of the pupil.  Inflammation of the iris (iritis)
causes photophobia.  Cyclitis is inflammation of the ciliary body,
which is made up of muscles that control the focusing ability of the
eye.


The retina and the middle layer of the eye are rich in blood vessels
which can carry Borrelia burgdorferi into the eye.  Normally, the
blood vessels in the eye are tightly closed, but if infection is
present, white blood cells, proteins, and lipids, leak out into the
aqueous, the gel-like substance that fills the anterior chamber.  
When these substances float in the aqueous, the patient is aware
of "floaters".  Dr. Chorich spoke of the "blood-eye barrier", which
is similar to the blood-brain barrier that restricts access of certain
substances to the brain.   So normally, bacteria and other substances
do not enter the eye.  Sometimes inflammatory debris collects on the
back of the eye and may stay there for a year.  This produces blurred
vision.  The cornea may even stick to the lens, preventing the pupil
from dilating fully.  Clouding of the cornea is called interstitial
keratitis.


The posterior chamber of the eye consists of a front and intermediate
part that is filled with vitreous.  White blood cells sometimes stick
on the collagen that floats in the vitreous.


Blurred vision may cause the patient to see double or see black spots
in the eye.  Elevated internal eye pressure can occur if inflammation
blocks the drainage channels of the eye, permitting fluid to build up.  
On the other hand, intraocular inflammation can even lower the
intraocular pressure because fluid is not produced in the eye during
inflammation.


Patients can get a Jarisch-Herxheimer reaction in the eye, causing
much inflammation.  This could lead to a detached retina from fluid
building up behind the retina.


Treatment of Lyme disease will relieve uveitis.  Some of the
antibiotics used are:


  Tetracycline and its derivative, Doxycycline
  Penicillin and its derivatives
  Rocephin IV (ceftriaxone)
  other cephalosporins


Concurrent use of steroids may be used to decrease inflammation.
If inflammation is not treated, permanent damage to the eye could
result.  Steroid therapy has been responsible for causing cataracts
and should be used judiciously.


Dr. Chorich recommended the article, "Ocular Manifestations of Lyme"
by R.L. Lesser in the American Journal of Medicine, vol 98 (4A), April
24, 1995, pp. 605 - 625.



=====*=====


III.  LYMENET: Great Imitator Party report
------------------------------------------
Sender: Ken Fordyce, The Lyme Disease Association of NJ
       <kenf@prinsep.com>


The Lyme Disease Association of New Jersey held the 6th Annual Great
Imitator Party on October 20, 1996 at Jenkinson's Pavilion in Point
Pleasant Beach. What a party!  Everyone's favorite Lyme DJ, "Mr. Bill",
powered the party, and "Dr. D and the Blues Brothers" (John Drulle and
Ken & Kirk Fordyce) brought a measure of hilarity to the day. (As
someone said, "Kerry, I think they should keep their day jobs!")
Seriously, this was one of the liveliest crowds in years, with almost
100 kids swarming around the temporarily energized adults (all of whom
had relapses for the next week). We were so pleased that some of
our "graduates" (kids who have grown up and gone off to college) came
back with their friends for the party.


We had bagpipes, costume contests (watches donated by Valdawn), door
prizes for the kids, food (donated by Jenkinson's) and drink (donated
by Pepsi), and special awards to Drs. Bayer, Pietrucha, Fallon, Drulle
and Eiras, as well as the Barnegat Bay Pipe Band.


The end result: exhaustion....plus substantial funding to go directly
into research (NO overhead to the LDANJ): $14,000 from party, raffle
and journal, a $5,000 grant, and a $2,000 donation specifically for
the work of Dr. Fallon - a total of $21,000 for research !


The best thing about this party is how everyone pitches in - some
before the party, and some on that day.  People who have only
communicated on the Net meet face to face.  It's a thrill.  Thank you
for all your help!!



=====*=====


IV.   EDITORIAL: NIH Contracts and the "Universal Fudge Factor"
---------------------------------------------------------------
Sender: Steven Gottschalk <RACEr91@aol.com>


There was a running joke amongst my fellow engineering students during
my college years. If you couldn't arrive at the answer your professor
was looking for, just add in the "Universal Fudge Factor". As humorous
as it was to us, I'm quite sure its use would have resulted in a
failing mark.


Apparently, the same practice that would have flunked me out of
engineering school is an accepted practice at NIH when it comes to
awarding scientific contracts.


BACKGROUND
----------
In June, 1996, the National Institute of Health (NIH) announced their
intention to award $4.2 million to Tufts/New England Medical Center
for a study on the use of longer term antibiotics for relieving the
symptoms of chronic Lyme disease.  Many in the patient community were
outraged at this selection.  They could not understand, and rightly
so, how the NIH could have selected a team of investigators to study
an issue that those same scientists have doggedly dismissed as
poppycock for many years.


Also outraged and crying foul was the primary competitor for the NIH
contract, State University of NY at Stony Brook (SUNY/Stony Brook),
a far more open-minded and credible bunch when it comes to admitting
the possibility of persisting infection (unlike the bunch at Tufts,
they have published articles proving the existence of persisting
infection).  Stony Brook was certain they had real evidence of foul
play in the selection process and embarked, with the help of Senator
Alphonse D'Amato's [R-NY] office, on making an appeal to the US
General Accounting Office (GAO). That resulted in a hold being placed
on the study and a hearing being scheduled by the GAO.  That hearing
has now taken place.


THE AWARDING PROCESS
--------------------
While I originally had had high hopes that justice would be served by
this hearing, the resulting decision by GAO to deny all aspects of
Stony Brook's appeal has taught me just how easy it is for those
in power at NIH to corrupt the scientific process and get away with
it.  To understand how easy it is, one must know a little bit about
how the NIH awards a contract of this magnitude.


First, a secret panel of esteemed scientists is selected by NIH to
review all submitted proposals and rate them. The scientists are
then instructed to review and rate the proposals on 3 categories,
weighted as follows:


  "Scientific and Technical Approach" (50 percent)
  "Personnel" (25 percent)
  "Facilities/Resources" (25 percent)


The scores for each of the above are tabulated and a total arrived at.
Then NIH awards the contract based on the ratings and recommendations
of that panel.


Sounds pretty reasonable so far, right?

THE SUPERIOR PROPOSAL WINS?
---------------------------
Specifically, in the case of the chronic Lyme extramural contract, we
now know that both Tufts and Stony Brook were scored equally at 79
points by the panel.  It was then up to NIH to break the tie, which
they did by selecting the lower cost proposal, which belonged to
Tufts ($4.2 million vs. $5.3 million).


This seems pretty reasonable, assuming of course, as I once did, that
the Tufts proposal was really better than or equal to the Stony Brook
proposal.  However, that is far from the truth.  You see, Stony
Brook's proposal actually OUTSCORED Tufts' proposal (Stony Brook
scored higher in the ONLY category that dealt with the quality of the
actual study design, that being "Scientific and Technical Approach").


This means that despite submitting a technically inferior proposal,
Tufts won the contract based on the panel's belief that their
personnel and facilities were superior to Stony Brook's.  Am I the
only one who sees a little hypocrisy here?  The very same scientists
who failed to devise a scientifically superior study are rated
superior?


THE SUPERIOR PERSONNEL?
-----------------------
To understand just how ludicrous this is, let's have a more detailed
look at the personnel involved.


The Tuft's team is led by Dr. Mark Klempner, who's credentials as a
researcher are quite good, but who has never, to my knowledge,
conducted a clinical trial.  Most troubling to me is that Dr.
Klempner privately stated to me in a telephone interview that 3
months of antibiotics is twice what he believes is necessary for
Lyme disease and that he does not know of ANY infection that can't
be brought under control with 6 weeks or less of antibiotics (he
apparently hasn't studied tuberculosis, syphilis, leprosy or
hepatitis B/C - and obviously never had a case of zits).  Is it just
me, or does it seem odd that a team which is led by someone with no
experience at running clinical trials and holds a distinct bias
against the purpose of the study he is supposed to be conducting would
be rated superior to one who's leader, Dr. Ben Luft of Stony Brook,
appears to be far less biased about persisting infection and has
experience at conducting clinical trials?


Another prominent figure on this team is Dr. Allen Steere, head of the
Tufts Lyme disease clinic.  His credentials are well known.  Dr.
Steere believes that Lyme disease is an overtreated and overdiagnosed
"fad illness".  For 21 years he has ridiculed, stepped on and
testified against those who believe differently than he does and who
treat outside his protocols.  His dogmatic denials of the benefits of
longer term antibiotic treatments make him the LAST person one would
want to have involved in a study that explores the value of such
treatment.  Furthermore, he is on record as stating that the very
study NIH just awarded to him would be a waste of money and would never
have come about if the scientific community had any say in the matter
(the money to study chronic Lyme disease was appropriated through
patient advocacy with the help of congressman Rosa DeLauro [D-NY]).


Rounding out the team are Drs. Gary Wormser, Arthur Weinstein and the
crew at Westchester Medical Center (WMC) in Valhalla, New York - the
primary site for patient selection, evaluation and treatment.  You may
recall them as the defendants in a $1.2 billion lawsuit for alleged
misconduct in the treatment of patients during the Connaught Labs Lyme
vaccine trials.  Their alleged failure to recognize a relapse of Lyme
disease in one of their patients resulting in his being confined to a
wheelchair or walker due to neurological damage.  They then,
allegedly, compounded their error by attempting to cover it up.  
Yeah, this seems like a superior place to conduct a clinical trial on
the diagnosis and treatment of patients with chronic Lyme disease, NOT!


And these people outscored the scientists at Stony Brook?  I find that
scary!


ARTFUL USE OF THE UNIVERSAL FUDGE FACTOR
----------------------------------------
One must ask themselves "how is it that a team of scientists who
produced an inferior proposal, could rate higher in the category of
personnel than one who produced a superior proposal?".  Knowing a
little about the teams of researchers involved and the quality of
their proposals, the only answer that makes sense to me is the
"Universal Fudge Factor."  Let's face it, the categories of "Personnel"
and "Facilities" are so subjective in nature that it'd be a piece of
cake to add in a little fudge factor to get the score you want.


So, let's say, hypothetically, that the secret scientific panel
includes a bunch of scientists like, say, Dr. Alan Barbour (rumored
to have been on the panel), who are friends of Dr. Steere's.  And
those people really want Dr. Steere's team to get the contract.  And
maybe someone high up at NIH suggests to these panel members that NIH
would be "more comfortable" working with Dr. Steere & Co.  Well, hey,
all they'd have to do is jack up Tufts' scores for personnel and
facilities so that the total score was equal to or better than
the Stony Brook score.


And if they did do that, who could ever question it.  The panel is
secret.  The minutes of their meetings are secret.  And what could be
easier to defend than how you scored a category which is based totally
on opinion and judgment?  Heck, why would anyone question the scoring
to begin with.  After all, the marks were arrived at by an elite panel
of PhD scientists.  And we all know that these people are tirelessly
devoted to truth and scientific fact. Right? RIGHT?


This is the largest and most important Lyme disease contract ever
awarded by NIH and their first effort ever to delve into the mystery
of persisting illness.  The NIH had a mandate, according to the GAO
hearings, to select the technically superior proposal regardless of
its cost.  In point of fact, they selected a technically weaker
proposal.  The scoring on personnel and facilities allowed them the
subjective latitude to create a tie.  They then justified the tie-
breaking selection by using the smokescreen of lower cost.  I believe
that NIH wanted this contract at Tufts and they found the loopholes
to make it happen (if you think this seems far fetched, read "Osler's
Web", by Hillary Johnson).


Whether I am correct in that assumption or not, one thing cannot be
denied.  The NIH has publicly admitted that they funded an inferior
study design due to its lower cost.  The NIH's actions display a very
callous disregard for the very things that they are supposed to stand
for - quality of science and commitment to public health.  The decision
process for a study of this importance is reprehensible.


EPILOGUE - PUTTING THE CART BEFORE THE HORSE?
---------------------------------------------
Many of you will be debating over the next few weeks about what the
Lyme community should do about this issue.  Before you get too hyped
up about switching the contract to Stony Brook, I'd like to pose a
question - Why are we conducting clinical trials of "longer term"
antibiotics when we have no reliable way of proving whether the
treatment used has provided a cure?  Doesn't that seem like putting
the cart before the horse?  Does anyone believe that treating chronic
Lyme patients with 3 months of antibiotics will tell us anything of
importance?


As much as I think Stony Brook has the better proposal, better
approach, better team and better facilities, the only thing our 4-5
million dollars will MAYBE buy us is the answer to whether 3 months
or so of antibiotics relieve symptoms based on neuropsych testing
and subjective ratings.  In the end, we will be no closer than we are
now to knowing whether the subjects' Lyme disease has been cured.
And we will then be arguing about whether patients should be treated
for longer than 3 months.


This money, in my opinion, should be used for research into better
testing methods, into animal studies of persisting infection, and into
pathological studies on humans believed to have lost their organs or
lives to Lyme disease to see whether spirochetes were involved in those
losses.


I believe we should do everything in our power to see that the
extramural chronic Lyme disease contract is rescinded and the money
used for better research projects.  And if the only choice we have is
Tufts or "goodbye money", the latter choice is the only one that I
find palatable.



=====*=====


V.    ABOUT THE LYMENET NEWSLETTER
----------------------------------
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LymeNet - The Internet Lyme Disease Information Source
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Editor-in-Chief: Marc C. Gabriel <a229@Lehigh.EDU>
           FAX (for contributions ONLY): 908-789-0028
Contributing Editors: Carl Brenner <cbrenner@postoffice.ptd.net>
                     John Setel O'Donnell <jod@Equator.com>
                     Frank Demarest <76116.2065@CompuServe.com>
Advisors: Carol-Jane Stolow, Director <carol_stolow@lymenet.org>

         William S. Stolow, President <bill_stolow@lymenet.org>
         The Lyme Disease Network of New Jersey
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