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CT – US Senate HELP Committee Field Hearing

Click here for entire published hearing

Senator Blumenthal & HELP Committee Members:

My experiences with Lyme disease began about 27 years ago when, as a board of education member in my NJ township, I witnessed students and staff, in particular from one area of the community, develop a disease called Lyme disease, one which we in the public sector knew nothing about. I got the district to agree to put out information through the schools, after I spent weeks trying to find out what Lyme was and where I could find that information. I finally found what I needed on a local military installation, where some of the first cases of Lyme in NJ had been diagnosed and treated. It was the first time I heard about Juvenile Rheumatoid Arthritis, which had often been the initial diagnosis of the children who were later correctly diagnosed with Lyme.

A few years later, first one then another of my children developed Lyme disease. Fortunately, I was aware of the symptoms of Lyme and when my oldest daughter had symptoms which could be described at best as weird, I sent her to a hospital near her college, where they readily, without fanfare, diagnosed and treated her for Lyme disease. My youngest daughter was not so lucky. Her symptoms were vague and in the intervening years between the onsets of my daughters’ health problems, suddenly those who had Lyme became pariahs, and the journey to get my youngest daughter diagnosed and treated was a nightmare which I liken to a trek through Dante’s Inferno, with each downward spiral worse than the previous one.

I had intended to raise my 3 children and reenter the work force when the last had finished elementary school. That was not to be, as my youngest became sick around 10 years old, and remained in the grips of a disease that took her through arthritis, petit mal and grand mal type seizures, temporal lobe type seizures, gastrointestinal problems, back and neck problems, memory loss, mental confusion, tachycardia, brachycardia, panic anxiety attacks, hallucinations, balance problems, eye problems, muscle pain, nerve pain, later morphea sclerodoma and a condition similar to POTS, and blackouts. If you are not familiar with some of those terms, welcome to our Lyme world of the 80s, 90,s and later. I was a mother, not a doctor, but soon had to not only argue legally, scientifically and morally for treatments that worked but had to mix and dispense meds through pumps and hang IV drips. I remember worrying at 3 am whether I would kill my daughter, as I carefully tapped air bubbles out of syringes on a “sterile” kitchen table.

The worst of times were the 3-4 years of seizures, where she was out of school, technically on home instruction, although many sessions had to be cancelled. The “episodes” she had were something no mother should have to deal with, and when a doctor finally gave me a name to put with it, I was ecstatic. A name meant the ability to deal with it. Temporal Lobe Seizures, he said. I searched for an expert on temporal lobe seizures in the US and called him up. He was kind enough to listen to what I told him about my daughter, what her Lyme had triggered, what I had done, and when I finished my tale, he said, congratulations, you now know more about temporal lobe seizures than most doctors in the world. I was stunned and did as much research (no internet then) as I could into what was happening to her, the different manifestations–the times when she spoke with no “affect,” the times she spoke like a little girl, the times she just sat and stared for hours on end, the times she screamed for us and did not know we were there, the times she woke up screaming that she had “6” fingers (on one hand), counting them and showing her were useless in those times, there was no rationality during those episodes. I remember the nights I slept on a mattress on the floor beside her bed, so if she woke up in a seizure state, I would be there to calm her from the awful nightmares and assure myself instantly that the bloodcurdling screams were not someone killing her. These seizures states seemed to be controlled by a switch. They turned on, lasted 16 hours or so a day, and turned off. She, fortunately, was left with no memory of what occurred during them, we were not as fortunate. We were all exhausted, and my entire life was spent tied to my daughter and her terrible illness, trying to find people to help save her life. I wore a beeper (no cell phones yet) so my husband could beep me if I ran to the store and something happened. I rarely left home. Once I came back and found she had retreated into the fetal position. That is when I decided that if my daughter survived, I would never let a family go through this alone again. I have tried to keep that promise.

Fast forward to today, where after many years of antibiotic treatment and alternative treatments, my daughter has a life after graduating with honors from a prestigious college (ironically, the doctors associated with that college refuse to treat chronic Lyme patients) and has held corporate jobs in a medically-related field. Does she still have Lyme disease? Yes, I say that not as an “expert,” but from the perspective of 121 mother years of experience and 24 grandmother years of experience of dealing with children with and without Lyme.

There is discourse out there from some who call themselves experts who know nothing about Lyme disease, or worse, do know, but are led by vested interest. They claim Lyme patients and their families think everyone has it. Not true. Two of my daughters have Lyme, one doesn’t; all four of my granddaughters do not. I want to keep it that way.

Instead of entering the paid workforce, I devoted my life and energies to volunteer to help those afflicted with Lyme and help others avoid Lyme. To that end, I have spoken and/or testified in numerous state capitals across this country and in Washington, DC. I have met with leaders connected to all levels of government and all branches of the federal government and met with the military. My 12 years as a board of education member and board president taught me how government should operate, how it does operate, and how to get problems solved. The first issue requires educating people to the problem. I have done that, the next requires lobbying, I have done that—when that fails, it is time to rally those who have the same types of problems—I have done that, and I continue to do all of the above.

It is time now that government recognizes that Lyme has gone from an unknown infectious disease to one which has spread from a few states in the 70s & 80s to all states and to 65 countries throughout the world. It is time to recognize that in 2009, the Centers for Disease Control & Prevention, CDC, said that Lyme surpassed HIV in incidence in the US. It is time to recognize that the testing used for Lyme disease is ancient–while scientists are mapping genomes and using DNA testing, Lyme doctors are forced by government agencies to diagnose by looking for antibodies that may take weeks to develop, if at all, or may not be testable when they do develop.

Patients are caught in the middle of vested interest “experts” who saturate the media with their take on the science of Lyme, shutting down discussion of all the aspects of the science, refusing to partake in any meaningful dialogue with those who hold different opinions based upon science the experts have decided is unworthy. These experts use their influence as medical journal reviewers and also walk the halls in State Capitols and in Washington, DC, and use their significant financial clout to make sure their message is heard and accepted. That leaves us, the patients, the families of patients, who are also advocates, to stand up for the patients who are physically, mentally, emotionally, and financially drained from Lyme disease, to try to get them the help they desperately need. The “experts” have decided that we too, the advocates, are crazy, unknowledgeable, unstable, and they use their bully pulpit to spread those lies with relish, trying to discredit the people in the trenches who are working to help humanity.

You have the ability to help patients and to prevent others from becoming patients. To borrow from a once popular TV series, “the truth is out there.” You need to uncover that truth, wresting it from those who would prevent it from reaching daylight, those whose gravy train will be derailed if that truth comes to light. On behalf of patients everywhere, I ask that you make that effort. Read the testimony from this hearing and for further details on the science, the reporting, the testing, the numbers, I ask that you go to the US House Foreign Affairs Committee, Africa, Global Health & Human Rights Subcommittee Hearing Record on Lyme disease on July 17, 2012. There, you can find some measure of that truth and have a springboard for actions, which you as government officials, can take to end Lyme disease. Thank you.




ME – Joint Health & Human Services Committee

April 16, 2013

The Honorable Senator Cravens and Representative Farnsworth
Joint Health & Human Services Committee
Attn: Anna Broome, committee analyst
anna.broome@legislature.maine.gov
Maine Legislature

Dear Senator Cravens and Representative Farnsworth,

At this time, I know that your committee is considering LD 597, a bill which directs that “The Maine Center for Disease Control and Prevention shall maintain a publicly accessible website to provide public aware-ness and education on Lyme disease and other tick-borne illnesses.” That is certainly a worthy goal to help the public prevent future cases of Lyme and other tick-borne diseases and also to help those already afflicted with the diseases. It also happens to be the mission of the Lyme Disease Association, Inc. (LDA), designated by IRS as a public charity operating under 501(c) (3) non-profit status. (EIN # 22-3123551, Maine Charities License # CO3875)

LDA has been in existence since 1992. Its mission is promoting awareness of and controlling the spread of Lyme and other tick-borne diseases (TBD) and their complications through education and other means; raising and distributing funds for Lyme and tick-borne diseases (TBD) research, education and other related Lyme and TBD issues; assisting underprivileged patients in connection with Lyme and other TBD. In 2011, 120 individuals volunteered 20,451 hours to assist with LDA programs. LDA gets approximately 1 million unique viewer page views per year on its website.

The LDA respectfully asks that this committee consider adding to its resource list the LDA website, www.LymeDiseaseAssociation.org. To that end, I am providing some background on the LDA.

On average, 95% of funds raised by LDA go directly to programs. LDA presents fully accredited CME annual scientific/medical conferences, funds research nationally, provides monies for children without insurance coverage for Lyme, provides free literature, has free information line, hosts free online doctor referral and heads an umbrella organization, LDAnet, of 41 associated organizations nationwide that work together on national issues. LDA has been awarded the Guidestar.org seal for transparency.

For the past 7 years, the LDA has been accepted into the Combined Federal Campaign, CFC, with the LDA designated as a national charity on the CFC’s list of government approved charities for federal workplace giving. Additionally, the LDA is a partner in the (EPA) Environmental Protection Agency’s PESP program. In that capacity, the LDA helped EPA form a network of government and outside groups including the federal Centers for Disease Control & Prevention (CDC) called the Network to Reduce Lyme Disease in School-Aged Children. LDA and several others from that Network collaborated to author an article which appeared in May 2010 NASN School Nurse, the official publication of the National Association of School Nurses. Additionally, LDA co-chaired a session with the national CDC in the EPA’s Lyme Disease Prevention conference in Virginia in 2010. LDA was also invited by EPA in 2013 to present at another conference for educators in which EPA chaired the Lyme section, but due to a blizzard, LDA was unable to attend but did provide a PowerPoint for attendees.

In 2007, the national CDC invited me to meet with them in Ft. Collins, CO, where I spent the day with the Vector-Borne Disease Division which oversees Lyme and tick-borne diseases. I have just been invited back for another visit in June 2013. In 2012, I was invited to testify on the plight of patients worldwide before the Foreign Affairs Global Health & Human Rights Subcommittee Lyme hearing in 2012 in DC, since Lyme disease is now found in approximately 65 countries.

In its search for prevention and diagnosis of and a cure for Lyme disease, the LDA has funded dozens of research projects coast-to-coast at institutions including Columbia University College of Physicians & Surgeons, NJ Medical School, Fox Chase Cancer Center (PA), University of California, Davis, University of New Haven (CT), and Stony Brook University (NY), NY Medical College, Boston Medical, Rockefeller University, University of North Florida, Shenandoah School of Pharmacy (VA), and University of Rhode Island. The LDA has even provided research grants to the US Department of Agriculture for tick killing nematodes and to a researcher for a combined project under the NIH and NASA looking at lone star ticks.

Much of LDA-funded research has been featured in 29 peer-reviewed journal publications to date, including Journal of the American Medical Association (JAMA), Proceedings of the National Academy of Science, Emerging Infectious Diseases, Psychiatric Clinics of North America, Infection, Journal of Neuropsychiatry & Clinical Neurosciences, Journal of Clinical Microbiology, Journal of International Neuropsychological Society, Neurology, Immunology, Open Neurology Journal, Archives of General Psychiatry, Journal of Medical Entomology, Neurobiology of Disease, PLOS One, Gene, and Genetics.

In 2007, Columbia University in New York opened the Lyme & Tick-Borne Diseases Research Center, the first in the world devoted to the study of chronic Lyme disease. LDA co-funded the Center and has recently given a grant creating a tissue bank there to store samples for Lyme disease research, now ongoing. Genome work initially funded by LDA through University of Medicine & Dentistry has shown that different strains of Borrelia have the ability to exchange genetic material among themselves, a trait greatly benefiting their survival and probably confounding the body’s ability to eradicate the organism. LDA funding of genome mapping has led to 17 strains being mapped. The LDA has funded cutting edge published work with University of New Haven into the presence of Borrelia burgdorferi biofilms which may be one of the survival mechanisms of the Lyme organism even after long-term treatment.

The LDA has presented 13 fully CME accredited (continuing medical education) scientific conferences for researchers, doctors, and health care providers, featuring international speakers on the topic of Lyme and other tick-borne diseases, most jointly sponsored by Columbia University. The 14th LDA conference will be held at the University of Minnesota on June 1 & 2, 2013 with a faculty of 17, physicians & researchers, including one from Switzerland. The LDA website contains video clips of various conferences.

Since children ages 5-14 are at the highest risk of acquiring Lyme disease, the LDA created LymeAid 4 Kids, a fund that helps children without insurance. Initiated in conjunction with internationally acclaimed author Amy Tan, a Lyme victim, the LDA fund has awarded almost $250,000 in grants. LDA has compiled a website section, Lyme in the Schools, containing tools which can be accessed for free by schools, parents, and the general public. Resource articles, statistics, and an LDA educational PowerPoint, How A Tick Can Make You Sick, can be run for free in the classroom from the computer as can a prevention video for kids that the UMDNJ created in partnership with the LDA under an EPA grant. LDA’s book for children with chronic Lyme, Lyme Disease Is No Fun, Let’s Get Well! can be ordered on the site as can free pamphlet designed especially for parents and educators, The ABCs of Lyme Disease.

The LDA’s extensive resource list also includes free materials such as LymeR Primer, Tickmark, and Tick Card; National Case Map, Case Number Graphs, Personal & Property Prevention Posters, Symptoms’ Lists and at cost materials including conference DVDs, and books. The site also houses an extensive collection of tick and rash pictures and tick-borne microbes. Finding doctors who are experienced in treating tick-borne diseases is difficult, thus LDA created an automatic doctor referral system to help
people through the US and some other countries.

LDA has educated through public, school, corporate and government seminars. It has developed bill-boards including an electronic one on Times Square in 2012 featuring the spread of chronic Lyme worldwide and several in PA and MA. Annually, LDA awards education grants to many other Lyme groups, universities and other organizations to further their mission against tick-borne diseases.

If you require further information from me, do not hesitate to have your offices contact me at President@LymeDiseaseAssociation.org or 888-366-6611.

Sincerely,

Patricia V. Smith
President




DC – Oral Testimony, US House Global Health & Human Rights Committee

Congressman Smith and Members of the Global Health & Human Rights Committee,

Thank you for the opportunity to testify on a problem I’ve seen blossom from a regional to international issue. 27 years ago I saw the devastation in my school district caused by an unknown disease affecting staff and students. To educate myself and fellow school board members, I had to contact a nearby naval base, although many of my enquiries were returned with, that’s classified.

The past 20 years, I’ve traveled the country, 15 as president of the all-volunteer national non-profit Lyme Disease Association, listening to patients, scientists, doctors, and government officials. Through the perspective of Lyme, I’ve found some individuals charged with public welfare have lost their focus; instead of solving the problems of humanity, some have abrogated their responsibilities, affecting people worldwide.

Over time, I have heard Lyme called a housewife’s disease, a Yuppie disease, hard to catch, easy to cure; heard patients referred to as hysterical, faking, crazy, paranoid, even antibiotic seeking; and heard Lyme advocates portrayed as crazed-know-nothings responsible for mass hysteria over Lyme. Many US Lyme organizations and others have been victimized in peer review by noted researchers who do not agree that Lyme doctors should be permitted to use clinical judgment in treating Lyme, attacking those who are working tirelessly to raise research and education funds for Lyme disease advocates and patients. Many patients confide to me they would rather have cancer.

CDC and NIH have awarded grants to many of the same people, some for studies that rely on the strict CDC surveillance criteria for inclusion, including the use of faulty tests. Thousands of patients have questioned this practice and ask for studies which can provide solutions to their dilemmas as chronic Lyme patients: My doctor won’t treat me when I’m sick, No one believes my children and I are sick. A common refrain is, why isn’t the government doing anything about Lyme?

NIH funded several treatment studies, and the broad brushed conclusions put a nail in the coffin of Lyme patients. One could possibly conclude from the studies that specific treatments used by study participants over the length of the study were not effective for the restrictive population chosen for research purposes. Instead, conclusions became “no long-term treatment is effective for anyone with Lyme.” Many doctors in mainstream medicine who had treat to date, now turned a blind eye and deaf ear to patients with Lyme.

The CDC Lyme surveillance system is in shambles. CDC criteria have become stricter, reducing the patient pool for reported cases. Lyme surveillance is very labor intensive, including calling doctors to verify data. Human resources have been cut, forcing states to institute cost savings measures involving changing case reporting methods, affecting national and regional numbers.

Officials continue to declare there is ” no Lyme in the South/Midwest.” Reasons given for that stance range from: there are no deer ticks in the South; if there are deer ticks there, they are not infected with Lyme because there are no reservoir hosts in the South (those are small mammals that carry Lyme bacteria and transmit it to ticks who infect people); deer ticks in the South feed on lizards which do not transmit Lyme bacteria to ticks; deer ticks in the South behave differently; and deer ticks in the South do not bite people. Scientific studies do not support those conclusions, yet many physicians still refuse to diagnose and treat Lyme in the South, forcing patients to seek medical treatment in endemic areas of the country, adding to already overburdened medical practices.

Compounding the problem, the very strict Lyme definitions meant for surveillance only are abused by mainstream medicine, insurance companies, pharmacists, and even public officials who are charging moms with Munchausen’s by Proxy and taking away their children. Their crime? Having a licensed doctor prescribe antibiotics for their children’s Lyme.

On its website, CDC disclaims any responsibility , stating its criteria are for surveillance only. Its actions belie that position. CDC openly endorses the IDSA guidelines , featured on its website, guidelines written by researchers, not clinicians who care about patient outcomes. For example, IDSA guidelines recommend against any long term treatment with antibiotics, recommend against any alternatives, and recommend against supplements for Lyme patients. Patients have no treatment options open to them under these guidelines, even if they can find a doctor still willing to treat under the threat of license removal for exercising clinical judgment in treating Lyme.

The CDC surveillance criteria form the basis for the IDSA guidelines. Intertwined, inseparable, like strands of a rope, they form a noose around the neck of Lyme patients, sometimes leaving them die a very slow painful death without medical treatment. Even in death, there’s no rest for Lyme victims and their families. A published study examined 114 death certificates listing Lyme as a cause, and the researchers concluded ” most terminal events listed on death certificates for which Lyme was the underlying cause of death were inconsistent with the well
characterized complications of Lyme disease,” leaving only one death record standing as Lyme disease, a conclusion reached without even conducting medical chart reviews.

Researchers have concluded that Lyme causes more pain and suffering than osteoarthritis, myocardial infarction, and type II diabetes, but they still have not left patients any recourse, denying any clinical judgment in patients who otherwise have no treatment options. Since Lyme often affects more than one family member and those at the highest risk are the most defenseless, children ages 5-9, mothers often forgo their own treatment to save their children.

These same moms may find themselves accused of Munchausen’s by Proxy, a controversial diagnosis which blames parents for making their own children sick. I’ve advocated for parents and children whose schools accuse them of faking illness, despite reputable research showing a drop in IQ of 22 points in children with Lyme, rectified by antibiotic treatment. I have mourned with those families whose children committed suicide after leaving notes which said no one believed them to be sick, and they could not bear the pain of the disease and of the rejection.

This hearing provides a public forum for Lyme issues to be discussed before an impartial audience with the ability to initiate and implement changes. Whatever our differing viewpoints today, we all came to testify and be part of the solution. I came today as a grandmother of 4, trying to protect my granddaughters and others against the agonies of Lyme experienced by 2 of my daughters.

Yet, as I look around the room, I notice the absence of key players in Lyme, CDC, NIH, IDSA, who were invited to be part of the solution and instead chose to remain part of the problem, at the least, abrogating their responsibilities, at the worst, violating a basic tenant of medicine, first do no harm. They need to be brought to the table with patients, advocates, and treating physicians who have heretofore been locked out of the process, so that patients who suffer from Lyme can find treatment and the millions of potential victims worldwide can be spared the medical and political debacle we call Lyme disease. Thank you.

Patricia V. Smith, President, LDA July 17, 2012




PA – Senate Banking & Ins. Committee SB 1199

June 22, 2010   Patricia V. Smith, President, Lyme Disease Association, Inc.  

Testimony to: The PA Senate Banking & Insurance Committee

The Honorable Senator Donald C. White, Chairman

 

As background on Patricia V. Smith:

President, LDA
Strategic Advisory Board, Columbia University Medical Center Lyme & TBD Research Center
Advisor to Time for Lyme (CT) Former Chair, [NJ] Governor’s Lyme Disease Advisory
Council Washington DC- met with HHS, CDC, NIH, military
Invited to CDC Ft Collins, Vector-Borne Diseases Division (Lyme Program Headquarters)
Testified/invited to educate officials > dozen states
 
 

TESTIMONY: Thank you for the opportunity to testify favorably on Lyme disease bill SB 1199.

The Lyme Disease Association (LDA), an all-volunteer national non profit with 37 allied organizations nationwide, including a Pennsylvania affiliate, Chapter, and coalition, made the 2010 Combined Federal Campaign (CFC) as an approved national charity. Its 11th CME accredited scientific conference will be held in October in Philadelphia. 19 Pennsylvania children benefited from LDA’s LymeAid 4 Kids, providing children without insurance access to Lyme testing and treatment. LDA research grant recipients in Pennsylvania include Fox Chase Cancer Center, University of Pennsylvania, Edinboro University of Pennsylvania, and University of Pittsburg School of Nursing. LDA is an Environmental Protection Agency (EPA) PESP partner and network partner with EPA and CDC, developing measures to reduce exposure to Lyme disease. 
 

Lyme has been reported in all 50 states and 65 countries worldwide. According to the 2009 Armed Forces Health Surveillance Center report, confirmed cases of Lyme disease in the services were diagnosed at more than 120 military locations worldwide(i)

 

CDC states ages 5-9 are at the greatest risk of acquiring Lyme(ii),  the most prevalent vector-borne disease in the US. From 1990-2008, CDC reported 51,266 cases of Lyme in Pennsylvania, a number including my late parents. Only 10% of cases meeting CDC’s narrow surveillance criteria are reported, thus, more than 1/2M (512, 660) cases occurred in PA − not counting those clinically diagnosed, who most often develop chronic Lyme disease. 

 

Treating doctors estimate 15-20% of patients develop chronic Lyme disease − one study shows that that the impact of Lyme disease on physical health was at least equal to the disability of patients with congestive heart failure and osteoarthritis(iii). Many of these patients, often multiple family members(iv) now have to travel many hours outside Pennsylvania to find care. They don’t have the resources to fight the vested interests stacked against them, which is why legislation is necessary to protect doctors who treat, ensuring that in-state treating doctors can’t be prosecuted solely for providing necessary long-term treatment.

 

 




DC – IOM Lyme Disease Panel Statement

April 29, 2010   Patricia V. Smith, President, Lyme Disease Association, Inc.  

Testimony to:  Institute of Medicine (IOM)

I’m Pat Smith, president of the national non profit Lyme Disease Association which funds research and education grants, partners with the Environmental Protection Agency PESP Program on prevention for high risk groups including children and which collaborated to open a Lyme disease research center at Columbia University. LDA works with 36 organizations nationwide on Lyme disease.

I would like to spend my five minutes talking about the science, but in good conscience, I can’t do that and need to also address the process issues.

2010 Labor HHS appropriations language adopted by Congress clearly directs this IOM process. NIH assured me in discussions that the process would be one that Lyme organizations would find in compliance in every way with the intent of that language, including a guarantee that this process would be totally open and public. IOM told me that adequate time would be allotted so that all public comment would be heard. The only public comment time is 5 minutes, hardly adequate to cover crucial topics that need addressing and has even discouraged those geographically distant from attending.

Instead of providing an unbiased panel on this most controversial topic, IOM indicates bias is not relevant thus isn’t considered in panel selection. However, balance is stressed by IOM, yet the chosen panel does not represent the diverse viewpoints that exist on selection and interpretation of existent scientific Lyme research. Several individuals are clearly associated with entities that hold preconceived ideas about Lyme, especially chronic Lyme. LDA and other organizations sent IOM recommendations for panel
members, none of whom were selected, and later sent concerns about imbalance in the chosen panel, including recommendations to provide that balance. That issue has not been addressed to date.

We also articulated concerns that anonymous reviewers will be allowed to present input on the panel report. “As a final check for quality and objectivity, all IOM reports undergo an independent external review by a second, independent group of experts whose comments are provided anonymously to the committee members.” According to an IOM official “The reviewers will not sign their names to their reviews and thus, be free to review the report as they read it. The committee responds to the review and the final report is published.” The panel and public are unaware of reviewers’ identities until after
the fact and unaware of which reviewers provided which comments. It is unclear if the outside review itself is made public. Bottom line, the concepts of transparency and accountability go by the wayside.

Appropriations language requires the September meeting to address the state of the science. To that end, we want to ensure that science considered not only includes basic science, animal model, human clinical trial, but also clinical evidence from practicing physicians, a group that has been under represented in the Lyme disease science to date.

Additionally, it is important that the panel consider limitations of any evidence presented even that from controlled trials created by small sample sizes and whether the study’s findings

Are compromised by loss to follow-up

Are consistently confirmed by other studies,

Are clinically relevant,

Lack generalizability due to restrictive sample selection criteria,

Are statistically meaningful, and whether

Its conclusions are supported by the findings or represent the author’s opinion.

We believe the following areas of science require inclusion in the September public workshop session. Testing is of priority importance, since its sensitivity remains in question. Peer review and other data [1]supports the conclusion that the recommended ELISA does not pick up enough patients to be a screening test, with issues of timing of the test, antibody/antigen complexes,[2] effect of treatment on test results, strain variations, and other factors.[3] Persistence of infection needs to be explored, including
in-depth examination in animal models of mechanisms of persistence and [4] , [5] , [6] establishment of criteria for a specimen bank that includes samples inside and outside the CDC criteria.

At the workshop’s conclusion, please ensure that all diverse viewpoints are included in any report, areas of divergence are identified, the limits of the existing science are demarcated, and research opportunities are highlighted. In addition, all information provided to the panel and the identity of the contributing source of that material should be made public.

We believe that no information should be anonymously provided to the panel given the highly polemic nature of this debate. Also, since the intent is state of the science, the conference summary should be related to what is lacking in the science area, and gaps and limitations in science should not be filled with expert opinion of the panel. In short, this is not a consensus conference, the science is still unfolding, and it would be irresponsible for anyone to “call” the science. Thank you.


[1] According to a letter from the NY DOH to the CDC, if NY had followed the 2-tier testing requirement
for a particular year─ a + ELISA then followed by Western Blot─ 81% of non-EM cases would not have
been confirmed.

[2] S. Schutzer et al, Lancet 1990, Journal of Clinical Investigation 1994 & JAMA Vol 282, No. 20
Borrelia Burgdorferi: Specific Immune Complexes in Acute Lyme Disease, Nov. 24, 1999; also in JCI

[3] P. Coulter et al, J. Clin Microbiol.. 2005Oct.; 43(10): 5080-4 Two Year Evaluation of Borrelia
burgdorferi Culture and Supplemental Tests for Definitive Diagnosis of Lyme Disease

[4] S.W. Barthold et al, Infection and Immunity, Aug. 2006 Antibody-Mediated Disease Remission in the
Mouse Model of Lyme Borreliosis

[5] RK. Straubinger Journal of Clinical Microbiology, June 2000, PCR-Based Quantification of Borrelia
burgdorferi Organisms in Canine Tissues over a 500-Day Postinfection Period

References and further reading may be available for this article. To view references and
further reading you must purchase this article.

[6] M Embers, MT Philipp et al, Microbes and Infection, 2004 Survival strategies of Borrelia burgdorferi,
the etiologic agent of Lyme disease
 




RI- School Legislation Testimony 2010

March 10, 2010

Dear Mr. Chairman,

We all have a responsibility to protect our children, and Lyme disease numbers have risen and its spread has increased, with it now being found in 65 countries worldwide. Currently, awareness is the only tool we have to prevent further disease and to ensure that those who are at the highest risk take precautions against acquiring Lyme disease.

At this time, I respectfully request that you examine the suggested wording changes for inclusion in this bill. If I can be of further service, I can be reached at Lymeliter@aol.com, and the LDA Rhode Island Chapter can be reached at jumerol@yahoo.com.


Thank you.


Patricia V. Smith
President

LDA Support for MN Bill – HF 2597

The Honorable John Ward
533 State Office Building
100 Rev. Dr. Martin Luther King Jr. Blvd.
Saint Paul, Minnesota 55155

Dear Representative Ward,

I was pleased to have the opportunity to speak with you when I traveled to Minnesota last summer to take part in the Senator briefing hosted by Senator Marty on the Lyme disease physician protection bill. I am writing now to express the support by the Lyme Disease Association for HF 2597, of which you are Chief Author.

As you may already know, the Centers for Disease Control and Prevention (CDC) reported numbers which show that confirmed cases from Minnesota represented close to 4% of the total reported confirmed cases for the US for 2008, a startling statistic indeed. The 1,046 confirmed cases in Minnesota for 2008 translate into10,460 actual cases in Minnesota, as the CDC indicates reported cases numbers are about 10% of actual cases that meet their surveillance criteria—neither of those numbers include clinically diagnosed cases by the way.

According to an IDEXX Reference Lab (veterinary) survey over a roughly 6 year period ending early in 2007, 15,782 canine cases of Lyme disease occurred in Minnesota with over 500 cases in dogs found in each of 14 counties, and many other counties with lesser numbers of cases. During the same period, 15,153 Minnesota dogs were positive for anaplasmosis, a disease transmitted by the same deer tick that transmits Lyme disease.

The military is obviously concerned about Lyme disease in the State. To monitor the prevalence of tick-borne diseases such as Lyme, Camp Ripley has implemented a Lyme Disease Risk Assessment Survey partnering with the Mayo Clinic, the U.S. Army Center for Health Promotion and Preventative Medicine, the University of Minnesota and the Minnesota Department of Health. The Camp has the largest database on tick infestation in the State of Minnesota.

It is imperative that those who develop a Lyme disease infection get diagnosed and treated early to avoid chronic Lyme disease. Congress has recognized the seriousness of Lyme and its chronic nature in the recently enacted “Fiscal Year 2010 Labor, Health & Human Services, Education Appropriations bill.” Report language in the appropriations in the area of the CDC includes “Lyme Disease- The Committee encourages CDC to expand its activities related to developing sensitive and more accurate diagnostic tools and tests for Lyme disease, including the evaluation of emerging diagnostic methods and improving utilization of diagnostic testing to account for the multiple clinical manifestations of acute and chronic Lyme disease; CDC was also given an additional $3.6 million toward its work on Lyme disease including the above language.”

In the section on the National Institutes of Health, NIAID, “The Committee encourages the NIAID to sponsor a scientific conference on Lyme and other tick-borne diseases that would represent the broad spectrum of scientific views on Lyme disease and include input from individuals with Lyme disease. The Committee also encourages NIH to intensify research that will increase understanding of the full range of Lyme disease processes and the physiology of Borrelia burgdorferi, including the mechanisms of persistent infection, and research that may lead to the development of more sensitive and accurate diagnostic tests for Lyme disease capable of distinguishing between active and past infections.”

It is clear that Congress, including, US House of Representatives Appropriations Committee Chair Dave Obey of neighboring Wisconsin, recognizes the seriousness of Lyme disease, the chronic and persistent nature of the disease, and the problems associated with the current tests. The testing is precisely why this physician protection bill is necessary − physicians need to treat based on clinical judgment.

As the national patient organization which serves as an umbrella for 34 organizations, one in Minnesota, LDA strongly supports this legislation and the benefits it will provide for patients, who have had the “deck stacked against them” from the beginning of this disease by those with vested interests.

Lyme patients have the right to be treated with the standard of care they choose. Over 41,000 people have signed the LDA petition against the Infectious Diseases Society (IDSA) guidelines, which have become de facto law and prevented patient diagnosis, treatment, and clinical judgment by physicians. The Guidelines process was investigated by the Attorney General of Connecticut (AG), a settlement was reached by the IDSA and the AG, with IDSA agreeing to review the guidelines with a new panel. Now it appears from documents “FOIAed” (Freedom of Information Act) on behalf of patients, that the IDSA has violated the terms of the settlement agreement and substituted its own panel voting arrangement for that found in the settlement agreement. The example of improper voting given by the AG concerns the testing guideline, the one which holds so much power over patient lives.

Right now, you have an opportunity to level the playing field, prevent development of chronic disease, and help those who already suffer from chronic Lyme disease lead productive lives. It’s a win-win situation.

Thank you on behalf of patients in Minnesota and everywhere.


Sincerely,

Patricia V. Smith

Lyme Disease Association, Inc.

PO Box 1438, Jackson, New Jersey 08527  

 888-366-6611  Lymeliter@aol.com  732-938-7215 (Fax)

LymeDiseaseAssociation.org

 


(i) http://www.dogsandticks.com/

(ii) http://www.minnesotanationalguard.org/campripley/envir/overview/extras/es_award1.pdf

 

 

 




PA – House Majority Policy Comm. Hearing

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Testimony/Recommendations to: The House Majority Policy Committee Hearing on Combating Lyme Disease Dec. 2, 2009 Worcester PA

Representative Mike Sturla, Chairman; Representative Matthew Bradford, Host

Thank you all for the opportunity to testify on this very important issue, Lyme disease.

As background: The Lyme Disease Association (LDA) is all-volunteer national non profit devoted to education, research funding, prevention & patient support. It has 34 allied organizations nationwide, including a PA affiliate, LDASEPA, and a PA Chapter, which primarily focuses on education. LDA is part of the 2009 Combined Federal Campaign (CFC) as a national charity. We have presented 10 fully CME accredited scientific conferences, 8 jointly sponsored by Columbia University, 3 held in Philadelphia, which is also being considered as our 2010 conference venue.

LDA’s LymeAid 4 Kids fund, developed with author Amy Tan, dispenses money for children without insurance − 19 Pennsylvania children have benefited to date from this fund. LDA provides research grants coast-to-coast and has funded several projects in Pennsylvania connected to researchers at Fox Chase Cancer Center, University of Pennsylvania, Edinboro University of Pennsylvania, and University of Pittsburg School of Nursing and has partnered with its CT affiliate, TFL, to endow the first center in the world at Columbia to study chronic Lyme in 2007. That same year, I was invited to speak at Ft. Collins, Colorado, to the Centers for Disease Control & Prevention’s (CDC) Vector-Borne Diseases Division where Lyme is studied.

LDA is an Environmental Protection Agency (EPA) PESP partner and sits on a working group with EPA and with CDC. We are currently developing measures to help reduce children’s exposure to Lyme disease. We hope to use existing tools such as the LDA website which is also linked with EPA’s site, to provide parents with educational materials to complement an EPA-funded prevention video and an interactive video game for kids being developed by NJ Medical School in collaboration with LDA. The parent materials may contain links to composition/effectivity of pesticides and property management techniques for schools. We are also seeking to publish with the National Association of School Nurses, possibly using existing publications to publish the prevention message to schools.

A CDC study of New Jersey children K-12 with Lyme showed the median number of missed school days was 140; median duration of home instruction, 153 days; 78% of parents said their children experienced a fall in grade point average during illness; 79% experienced a decrease in friends; “…isolated from social groups and missing out on cultural, sports and social activities….School performance of nearly all patients fell sometimes drastically, and in several instances, was said to interfere with selection by colleges and universities.”i A study at Columbia demonstrated a drop of 22 IQ points in a student with Lyme disease, later reversed with treatment.ii

According to CDC, boys & girls ages 5-9 are at the greatest risk of acquiring Lyme,iii the most prevalent vector-borne disease in the US today, reported in all 50 states. From 1990 through 2008, PA ranked #2 nationwide with 51,266 reported Lyme cases. CDC states only 10% of cases that meet CDC surveillance criteria are reported,iv meaning over 1⁄2 million (512,660) PA residents developed Lyme that met the surveillance criteria over that time, a number that includes my now late parents.

That number is only a fraction of cases that probably occurred, since CDC’s surveillance criteria are meant for comparing cases of Lyme in one state to another and don’t include cases clinically diagnosed by physicians − meaning cases without an EM rash or without a positive test. Numbers in PA are sharply rising, with 2009 numbers already more than double 2008 total numbers (7,540/3602).

The situation isn’t likely to improve soon. Deforestation, increase in deer herds and climate changes are said to be contributing to increased tick populations and expanded tick ranges, increasing disease burden. According to Penn State College of Agricultural Sciences, a 1960’s survey in PA identified 20 tick species in-state, with deer ticks found only in Philadelphia County. Furthermore, in the late 80s, deer ticks were mostly limited to the southeast corner, the north central region around Elk State Forest and the Presque Isle peninsula in Erie but now they are established in more areas around the state and 25 species have been identified.

Ninety percent of tick identification submissions to Penn State consist of 4 ticks, 3 of which transmit many tick-borne diseases to humans:
1) American dog tick (RMSF, tularemia, ehrlichiosis, tick paralysis);
2) blacklegged tick [deer tick] (Lyme, babesiosis, anaplasmosis, Powassan encephalitis, tick paralysis, tularemia, bartonellosis); and
3) lone star tick (ehrlichiosis, tularemia, RMSF, tick paralysis, Q fever, and STARI). Southern Tick- Associated rash illness (STARI), looks and acts like Lyme, sometimes has the same bull’s eye rash, is treated the same way, but there is no test for it. The lone star tick is much more aggressive than a deer tick and will stalk you from 50 feet away. Tick-borne diseases are increasing in general, but Lyme itself increased 250% nationwide from 1993 through 2008.

Lyme is now found in 65 countries worldwide. A UN commissioned study indicates ticks in Sweden have moved almost as far north as the Arctic Circle and are being found in January. Reports from researchers and patients seem to confirm that latter finding in the Northeast. In January 2005, my daughter pulled a fully engorged deer tick off my then 5-year old granddaughter’s ear. It was 25°.

Two items greatly influence the ability and willingness of doctors to diagnosis and treat Lyme patients, including children − the first is the CDC surveillance criteria. Despite CDC’s warning that the surveillance criteria are NOT intended for diagnosis, treatment, or insurance reimbursement, but are only intended for disease surveillance reporting, most doctors are inappropriately using them to diagnose and treat and insurance companies are using them to deny treatment reimbursement. The CDC criteria for an endemic region are: an EM rash (plus a required test in a non-endemic region), OR major system involvement plus positive blood work.

Although CDC criteria are for surveillance purposes only, patients who do not meet that criteria must scramble to find physicians willing to risk making a clinical diagnosis for Lyme disease, one based on symptoms, history, ruling out other diseases, one which does not require a positive test for diagnosis. Problems about diagnosis are fueled by unreliable Lyme testing that is 40-60% accurate, v and by the fact that less than 50% of people develop the classic bull’s eye rash. vi

The second item influencing doctors’ ability and willingness to treat is the Infectious Diseases Society of America (IDSA) Lyme treatment guidelines (“Guidelines”). They recommend against any long-term treatment for chronic Lyme; against entire classes of antibiotics; against alternative treatments; against some supplements; and against individual physician discretion in diagnosis and treatment. IDSA says there is NO chronic Lyme disease.

Despite a disclaimer that says they are NOT mandatory, actual experiences demonstrate the Guidelines have become de facto law. Medical boards, health departments, hospitals, insurers, schools, pharmacists, and IDSA doctors themselves often hold that position, leading to doctor prosecution and inability of patients to get medical care for Lyme disease. The abuse has been so blatant that Connecticut State Attorney General Richard Blumenthal initiated an investigation of the IDSA Guidelines’ development process.

In a 2008 settlement Agreement with IDSA, Mr. Blumenthal stated: “This agreement vindicates my investigation−finding undisclosed financial interests…held by several of the most powerful IDSA panelists.  The…panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science…The IDSA’s Lyme guideline process lacked important procedural safeguards….”vii IDSA had to form a new panel, which heard testimony in July 2009, re-looking at the guidelines, but it again excluded chronic Lyme treating doctors as panel members.

There are other Lyme treatment guidelines which differ from IDSA’s, which do allow doctor discretion in diagnosis and treatment, and do recognize that Lyme sometimes requires more than a short course to make people better. They provide the basis for a second standard of care for Lyme disease. Published by the International Lyme & Associated Diseases Society (ILADS), a professional medical and research organization,viii they’re ignored by IDSA and often not disclosed as an option by doctors to patients. They are published on the Department of Health and Human Services National Guidelines Clearing House website, recognizing them as being evidenced-based.ix

ILADS’ approach recognizes that patients who are not diagnosed quickly or not treated appropriately can become chronically ill− one study shows that Lyme patients suffer a degree of disability equal to that of patients with congestive heart failure.x Yet many of these patients, often multi-members of one family,xi now have to travel many hours outside Pennsylvania to find care for their Lyme. They don’t have the resources nor the health to fight the vested interests stacked against them, which is why legislation is often necessary to protect doctors who treat, ensuring that in-state treating doctors cannot be prosecuted for unprofessional conduct solely for providing long-term treatment based on clinical judgment. Rhode Island, Connecticut and California have passed protective legislation. Massachusetts, Minnesota, and Pennsylvania have introduced it, with another state about to do so.

Despite two standards of care for Lyme, physicians continue to be monitored by insurance companies who say stop prescribing antibiotics for Lyme disease or leave the insurance plan. Some doctors then leave the plan voluntarily, others are forced out. Some continue treating patients without accepting insurance. Other physicians fear scrutiny from the insurance companies and stop treating Lyme disease entirely, leading to a scarcity of physicians.

Patients lack of insurance coverage leads to limited courses of antibiotics, often not effective in eradicating the Lyme bacterium, which has the ability to hide inside cells, kill human lymphocytes and certain B cells and to change into other forms. Legislation requiring insurance companies to cover patients for Lyme treatment has been passed in Rhode Island and Connecticut and has been introduced in Pennsylvania. The legislature should pass Pennsylvania Lyme bills HB 894 & SB346 which provide for doctor protection, insurance coverage, and creation of a task force.

Most of the opposition to Lyme doctor protection legislation comes from the IDSA itself. You have heard how doctors who don’t follow IDSA Guidelines but use their own clinical skills to diagnose and treat face medical board discipline, hospital privilege/post revocation, and insurance plan exclusion if they do not march lockstep with IDSA, creating a “chilled” treatment climate.

IDSA sometimes cites development of antibiotic resistance for opposing legislation, despite resistance most often developing due to under usage rather than over usage of antibiotics. The Union of Concerned Scientists feels a significant cause of resistant bacteria may be an estimated 70% of antibiotics in the U.S. being fed to healthy pigs, cows, and chickens to promote growth and prevent disease.xii Antibiotic resistant strains often spread due to improper hygiene by medical personnel in hospitals. IDSA also ignores the fact that other diseases are allowed long-term treatment with antibiotics including tuberculosis, Q fever endocarditis, and even acne. Terribly sick Lyme patients are singled out to be left without treatment because of undocumented accusations of resistance due to treating sick people.

IDSA even opposes federal legislation (HR 1179 C. Smith [NJ] 86 co-sponsors, S 1352 C. Dodd [CT] 8 co-sponsors), Lyme & Tick-Borne diseases Prevention, Research and Education Act 2009, which provides much needed research funds − $100M over 5 years, particularly for an accurate test to help resolve many Lyme-related issues. IDSA indicates they do not like the constitution of a Lyme and tick- borne diseases federal advisory committee created by the bills because it contains patient and treating physician reps with different viewpoints, although many other diseases have that type of panel.

Following IDSA Guidelines can lead to delayed diagnosis and treatment. According to an actuarial study on Lyme costs, “37% of the financial costs of this disease is incurred before the correct diagnosis is made.” xiii A delay in diagnosis also leads to more chronic disease since the Lyme bacterium can get into the brain within 24 hours of a tick bite.xiv Chronic Lyme is more costly to patients physically, mentally, and financially. According to a 1998 CDC journal study, early Lyme costs* averaged $161 per patient and neurologic longstanding Lyme disease averaged $61,243.xv Chronic Lyme is also more costly to the state and federal government in terms of disability and education e.g., special services, home instruction, substitute teachers. xvi Allowing doctor discretion in diagnosing and treating can cut costs and most importantly, human suffering.

In 2009 LDA and its partner groups were successful in having language included in the US House Appropriations bill which passed the full House and includes the terms “chronic Lyme disease” and “persistence.” The language also passed the Senate Committee and is awaiting full Senate vote. Full passage will help Lyme patients receive the medical treatment they require.

Besides legislation, public and physician education is very important. LDA just received a copy of a letter from a western PA physician to his patient. The patient was bitten by something and had a possible bull’s eye rash. The doctor was unsure if Lyme was even in the county, checked with health department officials who said the reported cases there were not from within the county, although how that was determined is not stated. He thus determined Lyme was probably not endemic there. The doctor requested supporting info from the patient about Lyme in the area, although he did prescribe a minimal dose of medication. A quick check by me of the canine cases in that county reported by an IDEXX Veterinary Labs survey, an LDA corporate partner, shows 122 Lyme cases there in dogs, which are sentinels for the disease.

To help states educate and combat against tick-borne diseases, LDA has developed a table of general recommendations for states:

2009-12-02 PA HouseMajPolicyComm1

2009-12-02 PA HouseMajPolicyComm2

On Thanksgiving at my home last week, 4 of the 12 adults had been diagnosed with Lyme disease, 2 from NJ, 2 from PA. Another from PA will probably be diagnosed with Lyme and/or another tick-borne disease called anaplasmosis. All states need to take actions to prevent the further spread of Lyme and other tick- borne diseases which are devastating entire families and to help those already infected. No one is safe from these complicated infections.

Thank you.

 

i David Dennis, CDC, presented study in Wall Township, NJ, October 1992, Congressional meeting. Later pub. Lyme Times Children’s Educational Issue, ed. CALDA, Summer 2006.
ii Brian Fallon MD The Underdiagnosis of Neuropsychiatric Lyme Disease in Children & Adult, The psychiatric Clinics of North America, Vol.21, No.3, Sept.1998.
iii Centers for Disease Control & Prevention, Average Annual Incidence of Reported Cases of Lyme Disease by Age Group & Sex, http://www.cdc.gov/ncidod/dvbid/lyme/ld_MeanAnnualIncidence.htm.
iv Paul Meade, CDC, Herald News 5-4-04, Jessica Adler.
v P. Coulter et al, J. Clin Microbiol. 2005 Oct.; 43(10): 5080-4 Two Year Evaluation of Borrelia burgdorferi Culture and Supplemental Tests for Definitive Diagnosis of Lyme Disease. Lancet 1990, Journal of Clinical Investigation 1994 & S. Schutzer et al, JAMA Vol 282, No. 20 Borrelia Burgdorferi:Specific Immune Complexes in Acute Lyme Disease,Nov. 24,’99
vi R. Smith et al, Annals of Internal Medicine 2002;421:421-428, 477-479; A. Pachner, Reviews of Infectious Diseases-Vol. II, supplement 6 – September- October 1989 Neurologic Manifestations of Lyme Disease, the new “Great Imitator”; J.M. Johnson, Ph.D., Chief, Public Health, NPS Ticks and Disease. vii Office of the Connecticut Attorney General, press release, May 1, 2008.
viii Daniel Cameron, et al, Expert Review of Anti-infective therapy 2(1) Suppl. 2004
ix AHRQ, http://www.guideline.gov/.
x Connecticut Agricultural Experiment Station, “Summary of Tick Testing Results for 2003.” www.caes.state.ct.us.
xi CDC unpub. study data presented in Congressional forum, Wall NJ Oct 1992 (Later pub. in Lyme Times)
xii http://www.ucsusa.org/food_and_environment/antibiotics_and_food/myths-and-realities.
xiii Irwin Vanderhoof, Lyme Disease the Cost to Society, Contingencies January/Februray 1993.
xiv Steere, Allen, Mandel, Douglas, and Bennett’s Principals & Practices of Infectious Diseases, 4th ed. 1995. xiv Martin I. Meltzer The Cost Effectiveness of Vaccinating against Lyme Disease CDC Emerging Infectious Diseases; Vol.5, No.3; 1999 May-June;5(3)321-8. * This is in 1996 costs not adjusted. The following additional significant costs to society aren’t measured by this table: special education needs for children, disability, increased medical and insurance costs, and livestock losses, etc. Also, there are personal loses: friends, employment, self, esteem, domicile, and breakup of families.
xv Martin I. Meltzer The Cost Effectiveness of Vaccinating against Lyme Disease CDC Emerging Infectious Diseases; Vol.5, No.3; 1999 May- June;5(3)321-8. * This is 1996 costs not adjusted to 2007. The following additional costs to society aren’t measured by this table: special education needs for children, disability, increased medical and insurance costs, and livestock losses, etc. Also, there are personal loses: friends, employment, self, esteem, domicile, and breakup of families.
xvi Patricia Smith, Wall Township, NJ, Board of Education member NJ School District Study on Impact of Lyme Disease on School Districts presented in Washington DC Congressionally hosted meeting with CDC & NIH, March 12, 1992.

*LDA recommends that State agencies consult with patient groups within state and/or the national LDA to provide input into these areas since these groups can often provide a perspective the State does otherwise not have access to, and they can provide feedback from solutions other states may have attempted/implemented. ©Lyme Disease Association, Inc. 2005 www.LymeDiseaseAssociation.org PO Box 1438 Jackson, NJ 08527 888 366 6611





MA – Spoken Testimony, Public Health Comm.

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Spoken Testimony September 22, 2009
Before the Massachusetts Public Health Committee September 22, 2009
Patricia V. Smith, President

In 2008, Massachusetts jumped to number two in national reported case numbers. The situation isn’t likely to improve soon. Climate changes are contributing to increased tick populations and expanded tick ranges, increasing disease burden. According to University of Massachusetts researcher Steven Rich who discovered deer ticks halfway up Mount Greylock, one of the coldest areas in state: ”Deer ticks used to be limited primarily to a 15-mile zone along the coast of New England….Now they are moving much farther inland as they seemingly adapt to the cold.”

In January 2005, my 5 year old granddaughter had a fully engorged deer tick behind her ear. It was 25°. Lyme is hitting our children ages 5-9 the hardest, according to CDC. A CDC study of 65 children with Lyme showed the median missed school days at 140, with median duration of home instruction, 153 days and 78% of children’s grade point average fell. A Columbia study documented a 22 point drop in IQ, reversed with treatment.

Two documents greatly influence ability and willingness of doctors to treat Lyme patients, including our children − the first being CDC surveillance criteria. Despite CDC’s warning that Lyme surveillance criteria are NOT intended for diagnosis, treatment, or insurance reimbursement but only for disease reporting, most doctors inappropriately use them to diagnose and treat. Patients not fitting the surveillance criteria scramble to find doctors willing to risk making a clinical diagnosis for Lyme disease, one based on symptoms, history, ruling out other diseases, one which does not require a positive test for diagnosis—necessary due to unreliable tests and often no bull’s eye rash.

The second document is the Infectious Diseases Society of America (IDSA) guidelines which are meant for diagnosing and treating. They recommend against any long-term treatment for chronic Lyme; against entire classes of antibiotics; against alternative treatments; against some supplements; and against individual physician discretion in diagnosis and treatment. IDSA says there’s NO chronic Lyme disease. Despite a disclaimer that they are only guidelines, experience demonstrates they have become de facto law. The misuse by medical boards, health department, hospitals, insurers, schools, pharmacists, IDSA doctors themselves, is so blatant that Connecticut Attorney General Richard Blumenthal felt compelled to legally investigate the IDSA Guidelines’ process citing conflicts of interest and exclusionary conduct.

Patients are often delayed in getting or unable to get diagnosed and treated due to these rigid guidelines, leading to increased chronic Lyme and higher costs. An actuarial study showed 37% of cost is incurred before the correct diagnosis is made. A CDC journal cited average early Lyme per patient costs at $161 and neurologic longstanding Lyme $61,243. Chronic Lyme is more costly to government in terms of disability and education e.g., special services, home instruction Permitting doctor discretion in this bill can cut costs and most importantly, human suffering.

Other Lyme treatment guidelines allowing doctor discretion, recognizing the need for longer term treatment, addressing early infection and chronic disease, provide the basis for a second standard of care. Published by the International Lyme & Associated Diseases Society (ILADS), they’re ignored by IDSA, not disclosed as a treatment option by most doctors, and used as a basis by medical boards to charge doctors who treat under them. Yet they’re published on the Department of Health and Human Services National Guidelines Clearing House website, recognizing them as being evidenced-based.

One study shows Lyme patients suffer a degree of disability equal to patients with congestive heart failure. These same patients now have to travel many hours outside Massachusetts to find care for Lyme. They don’t have the resources nor health to fight the vested interests stacked against them, thus the need for legislation−ensuring that in-state treating doctors cannot be prosecuted for unprofessional conduct solely for providing long-term treatment based on clinical judgment. Rhode Island, Connecticut, and California have passed doctor protection legislation, others are considering it.

Passing a doctor protection bill levels the playing field by providing treating physicians with a measure of protection they are entitled to, since there are two standards of care. Doctors should not be penalized for following the standard that best improves patient health. This bill DOES NOT mandate treatment of any kind but does allow clinical discretion. Massachusetts owes it to physicians and patients. Thank you.


Endnotes


iRecorder.com, July 30, 2007.
iiCenters for Disease Control & Prevention, Average Annual Incidence of Reported Cases of Lyme Disease by Age Group & Sex, http://www.cdc.gov/ncidod/dvbid/lyme/ld_MeanAnnualIncidence.htm.
iiiBrian Fallon MD The Underdiagnosis of Neuropsychiatric Lyme Disease in Children & Adult, The psychiatric Clinics of North America, Vol.21, No.3, Sept.1998.
ivBrian Fallon MD The Underdiagnosis of Neuropsychiatric Lyme Disease in Children & Adult, The psychiatric Clinics of North America, Vol.21, No.3, Sept.1998.
vIrwin Vanderhoof, Lyme Disease the Cost to Society, Contingencies January/Februray 1993.
viMartin I. Meltzer The Cost Effectiveness of Vaccinating against Lyme Disease CDC Emerging Infectious Diseases; Vol.5, No.3; 1999 May-June;5(3)321-8.
         * This is in 1996 costs not adjusted to 2007.  The following additional significant costs to society aren’t    measured by this table: special education needs for children, disability, increased medical and insurance costs, and livestock losses, etc. Also, there are personal loses: friends, employment, self, esteem, domicile, and breakup of families.

viiPatricia Smith, Wall Township, NJ, Board of Education member NJ School District Study on Impact of Lyme Disease on School Districts presented in Washington DC Congressionally hosted meeting with CDC & NIH, March 12, 1992.
viiiDaniel Cameron, et al, Expert Review of Anti-infective therapy 2(1) Suppl. 2004
ixAHRQ, http://www.guideline.gov/.
xMark S. Klempner, M.D., TWO CONTROLLED TRIALS OF ANTIBIOTIC TREATMENT IN PATIENTS WITH PERSISTENT SYMPTOMS AND A HISTORY OF LYME DISEASE, N Engl J Med, Vol. 345, No. 2 July 12, 2001




MA – Written Testimony, Public Health Comm.

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Written Testimony for the Massachusetts Public Health Committee September 22, 2009

Co-Chairs and Committee Members,
Thank you for the opportunity to testify on this very important legislation, H.1148, Hargraves.

As background: Lyme Disease Association (LDA) is all-volunteer national non profit devoted to education, research, prevention & patient support and has 34 allied organizations nationwide. It’s registered in Massachusetts & has a Chapter on Cape Cod, which has presented many Lyme disease in-services in the Massachusetts schools. LDA and TFL, its CT affiliate, opened the first center in the world to study chronic Lyme at Columbia University in 2007. LDA’s LymeAid 4 Kids fund, developed with author Amy Tan, dispenses money for children without insurance − 17 families here in Massachusetts have benefited from this fund. I have spoken at several public forums here and in 2005 was invited by then Joint Health Chair Koutoujian to sit on an Ayer panel to hear Lyme patient stories and later to testify before the Joint Health Committee in Boston. LDA hosted its 8th scientific conference in Boston in 2007, jointly sponsored with Columbia University. Its 10th on Oct 23 outside DC, features 14 faculty presenters including CDC’s Chief of the Vector-Borne Division and two professors from Harvard. LDA is on the federal government approved charities list as part of the 2009 Combined Federal Campaign and is an Environmental Protection Agency PESP partner.

According to CDC, from 1990 through 2008, Massachusetts had 21,196 reported cases of Lyme. CDC states only 10% of cases that meet CDC surveillance criteria are reported, which means that 211,960 Massachusetts residents developed Lyme that met the surveillance criteria over 18 years. Those numbers are only a fraction of cases that probably occurred, since CDC’s surveillance criteria numbers are meant for comparing one state to another. They don’t include cases clinically diagnosed by physicians − meaning cases without an EM rash or without a positive test.

The situation isn’t likely to improve soon. Climate changes are contributing to increased tick populations and expanded tick ranges, increasing disease burden. According to University of Massachusetts NIH-funded researcher Steven Rich who discovered a thriving population of deer ticks halfway up Mount Greylock, one of the coldest areas in the state: ”Deer ticks used to be limited primarily to a 15-mile zone along the coast of New England….Now they are moving much farther inland as they seemingly adapt to the cold.” Confirmation of that observation comes from a UN commissioned study which indicates ticks in Sweden have moved almost as far north as the Arctic Circle and are being found in January.

In January 2005, my daughter pulled a fully engorged deer tick from behind the ear of my then 5-year old granddaughter. It was 25°. According to CDC, increased case numbers are hitting our children the hardest−at highest risk combined boys & girls 5-9. A CDC study of 65 New Jersey children K-12 with Lyme showed the median number of missed school days was 140, with median duration of home instruction, 153 days. 78% of parents said their children experienced a fall in grade point average during illness. 79% experienced a decrease in friends; “…often, patients spent large blocks of time as semi-invalids, isolated from social groups and missing out on cultural, sports and social activities….School performance of nearly all patients fell sometimes drastically, and in several instances, was said to interfere with selection by colleges and universities.” A study at Columbia demonstrated a drop of 22 IQ points in a student with Lyme disease, later reversed with treatment.

Two documents greatly influence the ability and willingness of doctors to treat Lyme patients, including our children − the first is the CDC surveillance criteria. Despite CDC’s warning that Lyme surveillance criteria are NOT intended for diagnosis, treatment, or insurance reimbursement but only for disease reporting, most doctors are inappropriately using them to diagnose and treat. In an endemic region, an EM rash (plus a required test in a non-endemic region), OR major system involvement plus positive blood work meet the surveillance criteria for reporting purposes. Patients who do not meet that criteria scramble to find physicians willing to risk making a clinical diagnosis for Lyme disease, one based on symptoms, history, ruling out other diseases, one which does not require a positive test for diagnosis. Problems about diagnosis are fueled by unreliable Lyme testing that is 40-60% accurate, and by the fact that less than 50% of people develop the classic bull’s eye rash.

The second document influencing doctors’ ability and willingness to treat is the Infectious Diseases Society of America (IDSA) guidelines (“Guidelines”) which are meant for diagnosing and treating. They recommend against any long-term treatment for chronic Lyme; against entire classes of antibiotics; against alternative treatments; against some supplements; and against individual physician discretion in diagnosis and treatment. IDSA says there is NO chronic Lyme disease.

The CDC surveillance criteria are misused for diagnosis, and the IDSA guidelines are misused as being mandatory. Despite a disclaimer that Guidelines are guidelines only and not mandatory, actual experiences demonstrate they have become de facto law. The misuse by medical boards, health department, hospitals, insurers, schools, pharmacists, IDSA doctors themselves, is so blatant that Connecticut Attorney General Richard Blumenthal felt compelled to legally investigate the IDSA Guidelines’ process.

He acted because of Connecticut residents inability to get diagnosed and treated in state. The Guidelines created a chilling effect on treatment climate. Why would doctors want to treat a disease knowing their treating peers were being investigated and harassed? The same situation was occurring nationwide, thus to date, 41,000 people have signed an LDA petition opposing the IDSA treatment guidelines on humanitarian grounds. (www.LymeDiseaseAssociation.org)

In May 2008, the AG and IDSA reached a settlement Agreement. Mr.Blumenthal stated: “This agreement vindicates my investigation−finding undisclosed financial interests and forcing a reassessment of IDSA guidelines…My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists.The IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science…The IDSA’s Lyme guideline process lacked important procedural safeguards….” IDSA had to form a new panel, which heard testimony in July, re-looking at the guidelines, but it again excluded chronic Lyme treating doctors as panel members.

There are other Lyme treatment guidelines which differ from IDSA’s, which do allow doctor discretion, and do recognize that Lyme sometimes requires more than a short course to make people better. They address early infection and chronic disease. They provide the basis for a second standard of care. Published by the International Lyme & Associated Diseases Society (ILADS), a professional medical and research organization, they’re ignored by IDSA and often not disclosed as an option by doctors to their patients. They are published on the Department of Health and Human Services National Guidelines Clearing House website, recognizing them as being evidenced-based.

ILADS comprehends that patients who are not diagnosed quickly or not treated appropriately can become chronically ill− one study shows that Lyme patients suffer a degree of disability equal to that of patients with congestive heart failure. Yet these patients, often multi-members of one family, now have to travel many hours outside Massachusetts to find care for their Lyme. They don’t have the resources nor the health to fight the vested interests stacked against them, which is why legislation is necessary. It ensures that in-state treating doctors cannot be prosecuted for unprofessional conduct solely for providing long-term treatment based on clinical judgment. Two contiguous neighbors, Rhode Island and Connecticut, have passed protective legislation, as has California. Others have or will introduce soon.

The primary opposition to all Lyme doctor protection legislation comes from the same organization which has created the need for doctor protection, the IDSA. Doctors who don’t follow IDSA Guidelines but use their own clinical skills to diagnose and treat face medical board discipline, hospital privilege revocation, insurance plan inclusion revocation, and loss of hospital posts if they do not march lockstep with IDSA, leading to physician scarcity and a “chilled” treatment climate nationwide, even worldwide, where Lyme is now found in about 65 countries.

IDSA sometimes cites development of antibiotic resistance for opposing legislation, despite resistance most often developing due to under usage rather than over usage of antibiotics. The Union of Concerned Scientists is concerned that a significant cause of resistant bacteria may be an estimated 70% of antibiotics in the U.S. being fed to healthy pigs, cows, and chickens to promote growth and prevent disease. Improper hygiene by medical personnel in hospitals often fosters the spread of resistant strains.

IDSA ignores the fact that other diseases are allowed long-term treatment with antibiotics including tuberculosis, Q fever endocarditis, and even acne. With little outcry, healthy animals can be fattened with antibiotics, health care workers can practice shoddy hygiene leading to more resistant strains, acne sufferers can get years of treatment, but terribly sick Lyme patients are singled out to be left without treatment because of undocumented accusations of resistance due to treating sick people.

IDSA even opposes federal legislation (HR 1179, S 1352) which provides much needed funds for research, particularly for an accurate test to help resolve many Lyme-related issues —legislation that the late Senator Ted Kennedy felt so strongly about he signed onto as a co-sponsor this past summer. IDSA indicates they do not like the constitution of a Lyme and tick-borne diseases federal advisory panel created by the bills because it contains patient and treating physician reps, just as other diseases have.

Following IDSA Guidelines can lead to delayed diagnosis and treatment. According to an actuarial study on Lyme costs, “37% of the financial costs of this disease is incurred before the correct diagnosis is made.” A delay in diagnosis also leads to more chronic disease since the Lyme bacterium can get into the brain within 24 hours of a tick bite. Chronic Lyme is more costly to patients physically, mentally, and financially. According to a 1998 CDC journal study, early Lyme costs* averaged $161 per patient and neurologic longstanding Lyme disease averaged $61,243. Chronic Lyme is also more costly to the state and federal government in terms of disability and education e.g., special services, home instruction, substitute teachers. Allowing doctor discretion can cut costs and most importantly, human suffering.

Massachusetts owes it to patients and physicians to pass a doctor protection bill, leveling the playing field by providing treating physicians with a measure of protection they are entitled to, since there are two standards of care. Doctors should not be penalized for following the standard, which in their clinical experience, best improves patient health. Don’t be fooled by rhetoric saying legislators shouldn’t be mandating treatment. This bill DOES NOT mandate treatment of any kind. Your Connecticut peers weren’t fooled by that argument whispered into their ears behind the scenes, both houses passed the bill unanimously. You should do the same.

Thank you.


1Paul Meade, CDC, Herald News 5-4-04, Jessica Adler.
2Recorder.com, July 30, 2007.
3Centers for Disease Control & Prevention, Average Annual Incidence of Reported Cases of Lyme Disease by Age Group & Sex, http://www.cdc.gov/ncidod/dvbid/lyme/ld_MeanAnnualIncidence.htm.
4David Dennis, CDC, presented study in Wall Township, NJ, October 1992, Congressional meeting. Later pub. Lyme Times Children’s Educational Issue, ed. CALDA, Summer 2006.
5Brian Fallon MD The Underdiagnosis of Neuropsychiatric Lyme Disease in Children & Adult, The psychiatric Clinics of North America, Vol.21, No.3, Sept.1998.
6P. Coulter et al, J. Clin Microbiol. 2005 Oct.; 43(10): 5080-4 Two Year Evaluation of Borrelia burgdorferi Culture and Supplemental Tests for Definitive Diagnosis of Lyme Disease. Lancet 1990, Journal of Clinical Investigation 1994 & S. Schutzer et al, JAMA Vol 282, No. 20 Borrelia Burgdorferi: Specific Immune Complexes in Acute Lyme Disease, Nov. 24,’99
7R. Smith et al, Annals of Internal Medicine 2002;421:421-428, 477-479; A. Pachner, Reviews of Infectious Diseases-Vol. II, supplement 6 – September-October 1989 Neurologic Manifestations of Lyme Disease, the new “Great Imitator”; J.M. Johnson, Ph.D., Chief, Public Health, NPS Ticks and Disease.
8Office of the Connecticut Attorney General, press release, May 1, 2008.
9Daniel Cameron, et al, Expert Review of Anti-infective therapy 2(1) Suppl. 2004
10AHRQ, http://www.guideline.gov/.
11Connecticut Agricultural Experiment Station, “Summary of Tick Testing Results for 2003.” www.caes.state.ct.us.
12CDC unpub. study data presented in Congressional forum, Wall NJ Oct 1992 (Later pub. in Lyme Times)
13http://www.ucsusa.org/food_and_environment/antibiotics_and_food/myths-and-realities.
14Irwin Vanderhoof, Lyme Disease the Cost to Society, Contingencies January/Februray 1993.
15Steere, Allen, Mandel, Douglas, and Bennett’s Principals & Practices of Infectious Diseases, 4th ed. 1995.
16Martin I. Meltzer The Cost Effectiveness of Vaccinating against Lyme Disease CDC Emerging Infectious

Diseases; Vol.5, No.3; 1999 May-June;5(3)321-8.
* This is in 1996 costs not adjusted to 2007. The following additional significant costs to society aren’t measured by this table: special education needs for children, disability, increased medical and insurance costs, and livestock losses, etc. Also, there are personal loses: friends, employment, self, esteem, domicile, and breakup of families.

17Patricia Smith, Wall Township, NJ, Board of Education member NJ School District Study on Impact of Lyme Disease on School Districts presented in Washington DC Congressionally hosted meeting with CDC & NIH, March 12, 1992.