Medical Miracle or Masterful Mirage
By Dr. Raymond Obomsawin
(This book first appeared at the Soil and Health Library, an important source of books
on holistic agriculture, holistic health, self-sufficient living, and personal development)
BIOGRAPHICAL SKETCH OF: RAYMOND OBOMSAWIN
The Unresolved Issue of UCI/EPI Effectiveness and Impact
The Unresolved Question of Potential Adverse Effects
The Unresolved Issue of Long-Term Adverse Effects
The Unresolved Issue of Safer and More Effective Alternatives
The Unresolved Question of Ethics
SECTION I: MIRACLE IN THE MAKING: REALITY OR DELUSION?
EPI--Field Evaluation Experience
UNICEF's General EPI Strategy and Stated Achievements
A Case History
Immunization's Impact in the Declension of Infectious Diseases
Incomplete Statistical Reporting
The Developmental Implications of UCL/EPI
Is Immunization Effectiveness a Certainty?
Early Theoretical Foundations Re-Examined
Artificially Induced Immunity--Reality or Delusion?
An Historic Overview of the Bacterial/Viral Theory of Disease Causation
The Bacterial/Viral Versus the Cellular/Ecological Theory of Infectious Disease
Infectious Disease Tables I--XVIII
Immunization Effectiveness Data
Data on Diphtheria
Data on Measles
Data on Polio
Data on Pertussis (Whooping Cough)
Data on Tetanus Toxoid and Immune Globulin
WHO Smallpox Eradication Success Reconsidered
Vaccine Associated Dangers--General Observations
Of What Do Vaccine Products Consist?
Some Observed and Potential Adverse Effects of Spacific Vaccines and Toxoids--Diagnosable in the Short Term
Extent and Nature of Observable Vaccine Damage
Long Term (Delayed) Potential Adverse Effects of Immunization
Evidences for Immunization Induced Immune Malfimction
The Ethics of Universal Childhood Immunization
Bane or Boon? Selective Medicine in Primary Health Care
SECTION II: TOWARDS MORE APPROPRIATE PRIORITIES IN
DEVELOPING WORLD PRIMARY HEALTH CARE
Eclipsing the Spirit of Alma Ata
Emerging--A More Practicable Primary Health Care Model
SECTION III: A CONSIDERATION OF ALTERNATIVES TO ENSURING NATURAL IMMUNITY
The Soil as Chief Determinant of Health and The Foundation of Public Health Policy
Soil Re-Mineralization--A Return To Primeval Conditions
Soil Dietetics and Disease
Key Nutritional Measures in Preventing Infectious Disease
I. Viral Infections
II. Bacterial Infections
III. Phagocytotic Activity
A New and Better Strategy
General Conclusion on Appropriate Alternatives
References to sections 1,2 & 3
ANNEX 1: PROBLEMS WITH DEVELOPING WORLD MEDICALIZATION AND THE TRADITIONAL MEDICINE ALTERNATIVE
The Disturbing Dilemma of Developing World Medicalization
India--An Alarming Case In Point
A Compelling Voice of Protest
The Traditional Medicine Alternative
Critical Conclusions and Directions
ANNEX II: AGROCHEMICAL AGRICULTURE--THE NEED FOR A SANER ALTERNATIVE
The Dilemma of Chemical Fertilization
Biologically Sound Alternatives To Pesticides
The Promise of Clean Organiculture Methods
A Recent International Initiative in Clean Organiculture
BIOGRAPHICAL SKETCH OF: RAYMOND OBOMSAWIN
Raymond Obomsawin was born in the United States on August 16, 1950 and holds dual US and Canadian citizenship. He married Marie-Louise in August of 1976, and they have three, vibrant children: Sunrise, Sunbeam and Sundown. These children--two are still in their teens, and one is twenty-one--have never received the prescribed regimen of childhood vaccines, and due to a healthful lifestyle have exhibited total immunity to the diseases that are common to the childhood years. (Time and again they've been physically exposed to those ill from some of these very diseases.)
Dr. Obomsawin holds over two decades of cross-cultural experience--both in North America and internationally--in the primary disciplines which impact on human bio-social development. He holds a Baccalaureate Degree in Health Education and Communications, Masters Degree in Development Education, and PhD with concentrations in Health Science
and Human Ecology.
He is currently serving as President of the Circle of Nations Institute of Life Sciences & Sustainable Development an international R&D institution legally established in Hawaii, and has previously served as: Manager of Overseas Operations for CUSO (Canada's largest International Development NGO); Evaluation Analyst in the Canadian International Development Agency; Evaluation Manager with the Department of Indian Affairs & Northern Development; Executive Director in the California Rural Indian Health Board system; Director of the Office for National Health Development NIB (Now Assembly of First Nations); Founding Chairman of the National Commission Inquiry on Indian Health; and Supervisor of Native Curriculum for the Government of the Yukon Territory.
Some key highlights of Dr. Obomsawin's professional experiences and achievements follow:
* Chaired and served on regional, national, and international committees holding development related policy, management, and research mandates.
* Advised senior decision-makers--in both public and NGO sectors--providing critical analyses and recommendations on international development policies, project, and programming initiatives in health, education, agriculture, nutrition, agro-forestry, environmental sustainability, and multi-year country planning.
* Spearheaded the first world-wide inter-sectoral review funded by a Western government on Indigenous Culture Based Knowledge Systems in Development. The study elicited the involvement of public and NGO sector bio-social development, technical and research institutions in all world regions; and entailed exploratory field missions to the Andean and Upper Amazon regions of South America, as well as East Africa, South and Southeast Asia.
* Organized, administered, and executed socio-politically sensitive evaluation studies on complex bio-social service interventions, as well as educational and development initiatives internationally, eg, as a team member evaluated: UNICEF's Integrated Services Project which served over 900 villages in Northeast Thailand; and other development projects at the Asian Pacific Development Centre, Malaysia; Asian Institute of Management, and The Woman for Woman Foundation, Philippines; and Institute of Social and Administrative Studies, University of the South Pacific, Fiji.
* Coordinated (in Canada and Norway) the initial development of Terms of Reference for a comprehensive evaluation of the United Nations World Food Program--operant in 90 countries under the trilateral sponsorship of Canada, Norway, and the Netherlands.
* Spearheaded the establishment and chaired Canada's National Commission Inquiry on Indian Health which served as a national--grass-roots mandated--indigenous health policy development body.
* Presented--in plenary session--the paper "From Selective to Indigenous Medicine: Repossessing the Ancient Wisdom,' at the International Development Research Centre and National Institutes of Health sponsored International Workship on Traditional Health Systems and Public Policy.
* Presented the keynote address "Re-Discovering Our Roots: The Ancient Wisdom of Sustainable Societies" at the Community Sustainability Resource Institute's 3rd Annual Conference, USA.
* Experienced multi-cultural exposure including private, voluntary, and or public sector interchange in over 25 countries on five continents, as well as Australasia and select Pacific island nations, and
* Produced academically and professionally over 75 articles, reports, proposals and publication documents.
TO THE THIRD EDITION
Dr. Raymond Obomsawin, PhD
This extensive report focuses on the current massive international effort to administer artificial immunization to the children of the world. The actual launching of the World Health Organizations's Universal or "Expanded Program on Immunization" (EPI) occurred in the year 1983. Its overriding purpose was to achieve maximum immunization coverage of the world's children. Under the influence of the WHO--which is a United Nations created and sustained multilateral agency--all national political leaders (then representing 158 nation states) made a commitment to achieve 80% immunization coverage in their respective countries by the year 1990. In that year the WHO set a new standard for the governments of the world, ie, a more intensified goal of achieving 90% immunization coverage by the year 2000. As a review document, this report poses an open challenge to the scientific, developmental, and humanitarian basis of this global public policy, in turn urging national governments to establish a far more rational, effective and harmless inter-sectoral approach in seeking to ensure that the children and families of our world community enjoy lifelong natural immunity to infectious diseases.
The research covered in this document tackles the issue of universal immunization from a very broad perspective, thereby going well beyond the more obvious realities of its being a "medical racket" hatched by a pharmaceutical industry beholden to its investors, and religiously dispensed and defended by allopathic medicine men. Through employing trans-disciplinary and integrative analyses it draws upon wide-ranging disciplines and fields of thought as it considers the purposes, policies and practices surrounding mass immunization. The effort to research and pull together this report occurred while I was serving as an Evaluation Analyst in the Evaluation Division at the Canadian International Development Agency. My initial research began early in 1991, contextual to conducting a field evaluation of the EPI component of a major UNICEF project then affecting several hundred communities in Northeast Thailand. The report is being distributed and or sold in its present form under the auspices of a non-profit public health advocacy organization, the Health Action Network Society, Burnaby, British Columbia, Canada. (As author, I will receive no royalties from either its sale or distribution.)
Since the first edition came out in the early 1990s, the many serious issues and concerns which are raised in this study have not by any means been properly addressed or resolved. The medico-industrial complex has neither wavered nor modified its posture of providing a white washed endorsement and promotion of what is largely an unproven technological fix of dubious origin, which carries its own seeds of disease and death. For the most part, the same can be said for the public sector policies whereby government such as that of the United States place themselves in an untenable conflict of interest position by playing a direct role in the development of new vaccines, the active promotion and enforcement of mandatory artificial immunization, and the monitoring of vaccines for adverse side effects thereby setting its own criteria and degree of liability in the compensation of victims. (Only one in four vaccine injury victims, who apply for compensation under US law, are compensated for their often catastrophic vaccine injuries. Government qualifying rules require that the onset of adverse symptoms must have occurred within four hours of the administration of the vaccine. Despite these severe limitations in legal liability, since passage of the National Childhood Vaccine Injury Act of 1986, up to February 28, 1998, compensatory payments have totalled $871 million 800 thousand.)
Sad to say, the public sector's world-wide reliable monitoring for adverse side effects (not excluding that of the US Government) does not appear to have noticeably improved from its abysmal state since the initial issuance of this report. As well, multilateral development agencies such as UNICEF continue to push this unproven and essentially spurious technology on a largely uninformed and intimidated public throughout the Developing World nations. On a positive note, within First World nations public awareness of the problems and dangers associated with mass immunization programs appear to have broadened and intensified. Vehicles of the information revolution, such as the Internet have helped considerably. Even physicians themselves are at long last waking up to and advocating the truth, e.g., in France, 200 doctors have called on their govemement to immediately halt the hepatitis B vaccine program because of the many cases of neurological disorders and multiple sclerosis being caused by this vaccine, and in Switzerland, 500 doctors continue to oppose their govemement's MMR vaccine campaign.
Lawsuits for vaccine damages have as well become increasingly common. In the summer of 1997, various news reports in the Commonwealth countries reported that Dawbams law firm in Norfolk, England is carrying forward a major class action lawsuit for widespread damages arising from Britain's 1994 MMR campaign. In a public statement issued by this law firm it is affirmed that:
We know of hundreds of children who were fat and well before being vaccinated, but who are now chronically ill or seriously mentally or physically disabled. Of some 600 cases: the most common are autism (202); serious digestive problems (110); epilepsy (97); hearing and vision problems (40); arthritis (42); behaviour and learning problems (41); ME (24); diabetes (9); paralysis (9); blood disorders (5); brain damage (3); and death (14).
Bolstering the firm's case is the fact that the affected children's pediatricians and neurologists continue to state in British radio and TV documentaries that the children's varied injuries were in fact caused by administration of the MMR vaccine.
Additionally, growing numbers of affected parents and professionals have been instrumental in the emergence of multiple research and activist organizations such as the Immunization Awareness moni Society (IAS), New Zealand; Vaccine Awareness Network (VAN), Australia; Association for Vaccine Damaged Children (AVDC), Canada; Global Vaccine Awareness League (GVAL), California; and the National Vaccine Information Center (AWIC) in the Greater Washington DC area. This phenomena tells us that there are still some heroic and honest hearted people left in our world who are willing to stand together for the right, and make personal sacrifices of their time, resources, and reputations in the face of the combined efforts of government and industry to both slander and silence them. In fact, in recent weeks a prominent member of the IAS has been in touch with me, and shared information which included the fact that a 1992 survey by their organization found an almost 500% greater incidence of asthma among New Zealand children who've received routine childhood vaccines, than among those who haven't.
It is also of interest that on September 13-15, 1997, more than 500 parents, physicians, university scientists, health officials, legal experts, ethicists, journalists and activists from 34 states and five countries convened for the First International Public Conference on Vaccination. This historic session was organized under the auspices of the National Vaccine Information Center (NVIC). According to information provided by the NVIC, the Conference inter alia examined issues such as vaccines and infant dealth; biological mechanisms of vaccine injury; vaccines and learning disorders; hepatitis B vaccine injuries; viral vaccinces and chromosome damage; polio vaccine contamination; and vaccine regulation. A number of the more important observations made by the presenters at the conference further corroborate and complement the alarming findings that are raised in my report. Some key observations follow:
* The "P" in the old DPT vaccine is so highly toxic to the human brain that the whole cell pertussis vaccine should be immediately withdrawn from the market.
* Vaccines which cause brain inflammation and severe brain damage, such as DPT, are also biologically capable of causing milder forms of brain damage, such as learning disabilities and Attention Deficit Disorder.
* Live viral vaccines are implicated in brain injuries, such as the MMR vaccine which is now linked to autism, while the same vaccine has never been fully investigated for its long term effects on human immune and neurological systems.
* Live viral vaccines may also be implicated as a cause of genetic damage in humans.
* There are many reports of adults in Canada, who have suffered central nervous system and immune dysfunction or death following hepatitis B vaccination.
* Polio vaccines contaminated with monkey viruses may have caused the development of HIV- I and rare forms of bone, brain and lung cancers in humans.
* Children injured by vaccines and other toxic insults, have disturbances in biochemistry such as imbalances in fatty acid metabolism and neurologic dysfunction such as autistic spectrum disorders and seizure disorders.
* Data from New Zealand and several European countries suggests that early childhood vaccination
has caused an increase in juvenile diabetes.
* A combination of multiple vaccinations
and multiple exposures to environmental and chemical toxins may cause immune and neurological dysfunction in the general population like that being suffered by Gulf War veterans.
* Government health officials in federal health agencies have withheld information about vaccine risks from the public.
The general consensus among research scientists in attendance was that current immunization programs are causing injuries and deaths because of inadequate vaccine safety research, testing, manufacturing and monitoring for long term effects. What's new? (Conference proceedings are available to the public from the National Vaccine Information Center: #206-512 W. Maple Avenue, Vienna, VA, USA, 22180, Telephone: 1-800-909-SHOT.)
It also bears mentioning that I recently came across a June, 1995 interview with an old acquaintance, the veteran physician to the Aboriginal People of Australia, Dr. Archie Kalokerinos. The interview was published in the International vaccination
Newsletter (Krekenstraat 4, 3600 Genk, Belgium). Archie is in many ways a man deserving of great recognition for his brave struggle with the establishment forces in his country, who attempted to block his efforts to expose and reverse the massive death rates (as high as 50%) being caused by mass immunization in a population at great risk to its dangers. In this interview he states that it was this "extreme hostility" that:
. . . forced me to look into the question of vaccination
further, and the further I looked the more shocked I became. I found that the whole vaccine business was indeed a gigantic hoax. Most doctors are convinced that they are useful, but if you look at the proper statistics and study the instances of these diseases you will realize that this is not so . . .
My final conclusion after forty years or more in this business [medicine] is that the unofficial policy of the World Health Organization and the unoffical policy of the 'Save the Children's Fund' and ... [other vaccine promoting] organizations is one of murder and genocide. . . . I cannot see any other possible explanation. . . . You cannot immunize sick children, malnourished children, and expect to get away with it. You'll kill far more children than would have died from natural infection.
Although the public sector in Canada hired a biomedical protagonist of artificial immunization to attack and undermine the original findings and observations contained in this document, nothing was effectively challenged or disproven in this determined effort, nor has there been any challenge from any other quarter since. Furthermore, I've received some very good news from a reliable source in Montreal, Canada, that a number of practicing physicians in that city have ceased using vaccines in their practice after having read this report. I fully trust that it will prove of lasting value in informing and influencing other professionals, parents and interested lay persons who may be honestly seeking to explore both sides of the controversy for the first time.
Finally, it is my sincere hope that the re-issuance of this document will provide a considerable source of valuable documentation and commentary for those who are at the forefront in the battle for biomedical truth and right in a world largely beholden to the bottom line of capitalists who value their profits above seemingly everything else. In the end, the truth with prevail.
"Discovery Consists In Seeing
What Every body Else Has Seen
And Thinking What Nobody
Else Has Thought . . . "
Despite the widely accepted view that millions of children now enjoy freedom from various life threatening infectious diseases, and thus improved health, because of highly effective and safe vaccine programs, at the outset of the 90's an Evaluation of Canada's International Immunization Program Phase I (CIIP--I), concluded that in fact there are "many pressing questions which remain to be investigated within EPI (Expanded Programs of Immunization) and Primary Health Care." A range of critical issues relative to Universal Childhood Immunization (UCI) and EPI programs have been examined and responded to in the main report. These follow:
The Unresolved Issue of UCI/EPI Effectiveness and Impact
The verifiable measurement of UCI/EPI effectiveness and impacts, has been pervasively deficient in the major immunization programming investments made by The Canadian International Development Agency (CIDA)--approaching $150 million--in the 1986-1991 time period. The aforenoted CIIP--I evaluation study further noted that the actual impact of UCI/EPI on mortality levels remain essentially undetermined and unsubstantiated. To quote: "at present it appears that there is no conclusive evidence on the impact of immunization on child mortality from all causes. . . . It may be that EPI's effect is merely to bring about replacement mortality, whereby children . . . succumb to other diseases instead. The uncertainty over the impacts of EPI remain a major question in PHC [primary health care] programming." In light of the compelling need for the proper and periodic evaluation of the impacts of publicly financed programs, this deficiency remains a very serious one.
Unexpected and unexplainable outbreaks among "immunized" persons, have led immunologists to now seriously question whether their current understanding of what constitutes reliable immunity is in fact trustworthy. For example, the admission is being made that immunity (or its absence) cannot be determined reliable on the basis of history of the disease, history of immunization, or even history of prior serologic determination. There is as well an emerging body of mathematically based epidemiological research which suggests significant problems with UCI/EPI targeted efforts for the control and eradication of measles in the Developing World, where in spite of high measles immunization coverages, measles epidemics are being reported with surprising frequency.
Vaccine failures in the Oman polio epidemic could not be explained by failures in the cold chain, nor on suboptimum vaccine potency. It was further observed that the efficacy of OPV in inducing humoral immunity has been lower than expected, and that primary reliance on routine immunization may be inadequate to achieve the goal of eradicating polio by the year 2000. (Similar polio outbreaks have been occurring in other highly vaccinated populations, e.g., the Gambia, Brazil, and Taiwan.)
The Unresolved Question of Potential Adverse Effects
Another basic issue that has never been addressed in UCI/EPI programming is the need for the effective monitoring and evaluation of potential vaccinal adverse effects. Past estimates on the degree of adverse reactions are both unreliable and optimistic since actual monitoring efforts have generally been negligible. Furthermore, many physicians and nurses are not cognizant of the importance of reporting untoward reactions, and or remain unaware of their clinical features. Overall, the evidence strongly suggests that the chronic underreporting of vaccine-induced morbidity, disability, and mortality is in fact the norm, whether in the Developing or Developed Worlds. The first definitive policy statement on this issue by the World Health Organization (issued on April 1991) indicates the WHO's recognition of the significance of this problem. It should be considered as a priority issue in future UCI/EPI research, monitoring and evaluation.
The Unresolved Issue of Long-Term Adverse Effects
A minority of qualified scientists are now postulating that the full vaccine schedule as routinely employed in early childhood vaccination inevitably weakens the immunologic system of the child, leaving this system crippled in its ability to protect the child throughout life, and in turn opening the way for other infectious diseases due to such immunologic dysfunction. It is also being postulated by such scientists that mass immunization is directly contributing to the now widespread escalation of various auto-immune, degenerative disease and allergic conditions.
The Unresolved Issue of Safer and More Effective Alternatives
Sufficient evidence now suggests that an increasing awareness of the potential dangers that are being increasingly associated with mass vaccination programs, will serve to precipitate public demand for greater research investments in the further exploration and testing of promising and danger-free alternative prophylactic methods. A considerable body of literature on lifestyle (especially nutrition) based prophylaxis and treatment for both bacterial and viral infectious diseases suggest that this is the optimum alternative to the artificial immunization dilemma.
The Unresolved Question of Ethics
UCI/EPI--as presently conceived and executed--represents two major departures from the time honoured ethics and traditions of medicine:
* that all forms of treatment should be individualized, particularly when prescribing or injecting substances which carry the potential for disease, disablement, and death; and
* the objectively informed patient (or parent) should always have absolute freedom to accept or reject any given measure or therapy, and have reasonable opportunity to consider alternatives.
The foregoing observations indicate that there is a genuine need for world governments to reconsider their policies with respect to universal childhood immunization, ensuring particular focus on clarifying the vital issues of the short and longer term impacts of UCI/EPI, and the pressing need to establish far safer and more effective alternatives.
MIRACLE IN THE MAKING:
REALITY OR DELUSION?
Universal Childhood Immunization (UCI)--in its more localized context referred to as Expanded Program of Immunization (EPI)--stands worldwide as a top health programming priority among various multilateral, bilateral, and nongovernmental (NGO) international development agencies. This appears to be the case because immunization programs are widely accepted and actively promoted as offering recipient beneficiaries more substantive disease prevention benefits than any other modality in the arsenal of modern medicine, coupled to its unique capacity to offer the surest and "quickest" results. When compared to the more basic intersectoral and developmental requisites for public health sustenance and disease prevention, UCI/EPI is generally considered to be the easiest to implement programmatically, promote publicly, and defend politically. The World Health Organization (WHO) has gone on record to affirm that, "Immunization is one of the most powerful and cost-effective weapons of modern medicine. Immunization services, however, remain tragically under-utilized in the world today."1
Despite the Canadian govemment's confirmed support of the comprehensive primary health care approach--as defined in the Alma Ata Declaration--the majority of increases in the Canadian International Development Agency (CIDA) Health Sector disbursements, in the last half of the 1980s, have been for the selective and vertical modality of UCI/EPI. In fact, according to observations made in the 1989, Evaluation Assessment of CIDA Investments in the Health Sector, immunization has become the dominant health activity supported by CIDA. "Annual disbursements over the past three years have risen from $3 to $22, to $49 million."2 The lion's share of this increase stemmed from the launching of Canada's International Immunization Programme (CIIP), covering the period of 1986-1991. (An October 10, 1991 Fact Sheet on Canada's Role in Immunization, states that of the $43 million expended by CIIP in the period 1985-1990, involved the execution--by more than 30 nongovernmental organizations--of over 100 projects in more than 50 countries. When we include the government-to-government [bilateral] program, total CIDA funds committed to UCI/EPI in the 1986/1987-1990/1991 fiscal year periods equal some $143 million. At the end of 1991/1992 it was the intention of the government to expend roughly another $50 million on UCI/EPI over the next five years, with about $30 million for CIIP II.) According to a Mid-Term CIIP Operational Review completed November 20, 1989, UNICEF took almost $27 million from the Program for 37 EPI projects, amounting to 67% of CIIP funds. Additional CIIP funding passed indirectly to UMCEF, via Rotary for vaccine purchases, and via Canadian partners who purchased project equipment from UNICEF stockpiles.3
Speaking of this major shift in priorities, wherein by the end of the 1980s immunization support accounted for one half of all health sector disbursements, the CIDA Health Sector Evaluation Assessment recommended that "this situation merits examination on the grounds of both the heavy focus by CIDA on this one type of health program and the nature of immunization efforts . . . Primary Health Care is more complex and multifaceted then the provision of this one . . . technology."4 This need to re-examine immunization support was further affirmed when the Assessment identified certain "important am that merit further review," including: case studies of the health impact of projects involving or crossing varied sectors; the level of sustainability achieved in completed CIDA health projects; and areas of large spending or of controversy, i.e., immunization."5
Although the Assessment did not go on to define the nature of the controversies surrounding immunization, mass immunization programs have been seriously questioned on both developmental and scientific grounds. It will be the purpose of this report to proceed with a detailed examination of the issues of controversy, draw some conclusions, and make appropriate recommendations. The critique of these issues stems from a careful review and evaluation of wide ranging biomedical literature sources of relevance to the subject. This work has been carried out in the spirit of honest inquiry, thus affording a fresh and critical analyses of the fundamental issues.
Although the conclusions as reached visibly sustain "one side" of what is largely a hidden and professionalist dominated debate on immunization, the reader should note that this is done in order to provide a long neglected and constructive counterbalance to the predominating supportive declarations of the establishment, and in turn the parroted promotion of the same view by the popular media.
It must further be appreciated that past and ongoing investments in the drive for universal immunization extend well beyond the mere allocation of substantial government and publicly donated funds (which translates into biennial expenditures of a billion US dollars, 63 percent of which comes from Developing World countries themselves)6 to include:
* extensive public and private sector commitment to meeting the infrastructural, service, product and marketing requirements of the world-wide medico-industrial complex which employs tens of thousands of people in drug companies, private laboratories, universities, governmental health departments, hospitals etc. (furthermore it is estimated that there are 25,000 professional national and international staff who directly oversee hundreds of thousands of field workers involved in the annual vaccination of 60 million children);7
* related domestic and international legislation and politics; and
* massive public educational indoctrination initiatives that are largely predicated on promoting the unquestioned effectiveness and relative safety of immunization, and which by design engender an impelling fear in those "unprotected."
UNICEF's Executive Director has gone on record in many fora to herald the substantive value and potency of immunization. In advance of the inception of Canada's current and greatly expanded International Immunization program he gave a full and unqualified assurance that "Expanded immunization--using newly improved vaccines" will "prevent the six main immunizable diseases from killing an estimated 5 million children a year and disabling 5 million more."8
The front page of the January/February, 1988, issue of Development Forum, published by the U.N. Department of Public Information, unequivocally affirms that "immunization is the success story of the decade. In the Developing World immunization has reached 50 percent for DPT vaccine and 40 percent for measles, and is now saving over 1.3 million lives annually." Everyone is encouraged--bordering on religious fervor--to get on the bandwagon.
UNICEF.. calls for a 'Grand Alliance' of all possible resources teachers, and religious leaders, mass media and government agencies, voluntary organizations and people's movements, business leaders and labour unions, women's groups and health services to create an informed public demand for. . . the methods which could now bring about 'a revolution' in child survival and development. In Turkey, for example, 200,000 school teachers and 54,000 imams have helped to treble the nation's immunization coverage. In Syria and Egypt, television has succeeded in getting the immunization message into every home . . . UNICEF argues that 'there is no greater cause in which to march.' 9
Indeed, immunization has of late gained the distinction of being considered the "leading edge" in primary health care, and is extolled by its advocates as "the single most successful component of the child survival program." Its high acceptance and apparent success relate to a number of factors:
A technological package that is easily understood and readily available . . . the fact that vaccination does not require substantial behaviourial change; the relative ease of measuring coverage and its offer of an opportunity for political leadership at all levels to be visibly involved. Finally, it is the single component of PHC that provides the greatest opportunity for the private sector to participate through the supply or production of vaccine and cold chain equipment.10
It is accepted wisdom among medical professionals and in turn the public, that millions of children now enjoy improved health and freedom from various life-threatening diseases because of safe and effective vaccines. In the words of Fulginiti, "morbidity and deaths secondary to the contagious diseases have either been eradicated, measles greatly reduced in occurrence, and rubella, mumps, pertussis, and other diseases significantly lessened in terms of their impact."11
EPI--FIELD EVALUATION EXPERIENCE
This general examination of Immunization as a central modality in the prevention of common infectious diseases in the Developing World will begin with some salient extracts taken from the writer's findings in a field evaluation he carried out on a UNICEF--Expanded Program of Immunization and Primary Health Care initiative in Northeast Thailand, in March of 1990. The data derived from evaluating the EPI component is being provided as basic background information because it provides some useful insights on comparable UNICEF-EPI initiatives that are now occurring throughout the Developing World, and points to some critical issues meriting further investigation. (EPI was one of eight components in the Integrated Services Project for Children, extending over a five year period, at a cost exceeding $8,500,000.(Cdn). This funding was primarily provided by the Canadian Government, and supplemented with public contributions. The Project was executed by UNICEF Thailand, in cooperation with the Royal Thai Government.)
The EPI in Northeast Thailand proved to be a considerable undertaking. It included: the execution of a cluster survey on immunization coverage in all 59 districts (in which there are over 900 villages); provision of EPI training for 600 Village Health Volunteers, Village Health Communicators, and religious leaders; similar training for 200 health care providers, and 40 multiple WHO staff, EPI information strengthening and finally social mobilization to vaccinate, viz. provide BCG/OPV/DPT and measles coverage for all 59 districts. It further involved the equipping of 373 tambon (subdistrict) health centres with sufficient numbers of. refrigerators; vaccine carriers with four icepacks; BCG vaccine kits; thermometers; cold chain monitoring cards; and steam sterilizers.
The EPI initiative placed its strategic concentration on the following areas:
1. EPI training of village and religious leaders
2. emphasis on reaching progressively higher annual vaccination targets
3. provision of cold chain equipment and support to targeted Tambons
4. information campaigns in primary and elementary schools
5. public education campaigns in targeted villages
6. increased vaccine production; and
7. strengthening the EPI information system at the district and provincial level.
In reviewing figures for the project covering the first three years (1985-1987), the priority emphasis on immunization is evident. Project expenditures for this component reached 126 percent of the original target for immunization, compared to only 28 percent for primary health care. Food and nutrition fared somewhat better at 60 percent of the target, a little under the project average of 61 percent. A budget analysis conducted on the project for this period states that "Implementation of the community action component is . . . low. However, the savings obtained here will be passed on to the EPI and pre-school components . . ." The reason given for exceeding the original budget projections for EPI, was "because of the demands and opportunities for support presented."12
Recognizing the central importance of "health care outcomes," both the evaluation exercise and this broader examination of the issues have purposely focused on concerns surrounding the qualitative issue of EPI health care outcomes and effectiveness. However, it became readily apparent in the evaluation of the Program that--due to the absence of base line data on any sample of the recipients, let alone the additional need for a comparable control group, and the control or monitoring of intervening variables it was not really possible to proceed with any accurate or verifiable determination of health care outcomes (i.e., to establish a cause and effect relationship) for EPI.
This need to provide verifiable measurement of a program's health care outcomes appears to be pervasively deficient throughout most health programming directed to the Developing World. The implications of this general deficiency to the specific measurement or determination of EPI effectiveness, remains a serious one, and will be addressed more thoroughly at later points in this report.
UNICEF'S GENERAL EPI STRATEGY AND STATED ACHIEVEMENTS
In a UNICEF sponsored research study on immunization coverage conducted in Thailand in the mid 80's, the following general observation is made:
[The] immunization programme has been proven to be an efficient, and relatively inexpensive method of disease prevention in both developing and developed countries. In the last decade, we have seen an increase in immunization usage, public acceptance, improved delivery techniques and more stable vaccines. The more extensive use of vaccines has resulted in a dramatic decrease of many leading communicable diseases in all parts of the world. However, this condition is by no means true in developing countries where most of the vaccine preventable diseases like diphtheria, pertussis, neonatal tetanus, poliomyelitis and measles remain to be a serious health menace among infants and children in these countries."13
The view as expressed here--during the early stages of this project--provides a fair representation of the rationale behind UNICEF'S resolve to proceed with its universal disease eradication drive, via vaccine induced immunization. (It is of no passing interest that WHO and UNICEF sponsored literature, such as above, now embody a new nomenclature, in which one does not refer to preventable diseases, but more precisely "vaccine preventable diseases" thus tending to convey the unsubstantiated conclusion that such diseases are only preventable through the use of vaccines.)
In UNICEF's Fourth Progress Report on this project issued in 1989, it was affirmed that, "Impressive progress has been made towards the achievement of Universal Child Immunization (UCI). Immunization coverage has been increased and the incidence of immunization diseases reported has reduced." This achievement was reported as taking place despite such persistent obstacles as: insufficient "awareness and knowledge among health officials and community leaders;" inadequate "availability of vaccines and cold chain in remote areas;" and the problem of "drop-out due to ignorance, distance, and fear of side effects."
On the basis of structured and semi-structured interviews in five provinces, five districts, and nine villages visited, the following facts came to light:
* The EPI component objectives were comprehensively and successfully implemented, exceeding the original numerical targets
* EPI was reported as the "only activity that is implemented and recorded entirely by government (health) officials"
* All parents had been informed that: immunization was an effective, and essential life-guarding measure, and although it could result in fever or a minor rash for their infants, this should be expected as normal (a small price to pay for the benefits received); and that otherwise the procedure was very safe and should pose no cause for fear or alarm
* The most commonly reported side effect of infant vaccinations
was fever, with village reports ranging from a low of 6% of infants immunized to "99%." (Rashes were the second most commonly reported side effect)
* Fever reducing drugs are either routinely administered to vaccinated infants, or administered on request of parents (however, one village did report the effective use of water instead of drugs to reduce fever), and
* Sisaket province reported that "rare" cases of post-vaccination shock have occurred, attributing this to vaccinal "overdose." Surin province reported that there were cases of post-vaccination shock in various other provinces, but not in Surin. Such cases were attributed to the vaccine vial not being "sufficiently shaken."
Evidence indicated that the EPI program did not incorporate adequate measures for contraindications pre-screening and post-monitoring.
1. All infants received the vaccines regardless of their weight or nutritional status (only one village indicated that vaccines were not given to infants severely underweight, and only one province reported post-vaccination monitoring of infants under 3 kg).
2. Actual nutritional status assessment does not appear to be conducted on infants (excepting the body weight factor) before administering vaccination.
3. There did not appear to be any procedural requirements for checking family histories to determine whether there existed any history of neurological disorders before administering vaccination.
The official view historically held and still articulated by the World Health Organization (WHO) is that both the provision of screening for contraindications, and post operation monitoring for adverse reactions are uncalled for in the context of Developing World EPI campaigns. The underlying rationale has been that the life saving benefits of EPI so far outweigh any risks, that attention to potential risk factors and the potential for vaccine induced damage in vaccinates remains impracticable, and thus a non-issue.14
Despite this unqualified optimism, according to information provided by CIDA's Health and Population Directorate sector, the WHO effective October, 1990, instituted a policy for "adverse event monitoring" in Developing World Immunization activities. A definitive policy statement on this issue titled Monitoring of Adverse Events Following Immunization, has been available since April 1991. (The implications of WHO's recognition of the significance of this issue in setting UCI/EPI research, monitoring and evaluation priorities should be apparent.)
It is thus important to point out that there is by no means a consensus on this issue within the Bio-science community (including the inconsistencies exhibited in the public pronouncements, and policies of the WHO). In one of the most recent scholastic manuals available on immunization practice, noted authority, George Dick--Professor Emeritus of Pathology, London University--provides the following cautions relative to the traditional assumptions of the WHO:
* Before considering immunization it must be determined that the disease in question is of sufficient severity, frequency or other importance to justify immunization against it. Furthermore, "if the infection is readily treatable, there is seldom justification for immunization."
* "immunization is indicated only when the classic methods of control are [demonstrably] impracticable or unsuccessful."
* Before any vaccine is introduced "there must be good evidence that the vaccine is effective and relatively safe . . . Sufficient time has not yet elapsed to predict with any certainty the durability of immunity with the live virus vaccines, which are now in common use, such as poliomyelitis, measles . . . [etc.]"
* "The best type of active immunization follows a clinical or subclinical natural infection. With many diseases this often gives lifelong protection at little or no cost to the individual or to the community."
* The pre-immunization era declines in infectious diseases "should make one careful in attributing changes in the epidemiology of some diseases to the result of a specific treatment or immunization."15
He further confirms that in the following conditions, the EPI vaccine as noted should not be administered. (Obviously pre-vaccine screening measures must be in place in order to ensure that these guidelines are met.) Dick's recommendations follow on Table A.
TABLE A -- GUIDLINES FOR CONTRAINDICATIONS SCREENING Diphtheria acute febrile illness (fever)
(pertussis) acute febrile illness
a history of seizures, convulsions or cerebral irritation in the neonatal period
any neurological defects
any severe local or general reaction to a previous dose of pertussis
"Children whose parents or siblings have a history of idiopathic epilepsy or neurological defects require careful assessment as to the advisability of imunization."
Polio acute illness including diarrhoea, or other (OPV) acute intestinal dysfunction
anyone on corticosteroids or immunosuppressive therapy
Measles acute febrile illness
immune mechanism deficiencies
anyone on corticosteroids or immunosuppressive therapy
Hodgkin's disease and leukaemia, or other diseases of the lymphoid, or mononuclear phagocytic (reticuloendothelial) system
Preliminary PHC and EPI research conducted for CIDA's Evaluation Division indicates as well that vaccines should not be administered to children who are suffering from malnutrition due to associated immunodeficiency problems (of which--inter alia--chronic infections are symptomatic). However, the official WHO position on this point is that "Fever, respiratory tract infections, diarrhea, and malnutrition should not be considered as contraindications to immunization." This is based on the relationship between immunodeficiency status and increased risk of natural infection.16, 17, 18 (For a cross-sampling of other reference sources which support a counter-view to the WHO stance on immunodeficiency and contraindications to vaccines, please see ref.18)
The Project's failure to address this issue--in a responsible manner--has undoubtedly caused some very real harm, when only good was meant, as the following shows.
A CASE HISTORY
Upon completing the briefing session with a large contingent of Surin provincial and Northeast regional health officials--at which the chief provincial spokesperson confirmed that although post-vaccination shock was a problem in other provinces, there were no known cases being reported in his province evaluation team members departed for their respective village destinations. Upon entering the village of Kanjarong, in the Chom Phra district (only 35 miles distant from the provincial capital) in company with the UNICEF Integrated Services Project Monitor, we encountered and met with the village Head Man and the Deputy Head Man.
In the course of the interview, the Deputy Head Man, with some intensity explained that his own son had experienced what he considered as very serious damage as a result of immunization. The Project Monitor and I returned the following day, at which time we both interviewed the mother and observed the affected child during the interview. As a result of this more careful and thorough interview, the following facts of the case were ascertained:
* Up to the age of 3 months the infant had been breastfed. Breastfeeding was terminated by the mother due to a diagnosed thyroid deficiency, per the "doctor's" request. She subsequently began feeding him powdered milk, supplemented by egg, meat, and white rice. The use of fresh fruit and vegetables in the infants diet remained very marginal.
* At the age of 8 months the infant was taken in for his final DPT (triple antigen) vaccine. He almost immediately went into what was diagnosed and described as a state of "shock," for which he was duly treated by a physician. As well, a whole series of serious problems began:
1. chronic sleeplessness
2. high fever
3. unbroken colds and runny nose continuing over several months
4. unbroken crying (except when held) for a period exceeding 2 months
5. in the eleven months following the vaccine (the child at time of inter-view was I year 7 months) there appeared to be severely impaired weight and growth developments.
Although cognizant that this case history could be construed (and in turn dismissed) as a rare anecdotal occurrence that was only coincidental to the administration of the triple antigen vaccine, after careful thought I've decided to included it in some detail for three basic reasons:
I. evidence suggest that for multiple reasons--as noted throughout this document--such adverse reactions are likely to be taking place at a significantly greater level than is popularly believed;
II. a calm, intelligent and caring mother's direct experiential observations and hindsight about her child represent a fully valid and trustworthy source of information; and
III. overall, the clarity and force of the evidence was such that the child's reaction was clearly more than a mere coincidence, and thus not attributable to other direct causes. (As well there is clear evidence suggesting that the occurrence and severity of adverse reactions to vaccines--among infants--correlate proportionally to both lack of breasffeeding, and Vitamin C deficiency (e.g., see refs. 17 & 18).
The following comments should be made with respect to points (a)-(e) above:
* The evidence of unabated infections suggests general impairment of the child's immune system, i.e., vaccine induced immune malfunction.
* The unbroken crying (its unfortunate that children under the age of one can't verbally explain the nature and extent of their distress) suggest the possibility of permanent nervous system damage. (In observing the child walk about, it was visibly evident that his general motor functions and coordination were impaired.)
The reported growth stunting effect was also visibly obvious, as the child appeared to be at most the size of a one year old. (In that impaired growth is generally not identified in the literature as a vaccine related or induced hazard, this condition may well have been principally related to other factors bearing on the child's nutritional intake and or assimilative capacities.) The mother reported that his weight at birth was 4 kilos (a very heavy baby by Thai standards) and at 5 months, 9 kilos. At the time we visited--though now I year and 2 months older--his weight was unchanged, still at 9 kilos.
It is also worth noting that the mothers three month old grandson, who was present during the interview, had been experiencing high fever, and continuous colds since having received recent inoculations. Given that I visited only 9 out of over 900 participating villages, and then only raised this issue with a fraction of respondents, poses serious concern as to just how widespread and serious the problem of adverse side effects is.
It is known for instance that when mass immunization programs were enforced in Australia's Northern Territory among what was a generally malnourished Aboriginal population (the most notable concern being Vitamin C deficiency) death rates doubled, in some areas approaching 50 percent i.e., "Every Second Child." According to the author of a book by that title and veteran physician to the Aboriginals A. Kalokerinos:
A health team would sweep into an area, line up all the Aboriginal babies and infants and immunize them. There would be no examination no taking of case histories, no checking on dietary deficiencies. Most infants would have colds. No wonder they died Some would die within hours . . . Others would suffer immunological insults and die later from pneumonia, 'gastroenteritis'or 'malnutrition'.19
In Northeastern Thailand, in the villages visited practically all mothers were breastfeeding, and were to some extent including fresh garden vegetables and fruit in their diets. This in turn provided a fair degree of protection from the kind of severe reactions and mortality just noted among Australian Aboriginals. Nonetheless, it is apparent that there still remains a sizable number of malnourished. To quote C. Guthrie:
Malnutrition seems to be declining in the Northeast... Still, malnutrition is widely prevalent. One does not need to go looking for it. In one school . . . in Don Luang, 50 percent of the children were suffering from one level of malnutrition or another. I found it somewhat disturbing to find that the objective expressed by most officials was restricted to the eradication of 3rd degree malnutrition, in spite of the wide prevalence of 1st and 2nd degree malnutrition.20
It appears that the mass coverage obsession common to UCI and EPI, have run roughshod over the repeated qualifications, and warnings that have been issued against administering vaccines to inimunodeficient infants and children, of which malnutrition is a prime indicator. The fact that a March 1988 Annual Report on this Project (p. 5) indicated that a WHO/UNICEF review team found that EPI "drop out rates were high, because of the fear of side effects as expressed by mothers," suggests that the prevalence of vaccine induced complications and morbidity in Northeast Thailand, may well be more significant than heretofore thought. (The broader question and implications of vaccine induced morbidity and mortality will be examined in more detail, later in the report.)
The rationale behind administering multiple vaccines and toxoids throughout the first 14 week period of an infant's life (excepting measles) is that in the first year of life--when the immune system is still relatively immature--a child is considered more susceptible to most infectious diseases. However, this view fails to admit the corollary that the immune and nervous systems of infants, are immature thus making them potentially more vulnerable to the toxic effects of vaccines and toxoids.
Nonetheless, the argument is commonly raised that vaccines must be administered in accord with the recommended schedule," (particularly in the Developing World), as the risk of dangers is so marginal, and the dangers of widespread and unchecked infectious diseases so great that the infant must have the vaccines--or else. Of course this view is acceptable only insofar as the multiple beliefs surrounding UCI/EPI are valid, i.e., that there are no better disease preventative measures; that the presence of such infections cannot be safely handled or treated; and that vaccines are both highly effective and very safe.
The current WHO recommended schedule vaccination follows: At birth BCG (Tuberculosis) and OPV-0 (Polio--Live Oral, Trivalent)
6 weeks DPT#L (Diphtheria Toxoid; Pertussis/Whooping Cough; and Tetanus Toxoid) and OPV#L
10 weeks DPT#2 and OPV#2
14 weeks DPT#3 and OPV#3
9 months Measles
It is instructive to consider the experience of Japan in this regard. Delay of DPT immunization until 2 years of age in Japan has resulted in a dramatic decline in adverse side effects. In the period of 1970-1974, when DPT vaccination was begun at 3 to 5 months of age, the Japanese national compensation system paid out claims for 57 permanent severe damage vaccine cases, and 37 deaths. During the ensuing six year period 1975-1980, when DPT injections were delayed to 24 months of age, severe reactions from the vaccine were reduced to a total of eight with three deaths. This represents an 85 to 90 percent reduction in severe cases of damage and death. 21
Although it is obvious that conditions in Japan remain distinctive from that of most Developing World countries, it must be noted that insofar as susceptibility to infectious disease remains greater in lesser developed countries, it clearly follows that susceptibility to vaccine damage will also be proportionally greater. Thus the lesson from Japan carries a valid message relative to the prevention of vaccine damage in Developing World EPI campaigns.
IMMUNIZATION'S IMPACT IN THE DECLENSION OF INFECTIOUS DISEASES
Statistics indicate that over the life of this project, Thailand (and presumably the Northeast region, for which direct figures were not available) has exhibited some degree of declension in childhood infectious diseases (excepting measles) for which immunization has--in recent years--been made generally available. However, it must be borne in mind that prima facie improvement in morbidity levels--in end of itself--falls far short of proving any actual interventional cause and effect relationship for EPI.
Direct discussions with the International Development Research Centre's Health Sciences Division confirms that in selective primary health care activities, such as EPI, there exists "no good base line data from which to measure health care outcomes. SPHC (Selective Primary Health Care) programs in the implementation of EPI appear to ignore this whole issue," Due to the strong and widely maintained assumption that interventions such as EPI serve inextricably and directly as the basis for health improvement outcomes, there has been a general failure since the inception of the first vaccine programs to establish genuinely verifiable evidence for their long term effectiveness, and safety. 22
The general nature of this problem in Selective Primary Health Care activities is well expressed by prominent Medical Sociologist J. Williamson, when he says there has been a failure to "assess explicitly the degree of validity and sufficiency of the evidence linking care structures (facilities, personnel), and processes (what providers do, e.g., EPI) to outcomes of care in general and to health outcomes in particular."23
is largely predicated on the reality that changes in morbidity and mortality in populations are necessarily linked to a whole series of contributive factors." (Noted authority George Dick states that: "Many infectious diseases can be prevented without immunization, because once the natural history of the disease is understood, the source may be eliminated or transmission prevented [e.g.,] . . . . When it was discovered that cholera and typhoid epidemics were regularly transmitted by faecal contamination of water, the provision of clean water supplies nearly eradicated these diseases from many countries without recourse to immunization.")24 It is widely acknowledged that factors such as: nutrition, sanitation, potable water; the natural and social environments (e.g., agricultural practices, food supply, education and income), all play vital roles in determining the onset, severity, and eradication of both infectious and degenerative diseases. Diseases such as cholera and typhoid, have been strongly linked to water and sanitation, whereas evidence continues to accumulate that nutrition remains likely the most critical determinant factor in the full range of infectious and degenerative human diseases.25
The very fact that in this UNICEF project--as in many others--EPI is implemented over a period of years in the midst of a whole series of other natural and basal socioeconomic improvement measures, each having their own critical impact on any population's health status (including epidemicity levels) suggests that EPI could actually be playing a negligible or even a negative role, and no one would really know the difference.
According to the recently completed comprehensive Program Evaluation of the Canadian International Immunization Program--Phase 1, this poses a situation in which the relative impact of expanded immunization programs on mortality levels in the Developing World remain largely unsubstantiated. To quote: "at present it appears that there is no conclusive evidence on the impact of immunization on child mortality from all causes . . . It may be that EPI's effect is merely to bring about "replacement mortality," whereby children . . . succumb to other diseases instead. The uncertainty over the impacts of EPI remain a major question in PHC programming."26
In a similar vein, Debabar Banerji, Chairman of the Centre of Social Medicine and Community Health at Jawaharlal Nehru University raises serious concerns with the UNICEF sponsored Universal Childhood Immunization program in his own nation. He suggests that:
If we turn to the epidemiological analysis of UCI-90 in India, we are astonished to learn that such a gigantic program has been launched without having even the most basic data on infectious diseases . . . Then how will it be possible to determine the cost-effectiveness of the program? Actually, there ought to have been much more detailed analysis. . . .
For example, with regard to disease levels and factors, he urges that very basic questions should have been addressed before implementing UCI, such as: . . . how different are the rates in different parts of the country and what are the ecological, cultural, social and other factors which affect the rates--through influencing the balance between the host, the parasite [i.e., virus or microbe] and the environment. Information should have been provided on what are the trends in the epidemiological behaviour of the different diseases over a time period, what should be the epidemiological strategy for intervention in the natural histories of the diseases, and so on. Paying scant attention to such critical epidemiological considerations, the crusaders of UCI-90 have opted in favor of saturation spraying with "silver bullets " [vaccines]. Over and above this, there are also the important questions of efficacy of the vaccines. . .
Administratively, the exponents of UCI-90 seem to indulge in collective amnesia to wish the bitter experiences of major vertical [top down] programs like the mass BCG Campaign, the National Malaria Eradication Program, and the three [na