Hep B Vaccine: Will the controversy ever end?

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http://www.vaccination.org.uk/a/spalding.htmlFirst Posted 11/11/99The Hepatitis B Vaccine Controversy Few US public health initiative seem as successful as our mandatoryvaccination programs. But a growing number of people believe that onevaccine--that for the hepatitis B virus--is both dangerous and largelyunnecessary. Emotions run high in a debate that involves pharmaceutical andbiotech companies, US health agencies, Congress, and the parents ofchildren now dead or disabled from what they believe is a vaccine aboutwhich too little is known.By B.J. Spalding http://www.biospace.com/articles/111199_print.cfm (thisURL doesn't work)About a year ago, Michael Belkin's five-week-old daughter, Lyla Rose, gother third and final shot of the hepatitis B vaccine. She'd never been sick before getting that shot, but she was agitated and fussy at her finalfeeding that evening,. "And then she fell asleep and didn't wake up," saysBelkin, president of Belkin Limited (New York), which provides statisticaleconomic forecasts and financial forecasts to international mutual fundsand investment

banks.About five years ago, Bohn Dunbar, who at the time was healthy andathletic, got his first shot of the hepatitis B vaccine. Within 24 hours,he came down with a fever and severe fatigue, symptoms that lasted around aweek, and roughly two weeks after that, he developed chronic joint pain andmuscle pain, as well as fatigue and symptoms similar to multiple sclerosis.Today, Dunbar is rated permanently and totally impaired at greater than90%. His health care has already cost Texas--where he got thevaccination--over $500,000 through its worker's compensation program, afigure that will only grow given the severity of his illness. "His problemshave been attributed to the hepatitis B vaccine by over a dozen differentspecialists of unquestionable medical expertise," states his sister, BonnieDunbar, a professor of molecular biology and cell biology in the departmentof cell biology--the largest such department in the US--at

Baylor Collegeof Medicine (Houston, TX).Indeed, Lyla Rose Belkin's death and Bohn Dunbar's debilitating injuriesare just two of the tens of thousands of adverse reactions attributed tothe hepatitis B vaccine, which debuted in 1986 as the first recombinantvaccine to reach the US market. The safety of the controversial vaccine--aswell as numerous other aspects of its commercialization--has come up atfour recent Congressional hearings, though no legislation has yet beendrafted regarding the product. Two of the hearings were held by the Housesubcommittee on Criminal Justice, Drug Policy, and Human Resources of theCommittee on Government Reform, which is chaired by Congressman John Mica (R-FL). One of those hearings was devoted solely to investigating reportsof hepatitis B vaccine injuries and deaths. The other two hearings wereheld by the Committee on Government Reform, which is chaired by CongressmanDan Burton (R-IN).Burton, who has two grandchildren, said at the hearings that hisgranddaughter was hospitalized within hours of receiving the hepatitis Bvaccine, while his grandson became autistic after getting shots of thevaccine. "You can call that a coincidence, but I think it's more," saysBurton, adding that "we're going to be beating on this issue as long as I'mchairman of this committee." States Baylor's Dunbar, "Just about every timeI talk to someone, they know someone who got sick after getting thevaccine. A lot of times, though, that person just

didn't put the twotogether, the getting sick and the taking of the vaccine."Developed by Chiron (Emeryville, CA), the hepatitis B vaccine--which rackedup over $2 billion in worldwide sales last year--was licensed to Merck(Whitehouse Station, NJ), which subsequently licensed it to SmithKlineBeecham (SKB, Philadelphia, PA). Biogen (Cambridge, MA) also played a rolein developing the product and still receives royalties on its sales fromboth Merck and SKB, as does Chiron."One of the main reasons we formed Chiron was to continue development ofthe hepatitis B vaccine," explains Bill Rutter, chairman emeritus of thefirm. Along with his colleagues, Rutter began working on the vaccine in thelate 1970s at the University of California at San Francisco. When his teammoved to Chiron in 1981, the work continued under contract to Merck, withChiron responsible for developing the vaccine and Merck responsible formanufacturing

and marketing it. "It was beautiful and mysterious andcomplex. It turned out that in yeast over 100 different peptidesself-aggregated to form a true mimic of the hepatitis B surface antigen. It was the first time such a major structure had been formed in such a novelsystem," exclaims Rutter. "Forming the particle was both a major milestonein molecular biology and vaccinology, as well as one of the major successstories of the 20th century in disease prevention."Naturally, the merits of any achievement depend on a person's point ofview. Says

Michael Belkin, "It will only be just when, in their afterlives,all of the people responsible for that vaccine meet my daughter, Lyla Rose.When they meet all those babies whose lives were stolen, who never got achance."Therein--in the irreconcilable and unresolvable contentions of thevaccine's detractors and supporters--lies the story of the hepatitis Bvaccine, a story of contradiction and conflict, some of which iswell-intended and some of which isn't.Irreconcilable DifferencesOne contention, one that would seem simple to solve, is the number ofpeople in the US infected with the hepatitis B virus. Generally transmittedthrough infected body fluids, mainly through infected blood, the virus ismost prevalent in such high-risk populations as intravenous drug users andsexually promiscuous adults, and in lower-risk populations such as babiesborn to virus-infected mothers. Symptoms of the

disease include fatigue,fever, and yellowing of the skin. About 95% of patients suffer an acuteform of the disease, in which they clear the virus from their blood withinsix months. Approximately 5% of patients suffer from chronic infections,meaning that they never clear the virus and that they always remaininfectious.Up until the latter half of 1991, the Centers for Disease Control andPrevention (CDC, Atlanta, GA), along with most other medical authorities,stated that the US had one of the lowest rates of hepatitis B in the world,with only 0.1% to 0.5% of the population infected. This compares to countries in the Far East and Africa, where the disease affects 5% to 20%or more of the population. Indeed, early in 1991, the CDC reported only18,003 cases of hepatitis B in a total US population of 248 million.Yet late in 1991, the CDC did an about face. It was then that its AdvisoryCommittee on Immunization Practices (ACIP) recommended that all infants beinjected with the first of three doses of hepatitis B vaccine at birth,before being sent home from the hospital. And almost immediately, the CDCgenerated disease statistics to support this recommendation, stating thatthe US had an "estimated" 1 million to 1.25 million people with chronichepatitis B infections and that each year about 4,000 to 5,000 of thesepeople die from chronic liver diseases. It added that from 1980 to 1991,roughly 200,000 to 300,000 new hepatitis B infections occurred annually."I guess the drug companies wanted a big increase in

US sales of thehepatitis B vaccine, because all of a sudden the CDC started hyping thedisease as a huge health threat. And it generated disease statistics, whichhad no anchor in documented fact, to support this threat," says Barbara LoeFisher, the president of the National Vaccine Information Center (NVIC,Vienna, VA). Fisher, in fact, has filed a request under the Freedom ofInformation Act (FOIA) with the CDC, asking the agency to release copies ofthe "medical and laboratory criteria used by the CDC to estimate the totalnumber of American adults and children chronically infected with hepatitisB disease."Furthermore, Michael Belkin, who earns his livelihood working withstatistics, states that the CDC is passing off "estimated, hypotheticalnumbers as actual cases. This is statistical fraud. In the financial world,such misrepresentation would lead to criminal charges. The whole exerciseis designed to increase public

hysteria about the risk of a low-risk disease, so the CDC can extend its pervasive influence, and so Merck andSKB can increase their annual vaccine revenues."For its part, the CDC defends its 1991 change of the number of hepatitis Bcases in the US. The first set of numbers that it reported--18,003cases--were "acute, symptomatic" cases of the disease that doctors wereseeing and reporting to their state health departments, which then sentthese numbers on to the CDC, says Rob Lyerla, an epidemiologist in theagency's hepatitis branch. "But the CDC wanted to get a better

idea aboutwhat was really happening in the states, because we knew we were justseeing the tip of the iceberg, the numbers for the symptomatic cases."So the agency came up with the second set of numbers, including the 1million to 1.25 million chronic cases of the disease. These numbers areactually estimates derived from a blood survey that took place over afour-year cycle and that was made up of hundreds of thousands of tests onblood drawn from randomly selected people who comprised a cross sectionalsurvey of the US population, according to Lyerla. The survey picked up bothsymptomatic and asymptomatic cases of the disease, both acute and chroniccases. It showed that there had been a vast underreporting of the disease,that doctors had only been reporting acute, symptomatic cases. "So weprojected from the survey the number of, not only acute cases of hepatitisB, but acute and chronic cases of hepatitis B that we would

expect to findin the entire US. We estimated from the survey, based on statisticalscience, the actual number of US disease cases," Lyerla explains.Both Merck and SKB stand by the CDC estimates. In fact, the CDC estimateshave become facts. Somehow, they have evolved into the gold standard, citedunquestioningly by just about every mainstream medical organization on theglobe, including the World Health Organization (Geneva), the American Medical Association (Chicago), and the American Academy of Pediatrics(Chicago), to name just a few such organizations. "They're the

primarynumbers. The CDC only reports primary data," says a Merck spokesperson,Isabelle Claxton. Adds an SKB spokesperson, Brian Jones, "These numbers arethe rationale for our vaccinating for hepatitis B. They tell us thathepatitis B is a serious and life-threatening disease."Is it safe?Another contention between the victims and the supporters of the hepatitisB vaccine--aside from the true number of virus-infected Americans--is thesafety of the vaccine, particularly its safety in babies and children.Following the 1991 ACIP recommendation to begin vaccinating babies forhepatitis B at birth, roughly 40 states mandate that children show proofthat they have received three doses of the hepatitis B vaccine beforeentering daycare or school, with many states beginning the vaccinationprocess near birth. "This, despite the fact that almost nothing is knownabout the health and integrity of an individual

baby's immune system andneurological system at birth," states NVIC's Fisher. Her FOIA to the CDC,in fact, also requests copies of the "peer-reviewed, scientific studies"used to support the safety of the ACIP's 1991 recommendation."I would challenge any clinician or researcher to claim that we have abasic understanding of the human newborn immune system," says Baylor'sDunbar. "It's well-established in studies in animal models that the newbornimmune system is very distinct from the adolescent or adult. In view ofthis lack of scientific and medical information of neonatal immunology,it's remarkable to me that newborn infants are being administered multipleinjections of this vaccine, especially since there have been few, if any,clinical trials to adequately evaluate the potential long-term effects of neonatal immunization."Michael Belkin has generated numbers that support these safety concerns forinfants. He states that in 1996 doctors reported only 54 cases of hepatitisB to the CDC in babies between the ages of hours and one year. Yet thatsame year, the Vaccine Adverse Event Reporting System (VAERS)--a systemjointly managed by the CDC and the Food and Drug Administration (FDA,Rockville, MD)--received a total of 1,080 reports of adverse reactions tothe hepatitis B vaccine in babies from hours to one-year old, including 47deaths. Exclaims Belkin, "So total VAERS hepatitis B reports for the 0 to 1age group outnumber reported cases of hepatitis B by 20 to 1."Overall, VAERS has received a total of 17,497 reports of adverse

reactionsto the hepatitis B vaccine, reactions that occurred after people receivedthe vaccine alone, rather than in combination with other vaccines, duringthe period between July 1, 1990 and October 21, 1998. Moreover, fully 5,983of these reports chronicled such serious events as hospitalizations, while146 of them told of deaths. VAERS, furthermore, is a passive system, not amandatory one. This suggests that only a fraction of adverse events areactually reported, a fraction estimated by FDA officials to be as low as 1%to 10%.The CDC puts little stock in VAERS, since "case reports of adverse eventsfollowing vaccination rarely provide a convincing link between the eventand vaccination," claims Harold Margolis, chief of the CDC's hepatitisbranch. VAERS case reports of adverse events may be "temporally linked, butcausally unrelated. By chance alone, some patients who develop symptoms ofillness will do so within

several days of receiving a vaccine. Or a vaccinemay lead to the earlier recognition of an illness, without increasing theoverall risk of that illness occurring," Margolis states. Interestingly, Merck, like the CDC before it, has come up with its ownhepatitis B numbers, though Merck's figures deal with vaccine-relatedadverse reactions. These numbers, according to spokesperson Claxton, focuson Indiana, the home state of Congressman Burton, who chaired two of thehearings in which the safety and other aspects of the hepatitis B vaccinewas raised. "If you immunized all of the people in the three biggest citiesin Indiana with our

hepatitis B vaccine, only one person would be at riskof suffering an adverse reaction. The risk of a serious adverse event wouldbe over 1 in 10 million," says Claxton, though she didn't say how Merckgenerated these numbers.Baylor's Dunbar, for her part, found the VAERS reports at least partiallyuseful. "What was obvious from the information I obtained from the VAERSreports was that there are thousands of reports listing such conditions asneurological damage, arthritis symptoms, and other serious immunologicaldisorders. These are the same types of medical conditions that, in myextensively detailed investigation of the literature, have been publishedin dozens of medical journals that cite the correlation of this vaccine andsevere immunological reactions."Dunbar, in fact, has put together a table entitled "Reports of adversereactions to hepatitis B vaccine" that lists 110 references from medicaljournals including

the New England Journal of Medicine, the Journal of theAmerican Medical Association, and the Archives of Internal Medicine, aswell as numerous overseas publications, including the Lancet and theBritish Journal of Rheumatology. All of these references detail thediagnosis of adverse reactions to the hepatitis B vaccine, including lupus,arthritis, vascular disorders, demyelinating disorders, and chronicfatigue, among other diseases. A minority of these references, however, report on the original plasma-derived hepatitis B vaccine, which predatedthe recombinant form of the vaccine. "Patients are

reacting to a protein inthe vaccine," says Dunbar. "The source of the protein doesn't matter. It'sstill the same protein, whether it's plasma-derived or recombinant."Molecular Mimicry: A Possible CulpritDespite the weight of the evidence to the contrary, supporters of thehepatitis B vaccine deny that it causes any more adverse reactions thanexpected, as all vaccines cause at least some bad reactions. "No causallink has been scientifically proven between the vaccine and an unexpectedlyhigh number of adverse events," says SKB's Jones. CDC's Margolis states,"Both pre-licensure and post-licensure reviews have shown that thehepatitis B vaccine is among the safest vaccines we have." And Chiron'sRutter adds, "The data show that the benefits of the vaccine far outweighits risks, if it has any risks at all."Dunbar, along with other researchers, believes that the risks of thehepatitis B

vaccine are great, particularly to specific geneticpopulations. These researchers postulate that the hepatitis B protein usedin the vaccine can cause autoimmune diseases in these subpopulationsthrough several potential mechanisms. One is through a process calledmolecular mimicry. This process occurs when a person's immune systemcommits a colossal mistake, confusing a foreign protein for one of thebody's own proteins. Consequently, when the immune system attacks theforeign protein, it also attacks its own protein, one of the very proteinsthat the immune system exists to protect. Such foreign proteins arecontained by pathogens like viruses or, more specifically, viral antigens.The hepatitis B vaccine, for its part, is practically an exact replica of aprotein antigen on the surface of the hepatitis B virus. When the body encounters a virus, for instance, certain immune cellsliterally engulf the virus and chop it up into thousands of proteinfragments, known as peptides, each of which is made up of 10 to 15 aminoacids. A few of these peptides are carried to the immune-cell surface andplaced in a sort of pocket atop what is called a major histocompatabilitycomplex (MHC). This signals the immune system to destroy all cellscontaining that peptide. Yet the immune system destroys not onlyvirus-infected cells containing the peptide, but also cells in the bodythat contain similar peptides. "The process can set into motion a cascadeof self destruction. And certain

people end up developing autoimmunedisorders," says Dunbar.The reason for this is an individual's MHC genes, as well as potentiallyother genes involved in regulating the immune system. An individual'sspecific genetic makeup determines which of the thousands of peptides thatthe immune cell chops the virus into is eventually placed in the pocket ofthe MHC.In the case of the association of the hepatitis B vaccine and demyelinatingdisorders, a number of phenomena appear to occur, Dunbar states. Oneinvolves a subpopulation of people, most probably of Caucasian origin, whoshare similar MHC genes or other genes regulating the immune system. Asecond involves the MHC genes, which seem to code for the selection of apeptide to be placed in the MHC pocket that is similar in structure to apeptide that is associated with myelin, a substance containing numerouspeptides that insulate the nerves of the central nervous system.

The thirdinvolves the hepatitis B vaccine, which must contain one or more similarpeptides that have similar amino acid sequences or similar structures tothe myelin-associated peptides."Molecular mimicry can then occur, as has been shown in numerousanimal-model studies," states Dunbar. She adds that the National Institutes of Health (Bethesda, MD) has twice refused to fund a research proposal inwhich she and her colleagues would, among other aims, have attempted to"test our hypothesis that subsets of patients having adverse reactions tothe hepatitis B vaccine have similar and predictable MHC gene sequences."In near-absolute agreement with Dunbar is Burton Waisbren, a doctor inMilwaukee, WI, who presently is focusing on neurological disorders and whois a founding member of the Infectious Disease Society of America(Alexandria, VA). Says he, "The literally thousands of individuals who'vebeen reported to VAERS and pharmaceutical companies, who claim to havesuffered demyelination and autoimmunity from the hepatitis B vaccine,should be followed up to determine their MHC gene sequences to ascertain ifhost factors are partially causative of the complication." And he statesthat the hepatitis B vaccine should be "tested for the extent

of itspolypeptide homology with human tissue. If significant homology is shown,the offending polypeptides could be removed from the vaccine, or asynthetic vaccine could be produced without them.Indeed, aside from hotly criticizing the CDC's recommendation to immunizeall children with the hepatitis B vaccine, NVIC's Fisher cites a recentNVIC poll of 1,000 registered voters, in which 68% of Americans support aparent's right to choose whether or not their children should receivecertain vaccines that could potentially hurt them. States Michael Belkin,"If the hepatitis B vaccine was recommended in 1991 without scientificproof that it was safe in a broad sample of racially and geneticallydiverse babies less than 48 hours old, then the CDC has been experimentingon babies like guinea pigs, and the universal immunization policy should besuspended."Both Fisher and Belkin believe that the US should do what France

hasalready done. Late last year, France became the first country to end itshepatitis B vaccination requirements for schoolchildren, after reports ofadverse reactions associated with the vaccine simply overwhelmed thecountry's Health Minister."In conclusion, vaccines are a perfect manifestation of everything that is satanic. They represent an adulterous and arrogant tampering with divine creation, based on the intellectual conceit of "perfecting" creation. They are poisonous, containing derivatives from metals such as mercury and aluminum, and from formaldehyde. They are made from the cell lines and viruses of biblically unclean animals such as monkeys, cats, etc. Worst of all, they are made from the cell lines of premeditatedly murdered children. " Bob Sperlazzo Christian Digest 11/29/2002

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