BMJ 2002;325:569 ( 14 September )


Observational study of vaccine efficacy 14 years after trial of hepatitis B vaccination in Gambian children

Hilton Whittle, deputy director, a Shabbar Jaffar, senior lecturer, b Michael Wansbrough, MSc student, b Maimuna Mendy, senior scientific officer, a Uga Dumpis, visiting research fellow, Riga University, a Andrew Collinson, clinical scientist, a Andrew Hall, professor. b  a Medical Research Council Laboratories, PO Box 273, Banjul, Gambia, b London School of Hygiene and Tropical Medicine, London WC1E 7HT

Correspondence to: H Whittle hwhittle@mrc.gm


Objective: To determine the duration of protection from hepatitis B vaccine given in infancy and early childhood.
Design: Cross sectional serological study of hepatitis B virus infection in children of various ages 14 years after the start of a trial of vaccination regimens.

Setting: Two villages in the Gambia.

Participants: Children and adolescents given hepatitis B vaccine in infancy or early childhood: 232 were aged 1-5 years, 225 aged 5-9 years, 220 aged 10-14 years, and 175 aged 15-19 years. Main outcome measures: Vaccine efficacy against infection and against chronic infection in the different age groups.

Results: Vaccine efficacy against chronic carriage of hepatitis B virus was 94% (95% confidence interval 89% to 97%), which did not vary significantly between the age groups. Efficacy against infection was 80% (76% to 84%). This was significantly lower in the oldest age group (65%, 56 to 73). Of the uninfected participants in this age group, 36% had no detectable hepatitis B virus surface antibody. Time since vaccination and a low peak antibody response were the most powerful risk factors for breakthrough infection (P<0.001 in each case). Low peak antibody response was also a risk factor for chronic carriage (odds ratio 95, 19 to 466).

Conclusions: Children vaccinated in infancy are at increased risk of hepatitis B virus infection in the late teens. The risk of chronic carriage after sexual exposure needs further assessment to determine if booster vaccines are necessary.

(My conclusion: Hep B doesn't work)

Hepatitis B Vaccine Linked to Increase in Diabetes

A study presented to the annual meeting of the American Diabetes Association finds that children who are vaccinated with the hepatitis B vaccine are at a greater risk for developing type 1 diabetes than children who have never received the vaccine.

Type 1 diabetes is where the body doesn't make enough of the insulin that it needs and is a relatively rare condition. In the study, 150,000 children who received the hepatitis B vaccine at 3 months of age were compared to 150,000 children who had not received the vaccine. Type 1 diabetes developed at the rate of 46 per 100,000 in the vaccinated kids and only 34 per 100,000 in the kids who didn't get vaccinated. Waiting to vaccinate until later in life also seems to increase rates. In kids who didn't receive the vaccine until they were 12 years old, the rate of type 1 diabetes was 17.8 cases per 100,000 while kids who had never received the vaccine only developed 6.9 cases per 100,000.

This is not the first time problems have been documented with the hepatitis B vaccine. Data released at the 62nd annual meeting of the American College of Rheumatology in November, 1998, shows that the hepatitis B vaccine has also been linked to an increase in autoimmune diseases such as lupus and rheumatoid arthritis in children and adults who have been vaccinated.

health archive how to read a news script index of previous eye on health scripts

hepatitis b new information!!! more information

[air date=6pm monday 4-27-98][repeat=11pm monday 4-27-98]

every day, in clinics nationwide, children get vaccinated to protect them from disease. we, as parents, trust those immunizations will save lives-- and not hurt people. but, eye on health reporter kristi krueger has found one vaccine is causing concern among some doctors, and it's a vaccine that's mandatory for *your* children. this report isn't meant to scare you! but, i think it's important for you to know the very real concerns a growing number of doctors *worldwide* have about the hepatitis b vaccine.

a series of three shots are supposed to protect people form a horrible virus that attacks the liver. the problem is, some experts fear it may be the *vaccine* is doing the attacking. on french national television....at a lab in houston...exam rooms around the world...and a home in south florida....concern about the hepatitis b vaccine is growing. doctors say the vaccine may have debilitating side-effects for some people.  many states, including florida, mandate children get it. [super: dr. andrew campbell/houston immunologist] "we now are seeing a whole bunch of people very affected whose lives have been destroyed by this product."

in this adverse reaction document compiled by the federal government, thousands of people reported developing everything from fevers and flu to arthritis, blindness, chronic fatigue syndrome and multiple sclerosis soon after having the vaccination.

it's the not the first vaccine linked to adverse reactions. a whooping cough vaccine and the swine flu vaccines were both banned. [campbell] "i think this is extremely dangerous. i think this is an issue that requires the federal government to step in immediately." one coral springs family hopes that happens. 15 year old lindsay kirschner might not look ill, but she is. lindsay's,problems started four days after her first hepatitis b shot last august.

[super: marilyn kirschner/mother] "she's constantly dizzy, nauseous, vomiting. she is having problems with her sight, running from blurriness to total black-outs." it wasn't until lindsay's third shot that her doctors and parents made a connection. [super: lindsay kirschner/patient] "i used to love to roller blade and play tennis and now that's really hard for me." [marilyn] "it's a never ending battle. i don't think there's a day since she's been sick that i haven't spoken with a doctor." one houston doctor she spoke to was vaccine researcher bonnie dunbar. for most of her career, dr. dunbar has developed vaccines. she's written books, and won national awards. for the last two years she's studied potential side effects of the hepatitis b vaccine.

[super: bonnie dunbar, ph.d./baylor college of medicine]"there are several different types of side effects. but they are all associated with what we call auto-immune disorders. that is the body's immune system has turned against itself." two years ago, both dunbar's brother and a lab assistant got sick soon after getting the hepatitis b vaccine. dr. dunbar learned they're not alone. [dunbar] "there's one report from a nurse who reported 15 cases of ms following the vaccine." here's how dr. dunbar explains it. some people are predisposed to autoimmune  disorders. in these people, she thinks the genetically-engineered vaccine may be doing a changing act called molecular mimicry-- *causing* the symptoms it was meant to prevent.

[dunbar]"but what is amazing to me is the number of doctors, nurses, health care workers and people who were totally active and healthy." [super: Kristi krueger/eye on health]"from her lab here at the Baylor  college of medicine, dr. Dunbar is putting her career on the line asking the federal government to stop, take a step back, and really study the long term effects of the hepatitis b vaccine." [Dunbar]" doctors need to be warned to look out for these side effects."

dr. Andrew Campbell is looking out. he's treating dozens people who he believes developed a severe rash and auto-immune problems after getting the vaccine. dr. Campbell fears there are many sick people who don't know the hepatitis b vaccine may be to blame. [Campbell] "we are going to see some major health concerns throughout the country that is going to decimate the public."  right now, french doctors and patients are pressuring their government for long term studies.... doctors in canada and england are doing the same.  the vaccine makers, and our government maintain there have been isolated reactions... but millions are vaccinated without incident.

[dr. Walter Orenstein/centers for disease control] "no vaccine is completely safe or completely effective.. and what we try to do is balance the benefits with the risk." but back in coral springs... the kirschers just want lindsay to get better. [marilyn] "i can't even think about the future because thinking about tomorrow is hard enough.. and thinking about how we're going to get through each day." we spoke to the two drug companies that make this vaccine. we were told if more cases of adverse reactions are reported, they'll investigate.

that's what happened with both the old whooping cough and swine flu vaccines. once people spoke out about side effects, both vaccines were pulled off the market. one more note. the hepatitis-b vaccine was mainly studied in asia and africa. but dr. dunbar says most of the problems she's seen are in caucasions. that leads her to believe there's something *genetic* going on here. what should parents do? don't stop getting vaccines! they are lifesavers! but, inform yourself. talk to your doctor. he or she has a physicians desk reference. this book clearly outlines all possible drug reactions. finally, no one is asking for a ban on this vaccine. it helps many people. but, doctors want long-term research to discover why certain people are having adverse reactions.  to report an adverse reaction to a vaccine, or if you want more information, call the national vaccine information center at (800) 909-shot. their website url is www.909shot.com 

hepatitis b follow up we have more information about the hepatitis b vaccine...and whether it could be harming... not helping your children. ever since our story on the possible side effects of the hepatitis b vaccine first aired last night... our phones have been ringing off the hook. doctors' offices have been busy too... fielding calls.. and answering questions about the vaccine. eye on health reporter kristi krueger broke the story. she's here with more on hepatitis b. [kristi] parents, doctors, and public health experts are reacting tonight to new concerns about the hepatitis b vaccine-- a vaccine all florida children are required to get. we're hearing from doctors-- who tell us there is no reason for people to avoid the vaccine. statistics show it's protected thousands of people from a deadly disease. we've also heard from more people-- who say the vaccine made them very sick.

[super: kendall/eye on health]

[phyllis walking]

the past few months have been tough for phyllis noe (no-ee). she got her hepatitis b shots late last year. noe is convinced the vaccine gave her seizures. [super: phyllis noe/patient] "i felt faint, dizzy, so some of the people i work with had me lie down, and then i started having seizure like episodes."

noe wanted to talk to us--  after hearing about lindsay kirschner's reaction to the hepatitis b vaccine. the fifteen-year-old coral springs girl has been diagnosed with chronic fatigue syndrome and heart problems. she got very sick after being vaccinated. [super: marilyn kirschner/mom] "the next day she woke up and couldn't stand up without holding the walls of the house.'

houston vaccine researcher doctor bonnie dunbar-- has been studying potential problems for 2-years. today, she's gotten dozens of calls from people convinced hepatitis b vaccinations made them sick.  dunbar wants the federal government to take a closer look mat these vaccines-- so far-- she says no one has listened.

[(dunbar]"i was told by one major agency, for which i consulted, that my research and ideas about this belong in church, not in a laboratory." in dunbar's lab-- she's been looking at potential reactions--such as fevers and flu--to arthritis,  blindness, and multiple sclerosis-- in people who've had the vaccination.

pediatricians' offices-- like this one in coral gables-- and the miami children's hospital-- were flooded with calls today from scared parents who know the vaccine is required for school children.  parents are being
assured, the number of people protected by the vaccine-- far outnumber the people who've experienced serious side effects.

[dr. elani sfakianaki/florida dept. of health] "now side effects occur in one in every 10-thousand vacciantions. that's a very rare occurence." and the health department wants anyone who's had medical problems following *any* vaccination to call: national vaccine injury compensation program 800-338-2382

if you would like some more information.. we've set-up a hotline number at
the station... the number is 305-325-2435.

 more information

[air date= 6pm wednesday 4-29-98 ]

more people who got the hepatitis-b vaccine and then got sick are speaking out tonight, saying it's the vaccine's fault they're  sick. kristi krueger broke the story to the country this week. she has more tonight from patients, doctors and public health experts. kristi.  the hepatitis-b vaccine is required for enrollment into kindergarten in florida this fall. and, that's cause a lot of concern among parents. but, the state department of health *insists* the vaccine is *extremely* beneficial and school kids *need* the vaccine. but, some people who say they got sick nafter getting the shots question the safety of the vaccine.

[super: cooper city]

Anthony sikora's motor skills haven't been the same since he got vaccinated against hepatitis-b when he was four. his coordination was so bad, the staff at Anthony's day care center got worried. [super: gale sikora/Anthony's mom] "then his day care teacher called me and said i don't know what's wrong, but when kids bump into him on the playground, he just falls over." now Anthony is seven. after test after test, he's now diagnosed with ataxia. the boy's neurologist and pediatrician both say Anthony's condition was the result of his hepatitis-b vaccination.

[super: kristi krueger] "Anthony's doctors did report his adverse reactions to the fda. but some experts are very concerned that other doctors are not doing that reporting because they just don't know the symptoms."
[super: bonnie dunbar, ph.d./baylor college of medicine] "there are several different types of side effects. but they are all associated with what we call auto-immune disorders. that is the body's immune system turnign against itself."

reactions such as flu and fever,arthritis,blindness, and multiple sclerosis have been reported to the government. these symptoms are familiar to tony lamberti of coral springs. the 24-year-old firefighter says his health has declined since his hepatitis-b vaccinations. just days after his final shot, he couldn't stand-up. [super: tony lamberti/firefighter] "i had hip pain, and it just got worse as the day went on to where at the end of the day i just couldn't walk on it. i felt like knives were being stabbed in my leg." now tony's taking pain medicine.

[super: kathy lamberti/tony's mother] "the other night at dinner, we were eating dinner, and my son couldn't cut his own meat. he couldn't walk by himself." despite new concerns, the florida department of health says the vaccinations have led to a dramatic decline in the number of hepatitis-b infections. the department *is* concerned about adverse reaction reports. but the state wants more proof the cases are *directly linked* to the vaccine.

[sikora] "well, it's isolated, until it's your child. then it becomes a major concern." and the department says the vaccine has helped far more people than it has harmed.  [super: dr. deise granado/miami children's hospital] "parents have no reason to be alarmed. but they have to be on the lookout for some mild side effects that might derive from this vaccine. and that it is far more important for their children to be protected from the disease itself."

if you've ever had an adverse reaction to a vaccine your doctor must call the f-d-a and report it. doctors should call 800-fda-1088

and then, you need to call the national vaccine injury compensation program. the number is 1-800-338-2382. those hurt by vaccines may be eligible for damages.  and if you would like some more information about hepatitis b.. we've set-up a hotline number at the station... the number is 305-325-2435. people who have gotten sick from the vaccine can call the national adverse reaction hotline at the fda. the number is 800-822-7967. also, report your case to the national vaccine injury compensation program. tell the operator you've been hurt by the hepatitis b vaccine. you may be eligible for payment. call 800-338-2382.  your doctor must also make a report to the fda's medwatch. give your doctor this number. 800-fda-1088.

to reach dr. pancheta wilson, who is investigating adverse reactions, and treating patients in coral springs-- call 954-344-2793. attorney david krathen is helping patients with lawsuits. call 954-467-6400.

hepatitis b investigation [writer=stachowiak / krueger] [air date=6pm tuesday 5-19-98][repeat=11pm tuesday 5-19-98] the hepatitis 'b' vaccine is supposed to protect people from a serious-- and often fatal-- liver infection. and the series of three shots is required among florida children. but as eyewitness news first reported-- thousands of people suspect they got chronically ill-- after getting vaccinated.  and now, some researchers now question if the vaccine is safe for everyone. eye on health reporter kristi krueger broke the story a few weeks ago. she's here tonight to tell us-- what action is being taken-- to investigate this vaccine.

ever since the story broke-- we've received hundreds of calls from concerned doctors and viewers.  we've learned the federal government has heard 250 new complaints about illnesses linked to the vaccine.  and, we've heard about dozens of south florida people who say the vaccine made them very sick.  tony lamberti is sick-- in bed-- and, he hasn't felt well since he got vaccinated against hepatitis 'b' several months ago.

the coral springs firefighter was immunized while he was being trained as a paramedic.   now, he's in constant pain. [tony lamberti/patient]"in my wrists, my fingers, sometimes i feel like they're broken, my knees, i get fluid in my knees sometimes, my ankles, the bottom of my feet." lamberti's mother, kathy, spends her days managing tony's care. she's worried about the medical bills. [kathy lamberti]"i feel that someone should pay for my son's illness." lamberti's doctor-- pancheta wilson--is the first south florida physician to investigate adverse reactions linked to the vaccine. [dr. pancheta wilson/internal medicine] "this is not a coincidence. there are too many cases right now that have been reported to take this as a coincidence." doctor wilson is so concerned about patients like tony lamberti she wants action from the federal government.

[wilson] "...to pull the vaccine, until further studies are completed, and we know how to treat these patients at least." [kristi krueger]"i've talked at length to the centers for disease control, the food and drug administration, and the florida department of health. *all* agencies tell me there will be an investigation into the adverse reactions, and each complaint will be taken seriously."

but, anthony sikora's family has heard *nothing* from the government. anthony's mother says adverse reaction reports were filed last year by the boy's doctors-- blaming the vaccine for causing anthony's nerve and movement disorder. [gale sikora/anthony's mother]"he comes home and tells me the kids laughed at me and told me i walk funny or they told me i'm stupid because i can't write, then i get really angry."

[kathy lamberti/tony's mother]"we need help. we all need help."

but, help for tony lamberti, anthony sikora, and thousands of other patients, may come-- only if drug companies or the government fund more research into this vaccine. researcher bonnie dunbar develops vaccines for a living in houston.  she found out about the adverse reactions to the hepatitis 'b' vaccine-- after her own lab assistant-- and her brother-- got mysterious illnesses after immunization.

[bonnie dunbar, ph.d./baylor college of medicine]"we need to have a large, epidemiological study to look at the effect to the vaccine, both from the positive, who is going to be protected, and the other side, who is going to have an adverse reaction." but, the vaccine makers and the government must admit there's a possibility this shot may make people sick before any more money is spent on research. [dunbar] "while there are millions of dollars out there to develop vaccines, there's no money for research into adverse reactions for people who admittedly are having these problems."

doctor dunbar says-- in the meantime-- hundreds of thousands of dollars are being spent treating the health problems of the people who say the vaccine made them sick. an estimated 23-thousand people who've complained to the government about adverse reactions from the hepatitis 'b' vaccine. meanwhile, up to 25-thousand americans get severe hepatitis 'b' infections each year... and many more people carry the virus, but have no symptoms. the health department-- and many doctors-- insist vaccinations continue-- because the shots do more good than harm.  health archive how to read a news script index of previous eye on health scripts hepatitis b follow-up

[air date: 6pm 6-15-98]

the hepatitis b vaccine is again under scrutiny tonight, following an exclusive eyewitness news investigation. two government agencies are now taking a closer look at the severe adverse reactions-- the vaccine might cause. the response from our investigation was overwhelming. we took hundreds of calls from concerned parents, and even from doctors critical of our report.  then today the mother of a broward boy-- who's been sick ever since he got the hepatitis 'b' shots-- filed a lawsuit - against one vaccine-maker.

the hepatitis b vaccine was made to protect people from a debilitating virus... patients in the original studies were followed for five days. but some researchers think people can have adverse reactions weeks or even months after the injection. thousands of people have reported serious auto-immune problems to the federal government.

[bonnie dunbar, ph.d./baylor college of medicine]

"there's one report from a nurse who reported 15 cases of ms following the vaccine. [kristi] "but the federal health officials i talked to say those numbers can be deceiving-- that just because people *report* side effects.. doesn't mean the vaccine is to blame. but i have learned the food and drug administration and the centers for disease control.. have started studies to look at the possible link. one study is focusing on multiple sclerosis.. the other on a muscle disorder called myositis. gale sikora thinks there' is a connection.. her son anthony lost muscle control right after his first injection.

[gale sikora/anthony's mother] "his daycare teachers called me and said i don't know what's wrong. but when kids bump into him on the playground, he just falls over." anthony's doctors filed adverse reaction reports with the federal government. no one ever investigated. so today, anthony's mother filed a lawsuit against merck..one of the companies that makes the vaccine... claiming the company knew there could be side effects and didn't warn doctors..

the sikora's attorney says doctors did alert the company about the side effects... but were ignored. [david krathan/sikora's attorney] "that causes us great concern as to whether or not merck really wanted to know what the answers are. but we'll find that out during the discovery process." while the legal process begins for anthony.... the treatment process begins for tony lamberti.. tony's doctor believe the hepatitis b vaccine made him sick..... now, every saturday, he has hours of gamma globulin therapy.... it's a treatment people with the hepatitis b *virus* often get.

[tony lamberti/coral springs firefighter]

"i couldn't move my arms or legs. i couldn't walk around the house.. and now, i'm practically normal again."
a spokesperson for merck... the drug company involved in the lawsuit tells me the company never comments on pending litigation. meantime, several researchers have submitted a grant proposal to the national institutes of health. the study is being reviewed and we'll soon learn whether money will be allocated for a long-term study on the hepatitis b vaccine. at the very least, these doctors hope to get pediatricians and their patients talking and aware of potential side effects--- especially, perhaps, in families with a family history of auto-immune diseases.

 

Dear Mrs. T
I received your letter last night, forward by Pennsylvania Parents for Vaccine Awareness. I was up until 3:00 AM, reformatting it into a MicroSoft Word document (I've only recently acquired a computer, my skills need improvement.) I was deeply moved by your letter and am so sad for what has happened to your family.I am nurse who was forced to receive the shots in nursing school. I had all 3, the last being administered March 19, 1991. Within 2 weeks (April Fools Day 1991) I learned that I my auto immune system was mysteriously creating anti-nuclear antibodies, detectable at 2580  dilutions!

What followed was nothing short of conspiratorial (long story -- let me know if you want it.) Suffice it to say at this point that I didn't make a connection until 1994 the cause of my injury, which a neurologist at the Hospital of the University of Pennsylvnia (where I am employed) diagnosed as: severe sensory neuronopathy of IDEOPATHIC origin. Also:undifferentiated connective tissue disease has been diagnosed.

I filed a report with VAERS in early 1995. The administering hospital neglected to record manufacturer names of the 2nd and 3rd shots. NO lot numbers for any of them -- and yet VAERS informed me that the hospital was not remiss in not recording this data because it was not required at that time! While they informed me that the vaccine was not covered under the national compensation program, they did not contact me when that changed in August 1997. Nor have they ever offered treatment.

My condition is somewhat odd-ball, because I have a rare non-demylenating condition. My peripheral sensory nerves were attacked, while the myelin sheath is unaffected. Finally I learned about others following the 20/20 episode in January of this year. Because I am single and didn't own a computer, I have been living with the impact of all this in relative isolation up until them (although my neighbors are supportive and several have changed their personal vaccination decisions based on our day-to-day interactions).

I am happy to report that I will be submitting blood samples to Bonnie Dunbar, PhD for the Baylor College of Medicine study: "Mechanisms of Adverse Reactions to Hepatitis B Vaccine." I will be forwarding your letter to Dr. Louis Bell, Infectious Disease, Children's Hospital of Philadephia (my former employer -- I 'put a face on one of the adult statistics' for them just last week. I had never told any of them why I believe I developed a steppage gait, etc.) I am also sending your eloquent letter to Huntly Collins, medical writer for the Philadelphia Inquirer who is doing a story in a few weeks and with whom I've interviewed.

God bless you and and your family. Please feel free to contact me if I can be of ANY help. I did provide written testimoney to Congressman Mica's Committee for the May 18th hearing which I attended, and have
just returned from the hearings August 3rd regarding vaccine safety. Despite arriving to the hearings 2 hours early, my father (traveling from NH) and myself were unable to get a seat in the main room due to the number of line-holders Merck had paid to crowd the room 4 hours prior to the procedings! We listened to the procedings from a remote location set up 1/2 hour after testimony had gotten' under way. With uncharacteristic boldness, I introduced myself to Congressman Burton as he was on his way out. He is a wonderful man.

Sincerely,
Susan Kreider, RN
 

 Testimony
May 18, 1999
 House of Representatives
Government Reform
Criminal Justice, Drug Policy and Human Resources
 
   Effectiveness of Hepatitis B Vaccine
   Dr. Bonnie S. Dunbar
   2001 Holcombe, #2401
   Houston, Texas 77030
 
   May 12,1999
   Congressman John L. Mica
 
   Chairman,
 
   Subcommittee on Criminal Justice, Drug Policy and Human Resources
   United States House of Representatives
   2157 Rayburn House Office Building
   Washington, DC 20515-6143
 
   Good morning and thank you for this opportunity to discuss these    critical health care issues. My name is Bonnie Dunbar, and I am a  research scientist and medical and graduate student professor who has worked in the areas of autoimmunity and vaccine development for over twenty five years (the past 17 years at Baylor College of Medicine in Houston).
 
   I have been honored by the National Institutes of Health as the    first Margaret Pittman lecturer for my pioneering work in vaccine development. This honor was special for me because Dr. Pittman's    contributions were instrumental in early aspects of vaccine   development and because I understand the impact that some    vaccines have had, and will continue to have, on our society. My    ongoing research in the area of vaccine development continues to   be a major commitment. I have worked extensively with the US Agency for International Development and the World Health Organization programs and have a life long commitment to carrying  out research to understand, and hopefully, to help solving problems associated with world population as well as disease problems.
 
   As I have been invited to speak to this distinguished subcommittee, it is important to discuss my experience with the  clearly apparent severe adverse effects of the Hepatitis B vaccine. About five years ago, I had two individuals working in  my laboratory who were required to take the Hepatitis B vaccine.  Both of those individuals developed severe and apparently  permanent adverse reactions as a result of the vaccine. Both of  them were completely healthy and very athletic before this  vaccine and have now suffered severe, debilitating autoimmune  side effects from the vaccine.

   I have studied the complete medical history of my brother, Dr. Bohn Dunbar,  who developed seriously chronic joint and muscle pain, fatigue, and multiple sclerosis-like symptoms. And now he has further been diagnosed with POTS (an autoimmune, cardiovascular, and neurological problem) and subsequently with chronic inflammatory, demyelinating polyneuropathy. His problems have been attributed to the Hepatitis B vaccine by over a dozen different specialists around the United States of unquestionable medical expertise. He  has now been rated permanently and totally impaired at greater  than 90%. His health care has already cost the state of Texas  about a half million dollars in the Texas Worker's Compensation Program to date, and that figure will continue to rise given the  seventy of his health condition.
 
   My other student went partially blind following her first booster injection, a medical condition that was markedly exacerbated by her second booster that resulted in hospitalization. Personal  communications are that her eyesight is continuing to deteriorate. Because she is in medical school she has been,  understandably in my opinion, afraid to pursue investigation into her medical problems because of her concern that they might  affect her medical career.
 
   I am extremely sensitive to the need to evaluate the risk vs.  benefits of any vaccine. Because of my experience in this area, it became intuitively clear to me that these two active, healthy  individuals working in my laboratory developed autoimmune syndromes within a predictable immunological time frame following  their booster injections of the Hepatitis B vaccine. After carrying out extensive literature research on the nature of this  virus and this vaccine, it became intuitively obvious to me that there is a significant scientific probability that the vaccine is  the cause of those adverse reactions. Both the published studies   of reactions to viral infection and the temporal relationship of vaccine administration to adverse events suggest strongly that these adverse reactions are related to the nature of the viral protein, the recombinant surface antigen of which is the principal component of the vaccine.
 
   I have been in contact with numerous physicians and research scientists from several countries who have independently  described identical severe reactions to the vaccine in thousands  of Caucasians. Their observations have been, for the most part, denied or ignored by the public health systems, as is evidenced
   by the serious charges against healthcare officials and pharmaceutical companies brought recently in France. The reversal of the vaccine mandate for children in France was not based on lack of documentation. I have now been contacted personally by  hundreds or more individuals (including parents of infants and
   children) who have reported deaths, severe health problems and life long disabilities, resulting in major medical costs  following the administration of this vaccine. It appears that the adverse events related to this vaccine are within a gene pool  that is capable of genetic definition. I respectfully submit that rigorous scientific studies into the possibility that the vaccine can cause severe autoimmune disorders is necessary.
 
   The following points specifically address the issues listed in my invitation to speak to this committee.
 
   1.The Food & Drug Administration has set up a system for reporting adverse reactions to the vaccine. How does this system work? What is being done to study these adverse reactions.  My first experience with this reporting system followed my  observation of the two individuals in my laboratory who developed serious medical problems within a time frame predictable for immunological reactions. After seeing that these reactions were  listed in the Physician's Desk Reference text as reported  reactions to this vaccine, I learned about the VAER's reporting  system. When I first called the FDA about this, I was told by an  individual that "this vaccine is a problem and it is a big one."  I was initially sent some information on reports of reactions
   that were similar, if not identical, to those of these two  individuals. I attempted to initiate a dialogue with individuals  at the FDA but was simply told that I could obtain the information under the Freedom of Information Act. I subsequently  paid to obtain copies of these documents; and I was overwhelmed by the thousand of pages of documents I received listing thousands of reports, hundreds of which were identical to the reports I had filed for the two individuals working in my  laboratory. Unfortunately, the details on these lists were  insufficient for studies to critically evaluate the mechanisms by  which these reactions occur.
 
   There was no response to my subsequent correspondence with  members of this branch of the FDA. (I am aware that the cutbacks  in FDA funding may have played a role in this issue.) It became  apparent that the essential medical details (e.g. patient  identity, genetic background, family history of autoimmune   diseases, etc.) are not provided by this reporting system and that there is no way to contact physicians reporting these reactions. This information is, therefore, inadequate and not accessible to those of us who are studying the serious adverse reaction events apparently related to this vaccine. It was also apparent that there is no follow-tip on these reactions since the two patients I reported were never contacted to evaluate their  deteriorating health conditions.
 
   What was obvious from the information I obtained from the VAERS reports were that there are thousands of reports listing such conditions as neurological damage, arthritis symptoms, and otherserious immunological disorders. These are the same types of medical conditions that, in my extensively detailed investigation of the literature, have been published in dozens of medical journals that cite the correlation of this vaccine and severe immunological reactions. (Table of references to be provided at time of hearing). The fact that this reporting system is "passive", i.e. not mandatory, also suggests that only some fraction of adverse events (estimated by FDA officials as 1-10%). In summary it is my opinion that the VAERS system, as currently structured, is highly inadequate to collect scientifically useful information.
 
   I have now been in direct contact with hundreds of severely ill patients (as well as with physicians who have hundreds more patients) having developed adverse reactions to this Hepatitis B vaccine. I feel that it is critical to investigate the early onset effects as well as subsequent development of autoimmune adverse reactions in the hope that we might find more directed treatments to avert the long term effects in those already afflicted with these problems. I believe this is possible in view  of new technologies for treatment of autoimmune diseases that are targeted to the identification of specific autoantibodies to  defined epitopes.
 
   2.Do the benefits of administering the vaccine to infants outweigh the risks?
 
   To date my studies have concentrated on the adult population. Sadly, even less is known about immunological reactions in infants, especially since they cannot communicate, as can older children or adults, their severe pain, fatigue, or other  neurological or physical disturbances. In the event of deaths   following vaccination, there is generally inadequate information collected by pathologists to adequately evaluate these reactions.
 
   I would challenge any colleague, clinician or research scientist to claim that we have a basic understanding of the human newborn  immune system. It is well established in studies in animal models that the newborn immune system is very distinct from the  adolescent or adult. In fact, the immune system of newborns in  animal models can easily be perturbed to ensure that it cannot respond properly later in life.   In contrast, it is highly improbable in the US that a newborn has any significant risk of contracting Hepatitis B as a child because the disease is caused by a blood-borne virus. Newborns  are not likely to engage in intravenous drug use or promiscuous  sex. Nor are they likely to suffer an accidental needle stick, as  might a medical worker. About the only way they are likely to be  exposed to the disease is by being born to an already infected mother.
 
   In view of this lack of scientific and medical information of  neonatal immunology, it is remarkable to me that newborn infants,  especially those not at risk for the Hepatitis B disease itself  are being administrated multiple injections of this vaccine and  that there have been few, if any, clinical trials to adequately   evaluate the potential long term effects of neonatal immunization especially as it relates to genetic diversity.   3. What process does the CDC employ to make a recommendation for   a vaccine: What role do pharmaceutical companies play in that process? Do conflicts of interest exist?
 
   As I am not an expert on public health policy, I am not familiar with all of the nuances of policies for recommending vaccine mandates. It is well documented, however, that committee members advising the CDC and members of organizations (such as the American Academy of Pediatrics, and the World Health   Organization) obtain substantial finding from pharmaceutical companies. Furthermore, it is well documented that investigators  who have carried out clinical trials on this vaccine also benefit personally and obtain laboratory funding as consultants promoting the vaccine and as expert witness in legal conflicts. It is also  documented that lobbyists who consult for pharmaceutical companies are the same lobbyists for medical health care providers. I leave it up to this distinguished committee to investigate and evaluate the seriousness of these apparent conflicts of interest.
 
   However, it is also apparent to me that the lack of government funding specified for independent scientists to evaluate adverse vaccine reactions is a major reason for scientists to seek funding for experiments dictated by pharmaceutical companies.
 
   4.What disclosure is required before the vaccine is given? Is it adequate?
 
   It is apparent to me, as it is to many others who have been investigating this issue, that adequate long-term follow-up information was not collected in clinical trials for this vaccine. This is particularly true with respect to the Caucasian population. One might therefore ask: "Is there is sufficient information concerning risks of this vaccine to be disclosed"?  The ominous lists of potential reactions listed in the vaccine inserts appear not to be given to patients by their physicians. The physician-patient relationship is fiduciary. That is why the lawyer representing my brother, who had an adverse reaction to this vaccine, made a claim of fraud, a claim which this lawyer says has a strong basis in the Restatement of Torts.
 
   Many physicians and medical students have told me that, if this vaccine is recommended and mandated by government officials, "why should they look at it or discuss it with their patients?" Others have said that their colleagues do not report these incidences because they "don't want to get involved." They further tell me that they have been informed that this vaccine is the safest ever developed because it is a recombinant DNA vaccine and "therefore  you can't get the disease". Unfortunately, they have clearly missed a major point of basic immunology. Any peptide (a limited sequence of amino acids of a protein) or a full length or
truncated protein (produced by purification from a biological source or using recombinant CDNA technology) when introduced into the body will be "processed by the immune system" and, depending on the nature of that protein, could result in long term  autoimmune reactions.
 
   Sadly, in basic science courses in medical schools. many of these details of immunology (a medical research field that has exploded over the last decade) are not taught. I have taught in the basic science curriculum for over 15 years so I am well aware of this limitation. In fact, I recently was invited to speak at the Institute of Medicine at the National Academy of Sciences on this subject. I was quite shocked when a senior member of a national health committee (involved in recommending mandates for childhood  vaccines) came up to me and said: "Very interesting talk. I know you teach beginning medical students. Could you recommend me a basic immunology textbook? I think I need to catch up on some of this immunology stuff."
 
   In summary, it is essential in my opinion that physicians be better educated on the potential risks of this vaccine, as well as the interactions with other vaccines and the increased risks of vaccinations of sick children. It is also critical1v important to conduct the research necessary so that they will have better  information to identify people at risk for adverse reaction. In any event early diagnoses of these reactions will result in more effective therapies.
 
   My colleagues and I have submitted proposals to investigate the scientific bases for these vaccine adverse reactions. Many of these reactions are similar to those reactions from individuals having the virus itself. It is also apparent that there are major histocompatability, genetic linkages among patients who are having the severe reactions. It has already been shown that as many as 10 to 30% have been reported as not developing antibodies when they are vaccinated and, therefore, they may not to be protected from the disease. This non-responsiveness may be attributed to the individual histocompatability genes.
 
   We have proposed to carry out research to determine the long-term prognosis for patients having such adverse reactions for two  purposes: (1) Developing a prophylactic strategy of identifying those likely to react adversely so they can avoid the vaccine if at risk; and (2) developing a therapeutic strategy by early and more effective identification of those who have had adverse reactions with the hope of developing more specific therapies. I  and my collaborators have well equipped laboratories for state of the art immunological and biochemical analyses and we have already collected blood samples throughout the period of these adverse reactions. We therefore, have unique samples to begin to  scientifically pinpoint the reasons for the adverse reactions. We  have significant preliminary evidence that may explain these   responses and we will continue to seek funding to continue these  studies. We have obtained some limited funding from private  sources but as yet there are no government funds allocated for studying adverse reactions to this vaccine, so the progress of these studies is slow.
 
   It is apparent that the Hepatitis B virus (and vaccine developed from the Hepatitis B surface antigen) is very unique from many  other viruses and vaccines. New theories and experiments (i.e.  molecular mimicry and anti-idiotypic antibodies) have been developed which could explain reasons for autoimmune reactions
caused by this virus or the viral protein used in the vaccine.  (The December 26, 1996, New York Time's article which summarizes  studies on "molecular mimicry" theories for viruses causing autoimmune diseases may be right on point.) The fact that there are dozens of publications on the correlation of this virus as well as the vaccine with autoimmune and other connective tissue disorders provides strong evidence for the correlation of this viral antigen causing autoimmune diseases.
 
   In summary, no one, especially myself. would ever assert that the  Hepatitis B virus is not causing serious health problems in the world. However, if this, or any other vaccine, by nature of the protein or parts of the protein (native or produced from a cDNA as a recombinant protein), has the ability to adversely effect the immune system of large numbers of individuals resulting in severe adverse reactions (even if restricted to some genetic populations), then the public reaction to ALL vaccines, including those that clearly DON'T have related adverse reactions will be doomed in the public's eye. That includes the development of vaccines to evolving airborne viruses that might become a serious threat to the world population. Thanks to the success of the Government funded Human Genome Project and advances in computer programs, it may soon be possible to evaluate potential molecular structure to predict these problems with vaccine in advance or early in vaccine development.
 
   I will conclude by relating an observation. In my research on vaccines that have been used for the humane control of animal populations, I have had the opportunity to observe first hand African elephant family behavior. Whenever a baby cries, the entire herd of up to a hundred will immediately trumpet, and   charge with great flurry to surround the infant elephant. When it  is apparent that there is no danger, they will one by one touch trunks with that infant, ensuring that he is okay before going  about their business. They would certainly never allow a single baby or family member to be exposed to unknown danger.
 
   I ask you in your task of investigating our public health system that as do our friends the elephants, listen to the cries of  babies (and family members) that might have been adversely affected by this vaccine or who may be at risk. Please demand adequate scientific documentation and medical information to make   responsible decisions concerning mandating vaccines for children.  In addition to your investigation on the adverse reactions of  this vaccine I would urge you to help to provide research funds which are currently not available to study the serious adverse reactions of this vaccine as well as other vaccines.
 
   Thank you for the opportunity to appear before this distinguished  subcommittee. I will be glad to answer any of your questions or  provide you with additional information you may request.
 
   Sincerely, 
   Bonnie S. Dunbar, PhD, Professor Department of Cell Biology    Baylor College of Medicine, One Baylor Plaza Houston, Texas 77030  Dunbar May 14,1999 Page 6

Acute Hepatitis B Infection after Vaccination
Lancet Vol 345 Jan 1995

Multiple Evanescent White Dot Syndrome After Hepatitis B Vaccine
American J of Ophthalmology  Vol 122 No 3   [2pgs]

Systemic Lupus Erythematosus and Vaccination Against Hepatitis B
Nephron 1992; 62  [1pg]

Postmarketing Surveillance for Neurologic Adverse Events Reported After HepB Vaccination American J of Epidemiology Vol 127 no 2 [16pgs]

Severe Acute Hepatitis B Infection After VaccinationLiver Dysfunction and DNA Antibodies After Hepatitis B Vaccination Thrombocytopenic Purpura After Recombinant Hepatitis B Vaccine Lancet Vol 344  [2pgs]

Central Nervous System Demyelination after Immunization with Recombinant Hep B Vaccine Lancet Vol 338 1991  [2pgs]
 

http://www.whale.to/freeserve.co.uk/Vaccines/fluck.html

Testimony of Betty D. Fluck for U.S. House of Representatives Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy, & Human Resources. John L. Mica. Chairman

Effectiveness of Hepatitis B Vaccine

May 18, 1999

I would like to thank you for allowing me to come before you today to share my experience with you. Never did I dream that I would have this opportunity. I am a diagnosed victim of the Hepatitis B vaccine. My husband and I are not anti-vaccine. Each of our three boys has been vaccinated per Health Department Guidelines. However, they will not have the hepatitis B vaccine. On December 2, 1997, I took my second Hepatitis B vaccine in the series of three. I was required to have the immunization for my job. I am a Registered Nurse and have been for twenty years. I had just started a new  job as a Public Health Nurse for the local Health Department in Kokomo, Indiana. Part of my job description was to give immunizations in the department's weekly clinic.

Roughly twelve hours after receiving my vaccine, I woke up in severe pain - I developed a 104 F fever, nausea and vomiting, respiratory problems, a rash, severe head, neck and back pain, swollen joints and I was unable to move my legs. When the fever broke several hours later, I regained a small percentage of my leg strength. but the severe damage had already been done. I had to use a cane to move around. I had absolutely no energy and I had constant joint and leg pain. I was sleeping approximately 22 hours per day.
I continued to rim intermittent low grade fever.

The first doctor that I went to said that I had a reaction to the Hepatitis B vaccine but was unable to help. I went from doctor to doctor looking for help. I ended up at Indiana University Medical Center in Indianapolis. I first saw a doctor who was very kind and told me that he had read about some of the problems with the vaccine. He promised to do some research into the vaccine adverse reactions. He asked me to see one of his colleagues at I. U. Med Center, a rheumatologist. This rheumatologist from I U. was simply hostile to the idea that the Hepatitis B vaccine could have caused my problems. He suggested that some of my problems could be attributed to a kidney stone. Please be aware that at that point, my fingers were so painful that I could not open a soda can.

I returned to the first doctor at I. U. Med Center one month later for a scheduled follow up. This doctor who had been encouraging and sympathetic one month ago now refused to use the word vaccine and attributed some of my problems to the "aging process". Unhappy with both of these doctors, I requested a meeting with a patient advocate and the I. U. doctors. At this meeting, the first doctor finally told me that I had a "political problem. not a medical one."

My condition continued to deteriorate from cane, to walker, to kneebraces. Finally in September, 1998, 1 was put in full leg braces that run from my toes to my hips. With the use of the braces and forearm crutches, I have some mobility. Eight months after the initial injury, I was able to find an out of state doctor who was treating people for vaccine damage. I must now see him every three months.

The vaccine has caused nerve damage to my legs and hands. The medical name for my problem is Chronic inflammatory Demylenating Polyneuropathy (CIDP). I also have multiple types of auto immune disorders, and I now have an elevated rheumatiod arthritis factor. I undergo weekly IV treatment s that cost several thousand dollars per week. Although I have more energy now there is no real prognosis for my condition.

Immediately after I was injured, I contacted the pharmaceutical company asking them for help. They told me that they had never heard of this problem before. I realized at that point that I was not that unique and decided to write to the FDA through the Freedom of Information Act. I requested any reports on file about adverse reactions to the Hepatitis B vaccine for one particular company from 1991 to present. Four months later I received a box containing a 1045 page report. On each page, there were summaries of approximately eight reactions . These 8000 + reactions ranged from mild to death.

I made an appearance on ABC's 20/20 in January, 1999 on their story about the Hepatitis B vaccine. Since that show was aired. I have received numerous calls from adult victims and parents of children who have been injured after taking the Hepatitis B vaccine. One common theme among victims is that their doctors told them that it couldn't be the vaccine because it was perfectly safe.

I recently testified for the State Senate Committee in Indiana with the intent of removing the mandate for the Hepatitis B vaccine for school entry. The proposed ammendment was designed to give the parents the choice to wave the vaccine for any reason.

On March 2, 1999, it passed the State Senate by a vote of 45 to 4. However, the House sponsor of the original bill killed it rather than bring the bill up for debate.

In Indiana, a doctor from the Department of Health told the Senate Committee that one of the arguments for the vaccine was that it was the "first anti-cancer vaccine." Fortunately, we were able to show that the "anti-cancer vaccine" theme was taken from the PATH website. PATH is an organization within the World Health Organization. PATH suggested that the "first anti-cancer vaccine" theme was a good marketing tool to bring about interest in a "boutique" vaccine.

I have minutes from a CDC Study Group Meeting on the Hepatitis B vaccine held in March, 1997. The minutes of the meeting show that it would take at least a 60 day study to show the onset of MS. Clinical studies done by the two manufacturers were four and five days in length, respectively. It should be noted that the afternoon session of this meeting was chaired by Dr. Robert Sharrar of Merck. This group was to decide how to identify various types of adverse reactions such as MS and demylenating disease and to plan meaningful studies. When Dr. Sharrar appeared on ABC's 20/20 in January he said that he honestly believed that the Hepatitis B vaccine had not caused any problems. Can an employee of a pharmaceutical company that manufactures the vaccine be objective in designing experiments to show fault in a product that generates close to a billion dollars in sales for his company?

The form that people are given about the vaccine was written by the CDC. It does not address serious adverse reactions. When you look at the vaccine insert provided by the manufacturer, several adverse reactions are noted. I have since talked to many Healthcare professionals who are also unaware of the potential adverse reactions listed on the vaccine insert. It makes me wonder why the pharmaceutical company representative that I talked with earlier, the one who was unaware of any adverse reactions, was unaware of what their own company's insert said. A vaccine that still has so many unanswered questions should not be mandated for children. It just does not make sense. The right to decide if it is in the best interest of the child should be made by the parents. After all, it appears that for the most part when a child is severely handicapped by this vaccine. the parents are on their own. No one pushing the mandate is there for help or comfort.

In an article on the Hepatitis B vaccine that was printed in the Washington Post. a spokesperson for the CDC, said that nothing unexpected had been observed in the way of adverse reactions. At first. I thought they meant that their position was that no adverse reactions had occurred. Now, I really don't think it was denial. Despite over 20,000 reports to VAERS for the two manufacturers nothing unexpected had occurred. I really believe that the number and type of injuries is no surprise to the CDC. May be the only surprise for the CDC is just how hard the victims are fighting back.

BETTY D. FLUCK

 

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&
list_uids=14677029&dopt=Abstract

Clin Rheumatol. 2003 Dec;22(6):461-3. Epub 2003 Oct 07. Related Articles,
Links   
 
Kawasaki disease in an infant following immunisation with hepatitis B vaccine.

Miron D, Fink D, Hashkes PJ.

HaEmek Medical Center, Afula, Technion Medical School, Haifa, Israel.

The known association between hepatitis B and vasculitis has been reported in rare cases in adults after hepatitis B vaccination. We here describe a 35-day-old infant who developed Kawasaki disease 1 day after receiving his second dose of hepatitis B vaccine. Although extremely rare, this possible side effect should be noted and further investigated.

PMID: 14677029 [PubMed - in process]   

 

Pediatrics 1980 Oct;66(4):633-6

Urine mercury levels in Kawasaki disease.

Orlowski JP, Mercer RD

Six patients with diagnostic criteria for Kawasaki disease had abnormally high urinary excretions of mercury. They were compared by age, sex, and geographic location with matched controls. Improvement of one patient was temporally related to chelation of mercury with penicillamine. There are numerous clinical similarities between acrodynia and Kawasaki disease and the appearance of the mucocutaneous lymph node syndrome (Kawasaki disease) has been related temporally and geographically to environmental pollution with mercury. The mucocutaneous lymph node syndrome(Kawasaki disease) may represent a disease caused by environmental pollution with mercury, or clinical symptoms compatible with Kawasaki disease may indicate environmental exposure to mercury.
 

http://www.clinexprheumatol.org/pdf/vol22/no6/ab22609.html
Clin Exp Rheumatol. 2004 Nov-Dec;22(6):749-55. Related Articles, Links


A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: analysis of the
Vaccine Adverse Event Reporting System (VAERS) database and literature review.

Geier MR, Geier DA.

The Genetic Centers of America, MedCon, Inc., Silver Spring, Maryland 20905,
USA. mgeier@comcast.net

OBJECTIVES: Adverse events and positive re-challenge of symptoms reported in the scientific literature and to the Vaccine Adverse Event Reporting System (VAERS) following hepatitis B vaccination (HBV) were examined. METHODS: The VAERS and PubMed (1966-2003) were searched for autoimmune conditions including arthritis, rheumatoid arthritis, myelitis, optic neuritis, multiple sclerosis (MS), Guillain Barre Syndrome (GBS), glomerulonephritis, pancytopenia/thrombocytopenia, fatigue, and chronic fatigue, and Systemic Lupus Erythematous (SLE) following HBV. RESULTS: HBV was associated with a number of serious conditions and positive re-challenge or significant exacerbation of symptoms following immunization. There were 415 arthritis, 166 rheumatoid arthritis, 130 myelitis, 4 SLE, 100 optic neuritis, 101 GBS, 29 glomerulonephritis, 283 pancytopenia/thrombocytopenia, and 183 MS events reported following HBV A total of 465 positive re-challenge adverse events were observed following adult HBV that occurred sooner and with more severity than initial adverse event reports. A case-report of arthritis occurring in identical twins was also identified.