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Food and drug administration - старонка 15

CHAIR DAUM: Thank you for your time, Ms. Smith, as well.

Ms. Lori Gelbart please, and then followed by Linda Scharf Lurie, and Terry Elias. I hope I'm saying that right. Ms. Gelbart, please.

MS. GELBART: I'm grateful to have the opportunity to address --

CHAIR DAUM: No, not well, sorry.

MS. GELBART: Am I okay now? Thank you.

I'm grateful to have the opportunity to address this committee, and devastated by the circumstances that bring me before you.

Since taking the LYMErix vaccine my life has changed dramatically. Let me explain. My family and I live in Chicago, I have been married for 29 years, have two children, and am a social worker.

Most importantly, until I took the LYMErix vaccine I was a healthy and productive person. My family spends summers in southern Maine, in an area with high lyme incidence, where we are surrounded by woods and grasses, viewing deer in the yard nightly.

Already following recommended safety procedures we decided to further protect our health by having the LYMErix vaccine. We received our vaccinations at the travel clinic of Northwestern Memorial Hospital, a major teaching hospital.

Neither the staff, nor the manufacturer's literature handed to us cautioned us about the possibility of any long term ill effects. We were given no reason to believe that LYMErix warranted different consideration than any other immunization.

My husband, 15 year old son, and I had the first two injections in the spring of '99. On May 15, 2000, my husband and I received the third shot. The very next day I experienced body aches, and on May 17th I awakened with severe pain and swelling in my hands.

I was unable to bend my fingers closer than 90 degrees to my palms. I became incapable of performing activities such as basic personal care, brushing my teeth, cutting food.

Since early June I have been constantly medicated, but I still have trouble with my hands. I continue to experience pain in other joints, such as my elbows, my knees, jaw, neck and feet, and I'm usually fatigued.

Previously I was healthy and energetic, routinely taking only calcium and vitamins. Only after experiencing this adverse reaction did I learn that there had been concerns expressed about the safety of the vaccine, particularly related to the genotype HLA DR4, for which I have since tested positive.

This information most certainly would have enabled us to more realistically judged the relative risks and benefits of taking this vaccine.

If we had still believed the vaccine worthwhile for us, I could have had the option of genetic testing to avoid a problem, rather than in response to one.

The lack of disclosure of this information had further ramifications for our family. After I became symptomatic, my son was still due for his third injection. To determine whether he should complete his series, I consulted the chief of infectious disease and travel medicine at Northwestern.

Because the concerns about a possible genetic vulnerability apparently had not been shared with the wider medical community, this doctor believed my adverse reaction was an idiosyncratic response to the vaccine that would have no bearing on my son's health.

I then consulted a physician at Tufts, more familiar with the vaccine, who advised against giving LYMErix to my son. Fortunately Jason had not had the third shot. Imagine how awful it could have been had Jason followed my path.

It is apparent that LYMErix, an entirely optional measure intended as a preventive intervention has harmed me physically, emotionally, financially, and has negatively impacted the life of my family.

My daily functioning remains compromised. I lack the ability, the energy to maintain my former level of activity and commitments, my ability to work, volunteer in the community, and share activities with my children has drastically diminished.

I was only trying to be diligent about my family's health. And as a result I now have a health problem for which no effective solution may exist. I am faced with such diagnostic possibilities as untreatable autoimmune disease arthritis, or an activation of a previous exposure to the lyme bacteria.

There are few acknowledged experts regarding this reaction, and no widely accepted treatments. It seems to me that when evaluating the vaccine the possibility of adverse reactions of unknown duration, having no known cure, should receive greater weight than those potential reactions with well understood treatment protocols.

My husband and I have always had great confidence in the FDA's approval of medications and its communication with the medical community. We expected that all information which physicians might reasonably need to make recommendations concerning our health would be made available to them.

We were not informed that this very group expressed reservations which were not disclosed in the manufacturer's literature. We had no idea that there were unresolved safety issues requiring further study, and that by taking this vaccine our family would unwittingly become subjects of an ongoing drug trial.

Doctors and their patients need to be given complete disclosure of a possible risk, as well as the claim benefits. Only then can they make prudent decisions together.

We hope that others will have the benefit of all of the information necessary to make well considered choices.

This morning I was thinking about your sources of data. Last May, when the nurse at Northwestern called SmithKline to report my arthritic reaction, and to seek information, she was told that there were no problems, just anecdotal reports.

They requested no further information about me. The nurse told me that she did not find SmithKline helpful, or concerned.

I thank you for this opportunity to share my experience. Thanks for your attention.

CHAIR DAUM: We thank you for your effort, and your experience. We would like to call on Ms. Linda Scharf-Lurie next, with Terry Elias following, and then a letter will be read on behalf of Nancy Vroon by Jenny Marra. Ms. Lurie.

MS. SCHARF-LURIE: Good afternoon. My name is Linda Scharf-Lurie, and I have been asked to speak on behalf of my daughter Vanessa.

Vanessa had a pretty normal childhood and adolescence until the year 1999. She had a horse that she used for exercise and enjoyment. She had competed on him in various venues. They enjoyed jumping and dressage.

She volunteered at a therapeutic riding barn, and worked with multiply handicapped children. Her plans were to get her degree in veterinary medicine, and have a small animal practice. She held down a job at a vet's office, and loved going to work and facing the challenges there.

In the spring of that year I decided to get her the lyme vaccine. She was in contact with various animals daily, and spent a lot of time in the woods with horses. It seemed like a good idea at the time.

She had had a simple case of unconfirmed lyme disease when she was around 12 years old, and it seemed to respond to antibiotics, so I thought LYMErix would be a good idea.

My primary doctor looked over the literature, and agreed to give the series of injections. Our lives have never been the same.

After the second injection Vanessa complained of ankle pain. I took her to an orthopedic surgeon who couldn't find anything wrong at that time. We sent her for physical therapy and gave her medications. She made the best of it, and never really got much better.

She had vague complaints about her joints bothering her, but again she kept plugging along. She developed flu-like symptoms, a rash, and woke up on October 31st, 1999, with peripheral blindness.

She was having terrible muscle aches and joint swelling and pain. We went to many specialists. She had a spinal tap, an MRI, Gallium scan, multiple blood tests, including PCRs for lyme, all negative.

Finally we decided to test her for HLA DR4 and lo and behold we had a positive. We also had a positive ANA.

To this day she continues to test negative for lyme, MS, lupus, Kroen's disease, and all of the other autoimmune illnesses that our doctors assumed were the possible cause.

There is no history of juvenile arthritis in either side of our family. Her arthritis just kept getting worse, even with treatments of anti-inflammatories, and all of the arthritis medications on the market.

She spent her entire senior year at home, too ill to even walk through the hallways, and put in a full day at school. She missed her senior prom, and any social activities that a normal senior in high school participates in.

Her horse could not be exercised, or jumped by her, for a very long period of time. We have taken Vanessa to many specialists in the New York and New Jersey area. They have no explanations for this sudden dramatic change in her health, except the probability that she had a reaction to LYMErix, which somehow caused an autoimmune reaction because of the body's exposure to OspA.

I'm not as knowledgeable as this distinguished panel of experts that I speak to, today. But I know one thing with all of my being. It was LYMErix which somehow had this devastating effect on my 17 year old child.

I think you have all considered that possibility before today. Maybe after today you will think it is more than just a possibility. You will see that this drug can have some long-lasting dangerous side effects.

Just remember, I have been told this by many a doctor in the last year and a half. They can treat and often cure lyme disease, but they cannot cure an autoimmune arthritis.

This is an 18 year old who will never again be able to run to catch a bus, jump her horse with abandon, her life will be forever changed by LYMErix. Please consider this very carefully when making your decisions about continuing keeping this on the market and giving it to children.

CHAIR DAUM: Thank you very much, Ms. Lurie. Ms. Elias, then a letter to be read by Ms. Marra followed by David Weld.

MS. ELIAS: You had it right the first time -- Elias.

CHAIR DAUM: Elias. I'm sorry.

MS. ELIAS: That's okay. I'm a health care professional licensed in the State of Maryland. I'm also a survivor of Lyme Disease. I am also a recipient of LYMErix Vaccine.

I'm not real sure how many people have received the vaccine. If you haven't I challenge you to. Knock yourself out. I'll give you my third dose. It's in my refrigerator. Anybody want it? I don't.

I survived Lyme Disease by sheer determination. I stand here today by shear determination and a good dose of Arthrotac.

They told me I didn't have Lyme Disease.

They told me my child didn't have Lyme Disease. When I presented to my doctor any possibility that I had any problem from the LYMErix vaccine, she jumped down my throat -- literally. I left that office in tears because the HMO's, number one, didn't want to pay for my first two shots.

Number two, they don't want to recognize it. They don't want to get involved. Because you know what, they just might have to do a little more paperwork. And then they may have to say you know what, we really shouldn't have given you that shot the day you walked into our office with a flaming infection from a tick bite that was bigger than the size of my hand.

But you know what, I was told that it was totally safe. I don't think so. I looked through any FDA file I could find. I combed Smith Klein & Beecham's files, anything, any kind of medical information I could get my hands on.

Dosage calculations, contraindications, you name it I did it. There's absolutely nothing. And I'd like to question something a lady asked before. Have you changed any information that you're giving to the public? No you haven't changed a thing.

They're still giving the vaccine. There is no information in any of it that says, do not give it if you have a current infection. My doctor told me it was totally safe. No it's not.

I was almost going to get it for my 18-year old daughter who now has Lyme Disease, that I kept telling them that she had. Not on a bet. I'll take her to any Lyme Disease literate medical doctor in the world before I would ever consider giving her that vaccine.

And I work in the private duty sector. But I live in a small endemic community in backwoods nowhere U.S.A.

I drive two hours to go to work on a private duty case that I love. I almost gave up my job because everybody kept saying no, no, no, no, no, no, no, no, you're wrong. And if not for fighting back, like everybody else has, where would we be.

I challenge you all. Go to your doctor. Get your first shot. I dare you. Thank you.

CHAIR DAUM: Thank you Ms. Elias. We call next on Jenny Marra to read a letter on behalf of Ms. Nancy Vroon who apparently couldn't be here today.

MS. MARRA: No. She's in a wheelchair in New Jersey.

CHAIR DAUM: Okay. And then we'll ask David Weld and then Pat Easton to speak following. Ms. Marra, please.

MS. MARRA: She writes, To Whom It May Concern. I am unable to attend the January 31st FDA Vaccine Advisory Committee meeting due to a restrictive condition, Transverse Myelitis, resulting from the LYMErix Vaccine.

In the Spring of 1999, I decided to get the series of LYMErix shots after viewing a very convincing T.V. commercial touting the importance of protecting oneself from Lyme Disease.

I felt this would be a good thing to take advantage of since I had had numerous bites from ticks which cause Lyme Disease.

I was given the first shot of the series on April 20, 1999. Thirteen days later I collapsed completely paralyzed. Many tests at the hospital confirmed the diagnosis of Transverse Myelitis, inflammation of the Myelin Sheath around the spinal cord.

After days in Intensive Care at the hospital, I was transferred to the rehabilitation center where I spend six months. After intensive physical and occupational therapy, some mobility returned but I am in a wheelchair most of the time. My life has been drastically changed for the last 21 months.

Up to the day I collapsed, I was constantly on the go with meetings of historical societies, community organizations, church activities, house tours, dinner parties, exercise classes, bus trips, theater outings, concerts, etcetera.

I used to wear my daughters out just telling them about all of the running around I did. I used to be a world traveler, but now because of the physical limitations I stay close to home.

I am able to live at home only with support from family and friends and a paid nighttime caregiver. For the first nine months, after coming home from the rehabilitation center, I required round-the-clock caregivers.

Prior to the LYMErix Vaccine, I was in excellent health, completely independent. I strongly urge you to take LYMErix off of the market to spare others the pain and suffering it may cause.

Very truly yours, Nancy Vroon.

CHAIR DAUM: Thank you very kindly, Ms.Marra. David Weld is next, then followed by Pat Easton and Dr. Kenneth Dardick.

MR. WELD: Good afternoon. I'm David Weld, Executive Director of the American Lyme Disease Foundation. Our organization does receive some unrestricted grant monies from Glyco Smith Klein which helps to support our overall programs and services.

Let me make it clear that it is the foundation's policy to maintain a strict scientific standard as a basis for all information we disseminate.

The American Lyme Disease Foundation is dedicated to promoting Lyme Disease prevention, diagnosis and treatment through educational programs and services.
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