Sunday, March 20, 2011

7 1993 Senate Testimony On Lyme Disease, Part 1

A lot of Lyme disease patients have referred to Dr. Joe Burrascano's Lyme disease treatment guidelines over the years, and from time to time,  some will mention how Dr. B testified before the Committee on Labor and Human Resources of the US Senate back at the 1993 hearing, Lyme Disease: A Diagnostic And Treatment Dilemma - Examining The Adequacy Of Current Diagnostic Measures And Research Activities In The Prevention and Treatment Of Lyme Disease. (Y 4.L 11/4: S. Hrg. 103-285)

Curious on that last bit, for years I tried to track down his testimony in vain and was unable to find it online. Then, more recently I found the entire document on the internet archive site, found here:

http://www.archive.org/stream/lymediseasediagn00unit/lymediseasediagn00unit_djvu.txt

I also have a printed copy of the actual hearing notes in my possession to check against the online version for accuracy in transcription.

Part of why I wanted it was because so many people had mentioned his testimony but no one had actually posted it anywhere it had been mentioned, and searches online when I first got ill with Lyme disease left me empty-handed.

Now the mystery is solved. The bulk of the testimony that everyone kept mentioning without citing it was this (very minor grammatical and typo edits made - refer to original text above for comparison):


Dr. Burrascano. Thank you very much for holding this commit- 
tee meeting, and again, thank you for the very nice introduction. 

You have heard today that there are many problems in the field 
of Lyme disease, and I want to address one of the core problems 
that you may not be aware of. Some have called this the "Lyme dis- 
ease conspiracy." 

There is in this country a core group of university-based Lyme 
disease researchers and physicians whose opinions carry a great 
deal of weight. Unfortunately, many of them act unscientifically 
and unethically. They adhere to outdated, self-serving views and at- 
tempt to personally iscredit those whose opinions differ from their 
own. They exert strong, ethically questionable influence on medical 
journals, which enables them to publish and promote articles that 
are badly flawed. They work with Government agencies to bias the 
agenda of consensus meetings and have worked to exclude from 
these meetings and scientific seminars those with ultimate opin- 
ions. 

They behave this way for reasons of personal or professional gain 
and are involved in obvious conflicts of interest. This group pro- 
motes the idea that Lyme is a simple, rare illness that is easy to 
avoid, difficult to acquire, simple to diagnose, and easily treated 
and cured with 30 days or less of antibiotics. 

The truth, however, is that Lyme is the fastest-growing infec- 
tious illness in this country after AIDS, with the cost to society 
measured in the billions of dollars. It can be acquired by anyone 
who goes outdoors, and very often goes undiagnosed for months, 
years, or even forever in some patients, and can render the patient 
chronically ill and even totally disabled despite what this core 
group of physicians refers to as "adequate" therapy. 

They feel that when the patient fails to respond to their treat- 
ment regimen, which is a common occurrence, it is not because the 
treatment has failed, but because they have developed a new ill- 
ness, what they call the "post Lyme syndrome." They claim that 
this is not an infectious problem, but a rheumatologic or arthritic 
malady due to activation of the immune system. 

The fact is, this cannot be related to any consistent abnormality, 
but it can be related to a persistent infection. As further proof, vac- 
cinated animals now in the vaccine trials whose immune system 
has been activated by Lyme disease have never developed this post 
Lyme syndrome. Yet on the other hand, there is a great deal of sci- 
entific proof that persistent infection can exist in these patients be- 
cause the one-month treatment did not eradicate the infection. 

Indeed, many chronically ill patients whom these physicians 
have dismissed have gone on to respond to, positively, and even re- 
cover, when additional antibiotics are given. 

It is also interesting to me that these individuals who promote 
this so-called "post Lyme syndrome" as a form of arthritis depend 
on funding from arthritis groups and agencies to earn their liveli- 
hood. Some of them are known to have received large consulting 
fees from insurance companies to advise the companies to curtail 
coverage for any additional therapy beyond the arbitrary 30-day 
course. And this is even though the insurance companies do not do 
this for other illnesses. 

Following the lead of this group of physicians, a few State health 
departments have now begun to investigate, in a very threatening 
way, physicians who have more liberal views on Lyme disease diag- 
nosis and treatment than they do. And indeed, I have to confess 
that today I feel that I am taking a personal risk, a large one, be- 
cause I am stating these views publicly, for fear that I may suffer 
some repercussions despite the fact that many hundreds of physi- 
cians and many thousands of patients all over the world agree with 
what I am saying here today. 

Because of this bias by this inner circle, Lyme disease unfortu- 
nately is both underdiagnosed and undertreated in this country to 
the great detriment of many of our citizens. Let me address these 
individually. 
 
With underdiagnosis, the first problem is underreporting. The 
current reporting criteria for Lyme disease are inadequate and 
miss an estimated 30 to 50 percent of patients. Some States cur- 
tailed their active surveillance programs and saw an artificial drop 
in reported cases of nearly 40 percent, leading the uninformed to 
believe incorrectly that the number of new cases of Lyme is on the 
decline. 

The reporting procedure is often so cumbersome that many phy- 
sicians have never bothered to report cases at all, and some physi- 
cians who have reported a large number of cases have found them- 
selves targets of State health department investigations. Finally, 
too many physicians and Government agents rely on the notori- 
ously unreliable serologic blood test to confirm the diagnosis. 

That brings me to my second point, which is the poor diagnostic 
testing. It is very well-known that the serologic blood test for Lyme 
is insensitive, inaccurate, not standardized, and misses up to 40 
percent of cases; yet many physicians, including many of those re- 
ferred to above, and the senior staff at CDC and NIH, insist that 
if the blood test is negative, then the patient could not possibly 
have Lyme. This view is not supported by the facts. Lyme is diag- 
nosed clinically and can exist even when the blood test is negative. 

The Rocky Mountain Lab of the NIH, which is the country s best 
laboratory for Lyme research, had developed an excellent diag- 
nostic test for this illness nearly 4 years ago, but further work on 
it has been stalled. Incredibly, if not for private donations to the 
Government from the National Lyme Disease Foundation, this and 
other related research would have had to be abandoned. Yet many 
physicians believe that thousands of dollars of grant moneys al- 
ready awarded by the Government to other outside researchers is 
poorly directed, supporting work of low relevance and low priority 
to those sick with Lyme. In spite of this, their funding continues, 
and the Rocky Mountain Lab is still underfunded. 

The third point is that the university and Government-based es- 
tablishment deny the existence of atypical presentations of Lyme, 
as some of those you have heard today, and the patients in this cat- 
egory are not being diagnosed or treated and have no place to go 
for proper care. 

The result of all this is that some Lyme patients have had to see. 
in my experience, as many as 42 different physicians over several 
years before being properly diagnosed, and also at tremendous cost 
to themselves. 

Unfortunately, the disease was left to progress during that time, 
and these patients were left forever ill, for by that time the illness 
was not able to be cured. 

Under the second category of undertreatment, number one is be- 
cause the diagnosis is not being made properly in many patients. 
Second, university-based and Government-endorsed treatment pro- 
tocols are empiric, insufficient, refer to studies involving inad- 
equate animal models, and are ignorant of basic pharmacology. 
They are not based on honest, systematic studies or on the results 
of newer information. 

Third, after short courses of treatment, patients with advanced 
disease rarely return to normal, yet many can be proven to still be 
infected and can often respond to further antibiotic therapy. Unfor- 
tunately, Lyme patients are being denied such therapy for political 
reasons and/or because insurance companies refuse to pay for these 
longer treatments. 

Fourth, long-term studies on patients who are undertreated or 
untreated demonstrated the occurrence of severe illness more than 
a decade later, reminiscent of the findings of the notorious 
Tuskegee Study. We have to take this illness seriously. 

Senator Wellstone. Dr. Burrascano, I don't want to be rude, but 
we're going to ask all of you to try to keep within about a 5-minute 
time frame. 

Dr. Burrascano. I am on the last paragraph. 

Senator Wellstone. OK I apologize. We just want to make sure 
that everybody has a chance to testify. 

Dr. Burrascano. I understand. 

Finally, the Lyme disease bacterium spreads to areas of the body 
that render this organism resistant to being killed by the immune 
system and by antibiotics, such as in the eye, deep within tendons, 
and within cells. The Lyme bacterium also has a very complex life 
cycle that renders is resistance to simple treatment strategies. 
Therefore, to be effective, antibiotics must be given in generous 
doses over a long period of time, sometimes many months, until 
signs of active infection have cleared. Also, because relapses have 
appeared very late, decades of follow-up are required before you 
can say someone has been adequately treated. 

I have to close by saying the very existence of hundreds of Lyme 
support groups in this country, and the tens of thousands of dissat- 
isfied, mistreated, and ill patients whom these groups represent, 
underscores the many problems that exist out in the real world of 
Lyme disease. I ask and plead with the committee to hear their 
voices, listen to their stories, and work in an honest and unbiased 
way to help and protect the many Americans whose health is at 
risk from what has now become a political disease. 

Thank you. 

----------

Comments:

It's 2011. This testimony was given in 1993. That's 18 years ago. 18. 

What has changed since this testimony was given?

I think most Lyme disease patients with persistent symptoms can relate to the statements made by Dr. Burrascano, and the echoes of what he said there have become part of the history and undercurrent for patients in discussions about insurance not covering their treatment and their ire about the IDSA Lyme disease treatment guidelines.

In discussion with a few people who were infected with Lyme disease many many years ago, I heard their uncommonly held opinion that this statement by Dr. Burrascano was perceived by them as a poor move on his part - even if some of the statements said were true. In doing so, he had raised the gauntlet and his open criticism before the Senate led to a backlash from different quarters.

As an aside, I'd really like someone to confirm if what I've heard about the time before his testimony was true: Prior to Burrascano's speech, some insurance companies were paying in full for IV antibiotic treatment for some patients. It wasn't a consistent practice - but in some places patients were able to get many months of IV antibiotic treatment covered by insurance. Insurance companies trusted the doctor's individual judgment for those cases.

Today, it is almost unheard of that an insurance company will cover any IV antibiotics for Lyme disease - if one receives 30 days' worth as a patient, they are lucky. It's almost as it neuroborreliosis doesn't happen, but it can and does happen earlier than one might suspect, given the stages of Lyme disease of which many people are familiar - and IV antibiotics is what neuroborreliosis requires.

Regarding the reaction to Burrascano's testimony, according to the LDF - there was retaliation - though I do not know the full story nor do I have independent confirmation of it.  What I do know is that to this day, there is a history of ongoing investigation into doctors who treat Lyme disease with long-term antibiotics - either by insurance companies, state medical boards, or both.

How this got started and who was the first doctor to do it is something I'd like to know - it had to be someone before Burrascano.

I look at all of this and what I hear in the Lyme patient community today springs forth from this event, and before this, the LDF, and before this, the Polly Murray story. I wonder how things came to be as they are - and inexplicably, why it is they haven't changed more in 18 years.

And interesting to note some of the other testimony by others that day... Sure, many people are familiar with the difference of opinion exchanged between Burrascano and Steere later that session, but how many are familiar with statements made by other researchers and doctors that day?

In my next post, part 2, I'll be pulling some of the more interesting passages out of the testimony for examination.


Note: For those of you who are concerned about my being plagued by virus yet still posting anyway when I said the frequency would slow down - I'm not great but okay. Most of what I'm writing here is copy and paste and not requiring much brain power... So I can post then lie down. - CO

7 comments:

  1. Camp Other asks: "It's 2011. This testimony was given in 1993. That's 18 years ago. 18.

    What has changed since this testimony was given?"

    Burrascano said: "They feel that when the patient fails to respond to their treatment regimen, which is a common occurrence, it is not because the treatment has failed, but because they have developed a new illness, what they call the "post Lyme syndrome." They claim that this is not an infectious problem, but a rheumatologic or arthritic malady due to activation of the immune system.

    The fact is, this cannot be related to any consistent abnormality, but it can be related to a persistent infection. As further proof, vaccinated animals now in the vaccine trials whose immune system has been activated by Lyme disease have never developed this post Lyme syndrome."

    Not true:

    ACVIM (American College of Veterinary Internal Medicine) Small Animal Consensus Statement on Lyme Disease in Dogs: Diagnosis, Treatment, and Prevention 2008

    http://onlinelibrary.wiley.com/doi/10.1111/j.1939-1676.2006.tb02880.x/pdf

    See section 25 of document.

    ReplyDelete
  2. Hi Anonymous,

    Just had a chance to sit down and review the linked publication you cited.

    I'm not sure which part of the statement you are quoting that I should take as being not true - perhaps more clarification is needed on your end?

    Clearly there is a relationship between vaccines and an OspA immune reaction that is demonstrated in this publication (and has been demonstrated in others). If you are calling what the dogs have as being 'Post Lyme Syndrome' rather than a chronic and persisting infection, then you are correct.

    Interesting publication - it sounds like veterinarians are somewhat divided on whether or not to use Lyme disease vaccines on dogs (referring to Table 1. - Pros and cons of Lyme vaccination), especially if their serology for Lyme disease is positive but they are asymptomatic at the time.

    Other reasons were cited, too - so I recommend anyone who has a dog at home review this document for their own consideration in why one should or should not vaccinate their pet.

    There is concern by some of the veterinarians that some dogs will react poorly to the vaccines - as it was stated there, "Almost 30%
    of dogs with putative Lyme nephropathy had been vaccinated."

    And there was a further mention upstream that, "OspA hasbeen shown to be proinflammatory and sensitizing in rat and hamster models of Lyme arthritis, causing them to have more severe signs upon challenge or re-exposure."

    Statements made by various people at the Lymerix vaccine investigation indicated that it was thought the OspA in the vaccine triggered an immune reaction in patients with an HLA-DR4 haplotype. Oddly, if I recall correctly, about 30% of the population has this haplotype - which matches the percentage of dogs which were vaccinated and ended up with neuropathy.

    This bit relates to some of the murine model research I've read by Stephen Barthold: "Nonviable spirochetes trigger the production of inflammatory cytokines in dogs." The point of debate in the Lyme patient community now is whether or not those remaining spirochetes are, in fact, viable rather than nonviable.

    If they are viable, and can be shown to be viable even after antibiotic treatment - then this changes how the issue is approached by more researchers.

    Does anyone know if blebbing occurs in this small number of remaining spirochetes? Just curious if you know.

    I think more research is needed, including independent confirmation of studies already completed.

    ReplyDelete
  3. C.O. said, re the link to vet study:

    ****I think more research is needed, including independent confirmation of studies already completed.***

    It seems as if the author of that article think so also:

    Summary and Future Questions

    Many questions about Lyme disease in dogs and
    humans remain. Studies for the future that are
    recommended include the following:

    1. Elution studies to find the antigen(s) that are bound
    in the immune complexes associated with immunemediated
    Lyme-associated nephropathy or chronic
    synovitis.

    2. Experimental studies that use predisposed breeds
    (or certain lines) such as Labradors or Golden
    Retrievers instead of Beagles. If we can produce
    a model of Lyme nephropathy, we can study
    treatment protocols and whether vaccination protects, sensitizes, or aggravates it.

    3. Studies that use capillary-fed ticks artificially
    infected with Bb to identify the relative contributions of infections with Bb
    or other pathogensbecause field ticks used in previous studies were
    collected in New England and often were coinfected, especially with
    A phagocytophilum, possibly B microti, Bartonella spp.,
    and very rarely tickborne encephalitis virus.

    4. Studies of possible predictive tests in Lyme-positive
    dogs that will help indicate which dogs are more
    likely to become sick, such as evaluating circulating
    immune complexes, sedimentation rate, inflammatory
    mediators, or certain types of antibodies.
    A prospective study could be done on the relationship
    of the concentration of Lyme Quantitative C6
    antibody in asymptomatic seropositive dogs and
    the development of future signs of illness.
    Veterinarians should keep their minds open and reevaluate these questions in the years to come.

    ReplyDelete
  4. Camp Other wrote: "Interesting publication - it sounds like veterinarians are somewhat divided on whether or not to use Lyme disease vaccines on dogs (referring to Table 1. - Pros and cons of Lyme vaccination), especially if their serology for Lyme disease is positive but they are asymptomatic at the time."

    Actually, if you look at the Table, of the 45 veterinarian diplomats surveyed, only 2 recommend the vaccine. Thirty nine do not recommend, and 4 use it rarely.

    ReplyDelete
  5. Anonymous,

    You are correct. Of 45 veterinarian diplomats surveyed, only 2 did recommend the vaccine, 39 did not recommend it, and 4 rarely used it.

    Looking back on it, I suppose in writing my comment I probably wrote "some" because the table as written is somewhat ambiguous in presentation:

    Is 45 enough of a representative sample to extrapolate to the whole? Also, the left column of that table *also* said that *many* doses of the vaccine had been given since 1990 without side effects. How many is "many"? The body of the text prior to the table states that less than 2% of vaccinated animals experience adverse effects... now I'd hate to be a dog in that 2%, but I don't know how the veterinarians define a vaccine as being worth the risk in dogs versus humans.

    So I ran into a problem with characterizing the data. Perhaps using "some" was a snap judgment in my statement, but I think that this is one of the reasons more research on the issue is needed - this table is lacking specificity in numbers and more data are required.

    (It may be, also, that there were more specifics in the references list that I did not read which contributed to this table - in which case, the table was poorly designed to begin with as it should have made a more direct comparison in numbers if available from sources.)

    ReplyDelete
  6. Camp Other wrote: "Is 45 enough of a representative sample to extrapolate to the whole?"

    From the intro paragraphs of the document:

    "Consensus Statements of the American College of Veterinary Internal Medicine (ACVIM) provide veterinarians with guidelines regarding the pathophysiology, diagnosis, or treatment of animal diseases. The foundation of the Consensus Statement is evidencebased medicine, but if such evidence is conflicting or lacking, the panel provides interpretive recommendations on the basis of their collective expertise. The Consensus Statement is intended to be a guide for veterinarians, but it is not a statement of standard of care or a substitute for clinical judgment. Topics of statements and panel members to draft the statements are selected by the
    Board of Regents with input from the general membership. A draft prepared and input from Diplomates is solicited at the Forum and via the ACVIM Web site and incorporated in a final version. This Consensus Statement was approved by the Board of Regents of the ACVIM before publication."

    And:

    "The purpose of this report is to offer a consensus opinion of ACVIM diplomates on the diagnosis, treatment, and prevention of Borrelia burgdorferi infections in dogs (canine Lyme disease)... The ACVIM diplomates believe the use of Lyme vaccines still is controversial and most do not administer them."

    ReplyDelete
  7. Anonymous,

    All of the above still doesn't tell me what all the veterinarians are doing in their practices or what number = "many" vaccinations without any adverse effect. It only tells me that those 45 diplomats selected put forth this consensus statement and the Board of Regents approved it.

    I'm trying to look at the actual statements they made about the data and not just the conclusion they drew. How did most of those 45 conclude they should not use the vaccines on dogs? The consensus paper itself is missing data. I'm not saying I support the use of vaccines for dogs one way or the other - I'm saying Table 1 would be more informative if it offered more compelling data on both sides of the debate for and against vaccination.

    If your argument isn't about this and something else, please clarify it for me. Maybe I am missing your point.

    ReplyDelete

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