Rest of Complexities of Lyme disease by Tomas Grier

[Guest guest]

Source: www.canlyme.com In the Research section

Too often, I have seen the word cured used in Lyme Disease Studies,

only to find that the researchers have redefined the word cure to

mean seronegative. Seronegativity is not synonymous with cure. The

numerous culture positive cases in recent years should have negated

that kind of logic years ago, and yet, in 1997, researchers are still

publishing studies that use antibodies and PCR as the end point for

cure. It's time to ask the patients one simple question: How are you

feeling?

So, let's say hypothetically you are bitten by an infected tick, you

get a rash, you get sick, and you have a positive test. So you get 2-

4 weeks of antibiotics and you get better, but then you get sick

again. No problem! You go back to your doctor, and he says, " Well,

we'd better give you another Lyme test " - and its negative. Why? Even

though you have an active infection, the antibiotics cleared that

infection from your blood stream. That is where your immune system

is. The rest of the pathogens are hiding from the immune system

inside your joints, your tendons, and your brain. Only now you don't

have antibiotics to fight the infection, or any antibodies!

In a study by Dr. Musher, M.D., he looked at incompletely treated

Tertiary Syphilis patients, and compared them to those Tertiary

Syphilis patients who never got antibiotics. He found that the

incompletely treated group went into dementia faster.

Why? Because they had no natural immunity left. Their ability to make

sufficient antibody was diminished, because the antibiotics

eliminated the stimulus from the blood stream, but the infection was

still hidden in the brain! (35,61,62,65,74,83)

Conclusion: Lyme is an extremely complex disease that can cause long

term chronic infections. Patients can be seronegative, yet culture

positive (even after aggressive antibiotic therapy). The infection

enters the brain early in the infection (within days). The

sequestered bacteria within the CNS can be so different from the

initial infection that serum antibodies are ineffective. Incomplete

antibiotic treatment of Lyme Encephalitis can harm the patient.

Addendum 1:

The Final Note: Recently, there have been some very large educational

institutions that have maintained a strong position on Lyme disease

being easily detected and treated, with a high degree of success. Let

me site two such examples:

First, several state health departments, including the Minnesota

State Department of Health, have received mailings from Yale

University pertaining to Lyme Disease. (Reference: The Yale Medicine

Special Report by Marc Wortman, 1996 Yale Medicine Magazine pp.1-15,

May 15th, 1996) This report was sent to several health departments

throughout the United States who had received a CDC grant to initiate

a patient education program on Lyme disease.

In the table of contents,Yale describes themselves as being the " Lyme

Dream Team " . The " dream team " then goes on to recommend what to

do, " If you are bitten by a Deer Tick.... " .(Excerpts from page 11,

Yale Medicine, May 15th, 1996)

If you suspect the tick was attached for at least 36 hours, observe

the site of the bite for development of the characteristic skin rash,

erythema chronica migrans, (sic) usually a circular red patch, or

expanding " bull's eye " , that appears between three days and one month

after the bite. Not all rashes at the site of the bite are due to

Lyme disease. Allergic reactions to tick saliva are common.

Preventative antibiotic treatment is not necessary, is costly, and

may cause side effects.

If symptoms of later-stage Lyme disease develop - arthritic swelling

of a joint, most often the knee, or facial nerve palsy - have a test

done. If the test is positive, have a more precise test done. Only if

this test proves positive should a course of antibiotic therapy

begin. Expect some symptoms to linger up to three months. No further

antibiotic treatment is necessary.

Once the Minnesota State Health Department became aware of this

passage, the reprint was pulled from their educational literature

sent to Health Department Lyme Education Trainers. (A program

developed from a CDC grant.) The advice in this excerpt is in direct

conflict with the Minnesota Guidelines for the Treatment of Lyme

Disease. More importantly, in my opinion, it is bad advice that is

potentially dangerous to patients!

The passage inferrs that, if you have a tick attached for 35 hours,

you couldn't get Lyme. If you do have a tick bite and a rash, there

is no need to seek treatment - don't go to the doctor unless you have

late symptoms. The symptoms the Yale medical " Dream Team " deems as

important enough to go to the doctor are a severely swollen knee, or

Bell's Palsy. Even if you have these symptoms, but your ELISA Lyme

test is negative, you can't have Lyme and should not seek treatment.

If the ELISA is positive, you need to have a second confirmatory

Western Blot Lyme test. If this test is negative, you can't have Lyme

disease!

Let's review this medical advice:You are bitten by a deer tick, it is

attached for 35 hours, you get a rash at the site of the bite, you

develop late stage symptoms, you have a positive ELISA Lyme test, but

you shouldn't pursue treatment if a second test is negative!!

Apparently, antibiotic therapy is more dangerous than having late

stage disease!

If your doctor wants to take on the medical/legal risk of not

treating a positive tick-bite rash, symptoms, and a positive test,

then he is a very brave soul. In my opinion he would be at risk of

malpractice and could be held accountable for any irreparable harm

that occurs due to refusal to treat late stage Lyme symptoms with

antibiotics.

This article by Yale is an example of two erroneous prevailing

attitudes within the medical community about Lyme disease. First,

don't treat seronegative Lyme disease (even apparently in presence of

a rash, and late state symptoms, post tick bite), the test are

accurate. Second, once you treat with antibiotics, even despite the

persistence of symptoms, the patient is cured. The trouble with

relying on these two absolutes in Lyme disease is that they are

quickly dismissed by any case of seronegative Lyme, or a single

patient that is culture positive post-antibiotic treatment.

I would not want my reputation and credential dependent upon such a

flimsy foundation. If one example of seronegative Lyme exists, or

culture positive Lyme post treatment, it refutes everything these

institutions have insisted is true. (See two such references,

Lawrence & Masters.)

Why do these erroneous beliefs persist? Let me site my second example

of large educational institutions disseminating information to

doctors that supports these beliefs. The American College of

Physicians and Surgeons offers a teaching seminar to doctors on how

to diagnose and treat Lyme disease. Included is a VHS video tape that

has several vignettes of doctors dealing with patients with potential

Lyme disease. In every case, there is either a dependence on Lyme

testing - or, once the patient has been treated, they are no longer

capable of sustaining infection.

In my opinion, the absence of information about the accuracy of Lyme

testing, the incidence of sero-negative Lyme, and the possibility of

relapse post treatment, indicated to me that the tape is designed to

give doctors a method of dumping Lyme patients. In no case presented

is sustained treatment advocated, suggested, or advised. If symptoms

persist, the patient has either post-Lyme Syndrome, or needs further

testing, including a psychological work up, to find some other cause

for the patient's symptoms.

In my opinion, the advice on the ACP video is based on two wrong

conclusions: First, that serological Lyme tests are accurate. Second,

that active infection cannot persist post-antibiotic treatment -

therefore treating relapses with further antibiotics is unnecessary.

(Unless supported by further serum antibody testing.) In every case

that is presented, the doctor is given an opportunity to give up on

his patient before considering sustained antibiotics to treat the

persisting symptoms. It is a wonder that any of the patients are

diagnosed at all, considering the apparent lack of recognition of

even the most common Lyme disease symptoms.

Nowhere on the tape do I hear doctors asking about common and

frequent symptoms of Lyme disease, such as: stiff, crunchy neck,

visual complaints, heart palpitations, muscle twitches (especially in

the face), fatigue, depression, urinary frequency, and memory

problems. The only symptoms the educators seemed concerned about was

a history of a deer tick bite, a bull's eye rash, and swollen joints.

How can you make a clinical diagnosis if you don't know the most

basic of symptoms? The truth is, there is no effort made to make a

clinical diagnosis, except by an erythema rash. What is distressing

about using the rash as diagnosis is that, in the Vanderhoof study of

over 1000 chronic Lyme patients, it took on average 5.3 doctors to

diagnose Lyme even in the presence of a bull's eye rash. This same

study showed that a delay in treatment of more than a few months led

to a much higher incidence of relapse, or chronic symptoms.

The key to dumping a Lyme patient is how to write the patient's chart

to support a non-Lyme diagnosis. In no instance is the patient ever

asked how they are feeling, nor is the patient's response to

antibiotics ever to be considered as the end point of treatment. Once

again, the clinical picture is ignored in favor of either serology,

or a blind belief that all Lyme patients are cured with a few weeks

of treatment. But I as you what brought the patient to the doctor?

Symptoms! So, if the cure does not alleviate the symptoms, what good

has the short course of antibiotics done? I can understand why

treatment is discontinued in patients who feel cured, but when they

are still sick it seems unconscionable. In fact, I find that the very

same doctors who advocate short term treatment in Lyme disease,

rarely seem to follow the same protocol when they or a family member

gets sick.

I once had a discussion with an Internal Medicine Specialist, whom

I've known for ten years, about the length of treatment for his Lyme

patients. He was very vocal about how most Lyme is really

Ehrlichiosis, and that all Lyme patients get two weeks of

doxycycline, period - no exceptions. Except one. When I met him at an

airport that summer, I came to learn his son had been bitten by a

tick that spring. As a precaution, he kept his son on amoxicillin for

three months, even though he had no symptoms or rash! Yet his late

stage Lyme patients still receive two weeks of doxycycline.

Apparently the treatment for the proverbial goose is different than

for the gander! It is always difficult to refute large educational

institutions, and any individual doctor who tries may be jeopardizing

his career. An equally difficult battle is getting doctors who have

adopted these false tenets as absolutes to change their minds. It is

a difficult thing for a doctor to admit that his or her paradigm of

diagnosis and treatment is flawed and possibly harmful. The

revelation that perhaps hundreds of patients should have received

extended therapy could be an unsettling realization for many doctors.

The first hurdle is having to go against large teaching institutions

who have the full support of the NIH, CDC, or AMA.Then, there is the

second issue of having to confront previous patients.What does a

doctor say to a patient who really had a treatable illness instead of

MS? Any new change in diagnosis and treatment is a scary proposition

for most doctors if it means confronting failures. Few want to be the

vanguard force in leading that crusade, but the ones who do support

their patients are heroes.

While large institutions continue to disseminate their opinions and

view points to millions, it is a much smaller audience that the

opposition can address. Right now, doctors have to win their battles

one patient at a time, and in doing so they face persecution and

criticism.

Treating Lyme patient is not a profitable endeavor. Lyme patients

take too much time, require lots of counseling and education, and

often continue to return with symptoms despite aggressive treatment.

The physician who treats Lyme disease aggressively enters into a

controversial area of medicine. It is simply easier to avoid Lyme

patients than treat them, because, in treating them, they have to go

against all the major medical institutions who have declared only

their treatment protocols are acceptable. But let's look at the real

area of interest that large institutions have in not treating Lyme

disease - profit!

No profit in treating Lyme patients - treatment is a low yield

return. Today's clinics thrive on high profit, low overhead

procedures. It is much more profitable and less risky to do a fifteen

minute $600 EMG test for carpal tunnel syndrome than it is to

encourage Lyme patients to spend an hour in an exam. The net reward

per time spent is too small. Low overhead, low risk, high dollar

return is why hospitals focus on programs to combat smoking, weight

loss, drug rehabilitation, repetitive strain disorders, depression,

birthing centers, diabetes education, etc. How often do you see

hospitals seeking out quadriplegics, MS patients, ALS, and other

chronic disabling diseases? Many of these programs have to be

government subsidized before they are profitable enough for

institutions to take them on.

Every major medical research facility in the last few years has been

focused on two areas of research: vaccines and tests. While only

15,000 patients a year are reported as having Lyme disease (CDC

figures), hundreds of thousands are tested. By one institution's own

figures, they give 100 tests for every case they treat. Amazingly,

Olmstead County in Minnesota has yet to report a single case of Lyme

disease to the CDC. This means they have made their money by testing,

not treating. (Most tests are unnecessary, because Lyme disease,

according to the NIH, is a clinical diagnosis made on the basis of

symptoms.) Perhaps millions of people will be vaccinated with the new

vaccines. So, whoever owns that concession stands to make a fortune.

Addendum 2:

It used to be a dogma that you either publish or perish, but now it's

apply for patents or perish. The last four major announcements

of " new Lyme tests " were released as press releases before a single

study was published in any peer review journal as to the real

effectiveness of the tests. Institutions now compete with each other

for patents on tests. The real money is to own the test that is going

to be the new standard in medicine. This is why they publicize the

slightest advancement even before they publish. They want the

business before they are forced to compare their product to the

competition. None of these institutions want to tell you how bad

their test is they only want to tell you how much better it is than

the competition's.

Let me give you an example: the University of Minnesota tried to

develop a new PCR test for early Lyme detection. The PCR test is only

as good as the primers1 you use, and, if you won the patent with bad

primers, you are stuck. You either buy the rights to use someone

else's primers, or you use what you have. So, what do you do if you

have lousy test results? You don't compare them to the competition,

but rather with an easier standard. In this case, the University

didn't compare their test to other PCR tests, but instead compared it

to culturing. The abstract stated that patients with tick bite and

bull's-eye rash were only successfully cultured 4% of the time, but

the PCR was 18% positive therefore, the PCR test was four times more

useful than culturing. The trouble with this comparison is that most

labs can get 80% culture success, thus the researchers are setting

arbitrary standards to make the test look good. This PCR test is

actually four times less accurate than culturing, if the culturing is

done by a competent lab.

What nobody seems to question is that the bull's-eye rash indicates

100% of the test subjects were infected, and that this PCR test only

detected 18 out of every 100 tested! But no one wanted to summarize

the conclusion that their test was poor, and worse than the

competition. The newspaper headline read " New Lyme Test More Accurate

in Early Lyme. " More accurate than what??? It's all in how you

express your conclusion. This study, of course, was never published,

because peer review journals would have rejected it. Instead, an

abstract was presented at a rheumatology conference, and a press

release issued on what the press called " …a new and better Lyme

test. "

The trouble is that it's all hype, yet many doctors will read the

headline and think that this is a better test just because it is new.

The fact is that most new tests aren't better, they just represent

new patents, and have better press. Recently, the Minneapolis Tribune

published a press release from the U of MN on a new, FDA approved PCR

test for Lyme that used synovial fluid from an enlarged knee. In the

article, it gave the cost of the test, where to send it, and the labs

telephone number for people to make arrangements for sending in

samples. What the article implied was this was the best and newest

Lyme test available. What the article failed to do was compare it to

any other test, or to emphasize that most press releases of this type

are less than altruistic. The patients have become secondary in the

business of Lyme disease. The patients are tested, vaccinated, and

sent out the door in a rush to maintain rapid turnover. Complicated

patients that require treatment slows this process down, and

decreases profits.

The days of doctors going on house calls are a thing of the past.

It's not the doctor's fault, though. Monthly administrative meetings

within most large clinics look at profit and loss statements just as

though medicine were any other business. Administrators address

issues of income and expenses, just like any other corporation. If

patents on tests are profitable, that's what you do. If house calls

aren't, then that's what you stop. The formula is maximum amount of

money per hour versus least expenses per hour, with the least

possible risk. The net result is: tests are profitable, vaccines are

profitable, and treating Lyme patients is not profitable.

So, how do you justify not treating? You create treatment protocols

that fit the needs of the clinic and not the patient. Then, you put

the entire weight of the institution behind these protocols, and

intimidate everyone who disagrees. Let's put these protocols to the

test. If one sero-negative, culture-positive patient exits post-

antibiotic treatment, their protocols crumble. It is interesting

that, while most published studies supporting Lyme as a relapsing

disease of active infection are either position papers,

opinion/editorial pieces, or are based on that institution's own Lyme

serology tests! When an institution uses its own serology tests as an

endpoint for cure, the fox is definitely watching the hen house.

Serology cannot determine cure. EVER! Yet it is still being done! The

American College of Physicians and Surgeons has recently published a

newsletter, " The ACP Initiative on Lyme Disease, Vol. 1, Issue 1 " .

Which sites a recently published paper that uses serology as an end

point for cure, and has a short period of a few months as a follow

up. At no time were the patients symptoms assessed as the basis of

successful treatment. Instead, serologies were used as the

determinant (Reference: Cetriaxone (IV Rocephin), compared with

doxycycline for the treatment of Lyme disease. Dattwyler RJ, Luft BJ,

Kunkel MJ, Finkel MF, Wormser GP, Rush TJ, Grunwaldt, et al New

England J. of Med. 3373(5):289:294 July 31 1997.) The conclusion of

this paper was that a short course of doxycycline (the least

expensive drug known for treating Lyme disease) is as effective as a

short course of " costly " IV Rocephin.

It is quite a bone to throw to the health insurance industry by

saying all Lyme patient can now be treated a short period of time

with the least expensive drug, but is it true? Let's examine this

article and premise: At the 1993 LDF Conference, a study was

presented by Dr. Cameron, MD. In his study of more than 40

nursing home patients, he found that the relapse rate for IV Rocephin

for four weeks was 25%, but the relapse rate for doxycycline was 87%.

The difference in this study was that the follow up was 13 months not

three months.

In a six year, ongoing study using the population of Nantucket

Island, there was an interesting statistic that occurred involving

the use of IV Rocephin. Since the entire population of 5000+ on the

island went to only four doctors, it was easy to do long term

followups on patients who were treated for Lyme disease. What was

found was IV Rocephin had the highest rate of relapse, unless

followed up for several moths with oral antibiotics. This was because

the short duration of four weeks of treatment was inadequate to

prevent relapse. This was why 57% of these patients had documentable

relapses.

So, any current study that compares short-term doxycycline success

with IV Rocephin is comparing two inadequate treatments to each

other. Yet, the conclusion does not talk about total effectiveness it

simply states the two drugs are equally effective (or ineffective).

By not doing long filially to determine overall relapse rate, the New

England Journal study makes doxycycline look good.

The key to the Nantucket Island study, spotting the high incidence of

relapse, was in the length of the followup. The longer the followup,

the higher the relapse rate. Some have said that this high relapse

rate may be due to reinfection, but subsequent animal models have

shown this to be otherwise.

At the 1997 LDF conference, a study was presented using naïve beagles

as subjects. In this study, three groups of six beagles were studied.

One group of six was infected; using infected ticks, and treated with

four weeks of amoxicillin. Another group was infected and treated

with a double dose of doxycycline for four weeks.

The third group was the control. In the doxycycline treated group, at

three months post-treatment, it appeared that 100% were cured. But,

at two years at autopsy, five of the six (5/6) beagles were shown to

have active infection, or complete relapse. The key to uncovering the

high incidence of relapse was a long, two-year followup period. The

current study cited by the ACP totally ignored this experience

showing the necessity of long followup periods, and the fallibility

of antibody serologies used as end points to treatment, or as a

measure of affecting a cure.

A more basic study showing the inadequacy of doxycycline goes back to

1989, in an abstract from Austria. Here, the researcher incubated a

live culture of Borrelia burgdorferi with doxycycline for two weeks.

The culture appeared to be dead, as both motility and reproduction

had ceased. The culture did not have the appearance, however, of the

amoxicillin treated culture, which was filled with Lysed cells. So,

using micropore filters, the researcher filtered doxycycline treated

cultures, and separated the intact Borrelia from the supernatant. He

then washed them, and placed the filtrate back into fresh culture

media. Over two thirds of the cultures reactivated, becoming motile

and beginning to reproduce. It appeared that doxycycline immobilized

the bacteria by interrupting protein syntheses and metabolism. This

pushed the cells into a non-metabolic state. Since the doubling rate

is often used as a means of determining if the cells are alive, it

was assumed that the cultures were dead, when they were in fact just

dormant.

The most recent New England Journal study is deeply flawed, yet it

will have an immediate impact on the use of IV Rocephin. The design

of this study has ignored previous studies that show a long-term

followup is needed. It ignores the fact that the use of antibody

serology cannot be used as the endpoint for treatment, or for

determining cure. It does not use adequate methods to document the

presence of live bacteria. The study does not use the patient's

symptoms as a basis of cure. So, I ask, who has something to gain

from this kind of study?

It seems very coincidental that, in the past, paid medical advisors

on Lyme disease for the insurance industry produce study after study

showing that, in the short term, doxycycline is as effective as other

more expensive drugs. Once again, the basis of this study is a

dependence on serologies, and short-term treatments leading to total

cure. There are dozens of studies, case histories and abstracts,

which document sero-negative.

Lyme, and culture positive Lyme post-treatment. Yet, these studies

are being ignored. Today, major health institutions have backed

themselves into a corner, and are using their influences, economic

resources, and authority to make their view point the only viewpoint.

But do these physicians that disseminate this anti-Lyme point of view

really believe what they are promoting, or are they just defending a

position they have taken because they don't what to admit they have

taken a position which may prove to be wrong? The answer is in the

fact that most of these researchers have chosen to completely ignore

studies documenting active infection post-treatment, or sero-negative

Lyme disease. Instead, they only accept their own studies, using

their own antibody tests as endpoints for cure.

1. A PCR primer is a short piece of specific DNA that primes the test

to only amplify any matching DNA.

2. Naive means uninfected animals.