Tina Garcia: Hello, I’m Tina Garcia and I founded Lyme Education Awareness Program at leaparizona.com. Our charity provides financial assistance to Lyme disease patients for treatment that is denied by insurance companies, and we struggle to keep up with the overwhelming request for assistance.

I thank you for serving on this Review Panel and with the invitation to speak to you today. I also thank Connecticut Attorney General Richard Blumenthal and his staff. His investigation uncovered egregious financial conflicts of interests of IDSA guideline authors. These conflicts were with drug companies Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies.

I am here to express to you the exasperation of the world wide Lyme patient community, as we are victims of these conflicts of interest. Patients feel violated and there’s a tsunami of patient frustration encircling this hearing today.

Excruciating musculoskeletal pain, debilitating cognitive dysfunction and crushing chronic fatigue - patients experience these life altering symptoms and the relentless suffering, due not only to Lyme infection, but the IDSA guidelines as well. What the IDSA guidelines do is sentence patients to life in prison for the chronically ill.

If you spent time in the homes of patients, you would observe the devastation in the lives of these families - some with several members infected. You’d witness parents with Lyme, as sick as they are, struggling to provide for their families, losing their jobs, their lifesavings and their homes in the process. Your hearts would break to see children with Lyme sequestered in their rooms with their closest friends -- an intravenous PICC line and an IV pole. Children with Lyme miss out on years of education and social activities. Our children are suffering and dying and it is past the time for the medical community to humanely respond to this crisis.

I contracted Borrelia burgdorferi (Bb) infection more than ten years ago. I lost my ability to function normally, was misdiagnosed and the infection ravaged my body for six years before I received Lyme diagnosis and treatment. I spent my days and nights in bed with the worst pain you could imagine. I awoke feeling as though someone had been pounding my spine with a hammer all night. I had to stop driving. I couldn’t do the housework. I could not prepare a meal. Due to the swelling in my brain, I began drooling and could barely hold up my head. I hobbled around with excruciating pain in my knees, ankles, and feet. And I tripped over edges of sidewalks and fell on several occasions. I had dementia and wandered from room to room. And my entire body spontaneously went rigid while sleeping.

The infection affected my lungs causing me to cough and choke for the past year and a half. I lost my job and my home. Had I not taken antibiotics, I wouldn’t be here today. And the only reason I’m able to testify with restored cognitive function is due to four years of intermittent oral Doxycycline and Flagyl and intramuscular injections of Bicillin antibiotics, through pulsing and in combination.

Not one doctor on my state-run insurance plan would treat me for Lyme disease. My family paid for my treatment. And for financial reasons, I was never able to have the intravenous antibiotics recommended. That lack of IV treatment caused extended suffering and delayed my recovery further. Although I’ve improved significantly with long term antibiotic therapy, I still have residual symptoms. I experienced facial paralysis in February of this year. The paralysis and the lung infection finally resolved with a three-month course of Rifampin 600 mg per day, which as you know, is used to treat tuberculosis and leprosy.

In reality, Bb infection is not often diagnosed in the acute stage. Patients experience a resolution of acute symptoms, with or without antimicrobial treatment, but over time, the telltale symptoms of Bb infection manifest. A simple word for this is relapse. People attribute this gradual progression of symptoms to stress, lack of sleep, or a busy lifestyle, and most just tough it out until the symptoms become so debilitating, they know something is seriously wrong.

In reality, it is during this late stage of infection, after the pathogens have colonized various tissues and organs of the body, that the majority of patients seek medical help. Patients report seeing doctor after doctor, who had they been given accurate information, could have determined the root cause of the conditions these patients were diagnosed with such as fibromyalgia, chronic fatigue syndrome, MS, ALS, myalgic encephalomyelitis, autism, Parkinson’s, and Alzheimer’s. In these cases, the root cause turned out to be the bacterium that causes Lyme disease, which manifests as all of these conditions. Research also shows that Bb can cause cardiac abnormalities and lead to certain types of cancer.

I have heard stories from patients across the U.S. and Europe. Patients are told chronic Lyme does not exist, their tests are invalid, it’s all in their heads and psychological exams are recommended. Or they are told to take ibuprofen or get a job or a hobby.

One woman I met worked outdoors on the East Coast and became quite ill from numerous tick bites. She went to doctors for help and asked them to test her for Lyme disease. Testing was refused and she was told she didn’t have Lyme infection. She was diagnosed with ALS. When I met her, she was quadriplegic. We met for lunch in a restaurant and her husband held her sandwich for her, so she could take bites because she couldn’t lift her hands. She was a really brave woman to eat in a public setting like this. She finally found a doctor who tested her and she was positive for Lyme. She began IV antibiotics and was able to arise from her wheelchair, to walk with her physical therapist. She was making significant progress until the insurance company stopped paying for the treatment, citing the IDSA guidelines, and she regressed into a paralyzed state.

Patients are experiencing denial of medical treatment for protracted periods of time. This exacerbates infectious damage and delays the chance of recovery. Patients are not just a collection of anecdotal stories as is portrayed by the so-called Lyme experts. The real Lyme experts are the Lyme-treating physicians who treat our neglected patient population despite the very real threat of medical board prosecution for doing so. They are the only physicians that Lyme patients can rely upon, for when we try to rely upon infectious disease specialists who adhere to the IDSA guidelines, we are denied treatment.

Our charity faxed a questionnaire to seventy-four ID specialists asking to place them on a referral list for chronic Lyme patients. Of seventy-four questionnaires, we received eight responses and all were negative such as "I don’t believe chronic Lyme exists." "I follow the IDSA guidelines on the diagnosis and treatment of Lyme’s disease." "I am not convinced such an entity exists after appropriate treatment. Consensus of opinion is that extended prescription is of no benefit and may be harmful." "Based on the Infectious Diseases Society of America Practice Guidelines, no antibiotics recommended for chronic Lyme disease."

To date, we have not found one ID specialist in Arizona willing to treat this chronic infection. Most disturbingly, this occurs in highly endemic regions as well. One important thing that should be done outside this hearing is for the CDC to post the published treatment guidelines from ILADS on their website, thereby providing informed consent to physicians and patients. However, the CDC has refused to do this despite many requests from the Lyme community.

Lyme disease patients are beating their heads against this wall of denial. Patients do not appreciate being told they are exaggerating, hysterical or that women with chronic Lyme are merely suffering from depression. The pain patients experience should not be flippantly compared to the aches and pains of daily living. The CDC published that cases are under reported by six to twelvefold. This equates to millions of Lyme cases. If you multiply my experience by all these people and read online the many tragic cases posted by Lyme patients, you’ll grasp the magnitude of this epidemic.

Cancer patients have the right to choose harsh therapies that bring them close to death’s door, yet they are not prohibited from making those healthcare choices. However, the IDSA guidelines wrench healthcare choices from the hands of those who should be making those decisions. The Lyme-treating physicians and their patients, who have the right to choose the therapy they think is most beneficial. Patients are not vulnerable. We are informed consumers. We are informed about the pathogens we are infected with and informed of our many treatment options.

I have provided each Review Panel member with a copy of this book by PJ Langhoff entitled The Baker's Dozen & The Lunatic Fringe. This is a well-researched book that contains evidence of the conflicts of interest. The binders I sent you contain a history of the Lyme conflicts and a significant series of letters between the IDSA and eight infectious disease physicians in which prior to the 2006 guidelines publication, the ID docs expressed their grave concerns about the guideline process, the conflicts of interest and the global science that was being ignored. Suffering Lyme patients are expecting you to carefully read this book, the history and the series of letters and please take such information into consideration prior to casting your votes on revision of the IDSA guidelines. The Baker’s Dozen may be found at Amazon.com and the letters are also posted on our website at leaparizona.com.

Patients have found egregious inconsistencies in the Guidelines, research and statements from the most influential IDSA Guideline authors, such as,

"These chronic neurologic abnormalities began months to years after the onset of infection, sometimes after long periods of latency as in neurosyphilis. The likely reason for relapse is failure to eradicate the spirochete. This last article is one of many studies that show continuing symptoms are most likely due to persistence of the spirochete."

And, "We studied seventeen patients who had presented with acute Lyme disease and received prompt treatment with oral antibiotics, but in whom chronic Lyme disease subsequently developed."

So, despite the recommendations in their Guidelines to the contrary, the most influential Guideline authors have published that Bb is not eradicated after a short course of antibiotics and that chronic Lyme infection persists post treatment.

On behalf of suffering patients, I must ask that the CDC and IDSA Guidelines authors and their other spokespersons stop making fraudulent public statements that chronic Lyme infection does not exist, due to the fact that the IDSA Guideline authors themselves proved years ago that Bb is a persistent chronic infection.

The denial of chronic Lyme infection in the IDSA Guidelines causes patients to question Lyme vaccine development. Acknowledging chronic Lyme infection would extend the need – the time needed for vaccine clinical trials and approval. Stating that chronic Lyme infection doesn’t exist and sweeping suffering patients under the carpet is one way to avoid this problem.

Why the focus on a vaccine instead of expanded treatment protocols, studies of congenital, blood transfusion and sexual transmission, and correction of the vaccine-friendly Dearborn two tiered-testing criteria? The horrible truth is the secret that is being kept from the public. A secret that the worldwide Lyme disease community already knows because we’re living it – that Lyme disease is a very serious and complex infection and a lot of money is being made through the manipulation of this disease – through research funds, patents for test kits, and vaccine development, resulting in the medical neglect of thousands if not millions of suffering people.

Chronic Lyme disease is a debilitating and torturous infection. Patients are bedridden, using walkers and wheelchairs, suffering relentless excruciating pain, and inhumane denial of medical treatment. This is a shameful travesty that should shock our collective conscience and spur compassionate change.

Extensive revision of the Guidelines is necessary and focus must be redirected toward neglected patients. After all, for whom are the Guidelines supposed to be written? Let’s make it for the patients this time.

In closing, we are here before government officials and attorneys, scientists, physicians, advocates and patients around the world. May we also remember that we are acting before our Creator, and honor the fact that honesty and accountability are requirements for our well-being, as individuals and a society. Let us use the power of discernment to recognize improprieties and exhibit the courage to take the uncomfortable but necessary steps to correct them. For the preservation of truth and integrity is paramount to our standing, in this world and the next.

Thank you.

Dr. Baker: Thank, you Miss Garcia for your testimony. Now, I think we have some time if you’ll stay at the podium for questions from the panel members.

Dr. Lantos: How much contact – how much contact have you had with medical-decision makers and medical officers at insurance companies?

Tina Garcia: I have not had contact with the insurance companies except in the beginning of my illness, when I qualified for my state-run insurance plan and they sent me a denial letter for treatment that my Lyme doctor had recommended, from the Chief Medical Officer and they cited the CDC and the IDSA Guidelines, also.

Dr. Lantos: I’m wondering if the – if you, or your colleagues know how exclusively medical officers and insurance companies take the IDSA Guidelines as the sole rationale for their coverage decisions or if they have other reasons behind their coverage decisions.

Tina Garcia: It’s my understanding that, that’s pretty widespread – the use of the IDSA Guidelines is quite widespread, but that might be a question that would be better answered by the Attorney General’s office in Connecticut.

Dr. Sanders: Thank you for that heartfelt presentation. To give us a better sense of how many patients are dealing with not having insurance coverage on this issue, can you tell me a little more about your organization, how many people that you’re providing assistance to and how much it costs?

Tina Garcia: Well, antibiotic therapy is very expensive and we try to help patients. I’ve tried to help patients over the last four years since I founded L.E.A.P. I call Lyme Education Awareness Program L.E.A.P. for short. But I’ve been very ill myself over the last four years, struggling tremendously as I mentioned with – especially with the respiratory infection, so I haven’t been able to do a lot of fundraising, but that’s my ultimate goal – is to be able to help more and more patients, but I have many patients that have contacted me. Unfortunately, I’m unable to help all of them. We’ve helped a few, a handful. But that’s my dilemma. I’m hoping that now that I’m feeling better, that I’ll be able to do more fundraising and that we can make a bigger difference to help all these people.

Dr. Baker: David?

Dr. Mushatt: Is this working? Miss Garcia, thank you very much for your presentation. Along the lines of what - one of the earlier questions, it’s not unusual of course, as we all know, for insurance companies to deny initially therapy for various things. This happens to me with my HIV patients. They’ll deny an initial request for a medication because it’s a little bit more expensive than some of the other medications but it’s very common practice for providers to go ahead and file an appeal with some supporting evidence and its – at least in the HIV arena, fortunately, it’s very rare that they have the – that they’re brazen enough to reject our appeal. Do you have any sense of how often that appeal occurs? I’m sure it happens all the time with people that you’re associated with and how do the insurers often relent?

Tina Garcia: In my own personal experience, I was very ill at the time, and with, you know, due to financial constraints, wasn’t able to hire an attorney to help me with my appeal with AHCCCS, which is our Arizona state-run Insurance plan, and so I went to the appeal myself, as sick as I was, and I spent – I had 10 minutes to explain my illness, I had submitted my records to them. 10 minutes didn’t do anything. I submitted – I even had a booklet that someone had prepared for me of research, you know backing up the chronic infection, and it didn’t make a bit of difference. But as far as the numbers of people I really think that the Attorney Generals’ office would have a better understanding of that, have better facts and statistics about that, because they – they received information from patients all across the country.

Dr. Baker: Thank you very much. In view of the time, we’re going to go ahead, but I will say that if we have extra time this afternoon, we may have additional questions for the presenters today.

Tina Garcia: Okay.

Dr. Baker: So, with that, thank you again and can we have Lorraine Johnson come to the podium…

Tina Garcia: Thank you very much.