Dr. Joseph J. Burrascano, Jr.
1993 Senate Committee Testimony
(2-3 minutes long- posted by Lyme Spain)
Statement of J. J. Burrascano, MD 139 Spring Road, East Hampton, NY 11937
RECOMMENDATIONS
1. Require that more realistic reporting criteria be developed and be adopted by all states.
2. Require states to report all cases of Lyme, even if it must include active case detection.
3. Fund fully the Rocky Mountain Laboratory and support its research on better testing and studies on vaccine research and pathogenesis.
4. If standardized protocols for diagnosis and treatment are to be developed, then they should be devised in conjunction with practicing physicians and exclude the current inner circle of biased individuals, many of whom have their own private agendas.
5. Press for in-depth, multimsciplinary study of chronic Lyme, l»ifav» with an inpatient unit at NIH, but not under the direction of the arthritis branch (NIAMb), but under the branch designated to study infectious diseases.
6. Prevent third party payers from arbitrarily cutting patients off from needed therapy, as prescribed by their own attending physicians, and not allow some un- seen clerk or consultant who never cared for the patient to make decisions of upmost importance to the patient's health and future.
7. Investigate and curtail the secret connection between insurance companies and those so-called Lyme experts who oppose long-term therapy yet who are being paid by these same companies to perpetuate and publicize this view.
8. Stop harrasment by individual State health departments of physicians who manage Lyme aggressively, and when these physicians' practices come under criti- cism, ensure that judgment is made by their clinical peers, experienced in the clun- eal management of this illness, and not by non practicing individuals of lesser expe-rience ana knowledge. ,,.,.. i i A i_ •
9. Develop a forum for afflicted patients and their physicians to relate their experiences to the scientific community so research will be directed more appropriately.
[Slight edits to break up long paragraphs, clarify/adjust transcript bloopers, etc. were done to make it readable on this page. Content was not changed. LB]
STATEMENTS OF DR. JOSEPH BURRASCANO, JR., PHYSICIAN, EAST HAMPTON, NY; KENNETH B. PLATT, VETERINARY MICROBIOLOGIST, IOWA STATE UNIVERSITY, AMES, IA; DR. MATTHEW CARTTER, EPIDEMIOLOGY PROGRAM COORDINATOR, STATE OF CONNECTICUT, HARTFORD, CT, AND DR. ALLEN C. STEERE, PROFESSOR OF MEDICINE, NEW ENGLAND MEDICAL CENTER, TUFTS UMVERSITY SCHOOL OF MEDICINE, BOSTON, MA
Dr. Burrascano. Thank you very much for holding this committee 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 disease 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 attempt to personally aiscredit 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
55
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 promotes the ids* 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 infectious 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 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. Yet on the other hand, there is a great deal of scientific proof that persistent infection can exist in these patients because 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 recover, 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 livelihood.
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 ao 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 diagnosis 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, because I am stating these views publicly, for fear that I may suffer some repercussions despite the fact that many hundreds of physicians 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 unfortunately is both underdiagnosed and undertreated in this country to the great detriment of many of our citizens.
Let me address these individually.
56
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 curtailed 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 physicians who have reported a large number of cases have found themselves targets of State health department investigations.
Finally, too many physicians and Government agents rely on the notoriously 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 diagnostic 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 already 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 category 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 because the diagnosis is not being made properly in many patients.
Second, university-based and Government-endorsed treatment protocols 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.
57
Unfortunately, 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 dissatisfied, 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.
[The prepared statement of Dr. Burrascano follows:]
Prepared Statement of J. J. Burrascano, Jr., M.D.
CURRENT PROBLEMS IN THE LYME DISEASE FIELD
I began treating Lyme patients in the mid 1980's in an area said to the highest case rate of Lyme Disease in the world. I have personally seen and managed the care of several thousand patients with this illness, and patients have come to me from thirty eight states and eight countries.
Physicians from all around the world call me daily lor my advice, and my copyrighted guidelines for diagnosis and treatment, currently in its eighth edition 1 has been distributed world wide, and has been translated into three languages.
I have attended every major conference on this subject, and have presented original research papers at many of them. I do not receive any unreasonable personal gain for the treatments I prescribe.
I do not now, and never have accepted money from pharmaceutical or home care companies in exchange for my referrals, and I manage patients as I do because I believe it is the correct approach.
I came here today at my own expense because I take seriously this illness and the implications of thin meeting here.
THE LYME DISEASE CONSPIRACY
There is 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 attempt to personally discredit those whose opinions differ from their own.
58
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 from scientific seminars those with alternate opinions.
They behave this way for reasons of personal or professional gain, and are involved m obvious conflicts of interest. .
This group promotes 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 thirty days or less of antibiotics. .•■...
The truth is that Lyme is the fastest growing infectious illness m this country after AIDS, with a cost to society measured in the millions of dollars.
It can be acquired by anyone who goes outdoors, very often goes undiagnosed for months, ears, or forever in some patients, and can render a patient chronically ill and even totally disabled despite what this core group refers to as "adequate" therapy.
There have been deaths from Lyme Disease.
They feel that when the patient fails to respond to their treatment regimens, it is because the patient developed what they named "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 other than persistent infection.
As further proof, vaccinated animals whose immune system has been activated by Lyme, have never developed this syndrome.
On the other hand, there is proof that persistent infection can exist in these patients because the 1 month treatments did not eradicate the infection.
Indeed, many chronically ill patients, whom these physicians dismissed, have gone on to respond positively and even recover when additional antibiotics are given.
It is interesting 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 livelihood.
Some of them are known to have received large consult- ing fees from insurance companies to advise them to curtail coverage for any antibiotic therapy beyond this arbitrary thirty day cutoff, even if the patient will suffer.
This is despite the fact that additional therapy may be beneficial, and despite the fact that such practices never occur in treating other diseases.
Following the lead of this group of physicians, a few State health departments have evenbegun to investigate, in a very threatening way, physicians who have more liberal views on Lyme Disease diagnosis and treatment than they do.
Indeed, I must confess that I feel that I am taking a large personal risk here today by pub- licly stating these views, for fear that I may suffer some negative repercussions, despite the fact that many hundreds of physicians and many thousands of patients all over the world agree with what I am saying here. ^^
Because of this bias by this inner circle, Lyme disease is both underdiagno5e@@ and undertreated, to the great detriment to many of our citizens.
Let me address these points in more detail.
UNDERDIAGNOSE 1. Under reporting: The current reporting criteria for Lyme are inadequate and miss an estimated 30% to 50% of patients
Some states curtailed their active surveillance programs and saw an artificial drop in reported cases of nearly 40%, 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, many physicians never bother to report cases.
Some physicians who have reported a large number of cases have found themselves the target of State health department investigators.
Finally, too many physicians and government agents rely on the notoriously unreliable serologic blood test to confirm the diagnosis.
2. Poor Lyme Disease diagnostic testing: It is very well known that the serologic (blood) test for Lyme is insensitive, inaccurate, not standardized, and misses up to 40% of cases, yet many physicians, including many of those referred 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 diagnosed clinically, and can exist even when the blood test is negative. The Rocky Mountain Lab of the NIH, which is the country's best government laboratory for Lyme research, had developed an excellent diagnostic test for this illness nearly 4 years ago, yet further work on it has been stalled.
Incredibly, if not for private donations of just $5,000 from the nonprofit National Lvme Disease Foundation headquartered in Connecticut, then this research would have had to be abandoned.
An additional $30,000 was donated by this organization to allow them to continue other valuable projects relating to vaccine development and disease pathogenesis.
Yet, many physicians believe that thousands oT dollars of grant moneys
59
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.
3. The university and government based Lyme establishment deny the existence of atypical presentations of Lyme, and patients in this category are not being diag- nosed or treated, and ave no place to go to for proper care.
Results: Some Lyme patients have had to see as many as forty two different doc- tors, often over several years, and at tremendous cost, before being properly diagnosed.
Unfortunately, the disease was left to progress during that time, and patients were left forever ill, for by that time, their illness was not able to be cured. Even more disturbing, these hard line physicians have tried to dismiss these patients as having '.Lyme Hysteria" and tried to claim they all were suffering from psychiatric problems!
UNDERTREATMENT
1. Because the diagnosis is not being made, for reasons partly outlined above.
2. University based and government endorsed treatment protocols are empiric, in- sufficient, refer to studies involving inadequate animal models, and are ignorant of basic pharmacology. They are not based on honest systematic studies or on the results of newer information.
3. 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 fur- ther antibiotic therapy.
Unfortunately, Lyme patients are being denied such therapy for political reasons and/or because insurance companies refuse upon the arbitrary and uninformed advice of these physicians, who are on the insurance company's payroll.
4. Long-term studies on patients who were untreated or undertreated demonstrated the occurrence of severe illness more than a decade later, reminiscent of the findings of the notorious Tuskeege Study, in which intentionally untreated syphilis patients were allowed to suffer permanent and in some cases fatal sequelae.
5. The Lyme 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 lifecycle that renders it resistant to simple treatment strategies.
Therefore, to be effective, antibiotics must be given in generous doses over several months, until signs of active infection have cleared. Because relapses have appeared long after seemingly adequate therapy, long-term followup, measured in years or decades, is required before any treatment regimen is deemed adequate or curative.
6. When administered by skilled clinicians, the safety of long-term antibiotic ther- apy has been firmly established. The very existence of hundreds of Lyme support groups in this country, and the tens of thousands of dissatisfied, mistreated, and ill patients whom these groups represent, underscores the many problems that exist out in the real world oi Lyme Disease.
I ask and lead with you to hear their voices, listen to their stories, and work in an honest and unbiased way to help and protect the Americans whose health has is at risk from what has now become a political disease.
Thank You. Senator Wellstone. Thank you very much, Dr. Burrascano, and I do apologize again for the interruption. Your testimony is very important.
*Please take some time to read the testimony of some very caring, concerned and brave people that appeared before the Senate Committee that day. Their reports can also be found at the link above.
Thank you to Dr. Joseph Burrascano, Jr. and all of the other amazing people who worked and continue to work behind the scenes and in public to make things better for billions of people around the world.