Testimony to the New York State
Assembly, November 27, 2001
Pat Smith, President, Lyme Disease Association, Inc.
The Battle to Allow American's Freedom to Purchase Affordable Canadian Scripts Reaches New Bizarre Low
"A government that's big enough to give you everything you want is big enough to take it all away."
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.
[LYMEINFO MODERATOR NOTE- QUESTIONS FROM THE PANEL]:
MR. GOTTFRIED: Just one question. You 10 made reference to several insurance companies using the CDC reporting guideline as a basis for payment decisions, and I guess the footnote in your testimony mentions in particular Aetna. It will be useful if you have documentation of other insurance companies doing similar things -- if you could provide that to us as a follow-up afterwards, that would be useful.
MS. SMITH: Thank you. I think I presented Aetna; and there was a Prudential, I believe, guideline from 1995 also in there. I don't know if that's their current -- that's as current as we have. I'll try to get you some other material.
MR. GOTTFRIED: Thank you. That would be useful.
DR. MILLER: Just one question. You mentioned the Tick-Borne Diseases Institute in New York State. Could you tell us how much money that institute receives to do all of the work that it has to do on ticks and Lyme disease?
MS. SMITH: Well, I hope my memory serves me correctly, but I believe it was $150,000. I think that the remaining funding that was supposed to go there, I believe, goes to another institution in New York. I suggest you reserve that question for Mrs. Auerbach. She's very knowledgeable in that area, and she can probably provide you with the details.
DR. MILLER: Thank you.
MR. GOTTFRIED: We're looking into the source of the static. Thank you very much. Oh, I'm sorry, Ms. Smith. Nettie Mayersohn has a question. I'm sorry.
ASSEMBLYWOMAN NETTIE MAYERSOHN: Maybe it's my voice. Hello? I can hear you now. Do you know of any cases that have been brought against doctors for undertreatment of Lyme disease as a result of patient complaints?
MS. SMITH: To answer your question, I know of several that were -- complaints that were initiated; none, to my knowledge, have, you know, borne out.
MS. MAYERSOHN: Okay. We should have a list of those cases so we can follow up on them. Thank you.
MS. SMITH: I'll see if we can fine them. Thank you.
MR. GOTTFRIED: Okay. Thank you.
For more information about Ms. SmithÕs many actions serving the country and advancing. Please log on to: www.lymediseaseassociation.org
The Lyme Disease Research Center at Columbia University
The Lyme Disease Research Center will use the vast resources of Columbia University in New York to address fundamental clinical and basic science questions that plague adults and children affected by Lyme disease (LD). While much is known about early Lyme disease, very little is known about chronic Lyme disease, despite its rising prevalence and disabling effects. These effects may include arthritis, cognitive loss, peripheral neuropathies, and debilitating fatigue. Rarely, LD may also cause strokes, blindness, severe psychiatric disorders, and multiple-sclerosis-like illnesses. Children may be home sick for months or years, missing the key academic and social influences so critical to healthy development.
Our clinical and research mission includes studies of new diagnostic tests, clinical phenomenology, immunopathogenesis, co-infections, genetic markers of vulnerability, functional and structural brain imaging, neuoropathology of post-mortem brains, and well-controlled studies of new treatments. This Center, the first such facility in the world devoted to chronic Lyme disease, will serve as a national resource, providing pilot grants to researchers nation-wide and focusing the latest scientific technology on helping to resolve the problems of chronic Lyme disease. Researchers at Columbia are now completing analysis on a 5 year NIH-funded study of the pathophysiologic effects of Lyme disease on the brain and whether a repeated longer course of IV antibiotic therapy helps to reverse the cognitive and physical dysfunction experienced by previously treated patients.
Brian A. Fallon, MD
I am writing with an urgent appeal concerning the most prevalent vector-borne disease in the US, reported in 49 states and the District of Columbia, and the most prevalent vector-borne bacterial disease in the world, Lyme disease. The CDC admits Lyme is vastly underreported nationally at almost 24,000 reported cases in 2002Ðrepresenting about 240,000 actual cases that year, an astounding 40% increase over the prior year.
Lyme disease can be acquired in your own backyard. It often attacks more than one family member, with children a high risk. Risky behavior includes petting the dog, jogging or playing outdoors, golfing, and even bringing home a live Christmas tree. 10-15% of those with the Lyme bacteria progress to chronic Lyme disease. Other tick-borne diseases may result from the same tick bite.
Despite this staggering data, little monies are spent for research. Therefore, the Lyme Disease Association (LDA) and its affiliate, Time for Lyme (TFL*) have reached an agreement with Columbia University to fund an endowed Lyme disease research center at Columbia, the first in the world devoted to the study of chronic Lyme disease. LDA and TFL have jointly raised over $1.3 million out of $3 million required to fully open the center with a dedicated researcher, although some Lyme research using state-of-the-art brain scans is already underway. *Formerly Greenwich Lyme Disease Task Force
DonÕt let Lyme disease destroy your life and the lives of your family and friends. Help us open the Columbia Center by sending a tax-deductible contribution today. Together, we can fund the cure.
Patricia V. Smith, President, LDA
Diane Blanchard, Deb Siciliano, Co-Presidents, TFL