New York
Oversight Hearing
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
August 5, 1993
430 Dirksen, 10:00 AM to 12:00 PM
Joseph J. Burrascano, Jr., M.D.
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 They adhere to outdated, self-serving views and attempt to personally discredit those whose opinions differ from their own. 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 alternate opinions. They behave this way for reasons of personal or professional gain, and are involved in 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 30 days or less of antibiotics.
The truth is that Lyme is the fastest growing infectious illness in this country after AIDS, with a cost to society measured in the billions of dollars. It can be acquired by anyone who goes outdoors, very often goes undiagnosed for months, years, 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 one month treatment 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 consulting fees from insurance companies to advise them to curtail coverage for any antibiotic therapy beyond this arbitrary 30 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 even begun 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 publicly 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 underdiagnosed and undertreated, to the great detriment to many of our citizens. Let me address these points in more detail.
UNDERDIAGNOSIS
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 have found themselves the target of state health department investigators. Finally, to 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 percent 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 due to lack of funding. Incredibly, if not for private donations of just $5,000 from the non-profit National Lyme Disease Foundation headquartered in Connecticut, then this reaseach 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 of dollars of grant moneys 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 diagnosed or treated, and have no place to go for proper care.
RESULTS: Some Lyme patients have had to see, as many as 42 different physicians 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, insufficient, 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 further antibiotic therapy. Unfortunately, Lyme patients are being denied such therapy for political reasons and/or because insurance companies refuse to pay for longer treatment, 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 life cycle 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 therapy 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 of Lyme disease. I ask and plead with you 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 now has become a political disease.
Thank you. -
Joseph J. Burrascano, Jr., M.D. --
139 Springs Fireplace Road
East Hampton, NY 11937
(516) 324-7337
Oversight Hearing
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
August 5, 1993
430 Dirksen, 10:00 AM to 12:00 PM
Andrea Keane-Myers
In the summer of 1989 I contracted Lyme disease. I did not realize it at the time, but this disease has had an unusual and profound impact on my life. After enduring a summer's worth of discomfort at the mercy of a bacterium I became interested in microbiology and immunology. This initial interest has culminated in my working on the immune response to Lyme disease for my doctoral thesis in the department of Immunology and Infectious Diseases at the Johns Hopkins School of Hygiene and Public Health.
During that summer, I was residing in Salisbury on the Eastern Shore of Maryland. I was on summer break from the University of Richmond and was living at home with my parents. To earn money for college, I was working two jobs; one as a waitress in a local crab restaurant and the other as a secretary in a doctor's office.
By the beginning of July I had begun to feel fatigued and suffered from recurrent bouts of malaise and headaches. I ascribed these ailments to a combination of allergies and to "burning the candle at both ends" with my jobs and busy summer social life. I also noticed around this time a large rash on the back of my right knee with a red center and a lighter ring on the outside. It wasn't until much later that I associated the flu-like illness and the tell-tale stigmata of Lyme disease, or erythema migrans, and assumed that the rash was most likely caused by a spider bite. I left work one evening in the end of July because of feeling chilled and because my joints were so painful it was becoming difficult to pick up a pitcher of beer much left serve a whole table. I took some aspirin and went to bed and remained there for a few days too fatigued and sore to even think about moving around. The best description I can think of for the misery of acute Lyme disease is a combination of debilitating mononucleosis and severe arthritis in the knees and elbows. At this time, I noticed more of the strange ring-like rash had appeared on my trunk and lower extremities and decided it was past time to visit the family physician.
Dr. Mary Fleury is our family physician and is an internist practicing; in Salisbury. My symptoms suggested an almost textbook case of Lyme disease although Dr. Fleury was aware of only one other case in the Eastern Shore at that time. I did not remember a tick bite preceding the initial rash but had spent some time earlier that summer on Assateague Island. (A recent study done on Assateague had suggested that the majority of large mammals and Ixodes ticks had contracted the bacteria that causes Lyme disease, Borrelia burgdorferi). During the initial visit, Dr. Fleury suggested that I get tested for Lyme disease and prescribed ten clays of tetracycline. I was tested a week after I had begun antibiotic treatment. Not surprisingly the blood test came back negative, testing procedures tended to be poorly standardized at the time and often gave false negative results especially if done after antibiotic treatment had begun. The diagnosis was then and is now primarily based upon clinical findings.
My condition began to improve with antibiotic treatment and I finished the initial course of antibiotics. However within a few weeks I began to experience malaise, fever, and migratory arthritis again and returned to the doctor s office. She determined that the initial treatment was of insufficient duration and prescribed high levels of tetracycline (one gram per day) for a month. Once again my symptoms began to recede within a few days of treatment and I finished the course with no further relapses.
Thankfully I have not had any further symptoms since the second treatment. However, antibiotic treatment does not always prevent further complications and so I may still be at risk. I am not pleased with the prospect of having to live with chronic Lyme disease and sincerely hope better preventive and curative measures are developed in the near future. As a result of this experience, I have chosen a career in medical science and am currently working on my doctoral thesis at Johns Hopkins studying the immune response to the Lyme disease agent. Such information is essential to the formulation of a vaccine. With continued funding, I hope that this work will move forward and that we will soon have a cure for this perplexing and debilitating disease.
Oversight Hearing
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
August 5, 1993
430 Dirksen, 10:00 AM to 12:00 PM
Mrs. Karen Forschner
In 1985 our only child was born. Unfortunately I had a bug bite and the full range of Lyme disease symptoms while I was pregnant, and soon after Jamie's birth his symptoms started.
During the pregnancy and after the birth I was seriously ill with multiple problems including joint swelling and pain. Shortly after giving birth a doctor told me that my crippling pain was arthritis and a permanent condition, but he expected me to remain on crutches until I required a wheelchair. However, there was this mystery illness called Lyme disease, and the doctors offered me two weeks of antibiotics just in case. If my symptoms went away, then I was cured and I had Lyme disease, if my symptoms remained, I didn't, and I would be wheelchair-bound for the rest of my life. At the same time all five of our beloved pets, three cats and two dogs, became seriously ill and required repeated hospitalizations. As fate would have it, all of us had contracted Lyme disease at the same location and time. Eventually all of our pets were lost due to their Lyme disease.
Jamie was the light of our life, he had blond hair, blue eyes, was always smiling. By the time he was six weeks old, his health was in question. He had repeated vomiting and eye tremors. By six months old, he was showing signs of brain damage, eye problems, possible deafness, and had ceased to grow properly due to malnutrition. I questioned the doctors about whether my son could get Lyme from me during pregnancy, and they guaranteed me, absolutely, no.
To understand this disease and what it did to our family I would like to tell you what it did to our son's brain. The bacteria attacked the part of his brain that controlled his eye movements, causing his eyes to swing rapidly back and forth, to turn inward at times and outward at other times; and he became light sensitive. This caused double vision, motion sickness, inability to open his eyes outside, and blindness. Jamie's facial and tongue muscles were also involved, causing his face to be partially paralyzed and droop, which is like a Bell's Palsy, resulting in excessive drooling, loss of speech, loss of the ability to eat or swallow, and allowed food or saliva to go directly into his lungs instead of into his stomach.
Children and adults started staring at him. The loss of speech frightened him. Feeding him by mouth became life-threatening, as repeated lung infections set in, and eventually a partially collapsed lung resulted in multiple hospital stays. Jamie could not tell us that he was scared, that he had a headache, that he was hungry, or that he needed to go to the bathroom. Jamie became mute, malnourished, and frustrated. His hearing was affected causing the hearing test to show - another blow to us - that he was profoundly deaf. It was only then when his speech started that we realized that the test was wrong and had been influenced by the damage done by the Lyme disease bacteria. He indeed wasn't deaf.
Jamie's stomach was involved, causing repeated vomiting, and since he was too weak to lift his head, we had to worry that he was going to drown. Jamie's nerve conduction was affected, which delayed the innervation to the muscles. This caused him to lose muscle tone and he became floppy. This meant that he couldn't sit, crawl, or hold his head up, and he certainly couldn't feed himself. The devastating state of involvements that are known to be Lyme disease involvements made Jamie 100% dependent for life. Tests, probes, biopsies, all could not pinpoint the problem. When Jamie was one and one half, he had surgery to realign his stomach in an attempt to stop the life-threatening vomiting. The surgery didn't work, and our son had a permanent hole cut in his stomach so that he could feed through a feed tube. Indeed, we only really needed antibiotics.
Tom's company, a CPA firm, declared that Tom no longer had that little zip that they expected for partners-to-be, and let him go. Today the family leave bill would have protected him and given him time to set his home life more in place.
As Jamie approached his second birthday, we found ourselves unable to provide the medical care needed, and were told to institutionalize him, or put him up for adoption, as there are families who are set up to handle multiple handicapped children. I turned into our son's advocate, no longer listened to what the doc said, and started searching the medical literature, and I realized Jamie had Lyme disease, I had Lyme disease, our pets had Lyme diqease, and trans-placental transmission had already been published. We fell through somebody's crack.
Then a doctor saw permanent damage in our son's eyes, damage caused by a congenital infection, one just like Lyme disease. We tested positive, we were told we would be cured, we got some treatment, and my life was good.
Unfortunately it wasn't quite true, and our son relapsed. The meningitis in his brain had caused his head to enlarge to the size of a fourteen-year-old, his clothes no longer fit, we had to get specially adapted clothing. As a little boy, the head still has room to grow larger when it's a lot of pressure, and the only time we had to worry is when his head stopped having that ability to enlarge. When his relapses were in process, his throat would collapse, and he would spend time on life support. Indeed, our lives were a mess.
Media people saw this child as a great example for some sort of TV little blurb in sound bites. Indeed, I think that what we saw was a child that was courageous and might indeed help other people learn a little bit about this disease, and maybe, God forbid, yeah, maybe he might be able to get some funding from the government, so there would be answers before he would die. Indeed, when I saw what was happening, when Dan Rather had him on television and showed the story, not of what I saw was a courageous story, like the courageous stories here, but all of a sudden a story of what was termed "every parent's worst nightmare".
Indeed, he wasn't the worst nightmare, and we hadn't gone through the worst nightmare yet. Those words will always haunt me. And then the nightmare began. Indeed, he was on life support many times, and when he received treatment he would recover, his vision returned, his speech started, he started to feed by mouth, the vomiting stopped, he gained weight, his lips could kiss, and his arms could hug, but despite the dramatic and documented improvements, over the years local doctors and health officials would interfere repeatedly with our son's re-treatment. Indeed, it was an obsession to make sure that our little boy didn't get treated, because it was curable, and you didn't need to treat more than four weeks.
After attending a medical conference, I realized much information about Lyme disease was not reaching the medical community nor the public. Only limited information, that was acceptable, was reaching them, and with the help of researchers, business people, lay people, across the country, established the first organization dedicated to Lyme disease. Our mission was to provide an area where scientific information could be discussed, all areas, all avenues, not just one or status quo, but what exactly is there out there known that we can get to the truth with. I gave up my career, spent 70 hours a week for the last five years to volunteer at this organization. The sacrifices were great, as many people in this audience know. We used up our life savings in the process, we had no money left, our parents provided us with food, clothing. Santa Claus didn't come unless my mom and dad bought the presents. We were in a race against time.
Within two years we had reached 210 million people across the country, and Lyme disease had become a household word. Not because of two to three of us, or because of the Lyme Disease Foundation, but indeed because of the public. Much of this effort was due to this massive grass-roots education, and indeed I must say Senator Lieberman helped greatly, as did other senators and congressmen, who then decided to set up Lyme awareness week.
In 1990, NIH's new test that they had developed, which is not available to the public yet, photographed the bacteria in my son despite his repeated treatment, and not only him, but other people across the country, showing that short-term treatment, for a few people, may not ever work, and may not work at all. I was dismayed. When I showed this to the pediatricians, they said if we retreated our son, based on what they got from our local health department and our local people in the state, they would cancel us, and they canceled my son as a patient. We had no physician in the state, and we took our son to New Jersey.
Once he was retreated, all his speech came back again, and for the third time he learned how to speak. Muscle tone came back, vision came back, indeed they were able to show his intelligence was very high. He was mainstreamed into kindergarten. He developed girlfriends, went to birthday parties, and we finally found a little boy inside the diseased body. We waited over one year for NIH's tests to be released. We were hoping we could use it to check on our son's progress so that he wouldn't have a relapse and die.
As my son started to relapse, I waited, and waited, and I waited too long. Our son's last relapse came on, and he started having seizures and brain infection. Within 24 hours he was dead. His brain had swelled up so much it had killed itself.
There was no tissue bank in the country to send his autopsy stuff to, so before I went down to see him and make arrangements, I picked up the phone and I called around the country and found some places that they could take the tissue and study it. One of those places was, indeed, where we couldn't find the test, at Rocky Mountain Lab at NIH. And indeed, please remember that name, because those people are wonderful, and they need your funding, more than any other area.
They took his tissue, as well as some other places in the country, and were able to document that when he died he was still infected with Lyme disease bacteria. And at some point, his report, combined with other deaths due to Lyme, combined with other children with trans-placental information, may indeed, at some time in the future, have enough peer-reviewed publications that the CDC may indeed accept trans-placental transmission or death due to Lyme, in which case public health policy can be improved.
Insurance limits for us were used up at two million dollars. The final cost to society for our son was that amount, we all paid the price, through insurance premiums, government policy places and the like. If public policy was prevention-oriented, instead of antibiotic-hysterical, trying to prevent people from getting treated, my son would have been treated much sooner, and I would have been treated, and so would the people here have been treated. We're a society that waits for a disease to happen, and hopes like hell we can catch up, and that's not the type of society we want for the future.
Our public policy must dictate strong prevention programs. Thousands of us have worked towards finding the truth about this disease, we are hoping that the government will move forward past its status-quo seeking behavior. We are not asking what the country can do for us, we are asking what the country can do with us, and what you will stop preventing us from trying to do with you. We have worked for over five years, us and people in the audience, all together, most of the time, and find it's now time for a change, and we are asking for your leadership. I hope that by the time the baby I am carrying is born, there will be some effective coordinated program in the government, that can help prevent any other children or adults from getting this disease. Remember, all of your own states have the right tick now, and all of your own constituents can get this, and your grandchildren, and your uncles, and aunts, and nieces, could get this disease.
I'd like to close by saying one thing that will let you know that we have received a grant, as of two years ago, from the CDC, for public education, and wound up producing a bi-lingual educational video that went out to 9,000 schools, and as of this spring, over 3.5 million children have directly seen this video on Lyme disease and remember about it. Because of the partnership between ourselves and the CDC.
I thank you for the chance to talk and I hope that you will take this into consideration.
Thank you.
Oversight Hearing
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
August 5, 1993
430 Dirksen, 10:00 AM to 12:00 PM
Ruchana White (and son Evan)
Everybody helps when everybody knows everybody can get together and help. I want help now.
Until September 1990, Evan was the most popular boy in his class, an outstanding athlete, and an excellent student.
All of this changed, however, when Evan came down with flu-like symptoms. Because his area is endemic to Lyme disease, his doctor ordered that he be tested; the results came back positive. He was then referred to a pediatrician who specialized in infectious diseases and was started on a treatment of oral antibiotics.
Evan did not respond well to the medication. He had severe headaches and was unable to raise his head off the pillow. He was given the drug Rocephin intravenously and as a result developed gallbladder sludge. During this period, Evan never had a blood test nor did he receive treatment for his side effects.
Evan was referred to a pediatric neurologist who said that he was not medically ill; his sickness was psychological, despite the fact that the original blood tests which showed that he did indeed have antibodies to Lyme disease. His parents, obviously were confused: "You don't want to be sick when you're eleven, on the traveling soccer team, an excellent lacrosse player, and have many girl friends." However, they had placed their faith in the doctors and found it difficult to question their prognosis, As a result, mediation was stopped, and Evan began seeing a psychologist.
During the third month of psychological treatment, Evan's parents finally convinced the doctors that his illness was not "psychological": his head would fall to his shoulder, he was beginning to atrophy from head to toe, and his hearing had become so sensitive that the slightest noise was deafening.
The Whites went back to their original pediatrician who ran a complete battery of tests. it was then that they discovered that Evan's Lyme disease had "skyrocketed". Because there had been no treatment during the crucial part of his illness the disease had ravaged his body. The doctors were forced to admit that they did not know what to do.
In April 1991, the doctors placed Evan in a hospital and given the drug Claforan intravenously. He could not walk, would scream due to the severe pain of his headaches, and his speech was beginning to become unclear. Evan spent two weeks in intensive care during his two month stay in the hospital. During this time he also became desensitized to the Claforan.
That summer, Evan made many trips to the hospital. He was dehydrated and had to receive naso-gastric feedings. He was then sent to a children's specialist hospital in New Jersey. His great pain caused him to scream day and night. At this point, his parents described him as being "completely gone in body and mind"; he could only recognize his mother and father-- sometimes.
Evan has begun the slow road to recovery. He has attended the Helen Hayes Day Hospital for the past year and a half where he receives intensive rehabilitation five days a week. He has received multiple types of therapy: occupational, physical, speech, and acupuncture. The results of these painful treatments were evident by February 1992: he had strength in his hands.
His progress has been very slow but steady. His legs, arms, and head are much stronger now. He is able to get around with the use a walker. Although he can only speak a few words, his vocal chords have not; been damaged, nor has any other part of his body. He is much more aware of his surroundings. He has feelings and desires, and he wants very much to let the government know how catastrophic this disease has been to his life. He feels that there is a way out of everything and that there must be a way out of this as well.
Obviously, Lyme disease has had a devastating impact on Evan's life. Although he was one of the most popular boys in his class, he no longer has any friends. Classmates continue to call and to send post cards, but Evan refuses to see them until he is well. The trauma of watching Evan suffer has taken a toll on his older brother who is in college and his sister who is currently applying to medical school as well as researching Lyme disease. Fortunately, Evan's family has health insurance because his illness has so far cost over $2 million.
He has lost his education. He can no longer read nor write and has not attended school in over two years. School is difficult; he cannot identify words but sometimes something in a newspaper will jump out at him. He knows everything is locked away in the back of his head, but as of yet he is unable to find a way of accessing his knowledge: "Sometimes I feel like I am in a bubble, but just can't get out."
Evan communicates through hand gestures. Frustrated with his situation, he is often angry and irritable. He has no appetite; although he is five foot four inches, he weighs only eighty pounds. He suffers from insomnia. He enjoys watching television, but without any sound--any noise is deafening, even though he wears earplugs and headphones. His voice has changed and matured. "Help" is the word that he repeats most often.
Evan has many questions: "Why me? Why did this happen to me to make me so sick? Why is no one helping me?" He is aware that he is losing his childhood. He is now fourteen and wants to be a teenager and to play lacrosse and soccer and to have friends and to socialize. One day he would like to be a psychiatrist and a stand-up comic--he feels that he has plenty of experiences upon which to draw. He wonders how this is possible when he is chronically ill. He desperately wants others to know his story so that no more time will be wasted and that a cure will be discovered.
Oversight Hearing
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
August 5, 1993
430 Dirksen, 10:00 AM to 12:00 PM
Lyme Disease -- Controversy and Conspiracy
Five people shared their Lyme experiences at the Senate Committee on Labor and Human Resources hearing on Lyme disease, August 5, 1993.
New York Assembly Resolution 2155
2002 Legislative Session
WHEREAS, Considerable scientific controversy surrounds the diagnosis and treatment of Lyme disease and other tick-borne illnesses; and
WHEREAS, New York State has the highest number of reportable Lyme disease cases in the United States; and
WHEREAS, Insurance companies can and do file complaints with the New York State office of Professional medical Conduct against doctors who treat chronic Lyme disease, and have thus injected themselves into the debate; and
WHEREAS, Doctors whose practices are devoted to treating chronic Lyme disease patients, and who continue to provide treatment if they feel such treatment is medically necessary, have noted significant improvement in the condition of their patients; and
WHEREAS, a high percentage of doctors who treat chronic Lyme disease patients, and who continue to treat patients if they feel such treatment is medically necessary, have been investigated by the OPMC pertaining to their treatment of Lyme disease; and
WHEREAS, Tests for Lyme Disease are highly inaccurate and often are negative even when a person has Lyme disease; and
WHEREAS, The federal Center for Disease Control has not developed treatment guidelines for Lyme disease; and
WHEREAS, Patients in whom the disease is not caught early and who are not treated adequately can progress to chronic disease with infection of the central nervous system; and
WHEREAS, Hundreds of Lyme disease patients have contacted legislators, expressing their concern that the intrusion of the Office of Professional Medical Conduct into their personal physician's treatment protocol is having a chilling effect on their doctor's ability to provide successful treatment for them; now therefor, be it
RESOLVED, That this Legislative Body pause in its deliberations to request that insurance companies and the Office of Professional Medical Conduct cease and desist from targeting physicians who fall on one side or the other of this controversy, until such time as medical research and the medical community have determined the appropriate parameters for the diagnosis and treatment of tick-borne illnesses; and be it further
RESOLVED, That a copy of the Resolution, suitably engrossed, be transmitted to the Office of Professional Medical Conduct.
PASSED UNANIMOUS FLOOR VOTE BY THE ASSEMBLY ON APRIL 22, 2002
Lyme Disease Association
Pat Smith's Testimony to State Assembly
November 27, 2001
Thank you, Mr. Chairman and Members of the Committee. I wasn't too nervous until I heard a little bit earlier that you have two committee members from Queens. And my daughter lives in Queens, and I just wondered if you know something about the health of Queens that I don't know and I should know, as a mother.
Anyway, thank you for inviting us today. We appreciate the opportunity to talk to you about something that we consider to be very serious. I would like to also say I am the former Chair of the New Jersey Governor's Lyme Disease Advisory Council; I'm the former president of the Wall Township Board of Education; and I also sit on the Board of Directors of the International Lyme and Associated Diseases Society, ILADS, which is a professional medical society. The Lyme Disease Association is an all-volunteer national organization providing Lyme disease research, education and research funding. Along with an affiliate, the Greenwich Lyme Disease Task Force, the Lyme Disease Association is prepared to open with Columbia University a research center, an endowed research center at Columbia. We're working on the logistics right now.
Lyme is the fastest growing vector-borne disease in the United States, yet it is rarely given the weight that if deserves. The situation facing patient and physicians in New York is not unique; it mirrors the nation. Patients frequently cannot obtain diagnosis, treatment, insurance reimbursement, disability, education, or even understanding from their families and their peers. Treating physicians have faced a variety of licensure sanctions, including being supervised, fined, not allowed to treat Lyme patients, and license suspension and revocation.
In one of the earliest responses to Lyme problems, New Jersey enacted the first Governor's Lyme Disease Advisory Council in 1991. California and Rhode Island are following suit. Minnesota, Connecticut, New Jersey, and even New York, with their Tick-borne Disease Institute, and Pennsylvania have enacted or introduced legislation addressing issues from treatment and tick control to mandatory in-service for educators in the schools.
At the federal level, several pieces of legislation are before Congress. Additionally, in 1993, Senator Edward Kennedy heard a prominent New York physician testify in Senate hearings in Washington concerning the problems facing treating physicians, and I quote from his testimony: "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 I am taking a personal risk, a large one, because I am stating these views publicly," unquote. That doctor was later charged by the New York OPMC.
In other areas at the federal level, the United States Army Centers for Health Promotion and Preventive Medicine has developed has a pocket-size lab to test ticks in the field. Soldiers may receive immediate treatment if bitten by ticks that test positive for Lyme disease. Babesiosis and ehrlichiosis are also being studied by them. Tick populations are being mapped. Satellites are beaming the data to special prototype helmets worn by the soldiers in the field, allowing armies to maneuver around heavy tick populations. NASA and the NIH have a joint culturing project for Lyme disease bacteria using microgravity chambers, which mimic conditions in space and in the human body.
New York, with its highest reported Lyme disease cases, joins its contiguous states, Connecticut, Pennsylvania and New Jersey, constituting a block of the top four states in the nation in reported cases. Reported cases have to meet the Centers for Disease Control surveillance criteria. And what that is, is that a person has to have either a physician's diagnosed bull's-eye rash or positive bloodwork and other system involvement. So, the actual number of Lyme cases is estimated to be ten times higher than the reported cases. The Centers for Disease Control reports 3,626 Lyme disease cases in New York for the year 2000. That actually equals 36,260 actual cases for that one year alone. Nationally, in 2000, the reported number is 15,328, which equals 153,280 actual new cases for that year. According to the CDC, the surveillance criteria is not to be used for diagnosis, since patients often do not meet the strict surveillance definition. Despite the CDC warnings, many physicians use the surveillance criteria to diagnosis cases, and many insurance companies deny treatment to anyone not meeting those criteria. Excerpts from two Lyme protocols used by insurance companies seem to base coverage on the surveillance criteria, since they require symptoms supported by positive antibody response tests. And that's included in your packet.
Additionally, I just obtained yesterday a communication -- it was written in 1996, but the mail is a little slow these days, and I just received it. It was from the New York Department of Health to the Centers for Disease Control. And in that communication, the New York Department of Health indicated that if they followed the two-tier testing requirement for their 1995 cases, 81 percent of cases without rashes would not have been confirmed as Lyme disease. Insurance companies use graphs depicting antibiotic prescribing patterns and they often do not except doctor-prescribed testing such as PCR, which shows the presence of the DNA of the infecting organism, although PCR is accepted for other diseases such as HIV, hepatitis, TB and, I understand now, even anthrax. They limit treatment to 28 days, sometimes they substitute orals for IV, and they use the surveillance criteria for reimbursement determination. Therefore, our doctors face a tremendous dilemma: They have to treat sick patients who do not meet the surveillance criteria.
Privately, several doctors have revealed that their insurance carriers strongly suggested they either leave the plan or stop treating Lyme patients long term. A few continue to treat, some refer their patients to long-term treating physicians, while others, fearing reprisals or facing economic hardship, stop seeing Lyme patients. An insurance company letter to a New Jersey patient states, quote, "Unfortunately, a number of unscrupulous practitioners in this and neighboring states have held themselves out as experts in the treatment of Lyme disease. These individuals have subjected patients to improper diagnoses, excessive treatments, inordinately long courses of intravenous therapy, and other activities not support by science or generally accepted standards of medical practice. Because our organization has been appropriately vigilant and aggressive in dealing with certain practitioners, they have chosen to leave our network." I would say that's some choice.
At issue nationally to patients and doctors is the volume of complaints by medical boards against these treating physicians who already constitute a very small number overall. To address this situation in New Jersey, in 1993, Congressman Christopher Smith, who is now the chair of the Veteran's Committee in the House of Representatives, held a public Congressional Lyme forum. And last year, the New Jersey State Board of Medical Examiners met with Smith's office and -- which was followed by a meeting with the Lyme Disease Association and a Lyme-literate physician. The LDA has also held other meetings on the controversy with state health commissioners in Connecticut, Rhode Island and New Jersey, and we addressed the Pennsylvania House of Representatives majority caucus.
I also have with me today - it also arrived too late to be included, but it is in your packet - a letter from Congressman Joseph Pitts from Pennsylvania. He has one statement which reads, "We believe that Lyme disease is a scientific controversy and, consequently, medical boards should not prosecute physicians based on their long-term treatment of this devastating illness."
What we are trying to do is advocate a regional approach to the disease. Today's hearings are not without precedent. Besides Attorney General Blumenthal's Connecticut hearings, Texas recently held state Senate hearing on the harassment of physicians who treat Lyme. A recommendation from that hearing committee, quote, "Directed the Texas Board of Medical Examiners to develop review guidelines for doctors who provide medical care related to tick-borne illnesses," unquote.
In New York, we met with representatives from the OPMC, Health Department and the Governor's office, motivated by the fact that almost 60 percent of doctors who treat chronic Lyme disease in New York State have faced OPMC scrutiny the past year. At a meeting this year, OPMC reps said that "some of our best tips come from insurance companies." New York law prevents doctors from ever knowing the original complaint or complainant, thus treating doctors run the risk of spending tens of thousands of dollars defending their right to treat a patient, even when the patient has improved, the patient is not complaining, and the patient objects to his or her records being used against the doctor.
And I've included a letter of testimony Dr. Sowell, who is a patient, in the packet. In a letter from Congressman Smith to the New York Assembly Health Committee, he states, quote, "While it is the job of state boards of medical examiners to review complaints logged against doctors and to take action when needed, a concern that was expressed in my state was that some of the complaints were filed not by patients, but by insurance companies - and entities associated with them - who did not want to pay for the costs associated with treating Lyme patients under an aggressive antibiotic regimen. Using a state panel that is supposed to investigate malpractice to help achieve financial gain is simply wrong," unquote.
Additional concerns arose from the New York meetings when officials repeated assured that none of the charges against the New York physicians was related to Lyme diseases. We subsequently discovered the word "Lyme" appears a total of 41 times in the factual allegations against two of the doctors. A New York assemblyman who viewed the charges confirmed at the meeting with the Governor's chief counsel that the charges were, indeed, Lyme-related.
The Department of Health indicated it was not actively soliciting complaints against treating doctors. A patient letter suggesting otherwise details her call to the New York Department of Health and two subsequent calls to her from them. Only seeking information on Lyme and other tick-borne diseases, she was subject to her diagnosis being questioned, told to see another physician other than her own, received an unsolicited complaint form in the mail from the Department of Health, and was pressured to file a complaint against her treating doctor. The DOH told her that he and the DOH could attain anyone's records that they chose, including hers. She never filed a complaint; however, her medical records were pulled soon after the call, and she never heard from that doctor again. Her treating physician eventually faced charges.
Lyme disease is so complicated that physicians whose publications are often quoted to deny persisting infection have been shown to make statements that appear to be conflicting. Witness a 1990 response letter from a prominent rheumatologist to the Connecticut Department of Health. He refers to a specific doctor, quote, "treating these people with prolonged courses of antibiotic therapy ... patients have usually not required the prolonged courses of antibiotics suggested in his handout ... I think it is unfortunate that the Lyme Borreliosis Foundation and the doctors often associated with them have been become major spokesmen for Lyme disease. I believe they are the principal force leading to the overdiagnosis and overtreatment of this illness. Do you have any ideas regarding what to do about this," unquote. Coincidentally, the two physicians named in the letter by the rheumatologist were subsequently charged in their respective states.
In 1994, that same rheumatologist wrote to patients, "I would like to invite you to participate in long-term follow-up studies of our patients who have had Lyme disease. It has becoming increasingly apparent that the Lyme disease spirochete ... may persist in some patients for years. Of particular concern, recent studies have shown that the spirochete may persist in the nervous system in a small percentage of patients and may cause chronic neurologic involvement," unquote.
Before I close, I would like to take this opportunity, first of all, to present the committee with a little what I consider to be weighty evidence. In this book are the documents which we believe support the persisting infection of Lyme disease. It has already been presented to the Governor's office, and also I presented it to Senator Hannon in a prior meeting. And I would like to say that you obviously have the opportunity to view it or not and make your own judgments. However, the doctors in New York who are charged do not necessarily have the opportunity to present this evidence. They have told us that when they go before the hearing body, that oftentimes the evidence, which is peer-reviewed literature, is not accepted; they are not allowed to present it to defend themselves and their right to treat.
One other comment that I would like to make, and I guess this is -- I'm going to call this a hypothetical question. If, at this time, I were to announce right now that I'm the CEO with a major pharmaceutical company, I would ask you how that would make you feel about my testimony. Would you, perhaps, have selected someone else to testify today? Would you be going back now over my testimony to determine what weight you would now give it, as prepared (sic) to before, when you didn't think I was a CEO? The reason I'm bringing that up is, we determined in the meetings with the OPMC that they do not have a disclosure provision and so, therefore, the witnesses that are used against our physicians, they do not have to disclose any monetary gain that they may be receiving, which of course would obviously change your testimony. And I would also like to add for the record that I'm not the CEO of a major pharmaceutical company. And please let my husband know that, because he might wonder where I'm hiding the money.
Lyme is an enigma. While the debate rages over proper diagnostic and treatment procedures, patients get sicker and some even die. The rational answer to this medical and moral dilemma lies in a quote from Ansel Marks, M.D., J.D., who is the Executive Secretary for the Board of Professional Misconduct. In a letter to a Lyme patient who filed a complaint against a doctor opposed long-term treatment, Dr. Mark states, quote, "As defined by law, a difference of medical opinion in and of itself is not medical misconduct," unquote.
Thank you for your time.
Legislative Hearing on Lyme Disease
November 27, 2001
On November 27, 2001, hundreds of Lyme disease patients traveled to Albany, NY, to attend a New York State Assembly Health Committee hearing focusing on the issues surrounding chronic Lyme disease. Patients requested a proclamation from the Assembly that there is a legitimate scientific controversy with regards to Lyme disease and other tick-borne diseases and that, therefore, the OPMC (Medical Licensing board for NY physicians) should not be taking sides.
Members of the health committee on the podium were Committee Chair Richard Gottfried, Assemblywoman Nettie Mayersohn, Assemblyman Joel Miller, Assemblywoman Maureen O'Connell, and Assemblyman Michael Cohen.
There will be a hearing on OPMC procedures in general in NYC on January 31, 2002. This hearing will be about OPMC procedures and is expected to consist of legal and technical material. A number of groups have been pushing for OPMC reform based on lack of due process.
Many thanks to the Assembly, speakers, attendees and planners!!!
THANK YOU NOTES:
Please send thank you notes to the legislators who attended the hearing and were very responsive to the information presented. They did a huge service to Lyme patients, and deserve a big huge thanks! Also, it would be helpful to request a resolution from the entire Assembly stating that there is considerable scientific controversy as to the diagnosis and treatment of Lyme disease, and that, therefore, the OPMC should not be targeting doctors who fall on one side of the controversy. Those legislators are as follows:
Assemblyman Richard Gottfried, Chair, Assembly Committee on Health, LOB 822 Albany, NY 12248
Assemblyman Michael Cohen, LOB 834, Albany, NY 12248
Assemblywoman Nettie Mayersohn, LOB 746, Albany, NY 12248
Assemblywoman Maureen O'Connell, LOB 326, Albany, NY 12248
Assemblyman Joel Miller, LOB 531, Albany, NY 12248
HOWEVER, to send a thank you with a contribution to Joel Miller's campaign fund, please, instead, send to:
*Committee to Re-elect Joel Miller*, 10 Walker Rd., Poughkeepsie, NY 12603 (and make checks out to the committee to re-elect joel miller) Everyone who went to the hearing knows how much he has earned our support!!
WITNESS LIST:
Patricia Smith- President, Lyme Disease Association
Kenneth Liegner, MD- Physician, Associate Editor, Journal of Spirochetal and Tick-Borne Diseases
Alan Muney MD- Chief Medical Officer, Oxford Health Plans
Honorable Richard Blumenthal (Speaker phone)- Attorney General, State of CT
Steven Phillips MD- Physican; President-elect, International Lyme and Associated Diseases Society
Steven Schutzer MD- Asoc Prof of Medicine, University of Medicine and Dentistry of New Jersey
Brian Fallon MD MPH MEd (Video tape)- Columbia University Dept. of Psychiatry
Alan Barbour MD (Speaker-phone)- University of CA at Irvine
Carolyn Briton MD (Video tape)- Neurologist, Columbia Presbyterian Hospital
Marilynn Barkley MD, PhD- Researcher University of CA at Davis
Eugene Shapiro MD (didn't speak)- Yale Professor of Pediatrics
Carl Brenner- Columbia University, Member, Chronic Lyme Disease Study Committee of NIAID.
Robert Bransfield MD- Lyme Alliance Inc, Professional Advisory Panel
Jill Auerbach- Hudson Valley Committee for Lyme Disease Patient Advocacy
Howard Hindin DDS- Foundation for the Advancement of Innovative Medicine
Patients: Sarah Rude, Lia MaCabe, Joanna Amato
Evan White, Robert Clydesdale, Norman Rosenthal
TRANSCRIPT:
They are working on how the transcript will be available. It is possible it will be available on the Assembly website, or on CD. Otherwise, people would need to get paper copies. But all this will take some time, and as of January 17 they do not know yet how it will be available.
PARKING:
If you reserved a parking spot and have not yet paid, please send a check for $8.00 ASAP, made out to the Lyme Disease Association and mail it to:
The Lyme Disease Association
Pat Smith
PO Box 1438
Jackson, NJ 08527
888 366 6611
MEDIA:
http://www.insidealbany.com/index.html - Inside Albany, December 16, 2001
"Is there chronic Lyme Disease?"
http://www.insidealbany.com/order.html - To order video
Pre-event Press Release: pr.html
Pre-event Media Alert: mediaalert.html
Media Coverage:
"Insurers criticized for denial of Lyme treatment coverage"
"Group cites targeting of doctors who treat chronic Lyme disease"
"Lyme Disease Hearing to Draw Activists"
"State panel to focus on Lyme disease"
"Task force talks tick control options"
MATERIALS:
Flyer that was distributed is available at: hearingflyer.html
Single-page flyer, smaller font, is available at: hearingflyer2.html
The legislative notice is available at FAIM's website
The Grassroots announcement is available at: Lymenet's Flash Board (Link Expired)
History of OPMC Controvery: OPMC.html
Kay's website for the hearing: http://www.medialyme.com/OPMC%20hearing.htm
WRITTEN TESTIMONY:
All in the Lyme community are encouraged to submit written testimony. If you have prepared your testimony but have not yet sent it in, please send it in asap. Many thanks for everyone's hard work on this! Written testimony should be sent to:
ASSEMBLY COMMITTEE ON HEALTH
Richard N. Gottfried Chair
Lara Kassel
Legislative Associate
Assembly Member Gottfried's office
822 Legislative Office Building
Albany, NY 12248
518-455-4941
Fax: 518-455-5939
Legislative Hearing information
January 31, 2002
DATE: Thursday, January 31, 2002
TIME: 10am til late
WHERE: Assembly Hearing Room, 250 Broadway, Rm. 1923, 19th Fl., New York, NY
WHY: To investigate the disciplinary process of Physicians and Physician Assistants.
WHO: Hearing is being called by the NY Assembly Committee on Health, Committee on Higher Education, and Committee on Codes. All individuals, from across the nation, are encouraged to attend.
SUGGESTIONS: Please wear a green ribbon or Lyme shirt to indicate that you are a Lyme patient/supporter. Dress for the cold weather, you might want to wear layers. Print address and directions in advance. Arrive with Picture ID.
For general Lyme shirts or ribbon pins, contact Brite at: lymeinformation@yahoo.com .
Be sure to scroll to bottom of page so as not to miss anything.
Many thanks to everyone planning to attend or assist others in attending!!!
FAQ's
WHERE AND WHEN IS THE HEARING?
250 Broadway (on corner of Park Place), Rm. 1923, 19th Fl., New York, NY
10 AM Thursday, January 31, 2002
WHO SHOULD ATTEND?
As many Lyme disease patients as possible, no matter what state they live in. No one will be turned away from the building. Remember that the purpose for coming is to stand up and be counted.
This will be the last of the Assembly hearings on the OPMC. It is being held by not only the Health Committee, as in the previous hearing, but also by the Education and the Codes Committees which are also involved in licensing of physicians in NYS. It is essential that we show up in huge numbers to show these additional Assembly members and the media the numbers of people effected by the OPMC harassment of Lyme disease doctors.
DO I NEED TO SEND IN THE REPLY FORM?
The official hearing notice, as well as a reply form, are available at the FAIM website. According to Shay Bergin, Legislative Associate, although the reply form is not absolutely required for attendance, it is included so that she has a way to get in touch with people in case any changes are made regarding the hearing. If you have not sent in the reply form, that is fine. The important thing is to show up.
Notice: http://www.faim.org/OPMC%20hearing.htm
Reply Form: http://www.faim.org/OPMC%20hearing%20form.htm
ARE THERE ANY SPECIAL INSTRUCTIONS?
Please remember to bring a picture ID on the day of the hearing, since it is a government building. PLEASE WEAR A GREEN RIBBON, OR ANY LYME SWEATSHIRTS OR T-SHIRTS YOU MIGHT HAVE. We want to make it completely clear that the hundreds of people entering the building are there because of Lyme disease. Also, please sign the sign-in sheet.
I HEAR THE WORLD ECONOMIC FORUM WILL BE IN NY ON THURS.
ANY SPECIAL INSTRUCTIONS IN THAT REGARD?
SEE: (link expired)
WHAT CAN I EXPECT AT THE HEARING?
SEE: (link expired)
WHAT IS THE FOCUS OF THE HEARING?
The focus of this hearing is not on the Lyme scientific controversy as was the previous hearing (at which the legislators heard about 9 hours of science) but on the OPMC and how it has abused its power and ignored issues of legal due process. Although an anonymous poster has stated that the hearing will be on alternative medicine, this is NOT true. The hearing is on the workings of the OPMC, which has been our focus in NYS from the beginning. As the OPMC has also harassed physicians who treat alternative medicine, there will no doubt be testimony from them as well, but the focus of testimony at this hearing is the legal and technical issues involved in the workings of the OPMC, not specific information about medicine.
It is hoped that the hearing will lead to legislation on OPMC reform and, while that is definitely one of our goals, we have the additional goal of asking the Assembly to make an IMMEDIATE resolution SPECIFICALLY about the OPMC's harassment of Lyme disease doctors. As you may know, the OPMC has appealed and is trying to overturn the largely favorable decision in Dr. Burrascano's case. This is one reason that it is absolutely urgent that we show up in numbers to make a visual impact on the Assembly and media. We need to make them see that the OPMC's actions against our LLMD's are unacceptable and must be stopped.
HOW LONG WILL THE HEARING LAST?
There are over 10 hours of testimony scheduled, so it will go very late. We are hoping people will stay for the first 4 or 5 hours, and it is during the first few hours that they are expected to have the more interesting testimony.
CAN I BRING FOOD INTO THE HEARING?
We were initially advised that we are not allowed to bring food into the hearing room, although recently special arrangements have been made to allow some munchies into the room. There are restaurants all around the building, so we can go out to eat at any point and re-enter the building. There is a small stand in the lobby, but it apparently has mostly snack food.
CAN I OBTAIN UPDATES BY EMAIL?
Yes. Because of the amount of misinformation distributed prior to the last hearing, Ellen and Cheryl have developed an e-mail announcement group. This will include both our action alert and any significant information about Lyme disease that people might be interested in- trying to limit the amount to between 5-10 emails to you a week. If you would like to sign up for that, please send a blank email to lymeinfo-subscribe@yahoogroups.com and you will be automatically subscribed.
Rest assured, though, that all further announcements from us about this event will be widely disseminated on all the boards. Also, hearing information can be found on Cheryl's website at hearing2.html
HOW DO I GET THERE? WHERE CAN I STAY OVERNIGHT?
See the Travel and Hotels sections below
CAN I MEET UP WITH OTHERS ATTENDING?
To discuss travel arrangements with others, I suggest posting to the Lymenet Flash board, General Discussion Area.
IF I CANNOT ATTEND, HOW CAN I HELP?
Thank you for your interest! You can help by contributing to the legal defense fund for Dr. Orens. See legaldefense.html You can also distribute information about the hearing, as well as send in written testimony. See below. Also, several people are funding travel for others. This is greatly appreciated!
Thanks to all of you who write and all who will attend the hearing!!
WRITTEN TESTIMONY:
For those of you who have asked what you can do if you cannot get to NYC for the hearing, here it is. Almost all of us have stories from our own experience that can show the points that are asked for. This testimony is extremely important and is for everybody no matter what state you're in.
Instructions: http://www.faim.org/OPMC%20writtentestimony.htm
Deadline: 2 weeks after the hearing (Feb. 14)
DIRECTIONS TO HEARING:
250 Broadway (on corner of Park Place), Rm. 1923, 19th Fl., New York, NY
***For Traffic and Transit Reports, see: http://wcbs880.com/traffic/
***SPECIAL TRAVEL UPDATE:
The world Economic Forum, which atracts thousands of protesters, will be in Manhatten on Thursday. The streets that will be closed off are 46th to 54th from 2nd Avenue to Fifth Avenue. That is a big part of the East side of midtown, so those coming in to the city at Grand Central Station (which is on the east side) really do need to take the subway if they do not want to spend the rest of their adult years in gridlock traffic. Those coming in at Penn Station or Port Authority, which are both on the West side, would also do best to take the subway, the #2 Seventh Avenue train, to Park Place. However, if you come in on the West side and cannot take the subway because of health, expect the trip to take much longer than originally estimated and to cost more, but to at least be possible. The subway ride from each location is really not very long.
SUBWAY DIRECTIONS:
250 Broadway is on the corner of Broadway and Park Place. The building is directly across form City Hall Park. The building has a large sign on it called Duane Reed, which is the name of a pharmacy.
FROM GRAND CENTRAL STATION:
-Take the Downtown Lexington IRT line, the 4 or 5 EXPRESS train. The train is inside of Grand Central Station.
-Get off at the Brooklyn Bridge station. Get off at the Front of the train or when getting off walk towards the front of the train. Go up the stairs, turn right and go thru the turnstile. Go up the stairs on your right side to the street level.
-Go left along Chambers St. 1 block. Then you will be on the corner of Chambers and Broadway.
-On the corner of Broadway and Chambers cross Broadway to the other side. Walk downtown on Broadway to the next street, which is Warren Street.
-Cross Warren onto Murray St., cross Murray onto Park Place. You now are on the corner of Broadway and Park Place. You will see the Duane Reed sign and now enter in the main entrance of 250 Broadway.
FROM PORT AUTHORITY BUS STATION:
Walk to 42nd Street and 7th Avenue. Take the downtown Seventh Avenue #2 Express to Park Place.
FROM PENN STATION 34th STREET:
Take the Downtown 7th Ave., the #2 train. Get off at Park Place. (10 Stops.) You will be right on the corner of Broadway and Park Place. Enter the building on Broadway.
TAXIS FROM PENN OR GRAND CENTRAL STATION:
There are taxi stands outside of each station. Because you will be getting there during rush hour, the trip downtown might take half an hour and cost $10 to $15 (plus tip), divided between those sharing the cab. **NOTE: Due to the World Economic Forum, taxis are not recommended from Grand Central.
PARKING GARAGES:
The building of the hearing is 2 blocks from 911 Ground Zero making parking virtually impossible. Ask someone in the street if you're not sure of where to go. Also, a large portion of the East side of Midtown Manhattan will be closed to traffic. The area that will be closed to traffic is from 46th to 54th Streets between Second Avenue and Fifth Avenue. Enter via westside hwy, or if on the east consider using Queens-Midtown Tunnel or below. But driving not recommended due to extreme parking difficulties with parts of the city closed off.
GETTING TO NYC:
For Amtrak information, see www.amtrak.com or call 1-800- USARAIL. Greyhound bus info is available at www.greyhound.com. Inexpensive flights to NY available through Jet Blue, see www.jetblue.com , 1-800-JETBLUE, but does not cover all regions. For other regions, see www.southwest.com and www.priceline.com to make bids. For ground transportation to and from the NY airports, and passenger security tips, see http://www.panynj.gov/aviation.html. The 3 NY airports are JFK, LGA (LaGuardia), and EWR (Newark).
HOTEL INFORMATION:
**HOTELS NEAR HEARING:
http://www.ctc-manhattan.com/About/hotels.asp
MISC. HOTELS:
Try for one of the hotels from midtown or below, because the hearing is way downtown in lower Manhattan. All hotels will require either cab or subway ride to the hearing.
I have no experience with any of these hotels, but just passing along what I've found. Hope it helps! Two hotels worth considering are found at: www.cheapnewyorkhotels.com (1-877-897-4420). One is the Howard Johnson Express on 34th and 8th. This is a business area, but busy enough so that it is probably safe. (Near Penn Station) "Thirty Thirty" (Phone # 212-689-1900) is given the best value by the budget list. It is on Madison and 30th, a business area as well, but quieter, more pleasant looking, not a dangerous area. Both these hotels are listed at about $90 per night.
Hotels can also be found at: http://newyork.hotel-directory.com. The Ramada New Yorker, also on 34th and 8th, is $90/night.
**NOTE: Due to the World Economic Forum, we are suggesting that people stay below midtown. However, this paragraph remains for anyone who might still be interested.
For those who want to stay further north, one Lyme patient recommends the Wyndham Hotel, 42 W 58th St. between 5th and 6th Aves. (Phone # 800-257-1111) Quiet as NY hotels go if you get a back room. Some rooms are large enough to sleep additional people. Probably around $130 a night. Safe area and near a grocery and pharmacy. Near the Plaza hotel. For a good rate there is a Holiday Inn on 57th near 9th for $109. It is a bit west (less desirable), but not too bad. See http://www.sixcontinentshotels.com/holiday-inn .
Two more hotels have just been listed as special values at www.cheapnewyorkhotels.com Westpark hotel at 58th and Broadway has a great rate at the moment starting at $75.95 through the discount hotel site. It also lists the Pennsylvania hotel, with the same rating, on 33rd and 7th (Near Penn Station) also starting at $75.95.
For 2 night minimum stays, see expedia.com. For instance, there is a 2 night rate at the Amsterdam Court Hotel, W. 50th, for $89/night, and there is a 2 night rate at the Crowne Plaza at the UN, 42nd St., for $109/night. NY Hotels can also be searched at http://www.a1-discount-new-york-city-hotels.com/
Hotel Discount Rates #: 800-964-6835
ADDITIONAL WEBSITES:
www.a1-discount-new-york-city-hotels.com/
www.expedia.com
Broadway Inn .Com
http://www.hoteldiscounts.com- Hotel Discounts
PRESS RELEASE:
HANDOUT:
MISC:
Legislative Hearing- OPMC
January 31, 2002
Speaker List
Dennis J. Graziano, Director, OPMC
Don Berens, General Counsel, SDOH
(Also with them were Brian Murphy and Pat Cunningham)
Patricia Donnelly
Ilene Corina, Director of PULSE
Ralph Speken, MD
Pearl Korn
Leonard Joseph
Gerald L. Conway, Dir., Governmental Affairs, NYS Medical Society
Scott Todd, Committee for Justice
Dr. Charles Gantt
Mark Ungar, Exec. Dir. ADD Action Group
Al Cutler, Patient
Blair Horner, NYPIRG
Art Levine, Center for Medical Consumers
Monica Miller, Government Relations, Foundation for the Advancement of Innovative Medicine
Pat Smith, Lyme Disease Association
Andrew Cheng, MD, President Elect of the New York County Medical Society
John Hallowell, NYS Physicians Assistant Society
Andy Schafley, American Association of Physicians and Surgeons
Lee Marks, Health Plan Association
Sheila Frawley, Health Now
Hugh Campbell, Pres. NYS Trials Lawyers Association
Howard Teich, Esq.
Peter Barber, Esq.
Nathan Denbin, Esq.
Steve Lockwood, Esq.
Wilfred T. Friedman, Esq.
Joanna Amato
Leah McCabe
Norman Rosenthal
Robert Giordano (didn't speak)
Marcus Cohen
Mark Barnes, Esq. Health Law Section NYS Bar Association
Lyme Disease Association
Pat Smith Testimony
January 31, 2002
The Honorable Chairmen Gottfried, Sullivan, & Lentol, and Members of the Committees,
Thank you for inviting me today. Besides president of the Lyme Disease Association, I serve on the Board of Director of ILADS, International Lyme and Associated Diseases Society, a professional medical society, am former chair of the (NJ) Governor's Lyme Disease Advisory Council and former president of the Wall Township Board of Education.
The Lyme Disease Association is in all volunteer nonprofit 501 (c) 3 organization dedicated to prevention, education and raising funds for research for Lyme and other tick-borne diseases, TBD's. In March, with our affiliate, the Greenwich Lyme Disease Task Force, we will be presenting a check to Columbia for the establishment of an endowed research center for Lyme and other TBD's to be opened at Columbia University. (At this time, I invite Chairman Gottfried, Assemblyman Miller, and Assemblywoman Mayersohn to attend the opening celebration on March 21.)
Lyme is the fastest growing vector-borne disease in this country with New York State reporting the highest number of cases followed by Connecticut, New Jersey, and Pennsylvania. The Centers for Disease Control & Prevention, CDC, announced last week that cases increased by 8 percent in the year 2000. Reported cases represent about 1/10th of actual reportable cases. The Northeast region constitutes about 90 percent of the cases in the country. There are thousands of patients in these states that require doctors to treat them for chronic disease-symptoms that last longer then a typical 28-day treatment and may include ophthalmologic, cardiac, and central nervous system problems including seizures, depression, and psychiatric manifestations.
To prevent chronic disease, individuals must be diagnosed early and treated adequately. Lack of effective tests and physician education combined with the increase in other TBD's is contributing to late diagnoses and often, undertreatment. The CDC has criteria for Lyme disease meant for surveillance purposes only, not for diagnostic purposes. Many people do not meet the surveillance criteria set up by the CDC, but some doctors are only diagnosing using that criteria and insurance companies are often only paying for treatment based on those criteria.
Lyme literate physicians, LLMD's, often treat patients who do not fit that surveillance criteria, and therefore, they frequently find themselves in the difficult position of battling with their insurance providers and also with their state licensing boards. LLMD's generally base their treatment regimen on clinical findings and sometimes use testing to support those findings. In NY, a small number of physicians are willing to take the risks associated with treating chronic patients, and we estimate that 60% of our LLMD's have been investigated for treatment practices by the OPMC.
New York, recognizing the significance of clinical practice issues states that in clinical practice cases, "Experts may be made available by the state medical society of the state of New York, by county medical societies and specialty societies, and by New York state medical associations dedicated to the advancement of non-conventional medical treatments."
The law does not, however, define "expert," so individuals who have little or no clinical experience treating chronic Lyme disease can be called to testify as experts in cases involving physicians treating chronic Lyme disease. Plus, the OPMC process does not include a disclosure mechanism for the expert witness or discovery proceedings. Thus, witnesses who may have significant vested interests may provide information to an OPMC committee or testify against doctors without ever disclosing these interests unless or until the doctor's attorney elicits them during the hearing. Since no discovery proceedings are available, it can't be determined if, for example, an expert against the doctor may have used the exact same practice or procedure for a patient in the same circumstance in his own practice, yet he is now testifying against the doctor for that same practice-a circumstance, which we know, has already arisen.
The initial interview the doctor has with the OPMC is an extremely important one in the process. This meeting is the basis for the determination of charging or not charging the doctor, yet no official transcript is kept of that meeting, thus, the doctor's attorney has no way of subpoenaing the record of this interview, if said interview results in the doctor being charged. An official transcript should be made of this meeting.
In clinical practice cases, the role played by supportive evidence is crucial. Currently, in New York State, evidence is only admissible after two tiers are satisfied. First, the hearing officer rules whether evidence is/is not admissible. Second, if evidence is ruled admissible, upon cross-examination, the state expert is asked to recognize the authoritativeness of a particular journal. That same expert has usually been involved in making the initial recommendations that the doctor be charged, and now he/she is deciding on the evidence to be admitted. If he/she refuses to recognize the journal, it cannot be admitted as evidence. In one instance, evidence was allowed to be introduced in a case in defense of the doctor, yet in another case, the same evidence was not allowed to be entered. The first doctor was able to support his practices and was vindicated on most charges, while the second doctor was unable to admit the same evidence and his case was not so favorably disposed. There is existing federal case law, which New York does not recognize, that says the judge may take judicial notice and allow the literature to be presented. A summary of the case is included.
Due Process is often an issue. The Federation of State Medical Boards states on its website "Whatever the complaint, physicians are afforded the rights of due process as the board investigates a complaint of misconduct. The tenants of due process state that an individual is innocent until proven guilty and apply to formal hearing/judicial procedures, which the medical board carries out by following established rules and principles, to ensure that a physician is not treated unfairly, arbitrarily or unreasonably." It seems that the literature standard results in unfair treatment of certain doctors since "hostile" experts solely determine which particular peer reviews qualify as evidence.
Rules of evidence, such as bringing in outside evidence such as decisions from another case, need to be modified. Currently, precedence is not set, so that the hearing committee may conclude in one case, for example, that Lyme disease is indeed mired in scientific controversy and should not be the basis for OPMC investigation, yet the next doctor can be similarly charged and may not be able use that previous finding.
Secrecy surrounding the process should be examined. Currently, doctors are never told the original complainant or complaint. It puts the doctor in the position of not being able to confront his/her accuser. While some secrecy is understandable, the legislature might consider a more equitable practice, perhaps following New Jersey's example with a form which clearly states on the application cover letter that "a copy of the complaint will be forwarded to the licensee with a cover letter from the Board requiring a detailed written response to the allegations in the complaint.. the complainant should understand that any information supplied on the complaint form may be subject to public disclosure." Another option is to have the OPMC use a form, which states that all complainants and complaints will be released to the doctor unless the complainant specifies why that disclosure could be harmful to him/her.
At the least, complainants could be separated by category, e.g., patients, insurance companies, peers, other entities. Patient complainant identities could always remain confidential if that is felt necessary, but other complainants would need to give a reason if they felt their identity should be kept secret. A peer's reason to remain anonymous could be evaluated by the OPMC and a determination made based on the reason(s) provided. Insurance companies or other entities most likely to have vested interests could be identified immediately to the charged physician and hearing committee. As expressed in a letter addressed to Assembly Health Chair Dick Gottfried by Congressman Christopher H. Smith, Chairman of the US House of Representatives Veterans Affairs Committee, "While it is the job of state boards of medical examiners to review complaints logged against doctors and to take action when needed, a concern that was expressed in my state was that some of the complaints were filed not by patients, by but insurance companies (and entities associated with them) who did not want to pay for the costs associated with treating Lyme patients under an aggressive antibiotic regimen. Using a state panel that is supposed to investigate malpractice to help achieve financial gain is simply wrong."
Secrecy has also perpetuated some questionable viewpoints. Officials have been publicly adamant in the cases of several of our treating physicians who were charged that the charges were unrelated to Lyme disease treatment. A few advocates, including me, and some NY assembly people attended a series of meetings with OPMC, health department, and other NY State officials. We were repeatedly told at these meetings that the Department of Health was not targeting Lyme doctors, nor were they soliciting complaints against them, and that charges against them were unrelated to Lyme disease treatment.
According to an NY assemblyman present at the last meeting we attended, the charges are indeed, directly related to Lyme disease treatment. We also subsequently discovered the word "Lyme" appears a total of 41 times in the factual allegations against two of the doctors. As for not soliciting complaints, a patient letter suggesting otherwise details her call to the NYDOH and two subsequent calls from them to her. Only seeking information on Lyme and other TBD's from the DOH, she was subject to her diagnosis being questioned, told to see another physician other than her own, received an unsolicited complaint form in the mail from the DOH, and was pressured to file a complaint against her treating doctor. The DOH doctor told her that he and the DOH could obtain anyone's record that they chose, including hers. She never filed a complaint; however, her medical records were pulled soon after the call, and she never heard from that DOH doctor again. Her treating physician was eventually charged, despite the fact that the patient never filed a complaint against him. (What concerns me about this morning's testimony relating to whether the OPMC solicits doctor complaints is that they appear not to be aware of what their employees are doing. I brought the above example to their attention at the first meeting in New York with health department and OPMC officials and Assemblypeople. Now at today's testimony, the OPMC indicated in response to Chairman Gottfried that the individual(s) mentioned have not been disciplined, despite the fact they appear to have violated the confidentiality of that doctor. They not only told a patient on the phone that she should file complaints against her doctor, whose indentity she had not revealed according to her, but also told her that other complaints had been filed against her doctor, which appears to violate NY confidentiality laws.)
We in the Lyme community believe the targeting of NY Lyme physicians began in 1993, when U.S. Senator Edward Kennedy heard a prominent New York physician testify in his DC Senate hearing concerning the problems facing Lyme treating 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 I am taking a personal risk, a large one, because I am stating these views publicly." Two weeks after that hearing, that physician received a notice that an investigation was begun by New York State.
Even after he was cleared by the OPMC on initial complaints, his lawyer informed him his case was kept open, something the lawyer had never seen in his 30 years of experience. The investigation continued with more charts pulled. Although chart selection was supposedly random, only charts of chronic Lyme patients were kept for further review. He was eventually charged. In 2001, eight years after the initial investigation, he was exonerated on most of the charges against him. Incredibly, the OPMC then filed an appeal of that decision rendered by its own hearing committee. Ironically, one of the OPMC officials told us at a meeting that New York State provided the best example of due process for doctor disciplines in the nation.
Targeting physicians and rendering discipline in a scientific controversy are not the role of the OPMC or any state licensing review board. Comments from numerous officials nationwide support this statement: Office of US Congressman Joseph Pitts, PA, to Health Committee Chair Dick Gottfried, "We believe Lyme disease is a scientific controversy and, consequently, medical boards should not prosecute physicians based on their long term treatment of this devastating illness."
Congressman Christopher Smith, NJ, to Chairman Gottfried: "Lyme disease is unique because debates among the medical and scientific community often revolve not only around treatment, as is the case for other diseases, but around diagnosis as well. Two well-trained and well educated physicians could review identical patient symptoms and make a different diagnoses..I do not want anyone.to suffer because the doctor they were depending on for treatment has decided to stop seeing Lyme patients out of fear that aggressive therapy will result in an investigation of their practice. The investigatory "chilling effect could have a real impact on the ability of patients to receive quality health care when seeking assistance with this disease."
From Connecticut Attorney General Blumenthal at his state hearings on Lyme disease: "Different people at various stages of the disease may need different treatments, and my own basic philosophy is that decisions about diagnosis and treatment ought to be made by the treating physician and the patient, and those decisions ought to be respected by insurance companies, by government officials and ought not to be governed by arbitrary artificial dictates or regulations."
From the interim report The prevalence of Tick-borne Illnesses in Texas from the Texas Senate Committee on Administration "The Committee has concluded from this study that insufficient information on how these diseases should be identified and managed over the long term exists for ANYONE [their emphasis] to make a definitive determination of appropriate diagnostic or treatment guidelines." Furthermore, a report recommendation "Directs the Board of Medical Examiners to develop guidelines in reviewing and investigating medical care providers when treatment of tick-borne illnesses is involved."
A letter to U.S. Senator Rick Santorum, PA, from the PA Commissioner of the Bureau of Professional and Occupational Affairs: "Regarding your inquiry into whether the office is conducting any investigations into the medical practices of Pennsylvania licensed physicians who treat Lyme disease.anecdotal responses indicate that there may have been one or two such complaints in recent years, which were closed without any action by the Prosecution Division because of lack of consensus in the medical community as to the appropriate standard of care made it difficult or impossible for a prosecutor on behalf of the Commonwealth, with an expert's opinion in support, that a particular method of treatment did not meet the standard of care."
The ultimate irony is embodied in my last quote, which also appears to hint at a double standard for Lyme disease treating physicians. In a letter to a Lyme patient who filed a complaint against a doctor opposed to long term treatment, Dr Ansel Marks, MD, JD, Executive Secretary for the NY Board of Professional Misconduct states: "As defined by law, a difference of medical opinion, in and of itself, is not medical misconduct."
The secrecy surrounding the OPMC process combined with the power of the agency is a concern for legitimate physicians and patients alike, since there appears to be little or no oversight of the OPMC. Through their actions, they have the power to bring New York physicians and consequently, patients, to bended knee, but where is the authority that can bring them to their knees? Even at the first hearing before the Health Committee in November, no one from that office appeared. I wondered what message that sent to the legislators. I know what message it sent to me-we are not accountable to you in the actions we have taken against Lyme disease treating physicians.
After hearing today's testimony, I ask that you find a way to rein in the power of the agency without losing site of its mission to protect the patients. Please remember Lyme disease patients
- are not being protected when their treating physicians are afraid to treat in New York and patients have to travel elsewhere to get treatment,
- are not being protected when their doctors must spend half their practice time defending their right to practice medicine according to their best clinical judgment, and
- are not being protected when their already small number of doctors become smaller because their licenses are revoked for treatment of a debilitating illness, Lyme disease, about which the then Commissioner of the New York State Department of Health, David Axelrod, MD said in a 1988 communication to all New York Physicians, "Treatment of secondary and tertiary LD may require prolonged therapy with intravenous antibiotics."
(Before ending, I would ask that the committee to ascertain when the OPMC changed their policies regarding Lyme disease treatment guidelines. This morning they testified that they did not use treatment guidelines in cases of Lyme disease physicians. Yet we have many letters, I would hesitate to say dozens, but probably dozens, to patients and Lyme disease groups which state the guidelines the OPMC said they used.
Chairman Gottfried, in response to your question as to whether an increased use of lay people on the committees would help, I would like to say it could be a factor, but it is my personal opinion as an outside observer studying this process these past few years and speaking with doctors, lawyers, and patients on the issue, I believe the most important change which could be made would be to lift the veil of secrecy surrounding the process. I think almost all the speakers here today have agreed that that aspect is necessary. It has been my experience in government, 12 years on the board of education, that government agencies are only accountable when you hold them accountable. I see very little accountability here for the OPMC due to the vast secrecy involved. When you lift that veil, as was begun today, I do not think you will like what you see, I know I haven't liked it.)
Thank you.
Call to Action- Maryland Assisting NY
This needs to be done immediately... even over the weekend is good. All responses should be to him no later than Monday afternoon. Please send this out to ALL your friends and ask them to do the same. It doesn’t matter where you are from.. this bill will help everyone all over the country if it is passed. They are getting ready to vote on this on Tuesday and we MUST have your support. Thanks!
Contact Gov. Pataki in New York by phone (leave a message) AND/OR by email and ask him to support the Lyme disease bills S-5221 and S-3000.
Governor George E. Pataki
TELEPHONE 518-474-8390
TO EMAIL THE GOVERNOR:
Go to the following web address and scroll down a bit. You will
find a form on which to include your email message.
http://161.11.3.75/
Thank you!
Lucy Barnes
After The Bite
Instructions for Dummies
(As Requested)
1. Click here to email Governor Pataki: http://161.11.3.75/
Write the message...
Please pass Bill #A4274b, for OPMC Reform. Thank you.
2. Call Governor Pataki’s office:
518-474-8390
Say... “Please pass the bill for OPMC Reform. Thank you.”
3. Call Senator Kemp Hannon’s office:
518-455-2200
Ask Sen. Hannon to please encourage Governor Pataki to sign the OPMC Reform bill. Thank you.
Action Notice to Call Senator Hannon
This is your lucky number!
Please...
Pick up the phone... NOW!
Dial THIS number- 518-474-8390
When the machine answers.. or the human answers... please say...
“Hi, My name is _______.
I am from _________.
Please ask Senator Hannon to support the Lyme disease bills, numbers S-5221 and S-3000.
Thank you.”
Then hang up.
Then... most important of all...
SMILE.
You have just made a HUGE contribution to saving our Lyme doctors!
Lucy Barnes
Letter to Governor Pataki in NY
December 2004
Dear Governor,
I have been requesting that you help "us" with the OPMC Reform Bill for more days, months, or actually years than I can count. Normally I write on behalf of others who are too sick to do it for themselves... and sometimes I write to you for those who have already died because they couldn't find a doctor to help them.
There are thousands of us all over the world who are chronically ill, and who depend on the doctors we have found to keep us alive and functioning. Tonight... as I sit here thinking about the possibility of the bill not being passed.. I suddenly realized that if you veto this bill.. I could die. Yes, ME.
I know the OPMC is backing off their witch hunt of trying to prosecute doctors right now, until the final decision is made on this bill.
Unfortunately, it will be "OPEN SEASON" on these doctors if this bill is vetoed.. and I.. yes ME.. may lose MY doctor. That scares me. I need him. I can't replace him. He, along with many others who help all of us, are trained by the doctors in New York, who also need this protection.
They are the ONLY hope I have had in over 18 years. They helped me return from a vegetative state and regain my health. No, my life is not perfect yet and I am still chronically ill.. but it is MUCH better than it has been ... and without them I will slip back into a non-functioning mode.. or die.
PLEASE... don't veto this OPMC Reform bill.
If I can spend every spare minute I have helping chronically ill people... as a volunteer... you could certainly give me ONE tool that will help in this effort... can't you? I don't ask for money from you... or gifts.. or even a holiday greeting card. I don't ask for anything... other than protection for the care givers who allow us to live and function.
Thank you for taking time to hear my plea.
And yes, it is a plea for MY life tonight.
Sincerely,
Lucy Barnes
Governor Pataki Veto's Bill
Veto message by Governor George Pataki:
S4148a and A.4274b
These bills represent a well intentioned attempt to respond to what some licensees and patients perceive to be a bias on the part of BPMC and OPMC against non-conventional medical practices.
However, there is considerable opposition to the bill from a broad spectrum of interested parties. The Federation of State Medical Boards of the United States, the Medical Society of the State of New York, the New York Chapter of the American College of Physicians, the New York State Society of Orthopaedic Surgeons, the New York State Society of Physician Assistants, the New York State Administrative Law Judges Association, the New York State Trial Lawyers Association, various patient advocates and the Department of Health are all opposed to one or more provisions of these bills.
While I agree with the sponsors and supporters of this legislation that any bias against non-conventional medical practitioners would be inappropriate, I am concerned that the bills could result in unnecessary and inappropriate delays in the process of disciplining medical professionals, and impede the efforts of BPMC and OPMC to protect the public against the small minority of physicians, physician assistants, and specialist assistants who are guilty of professional misconduct.
In the last decade, New York State's record in addressing the issue of professional medical misconduct has dramatically improved, and I am not willing to compromise that success by approving a series of procedural and substantive changes that could make the disciplinary process more cumbersome and complex. Much of the success in improving the disciplinary process over the last ten years is attributable to prior collaborative efforts by interested parties to review the structure, functions and operations of OPMC and BPMC and propose reforms to make the discipline process more effective and efficient. Absent further similar study and a reasonable consensus among interested parties, I cannot approve the far-reaching changes contemplated by this bill.
The bills are disapproved.
http://www.faim.org/OPMCvetomessage.htm
Memorandum Issued
June 15, 2005
The following memorandum was issued June 15, 2005 by OPMC Director Dennis Graziano to every staff member of the Office of Professional Medical Conduct (OPMC) and copied to all the members of the Board for Professional Medical Conduct and its chief counsel:
Subject: Investigation of Practitioners Utilizing Treatment Modalities That Are Not Universally Accepted by the Medical Profession.
"This memorandum is intended to memorialize and endorse the principles that are currently in place in the Office of Professional Medical Conduct regarding the investigation of physicians, physician assistants and specialist assistants who use treatment modalities that are not universally accepted by the medical profession, such as the varying modalities used in the treatment of Lyme disease and other tick-borne diseases.
"As you know, Article 131 of the Education Law defines the practice of medicine. Paragraph (e) of subdivision four of §6527 of the Education Law provides that Article 131 'shall not be construed to affect or prevent...[a] physician's use of whatever medical care, conventional or non-conventional, which effectively treats human disease, pain, injury, deformity or physical condition.'
Under current law, therefore, it is clear that so long as a treatment modality effectively treats human disease, pain, injury, deformity or physical condition, the recommendation or provision of that modality does not, by itself, constitute professional misconduct.
Consequently, it is contrary to the policy and practice of the Office of Professional Medical Conduct to identify, investigate or charge a physician, physician's assistant or specialist assistant based solely on that practitioner's recommendation or provision of such treatment modality.
"Please note that this prohibition does not exonerate such practitioners from otherwise applicable professional requirements."
According to New York doctor Joseph Burrascano,
This memorandum means that the pressure is now off of Lyme-treating physicians in New York, and it is certainly a reward for all the hard work and efforts of the Lyme community."
The Lyme Disease Association and Voices of Lyme/NY Lyme are pleased to announce that the New York State OPMC has issued this memorandum on investigating doctors who are treating Lyme disease and other tick-borne diseases.
The extensive public grass roots work of the Lyme community enabled a number of private meetings to be held in Albany, culminating with a January 2005 meeting with the Governor’s counsel. This meeting set in motion the issuing of the memorandum.
We are grateful to New York Assembly members Adam Bradley, Nettie Mayersohn, and Joel Miller for their constant support of the Lyme community including their initiation of and attendance at this January 2005 meeting with the Governor’s office, the Lyme Disease Association and Dr. Brian Fallon, Columbia University College of Physicians & Surgeons.
We thank Governor Pataki who responded to the thousands of communications he received from Lyme patients seeking protection for their medical care. He was instrumental in the work leading to the issuance of this memo.
Most importantly, we thank the Lyme community for its continued dedication to addressing the conditions in NY which had threatened the medical care of Lyme disease patients.
Without your continued grass roots efforts over the past four years through phone calls, faxes, emails, letters, and testimonies, this memorandum would not have been issued.
We also thank our physicians who have freely provided their time and expertise in this process, particularly ILADS and Dr. Brian Fallon. Jill Auerbach deserves special recognition for her role in the meeting process.
Thanks to Monica Miller of FAIM, who, working independently, consistently provided invaluable direction to the Lyme disease effort. Also thanks to Richard Gottfried, Chair, Assembly Health Committee, who called the Assembly hearings on Lyme disease and has been fighting very hard along with us for the OPMC reform bill.
YOUR CONTINUED EFFORTS AND SUPPORT CAUSED THIS TO HAPPEN!
THANK YOU ALL!
Pat Smith President
LDA
Ellen Lubarsky Voices of Lyme/NY Lyme
__________________
Pat Smith, President
Lyme Disease Association, Inc.
PO Box 1438
Jackson, NJ 08527
888-366-6611 information line
732 938-7215 fax
Please share the above information. Many thanks!
Lucy Barnes
June 6, 2014
New York Residents Only- Time Sensitive
We are on the brink of making good things happen in NY, or sadly not. The Lyme disease bill (A07558-A), one that helps everyone and hurts no one, has finally passed the Assembly!
Unfortunately, Senator Kemp Hannon is sitting on the Senate version (S05520-B), choosing not to bring it up for a vote. This is a shameful situation considering the tragic results (chronic illness, disability & death) being realized by those suffering from a lack of necessary treatment for a tick borne disease that is spreading across the nation like wildfire.
No one should, as has been the policy, be subjected to restrictive, antiquated, proven-not-to-work, riddled with conflicts of interest, Lyme disease treatment guidelines that require positive results on tests proven to miss 75% of those infected, and that restricts all but one insurance-friendly treatment protocol that has repeatedly proven not to cure everyone. We need choices! Our doctors need choices!
The NY bills allow the patient and doctor to have those treatment choices, a "patient's right” that is automatically provided to those with other diseases, just not for people with Lyme disease.
Will you please help the Davids (NY's volunteer advocates, patients and their doctors) who have been working so hard to change this situation for you - fight the Goliath's (handful of IDSA guideline authors with obscene conflicts of interest) who continue to restrict treatment options- by doing one or more of the following? Of course, the more the better because we are serious and need this bill passed now!
1.) Click HERE to send an easy to use automated letter to legislators asking for the passage of the Senate version of the bill. PLEASE, very important, write a short note about your situation in the box provided. Those are the letters they listen to! Your letter will be sent automatically to key legislators.
2.) Call Senator Kemp Hannon's office (518-455-2200) or email him ( hannon@nysenate.gov ) and tell him you support the Lyme disease bill (S05520-B) and you want the Senator to immediately pass it out of the Health Committee and get it on the floor for a vote.
3.) Call Senator Dean Skelos's office (518-455-3171) or email ( skelos@nysenate.gov ) and tell them you support the Lyme disease bill (S05520-B) and to please get the Republicans in Rules to pass it.
4.) Contact your Senator (and others if you'd like) by clicking HERE . You can tweet, face book post, phone or email from this site. Please tell them you support the Lyme disease bill (S05520-B) and need their help to get it passed. Let's get social media buzzing too!
5.) Emails for all NY Senators are listed HERE. Feel free to share your opinions with all.
Thank you for doing all you can to help! Without your assistance we will be forced to live with the status quo, which is NOT acceptable.
Lucy Barnes, Volunteer Patient Advocate
Link here https://sites.google.com/site/americanlyme/news
Letter From Senator Terry Gipson
From: Senator Terry Gipson <gipson@nysenate.gov>
Subject: Thank You – Lyme legislation passes Senate
Date: June 19, 2014 12:00:20 PM EDT
To: Lucy Barnes <afterthebite@gmail.com>
Dear Friend,
I have been so inspired by how many of you have taken action to help reach our shared goal of passing legislation in the State Senate to help those suffering from Lyme and tick-borne illness. Thank you.
I’m proud to tell you that last evening, the State Senate passed legislation (S.7854) that I co-sponsored which will protect doctors who treat patients with chronic Lyme disease and other tick-borne illnesses.
During my first term, advocating for those suffering from Lyme disease and tick-borne illness has been one of my most important causes. I have met with families across the Hudson Valley and have heard from individuals throughout the state who are living with the devastating effects of these diseases.
For far too long, those suffering from Lyme and tick-borne illness have not had the patients’ rights that they deserve. The State Senate has finally listened to your voices and has come together to pass this important legislation that will help thousands of New Yorkers.
This bill must now be passed in the Assembly and signed by Governor Cuomo to become law. It is my hope that this legislation will be the necessary stepping-stone for New York State to take further action and require health insurers to provide coverage for the long-term medical care of Lyme disease and tick-borne illnesses. I remain committed to fighting on behalf of those suffering from Lyme and tick-borne illness and their families. Our work is not done and it’s crucial that we continue to do everything in our power to address this serious health crisis.
Sincerely,
Terry Gipson
New York State Senator, 41st District
P.S. Please "LIKE" my page on Facebook to stay connected on our work ahead.
Albany Office:
617 Legislative Office Building
Albany, New York 12247
518-455-2303
District Office:
3 Neptune Road, Suite A19B
Poughkeepsie, New York 12601
845-463-0840
To ensure delivery of emails to your inbox, please add gipson@nysenate.gov to your email address book.
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LAST MINUTE CHANGES
NEW BILL FROM SENATOR HANNON
(Would NOT Bring Up Original Bill)
BASED ON PREVIOUS WORDING OF MEMORANDUM DATED JUNE 15, 2005
(SEE POST ABOVE FOR JUNE 15, 2005 MEMORANDUM)
| Advanced
Bill S7854-2013
Prohibits the investigation of any claim of medical professional misconduct based solely on treatment that is not universally accepted by the medical profession
Prohibits the investigation of any claim of medical professional misconduct based solely on treatment that is not universally accepted by the medical profession.
Details
Actions
- Jun 18, 2014: referred to health
- Jun 18, 2014: DELIVERED TO ASSEMBLY
- Jun 18, 2014: PASSED SENATE
- Jun 18, 2014: ORDERED TO THIRD READING CAL.1571
- Jun 14, 2014: REFERRED TO RULES
Meetings
Votes
VOTE: COMMITTEE VOTE: - Rules - Jun 18, 2014
Ayes (24): Skelos, Libous, Bonacic, Carlucci, Farley, Flanagan, Hannon, Larkin, LaValle, Marcellino, Maziarz,Nozzolio, Seward, Valesky, Little, Stewart-Cousins, Breslin, Dilan, Hassell-Thompson, Krueger, Montgomery,Parker, Perkins, Gianaris
Excused (1): Espaillat
Memo
BILL NUMBER:S7854
TITLE OF BILL: An act to amend the public health law, in relation to the identification, charging, reporting and investigation of charges of professional misconduct by health care professionals
PURPOSE: To ensure that the Office of Professional Medical Conduct (OPMC) shall not identify, investigate, or charge a practitioner based solely on their recommendation or provision of a treatment modality that is currently not universally accepted by the medical community
SUMMARY OF PROVISIONS:
Section one of the bill amends Section 230 of the public health law by adding a new subdivision 9-b to ensure that neither the board for professional medical conduct nor the office of professional medical conduct shall identify, charge, or cause a report made to the director of such office to be investigated based solely upon the recommendation or provision of a treatment modality by a licensee that is not universally accepted by the medical profession, including but not limited to, varying modalities used in the treatment of Lyme disease and other tick-borne diseases.
Section two of the bill provides for an immediate effective date.
JUSTIFICATION:
In New York State, the Office of Professional Medical Conduct (OPMC) is charged with ensuring that appropriate medical care is given to all New York residents, through the investigation and prosecution of professional misconduct by physicians, physician assistants and specialist assistants. Because the medical profession is one that continually evolves with scientific breakthroughs, it is important that the OPMC maintains a flexible, case-specific, investigations policy - particularly where new treatments and acceptance by the medical community do not align.
This has been relevant to concerns raised regarding the investigation of alternative medical treatment of Lyme and tick-borne disease with modalities not universally accepted by the medical community. As the debate surrounding acceptable protocols continues, it is important that the State takes a treatment-neutral approach where possible in order to ensure that medical professionals remain the discerning voice in defining appropriate medical care. To that end, recognizing that the determination of appropriate diagnosis and treatment on a case-by-case basis is a responsibility solely held by a medical professional, it is also critical to ensure that bodies such as the OPMC do not inadvertently endorse or preclude innovative treatments with rules that may dissuade medical professionals from pursuing new methods.
In a memo dated June 15, 2005, the Director of the Office of Professional Medical Conduct "memorialized and endorse(d)" these very principles. The memo, circulated to the staff members of the OPMC advised that so long as a treatment modality effectively treats a medical condition, within certain specifications, its recommendation or provision cannot, by itself, constitute professional misconduct.
Thus, the determination of effective and appropriate treatment remains in the hands of the proper entity, the medical professional. As such, this legislation codifies the existing policy of the OPMC to clarify that the OPMC shall not identify, investigate, or charge a practitioner based solely on their recommendation or provision of a treatment modality that is currently not universally accepted by the medical community.
LEGISLATIVE HISTORY:
New Bill.
FISCAL IMPLICATIONS:
No fiscal implications.
EFFECTIVE DATE:
This act shall take effect immediately.
Text- See Below
STATE OF NEW YORK ________________________________________________________________________ 7854 IN SENATE June 14, 2014 ___________
Introduced by Sen. HANNON -- read twice and ordered printed, and when printed to be committed to the Committee on Rules AN ACT to amend the public health law, in relation to the identifica- tion, charging, reporting and investigation of charges of professional misconduct by health care professionals THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Section 230 of the public health law is amended by adding a new subdivision 9-b to read as follows: 9-B. NEITHER THE BOARD FOR PROFESSIONAL MEDICAL CONDUCT NOR THE OFFICE OF PROFESSIONAL MEDICAL CONDUCT SHALL IDENTIFY, CHARGE, OR CAUSE A REPORT MADE TO THE DIRECTOR OF SUCH OFFICE TO BE INVESTIGATED BASED SOLELY UPON THE RECOMMENDATION OR PROVISION OF A TREATMENT MODALITY BY A LICENSEE THAT IS NOT UNIVERSALLY ACCEPTED BY THE MEDICAL PROFESSION, INCLUDING BUT NOT LIMITED TO, VARYING MODALITIES USED IN THE TREATMENT OF LYME DISEASE AND OTHER TICK-BORNE DISEASES. AS USED IN THIS SUBDIVI- SION THE TERM "LICENSEE" SHALL MEAN A PHYSICIAN, PHYSICIAN'S ASSISTANT, AND SPECIALIST'S ASSISTANT. WHEN A LICENSEE, ACTING IN ACCORDANCE WITH PARAGRAPH E OF SUBDIVISION FOUR OF SECTION SIXTY-FIVE HUNDRED TWENTY-SEVEN OF THE EDUCATION LAW, RECOMMENDS OR PROVIDES A TREATMENT MODALITY THAT EFFECTIVELY TREATS HUMAN DISEASE, PAIN, INJURY, DEFORMITY OR PHYSICAL CONDITION, THE RECOMMENDATION OR PROVISION OF THAT MODALITY SHALL NOT, BY ITSELF, CONSTITUTE PROFESSIONAL MISCONDUCT. THIS PROHIBI- TION SHALL NOT EXONERATE SUCH LICENSEE FROM OTHERWISE APPLICABLE PROFES- SIONAL REQUIREMENTS. S 2. This act shall take effect immediately.
NEW BILL WORDING
(Removes several definitions and wording regarding clinical diagnosis and long-term treatment.)
Introduced by Sen. HANNON -- read twice and ordered printed, and when printed to be committed to the Committee on Rules AN ACT to amend the public health law, in relation to the identifica- tion, charging, reporting and investigation of charges of professional misconduct by health care professionals THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Section 230 of the public health law is amended by adding a new subdivision 9-b to read as follows:
9-B. NEITHER THE BOARD FOR PROFESSIONAL MEDICAL CONDUCT NOR THE OFFICE OF PROFESSIONAL MEDICAL CONDUCT SHALL IDENTIFY, CHARGE, OR CAUSE A REPORT MADE TO THE DIRECTOR OF SUCH OFFICE TO BE INVESTIGATED BASED SOLELY UPON THE RECOMMENDATION OR PROVISION OF A TREATMENT MODALITY BY A LICENSEE THAT IS NOT UNIVERSALLY ACCEPTED BY THE MEDICAL PROFESSION, INCLUDING BUT NOT LIMITED TO, VARYING MODALITIES USED IN THE TREATMENT OF LYME DISEASE AND OTHER TICK-BORNE DISEASES. AS USED IN THIS SUBDIVI- SION THE TERM "LICENSEE" SHALL MEAN A PHYSICIAN, PHYSICIAN'S ASSISTANT, AND SPECIALIST'S ASSISTANT. WHEN A LICENSEE, ACTING IN ACCORDANCE WITH PARAGRAPH E OF SUBDIVISION FOUR OF SECTION SIXTY-FIVE HUNDRED TWENTY-SEVEN OF THE EDUCATION LAW, RECOMMENDS OR PROVIDES A TREATMENT MODALITY THAT EFFECTIVELY TREATS HUMAN DISEASE, PAIN, INJURY, DEFORMITY OR PHYSICAL CONDITION, THE RECOMMENDATION OR PROVISION OF THAT MODALITY SHALL NOT, BY ITSELF, CONSTITUTE PROFESSIONAL MISCONDUCT. THIS PROHIBI- TION SHALL NOT EXONERATE SUCH LICENSEE FROM OTHERWISE APPLICABLE PROFES- SIONAL REQUIREMENTS.
S 2. This act shall take effect immediately.
Senate Passes Bill to Address Lyme Disease Treatments
ISSUED BY
New York State Senate
June 19, 2014
The New York State Senate today passed legislation that will help doctors and patients treat the symptoms of Lyme and other chronic diseases. The bill (S7854), sponsored by Senator Kemp Hannon (R, Nassau), was among the recommendations in a report released today by the Senate Majority Coalition’s Task Force on Lyme and Tick-Borne Diseases.
“This measure helps strike an important balance between the ability of doctors to treat patients suffering from chronic Lyme Disease symptoms, and the state’s responsibility to help protect the public,” Senator Hannon, Chairman of the Senate’s Health Committee, said. “As treatment options evolve, more doctors would be better able to make informed decisions about how to help their patients. I look forward to continuing to work towards the implementation of this and other recommendations made by the task force to prevent, diagnose, and treat tick-borne illnesses.”
In October 2013, Senate Majority Coalition Co-Leaders Dean Skelos and Jeffrey Klein created the Senate Task Force on Lyme and Tick-Borne Diseases to examine state and federal efforts to combat the continued spread of these diseases and make recommendations for a state action plan to improve prevention, diagnosis, and treatment.
The task force is co-chaired by Senator Hannon, Senator David Carlucci (D, Rockland/Westchester), Senator Kenneth LaValle (R-C-I, Port Jefferson) and Senator Elizabeth Little (R-C-I, Queensbury). Additional members of the task force include Senator Mark Grisanti (R, North Buffalo), Senator Kathy Marchione (R-C, Halfmoon), Senator Greg Ball (R-C-I, Patterson), and Senator Bill Larkin (R-C, Cornwall-on-Hudson).
The Task Force released a report and legislation that provides a comprehensive set of recommendations for a state action plan to enhance research, prevention, diagnosis and treatment for harmful tick-borne illnesses. To date in 2014, more than 450 new cases of Lyme disease have been reported in New York alone, and the number is expected to continue rising each year as disease-laden ticks spread to more communities. The CDC now estimates that there are 300,000 cases of Lyme disease each year, the vast majority of which are centered in the north east.
The report’s recommendations focus on the need for: additional research and data about past, current and future disease trends; increased public awareness as the reach of the diseases spread to new communities; implementation of preventive measures such as “4 Poster” devices and bait vaccines for animals to reduce the infected tick population; and measures to enhance diagnosis and treatment for those who have the diseases.
One of the recommendations included codifying an existing state health policy and enabling the state’s Office of Professional Medical Conduct (OPMC) to maintain a flexible, case-specific, investigations policy, particularly where new treatments and acceptance by the medical community do not align.
Some individuals infected with Lyme disease may benefit from alternative medical treatment that is not universally accepted by the medical community. Too often, doctors choose not to pursue the alternative treatment – even if they believe it is best for the patient – fearing an investigation or charges by OPMC.
This legislation ensures that determinations of effective and appropriate treatment of Lyme and other illnesses remain in the hands of medical professionals and does not subject practitioners to OPMC identification, investigation or charges based solely on their recommendation or provision of an innovative and effective treatment.
Over the past nine months, the Task Force reviewed research, consulted with experts, heard from the public and worked to develop legislation and 19 recommendations to be incorporated into a New York State Action Plan on Lyme and tick-borne diseases. This Action Plan – similar in purpose to one created by the state Department of Health in 2001 to address the West Nile Virus outbreak -- should serve as a comprehensive roadmap for the state to prevent additional illnesses by improving research, education, diagnosis and treatment.
The bill voted on today is one of four initiatives that the Senate has implemented or is in the process of implementing during this session to address Lyme and other tick-borne diseases. The others include:
· Tomorrow, the Senate is adopting a resolution calling on the Centers for Disease Control to reevaluate its guidance on Lyme and other tick-borne diseases and for the National Institutes of Health, the Department of Defense, and other federal agencies to provide more funding for these diseases.
· The 2014-15 state budget included $500,000 to support the recommendations being developed by the task force, and $100,000, along with supporting legislation (S2115), sponsored by Senator Patricia Ritchie (R-C, Heuvelton) and recommended by the task force, for the creation of a 21st Century Work Group for Disease Elimination and Reduction within the Department of Health.
· The Senate will help increase public education through new informational brochures and wallet cards with important information about Lyme or tick-borne disease identification tools and resources.
The bill will be sent to the Assembly.
June 19, 2014- Report from NY-
"Passed the senate and assembly unanimously. Off to the governor."