COMMONWEALTH OF HOUSE OF REPRESENTATIVES

HUMAN SERVICES COMMITTEE HEARING

STATE CAPITOL HARRISBURG, PA

MAIN CAPITOL BUILDING ROOM 60 EAST WING

TUESDAY, AUGUST 30, 2 011 10:01 A.M.

PRESENTATION ON HB 272 (HESS) THE LYME AND RELATED TICK-BORNE DISEASE EDUCATION, PREVENTION AND TREATMENT ACT

BEFORE: HONORABLE GENE DiGIROLAMO, MAJORITY CHAIRMAN HONORABLE ROSEMARY M. BROWN HONORABLE SHERYL M. DELOZIER HONORABLE HONORABLE MARCIA M. HAHN HONORABLE SUSAN C. HELM HONORABLE THOMAS P. MURT HONORABLE HONORABLE MARK B. COHEN, DEMOCRATIC CHAIRMAN HONORABLE MICHELLE F. BROWNLEE HONORABLE PAMELA A. DeLISSIO HONORABLE HONORABLE

Pennsylvania House of Representatives Commonwealth of Pennsylvania 2

ALSO IN ATTENDANCE: HONORABLE JOHN R. EVANS HONORABLE HONORABLE C. HONORABLE DICK L. HESS HONORABLE DAVID M. MALONEY, SR. HONORABLE MARIO M. SCAVELLO

COMMITTEE STAFF PRESENT: ELIZABETH L. YARNELL MAJORITY RESEARCH ANALYST 3

I N D E X

TESTIFIERS

* * *

NAME PAGE

REPRESENTATIVE PRIME SPONSOR OF HB 272 ...... 5

JULIA F. WAGNER, MBA CHAIR, LYME ACTION PA; PRESIDENT, MONTCO LYME...... 9

JOY MANDRELL-BURDGE VICTIM OF LYME DISEASE...... 17

ROBERT C. BRANSFIELD, MD, DLFAPA PRESIDENT, INTERNATIONAL LYME AND ASSOCIATED DISEASES SOCIETY...... 24

HAROLD SMITH, MD EMERGENCY MEDICINE; PAST BOARD OF DIRECTORS, INTERNATIONAL LYME AND ASSOCIATED DISEASES SOCIETY; MEMBER, LYME DISEASE GUIDELINES COMMITTTEE...... 44

MIMI WAINWRIGHT, BSN, RN, CSN SCHOOL NURSE, GREEN WOODS CHARTER SCHOOL; MEMBER, PA ASSOCIATION OF SCHOOL NURSES AND PRACTITIONERS...... 53

SHAWN DeFREES, PH.D. PRESIDENT AND FOUNDER OF A BIOTECHNOLOGY COMPANY, MONTGOMERYVILLE, PA...... 61

EDWARD YOST, MD ANESTHESIOLOGIST; MEMBER, AMERICAN SOCIETY OF ANESTHESIOLOGISTS, INTERNATIONAL SPINE INTERVENTION SOCIETY, AND AMERICAN HEADACHE SOCIETY...... 65

JERRI-LYNN WIER ATTORNEY; CONGRESSIONAL CAMPAIGN MANAGER...... 71

LISA REED GAFFNEY MOTHER OF JOSIE, VICTIM OF LYME DISEASE...... 74 4

TESTIFIERS (cont.'d):

NAME PAGE

JONATHAN C. GREER VICE PRESIDENT AND SECRETARY, INSURANCE FEDERATION OF PA, INC...... 81

MICHAEL YANTIS DIRECTOR OF POLICY MANAGEMENT, BLUE CROSS OF NORTHEASTERN PA...... 85

JOHN GOLDMAN, MD INFECTIOUS DISEASE SPECIALIST, PA MEDICAL SOCIETY...... 88 5

1 P R O C E E D I N G S

2 * * *

3 MAJORITY CHAIRMAN DiGIROLAMO: Good morning,

4 everyone. Good to see everybody here for this meeting on

5 HB 272.

6 And I'd like to first point out, I'm

7 Representative Gene DiGirolamo. I'm the Majority Chairman

8 of the Human Services Committee, and I'd like to first give

9 all the Members a chance to identify themselves and let us

10 know what district they're from. But before I do that, I

11 would like to acknowledge Representative Dick Hess, who is

12 the prime sponsor of the bill, HB 272. And Dick, I really

13 appreciate you bringing this important issue to the

14 attention of the General Assembly and the Human Services

15 Committee.

16 REPRESENTATIVE HESS: Thank you, Mr. Chairman.

17 My name is Dick Hess. I'm a 25-year Member of

18 this House. I've served Bedford, Fulton, and Huntingdon

19 Counties for, like I said, 25 years, and this is a very

20 important piece of legislation.

21 I can't take -- I have to say this -- I can't

22 take 100 percent credit for this bill. I was second on the

23 bill last term. It was introduced by Representative

24 Phillips, a very dear friend of mine. So I'm carrying the

25 torch not only for myself but for Representative Phillips 6

1 also, who was a victim of Lyme Disease, and I'll go on

2 further about that later on.

3 Thank you, Mr. Chairman.

4 MAJORITY CHAIRMAN DiGIROLAMO: Okay. Thank you.

5 And I would also like to acknowledge my Minority

6 Chairman, Representative Mark Cohen from Philadelphia, who

7 I believe is on his way and will be here a little bit later

8 on.

9 Why don't we start with Representative Roae and

10 then work our way down. Brad.

11 REPRESENTATIVE ROAE: Good morning.

12 Representative Brad Roae, Crawford County.

13 REPRESENTATIVE MALONEY: Good morning.

14 Representative David Maloney, the 130th, Berks

15 County.

16 REPRESENTATIVE BROWN: Good morning.

17 Representative Rosemary Brown, the 189th District,

18 Monroe and Pike Counties.

19 REPRESENTATIVE HAHN: Good morning.

20 Representative from parts of

21 Northampton County.

22 REPRESENTATIVE HELM: Welcome, everyone; a great

23 crowd.

24 , the 104th District of Dauphin County.

25 REPRESENTATIVE BROWNLEE: Good morning. 7

1 State Representative Michelle Brownlee,

2 Philadelphia County.

3 REPRESENTATIVE DeLISSIO: Pam DeLissio, the 194th,

4 covering parts of Philadelphia and Montgomery County.

5 REPRESENTATIVE GABLER: Good morning.

6 Matt Gabler, 75th District, Clearfield and Elk

7 Counties.

8 MAJORITY CHAIRMAN DiGIROLAMO: And again,

9 Representative Gene DiGirolamo from the 18th District in

10 Bucks County.

11 And to my right and your left is Liz Yarnell, who

12 is on the Human Services Committee, on staff, and did a

13 great job in putting this hearing together. Thank you,

14 Liz.

15 John.

16 REPRESENTATIVE EVANS: Good morning.

17 Representative John Evans of the 5th Legislative

18 District in Erie and Crawford Counties.

19 REPRESENTATIVE SCAVELLO: Good morning.

20 Representative , the 176th District,

21 Monroe County. I want to thank the Chairman for allowing

22 me to sit in on this hearing.

23 REPRESENTATIVE HARRIS: Representative

24 Adam Harris, the 82nd District, Juniata, Mifflin, and

25 Snyder. 8

1 MAJORITY CHAIRMAN DiGIROLAMO: Okay. Thank you.

2 Maybe to just start out with a couple of ground

3 rules. The TV cameras are on, so we are -- I don't know if

4 we're being broadcast live, but I'm sure PCN will pick us

5 up, if not live, probably at a later date. So I just want

6 to remind everybody the TV cameras are on.

7 We're on a little bit of a time constraint. We

8 have to be finished the hearing today by 12 o'clock. So

9 what I am going to do is I'm going to allow everyone to

10 testify first before we open it up for questions, and then

11 if time allows at the end of the meeting, we will ask those

12 who are still here if you would come up and answer a few

13 questions from the Committee.

14 And again I want to thank Representative Hess,

15 and I also would like to mention Representative Merle

16 Phillips. Merle retired last year, and I know

17 Representative Phillips was very interested in this issue

18 also.

19 And Lyme Disease is on the rise, as everybody

20 knows, and again, I appreciate you all being here. The

21 latest statistics we have, from 2009, is that there were

22 almost 5,000 reported cases of Lyme Disease in the State of

23 Pennsylvania, and that is, by far, the highest number of

24 any of the States in the United States.

25 We've called the hearing to discuss a critical 9

1 issue surrounding the diagnosis and treatment of this

2 disease and related tick-borne illness. And again, we

3 really appreciate that some of you have traveled a long

4 distance to be here today.

5 We all, all the Members -- and we have a really

6 good turnout. I would like to recognize Representative

7 from Montgomery County who just arrived.

8 We're all interested in learning more about the

9 issues and about the seriousness of the disease. I'd like

10 to extend our appreciation to Julia Wagner, who is the

11 Chair of LymeAction PA, for coordinating the speakers for

12 the meeting today. And again, I did explain, because of

13 the time limits, that we're going to have to be finished by

14 12 o'clock. So I would please ask everyone who is going to

15 testify to please stick to your allotted timeframe, okay?

16 With that, we're going to start the hearing, and

17 the first person to testify is Julia Wagner, who is the

18 Chair of LymeAction PA, and I would ask Julia to come to

19 the end of the table.

20 MS. WAGNER: Good morning, and I am very honored

21 to be here, to be able to testify on the many thousands and

22 thousands of individuals that are affected by Lyme Disease

23 in the State of Pennsylvania.

24 I come to this by way of personal experience and

25 the experience of my family, including three young children 10

1 who were devastated by this disease. I am a management

2 consultant with an MBA and a concentration in developmental

3 psychology, and I consult with CEOs and senior executives

4 of Fortune 500 companies.

5 The impact of this disease was such that I was so

6 cognitively affected that I could not string a sentence

7 together. I could no longer recognize the meaning of a

8 red light when I stopped at a traffic light. We were

9 severely affected.

10 I'm not here to talk about my family's experience

11 today, but in the attachments I have my 2007 testimony,

12 which outlines how our family imploded as a result of this

13 disease, a tick-borne disease. I'm really here to speak on

14 behalf of LymeAction PA, which is a statewide coalition of

15 the now 19 Lyme Disease support groups in Pennsylvania. It

16 has more than doubled over the past 2 or 3 years that I

17 have been involved with this, which is an indication.

18 So I'm going to flip to the next slide and tell

19 you that there are over 100,000 people that support this

20 bill represented by us. So on the left side are all the

21 Lyme Disease support groups and on the right side we see

22 medical professional groups, many of whom are represented

23 today in the speakers, national groups, and the PA Farm

24 Bureau, who alone has, as I understand it now, 60,000

25 members who are in support of Pennsylvania taking action on 11

1 this serious disease. This is not fringe. This is a lot

2 of people and mainstream medicine.

3 Legislation has been passed in multiple other

4 States, including Connecticut, Rhode Island, et cetera, and

5 most recently in Texas -- and I wish I could read that from

6 here but I can't very well. What's important about Texas

7 is that a Senator there introduced that legislation who was

8 personally affected by Lyme Disease, and what happened to

9 him is that he could not get longer courses of antibiotics

10 when short-term treatment failed, but because he was a

11 Senator, his physician got 17 other physicians to prescribe

12 a month of antibiotics so he could get well on 17 months of

13 antibiotics. Now, us regular people don't have that

14 leverage. They have to go out of State in this State or

15 they go untreated, and the impact is not acceptable.

16 Pennsylvania, as you noted, is number one in

17 cases, but across the country the cases are skyrocketing

18 and the severity of the disease is skyrocketing. The one

19 science point I'm going to make is that the most recent

20 explanation for this is that there are different strains of

21 this disease, and some of them cause a very minor disease

22 and some cause a very serious disease. And that has been

23 documented now in the science, so there's explanation for

24 why it's more serious. Okay; that's the trend.

25 Pennsylvania needs a real prevention strategy. 12

1 What we've been doing is clearly not working. I'm going to

2 give you a few examples.

3 The group that I started was primarily started by

4 mothers who have children that were devastated by these

5 diseases. And we have been doing outreach and education

6 and we've been invited into schools to educate and to speak

7 to nurses, and what we found is that these kids are being

8 impacted dramatically.

9 There's nothing going on in terms of

10 surveillance. The EPA just said that surveillance is

11 critical. How can you address it if we don't know what the

12 ticks are carrying and how many of the ticks are in your

13 State? So surveillance is critical.

14 In addition, there are many ways you can prevent

15 getting a tick bite in the first place, and we're not

16 acting on that information. Studies in New Jersey found

17 you can cut tick populations by 90 percent or more if you

18 take the right actions. So Pennsylvania needs to study

19 this and act, and it's not acceptable anymore.

20 I'm not going to talk about that; I just

21 mentioned surveillance. So let's talk about patient

22 experience.

23 There's a lot of confusion about Lyme Disease,

24 and you're going to hear about the fact that there are two

25 schools of thought, both of which are valid and represented 13

1 by researchers and clinical practitioners. The problem is

2 education on the front line with family practice,

3 pediatricians, the ones seeing patients day in and day out.

4 They unfortunately have not been kept up to date on the

5 emerging science, so what happens is these diagnoses get

6 missed. The best way to treat Lyme Disease is in its early

7 stages, and in fact it's the only stage that we know of

8 where you can cure it.

9 So how do we catch these diagnoses early? I have

10 up here and in my testimony stories of the many children,

11 many individuals, who had obvious cases of Lyme Disease. A

12 bulls-eye rash is diagnostic, automatically, no test

13 required, and they're not diagnosing it. They're not

14 treating it. So we move from what is a short-term illness

15 to a chronic debilitating disease that costs you money and

16 me money. So I'll talk a little bit more about that later.

17 These rashes come in many different forms, and

18 they're not recognized. They're called spider bites.

19 They're called, you know, some kind of dermatitis, contact

20 dermatitis, et cetera. But the important point is that

21 science recently unveiled that there are some strains that

22 cause this rash and a little flu-like illness and it's not

23 a big deal. There are other strains that cause a serious

24 neurological disease, and for the most part, that's what

25 you're going to hear about today. 14

1 There are two standards of care, yet patients are

2 not told there are two standards of care. Pennsylvania has

3 a long history of support for what they call two schools of

4 thought in medicine. When I go to my doctor and I have a

5 tick bite and I get 3 weeks of antibiotics and it doesn't

6 work, I should be told there's another school of thought,

7 maybe we ought to explore that option, and that's all we're

8 asking to happen in this bill. It's what happens in

9 cancer. It is what happens in most other diseases where

10 there is rarely one approach to the disease.

11 In these cases, these are children who were

12 treated with 3 weeks of antibiotics. They did not get

13 better, and in some cases they went back to their physician

14 who said, there is nothing that can be done for your

15 malaise. Nothing, okay? That individual, who is a

16 State-winning soccer player, could not get off the bed and

17 go to school. She was out of school for 8 months, and it

18 wasn't until her mother found a doctor who would treat her

19 longer that she got well. There are more stories than you

20 want to know of that represent that same point.

21 So the key is that there are several kinds of

22 evidence. And you hear all the time there's no evidence,

23 but Dr. Bransfield will talk about that. From a patient

24 experience point of view, including my own personal as well

25 as the hundreds and hundreds of cases we've personally 15

1 documented and that are represented here, long-term

2 treatment restores health and functionality. So do we want

3 a healthy and functional public, or do we want a public who

4 can't go to school, who are getting learning-disabled

5 services, as my children would have gotten, who are on

6 Social Security, who are on Medicare, and all of those

7 stories are represented today. Or do we want patients who

8 are treated long term that get better?

9 The impact is unsustainable. You may think that

10 this is an issue of cost to insurance companies. It is

11 not. It is a case of shifting -- I was trained as an

12 economist, undergraduate -- this is a case of shifting

13 costs, and today, the insurance industry has successfully

14 shifted the cost to you, the State, and to us. And the

15 costs cannot be sustained by ignoring this disease.

16 They're only going to go up and up and up.

17 Examples of the costs, you can see them here. In

18 my family, we have spent the equivalent, because insurance

19 does not cover treatments beyond short term, of almost two

20 college educations. And we are lucky, because we were able

21 to afford it. We have no savings anymore, but we were able

22 to afford it. I can't tell you how many parents -- and

23 you're going to hear one of them today; I'm sorry I'm so

24 emotional -- who cannot afford to pay and she's watching

25 her daughter disappear. This should not be happening in 16

1 this State, and the facts support what we're saying.

2 The cost, the financial burden, is extreme. My

3 own children developed learning disabilities. My son

4 decreased his IQ by 26 points, which was restored with

5 long-term treatment, so instead of having learning

6 disability services, last year he was put in gifted

7 programming. Columbia University has documented a 22-point

8 decline in children who are affected by neurological Lyme

9 Disease. This is not little stuff.

10 If you don't take action on this bill, if

11 Pennsylvania does not take action on Lyme Disease, our

12 children are going to be decimated, and they are. Talk to

13 any educator and what they're seeing in learning

14 disabilities. I was just involved with a study out at the

15 University of South Dakota where they are finding that in

16 many autistic patients, they have underlying infectious

17 diseases, that when you treat them, and in this study there

18 were six children that, over the course of a year, one of

19 them moved off the spectrum and all the rest of them made

20 huge progress on the spectrum. So we are not talking about

21 minor things; we are talking about serious illnesses that,

22 if we don't address as a State, are going to cost us in the

23 long run.

24 So I thank you for your attention. I'm going to

25 queue up, I think next, another patient, and then we're 17

1 going to move on to the other testifiers. Thank you.

2 MAJORITY CHAIRMAN DiGIROLAMO: Julia, thank you

3 for your testimony. I appreciate it.

4 I'd like to recognize my Democratic Chairman,

5 Representative Mark Cohen. Mark, would you like to say

6 anything?

7 MINORITY CHAIRMAN COHEN: Yes. Thank you.

8 I'd like to thank Representative DiGirolamo for

9 calling this public hearing. This is certainly an

10 important subject facing us today. We have the duty and

11 the responsibility to see that our service systems run in

12 the best possible manner, and I'm hopeful that this hearing

13 today will expedite the process.

14 MAJORITY CHAIRMAN DiGIROLAMO: Okay, Mark. Thank

15 you.

16 Also, I'd like to recognize Representative

17 Emrick, who has come into the meeting. Joe. And also

18 Representative Pashinski. Welcome, Ed.

19 With that, our next testifier is Joy Burdge, who

20 is a patient, and you can begin whenever you're ready, Joy.

21 Thank you.

22 MS. MANDRELL-BURDGE: Hello. My name is

23 Joy Mandrell-Burdge, and I'm honored to be allowed to give

24 my testimony today.

25 In 1984, two of my children were diagnosed and 18

1 treated for Lyme Disease. One of them has since been

2 diagnosed again. My family is being devastated by Lyme

3 Disease. Most recently, my sister had a hip replacement

4 due to Lyme Disease, and my daughter's 7-year-old son woke

5 up one morning unable to walk due to tick-borne infections.

6 Unfortunately, I am a victim of Lyme Disease and

7 other tick-borne diseases. I am also a victim of a medical

8 establishment that is reluctant to test or treat these

9 diseases. Once an active person who could hike strenuous

10 hikes, I began to notice my health deteriorating.

11 Eventually, on my worst days, it became difficult just to

12 walk to the mailbox.

13 In the beginning of my illness, my symptoms were

14 drenching night sweats, flu-like symptoms, excruciating

15 headaches with severe neck pain and stiffness, my whole

16 body aches and pains, especially my knees.

17 As the disease progressed, it became a myriad of

18 symptoms affecting one part of my body one day and a

19 different part of my body the next. I have since learned

20 that Lyme Disease is a multisymptom, multisystem disease.

21 It affected my hearing, my vision, headaches so

22 excruciating I thought it had to be a brain tumor. I

23 thought that a headache that severe couldn't possibly be

24 anything else. Excruciating stomach pain would bring me to

25 the floor in sheer agony. My heart would race 19

1 uncontrollably while lying in bed. I became lost in a

2 store that I was very familiar with. At times, my legs

3 felt like they were going to give out on me, sending me to

4 a chair. I would describe it like a wobbly baby calf. I

5 would wake up mornings where the pain in the muscles of my

6 arms was so severe I couldn't lift them. I became so

7 neurologically impaired, there began to be days where I

8 couldn't drive. Everyday things like balancing a checkbook

9 or remembering what I read became extremely difficult. I

10 would have bouts where I couldn't catch my breath. Air

11 hunger would bring me collapsing to the floor, especially

12 after a shower. The fatigue became so extreme, I felt as

13 though I could just collapse.

14 With this myriad of symptoms, I found myself

15 running from doctor to doctor. For over 2 years, it seemed

16 as if I had a doctor's appointment each week. I was

17 determined to find out what it was that was causing my

18 illness, an illness so severe that I went to the emergency

19 room on four different occasions, only to be told that I

20 was fine and sent on my way.

21 I saw over 20 doctors -- specialists, allergists,

22 neurologists, gastroenterologists, urologists,

23 cardiologists, rheumatologists, opthamologists,

24 endocrinologists, et cetera. I endured test after test -­

25 numerous MRIs, CAT scans, EKGs, EEGs, endoscopies, 20

1 colonoscopies, a spinal tap, et cetera. I was poked,

2 prodded, analyzed. I began to feel as if I was everything

3 but dissected. Test after test revealed nothing,

4 absolutely nothing.

5 At this point, I requested a PET scan. There was

6 something wrong with me and no one could figure it out, so

7 I asked my neurologist at the time to order a PET scan. He

8 was reluctant, so I was adamant. It was at this point that

9 I was told I was going to need psychological help. I told

10 him that if he were as sick as I was, he would not be

11 sitting behind his desk at work. He ordered the PET scan,

12 and that, too, revealed nothing.

13 At a loss and feeling so desperate and sicker by

14 the day, I made appointments to top hospitals, over five

15 top hospitals. I went to Columbia Presbyterian in New York

16 City, Sloan-Kettering in New York City, the University of

17 Pennsylvania in Philadelphia, Hackensack Memorial in

18 New Jersey, Robert Wood Johnson in New Jersey -- all to no

19 avail. No diagnosis.

20 After my visit to Columbia Presbyterian in

21 New York City, I continued to have excruciating stomach

22 pain. I called numerous times and finally got a phone call

23 back, only to be asked, "Did you try Tylenol?" At my visit

24 to UPenn in Philadelphia, I was prescribed Prednisone, a

25 steroid, for my excruciating headaches and brain fog. I 21

1 e-mailed the doctor and told him that I was worse and

2 further studies needed to be done. He e-mailed back and

3 told me no further studies needed to be done. I now know

4 that steroids are the worst thing ever for Lyme Disease.

5 They suppress the immune system. I followed my instincts

6 and quit taking the prescription.

7 The prescription of choice seemed to be

8 antidepressants. I have a giant bag of useless

9 prescriptions. Many prescriptions I never filled, clearly

10 knowing they would do nothing. It was at this point where

11 I knew I had to make an appointment at a top diagnostic

12 hospital. I went to the Mayo Clinic in Jacksonville,

13 Florida -- twice. Each time, we spent 2 weeks there. I

14 was put on the Mayo Diet, as they call it, numerous times

15 and run through the Mayo gauntlet of testing. That, too,

16 revealed nothing. I boarded a plane home after the fourth

17 week spent there believing I was going home to die. Where

18 could I possibly go from here?

19 Six weeks after returning home from the Mayo

20 Clinic, I was finally diagnosed by my sister's neighbor, a

21 retired 35-year Johns Hopkins nurse. Upon hearing my

22 symptoms, she exclaimed, "That's Lyme Disease!" My sister

23 went home and started researching the Internet. I told her

24 I was already tested for Lyme Disease and the tests were

25 negative. Further research revealed that the tests are 22

1 unreliable with false negatives, and I had every symptom of

2 Lyme Disease.

3 Upon learning that it was Lyme Disease, I made a

4 phone call to the Mayo Clinic. I asked them, how did they

5 not know that this was Lyme Disease? I live in the

6 northeast and had every symptom of Lyme Disease. He

7 responded that upon reviewing my case, they thought that it

8 was fibromyalgia. Funny, he seemed to pull that one out of

9 nowhere. I asked him, who did he think he was talking to

10 and proceeded to tell him that two of my kids had this

11 disease in 1984, and clearly, this was Lyme Disease. I

12 then went on to ask him, "What in the heck is going on with

13 this disease?" to which there was dead silence on the other

14 end of the phone.

15 The Mayo Clinic's Website states that Lyme

16 Disease is "over diagnosed." I beg to differ. As

17 difficult as it was to get a diagnosis, I was soon finding

18 out that it was going to be just as difficult to find a

19 Lyme-literate doctor.

20 My first round of treatment was 56 days of IV

21 antibiotics along with orals. I was going to the Tick

22 Borne Disease Group in Phillipsburg, New Jersey. Shortly

23 after the PICC line was pulled and the treatment stopped,

24 my symptoms that had somewhat subsided were back with a

25 vengeance. Calls to the Tick Borne Disease Group were 23

1 fruitless. They had been shut down.

2 After this, I saw three doctors who were clearly

3 not going to get me well. One of them, fearing for his

4 license, gave me a referral to a doctor in New Jersey.

5 This particular doctor is "blacked out" in the documentary

6 Under Our Skin.

7 I was now more knowledgeable to the politics and

8 corruption surrounding this disease, and I began my own

9 homework on the Internet. Through phone calls, I was

10 directed to Dr. Lyme by a nurse. Dr. Lyme had treated her

11 whole family and had gotten all of them well again, and he

12 is the reason that I am well enough to be able to be here

13 today. I will be forever grateful. Words can't even

14 describe how grateful I was when I saw that this doctor was

15 going to step up to the plate and treat me. He has

16 literally saved my life.

17 The cost to my health insurance to diagnose

18 nothing was roughly $70,000. Had I been diagnosed and

19 treatment began early, it would have been a huge savings -­

20 a huge savings to my health insurance, but most

21 importantly, my life. I am proof that long-term treatment

22 is needed. Once this disease became so entrenched in my

23 body, a few weeks of antibiotics would have done nothing.

24 The cost to the nurse who diagnosed me was a

25 thank you, a big hug, and a bouquet of flowers. I find 24

1 that pitiful, and I would like to ask mainstream medical if

2 they are proud of that.

3 Lyme Disease is one heck of a battle -- a battle

4 to get a diagnosis, a battle to fight the disease, a battle

5 to get your insurance company to pay for your treatment,

6 and a battle to get the medical establishment to recognize

7 and treat this disease as the very serious disease that it

8 is.

9 Unfortunately, my story is not unique. Stories

10 just like mine are repeated over and over, and something

11 seriously needs to be done.

12 Thank you for allowing me to give my testimony.

13 Please pass HB 272. It is long overdue.

14 MAJORITY CHAIRMAN DiGIROLAMO: Thank you, Joy,

15 for that really compelling testimony. Thank you.

16 Next we have Dr. Robert Bransfield, who is the

17 President of the International Lyme and Associated Diseases

18 Society.

19 Doctor, you can begin whenever you're ready.

20 DR. BRANSFIELD: Okay. Thank you.

21 Thank you for inviting me here today, and I speak

22 on behalf of the physicians who actually treat Lyme

23 Disease, which is quite a large number of physicians.

24 I'm active. I'm the President of ILADS, the

25 International Lyme and Associated Diseases Society; 25

1 President of the New Jersey Psychiatric Association; on the

2 Board of Trustees of the Medical Society of New Jersey.

3 And I'm active in setting policy in regard to insurance

4 issues -- access, parity, pharmacy benefit management,

5 issues involving insurance with the American Psychiatric

6 Association, which is 37,000 members -- and I've testified

7 with other Lyme proceedings on behalf of these various

8 organizations.

9 There are almost a million physicians in this

10 country, and there are only a small number who actually

11 treat Lyme Disease and understand it. And it actually

12 involves a very broad base of physicians in this country,

13 so no one specialty claims to be the authority since it

14 spans many fields. It's particularly significant with

15 psychiatry and family practice, more so than infectious

16 disease where their primary emphasis is short-term

17 infections.

18 Now, our mission is we are the only organization,

19 ILADS, which specializes in dealing with the Lyme and

20 Associated Diseases Society. We're an international

21 organization. We hold international meetings. At our last

22 meeting in Germany, we had representatives there from

23 24 different countries, including China and different parts

24 of the world, and we're expanding in Australia, and it's

25 recognized as a worldwide epidemic. 26

1 In 1682, my ancestor, Dr. Thomas Wynne, was on

2 the ship Welcome -- I see there's a model of it out there

3 in the hallway -- and he was the first speaker of the

4 Pennsylvania Assembly. When the Welcome came here, there

5 was an epidemic of smallpox that decimated a third of the

6 members, people on the ship, and he treated that. And

7 today we have a different epidemic, Lyme Disease, and

8 that's the issue that we're dealing with. Infections

9 change over time, and this is what we have to deal with

10 now.

11 As you've heard, Pennsylvania is really number

12 one with the number of reported cases, and when we look at

13 these statistics, these are the formal statistics. But

14 when they are analyzed, the CDC recognizes those statistics

15 are about one-tenth of the actual true cases, and when

16 there was an analysis done by Dr. Boltri, he found that it

17 really was 1 in 40. So if you take that number and

18 multiply it by 40, that's the number of new cases per year.

19 Now, some of those people recover, but some go on to

20 chronic illness, which is a significant concern.

21 Now, as a psychiatrist, whenever there's a

22 problem that nobody can understand, people say, well, that

23 doesn't make any sense to me; we'll call it medically

24 unexplained symptoms, we'll call it all kinds of things,

25 and let's send you to a psychiatrist. And we often get 27

1 involved with the current controversy, whatever it may be,

2 and some controversies come and go. Lyme has persisted for

3 quite a while.

4 However, in addition, the main long-term

5 consequences of inadequately treated Lyme Disease are

6 neuropsychiatric in nature, and a number of studies support

7 this. They're not arthritic; it's neuropsychiatric, so

8 that's another reason why we get involved. And I've seen

9 thousands of patients, some from Pennsylvania, and we see

10 quite an aftermath. We see depression, cognitive

11 impairments, mood swings, suicide -- quite a few deaths

12 from suicide -- violence, criminal cases, murders, autism,

13 dementia, developmental disabilities. The toll is quite

14 significant.

15 Now, the prevalence of autism, when we study that

16 and look at it, about 20 percent test positive for Lyme

17 Disease. About 50 percent show positive testing for

18 various infectious diseases, including tick-borne

19 infectious diseases. A single case of autism can cost,

20 lifetime, $16 million. If you look at the number of cases

21 of Lyme Disease and the number of cases of autism, the cost

22 just in that one area is staggering, that if we could

23 prevent even a small percent of that, that would be quite

24 significant.

25 Now, one thing in trying to understand this, and 28

1 this is a major conceptual error, psychiatric diseases are

2 always caused by something. They don't just come out of

3 the sky. And invariably when we look at disease paradigms,

4 there's often infection and then an immune reaction to the

5 infection, and then we see the symptoms. Sometimes it's

6 hard to see what immune reaction is actually provoking it.

7 A good example may be syphilis, where it's a persistent

8 infection and then we see this persistent evolution of

9 disease that evolves over decades, sometimes having quiet

10 periods, relapsing, remitting, being a chronic persistent

11 thing.

12 And one thing that's seen is what's called

13 sickness syndrome. When the immune system is provoked,

14 sometimes by an occult infection that's hard to identify,

15 we see this malaise, apathy, cognitive impairment, that

16 many people describe. Some discount this as being

17 nonspecific or subjective. It's actually very objective.

18 You can measure it by cytokine measures, and we're active

19 with psychoimmunology. I'm active in a German

20 psychoimmunology group in organizing over 400 physicians

21 and other researchers with looking at how infections and

22 immune reactions cause mental symptoms.

23 Another effect is what we call molecular mimicry

24 or autoimmune pathways, and that accounts for some of the

25 symptoms. So when we look at these cytokine reactions, 29

1 that's an obvious symptom, but they're always caused by

2 something.

3 Now, there's a theory that is proposed that you

4 get Lyme Disease and then it starts this autoimmune process

5 that just is self-perpetuating, even though the infection

6 is gone. There is no evidence that supports that. It's a

7 hypothesis that has never been proven. Invariably when you

8 get provocation of the immune system, something is

9 provoking it, and you need to understand. And sometimes

10 it's hard to find what it is, and often when you look long

11 enough and hard enough, you can find an occult infection.

12 If we look at the medical literature, there are

13 thousands of articles demonstrating that various infections

14 can cause mental symptoms. There are about 250

15 peer-reviewed articles demonstrating a causal relationship

16 between Lyme Disease, other tick-borne infections, and

17 mental illnesses of various sorts, and it also supports the

18 clinical observation of physicians who work with this

19 population.

20 There's a list of some of the infections, and one

21 prototype is syphilis, as I said. Now, syphilis has only

22 22 genes whereas Lyme has 132. It's a much more

23 sophisticated organism that is far more adaptable, more

24 able to live in different environments, and can evade the

25 immune system with much more complex capability. It 30

1 survived for millions of years, and it didn't survive that

2 long by being something that was easy to kill.

3 There are some more infections we associate with

4 mental symptoms.

5 Now, mainstream medicine, we basically say and

6 the CDC says that most chronic illnesses are related to

7 some infection that's not well understood. That's a

8 mainstream medicine approach. And even though this is hard

9 to tell -- at one point, we thought of tuberculosis and

10 many illnesses as being psychosomatic. Everything's

11 considered psychosomatic until you can find out what the

12 real cause is, and then we lose it in psychiatry and then

13 the internists take it over. So I'm hoping someday the

14 internists are going to take over Lyme Disease and I won't

15 need to be bothered by it, but then I'll have something

16 else that I'll be dealing with.

17 So they also, the NIH has the Human Microbiome

18 Project, and this recognizes that we're a superorganism.

19 And being in that category, we have 10 times as many

20 bacterial cells in our body as human cells in a state of

21 health, so it's this balance of our internal environment.

22 You can never sterilize the body. And sometimes these

23 organisms within us that we need we depend on for things

24 like digestion. Sometimes they're pathological. Some

25 organisms can go either way; some are invariably 31

1 pathological. Sometimes we can peacefully coexist;

2 sometimes we reach a ceasefire and then that gets

3 disruptive.

4 Now, when we have an emerging disease, we have to

5 think outside the box because old explanations didn't get

6 it. All the diseases that were easy to figure out have

7 already been figured out. It's like finding the oil that's

8 easy to drill. Now you have to use a much more complicated

9 formula. So in order to move forward, just like we moved

10 from Newton to Einstein, we have to move to a new paradigm

11 for understanding models for disease. And some people are

12 very locked in to their older disease paradigms where

13 there's a clear cause, a single pathway, and a single

14 presentation. Instead, we're dealing with a complex

15 disease with multiple determinants, multiple pathways of

16 physiology of how it causes, and multiple presentations.

17 That's what we deal with with Lyme Disease.

18 Now, when we look at a broad spectrum of evidence

19 from theoretical biology, Darwinian medicine, evolutionary

20 biology, pathophysiology, immunology, psychoimmunology,

21 animal studies, clinical observation, epidemiology,

22 veterinary medicine, all of the patterns, it all adds up.

23 It all supports that there's this chronic, persistent

24 infection, an immune reaction with it, and a progressive

25 illness that occurs over decades, and you have to look at 32

1 the continuity. It's not just a disease of dermatologists,

2 it's not just a disease of rheumatologists who treat the

3 joints, it's not just different cardiologists, but it's all

4 of medicine that is involved in this because it's a

5 multisystem disease. That's what tells us it's infectious.

6 It affects all aspects of the body, and different people

7 may have a predominance of one group of symptoms or

8 another.

9 Now, if we look at basically the controversy, if

10 Lyme is a simple disease, then you look at risk-benefit,

11 then you wouldn't give a very aggressive treatment. But if

12 it's complex and has significant risk, then you would be

13 willing to give a more aggressive treatment; it would be

14 appropriate. It's a risk versus benefit. But you can't

15 just look at statistics. You never treat a statistic; you

16 always treat an individual patient, and every case has to

17 be individualized.

18 There are two standards of care. There is the

19 standard where if you think of Lyme as a short-term,

20 easy-to-treat infection, then that would go with minimal

21 treatment. But when we look at the evidence, all of the

22 evidence, and look at it in a properly weighted manner, you

23 can see that there is evidence, clear evidence for

24 persistent infection, and it's quite a significant amount

25 of evidence. 33

1 So one opinion is, Lyme is difficult to catch,

2 easy to treat. It's never chronic, and the tests are very

3 reliable. That's one opinion. That's not an opinion that

4 I find in experience. However, the fact that some people

5 feel this way is the reason why I as a psychiatrist end up

6 seeing so many of these cases, unfortunately, like the

7 story you just heard, and you'll hear thousands that are

8 just like that.

9 So if we look at the evidence, we in medicine,

10 and we in ILADS have evidence-based medicine, but it's the

11 proper implementation of evidence-based medicine. And if

12 we look at the current guidelines that existed, there was a

13 lot of challenge. I challenged the guidelines. I wrote a

14 rebuttal in the New England Journal of Medicine and a

15 rebuttal in JAMA with another position statement, and I've

16 written actually three articles rebutting some of this

17 research and a number of other positions in different

18 locations. It really is often based on opinion. I went

19 and I added up the citations, and I think 335 of the

20 footnotes were the authors quoting their own research,

21 which wasn't really research but was opinion. So there's

22 this opinion spinning opinion that keeps going around.

23 So we make the distinction between guidelines and

24 clinical judgment. We never treat diseases -- never. We

25 only treat patients. We treat patients who happen to have 34

1 diseases and have unique issues. So we cannot go by some

2 authoritarian third party that gives a guideline that says

3 that we should treat in a certain way when they are not

4 looking at the individual needs of that patient. If you

5 look at something like acne where people are on antibiotics

6 for years, what's the issue with Lyme where it's a much

7 more serious condition and can last much longer?

8 Sir William Osler, the father of American

9 medicine, who was in my school where I trained, he

10 emphasizes listening to the patient in clinical judgment.

11 That's a very critical thing. That's a core thing of

12 American medicine. Hippocrates emphasized that. There's

13 often a misinterpretation of what's called the surveillance

14 definition, where that's used for clinical reporting of

15 epidemiological cases. We don't care about that, and the

16 CDC, a formal position of the CDC, is this is for

17 surveillance, not for clinical diagnosis. Clinical

18 diagnosis is a different thing.

19 The ELISA, which is used as a screening test and

20 part of the surveillance definition, when you look at the

21 studies, one study showed it's 56 percent accurate.

22 Another study with more data which is harder to see shows

23 it's 46 percent accurate. That's like a coin toss, and

24 this is the test that we rely on. Think if that were AIDS;

25 how would we rely on that? 35

1 If we look at the proper use of evidence-based

2 medicine, there are three arms. One is the best evidence

3 available, not absolute evidence. You never have absolute

4 evidence. Clinical judgment is the second arm. That's the

5 second third. The final third is patient consideration,

6 patient values.

7 Now, from that standpoint, I'd like to ask, how

8 many people in this room today -- I'd like to see a show of

9 hands -- how many of you are affected by Lyme Disease in

10 your personal life or in your family? Okay. Now, out of

11 this number who have raised their hand, how many of you

12 from your personal experience would support the position

13 that we propose with ILADS and ILADS guidelines? I'd like

14 to see a show of hands for that. From your personal

15 experience in seeking treatment and diagnosis, how many of

16 you would support the position of the IDSA guidelines? I

17 don't know if there's anybody that raised their hand.

18 Okay.

19 So what obstructs forward progress? In Under Our

20 Skin, in the middle of the movie, the third time I saw it,

21 Dr. Willie Burgdorfer, who's the number-one person with

22 Lyme Disease, he discovered it. He was the key person.

23 And what he stated is, "The controversy...is a shameful

24 affair and I say this because the whole thing is

25 politically tainted. Money goes to the same people who 36

1 have for the last 30 years produced the same thing -­

2 nothing." That's the core of the controversy. I can never

3 quite figure it out. I saw that; that jumped out at me.

4 So I did a little bit of research and I looked: So what's

5 this about? What's he talking about here? It's all about

6 how you define a disease. If you define it one way, if you

7 define it as a "neuropsychiatric illness," the money is

8 shifted toward psychiatry. If you define it as an

9 autoimmune rheumatoid disease, then rheumatologists, other

10 people, get the research money.

11 When we look at the money, which I show up there,

12 we're looking at hundreds of millions of dollars. And some

13 people are very dependent on this research money,

14 particularly some people in academic institutions that are

15 replacing what used to be from insurance companies to keep

16 their institutions going, and a lot of that ends up going

17 towards more basic science research rather than clinically

18 relevant research. So a lot of it's spun around getting

19 patents and keeping different things going, and in the

20 words of Willie Burgdorfer, the discoverer of Lyme Disease,

21 producing the same thing -- absolutely nothing. So that's

22 why he calls it a shameful affair.

23 Now, if we look at the people that were on the

24 IDSA panel that made these recommendations who kept their

25 definition, which was a more restrictive definition -- we 37

1 at ILADS have a broader definition -- that group of people

2 received a significant amount of that research funding

3 based on the antiquated definition.

4 So how do we find the answers? Science is based

5 on evidence, and when you have a hypothesis and any

6 evidence refutes it, you have to rethink that hypothesis.

7 Medicine is based on a combination of evidence-based

8 medicine, the best evidence available, clinical judgment,

9 patient preference, and medical ethics.

10 Dr. Benjamin Rush, who was a signer of the

11 Declaration of Independence and personal physician to

12 George Washington, stated, "Unless we put medical freedom

13 into the Constitution, the time will come when medicine

14 will organize into an undercover dictatorship to restrict

15 the art of healing to one class of men and deny equal

16 privileges to others: The Constitution of this Republic

17 should make a special privilege for medical freedom as well

18 as religious freedom."

19 I've seen in other testimony a position that

20 politicians should not meddle with medical affairs. But

21 this legislation, it's not meddling with medical affairs;

22 it's protecting freedom from individuals or groups or

23 special interests that do meddle in medical affairs and

24 protecting access and freedom for a physician to treat.

25 The example of the Senator from Texas where he went around 38

1 to 17 different doctors to get his 1 month of prescription

2 from each so he could duck under the regulatory issues, the

3 average person doesn't have that resource. We need to

4 protect patients so that they can get proper treatment, and

5 people with a specialized interest who have biased the

6 definition of "Lyme Disease," there needs to be other

7 opinion. It needs to be open. It needs to be accessed for

8 more than that restricted point of view.

9 Thank you very much.

10 MAJORITY CHAIRMAN DiGIROLAMO: Doctor, thank you.

11 Next, I'd like to ask Julia to come up again, and

12 she's going to be reading some testimony submitted by

13 Dr. Sam Donta and Dr. Burton Waisbren. Julia.

14 MS. WAGNER: Okay. Thank you again.

15 I am submitting testimony that actually is

16 incredibly important, and if you're new -- how many of you

17 are new to Lyme Disease in this way? Okay. So all of you

18 have some sense of this. This testimony is from

19 Dr. Burton Waisbren, who is a founding member and fellow of

20 the Infectious Diseases Society of America.

21 This is not easy for someone with that legacy to

22 do, and I will tell you that he is a humane individual who

23 is incredibly concerned about how the current IDSA

24 approaches Lyme Disease. So I'm going to read his letter

25 to you: 39

1 "I am honored to be asked to testify before this

2 hearing. I am a practicing physician and infectious

3 disease specialist who has been treating patients with the

4 Chronic Lyme Disease Syndrome for 21 years.

5 "First I would like to share a few thoughts about

6 this syndrome. The Chronic Lyme Disease Syndrome is a

7 disease caused by its vector, a tick who injects into a

8 human three classes of microorganisms. These have

9 historically been enemies of humans on this planet for

10 centuries. They are spirochetes of the syphilis

11 family...Borrelia...Babesia; and small bacteria of the

12 Rickettsia family, that is, Bartonella...and Erhlichia.

13 "This triad of organisms, and there may be

14 others, causes a chronic illness of debilitating nature

15 that includes weakness, fatigue, mental difficulties, ... "

16 et cetera, "and multiple sclerosis-like findings.

17 Literally thousands of people in this country appear to

18 have this syndrome. Many of these patients are waiting

19 anxiously for this hearing to take place. Unfortunately,

20 at present there is no generally accepted method to prove

21 that a person has this syndrome.

22 "I will soon be publishing a book detailing my

23 experiences with 51 cases including essays in their

24 regard." This is patient experience. It is in fact a type

25 of medical evidence. That's my quote. "The vast majority 40

1 of these patients were told by well-trained physicians that

2 because their 'Lyme tests' were negative, they couldn’t

3 have this disease. The particular test that was a

4 culprit...is the Western blot Borrelia antibody test which

5 has been arbitrarily discounted by government...unless a

6 certain titer in its response has been documented.

7 "It boggles my mind that, because of this,

8 literally thousands of patients in this country have been

9 unable to find physicians who would LISTEN to their

10 complaints. My experience in treating Chronic Lyme Disease

11 is that, in certain instances, long-term therapy given on

12 an empirical basis may help some of these patients.

13 "These treatments must overcome the invasive

14 triad by the following maneuvers...." I'm not going to

15 read those in entirety because they're more technical.

16 "All of these treatments must be instituted to

17 theoretically eradicate the invading triad. To date there

18 is no way that it can be proven that these treatments will

19 be successful.

20 "My experience and that of many others who have

21 listened to and tried to help individuals with this

22 syndrome is that there are some who appear to get better

23 under empirical treatments of this type. Many also have

24 noted, as I have, that therapeutic results may disappear

25 when long-term therapy is no longer given. 41

1 "In my experience, ... " when this occurs, he talks

2 about the fact that both protozoa and Bartonella in fact

3 can be found. So if you look far enough, you find that in

4 fact there's evidence of continued disease. "We may be

5 coming to the point that agreement is reached that

6 treatment will be continued until no organisms can be seen

7 or demonstrated.

8 "When one should stop repressive therapy should

9 be decided upon by the physician who has instituted the

10 empirical program and by the patients who are carefully

11 briefed regarding observations made by those who are

12 treating this syndrome. In my opinion, the fact of

13 arbitrarily stopping therapy being decided upon by those

14 who are not directly involved in patient care, is

15 unconscionable.

16 "I want to thank this committee for allowing me

17 to share my heartfelt feelings regarding the Chronic Lyme

18 Disease Syndrome...

19 "It is a mystery to me that some of those who

20 have carefully listened to patients with complaints related

21 to this syndrome, can come to the conclusion that it does

22 not exist." From Dr. Waisbren.

23 I have a second statement that is also from an

24 infectious disease physician. In fact, Dr. Sam Donta was

25 on one of the IDSA's Lyme Disease committees, the original 42

1 guidelines that were published in 2000, and he is going to

2 speak to that experience in this testimony.

3 Dr. Sam Donta, he asked me to relay this to you,

4 appreciates the invitation to testify but he was unable to

5 attend. He is a researcher, a clinician, and as you can

6 see up here, he is an academic professor and a clinician,

7 chief of infectious disease in multiple different hospital

8 systems, and he started two Lyme clinics, one in

9 Connecticut and one at the Boston University Medical

10 Center. This is mainstream medicine, and he is an

11 infectious disease expert. In addition, Dr. Donta was part

12 of the original IDSA Lyme Disease Guidelines Committee in

13 the year 2000 and worked specifically on the chronic Lyme

14 portion of those guidelines.

15 His testimony in regard to this experience is

16 revealing. He states that a near final draft of the

17 guidelines was distributed. The section on chronic Lyme

18 Disease that he and Dr. Coyle had drafted had been replaced

19 by a different section, not ours, that basically stated

20 that there was no evidence for the existence of chronic

21 Lyme Disease, and I was told in a discussion that I could

22 choose to sign or not sign the document. I had stated

23 previously, and the chair concurred, that any guidelines

24 for the diagnosis and treatment of chronic Lyme Disease

25 were premature as there was insufficient information. 43

1 Since then, emerging evidence has further

2 emphasized this point. There are too many uncertainties

3 about the diagnosis and treatment of chronic Lyme Disease

4 to make the issuance of any firm guidelines tenuous and

5 likely misleading.

6 I had asked to be part of the second recent

7 guidelines committee but I was told that my comments were

8 not coordinate with those of the other committee members.

9 Science is based on divergent views.

10 I have attached for you the Connecticut Attorney

11 General's findings when they reviewed the process of this

12 guidelines committee, which were found to be faulty. So

13 you need to read that, because the findings are quite

14 disturbing.

15 He goes on to say that politics notwithstanding,

16 we have a big problem that will not go away by denying the

17 existence of chronic Lyme Disease, and the IDSA needs to

18 exercise leadership and move forward to address the

19 questions that surround the diagnosis and treatment of

20 chronic Lyme Disease. Until that time, the current IDSA

21 guidelines are inappropriate and too rigid. In his own

22 practice, he uses long-term antibiotic therapy and in one

23 published study indicates that the actual duration of

24 treatment needed to affect cure and maximum improvement has

25 yet to be determined, but in our observation, it appears to 44

1 be closer to 12 to 18 months in other studies or more. The

2 duration should not be surprising when considering the long

3 durations of therapy needed to control other chronic

4 infections such as TB, fungal infections, leprosy, and

5 Q fever, which is another tick-borne disease, which the CDC

6 states requires extensive long-term treatment.

7 Dr. Donta has specifically communicated that he

8 would be happy and available to answer any follow-up

9 questions either by phone, by video conference, or via

10 Skype, and he has submitted to you his testimony in front

11 of the IDSA panel's review guidelines that occurred in 2009

12 ordered by the Connecticut State Attorney General.

13 Thank you.

14 MAJORITY CHAIRMAN DiGIROLAMO: Okay, Julia.

15 Thank you again.

16 Next we have Dr. Harold Smith. I ask Dr. Smith

17 to come up. Dr. Smith is an MD with emergency medicine.

18 He is also with the International Lyme and Associated

19 Diseases Society and a member of the Lyme Disease

20 Guidelines Committee of 2004.

21 Doctor, whenever you're ready.

22 DR. SMITH: Thank you for this opportunity to

23 speak on the experience of a community physician in

24 Pennsylvania with tick-borne diseases. I think we've had

25 enough testimony about, is Lyme Disease a serious problem? 45

1 It certainly is in my office.

2 I'm going to touch on my experiences about

3 problems with the health-care system and about Lyme Disease

4 in Pennsylvania. Why aren't the germs cooperating? What's

5 wrong with the germs? Why aren't they easily killed in

6 2 to 4 weeks?

7 And what is the evidence? We hear a lot among

8 physicians about evidence-based medicine, so I want to

9 speak about the evidence of chronic Lyme Disease and then I

10 want to give about 10 reasons why to support bill 272 from

11 a physician's point of view.

12 As a physician, I've worked totally in

13 Pennsylvania in my health-care profession for 35 years.

14 The last 10 years, I've been involved with Lyme and

15 tick-borne diseases. I've seen and been involved with

16 about a thousand Lyme Disease patients. These patients

17 enter my practice either because they were treated short

18 term and then got sick again, were inadequately treated, or

19 were never diagnosed or treated and many years have gone

20 by.

21 I lecture at Lyme Disease international meetings.

22 I've published on Lyme Disease, and I was a coauthor of the

23 original ILADS guidelines.

24 Is Lyme Disease a serious problem? The number we

25 have is 5,000, and the estimate is, there could be 50,000 46

1 patients each year in Pennsylvania with this disease.

2 There could be a lot more. I don't know if that's not

3 reported or not diagnosed, but it's probably the tip of the

4 iceberg. It's in every county in Pennsylvania. It has a

5 severe quality-of-life impact. The number of deaths may be

6 fairly low, but the death in your quality of life is very

7 real.

8 The costs, let's add up some costs. I mean, if

9 it's $20,000 a year per patient and you have 50,000

10 patients, that's $1 billion in Pennsylvania, and I think

11 $20,000 a year is coming in on the low side when you look

12 at the previous testimony. The costs in pain and suffering

13 have already been documented in studies to be equal to that

14 of heart failure, postoperative pain, multiple sclerosis.

15 The conclusion from a doctor's office treating Lyme Disease

16 is our present approach is not working.

17 What's wrong with our health care? The major

18 problem I see is delay in diagnosis. The disease, when

19 it's early, is one disease; when it's late, it's a totally

20 different disease. Later disease is much more serious.

21 The delay is due to a lack of public education.

22 The patients don't know enough about Lyme Disease. They're

23 going to learn, but they don't know enough to begin with.

24 And secondly, physician education.

25 A major other problem is this reliance on the 47

1 testing. So many of my patients have seen another doctor

2 or many doctors previously and they said, "We'll do the

3 test"; "The test is negative; you don't have Lyme Disease."

4 I'm going to tell you, this test doesn't even test for Lyme

5 Disease. A test for Lyme Disease would find the germ and

6 it would show you how you're sick from that germ. This is

7 a test that sees if you have antibodies that'll stick onto

8 a strain of a germ in a kit. So the result is open to

9 interpretation. That's what it's worth. It can be

10 supportive of Lyme Disease or less supportive. It is never

11 and has never been diagnostic of Lyme Disease.

12 The second major fault is relying on very narrow

13 presentations of Lyme Disease. Lyme Disease is listed as

14 five problems that can be reported. Those are the tip of

15 the iceberg. Every one of the reportable conditions,

16 medical presentations, is the tip of the iceberg. Complete

17 heart block is a heart manifestation that can be reported.

18 Holter monitors of people with Lyme Disease show over

19 10 times as many other arrhythmias, predominately atrial,

20 building up to the final catastrophe of complete heart

21 block. But they're just tremendous. Bell's palsy is one

22 of 12 cranial nerves coming out of your head. Any one of

23 those cranial nerves can be involved; it's just that Bell's

24 palsy is easy to see when you look in the mirror or walk in

25 your doctor's office. Every one of these criteria that are 48

1 listed are just the tip of the iceberg, and that's based on

2 evidence.

3 Another problem is care isn't available to

4 patients. Patients have to struggle to find someone to

5 give them an option to look at this disease the way it

6 really is. Another major problem is, health care, like all

7 of us humans, we get a vested interest in what we've been

8 doing and it's very hard to change, and there are vested

9 interests in Lyme Disease.

10 I'm going to give you a 30-second microbiology

11 course. But if you learn about Lyme Disease and what this

12 germ does, you will walk away from your learning that this

13 germ is not going to be treated with 30 days of anything

14 when it's chronic. I don't care if it's antibiotics or if

15 it's the autoimmune presentations or if it's the

16 psychiatric presentations or it's the autism in your child;

17 this germ is not going to go away in 30 days.

18 Now, I mentioned a list of things there, but it's

19 inside cells and outside cells. If you treat it, it can go

20 dormant. A small number of these germs can make you

21 terribly ill, and they do it, as Dr. Bransfield mentioned,

22 by driving large waves of cytokines. Your own immune

23 chemicals make you sick. They're supposed to. When you

24 get sick, you're supposed to go lay down and don't infect

25 me, and go hurt, so you don't waste your energy, you know, 49

1 digging potatoes. Go lay down and get better. Those are

2 normal responses in the cytokines. But if you can't get

3 rid of a germ, you've got the flu every day. The only

4 difference is, some day is more hell than another day.

5 We know that the co-infections in these germs, in

6 these ticks, support each other. The more you get, the

7 sicker you are. And our present lifestyle in Pennsylvania

8 interplays with this illness, making it more serious than

9 probably it was for Susquehannock Indians. Our own

10 antibiotics aren't working, so why would an external source

11 of antibiotics work in 30 days? You make your own

12 antibiotics, and they're not working.

13 So short-term treatment of any kind is highly

14 questionable. If a patient came to me, I should at least

15 offer them the option, this is what we know about the

16 disease; do you want to go with the short term or do you

17 want to go long term?

18 What's the evidence we hear? We hear these

19 statements that this disease is cured in 2 to 4 weeks. The

20 serology tests are accurate. And two really bad things I

21 have to deal with in my office is, there's no proof that

22 long-term antibiotics work and that they're dangerous.

23 Well, first of all, the IDSA guidelines themselves which

24 make these statements are based on very inadequate

25 evidence. 50

1 There are two different schools of thought on

2 this disease. The counterevidence, even at the IDSA panel

3 meeting in 2010, tremendous evidence was given that

4 short-term treatment is not effective. There are many

5 studies showing success with longer term treatment. When a

6 statement is made that there is no evidence that long-term

7 treatment works, that is not the fact. I listed several

8 studies up there, but these go back 20 years.

9 Elizabeth Aberer was a German physician who kept

10 needle biopsying around joints as she treated her patients,

11 and every 3 to 6 months she saw less germ and less

12 inflammation. But it wasn't even really all gone in many

13 patients, even at the end of her treatment.

14 Barthold and Hodzic recently did excellent work

15 with mice. They treated them with 30 days. After 30 days,

16 every mouse was infected. When you looked for the germ by

17 DNA, by electron microscopy, or by feeding sterile ticks on

18 the cured mice, they gave it to new mice. The CDC itself

19 talks about co-infections, how they complicate the picture.

20 The cyclical pattern I want to mention is the

21 evidence in my office. When you treat patients, you

22 diagnose them by patterns. When somebody walks into the

23 office or an emergency room, nobody looks at you and goes

24 "IVP," "CAT scan," you know, "PET scan." They go, "What's

25 the pattern of your illness?" Chronic Lyme Disease 51

1 presents with horrible fatigue, horrible pain, and broad

2 neurologic problems. That's the triad. It's so common,

3 it's boring.

4 Now, there are individual variations. Some

5 people's pain is in their head, some it's in their bladder,

6 some it's in their back. Everybody has core energy lack,

7 and everybody has neurologic problems. But the pattern of

8 improvement when you treat these patients is the opposite

9 of normal. They feel sicker first. The germ has them

10 pinned down. You give the patient an antibiotic they

11 haven't seen before and they escape from being pinned, it's

12 up-fighting. You feel sicker first, then you start to see

13 a second pattern of improvement and a third pattern where

14 you finally are stable. Almost everybody with chronic Lyme

15 goes through that picture. It's a pattern. It's evidence.

16 In vitro research, you know, if you keep

17 culturing these germs and treating them, they appear to go

18 away. They're dormant.

19 What can 272 do for Pennsylvania? I think

20 recognize the diagnosis is on broad criteria. The negative

21 tests don't exclude it. New illness isn't the same as

22 chronic illness. There is a triad of the pattern of the

23 illness. And later-stage treatment is complex. If you

24 stop too soon, it comes back. And the benefits of treating

25 long-term illness with antibiotics long term far outweighs 52

1 the risks.

2 And government intervention in health care here,

3 in my experience, is appropriate and there are precedents.

4 If I'm in a car accident going home, I go to a trauma

5 center. That was set up by my government. If someone has

6 breast cancer, there's a law in Pennsylvania that says you

7 will be given options. The availability is constrained by

8 many things. I would like to see clinics set up in

9 Pennsylvania where we could treat patients at low cost and

10 offer them at least a modicum of care.

11 Patient choice is essential. A patient has to be

12 given options of what to do. And I think we have to be

13 aware that vested interests are what can be blocking our

14 progress.

15 Summary: You know, I think the main summary for

16 me in my office is that Lyme Disease is exciting. "What do

17 you mean?" It's treatable, it's preventable, and we can do

18 that. The savings in suffering and cost to Pennsylvania is

19 an exciting issue. I mean, what if lupus in some patients

20 is Lyme? MS is Lyme in some patients? Scleroderma is Lyme

21 in some patients? I'm treating patients from Johns

22 Hopkins. They're still getting treated there for

23 scleroderma; they're getting sicker. I get them and treat

24 them for Lyme Disease, they slowly, steadily get better.

25 So I think it's exciting for us what we could do. 53

1 Thank you for listening.

2 MAJORITY CHAIRMAN DiGIROLAMO: Very good, Doctor.

3 Thank you.

4 I'd like to recognize the presence of

5 Representative Delozier, who's a Member of the Committee,

6 and also Representative Wheatley, also a Member of the

7 Committee. Welcome.

8 Our next testifier is Mimi Wainwright, who is a

9 school nurse and a member of the Pennsylvania Association

10 of School Nurses and Practitioners.

11 MS. WAINWRIGHT: Good morning. I'm going to try

12 to speed this up in an effort to save some time.

13 My name is Mary Frances Wainwright. I have been

14 a registered nurse in the State of Pennsylvania for the

15 past 21 years. I've enjoyed thoroughly being a school

16 nurse in Philadelphia County for almost 10 years, and I'd

17 like to thank the Committee and Julia Wagner for having me

18 speak here today, as I'm very passionate about what I'm

19 seeing in schoolchildren.

20 As a school nurse, I'm also considered, so to

21 speak, a public health nurse. I'm on the front line, and

22 I'm living in the same county where our school is, which is

23 in Roxborough, that has a large deer population. Our

24 school has right now 220 students and has a very high

25 incidence of Lyme Disease. 54

1 Diagnosed cases of Lyme Disease are growing in

2 number at our school each year. Those students diagnosed

3 with Lyme have been sick with different presenting

4 problems, and less than half of the students remember, or

5 their parents, removing a tick, nor have they seen a

6 bulls-eye or any rash of any kind. Because these students

7 didn't report to their physicians about seeing a tick,

8 removing a tick, seeing a rash, the infamous bulls-eye, the

9 thought of Lyme Disease was totally dismissed, despite

10 parents telling them where they go to school, which is

11 literally in the woods.

12 In many instances, when a Lyme test was initially

13 drawn on a student, the test would come back negative, only

14 to find out many months and many lab tests later that in

15 fact it is positive for Lyme. It is my understanding

16 through reading and research that testing may be falsely

17 negative during the first several weeks of infection,

18 delaying the diagnosis and treatment. Therefore, the

19 student's symptoms are now worse, both physically and

20 cognitively.

21 Students may become too impaired to even come to

22 school. They miss many days, sometimes weeks. Students

23 who are chronically absent may miss many academic,

24 extracurricular, and social milestones. In one case I'm

25 familiar with, the student missed almost the whole year 55

1 last year of school.

2 The students' physicians fail to acknowledge that

3 Lyme can become a chronic condition and can be totally

4 disabling. When students have been diagnosed with Lyme

5 Disease and are unable to perform at school despite being

6 treated with antibiotics for 2 to 3 weeks, their physician

7 may now suggest that the student is experiencing

8 psychological issues -- faking, depressed, lazy, attempting

9 to avoid schoolwork, and miss work.

10 When this situation occurs, the parents are at a

11 loss as to what to do for their child. Parents spend

12 thousands of out-of-pocket dollars on psychologists and

13 antidepressants. When psychologists and antidepressants

14 are not helping, physicians move on to sleep studies and

15 MRIs.

16 Many students with Lyme also experience

17 gastrointestinal symptoms which are not considered, by many

18 physicians, related to a Lyme Disease diagnosis.

19 Accompanying the gastrointestinal symptoms are more tests

20 such as upper endoscopies.

21 This past April, a fifth grade student came to my

22 health room with a note that she had written: "I cannot

23 feel the side of my face, or my tongue and my right arm is

24 heavy and I cannot pick it up." The reason the student

25 wrote the note was because she was experiencing slurred 56

1 speech and she was very frightened. This student, who has

2 had a history of Lyme disease twice, was admitted to a

3 pediatric hospital in Philadelphia. Despite the student's

4 parents telling the physician at the hospital that our

5 student, her daughter, had had Lyme Disease twice, CT scan,

6 EEG testing, and bloodwork that included a Lyme were

7 obtained. At the student's discharge from the hospital,

8 physicians told her parents that the tests all came back

9 inconclusive. The parent was told that her child had

10 probably experienced TIAs, transient ischemic attacks, or

11 mini-strokes. This child, again, is in fifth grade.

12 Several weeks later, after discharge, the same

13 student's family doc diagnosed her appropriately with Lyme

14 Disease after her serology did come back positive. Parents

15 want to believe that the physicians have all the answers

16 and know what's best or at least appropriately how to guide

17 them into helping their child. However, when Lyme Disease

18 is the accurate diagnosis, mainstream physicians can be

19 unfamiliar with the difficult task of both diagnosis and

20 eliminating the microbes.

21 As I have witnessed with more than one student,

22 after a student with a diagnosis of Lyme Disease is treated

23 with the standard course of antibiotics, their symptoms

24 greatly diminish and might even completely go away.

25 However, with some students, the symptoms will return many 57

1 months later, and most commonly the physician will explain

2 to the parents after more lab tests that their children

3 have been infected for a second time with Lyme Disease.

4 If Lyme Disease is left untreated due to false

5 negative lab tests or improperly treated, it's not uncommon

6 for the infection to spread to other parts of the body,

7 producing different symptoms at different times. Some

8 symptoms that I have seen because of undiagnosed Lyme or

9 undertreated Lyme have been arthritis -- and typically that

10 has always been in the knees. There's no history of any

11 injury; a very swollen knee. It's extremely red, painful

12 to touch. All these tests are done. It has always been

13 Lyme when there hasn't been an injury to that knee, and I

14 know that seems extreme, but that's true -- neurological

15 symptoms such as numbness, nerve paralysis, in particular

16 affecting facial muscles, stiff neck, severe fatigue,

17 headaches.

18 Cardiac symptoms can also be experienced by

19 untreated Lyme. My own son's case of Lyme Disease

20 illustrates many of these points. Initially he had been

21 experiencing fever, extreme fatigue, as well as back pain

22 for over a month. He had a Lyme which was initially

23 negative. He then went on to experience severe

24 light-headedness, and after his physician saw a heart block

25 on his EKG, he repeated the Lyme test and then it came back 58

1 positive for Lyme.

2 Headaches, ongoing fatigue, sleep disturbances,

3 problems with memory and cognition, make it difficult for

4 students to make up the required work and school. At home,

5 parents have been told that, and they're frustrated when

6 they've been unsuccessful in getting longer courses of

7 antibiotics for their child. I've seen families change

8 physicians in order to receive longer courses of antibiotic

9 therapy. I do not work in the field of infectious disease.

10 However, as a registered nurse, it's hard to understand why

11 those diagnosed with Lyme Disease are given only 2 to 3

12 weeks of antibiotic therapy.

13 Fortunately, the International Lyme and

14 Associated Diseases Society, whose physicians are literate

15 in Lyme Disease, recognize that Lyme Disease can be a

16 chronic illness. It can be difficult to kill with only

17 2 weeks of antibiotics due to its shape and the length of

18 its lifecycle. We need to take action now. Pennsylvania

19 has waited too long.

20 The medical community as a whole is not

21 addressing the issues of Lyme Disease -- its prevention; a

22 more efficient diagnosis is needed; and when indicated,

23 longer treatment with antibiotics. Our families in

24 Pennsylvania have been suffering long enough. Let us open

25 our collective hearts and minds. Through education, we can 59

1 teach our children and families how to decrease the

2 likelihood of being bitten by a tick. We need to educate

3 our physicians in Pennsylvania about all the signs and

4 symptoms of Lyme Disease and other tick-borne infections.

5 Physicians need to know that the incidents of diagnosed

6 Lyme Disease in Pennsylvania are skyrocketing.

7 After speaking with parents of the children who

8 have had Lyme Disease, I would suggest the major areas for

9 physician education be that, first, physicians need to be

10 educated that a tick or a rash is not seen in many cases of

11 Lyme. Not everyone with Lyme Disease will develop the

12 infamous bulls-eye rash. Often, there's no rash.

13 Second, symptoms usually manifest within 3 days

14 to 30 days after a tick bite. However, many symptoms may

15 develop months, even years later.

16 Third, physicians in Pennsylvania need to be

17 informed that the current lab tests that diagnose Lyme

18 Disease are often not reliable. A negative Lyme test does

19 not mean that a patient does not have Lyme Disease.

20 Fourth, antibiotic treatment to rid the body of

21 Lyme Disease may take much longer than 2 to 3 weeks.

22 The tick population in Pennsylvania is exploding.

23 Pennsylvania is number one in the nation of newly reported

24 Lyme Disease and other tick-borne illnesses, and they're

25 having a significant impact on Pennsylvania students, both 60

1 physically and cognitively. This is evidenced by the

2 increase in the incidents of diagnosed cases of Lyme

3 Disease that I've seen at our school each year. Through

4 mandatory education in Pennsylvania public schools in

5 conjunction with public service ads, we can teach our

6 students and families about the serious nature of Lyme

7 Disease.

8 The best way for families and schoolchildren to

9 deal with Lyme is prevention, to avoid being bit by the

10 tick in the first place. Early-detection information along

11 with educating the public about Lyme and about the most

12 common signs and symptoms of Lyme Disease is an important

13 follow-up to prevention. Integrating standards and

14 accurate Lyme Disease information into the Philadelphia

15 public school curriculum will give students the tools to

16 take practical precautions that will decrease the

17 likelihood of being bitten by a tick -- the best chance to

18 avoid chronic, persistent Lyme Disease.

19 Please stand up in support of bill 272.

20 Remember, I speak here as a member of the Pennsylvania

21 Association of School Nurses and Practitioners with the

22 association's full support and endorsement, which is

23 attached in your packet, in your green folders. School

24 nurses are seeing this every day, and we are concerned for

25 our students -- our State's children. We need your help to 61

1 take action.

2 Thank you.

3 MAJORITY CHAIRMAN DiGIROLAMO: Mimi, thank you

4 very much.

5 And next we have two members of the patient

6 panel: Shawn DeFrees and Edward Yost. Gentlemen, you can

7 begin whenever you're ready.

8 DR. DeFREES: Thank you, and I'd like to thank

9 everybody for allowing me to testify today. I'll try to

10 keep this very brief.

11 I have a Ph.D. in medicinal chemistry, and

12 really, I've been working personally and managing as a

13 Senior Manager at various biotechnical and pharmaceutical

14 companies, research and development efforts, in a variety

15 of fields, everything ranging from cancer to infectious

16 disease and vaccines.

17 My testimony today is really based on my family's

18 personal experience, but there's also the underlying issues

19 that you've heard from various speakers today, and you'll

20 see how that has come out with what we've experienced.

21 I have three children and a wife. We moved here

22 from San Diego about 12 years ago. I really come from this

23 area, but we had moved on for a short time. On returning,

24 we're avid hikers, and we began to develop symptoms that at

25 first were not severe but became severe very quickly. 62

1 There was severe pain in joints, legs, heart,

2 limb-tingling, malaise, and so forth and so on, and this

3 began to get worse with time.

4 We saw a variety of physicians, as you've heard.

5 Several of the classes of physicians are up here on the

6 board, including a psychiatrist. Because there was no

7 diagnosis, there was never a mention of Lyme, and the only

8 treatment was palliative, basically Tylenol, aspirin, and

9 various anti-inflammatories. And when pushed to try to get

10 a result, eventually the symptoms worsened, especially for

11 my wife and oldest daughter. It became neurological. At

12 that point, one of the doctors did do a Lyme test. It was

13 negative. The new diagnosis from that doctor, however,

14 because of the negative Lyme test, was, and I will quote

15 him, "It's all in your head."

16 So my wife, again, was the worst affected. I got

17 a call one night that she was dying, and she was. She was

18 in severe pain; she had neurological effects. Before I got

19 home, she went to the pharmacy to fill another prescription

20 for an anti-inflammatory agent, another Tylenol derivative,

21 and the pharmacist is actually the one who made the

22 connection with Lyme Disease and recommended a physician

23 that would treat. So eventually the entire family was

24 diagnosed and was treated, and over very long periods of

25 time, we all began to recover. 63

1 Now, we've had a very interesting experience with

2 insurance companies. We had a PPO with a local health

3 insurer, and we thought with insurance, being a PPO, the

4 physician we were seeing was not covered by this insurance

5 agency, that we could submit claims and get some

6 reimbursement. The initial response was in fact to avoid

7 payment by all means. It required my place of employment

8 to restore those payments. But the worst part wasn't just

9 that.

10 Shortly after that, we were approached by the

11 insurance company again. This time we were accused of

12 insurance fraud for being treated for Lyme. And this point

13 was driven home when a private investigator came banging on

14 the door, making it very clear that we were doing something

15 illegal and we were bilking the system because we were

16 being treated for Lyme Disease. Fortunately, I contacted a

17 State Representative here, and he was able to help and the

18 attacks stopped.

19 But this prompted me to go out, being a

20 professional, to talk to friends and colleagues who are

21 MDs. I've been in the industry for a long time and been

22 through the scientific system, and what I found in the

23 State of Pennsylvania is, at least even the friends and

24 colleagues I have, no one will admit, they won't test, they

25 won't diagnose, nor will they treat Lyme Disease. And when 64

1 I had the conversation with them, I said, "Really, what's

2 the issue?" The issue was, "Insurance companies will

3 retaliate if we do anything in that regard." Initially it

4 would be financial if it's under part of some arrangement

5 with the insurance company. That leads to harassment by

6 the insurance company by a variety of means and eventually

7 attacks and the potential loss of a medical license, so

8 they're not going to go there. In fact, they wouldn't even

9 give me their names or come here to testify today. I did

10 contact them.

11 When treatment is provided, at least one doctor

12 told me that they can only give 2 weeks of antibiotics, and

13 although the patients are not cured, they have to use the

14 term "cured" and send the patients on their way. So it's a

15 real problem for physicians in this State. They cannot

16 treat Lyme Disease because of the perceived risk of losing

17 their medical license, and this is through economic

18 pressures, not through legal pressures initially.

19 Now, what's the net effect on the patients of

20 this State? Very quickly, it's denial of care, and the

21 patients suffer horribly. This disease, as you'll hear

22 from many people here, is a very horrible disease. And it

23 continues to progress. It just doesn't stay static. As

24 the years roll on, there are more and more symptoms. The

25 severity of the symptoms gets to the point where a person 65

1 becomes disabled, and at that point the State, whether they

2 like it or not, becomes involved, because there's

3 disability involved.

4 In addition to that, many times these patients,

5 because insurance companies won' t cover their costs, their

6 medical costs, their medical care then has to be picked up

7 by someone, and again, it ends up at the State then. The

8 worst part is, all this can be avoided, as you've heard

9 from everyone here. If the patients are diagnosed early

10 and treated early and antibiotics are given until the

11 disease is eradicated, which is done for any other

12 infectious disease -- pneumonia; you've heard of other

13 diseases as well, staph infections -- we wouldn't have this

14 problem today.

15 So really to summarize, the State is paying for

16 insurance companies' failure to provide contractual

17 coverage and care. In fact, they're preventing care in

18 many cases.

19 So in summary, I support the bill 272; I hope

20 that everyone does here, and thank you for your time.

21 DR. YOST: Hello, everyone. My name is

22 Dr. Edward Yost. I'm an anesthesiologist and I'm up in

23 New York, and I traveled from New York today to speak to

24 you.

25 I think it's important that we understand that 66

1 there are patients and patients who are doctors like myself

2 who also have Lyme Disease, so I would just like to read my

3 testimony to you and ask you if you have any questions.

4 And specifically I would like to say that if

5 anyone on this board had Lyme disease and was treated for a

6 small amount of time by a doctor with antibiotics and began

7 to feel better and then that care was withdrawn, what would

8 you do as you descended back into the abyss of Lyme

9 Disease, as you began to feel horrible again? So I find

10 that unconscionable that we can give people a short term of

11 antibiotics and then withdraw that care when they're

12 feeling better. So I just want to know, if you experienced

13 that, what would you do? You'd start seeing every doctor

14 you knew to provide you with more antibiotics.

15 So I'm going to read my testimony now.

16 Good morning. My name is Dr. Edward Yost. I'm a

17 board-certified anesthesiologist, a member of the American

18 Society of Anesthesiologists, International Spine

19 Intervention Society, and the American Headache Society,

20 and I come to speak to the Legislature today, not only as a

21 physician but representing those who, like me, suffer from

22 Lyme Disease.

23 I received my Bachelor of Science degree in

24 chemistry from Long Island University in 1984. Shortly

25 after, I joined the United States Navy. I was a United 67

1 States Navy pilot, carrier-based, and served with the Armed

2 Forces for 7 years, receiving an honorable discharge in

3 1991.

4 I was then hired by American Airlines and

5 operated a Boeing 727/757/767 aircraft as a copilot and

6 traveled throughout the world. It was during this time

7 that I attended Columbia University. I got my

8 Post-Baccalaureate Pre Med Program there. And in 1994, I

9 began my training at Stony Brook University Medical School

10 in Stony Brook, New York.

11 During my second year of medical school, I

12 discovered a tick on my scalp, and approximately 3 to

13 4 weeks later, I became ill with flu-like symptoms,

14 shortness of breath, and general malaise. As a physician

15 in training, I knew something was wrong, and I began to

16 speak to the physicians who were around me in medical

17 school. They had really nothing to offer. And over the

18 next 5 years, with the accessibility that my career in

19 aviation afforded me, I traveled to the esteemed Cleveland

20 Clinic and to lesser known areas of Europe with an attempt

21 to find me a remedy for this mysterious, chronic illness

22 that was rapidly causing me to become debilitated.

23 In total, I saw over 35 doctors, including

24 specialists in internal medicine, infectious disease,

25 chronic fatigue, cardiologists, rheumatologists, and 68

1 neurologists. And I'm a doctor. Every physician I met

2 dismissed my thoughts of having contracted Lyme Disease,

3 including two members of the IDSA that wrote the protocol

4 for 21 days of antibiotic treatment. I saw two of those

5 members on that board that wrote that darn protocol.

6 Every physician I met dismissed my thoughts of

7 having contracted Lyme Disease. Although I initially

8 presented with a tick bite and was suffering from joint

9 pain, muscle aches, and fatigue and I was trained in

10 medicine, I still had no diagnosis or a physician who was

11 willing to listen to my concerns.

12 As the obscure manifestations of the illness

13 persisted, I began my descent into failing health. My

14 illness was becoming more noticeable. I was having

15 neurological symptoms. At the urging of a fellow pilot, I

16 was informed about a Lyme-literate physician here in your

17 Commonwealth of Pennsylvania. With waning hope, I

18 consulted with this doctor, who examined and diagnosed me

19 with Lyme disease, and quite frankly, he saved my life.

20 And that's why I'm here today; he called me and asked me to

21 testify. So I drove from New York because this doctor, in

22 your State, saved my life.

23 After circumnavigating the globe, it was here in

24 Pennsylvania that I found what I had so desperately needed:

25 a physician who was trained in the diagnosis and treatment 69

1 of tick-borne illnesses and was sensitive to those

2 illnesses and understood them and made the diagnosis. I

3 went everywhere in the world looking for a doctor. I ran

4 up hundreds of thousands of dollars of medical costs.

5 After years of long-term treatment, including

6 antibiotics and antimalarials, I was able to improve my

7 health, graduated medical school, became board certified in

8 my specialty, and had a deeper understanding of medicine

9 while being a better physician to my patients. However,

10 because of the delay in my getting the proper treatment, I

11 am left with the lingering effects of chronic Lyme disease.

12 I truly believe my colleagues dismissed me

13 because they were not properly trained to acknowledge

14 tick-borne illnesses and their manifestations, or they

15 opted to challenge the research findings that there is a

16 chronic form of the disease. My personal experience

17 demonstrates that further education is warranted to train

18 physicians in the assessment, diagnosis, and treatment of

19 tick-borne illnesses.

20 Pennsylvania policy and lack of action regarding

21 this policy discourages current physicians from properly

22 treating patients with Lyme Disease throughout the

23 Commonwealth of Pennsylvania and inhibits doctors from

24 other States, including myself, from providing services to

25 the infirmed within your borders. 70

1 Ignoring the problem or the disease will not make

2 it go away. Lack of treatment in the acute phase will only

3 lead to a chronic condition. The abandonment and rejection

4 I received by the medical community over an extended number

5 or period of years contributed to me becoming a

6 chronically-ill individual. People suffering with chronic

7 illnesses are no longer in possession of the fruits of

8 their existence. Their lives are not their own. They are

9 enslaved under the conditions determined by the disease and

10 by those directing their medical care, specifically the

11 doctors and the insurance companies that have diametrically

12 opposed views on medical treatment. We can either

13 acknowledge that the patient is chronic and allow them the

14 proper course of therapy or dismiss them and essentially

15 abandon them or shuffle them from one physician to the

16 next, as I was.

17 In 1776, a group of Legislators, including five

18 doctors, affirmed the rights of the individual citizens in

19 a community not far from here in this State. Now this

20 Legislature has the chance to protect those liberties again

21 by defending the basic right of the patients. A good

22 society is one that takes care of its sick. A good society

23 is against alienation. A good society revolts against an

24 unhinged life. The chronically ill are estranged from the

25 constraints of those operating within our society who are 71

1 restraining care. Doctors must be able to do their jobs

2 and protect the patients who are seeking their care.

3 I believe as we work towards awareness in Lyme

4 Disease and continuing research, history will prove that

5 Members of this Legislature will have done the right thing

6 here and now with benevolence. Opening the dialogue on

7 this major health threat through addressing the public

8 policy and acting upon that policy on behalf of the

9 public's best interests will be a momentous step forward

10 for those suffering from Lyme Disease.

11 MAJORITY CHAIRMAN DiGIROLAMO: Go ahead; you can

12 begin your testimony.

13 MS. WIER: Thank you.

14 Hi. I'm Jerri-Lynn Wier. Thank you, Chairman.

15 Thank you, Representative Hess.

16 I'm an attorney. I'm also a congressional

17 campaign manager, and Merle Phillips and I drafted this

18 bill together. So I am speaking for myself and also for

19 Merle, because I know that Merle has been really, really

20 ill with this disease, and we have been working on this

21 legislation for more years than I ever want to talk about.

22 And I still work in Congress now.

23 What I wanted to talk about, everyone knows me

24 politically but no one knows my real story. And I'm going

25 to be brief, but I just wanted to talk about why I'm so 72

1 passionate about this bill, and I really haven't spoken

2 about it to people before.

3 About 14 years ago I moved from New York, like

4 you, and became really sick. My children were really

5 little then. I had four of them. They ranged in age from

6 2 to 6. And I was a very active practicing attorney,

7 political, going back and forth to DC, and I couldn't even

8 get out of bed. I couldn't move from a chair. I couldn't

9 open a jar of peanut butter to give my children a sandwich.

10 That's how bad it got.

11 And then I noticed I couldn't hear. When my kids

12 were crying, I couldn't hear what they were saying to me.

13 Everything was muffled. And like everyone else here -- the

14 same stories you've heard everywhere -- I went from doctor

15 to doctor to doctor. Thousands and thousands of dollars

16 wasted. One doctor told me I needed more attention. I'm

17 like, I have four kids; I don't need any more attention

18 than that. But I couldn't find a diagnosis.

19 I finally went to a rheumatologist who gave me a

20 spinal tap and told me I didn't have Lyme Disease. In

21 fact, he screamed it to me. The spinal tap leaked, I was

22 sick worse than ever, more money wasted, and lo and behold,

23 the spinal tap came back positive for Lyme Disease. He

24 couldn't believe it; he was shocked. He gave me a month of

25 IV antibiotic treatment and I started to feel better. I 73

1 could hear my kids crying again, which was a miracle to me.

2 And I really feel upset that all the blood tests I had

3 never diagnosed the disease, so there's definitely

4 something wrong with the blood tests.

5 I wish that I could say that was the end of the

6 story, but it's not. Once I was off IV antibiotics for a

7 month, symptoms came back. I have relapsed several times,

8 but long-term treatment and a doctor -- again, in

9 Pennsylvania -- that saved my life, I'm here today. I'm

10 active; I'm working and not wasting any more money for

11 anyone else.

12 But what I wanted to talk about more is, if I

13 hadn't had long-term treatment and physicians were more

14 educated on this disease, people would not be affected.

15 And I vowed, and I still vow to this day, that I will never

16 rest until this disease receives the recognition,

17 diagnosis, and treatment it deserves.

18 I have worked tirelessly drafting this bill with

19 Merle Phillips. I have bills in Congress; I have bills in

20 other States, and I will do everything in my power to get

21 this bill passed. I want doctors to be able to treat long

22 term without fear of reprisal and the medical community and

23 States to realize that Lyme is a long-term, serious

24 illness.

25 I've lost many things in my life because of this 74

1 disease, but I'm here to make sure others don't. I'm sure

2 that each of you here knows someone affected by this

3 disease, and if States like Connecticut, Rhode Island, and

4 Texas can pass it, then Pennsylvania can do the same.

5 Thank you.

6 MS. WAGNER: We have one last patient, and I'd

7 really appreciate you allowing us to go on. We're going to

8 have Lisa Gaffney.

9 MAJORITY CHAIRMAN DiGIROLAMO: No; go ahead.

10 Lisa, whenever you're ready.

11 MS. GAFFNEY: Yes. Thank you, Julia.

12 Good morning, Chairman and Human Services

13 Committee Members. I'm honored to be here today to share

14 with you my Josie's story.

15 Over the last 3 years, I've witnessed my daughter

16 decline from being a healthy, active young girl -- a

17 cheerleader, a dancer, a gymnast -- to being in a painful

18 and very debilitating state. At 13, Josie has the

19 diagnosis of JRA, juvenile rheumatoid arthritis, as well as

20 Lyme Disease, Bartonella, chronic anemia, and much more.

21 It all started in April 2008. Returning from the

22 local soccer field, Josie came to me saying something was

23 itchy on her back. There it was, a deer tick. Three weeks

24 later, we knew immediately she had Lyme Disease after a

25 bulls-eye rash had appeared. She was treated with 75

1 antibiotics for 20 days.

2 In August 2008, she twisted her right knee in

3 gymnastics. It immediately swelled to the size of a

4 grapefruit, remaining that way for 12 weeks. After being

5 seen by two specialists, they agreed it was arthritis.

6 What they didn't consider was that Lyme was causing the

7 arthritis. After being given a cortisone shot, her right

8 ankle blew up, doubled in size, and then her left knee and

9 left ankle. Not too long after this, she was diagnosed

10 with the JRA.

11 By spring 2010, she was unable to roll over or

12 sit up, unable to maneuver her upper or lower body. All

13 joints were inflamed. Everything she tried to do herself

14 was difficult -- trying to button a shirt, put on socks, or

15 brush her hair. Everything needed my assistance. She

16 could not bend over at her waist or bend her knees and

17 elbows. She couldn't raise her arms above her head or

18 barely turn her neck from side to side. She was being

19 carried around the house, unable to stand up on her own

20 without screaming out in pain, and she begged me not to

21 touch her frail, hurting body.

22 In July of 2010, she hit her worst period,

23 dropped to 50 pounds, and became unresponsive on our couch

24 in the fetal position for almost 3 weeks.

25 By fall of 2010, she was wheelchair bound. 76

1 Clearly what they were doing was not helping. At my wit's

2 end, I tried expressing my concern again that Lyme was very

3 much still an issue, but I got nowhere -- and neither did

4 they. I started looking for help elsewhere, and the only

5 pediatric Lyme specialist in PA had a 9-month waiting list

6 and was not accepting any insurance. My Josie didn't have

7 9 months to wait.

8 As any mother would, I panicked and called the

9 best pediatric Lyme doctor in the country. I lucked out.

10 After I called his office in a panic, they made room for

11 her within a few short days. It was an amazing experience

12 on its own. He had stayed up all night the night before

13 reviewing her records, and when we got there, he knew every

14 little detail. He did a full evaluation and comprehensive

15 testing, including Lyme testing that came back positive.

16 We started antibiotics and continued for about 3 months,

17 and she progressed nicely. Her little body was so filled

18 with spirochetes that she was having constant Herxheimer

19 reactions. Her other specialists tried to tell me that the

20 antibiotics were not working, but they were. They didn't

21 know because they weren't there with her on a daily basis.

22 The more she hurt, the more the Lyme symptoms

23 decreased and started to fade away. She started to regain

24 mobility again. All of this time I was trying to get our

25 local team here working with our Lyme expert in 77

1 Connecticut. They weren't interested. They considered him

2 inferior.

3 This past spring 2011, they asked us to take her

4 off the antibiotics in order to give her the best possible

5 start to yet another change in arthritis medicines,

6 Remicade. I was asked this by her rheumatologist. This

7 was our fourth switch by this time in medications in

8 attempting to gain control of the JRA.

9 Many of the Lyme symptoms have returned that had

10 gone away on antibiotics, and yet I cannot get anyone here

11 in Pennsylvania to treat her appropriately for late-stage

12 Lyme Disease. At one point, Josie was seen by an

13 infectious disease specialist here in Harrisburg. After I

14 explained Josie's story and her symptoms in full detail,

15 that specialist told me to my face that she saw absolutely

16 no reason -- I'm sorry -- to even perform any testing on my

17 daughter. I left that doctor's office sick to my stomach.

18 Recently they told me they couldn't find any

19 signs of systemic arthritis, yet they still want to switch

20 her arthritis medications yet again and try some new drug

21 just approved by the FDA, and yet there's no proof that she

22 has the systemic arthritis. Bear in mind that Josie's

23 worst joints to this day are the joints that steroids were

24 injected into, which are her knees, her ankles, and hips.

25 And they were all again injected this past June 2011 as the 78

1 arthritic pain became so unbearable, and at the time I had

2 no other choice, so she's starting to regress even further

3 once again.

4 Josie has many unexplained, nonarthritic symptoms

5 -- sciatica, pain all over, severe stomach pain, severe

6 blurred vision and focusing issues, poking and stabbing

7 pains, and hot-to-the-touch sensations, all of which are in

8 the literature connected to Lyme. She's been scoped,

9 biopsied, MRIs, x-rayed, placed on a feeding tube and more,

10 all with no answers. But with all of those expensive

11 tests, there has been a complete refusal to even consider

12 Lyme and other tick-borne diseases.

13 So many doctors say that prolonged antibiotics

14 are necessary, and yet each time Josie has been on

15 antibiotics, she has improved, more than any other

16 treatment. When she was taken off the Rocephin, Josie's

17 Lyme symptoms slowly but surely returned. When she was

18 prescribed amoxicillin for a repeat allergy test, her Lyme

19 symptoms decreased and she stopped complaining of her

20 stomach pains. Very interesting. A coincidence? I think

21 not.

22 Antibiotics are needed. Long-term antibiotics

23 are needed. How can she be given medications for systemic

24 arthritis when they have no proof of this diagnosis and not

25 be given antibiotics to fight Lyme for which there is 79

1 proof? Antibiotics are not addictive. We give them to

2 anyone who has acne. So what's really going on?

3 When Josie is on the antibiotics, it helps. When

4 she's taken off, she declines. How can we refuse treatment

5 that helps? But we are in Pennsylvania. Look at my

6 child's picture. We need options, and we need them fast.

7 Short-term treatment has clearly failed us.

8 We have since learned that steroids are

9 contraindicated in Lyme Disease as they shut down the

10 immune system, allowing bacteria to gain a foothold and to

11 quickly disseminate. Within 5 months, Josie's joints from

12 the neck down became diseased. They crippled her knees,

13 her ankles, her elbows, her wrists, her fingers, her back,

14 and her hips. After my numerous requests to her

15 rheumatologist, a PICC line was finally inserted for

16 30 days of IV Rocephin as yet another attempt to treat that

17 Lyme. He was very apprehensive. He kept saying he saw no

18 signs of Lyme Disease, and the Western blot he had ordered

19 had come back negative. She began making improvements, but

20 it was short-lived. This is doctor-noted in her file that

21 she made improvement on the PICC line in December 2009 and

22 also noted that she relapsed after those 30 days.

23 Please stand up and lead the way forward. Other

24 States have taken the lead. PA needs to place the health

25 and welfare of our children first. Please help my 80

1 daughter. Help the parents with sick children to be given

2 the choice to use long-term antibiotics. Don't take the

3 rights of the parent or the child away, and please, please

4 don't keep us from taking care of our children. Would you

5 want to look your child in the eyes and say, "I'm sorry,

6 honey, I can no longer help you"? "I've done everything I

7 could, but they've taken away my ability to make the best

8 choices for your health." You couldn't do it, so please

9 don't expect us to do that.

10 Thank you.

11 MS. WAGNER: There is a counterpoint to her

12 story, and I'm not sure if it was clear, but Lisa cannot

13 afford to pay for medical treatment out of pocket, and the

14 Medicare insurance will not cover an out-of-State doctor,

15 and that's why she has to continue to work with the

16 Pennsylvania doctors that she is trying so desperately to

17 get help from.

18 I want to offer a counterpoint to that story,

19 because the very first Montgomery County Lyme Disease

20 Support Group meeting that I had---

21 MAJORITY CHAIRMAN DiGIROLAMO: Julia, if you

22 could do your best to summarize the testimony---

23 MS. WAGNER: This is really fast.

24 MAJORITY CHAIRMAN DiGIROLAMO: -- we would really

25 appreciate it. 81

1 MS. WAGNER: Good.

2 MAJORITY CHAIRMAN DiGIROLAMO: Thank you.

3 MS. WAGNER: Rebecca Charen came to our first

4 meeting, and she was exactly like her daughter, in a

5 wheelchair, having seizures every 15 minutes. The

6 difference was, her family sold their house and went

7 bankrupt to pay for her medical care. She was also going

8 to Connecticut. She spent 2 years out of school in a

9 wheelchair, and today, she's back in school, she's 16 years

10 old, and she is doing well. That's the counterpoint.

11 Thank you.

12 MAJORITY CHAIRMAN DiGIROLAMO: Thank you for all

13 the testifiers in that panel. It was very compelling

14 testimony.

15 Next, from the insurance industry, we have

16 Jonathan Greer from the Insurance Federation and

17 Mike Yantis from Blue Cross of Northeastern Pennsylvania,

18 and you can begin, gentlemen, when you're ready.

19 MR. GREER: Thank you for the opportunity to be

20 here today. I am Jonathan Greer, Vice President of the

21 Insurance Federation of Pennsylvania.

22 We are a nonprofit trade association representing

23 commercial insurers and all lines of insurance in

24 Pennsylvania. Our members include many of the large

25 national health insurers and some of the few remaining 82

1 local health insurers. On behalf of these companies, we

2 appreciate the opportunity to speak before you today on

3 HB 272 dealing with the diagnosis and treatment of Lyme

4 Disease.

5 Section 2 of HB 272 notes that in 2009, there

6 were 4,950 confirmed cases of Lyme Disease in Pennsylvania.

7 I am one of those cases. My diagnosis occurred in June of

8 2009 following the manifestation of classic Lyme Disease

9 symptoms -- a red bulls-eye rash on the back of my leg,

10 severe fatigue, chills, and body aches. I can personally

11 attest to the seriousness of this illness and the need for

12 an accurate diagnosis and prompt medical treatment. My

13 personal experience also allows me to understand the level

14 of interest HB 272 has stirred within the advocacy

15 community.

16 Consistent with our testimony in the past on

17 similar legislation, we believe the approach taken in

18 HB 272 is a step in the wrong direction. The bill mandates

19 coverage for any prescribed treatment of Lyme Disease,

20 including long-term antibiotics or antimicrobial therapies,

21 if the diagnosis and treatment plan are documented in the

22 patient's medical record. In this way, HB 272 is not just

23 an insurance mandate; it also amounts to legislative

24 endorsement of a controversial course of medical treatment.

25 The science on long-term antibiotic treatment for 83

1 Lyme Disease is, at best, mixed. For example, the

2 New England Journal of Medicine concluded in a 2007 study

3 that there is no scientific evidence suggesting the chronic

4 symptoms associated with Lyme Disease improve when patients

5 are treated with prolonged antibiotics. The study further

6 noted the substantial risk associated with additional

7 antibiotic treatment for patients who have longstanding,

8 subjective symptoms after an initial course of treatment.

9 More recently, an investigation by the Chicago Tribune last

10 year called into question the very existence of chronic

11 Lyme Disease.

12 We mention these studies not to minimize the

13 significance of Lyme Disease or to marginalize the passion

14 felt by many in the advocacy community on the use of

15 long-term antibiotics to treat this illness. Rather, we

16 point out these studies to demonstrate the lack of

17 consensus within the medical community that the benefits of

18 this course of treatment outweigh the risks. Unless a

19 consensus, or at least a clear majority of opinion, is

20 reached, we do not believe the General Assembly should be

21 legitimizing the use of long-term antibiotics in this

22 regard, much less mandating that insurers cover it.

23 We do, however, support the bill's other

24 objective to increase public awareness and education on

25 Lyme Disease through the creation of a task force within 84

1 the Department of Health. After all, the best way to deal

2 with Lyme Disease is to prevent people from getting it in

3 the first place.

4 Going back to my personal experience with this

5 issue, had such a task force been in existence prior to

6 2009, it's possible I may not have contracted Lyme Disease

7 in the first place. I wasn't aware at the time that June

8 is the height of the Lyme Disease season, and I certainly

9 didn't take the appropriate precautions when working

10 outside. Had I known, as I do now, the illness I was

11 exposing myself to, I would have been less cavalier and

12 worn the appropriate clothing and generally been more

13 careful.

14 Because the task force is, in part, to develop

15 professional medical information and education on Lyme

16 Disease, it should include equal representation from the

17 competing viewpoints within the medical community. As

18 such, the task force should include representatives from

19 the Pennsylvania Medical Society as well as individuals

20 from the Infectious Diseases Society of America.

21 We're not sure what, if anything, the Department

22 of Health does in this regard now, though we are happy to

23 work with this Committee and the Senate Public Health &

24 Welfare Committee should you be interested in pursuing this

25 idea further. 85

1 Thank you for the opportunity to speak before you

2 today. I will now turn the microphone over to Mike Yantis.

3 MR. YANTIS: Thanks, Jonathan.

4 We've submitted written testimony, but I'd like

5 to waive reading that in the interests of time and I'll

6 just hit a couple of highlights from what we had submitted.

7 As Jonathan said, my name is Michael Yantis. I'm

8 Policy Director for Blue Cross of Northeastern

9 Pennsylvania. We serve 13 counties in northeastern and

10 north-central Pennsylvania, and we provide coverage to

11 nearly 600,000 people in our area.

12 One of the elements that I was asked to provide

13 some thoughts on is the impact that disease mandates could

14 have on Federal health-care reform and the intersection

15 thereof. As we're all aware, Federal health-care reform

16 has had and will continue to have significant impacts on

17 State budgets moving forward. Medicaid expansion has been

18 the headline grabber to date. An often overlooked

19 requirement of Federal health-care reform that will have an

20 impact on State budgets is the intersection between State

21 health-care mandates and health insurance exchanges.

22 In 2014, Federal health-care reform mandates that

23 States create health insurance exchanges, a virtual

24 marketplace, if you will, that will facilitate a consumer's

25 ability to purchase health-care insurance. One of the 86

1 requirements in there is that State health-care-mandated

2 benefits must be paid for by the State if they are not

3 included in the Federal definition of what is going to be

4 called an "essential health benefit." The "essential

5 health benefits" is essentially the core package of

6 benefits that will have to be offered by any policy that's

7 sold through the health insurance exchange. So if a

8 State-mandated health benefit is not included in that

9 essential or core health benefit package, Federal law

10 requires that the State pick up the tab for that health

11 benefit mandate.

12 In the case of mandating long-term antibiotic

13 therapy for Lyme Disease, it's unclear whether that's going

14 to be part of the essential health benefits. At this

15 point, we're awaiting Federal regulations to define that

16 package. But given that, the Centers for Disease Control,

17 the Infectious Diseases Society of America, the National

18 Institute of Allergy and Infectious Diseases, the American

19 Academy of Neurology, an independent Connecticut review

20 panel that was put forth as a result of the Connecticut

21 Attorney General's investigation that we had heard about

22 before, all recommend against long-term antibiotic therapy

23 for Lyme Disease. We don't anticipate that it will be part

24 of that, essentially shifting the cost to any States that

25 have mandated that as part of their State law. 87

1 Now, at the end of the day, the debate about this

2 particular issue is a little different than most health

3 insurance mandates. Lyme Disease is covered. Blue Cross

4 of Northeastern Pennsylvania provides coverage for Lyme

5 Disease. I would be surprised if there's a health

6 insurance policy out there that does not provide coverage

7 for Lyme Disease. The issue at hand is covered for a

8 particular type of treatment -- long-term antibiotic

9 therapy -- and on behalf of our medical directors, they

10 believe that the evidence out there does not support that.

11 At the end of the day, though, what you're

12 listening to isn't a symphony. You're hearing a cacophony,

13 a bunch of discordant evidence and viewpoints on whether or

14 not long-term antibiotic therapy works. At the end of the

15 day, the collective evidence is at best unclear. It's

16 really not clear whether it provides any benefit to the

17 individuals. The stories are compelling. The passion is

18 there. The evidence is controversial. At the end of the

19 day, we think that means it should not be established as a

20 mandate.

21 That being said, there are several things,

22 positive things, that you can do as a result of this. We

23 talked about them before: increasing prevention,

24 increasing education. The Departments of Health,

25 Agriculture, the Game Commission, they all have a unique 88

1 opportunity to help educate individuals to prevent this

2 disease from coming forward. The Commonwealth Universal

3 Research Enhancement Program: ability there to use

4 research dollars to help inform this debate and make better

5 public policy as it relates to Lyme Disease.

6 Thank you.

7 MAJORITY CHAIRMAN DiGIROLAMO: Okay, gentlemen.

8 Thank you. Thank you for your testimony. Mike, Jonathan,

9 thank you very much.

10 And our last testifier today is John Goldman.

11 Dr. Goldman is an Infectious Disease Specialist with the

12 Pennsylvania Medical Society.

13 John, whenever you're ready.

14 DR. GOLDMAN: I am ready.

15 Chairman DiGirolamo and Members of the House

16 Human Services Committee, I am John Goldman, MD. I'm an

17 Infectious Disease Specialist who practices here in

18 Harrisburg. My office is literally a couple of miles from

19 the Capitol. I also am the Internal Medicine Program

20 Director for the internal medicine residency at

21 PinnacleHealth Hospital. I've been practicing in the

22 Commonwealth for 15 years, and I've treated literally

23 hundreds of patients with Lyme Disease.

24 I wish to thank you for the opportunity to

25 testify before you on a topic that I believe merits your 89

1 careful consideration. To begin, I should tell you that

2 the Pennsylvania Medical Society opposes HB 272.

3 In a nutshell, HB 272 attempts to come to the aid

4 of those with Lyme Disease. If passed, this bill will

5 create the Lyme and Related Tick-Borne Disease Education,

6 Prevention and Treatment Act. While the desire to help

7 these patients is laudable, as written, the bill may

8 actually be harmful to those with the disease. As a

9 result, the Pennsylvania Medical Society opposes it.

10 One of the things I would, however, like to make

11 clear is, we've heard a lot of very compelling testimony.

12 As a physician and as a member of the Pennsylvania Medical

13 Society, we understand exactly how sick these patients are.

14 When we have looked at, when you look at, things like

15 chronic Lyme Disease or Post-Lyme Syndrome, it's shown to

16 have the same kind of effect on your life as having severe

17 congestive heart failure, severe emphysema, of having a

18 really severe chronic illness. No one is questioning

19 whether or not these patients are sick, no one is

20 questioning whether or not these patients need care, and no

21 one is questioning the suffering that they endure.

22 Furthermore -- I'll flat out state this -- no one is

23 suggesting it's in their head. What we do believe is that

24 the best way to treat this disease is according to

25 evidence-based protocols, according to evidence-based 90

1 medicine. What we may disagree on is whether or not the

2 evidence supports long-term antibiotics.

3 The research on this, as we've heard from

4 previous people, is far from -- there's far from a

5 consensus that they work. There have been a number of

6 trials where they've looked at treating people with chronic

7 Lyme Disease, giving them either long-term antibiotics or a

8 placebo. The only effect the long-term antibiotics had was

9 giving the patients side effects. This was published in

10 the New England Journal. This was done in patients both

11 with a documented Lyme serology and without a documented

12 Lyme serology.

13 Ironically, we're mandating treatment with

14 chronic antibiotics at a time when we're trying to curb the

15 use of unnecessary antibiotics. I would point out that

16 people who recommend against long-term antibiotics include

17 the CDC, the NIH, the Infectious Diseases Society of

18 America, which I am a member of, and that there are

19 multiple nationally published guidelines which say, I

20 believe with good evidence, that chronic treatment does not

21 work.

22 I've treated literally hundreds of patients with

23 short terms of antibiotics, 2 to 4 weeks -- generally about

24 2 to 3 weeks if they have acute Lyme Disease, generally

25 about 4 weeks if they have one of the more chronic forms -- 91

1 and I can tell you my patients get better. Do I have a few

2 people that I have given chronic antibiotics to?

3 Absolutely. I have one or two or three who, when I stop

4 their Doxycycline, when I stop their Epicillin, they feel

5 worse. And I've treated them with long-term, oral

6 antibiotics. I'll point out that the antibiotics I give

7 them are $4 Walmart drugs. I'll point out that the

8 antibiotics I give them may cause side effects but are

9 unlikely to hurt them.

10 I'll also point out that I'm a practicing

11 infectious disease physician. I have no affiliation with

12 any insurance company. The way I make my living is I give

13 people antibiotics. At this point, I've literally treated

14 thousands of patients with outpatient IV antibiotics. I

15 spend at least part of my week just simply signing those

16 forms. And the way I make my money is I give people

17 antibiotics. There is no financial incentive for me not to

18 give people long-term antibiotics. The reason that I don't

19 do it is I don't think it works.

20 I strongly agree with the people, the patients,

21 that it can be a difficult diagnosis to make. I strongly

22 agree that in acute Lyme Disease -- it's well documented -­

23 that up to half of the serologies are negative. I've

24 treated people with what I believe is Lyme Disease on the

25 basis of clinical symptoms in the absence of serologies. 92

1 On the other hand, unless you think of it, unless you know

2 to order the serology, it can be difficult to diagnose.

3 As a result, we strongly support, the

4 Pennsylvania Medical Society strongly supports the idea of

5 a committee to improve public awareness of the disease, to

6 improve diagnosis of the disease. However, the bill

7 currently specifies that two representatives from ILADS are

8 included on this committee. I would urge that you give the

9 committee a balanced representation, including

10 representatives from ILADS, including representatives from

11 the Pennsylvania Medical Society, including representatives

12 from the IDSA.

13 Again, no one disputes the suffering of these

14 patients, no one disputes the frustration these patients

15 have with the medical system, and no one disputes their

16 desire to get better. What we would like to do is ensure

17 they're treated properly and treated according to

18 evidence-based medicine and treated in ways that have been

19 shown to work. The case for long-term antibiotics is

20 borderline at best. There are clear studies that show it

21 doesn't work, and I do not believe it is that the

22 Legislature should be mandating unproven treatments.

23 Thank you very much.

24 MAJORITY CHAIRMAN DiGIROLAMO: John, thank you

25 for your testimony. 93

1 Because of the time constraints, I know probably

2 a lot of the Members have questions. I think what I'm

3 going to do as far as the questions go is ask you to submit

4 your questions either to Liz or Pam and we'll try to get

5 answers for you. But I will allow, if the Members would

6 like, maybe to make a brief statement -- if any of the

7 Members would like -- on HB 272 or any of the testimony,

8 without asking any questions.

9 So if any of the Members would like to make a

10 brief statement?

11 I would recognize Representative DeLissio.

12 REPRESENTATIVE DeLISSIO: Just very quickly.

13 Always compassion and sympathy is what motivates

14 myself. I can only speak for myself.

15 A concern would be that I've heard throughout

16 this testimony that there are many instances where the

17 system is broke, and this piece of legislation does not

18 appear to address those particular issues, is my concern at

19 this point. So when we talk about physician education, the

20 physician's capability and ability to diagnose, the fact

21 that this crosses multiple practice areas, et cetera,

22 et cetera, are very, very, very complex challenges, and the

23 idea is to look at this at the broadest conceptual level

24 possible to do the best situation possible.

25 So I do have questions; I'll be submitting them 94

1 to the Chairman -- thank you. But some of the things, I

2 have pretty much questions for every piece of testimony,

3 and they go along the lines of, how does this legislation

4 address some of the issues that I've heard articulated here

5 today, and they're the questions I'll be submitting.

6 Thank you.

7 MAJORITY CHAIRMAN DiGIROLAMO: Representative

8 Scavello.

9 REPRESENTATIVE SCAVELLO: Thank you,

10 Mr. Chairman, and thank you for allowing me to sit in on

11 this hearing.

12 In the past 10 years, I must have done about

13 100 or so legislative shows, and I did one on Lyme Disease,

14 and I had more calls in my office on that one show than any

15 other show that I've ever done. It's out there, and it's

16 scary.

17 A question that I'm going to submit is, if we

18 know that the test doesn't work, why aren't we looking for

19 a test that will work somehow or other, because I think the

20 early detection is so important, and it's something that I

21 hope we can look at with this legislation.

22 Thank you, Mr. Chairman.

23 MAJORITY CHAIRMAN DiGIROLAMO: Anybody else?

24 Well, I'm going to recognize, I guess,

25 Representative Hess, the prime sponsor of the bill, and 95

1 again, we really appreciate you bringing this bill to the

2 attention of the Committee. I'm going to ask you if you

3 have any final comments.

4 REPRESENTATIVE HESS: Thank you, Mr. Chairman.

5 At this point, I'll try to be as brief as

6 possible. I know we're running over. But I want to thank

7 Gene, for you bringing this bill forward, because it's

8 something very near and dear to my heart.

9 Some of the things that we have discussed here

10 today I'm not going to reiterate again, but I may be

11 submitting some questions to some of the testifiers,

12 especially Dr. Smith's testimony. I really enjoyed what he

13 had to say, and I will be communicating with you further

14 concerning it.

15 But on a personal basis, I just wanted to mention

16 some of the things that were talked about here today. I

17 have two people in my family that have Lyme Disease. I

18 have a daughter-in-law that is very, very bad. Some of the

19 things that were mentioned here today I've experienced,

20 I've seen, went through -- misdiagnosed by approximately

21 three or four different doctors. I'm not picking on them,

22 but this is why the education is so important.

23 All kinds of things were mentioned -- nerves,

24 stress, MS. You can go on and on. It went on over a

25 period of at least 10 months until, ironically, a 96

1 technician at one of the area hospitals said to her, "Liz,

2 I think you have Lyme Disease," and due to the discussion,

3 she was directed to a doctor in the Philadelphia area,

4 which we are very thankful for.

5 Through his treatment, we have her back. Some of

6 the things that she went through were the symptoms you

7 mentioned here today, but without his treatment, the

8 antibiotics and so forth, she would be a pillar of salt.

9 And I've seen her in that condition, as a pillar of salt -­

10 literally freeze up for half hours at a time; in the middle

11 of taking a bite of food; not being able to walk without

12 guidance; sleeping for 8 to 10 hours after she has one of

13 these seizures.

14 In speaking with her yesterday, she had seen what

15 was happening, knew what was happening around her, but she

16 couldn't communicate. She could hear you talking to her.

17 And without this particular doctor -- who I will not

18 mention his name -- without his help, she wouldn't be here

19 today. And also my son had Lyme Disease, but not the

20 severity that she had, and she's still suffering with it

21 today. She needs the long-term help.

22 If the long-term antibiotics are being opposed by

23 the Medical Society, tell us what's better. Tell us what's

24 better. We need to help these people now. This is the

25 best we have, so use the best we have, and that's what 97

1 we're doing. So don't chastise those people that are

2 helping us; give them help, and that's what we're going to

3 try to do with this bill.

4 If there are certain things in the bill at this

5 point that we might need to tweak a little bit -­

6 Ms. Yarnell, we talked about this yesterday -- I'm willing

7 to do that. But I'm committed to get this bill through.

8 With Gene's help and some other people's help, we're going

9 to get it done.

10 MAJORITY CHAIRMAN DiGIROLAMO: Dick, thank you.

11 And again, I want to thank everybody that's here

12 today. The passion you have for the issue is very, very

13 obvious. And Lisa, you testified; I mean, you had the most

14 compelling testimony, and we hear your concerns. I know I

15 learned an awful lot today about the disease and there's an

16 awful lot more I want to learn, and, you know, you have my

17 promise and commitment that all the Members of the

18 Committee are going to study this issue, are going to look

19 into the testimony that we've heard. We're going to study

20 it, and then we're going to give this bill every

21 consideration possible. So you've got my promise on that,

22 and again, good to be with you.

23 And I also want to mention, the Department of

24 Health did decline to testify today, but they did submit

25 testimony, and I believe, for the information of the 98

1 Members, that it's in all of your packets, if you want to

2 look at that also.

3 Again, thanks for being here, and this concludes

4 the meeting. Thank you.

5

6 (The hearing concluded at 12:14 p.m.) 99

1 I hereby certify that the foregoing proceedings

2 are a true and accurate transcription produced from audio

3 on the said proceedings and that this is a correct

4 transcript of the same.

5

6

7 Debra B. Miller

8 Committee Hearing Coordinator/

9 Legislative Reporter

10 Notary Public

11

12 Kristin M. O'Brassill-Kulfan

13 Transcriptionist