Byron M. Hyde, M.D., Chairman Incorporated as a charitable foundation in the USA & Canada.
In North America, Telephone (613) 728-9643 FAX (613) 729-0825
383 Danforth Avenue, Ottawa, Ontario, Canada K2A OE?
In the United States
602 State Street, Box 310, Ogdensburg, New York, 13669, USA
In the United Kingdom
12 Cooper Gate Close, Nafferton, Driffield, North Hunberside, England, Y025 OLX
October 6, 1994
Nightingale raises two questions:
(1) the cost, need and safety of the Hepatitis B immunization program starting this month in Ontario and Quebec,
(2) did officials in what was then called Health and Welfare Canada, act independently when they decided not to examine and test the multiple reported cases of individuals in Ontario and Quebec many of whom were significantly damaged by Hepatitis B immunization, some slightly damaged, some seriously damaged and two possible deaths or did they act with authority of the Conservative Government of the time. Also why did they move to create the impression to the press, Canadian physicians, Public Health Officials and to the public that they had thoroughly examined these individuals when they had not and that Hepatitis B immunization was safe for all persons?
Cost: Beginning this month with grade 7 students, the Government of Ontario is instituting a mass program of Hepatitis B inoculation that will eventually include all school children in the Province. The Nightingale Research Foundation estimates that the eventual cost to immunize those presently in school will exceed 396 million dollars in the Province of Ontario alone and over a $1,000,000.00 (1 billion) in Canada. Whether we consider the Ontario estimate or the Canadian estimate this is a significant amount of money at a time when health care and social benefits are being slashed by both Federal and Provincial governments across Canada.
Need: How do we know that our children need Hepatitis B immunization to ensure their safety when there are no Health Canada or Statistics Canada figures of any significant number of Canadian born children having ever died as a result of Hepatitis B infection?
Safety: Is Hepatitis B immunization safe for school children when it appears it was not safe for a large number of health care workers in the Province of Quebec? Some of the chronic problems that developed in these health care workers were muscle weakness, memory loss, chronic headaches, chronic exhaustion, and in a few cases permanent blindness; one case of total deafness and at least one death.
(A) The USA and Canada enjoy the position of being two of the countries with the lowest incidence of Hepatitis B in the world.
(B) Almost all Hepatitis B deaths in the USA are confined to the following high risk groups.
- I.V. street drug users,
- male homosexuals with multiple partners,
- individuals already infected with HIV/AIDS,
- elderly refugees and immigrants from Africa and the Orient,
- individuals who have received multiple transfusions,
- sexual partners of the above groups.
Why Experiment With Canadian School Children?
Canadian school children clearly do not belong in the above high risk patterns. Of the one in approximately 250,000 who dies in Canada every year of Hepatitis B, we believe that almost all come from the above high risk categories.
(C) Public health funding and the gathering of Hepatitis B statistics in Canada during the federal Conservative regime were insufficient to answer even basic questions on the danger of Hepatitis B in Canada and so no comparable and consecutive figures of such high risk groups exist in Canada.
(D) Nightingale is a public charity that attempts to assist Canadians who are disabled with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome / Fibromyalgia Syndrome (M.E/CFS). We have little in the way of funds to assist adequately a fraction of these disabled patients. When we began to receive considerable complaints from health care workers of significant CNS injury secondary to Hepatitis B immunization, we gave this information to Health and Welfare Canada since they were well funded and able to investigate these complaints thoroughly. Not only did they fail to examine and to test these patients properly for CNS and other damage, Health and Welfare Canada announced to the Canadian public, to physicians across Canada and to Canadian Public Health Care officials that they had fully researched this complaint.
(E) We believe that Health and Welfare Canada did not actually examine a single one of these Hepatitis B immunization disabled patients, did not run a single test, did not do any brain function examination, did not have their physicians do a hands-on examination of any of these 57 patients.
Nightingale believes that these 57 cases and another 3 patients given to Health and Welfare Canada may be the tip of the iceberg.
Although Nightingale believes that Hepatitis B immunization is a generally safe product for most individuals, we know that in some individuals it appears to have been a catastrophe. As concerned Canadians we would like to know why so many were injured? Why, until this complaint is properly examined, should Canadian school children be exposed to a similar potential injury?
Nightingale accuses Health and Welfare Canada in that they did not properly investigate the complaints of Hepatitis B immunization injured patients.
Nightingale accuses Health and Welfare Canada of not keeping sufficient or proper statistics on Hepatitis B in Canada to safeguard properly the public to the real dangers of Hepatitis B. Because of the failure of the above two measures,
Nightingale accuses Health and Welfare Canada of placing Canadian children in possibly dangerous, useless and costly jeopardy with the mass immunization Hepatitis B programs.
Nightingale accuses Health Canada of not putting in place a proper indemnity package to reimburse those Canadians already injured by Hepatitis B immunization and any future injured patients.
Nightingale accuses Health Canada, the Provinces of Ontario and Quebec, of not adequately targeting the high risk groups in their respective provinces to prevent the spread of Hepatitis B. Nightingale believes that were those individuals in high risk groups properly attended to, the already very low risk of Hepatitis B in Canada would fall even lower.
The Nightingale Research Foundation has neither mandate, nor funds to properly investigate those individuals damaged with Hepatitis B immunization. This is the responsibility of Health Canada. We raise this public health question so that an informed opinion on the possible darker side of the question of safety of Hepatitis B immunization can be made.
This material has been given to the Office of the Hon. Bob Rae, the Premier of Ontario, The Hon. Ruth Grier, the Minister of Health of Ontario, Melody Morrison in the Premiers office, repeatedly since May 30, 1994 and we have received no reply except on Sept. 16, 1994 a letter over Bob Rae’s signature stating the matter had been referred to Ruth Grier’s office.
The 396 Million Dollar Experiment
At a time when the Canadian public is faced with millions of dollars of cutbacks in essential health services, some provinces are not only wasting millions of dollars in questionable practices but have embarked upon what may well prove to be a dangerous health experiment with the nation’s children.
Summary of Events Concerning Nightingale’s Ongoing Research of Adverse Events Associated with Hepatitis B Vaccine
The information contained in this document is in an active file and is updated as new information becomes available. Nightingale is a charity that employs volunteers, some of whom are disabled. Nightingale operates on a very restricted budget without funding from any provincial or federal grant, and we apologize for any difficulties in this documentation that arise from this lack of funds. This updated document was completed in late September, 1994. For those reading this document, we would appreciate any charitable donation to assist our work. A charitable tax receipt will be sent for your donation.
An earlier edition of this document was sent to the Premier of Ontario, The Hon. Bob Rae, the Minister of Health for Ontario, The Hon. Ruth Grier, Melody Morrison, Principal Secretary of the Premier on 30 May 1994. We have received no acknowledgment of these three letters. On September 1, 1994, a letter was mailed and faxed to the Premier and a letter from the Premier was received on the 19 September stating the material had been referred to the Ontario Minister of Health.
(See ADDENDA 28, 29 & 30 for recent information not included in earlier editions of this publication.)
The Nightingale Research Foundation is concerned about the dangers of Hepatitis B infection for those in high risk situations. We are also concerned about the danger of Hepatitis B immunization. We believe it is a medical concern that should be properly investigated and researched.
Nightingale is pro-immunization and believes that any immunization program, properly researched, using stable immunization material, and properly monitored by the government agency concerned, represents a significant public health measure for all Canadians. We endorse all existing Canada-wide mass immunization programs, provided the proper immunization safeguards are enforced. However, we are deeply concerned about the public safety of any mass Hepatitis B immunization program in Canada whether existing or proposed. We are also concerned about Canadian children who are the basis for a Hepatitis B immunization experiment now underway.
The Nightingale Research Foundation is not against the use of Hepatitis B immunization for high risk groups so long as these groups are made aware of the side-effects and are protected in that:
- a universal federal program of reimbursement for immunization damage is in place for those who have sustained chronic disability due to this immunization;
- individuals are properly tested for immune or chronic viral illness prior to immunization;
- it can be shown that the Hepatitis B immunization is stable over time, transportation and temperature variation, and that proper immunization safeguards are maintained;
- the immunization can be shown to have a minimal seroconversion failure,
- it can be shown that apparently healthy, silent and unsuspecting carriers of Hepatitis B virus do not go on to develop liver failure upon immunization, or are exposed to other health dangers as a result of this immunization;
- the federal government undertakes to collect, analyze and report in greater detail, the question of Hepatitis B in Canada. We decry the former federal Conservative government policy of encouraging private business to pay for health information symposia and to be responsible for gathering and presenting Canadian health statistics. We believe that such a withdrawal from responsibility has seriously endangered Canadian public health and ultimately does not represent a cost benefit.
Why the Concern?
The Nightingale Research Foundation was concerned about a large number of patients who reported the occurrence of a chronic disease state after receiving Hepatitis B immunization. Subsequently, largely because of this unresolved issue, Nightingale remained concerned about the proposed provincial mass Hepatitis B immunization program; although apparently safe to most recipients, this immunization appears to have caused symptoms that resemble M.E./CFS in many adults and, in a few cases, permanent neurological damage, blindness, deafness and death. Consequently, Nightingale was concerned not only for the chronically disabled patients noted in this summary and the families of those who have died, but also for Canadian children engaged in this experiment.
Nightingale believes that if Hepatitis B immunization were given to large numbers of Canadian children not otherwise exposed to Hepatitis B, then many of these children would develop the symptom picture of M.E./CFS. i.e., difficulty in creating new memories, failure to recall stored memory, discalculia (loss of mathematical abilities), sleep dysfunction, absence spells (petite mal seizures), visual defects, chronic pain and muscle weakness. The result of this chronic symptom picture could be severe difficulty or failure at school, and due to chronic brain and physical dysfunction, failure to obtain employment and simply failure to enjoy the benefits of good health throughout life.
Unlike other previous Canadian mass immunization campaigns, the proposed Ontario government program of non-selective Hepatitis B immunization appears to be based simply upon fear, promoted by pharmaceutical corporation sales pitches and by Canadian physicians who have largely relied on statistics provided by the pharmaceutical industry.
There is almost no significant Canadian government statistically based epidemiological information on the need for Hepatitis B immunization. This dearth of information is disturbing. For instance, much is made of Hepatitis B deaths, yet there is reputedly only 1 death per year for every 250,000 Canadians. Yet, Statistics Canada has no sustained ongoing record of Hepatitis B deaths. For instance, neither the sex nor even the major risk group of individuals who have died from Hepatitis B or Hepatitis B related complications is known.
According to a scientific paper published in the Journal of American Medicine (JAMA), the principal USA groups are as follows:
(a) IV drug users (the largest group in the USA),
(b) male homosexual population (the 2nd largest USA group)
(c) chronically ill, aging Asian and African immigrants (3rd largest group)
Relative group risk not known:
(d) health care workers in contact with human blood or fluids
(e) spouse of a Hepatitis B carrier.
Four of the above groups could be selectively immunized at little or no government cost. The chronic Hepatitis B carriers cannot be immunized; yet they may never have been identified. We do not know the risk to these individuals even if they are immunized. With available Canadian information so minimal, it is quite possible that those individuals who fall ill with Hepatitis B and subsequently die (and who do not fall into one of the five above groups,) may be as low as 1 death per 5 or even 10 million in Canada or 1-4 Ontarian deaths per year. The chronic loss of work and subsequent social, health and financial disruption, the outright maiming and even death noted in this very limited study by the Nightingale Research Foundation suggest that the improperly researched mass immunization is a danger to the Canadian public.
We also estimate that the potential cost of immunizing the 9-10 million Ontario citizens against Hepatitis B, medical examinations, health care worker follow-up and maintaining booster and testing for seroconversion at present costs, would exceed 2 billion dollars. If this figure is even partially correct, we believe that even 1 billion dollars is a very high cost to save a potential one or two Ontarians in low risk groups from Hepatitis B death, particularly if more than this number of Ontario citizens may be disabled and even die as a result of the same immunization.
It is important for the reader to understand that there are no ongoing and indepth Statistics Canada figures for any sustained period for Hepatitis B illness in Canada or for the incidence of Hepatitis B in the above mentioned assumed high risk groups. It is not known by any Canadian public health authority whether the reported increased figures for hepatitis B in Canada are not simply a result of increased testing and reporting. Uncirculated Canada Department of Health documents just received through freedom of information suggest that there may not even be an increase in Hepatitis B infection in Canada.
In 1990, Dr. Hyde and the staff of the Nightingale Research Foundation advised Health and Welfare Canada, particularly P. Duclos, DVM and the then Assistant Deputy Minister of Health, A.J Liston, of a large number of Canadians who had incurred severe long term central nervous system disabilities after receiving Hepatitis B immunization injuries.
The Nightingale Research Foundation operates on donations and does and did not have sufficient funds to investigate adequately the patients referred to in this submission. Nightingale felt a moral duty to place these cases in the hands of the Government so that these injured patients would receive proper investigation, care and possibly compensation. The cases mentioned in this document were all turned over to Health and Welfare Canada, either to P. Duclos, a veterinarian in charge of adverse human immunizations for Health and Welfare Canada or to the then Assistant Deputy Minister of Health, J.P Liston. At no time subsequently did Mr. Duclos or the Assistant Deputy Minister of Health inform Nightingale by telephone or letter of the progress of these investigations. Although Health and Welfare has acknowledged our calls and letters, at the time of writing in May-June, 1994, we have yet to be made privy to any details of their individual alleged investigations.
Approximately one year later, Health and Welfare Canada reported to the public, to public health officials, and to physicians that they had thoroughly investigated this complaint and found no basis for Nightingale’s allegations. For reasons that are impossible to comprehend, Health and Welfare Canada appears to have both distorted and avoided the issue of post-Hepatitis B immunization damage. First, Health and Welfare stated that they rejected all patients who did not conform to the USA criteria for Chronic Fatigue Syndrome as a yardstick, thus removing individuals who had suffered blindness, deafness, and even death subsequent to immunization since they failed to comply to the US definition. We never stated that these patients had M.E./CFS.
Secondly, Health and Welfare Canada stated they had received no other reports of Hepatitis B immunization disabilities other than our 57 reports. Yet they reputedly contacted and had thoroughly investigated” 60 of the 69 injured patients, although we gave them only 57 patients. In a subsequent investigation in 1993-4, Nightingale was able to verify that only 17 of the original 57 patients had been telephoned and that not a single patient had been referred to a physician or for any form of investigation. The majority of these patients remain disabled or severely damaged, apparently as a result of Hepatitis B immunization and none of them, to our knowledge, has received compensation.
Health and Welfare Canada, under the previous Conservative government, appears not to have informed the Canadian public and Canadian health officials on the hazards of Hepatitis B immunization. The reason is difficult to comprehend: the interests of Merck Frosst and other Quebec pharmaceutical companies were protected. At the same time, the Conservative Government gave Merck Frosst in Montreal 10 million dollars for a capital expansion program. Merck Frosst is one of the wealthiest pharmaceutical companies in the world.
We believe the introduction of Hepatitis B immunization for children in Ontario is unwarranted; it represents a serious risk; and the problems raised in this document should be addressed before potentially endangering the health and lives of Ontario children.
History of Nightingale’s Involvement with Hepatitis B Immunization
(1) May 1990: Dr. Hyde was contacted by Celine Gaudette, a health care worker of Sherbrooke, Quebec. She had fallen seriously ill after Hepatitis B Immunization, and had to leave work sustaining considerable health and economic disability as a result. She felt that some of her symptoms of brain dysfunction were identical with Myalgic Encephalomyelitis /Chronic Fatigue Syndrome (M.E./CFS)
It is not now nor has it ever been the aim of Nightingale to link Hepatitis B immunization with M.E./CFS but rather to link Hepatitis B immunization with diverse disabling injuries of the central and peripheral nervous system that may appear to the inexperienced eye to be M.E./CFS. We believe it is merely coincidental that some of these injuries resemble M.E./CFS in their elements of brain dysfunction.
(2) May 1990: Dr. Hyde immediately telephoned Mr. P. Duclos, a Doctor of Veterinary Medicine, (in charge of human adverse immunization reactions for Health and Welfare Canada) concerning this case. He told us that Hepatitis B immunization was very safe and there had been no serious adverse reactions anywhere after millions of doses. Dr. Hyde relayed this information to Ms. Gaudette.
(3) June 1990: Dr. Hyde received a second call from Ms. Gaudette informing him she had located four chronically ill post-Hepatitis B immunization cases with sufficiently severe adverse reactions that they could no longer work. Dr. Hyde again telephoned P. Duclos and was told there was no basis for these complaints. This was again relayed to Ms. Gaudette.
(4) August 1990: Ms. Gaudette telephoned and stated to Dr. Hyde that she now had 10 patients displaying post-hepatitis B immunization chronic disabilities and that some resembled M.E./CFS cases. She stated that two nurses and one physician had separately telephoned Merck Frosst in Montreal and that each had been told that he/she was the only person ever to report a serious adverse reaction to Hepatitis B immunization and that he/she must be mistaken.
Ms. Gaudette requested that these 10 patients be examined and Dr. Hyde made arrangements to meet with them and give his opinion. He then telephoned Dr. Alin Prat, Executive Director-Medical Research at Merck Frosst, who stated that the two Hepatitis B immunizations produced by Merck Frosst have been given to millions of people around the world with absolutely no serious adverse reactions. Furthermore you are the first person to contact us with such a report and I assure you that you are mistaken. Since Dr. Hyde was aware of the other 3 calls that were handled in an identical manner, he assumed that Merck Frosst’s policy was to deny any potential product danger.
(5) September 1990: Dr. Hyde went to Montreal and examined 10 chronically disabled post-Hepatitis B immunization patients.
After receiving one or more injections of Hepatitis B immunization, they had developed the following conditions:
- – 1 had developed Myasthenia Gravis;
- – 1 had unrelated brain tumor with features of M.E./CFS;
- – 2 had developed shoulder arm syndrome with nerve involvement;
- – 6 had typical features of M.E./CFS with typical chronic cognitive, sleep, muscle and pain disorders sufficient to disable them from work.
(6) September 1990: Dr. Hyde met with P. Duclos DVM and gave him the above information. P. Duclos told Dr. Hyde that he was sorry he did not have any funds to research such a problem. Also, since these reported cases were in the Province of Quebec, he had no authority to investigate them. He also stated at that time that he was so poorly funded by Health and Welfare that he did not even have a private secretary. Assuming that Mr. Duclos’ remarks were accurate, then this is a sad state of health protection in Canada.
(7) At Ms. Gaudette’s request, Dr. Hyde appeared on a Sherbrooke, Quebec, open line television program and as a result was contacted by more patients from both Quebec and Ontario who claimed to have been unable to return to work since receiving Hepatitis B. immunization. Over 60 post-Hepatitis B immunization injuries are now on file at Nightingale.
(8) September 1990: Dr. Hyde returned to Mr. Duclos and was told again that there was no money to research these cases. Dr. Hyde then asked Mr. Duclos to call a meeting with Merck Frosst, Canada Health and Welfare, and Nightingale staff to discuss the matter. He declined. Dr. Hyde then said that, however reluctantly, he would be obliged to inform the press. Mr. Duclos then said he could arrange such a meeting.
The meeting was eventually scheduled for January 8, 1991.
During the fall, a total of 57 cases found by Ms. Gaudette and Dr. Hyde were turned over to P. Duclos. At that time, P. Duclos stated that his department had received no other post-Hepatitis B immunization complaints of severe or chronic injury.
(9) January 8, 1991: Nightingale, Merck, Health and Welfare Canada group met at Tunney’s Pasture. Dr. Hyde again voiced his concern regarding these 57 post-Hepatitis B immunization patients. Both P. Duclos of Health and Welfare and Dr. Prat of Merck Frosst still denied the existence of any other severe adverse reaction claims. Both Merck Frosst and Health and Welfare Canada refused to investigate. At that same time, Dr. Hyde suggested Health and Welfare and Merck Frosst might investigate these cases. Both groups stated that they would be happy to consider any requests. (These requests were eventually refused.) Aware that the government time to accept or refuse research grants often exceeded one year, Dr. Hyde stated that as a question of public health he would be obliged to go to the press unless Health and Welfare agreed to investigate the 57-case complaint.
A research project of 57 cases of post-Hepatitis B immunization injury was then initiated as a LCDC project headed by P. Duclos. It appears to have been conducted by Dr. Whalen, an epidemiologist at the Laboratory Centre for Disease Control (LCDC). Health and Welfare agreed to report their findings to Nightingale and to keep the Foundation informed. Nothing was heard subsequently by Nightingale from this project.
(10) During the following months, Nightingale continued to collect the names of Ontario and other Canadian and USA patients disabled following Hepatitis B immunization. In addition, Dr. Hyde gave the names of three Ontario residents, who had been seriously injured by Hepatitis B Immunization to the Deputy Minister of Health:
- One, an Ottawa graduate student in Edmonton, developed boils and a high fever immediately after the first Hepatitis B immunization. She then sustained brain injury sufficient to cause permanent blindness and deafness. She has still not recovered.
- Two, a nursing student from the Ottawa area developed permanent central blindness in the left eye after a second Hepatitis B immunization. Dr. Hyde saw both patients and felt there was good evidence that these were Hepatitis B immunization related.
- Three, a nurse, a resident of Oshawa was not seen by Dr. Hyde. According to her husband, this patient had developed boils after immunization as in case (a); she eventually went into a coma reputedly from brain damage associated with the immunization. This could not be verified: the patient was in a permanent coma in Oshawa. But this case too was submitted for follow-up to J.P Liston, Assistant Deputy Minister of Health. (It is important to note that none of these three individuals had the features of M.E./CFS; rather they had sustained severe central nervous system injury.)
(11) September 28, 1991: A research scientist from Merck Frosst visited Dr. Hyde. We agreed to keep his name confidential and regret that we are unable to verify his statements. They are as follows:
- After Merck had bought out Frosst (and their patents), it let go all of the viral research people at Frosst who had worked on the Hepatitis B immunization. At that time, Merck Frosst had no viral or immunization researchers employed in Canada. Only a small group in the USA was concerned with HIV viral research.
- Employees at Merck Frosst were obliged to have the Hepatitis B immunization. The nurse giving the immunization was now partially paralyzed and had lost the use of one of her arms. Some of the Merck Frosst staff were now disabled from what they believe were the effects of this immunization.
- Merck Frosst scientific workers were deeply concerned with the stability of the product. Large numbers of patients who had received either human-derived Hepatitis B or the Hepatitis B yeast-derived immunization had failed to seroconvert. (Failure to seroconvert is potentially dangerous since it can cause the sensitization of patients who are then not immune to Hepatitis B. These sensitized patients may develop severe reactions, if they either contracted wild hepatitis B or after they received further Hepatitis immunization.)
- There was no Canadian government legislation in place to oblige the pharmaceutical industry to reinvestigate any approved immunization or drug adverse reactions.
(12) Sept. 28, 1991: Since by this time no further communication had been received from Health and Welfare and, according to Ms. Gaudette, none of the patients appeared to have been seen, examined or tested by a physician, at its 1991 annual Nightingale meeting, the Foundation issued a press release summarizing the findings detailed above.
(13) Within a week of Nightingale’s press release, Health and Welfare Canada, and LCDC issued a report stating that:
- there is no link between Hepatitis B vaccine and CFS
- they had contacted 60 of 69 people with adverse reactions
- they had eliminated 29 cases as not consistent with CFS
In issuing these reports, Health and Welfare Canada gave the impression to the Canadian public, to Canadian physicians, and to provincial governments that the 57 patients had been completely and fully investigated. In the meantime, the 57 patients in the Health and Welfare file had grown to an unexplained 69. The French language questionnaire used was a multiple choice questionnaire that could not possibly make sense to the dysfunctional brain of an M.E./CFS patient even if the questionnaire were conducted personally. It is heavily weighted with psychiatric wording and is insulting to brain-damaged individuals. It was conducted by telephone, by an English-speaking person with a unilingual French patient suffering from brain dysfunction. The idea of giving this questionnaire on the telephone to the student who had become totally deaf as a result of the Hepatitis B immunization takes absurdity to the limits of incomprehension.
(14) It was as though, having given this information of adverse reactions to Hepatitis B immunization to the government the Nightingale Foundation had become the public enemy. Following these announcements by Health and Welfare, the Nightingale Research Foundation predictably received many complaints from senior physicians and public health officers. The College of Physicians and Surgeons in Ontario eventually criticized Dr. Hyde for bringing this information to light. At the same time, public attention caused a steady number of new cases from Ontario and across Canada to be brought to the attention of Nightingale.
(15) On May 2, 1992 at the Second Annual Immunization meeting in Toronto, concerned over the Hepatitis B immunization controversy, Dr. Roy West of Memorial University stated that regarding the proposed Hepatitis B immunization program, any mass immunization program must be accompanied by a national, non-fault compensation plan; the existing program, he said, in Quebec was adversarial and left little chance for Quebec patients to win a fair hearing. Dr. West added that post-marketing surveillance should be upgraded, since neither the government nor the public was protected due to the present lack of legislation.
(16) In November and December of 1992, a parliamentary committee was formed to examine the Hepatitis B immunization problem. This committee included the Conservative Minister of Health, the then Liberal Health Critic, the Hon. Ray Pagnakhan, and the NDP Health Critic. Dr. Hyde was speaking in Alberta at the time and was asked to speak to the committee in Ottawa, and given only two days notice. This would have required that Dr. Hyde cancel his speaking engagement to approximately 1000 patients in Calgary and fly back to Ottawa at his own expense. The Government was unwilling to pay the cost of transportation and so it was technically impossible for Dr. Hyde to attend. To our knowledge, no individual critical of Hepatitis B immunization was present at these hearings.
(17) P. Duclos claimed to have presented the actual research on these 57-69 patients at the Second Annual Conference on Immunization in 1992, but a summary of this conference obtained in May, 1993, suggests that he did not present any such research. As part of the then Conservative government’s policy to have Canadian industry pay for government conferences, this conference was financed and by Merck Frosst. Dr. Hyde was not invited. To the best of our knowledge, the Health and Welfare research, although commented on in a Health and Welfare weekly report, was never made public.
(18) In June, 1993, Dr. Hyde was told by one of the experts in charge of anti-chemical and anti-germ warfare for the US Government forces in the Gulf War, that many of the Gulf War sufferers never went to the Gulf but were hospitalized after receiving Hepatitis B immunization. One such female soldier remained in a Louisiana hospital, bedridden, for over 9 months with the symptoms of Hepatitis B immunization. The name of this expert is available on a need-to-know basis.
(19) On November 29, 1993, David Ben Nathan, a senior scientist working for the Israeli Government on anti-germ warfare, informed Dr. Hyde that the Israeli military had considerable problems with seroconversion of Hepatitis B immunization and other untoward effects.
(20) In spring, 1994, Dr. Hyde again spoke in Sherbrooke and, at this time, was informed by Ms Gaudette than none of the disabled patients in Quebec had been examined by Health and Welfare Canada and that the majority had remained disabled and unemployed.
(21) To verify this, in May 1994, Nightingale instituted a survey of the original 57 post-Hepatitis B immunization cases in Quebec. Despite the suggestions of Health and Welfare Canada of having exhaustively researched these injured patients, we obtained the following information:
- We were able to find only 17 of the 57 Quebec patients who had even been contacted by Health and Welfare Canada. Neither of the two Ottawa patients who had been injured had been contacted. We had lost track of the Oshawa woman who had been in a coma for months and presumed that she was dead.
- Despite Health and Welfare’s claim that a complete investigation had been made of the 57 cases, Nightingale staff were not able to find a single one of the 57 patients who had actually been seen or referred to a physician by Health and Welfare Canada. Not a single one of these patients had been sent for any testing to evaluate the complaints.
- It appears that the total actual patient research was based on a telephone questionnaire to a few of the 57 patients. Unless the patients were lying to us, and taking account of the inflated government figures from 57 to 69, there could have been no way that 60 of these patients had been contacted as Health and Welfare Canada.
- We were informed by Ms Gaudette that, when Dr. Whalen, the researcher for Health and Welfare Canada, telephoned her and other of the primarily unilingual French-speaking patients, Dr. Whalen was unable to understand the clarificatory questions put to her when the patients could not respond to her questions.
- We discovered that one of the 57 Quebec patients disabled by the Hepatitis B immunization had subsequently died as a result of the immunization, leaving three small children. According to the mother of this health care worker, no government worker or physician had ever investigated her case.
- The majority of the 57 patients still remain too ill to return to work. None, to our knowledge, has been compensated for their injuries.
(22) We cannot explain the considerable discrepancy between the Government Health and Welfare research and our own findings. We contacted Dr. Whalen (who no longer works for Health and Welfare Canada,). She refused our request in May 1994 for an interview.
(23) We requested from P. Duclos copies of his list of 69 names and addresses and the Health and Welfare questionnaires in order to compare this with our list and to verify that 60 of the patients had been actually telephoned. We were informed by telephone by Paula Krupe, of Health and Welfare Canada, that this list of names had been shredded.
(24) We requested from P. Duclos the English questionnaire from this survey. We were informed by telephone by Paula Krupe on May 19, 1994 that this questionnaire had been shredded along with all relevant research material. Despite this, when P. Duclos was away in May 1994, we visited Health and Welfare and were given a copy of the French questionnaire. We do not wish to suggest that there never was an English questionnaire, only that none of the English-speaking Ontario patients or their families appear to have been contacted.
(25) We regularly receive communications from injured post-immunization Hepatitis B patients. On Tuesday, May 24, we were telephoned by a chemist from Bloomington, Illinois, studying the adverse effects of a Hepatitis B immunization disabled patient from California. This chemist informed us that yeast-derived Hepatitis B immunization may be unstable during transport, and may undergo a shift in structure if there is a temperature fluctuation of more than 4 degrees Centigrade. This information has not been confirmed in writing; it apparently originates in a Merck document. We have requested the hard copy of. this original information.
(26) At the present time, Nightingale has on file over 100 separate medical publications outlining adverse reactions to Hepatitis B immunization. This file is growing rapidly.
The Nightingale Research Foundation is concerned that the Government of Canada under the Conservative regime was uninterested in public health and safety. We do not purport to have all of the answers to this complex question; however, we question whether children and adults in Canada should be placed at risk by proceeding with a mass immunization program without Government research to justify the need. We criticize the lack of a universal Canada-wide program of compensation for health care workers and others who have incurred chronic illness resulting from adverse reactions to Hepatitis B immunization.
(27) Addendum: Subsequent to the information noted in the above document we processed a request to Canada Health and Welfare via the Freedom of Information Act requesting release of all intragovernmental documents and communications concerning the reputed Health and Welfare research documented in this paper. Internal government documents that have come back to us as of August 1994 would suggest:
- either the Department of Health and Welfare has destroyed all work conducted on Hepatitis B research, or that little was ever done;
- there has been no progressive increase in Hepatitis B in Canada over the last few years. Therefore, one has to conclude that there should be no urgency in instigating any expensive and rash Hepatitis B program in Ontario, or any province, until we know more about the utility and safety of this immunization;
- some people who have seen this report have noted that the Ontario Government is immunizing only grade seven students and so the cost would be for only one year. However, the Ontario government intention is to ultimately immunize all school students. Estimating the cost of administering the routine 3 injections of Hepatitis B immunization to the 1,983,004 Ontario primary and secondary school students, and calculated to include the cost of the immunization, the federal and provincial staffing, and the physician would total $200 per child. The real cost of such a program for the Province of Ontario would be in excess of $396,000,000.00 that is 396 million dollars.
This estimate does not consider the cost of the following:
- spoilage of immunization material;
- transportation costs;
- the fact that the recipient must then be tested for seroconversion;
- regular re-immunization;
- the cost of any complications such as CNS injuries and death;
- the cost of any potential legal repercussions to the above.
(28) Addendum: We have received, in August and September 1994, separate confirmation from two legal firms in the Province of Quebec that they have commenced actions against the Province for injuries sustained by patients due to Hepatitis B immunization. We believe these cases represent just two of many actions that are pending.
(29) Addendum: In discussions in August 1994 with Claire Grenier of the Human Rights Commission for the Province of Quebec, many persons disabled from Hepatitis B immunization have requested their assistance in obtaining compensation.