Vaccination Risk Awareness Network, Inc.
November 1, 2012 Hand Delivered
Office of the Ombudsman of Ontario
Bell Trinity Square
483 Bay Street, 10th Floor, South Tower
Toronto, ON
M5G 2C9
Dear Ombudsman André Marin and staff,
Re: VRAN (Vaccination Risk Awareness Network) complaint that the Ministry of Health and Long-Term Care fails to ensure that Ontario citizens are adequately informed of their right to exemption from the vaccination requirements as set out in the Immunization of School Pupils Act (Ontario) and the Day Nurseries Act (Ontario). [1]
BACKGROUND
Vaccination is an invasive medical procedure that can cause injury and death. [2] Canadian Medical Law stipulates that full information about all possible significant risks of any invasive medical procedure must be granted and that a candidate or legal guardian of a candidate must understand those risks in order for legitimate consent to be given. Ontario’s Health Care Consent Act adheres to these principles. See section 11.(1) Elements of consent. [3]
The Public Health Agency of Canada affirms that, “immunization is not mandatory in Canada; it cannot be made mandatory because of the Canadian Constitution.” (Reference: Canadian Communicable Diseases Report; Volume: 23S4 – May 1997 – Canadian National Report on Immunization, 1996.)
Ontario is one of three provinces that have legislation governing the vaccination of school children. All three provincial Acts contain legal exemptions for all vaccines required for school entry. There is a widespread problem with mass immunization programs administered throughout the Ontario school system, namely, the belief that immunization is mandatory for school attendance. Immunization campaigns conducted annually in Ontario schools and suspension notices given to students often do not clearly advise students and their families of their legal right to vaccine exemptions for medical, religious or conscientious reasons under the Immunization of School Pupils Act.
STEPS TAKEN TO TRY TO RESOLVE COMPLAINT
In 1999 VRAN enlisted the services of Toronto law firm of Goodman and Carr in an attempt to address our very serious concern that the Ontario Ministry of Health is failing in its duty to adequately inform parents and legal guardians of the availability of exemptions to vaccination for school and daycare entry. You will see by the response from then Chief Medical Officer of Health Colin D’Cunha that not one of our concerns was addressed. Further correspondence with then Minister of Health Elizabeth Witmer also was in vain. [Please see Folder #1 for these documents]
Over a decade has passed since our failed contact with Ontario officials and during that time VRAN has been continually contacted by Ontario parents whose legal rights have been disregarded. [Please see Folder #2 for these documents]
In September 2012 VRAN was contacted by a parent who had received a “Request for Immunization Information” from York Region Community and Health Services via their school. In the 3 pages received by the parent there was no mention of exemptions for the vaccines for the six diseases covered under the Act (Measles, Mumps, Rubella, Tetanus, Polio, Diphtheria). This letter threatens suspension from school if the form is not completed and returned by October 31, 2012. VRAN sent a letter via Priority Mail to York Region Medical Officer of Health and the Chairpersons of the Catholic and Public School boards in York Region outlining the concerns that the information given to parents is lacking necessary information about exemptions – there has been no response. [Please see Folder #3 for these documents]
SCHOOLS
In 2007 VRAN sent letters to all of the Chairpersons of all Education Boards in Ontario (Catholic and Public) and all trustees of the Toronto District School Board regarding Vaccine Exemptions in Ontario Schools. We were asking for the Boards to insure that school officials in their area were “enlightened as to the availability of legal vaccine exemptions for all students in Ontario and that the misinterpretations of the Immunization of School Pupils Act are corrected in your governing area.” [Please see Folder #4 for these documents]
In 2001 VRAN sent a letter to the Chair of the Toronto District School Board in response to a parent’s complaint about an ‘Essential Guide’ distributed by the board that was lacking exemption information. Board Chair Irene Atkinson responded that she would forward out letter to the Manager of Communications and Public Affairs for “her response and to make appropriate changes for future publications.” No further response was forthcoming. As of 2012 the TDSB has some publications that mention exemptions, but others are still telling parents their children have to be vaccinated to go to school. The ‘Newcomer Brochure’ accessed in October of 2012 on their website states that you should bring “Proof of immunization, if available”. The ‘Frequently Asked Questions about Kindergarten’ flyer states that proof of “immunization (the card that shows a list of needles your child has received)” is needed for kindergarten registration. We have also gathered information from other schools across Ontario that fails to mention exemptions and implies that vaccines are mandatory for school attendance. In one Eastern Ontario school board International Students are also being told that there are “Mandatory Vaccines – required for attendance at school”. [Please see Folder # 5 for these documents]
HEALTH UNITS
Many Health Units across Ontario leave exemption information out of their publications and websites. Demand forms are sent out threatening suspension for vaccines like Meningitis C which are not covered under the Act and do no not require an exemption. In 2004 VRAN was contacted by a concerned parent from Cornwall. The Eastern Ontario Health Unit had placed a billboard in town and an ad in the local paper stating that Immunization was “Mandatory for school”. We have enclosed photographs of the billboard and ad. [Please see Folder #6 for these documents]
There is one Health Unit website that we found to be completely informative and it should serve as a template for other Units for their websites and documents. The Niagara Region Public Health’s website explains the exemptions available, links to the exemption forms, and provides clear directions on how to get the form signed before an Ontario Commissioner for Taking Affidavits. [Please see Folder #7 for this document]
We would also like to stress that it seems unfair that parents have to go to such great lengths for their medical choice and many parents must pay for having their exemption forms signed. Notaries can charge $25-$50 plus taxes just to stamp and sign the form, and many municipalities charge a fee as well. We have enclosed a ‘Form 2′ Statement of Conscience or Religious Belief Affidavit for your review. [Please see Folder #8 for this document]
MEDIA
The Media gets most of their information for their articles regarding vaccination and suspensions from school directly from Health Units. We at VRAN have been gathering Ontario media reports that are void of any mention of vaccine exemptions, or are misleading. We have included copies of 85 articles, as well as a summary sheet of these articles indicating why they are a complete failure in informing the public of their exemption rights. It should be mandatory for Health Units to include clear exemption information in their press releases and when they are speaking to the media. [Please see Folder #9 for these documents]
INFORMED CONSENT
How can parents or students (there is no age of consent under the Health Care Consent Act) give informed consent to be vaccinated when the information provided is lacking?
A 2011 study ‘Ill-Informed Consent? A Content Analysis of Physical Risk Disclosure in School-Based HPV Vaccine Programs’[4] that was published in the journal Public Health Nursing concluded:
“Inaccurate, incomplete, and inconsistent information can threaten the validity of consent/authorization and potentially undermine trust in the vaccine program and the vaccine itself. Efforts are needed to improve the quality, clarity, and standardization of the content of written documents used in school-based HPV vaccine programs across Canada.”
That is a stunning admission. The study also states:
“In provincial/territorial school-based vaccine programs, it is common practice to ask students to deliver written documents about the immunizations to their parent(s) or legal guardian(s) and to return completed consent/authorization forms to the school prior to the student receiving the vaccine (Cawley, Hull, & Rousculp, 2010). This practice is thought to be cost-effective and efficient (Cawley et al., 2010). To date, concerns about consent in school-based programs have focused on issues around maximizing return of the consent form, not on ethical issues related to the quality of consents/authorizations obtained (Cawley et al., 2010). There are, however, a number of such issues. For example, in school-based vaccine programs, there may be no direct interpersonal contact between the immunizer and the parent(s) or legal guardian(s) who provide the consent/authorization, and thus limited opportunity to directly ask and receive answers to questions. The written information provided to the parent(s) or legal guardian(s) may differ from the written and verbal information provided to the students at school, at the time when they are asked to deliver the written documents. Additional information about potential harms and benefits may be provided at the time of vaccination, when the parent(s) or legal guardian(s) who have provided consent/authorization likely are not present, which could put the validity of the original consent/authorization into question. These are significant ethical challenges for which there are no easy solutions. An important first step, however, is to ensure that the parents, legal guardians, and students receive accurate, complete, and consistent written information on which they can make an informed choice.” [emphasis ours]
AND THIS STUNNING ADMISSION:
“This review found important discrepancies in the accuracy, completeness, and consistency of information disclosed about HPV vaccine-related physical risks, with respect to both the nature and probability of risks. These discrepancies have a significant effect on the legal validity of the consent/authorization process.
First, for there to be a legally valid consent, all material risks must be disclosed in the consent, it must be free and informed and made by a competent individual with decision-making authority. To be properly informed in relation to risks, the person from whom consent is sought must be told of the following:
the nature of the intervention and its gravity
all material risks (including probability and gravity, grave consequences even if they have a low probability, and what the doctor knows or should know the patient deems relevant)
any special or unusual risks
any alternatives (including doing nothing) and their risks
answers to any questions posed by that person (Peppin, 2007)
On the basis of Table 2, one can reasonably ask which, if any, of the ten provinces were getting valid consents given the variation in risks presented compared to those cited in the NACI evidence-based review of HPV vaccine.” [Emphasis ours]
The discussion ends with this admission:
“This review of available Canadian provincial school-based HPV vaccine program documents demonstrates the failure of the current regionally idiosyncratic and independent approach to providing audience-appropriate, accurate, complete, and consistent information for all Canadians. This failure is particularly concerning in the context of school-based vaccine programs where the information is primarily provided in written form with very limited opportunity for discussion. Ideally the ten provinces, three territories, and national health authorities could work more closely together to develop written documents that will provide parents, legal guardians, and students with appropriate vaccine risk and benefit information. This will help ensure that valid consents/authorizations are obtained, especially for school-based vaccine programs such as HPV. Furthermore, having accurate, complete, and consistent vaccine-related information would help the general public make a better informed decision regarding immunizations especially when confronted by controversial magazine articles such as that written by Gulli (2007), that may not specifically disclose all the physical risks and benefits associated with the HPV vaccine.
Given that many countries are now considering wider use of influenza vaccine, including school-based programs (Cawley et al., 2010) there is international relevance for the points raised in this review concerning accuracy, completeness, and consistency of information for decision makers who are not present at the time of vaccination. Thus, other countries may also do well to assess the accuracy, completeness, and consistency with respect to physical risks in documents they use to inform the consent/authorization process (particularly in school-based programs) across their countries.
For all vaccine programs in Canada and abroad, clear vaccine risk and benefit disclosure is recommended to avoid confusion, promote the integrity of the consent/authorization process, and build trust in the vaccine program and the vaccine itself. Further research initiatives that help clarify vaccine risk language into best practice guidelines to help ensure that accurate, complete and consistent consent/authorization forms are available for school-based immunization programs are warranted.” [Emphasis ours]
We are also enclosing in the Informed Consent folder an article from Durhamregion.com from June of 2012 entitled ‘Vaccine a sore spot for Whitby teen’. The article describes the terrifying adverse effects experienced by Kaitlyn Armstrong from the HPV vaccines she received at school. The article states, “…..she’s still left with questions, like why she was able to get the vaccine in the first place? ‘When it came to allergies, I even told them,’ she says of the nurse on the day she received the vaccine, adding her mother had noted her allergy on the consent form.” … “School boards must approve the information packages before they go home, and Ms. Armstrong feels they should include more information on possible severe side effects. She has also created a Facebook page called Kaitlyn’s Journey to fight back against post Gardasil syndrome.” Clearly Kaitlyn and her mother were not given enough information to have given fully informed consent to this vaccine.
Our Informed Consent folder contains the 2-page information sheets provided by the Ontario government for the HPV vaccine – this is titled “Human Papillomavirus (HPV) Vaccination Program for Grade 8 Females: What you need to know”. We would like you to compare those sheets with the manufacturer’s package insert for Gardasil, which has 30 pages and covers Contraindications, Warnings and Precautions, and Adverse Reactions.
We have also included York Region’s information sheets for Adacel vaccine for you to compare it to the 26 page package insert. Parents should be advised where they can access these package inserts in the material given to them to sign their informed consent.
Also included is an e-mail exchange from 2005 when the Halton Region Health Department falsely stated on their website that the Meningitis C vaccine was required before students can be admitted to “many” colleges and universities. You can see from the e-mail exchange that this statement was false. How many children and parents consented to this vaccine thinking the vaccine was mandatory to get into college or university? Information sessions for Hepatitis B vaccine and Meningitis C vaccine (Grade 7) and HPV vaccine (Grade 8) are given in schools without the parents being invited to attend. Glitzy videos (see http://vimeo.com/12489927 ) are shown to the students to encourage vaccination.
On pages 152-153 of her book, Immunization, History, Ethics, Law and Health, Catherine Diodati, M.A. describes a school based immunization program: “The Assembly-line nature of mass immunizations precludes individual attention: the essential factor underlying informed consent. Furthermore, in this scenario, the family physician, who is most familiar with the particular individual, is excluded. … “Generally speaking, accurate and thorough information is unreasonably difficult to obtain. Due to this incredible general lack of disclosure, truly informed consent is not remotely possible.”
Many parents are unaware that their children can be vaccinated without their permission at school. Under the Health Care Consent Act (HCCA) the health professional providing the treatment determines that the person is capable of consenting to a medical treatment. We have included a copy of the ‘Consenting to Immunization At School-Based Clinics’ flyer from Durham Region that states, “If a student arrives at a school-based immunization clinic without the signature of a parent/legal guardian on his/her consent form, the nurse must determine the student’s capacity to provide consent. If the student is capable of providing consent, the nurse will proceed as the student wishes.”
In 2010 a Bowmanville boy with autism spectrum disorder was charged with “threatening” because of an outburst after realizing he was going to be getting a hepatitis B vaccine at school. The police were called and the 12 year old boy was taken into police custody and kept in 17 Division in Oshawa overnight. A Toronto Sun article stated that the school principal sent home a letter to parents that included, “While Durham Health Department nurses were here giving students their required immunizations, one of the students became upset.” Wait a minute – REQUIRED IMMUNIZATIONS?? The hepatitis B vaccination is not a required immunization! An exemption is not required for the Hepatitis B vaccine as it is not a disease covered under the Act. A clear case of school personnel misinforming parents. What message did this send to the other children waiting in line for their shots? Take the shot or else you’ll be taken away by the police and thrown in jail! Also, why couldn’t this boy refuse the vaccine under the Health Care Consent Act?
The criminal charge against the boy was withdrawn in August of 2011, when Durhamregion.com reported that “the boy entered into a peace bond.”
[Please see Folder #10 for all of the above “informed consent” documents]
WHY DOES INFORMED CONSENT MATTER?
As we stated in the first paragraph of our complaint – as much as health officials and some doctors refuse to admit, vaccines can and do cause severe injury and death. We have included in this folder data from VAERS (US Vaccine Adverse Event Reporting System), lawsuits from other countries, personal stories, and information regarding Canada’s adverse event reporting system for your review. [Please see Folder #11]
OTHER GOVERNMENTAL AGENCIES
Even though it is outside the scope of the Ombudsman’s office, we also provide you with evidence that the federal government neglects to tell parents that vaccine exemptions from “required” vaccines are available. See “Is my child required by law to be immunized? In some parts of Canada, children are required to have all of their immunizations up-to-date before starting school. Laws vary in different provinces and territories.” (Page 11 A Parents Guide To Immunization, Public Health Agency of Canada). [Please see Folder # 12]
REMEDY SOUGHT
From the original 1999 Letter from lawyer L. Stoltz to the Chief Medical Officer of Health for Ontario:
To redress its very serious concern that the Ontario Ministry of Health is failing in its duty to adequately inform parents and legal guardians of the availability by statute of exemptions to otherwise mandatory vaccination requirements, VRAN seeks:
amendment of all publications and other information disseminated by the Ontario Ministry of Health regarding vaccination requirements to provide information about the availability of statutory exemptions to vaccination requirements that is accurate, comprehensive, easily understood, unambiguous and readily noticeable;
issuance of a direction (i.e., by letter or informal guideline) under your name as Chief Medical Officer of Health to all medical officers of health in the Province, requiring that they take immediate steps to ensure that their own publications and information regarding vaccination requirements and those of all school boards and schools within their territory, provide information about the availability of statutory exemptions to vaccination requirements that is accurate, comprehensive, easily understood, unambiguous and readily noticeable;
Design and implementation of an effective strategy to communicate accurate and comprehensive information as to the availability of statutory exemptions to vaccination requirements to all family physicians and paediatricians in Ontario;
inclusion in the Mandatory Health Programs and Services Guidelines issued pursuant to section 7 of Health Protection and Promotion Act of a clear requirement that all publications and other information disseminated by boards of health regarding vaccination requirements provide information that is about the availability of statutory exemptions to vaccination requirements which is accurate, comprehensive, easily understood, unambiguous and readily noticeable; and
amendment of section 38(2) of the Health Protection and Promotion Act to expressly require that physicians (and other persons authorized to administer immunization agents) and school principals advise parents and legal guardians of the availability of statutory exemptions to vaccination requirements and of the process of securing their informed consent as (such an amendment may be analogized to section 22(7) of that Act which provides that an order by the medical of health under section 22 “is not effective unless the reasons for the order are set in the order” and other comparable sections in the Act).
It is essential, of course, that this information be included in all publications directed to parents and legal guardians of newborns and infants, and not just to parents and legal guardians of school-aged children as it is in the first year of life that these difficult decisions are made.
FURTHERMORE (October 2012):
For fully informed consent to be obtained, parents should be advised in writing on the consent forms that there is no vaccine injury compensation in Ontario. If their child has a devastating vaccine injury or death they are on their own.
Parents and students should be directed to where they can obtain a copy of the manufacturer’s package insert for the vaccine they are giving consent to. These inserts include Contraindications, Warnings and Precautions, and Adverse Reactions so parents and/or students can be fully informed of all risks and benefits.
All Health Units should have clear and concise information regarding vaccine exemptions on their websites with links to the printable copy of Form 2 Affidavit with instructions on how to complete the form and where they get the form notarized. [See Folder #7 for a good example]
It should be made mandatory for Health Units to include clear exemption information in their press releases, print material, videos and when they are being interviewed by the media.
The Ontario Ministry of Health and Long Term Care should, at the very least, have a link to the “Form 2” exemption form on their website ‘Immunization: Your Best Protection.’ Links to manufacturers package inserts should be available as well. [Please see Folder # 13]
With appreciation for your time and attention to this matter,
Sincerely,
Rita Hoffman Edda West
Vice-President VRAN Co-Ordinator VRAN
Enclosures:
Folders # 1 through 13 [Contact info@vaccinechoicecanada.com for further information regarding enclosures]
[1]
Immunization of School Pupils Act R.S.O. 1990
http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_90i01_e.htm
Immunization of School Pupils Act R.R.O. 1990, REGULATION 645
http://www.e-laws.gov.on.ca/html/regs/english/elaws_regs_900645_e.htm
Day Nurseries Act
http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_90d02_e.htm
[2] Please see Folder # 11 – Why Does All of This matter?
[3] Health Care Consent Act
http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_96h02_e.htm
[4] Ill-Informed Consent? A Content Analysis of Physical Risk Disclosure in School-Based HPV Vaccine Programs” – Public Health Nursing (2011)
http://onlinelibrary.wiley.com/doi/10.1111/j.1525-1446.2011.00974.x/full
Update August 2015 – We have not received anything in writing from our Ombudsman Investigator. VRAN board members did have a teleconference with Ministry of Health Officials on February 24, 2014:
VRAN-MOHLTC Teleconference Notes (pdf)
VRAN-MOHLTC Teleconference Follow-up (pdf)
Vaccine Choice Canada continues to receive complaints from parents regarding lack of exemption information in materials regarding vaccination in Ontario, and media reports continue to leave out exemption information.