Influenza & Nursing Home Deaths

October 31st, 2000

To Our Honourable Members of the Ontario Provincial Parliament, I respectfully submit the following report in response to concerns expressed to me by hundreds of health care workers over the past few months. Many health care workers have contacted me for assistance regarding an influenza vaccine and Amantadine mandate that has been imposed by their employers and which, I understand, will soon be brought to you as a proposal for legislation. As for my qualifications to respond to this issue, I submit the following: In 1995, I graduated with honours from The University of Windsor and was awarded numerous scholarships, bursaries and the Board of Governor’s Medal. I was the first recipient to be awarded the University Windsor Postgraduate Scholarship and Ontario Graduate Scholarship simultaneously. During my post-graduate work, which involved extensive research on vaccination and biomedical ethics, I was afforded the benefit of the expert guidance of:

1. Dr. Dietmar Lage, B.A., M.A., Ph.D. Dr. Lage served as my Thesis Director and contributed his expertise in biomedical ethics. Dr. Donna Foley, Dip. N. Educ., B.Sc.N., M. Ed., R.N., PhD. Dr. Michael Dufresne, B. Sc., Ph.D., an immunologist and research scientist at the University of Windsor and Research Coordinator for Cancer Care Ontario, Region South. Dr. Mahesh Mehta, B.A., M.A., LL.B., Ph.D.

My Thesis committee was integrally involved in all aspects of my research and they were diligent in assuring that my interpretations were accurate and supported. My Thesis, a 300-page document entitled Biomedical Ethics: The Ethical Implications of Mass Immunization, was successfully defended on 17 April 1998 and I graduated with the grade of A+. Since that time, I have published a book entitled Immunization: History, Ethics, Law and Health (Integral Aspects Incorporated, 1999) as well as a number of vaccine-related articles. My research has become well-known very quickly and I have presented my findings at a variety of conferences and seminars, both nationally and internationally, to health care professionals and lay persons alike. Please feel free to contact me with any questions.

Yours Respectfully,
Catherine J. M. Diodati, M. A.

Report on the Proposed Influenza Vaccine and Amantadine Legislation: Concerns for Health Care Workers.

Presented to the Ontario Members of Provincial Parliament

October 31st, 2000

Between 26 December 1998 and 20 January 1999, 25 residents of Central Park Lodge, a long-term care facility located in Kitchener, Ontario, died. An inquest was called in order to determine the extent to which Influenza A was a causative factor, to assess established outbreak prevention and control measures and to propose potential preventive and therapeutic treatments for residents and their care providers. Recommendations made by the inquest jury are of particular interest as they have resulted in enforced vaccination and/or medication of care providers in the absence of supporting studies regarding the safety and efficacy of such measures, without the informed and voluntary consent of the care providers, and without any provision for compensation for those who may encounter adverse events as a result of the immunization and/or medication mandate.

Steps are underway at this time to introduce legislation enforcing these recommendations without adequate exemptions. It is vitally important that our Member’s of Provincial Parliament receive full disclosure regarding the impact of such legislation before this issue is brought to a vote. In 1982, a similar measure was introduced for school children in Ontario. The original Immunization of School Pupil’s Act, which also precluded immunization exemptions, was over-turned 2 years later because the Act violated basic rights and freedoms guaranteed by the Constitution. The amended Act includes exemptions to immunization based upon religious and philosophical beliefs. The proposed legislation mandating influenza vaccination and Amantadine administration, for all long-term care facility workers, would similarly violate the rights and freedoms guaranteed by the Constitution and abrogate safeguards built into the Health Care Consent Act. In the following pages, I respectfully submit specific concerns regarding the safety and efficacy of these medical interventions and the potential conflicts of the proposed legislation with the Constitution and the Health Care Consent Act.

Background

From 26 December 1998 to 20 January 1999, 25 (10.415%) of the 240 residents of Central Park Lodge died. Seven of these deaths were attributable to pre-existing conditions while 18 deaths were attributed to Influenza A (7 confirmed; 11 met case definitions). On December 23rd, 1998, a Christmas party was held at Central Park Lodge which was attended by most residents and staff.⁽¹⁾ The onset of the first resident case of influenza occurred approximately 48 hours later and it is believed that transmission of the influenza virus was facilitated by contacts made at the Christmas party. On December 27th, 24 residents and staff were symptomatic but it was not until December 28th, when another 21 individuals were symptomatic, that an outbreak was recognised.⁽²⁾ Dr. Thomas Wilson, Regional Coroner, noted that interventions to prevent influenza transmission were delayed by 12 hours due to communication deficiencies between the public health laboratory and the health unit staff regarding the results of nasopharyngeal swabs used to confirm the influenza.⁽³⁾ Further frustrating control attempts, was the absence of the Infection Control Practitioner in the facility.⁽⁴⁾ In total, it was determined that 82 residents and 49 staff met the case definition for influenza.⁽⁵⁾ Nasopharyngeal swabbing is not typically done for all persons exhibiting symptoms. Rather, once a few cases have been confirmed, it is common practice to include any cases that exhibit 2 or more symptoms of influenza.⁽⁶⁾ According to Sally Cameron, Infection Control Officer of Central Park Lodge, of the 82 residents who exhibited symptoms, 28 received NP swabs, 11 of which were positive for Influenza A.⁽⁷⁾ Of these 11 positive resident swabs, 7 were from the individuals who died during the outbreak. Four nasopharyngeal swabs were done for staff and 1 of the 4 was positive for Influenza A.⁽⁸⁾ Of those exhibiting symptoms, for whom swabs were done, there were 13.41% of residents with confirmed influenza A and 2.05% of staff. It should be noted that there are already measures in place for staff to remain off of work while ill with a communicable illness. Participants in the Central Park Lodge Inquest presented their verdict on 22 September 1999 with 25 recommendations for the prevention of influenza transmission and outbreak control. While many of the recommendations made will certainly contribute greatly to the prevention of influenza transmission, there are a few recommendations which are causing great concern to the health care workers affected. These concerns are well-founded, affecting the health and safety of the care providers themselves, and bring to light potential violations of the Canadian Charter of Rights. Since this matter will be presented for legislative consideration, it is imperative that such considerations are addressed before any legislation is decided.

Selected Recommendations of the Coroner’s Inquest and Concerns for Health Care Providers:

Recommendation #1 Provincial legislation should be in place prior to July 1, 2000 requiring residents of LTCF and all staff of those facilities to be vaccinated against influenza annually, prior to flu season unless there is proof of medical contraindications. The legislation should specifically disallow philosophical objections and include monitoring and enforcement elements. (emphasis added)

1) Legislation requiring annual influenza vaccination for LTCF (long-term care facility) residents and staff specifically disallowing philosophical exemption has no foundation in either provincial or federal law. In 1982, the Immunization of School Pupil’s Act was introduced in Ontario requiring vaccination of school pupils without exemption. This Act was amended in 1984 to include religious and philosophical exemptions based upon violations of the Canadian Charter of Rights and Freedoms. Relevant excerpts from The Constitution Act, 1982:

1. Fundamental Freedoms
2. Section 2 [Freedom of Religion, Speech, Association]Everyone has the following fundamental freedoms:(a) freedom of conscience and religion;(b) freedom of thought, belief, opinion and expression, including freedom of the press and other means of communication
3. Legal Rights
4. Section 7 [Personal Integrity]Everyone has the right to life, liberty, and security of the person and the right not to be deproved thereof except in accordance with the principles of fundamental justice.
5. Section 12 [No Cruel Punishment]Everyone has the right not to be subjected to any cruel or unusual treatment or punishment.
6. Section 15 [General Equality, No Discrimination] ⁽¹⁾ Every individual is equal before and under the law and has the right to the equal protection and equal benefit of the law without discrimination based on race, national or ethnic origin, colour, religion, sex, age, or mental or physical disability.⁽²⁾ Subsection (1) does not preclude any law, program or activity that has as its object the amelioration of conditions of disadvantaged individuals or groups including those that are disadvantaged because of race, national or ethnic origin, colour, religion, sex, age, or mental or physical disability.

Comments on Recommendation #1

The proposal to specifically disallow refusal of influenza vaccination or Amantadine administration based upon reasons of conscience or religious belief categorically violates the basic freedoms and rights guaranteed by our Constitution. Under the current proposal, those individuals wishing to refuse such medical interventions are being denied the opportunity to protect their health by determining which substances will enter their bodies, avoid unwanted and personally unnecessary medical interventions that may pose personal health risks and to retain their gainful employment or live within a LTCF.

Recommendation #18

In advance of flu season, the LTCF prepare a list of staff who have not been vaccinated against influenza, and who will need to be prescribed Amantadine or excluded from work in the event of an influenza A outbreak, to ensure timely implementation of this control measure. (emphasis added)

Comments on Recommendation #18

The interventions proposed cannot be defended in the same way that enforcing treatment for communicable diseases can be defended. In this case, the individuals are not posing a threat of disease transmission because they are not already infected with a communicable disease. There is no clear and present danger that requires immediate recourse. It is unconscionable to invade the bodily integrity of any individual against their will on the presumption that they might contract an illness that may pose a health-threat to others. Allowing long-term care facilities the authority to decide access to LTCF resident spaces or to suspend (without pay) or halt employment of healthy workers constitutes cruel and unusual treatment that is not supported under any other venue. Further, since many LTCFs utilize an Attendance Management System, allowing employers to fire employees on non-punitive grounds for absences, the economic coercion inflicted by the vaccine/Amantadine mandate extends well beyond the period of suspension during any given influenza outbreak. Measures to ensure that ill workers do not report for work until they are again well should be sufficient.

Recommendation #24

The College of Physicians and Surgeons should remind physicians of sections 26 and 34 of the Health Promotion and Protection Act. Physicians should be encouraged to comply and urged to encourage all of their patients and especially health care workers to get flu shots. Physicians should be encouraged also to live by the motto “if you can’t say something positive, don’t say anything” regarding flu vaccine. (emphasis added)

Comments on Recommendation #24

This recommendation contravenes the basic trust between patients and their physicians. If our physicians are effectively silenced regarding their concerns over this, or any other, medical intervention, the health of their patients will be placed in peril based upon the whims and agendas of those promoting specific medical interventions.

Sections 10(1) and 11 of The Health Care Consent Act, 1996 states:
10.(1) A health practitioner who proposes a treatment for a person shall not administer the treatment, and shall take reasonable steps to ensure that it is not administered, unless,

1. (a) he or she is of the opinion that the person is capable with respect to the treatment, and the person has given consent; …

(a) he or she is of the opinion that the person is capable with respect to the treatment, and the person has given consent; …

1. 1. The consent must relate to the treatment.
2. 2. The consent must be informed.
3. 3. The consent must be given voluntarily.
4. 4. The consent must not be obtained through misrepresentation or fraud.

(2) A consent to treatment is informed if, before giving it,

1. (a) the person received the information about the matters set out in subsection (3) that a reasonable person in the same circumstances would require in order to make a decision about the treatment; and
2. (b)the person received responses to his or her requests for additional information about those matters.

(3) The matters referred to in subsection 92) are:

1. 1. The nature of the treatment.
2. 2. The expected benefits of the treatment.
3. 3. The material risks of the treatment.
4. 4. The material side effects of the treatment.
5. 5. Alternative courses of action.
6. 6. The likely consequences of not having the treatment. (emphasis added)

1. The purposes of this Act are,

1. (b) to facilitate treatment, admission to care facilities, and personal assistance services, for persons lacking the capacity to make decisions about such matters;
2. (d) to promote communication and understanding between health practitioners and their patients or clients; …

It would seem that patients are guaranteed proper disclosure but, if the recommendations take force, and the College of Physicians and Surgeons utilize their authority to impel physicians to vaccinate their patients, while restraining the serious concerns of these physicians regarding universal vaccination, our health care system will have become a fraud. In fact, it will have become much like a dictatorship that promises democratic theory but fails to deliver in practice. There is no medical intervention that legitimately subscribes to the “one-size-fits-all” philosophy. Diminishing the free discourse between a physician and patient opens the door to behaviors that have been effectively condemned by international ethical codes, such as the Nuremberg Code and the Declaration of Helsinki. Safety and efficacy issues associated with any medical intervention must be addressed for each individual and consent provided freely and with adequate disclosure.

Serious Questions Regarding the Safety and Efficacy of the Influenza Vaccine

Vaccine Efficacy

The influenza vaccine has been demonstrated to be of questionable efficacy based upon past experience. In the case at hand, 220 (91.67%) of the 240 residents of Central Park Lodge received the influenza vaccine, only 3 of the 18 deaths were amongst unvaccinated individuals. All of the residents of Central Park Lodge had received Amantadine. Although complete details are unavailable, at least 161 (78.15%) of 206 staff members were vaccinated (132 prior to the outbreak; 29 following the outbreak of influenza) and 29 staff members received Amantadine. With 91.67% of residents and 78.15% of staff having been vaccinated against influenza A, and 100% of residents having received Amantadine, questions concerning vaccine-efficacy must be addressed.

The method for determining which 3 influenza strains used in the vaccine depends upon guessing which strains will circulate in the forthcoming flu season. This is done primarily by assessing which strains appeared in the previous season and which strains have been most prevalent in other parts of the world. Sometimes there is a relatively good match between the vaccine and circulating strains, as was the case during the 1999 influenza season which affected Central Park Lodge. Frequently, however, there is little correspondence between the vaccine strains and circulating strains. The vaccine strains used for the 1997/98 flu season, for example, matched a mere 16.2% of isolates studied by the Laboratory Centre for Disease Control.⁽⁹⁾

Influenza vaccines, at their best, can claim no better than a 30-40% efficacy rate amongst individuals >65 years of age. When immunity is conferred, it will wane within 6 months in those <65 years and in #4 months in those >65 years of age. In other words, the flu season lasts approximately 3 months longer than the expected immunity rendered by the vaccine. Even if the vaccine and circulating strains correspond, there is little support for enforcing influenza vaccination. The recommendation for vaccination of health care workers stems from a 1997 study conducted in Glasgow.⁽¹⁰⁾ In this study, which itself admits to methodological flaws (e.g. reporting bias, etc.), it is stated that:

1. The numbers of patients with virologically confirmed influenza [(5% for both types A and B)] was therefore small, and it was not possible to demonstrate the presence or absence of an association between nonvaccination of HCWs [(Health Care Workers)] and virologically proven influenza among patients. Therefore we do not have any direct evidence that the reductions in rates of patient mortality and influenza-like illness that were associated with HCW vaccination were due to prevention of influenza.⁽¹¹⁾

…and later…

1. Most cases of influenza-like illness in long term care are due to other pathogens, such as coronavirus, RSV, rhinovirus, and adenovirus, all of which can cause pneumonia.⁽¹⁾

Vaccination of health care workers is clearly based upon a belief that they are a primary source of influenza transmission and that vaccination will prevent primary infection from health care workers to their patients. The study used to support health care worker vaccination is itself inadequate to demonstrate any real correlation of this sort. Since most influenza-like illnesses, which are virtually indistinguishable from influenza without testing, are caused by other pathogens, can we suppose that forcing health care workers to accept vaccine-related risks is justifiable?

Vaccine Safety

The safety of the influenza vaccine presents serious questions. Dr. Hugh Fudenberg, who is perhaps the most published and quoted immunogeneticist in the world, presented findings which indicated that those who receive 5 consecutive influenza vaccines, increase their chances of developing Alzheimers by ten times in comparison with individuals who have 1, 2, or no influenza vaccinations due to the vaccine’s aluminum and thimerosal (mercury) content.⁽¹³⁾ Although the Canadian vaccine does not contain aluminum, it does contain thimerosal, a known neurotoxin.⁽¹⁴⁾ This leads to 3 important questions: how many of our LTCF workers will necessarily lose their quality of life and become LTCF residents due to enforced vaccination and the subsequent onset of Alzheimers or other serious adverse events; who will be left to care for them; and, can our health care budget support the additional expenditures required for their care? The influenza vaccine, like most other vaccines, has not been tested for its effect on reproduction. Are there factors affecting fertility; are there teratogenic effects? Some studies (and vaccine package inserts) indicate that the vaccine increases HIV viral replication, indicating that the vaccine has a significant suppressive effect on the immune system. The vaccine has also caused a significant number of side effects and adverse reactions. At least 30% of recipients can expect some sort of reaction. These reactions range from mild, e.g. fever, malaise, tenderness at the injection site, and influenza-like symptoms, to more serious events such as Guillain Barré Syndrome, Transverse Myelitis, facial paralysis, encephalitis, encephalopathy, demyelinating diseases, fatalities, and et cetera.⁽¹⁵⁾ These significant health risks have not been disclosed to the health care workers prior to vaccination. It must be noted, however, that their consent forms included a release of responsibility should adverse events occur. Enforced vaccination, lack of disclosure and this general abandonment of culpability is, to be sure, a severe violation of the Constitution and the Health Care Consent Act.

Amantadine

Amantadine is a drug typically used to treat Parkinson’s Disease. This drug is also currently being proposed for influenza type A outbreak-management in LTCFs. Amantadine’s drug monograph⁽¹⁶⁾ includes information confirming embryotoxic and teratogenic effects in both laboratory rats and rabbits, the extent of which appears to be dose-related. There are no adequate, controlled studies determining the risk to pregnant humans. Amantadine is expressed in human milk but safety data for nurslings has not been established. The drug may increase seizure activity in epileptics and it has been associated with:

1. nausea, dizziness…insomnia… depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue. [Other symptoms include:] congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, visual disturbances, including puctutate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy. [Further, this drug can cause] leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes … and suicide attempt, suicide, and suicide ideation.⁽¹⁷⁾

This drug clearly presents significant risks to both the individuals taking it and to those in their charge who are dependent upon the care-giver’s mental, emotional and visual stability and acuity. Based upon the questionable safety and efficacy of the vaccine and Amantadine, these measures should not be forced upon either residents or long-term care facility workers. Each Canadian citizen, without exception, has the right to freedom of conscience and the right to life, liberty and security of the person, which certainly must include accepting or refusing any preventive medical treatment. Health care workers, in addition to the risks posed by these medical interventions, are also facing suspension or dismissal for their refusal, constituting cruel and unusual treatment. Additionally, if private physicians are to remain silent regarding their serious concerns, then their value will be diminished. This would set a serious and negative precedent if our physicians were to become mere puppets for pharmaceutical company interests and were estranged from the true interests of their patients.

It is with great respect that this information has been presented to you, our representatives in Provincial Parliament, and with great hope that you will not allow such medical mandates to become law.

Notes

1. Thomas Wilson, “Verdict Explanation: Central Park Lodge Inquest, n.d., 9. Please note, there is no information indicating whether visitors also attended the Christmas party.
2. Ibid., 4.
3. Ibid., 4. Dr, Wilson has made recommendations to improve communication efficiency between the involved parties.
4. Ibid.
5. Letter written by Naideen Bailey, Manager, Communicable Disease Programs for the Regional Municipality of Waterloo, to Linda Loder, dated 3 May 2000.
6. Telephone conversation between Dr. Tom Wilson and Linda Loder in reply to faxed inquiry sent 10 April 2000.
7. Fax to Linda Loder from Sally Cameron, dated 21 February 2000.
8. Ibid.
9. Health Canada, “1997-1998 Influenza Season: Canadian Laboratory Diagnoses and Strain Characterization,” Canada Communicable Disease Report 25 no.2, 15 January 1999.
10. J. Potter et al., “Influenza of Health Care Workers in Long-Term-Care Hospitals Reduces the Mortality of Elderly Patients, Journal of Infectious Diseases 175 (January 1997): 1-6.
11. Ibid., 3f.
12. Ibid., 4.
13. Dr. Hugh Fudenberg, speech presented at the NVIC International Vaccine Conference, Arlington, VA, September 1997.
14. Aluminum is present is many vaccines, as it is considered to be one of the safer adjuvants, so exposure is virutally guaranteed. Thimerosal has a cumulative effect so there is no reassurance in the fact that each vaccine contains only a small amount of the preservative. Thimerosal is included in the vaccine to prevent contamination but it is considerably more toxic to white blood cells, and particularly to phagocytes which are the immune system’s first line of defense, than to microorganisms that might contaminate a vaccine. Thimerosal is particularly destructive to brain, kidney and liver cells and it is associated with chromosome damage, depletion of zinc in the brain tissues, systemic poisoning, genetic defects and it has been implicated in autoimmune pathology. Recently the FDA banned the use of thimerosal in over-the-counter drugs since its safety and efficacy have not been established. Cf. Catherine Diodati, Immunization: History, Ethics, Law and Health (Windsor, ON: Integral Aspects Incorporated, 1999), 69ff.
15. It must be noted that our VAERS (Vaccine-Associated Adverse Event Reporting System) is based upon passive (voluntary) reporting and, even then, if the person administering a vaccine subjectively decides that a particular event is not vaccine-related, the event will not be reported. Only about 1/10 of the 4,000-5,000 reported adverse events in the country are investigated, so it is virtually impossible to support claims of vaccine-safety because reporting and investigative strategies are completely inadequate. Although Ontario does require adverse event reporting, approximately 99% of those who have contacted me, regarding adverse events to any vaccine, state that no report was submitted on their behalf.
16. The incidence of the above adverse events range from 10%-<0.1%. It should be noted that suicidal tendencies have developed in both patients with and without a prior history of psychiatric illness. Cf.   http://www.mentalhealth.com/drug/p30-s05.html (link no longer accessible)
17. Ibid.
18. Catherine Diodati may be contacted by Email at:  diodati@mnsi.net