LymeNet Newsletter Volume 4 Issue 18

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 <[email protected]>

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: [email protected] or visit the LymeNet Home Page at:

http://www.lymenet.org/

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II. LYMENET: Lyme Disease and the Eye --------------------------------------- Sender: Phyllis S. Tysenhouse <[email protected]>

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.

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III. LYMENET: Great Imitator Party report ------------------------------------------ Sender: Ken Fordyce, The Lyme Disease Association of NJ <[email protected]>

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!!

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IV. EDITORIAL: NIH Contracts and the "Universal Fudge Factor" --------------------------------------------------------------- Sender: Steven Gottschalk <[email protected]>

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.

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V. ABOUT THE LYMENET NEWSLETTER ---------------------------------- For the most current information on LymeNet subscriptions, contributions, and other sources of information on Lyme disease, please refer to the LymeNet Home Page at: http://www.lymenet.org ----------------------------------------------------------------------- To unsubscribe from the LymeNet newsletter, send a message to: [email protected] On the first line of the message, write: unsub lymenet-l ----------------------------------------------------------------------- LymeNet - The Internet Lyme Disease Information Source ----------------------------------------------------------------------- Editor-in-Chief: Marc C. Gabriel <[email protected]> FAX (for contributions ONLY): 908-789-0028 Contributing Editors: Carl Brenner <[email protected]> John Setel O'Donnell <[email protected]> Frank Demarest <[email protected]> Advisors: Carol-Jane Stolow, Director <[email protected]>
William S. Stolow, President <[email protected]> The Lyme Disease Network of New Jersey ----------------------------------------------------------------------- WHEN COMMENTS ARE PRESENTED WITH AN ATTRIBUTION, THEY DO NOT NECESSARILY REPRESENT THE OPINIONS/ANALYSES OF THE EDITORS. ----------------------------------------------------------------------- THIS NEWSLETTER MAY BE REPRODUCED AND/OR POSTED ON BULLETIN BOARDS FREELY AS LONG AS IT IS NOT MODIFIED OR ABRIDGED IN ANY WAY. ----------------------------------------------------------------------- SEND ALL BUG REPORTS TO [email protected] -----------------------------------------------------------------------