VIA REGISTERED MAIL AND E-MAIL
December 12, 2016
The Honorable Jane Philpott
Minister of Health
House of Commons
Ottawa, Ontario K1A 0A6
The Honorable Eric Hoskins
Minister of Health & Long-Term Care
10th Floor, Hepburn Block
80 Grosvenor Street
Toronto, Ontario M7A 2C4
Dear Ministers Dr. Philpott and Dr. Hoskins,
Re: PENTA 5 in 1 vaccine injected into babies in Canada (except Manitoba) from 1994 to 1997 and its relationship to the epidemic of anaphylaxis in children and young adults
I could not let another New Year go by without writing heads of government to ensure that the sordid history of the PENTA vaccine is recorded in your correspondence archives.
According to the SickKids Foundation, anaphylaxis to foods is affecting approximately 300,000 children and their families in Canada. It is unsure whether this estimate includes the first wave of the epidemic that included my son, who is now an adult at 23. What was the difference between his vaccination schedule and his mildly allergic sister 6 years older? While our daughter received the polysaccharide Hib – on its own – at the age of 18 months, our son was in the first wave of children to receive various conjugate Hib vaccines (adjuvanted) concurrent or combined (PENTA 5 in 1) with the DPT-IPV in infancy. The scientific literature is clear …. Vaccines can cause anaphylaxis.
Since the introduction of concurrent administration of DPT-P + haemophilus influenza B conjugate in infancy in 1993 there has been a dramatic increase in life threatening chronic children’s health conditions including anaphylaxis. In 2008, then Prime Minister Stephen Harper announced additional funding (for a total of $5 Million) for the MedicAlert Foundation’s No Child Without program including free medical bracelets for children. Stunningly, the press release states:
“In Canada, the number of children suffering from afflictions such as allergies, asthma, or childhood diabetes, is ever increasing. Critical conditions (e.g. asthma, various allergies) sometime require urgent medical attention by paramedics and/or doctors. It’s estimated that one in 10 Canadian children have severe allergies, asthma, diabetes, epilepsy and other conditions that can be life-threatening if emergencies are not treated properly and promptly.”
That was in 2008. I would hope that you and every other doctor, government and public health official in this country would find it unacceptable that 1 in 10 children in Canada live with life threatening conditions, and would leave no stone unturned to find out WHY. While a single measles case can cause pandemonium, the numbers of these affected children continue to rise without any alarm bells. What is being done by government and health officials, other than throwing money at MedicAlert bracelets, to address the epidemic of life threatening conditions in children?
Parents of children affected by food anaphylaxis and/or autism have spent numerous years and countless hours investigating why our children are affected with such severe immune system and brain malfunctions. The PENTA Project investigations have revealed that the PENTA 5 in 1 combination (1994 – 1997) did not have a DIN # or a Notice of Compliance rendering it illegal according to Health Canada. 11,000+ adverse events, including deaths, were reported to PHAC for the PENTA combination over the three years that PENTA was in use. You may request PHAC ATIP reports A-2013-00096 and A-2013-00097 to view all of this data, which is too large to upload to a website. All subsequent 5 in 1 vaccines including Pentacel and Pediacel are based on this illegal combination, putting into question all vaccine schedules since 1994.
Access to Information requests over many years to all levels of government including requesting PENTA licensing information provided scant information, and Ontario, Canada, and local health unit ATIP responses did not acknowledge that the PENTA combination existed at all!
Parents like me have scoured the medical literature to find scientific proof of a vaccine connection to anaphylaxis. The website http://www.deadlyallergy.com resource and science sections outline some of that literature. The book The Peanut Allergy Epidemic, What’s Causing It and How to Stop It by Canadian Historian Heather Fraser MA, BA, B.Ed. details the history of the whole sordid mess. Mrs. Fraser’s book is fully referenced, and should be read by every doctor, nurse, politician, health official and parent.
Heather Fraser contacted her Member of Parliament, Nathaniel Erskine-Smith, on June 27, 2016 with a “Request for an investigation into the unlicensed PENTA vaccine & its long term consequences” that was sent to you, Health Minister Philpott, on Heather’s behalf. The extensive binder of evidence, memory stick with the full file of PENTA adverse events, along with a copy of the book, The Peanut Allergy Epidemic, never received a response or even the courtesy of an acknowledgement. Minister Philpott, what happened to this material, and when are you going to respond to Heather Fraser?
I will send any recipient of this e-mail a copy of Heather Fraser’s book upon request in hopes of SOMEONE finally addressing the long term health effects experienced by the recipients of the PENTA vaccines and children continuing to be affected by the epidemic of anaphylaxis.
Surprisingly, the Canadian Medical Association Journal published my letter in 2004: http://www.cmaj.ca/content/170/4/437/reply#cmaj_el_942 which includes some information on the PENTA saga prior to our knowledge of this vaccine combination being illegal:
“After retrieving the lot numbers of the vaccines given to my anaphylactic child I sent in an Access to Information request to Health Canada for 1) the 100% composition of the vaccines my child received and 2) a list of vaccine adverse events reported for the 8 lots he received. Health Canada can’t provide me with a 100% composition because it’s proprietary information. For the adverse event information I was asked to pay $600 down and $1200 in fees. This information, from 1993-95, was not on a computerized database – why wasn’t it?
After waiting a year and paying only for photocopying, I received the data from Health Canada. I had to manually count the 975 reactions: death, seizure/convulsion, dysopnoae, speech disorder, allergic reaction, adenopathy, hypotonic-hyporesponsive episode, severe pain and/or swelling, screaming episode, hypokinesia, persistent crying, severe vomiting and/or diarrhea, lethargy, fever, cyanosis, rashes, eczema, pneumonia, lymphocytosis, sterile abcess/nodule/necrosis, infective abscess, tachycardia, gait abnormal, ataxia, bulging fontanelle, sepsis, vaso-vagal reaction, tremor, arthritis, cellulitis, bradyapnoea, delirium, reduced consciousness, shaking, somnolence, anaphylaxis, apnoae, encephalopathy, asthma, injection site reaction, shortness of breath, and confusion.
Repeated attempts to get an explanation as to why one particular lot was able to rack up 664 reactions (including 34 seizures/convulsions) without being pulled from the market have gone unanswered by local and Ontario health officials, officials with Health Canada and participants of IMPACT. Also unanswered: The National Report on Immunization, 1996 states: “If the number and type of reports for a particular vaccine lot suggested that it was associated with more serious adverse events or deaths than are expected by chance, the federal government has the responsibility and will, as well as the legal authority, to immediately recall that lot.” The U.S. Centers for Disease Control considers a vaccine “hot lot” one that generates reports of more than two deaths or two convulsions or a total of 10 adverse reports. Health Canada officials reported an investigation should be initiated after a “cluster of reports” and that means “3 or more.” This being the case the majority of vaccines my child received should have been recalled? Why weren’t they?
Another of the many unanswered questions is “How do you determine whether the adverse event is attributed to the DPT-P or the Hib when they were both given at the same time, and now in the same syringe? Could anyone provide me with safety studies relating to the DPT-P and Hib being given concurrently, and whether IgE levels were tested pre and post vaccination?”
To make matters worse, my recent Access to Information request for a product monograph, including studies that the licensure was based on, for the 5 in 1 “PENTA” (whole cell pertussis, DTPolio combined with Hib) vaccine that Health Canada supposedly licensed in 1994 and my child received in 1995 was answered with “After a thorough search for the requested information, no records were located which respond to your request.” The “PENTA” vaccine is not even listed in the Compendium of Pharmaceutical Specialties for 1993, 1994 or 1995.
The United States FDA never approved the 5 in 1 PENTA, and the FDA waited until 2008 to license the acellular pertussis version of PENTA called Pentacel. The FDA approval document for Pentacel lists “several items of concern” … this with a vaccine that had been injected in Canadian children since Pentacel was rushed in to take the place of PENTA on July 1, 1997.
As stated above, the Toronto’s SickKids Foundation reports that there are 300,000 children in Canada living with life threatening food anaphylaxis. Are they including the children who received the PENTA vaccine who are now adults? We don’t know. Clearly, anaphylaxis continues to affect children at epidemic proportions in this country.
To not mention the vaccine connection to allergy (as shown in the medical literature) prior to vaccination means that parents do not have fully informed consent to vaccination. Now that Ontario is intent on changing the legislation of the Immunization of School Pupils Act to require an “education session” prior to a parent filing an exemption, the province must ensure that fully informed consent is given. I would suggest that until such time that concrete causes of anaphylaxis are found that “vaccines are not tested for their potential to cause allergic disease” must be included in any informed consent discussions with Ontario parents and children prior to vaccination. For that matter, until such time that the cause of cancer is found, a statement such as “vaccines are not tested for their potential to be carcinogenic or mutagenic” (see Section 13) must also be included.
Informed consent, according to the Health Care Consent Act in Ontario:
Elements of consent
- (1) The following are the elements required for consent to treatment:
- The consent must relate to the treatment.
- The consent must be informed.
- The consent must be given voluntarily.
- The consent must not be obtained through misrepresentation or fraud.
and must include:
- The nature of the treatment.
- The expected benefits of the treatment.
- The material risks of the treatment.
- The material side effects of the treatment.
- Alternative courses of action.
- The likely consequences of not having the treatment.
Members of the National Advisory Committee on Immunization (NACI) and vaccine decision makers in upper levels of provincial and federal governments should not be allowed to have any Conflict of Interest with any pharmaceutical company. Of the current NACI Chair and Vice Chair (voting) and the 10 voting members 11 out of 12 have indirect or direct conflict of interest. This is unacceptable. According to this Conflict of Interest report the IMPACT network, which is supposed to monitor vaccine injury in this country, is conflicted! (See Wendy Vaudry) ….. “YES …Co Primary Investigator of the IMPACT Network – which is partially supported by grants from Industry (Novartis, GlaxoSmithKline, Sanofi)” This is an outrage! No wonder I never heard from any of the IMPACT participants after pleading for them to look into anaphylaxis in 2002!
I request a reply with your suggestions on how to put a halt to this epidemic of anaphylaxis. At the very least, children exhibiting any form of rash or other allergy symptoms should have their vaccinations delayed or offered in individual (one at a time) vaccinations in fractioned doses to prevent the development of severe allergic disease (this was done in the past, see History section of deadlyallergy.com ). Sadly individual doses of infant/toddler vaccine are no longer available. 5 or 6 in 1 and 3 in 1 combination vaccines are the only choices for parents now. Is there any wonder parents are worried when the vaccination schedule begins at 2 months with 7 or 8 different vaccines in 5 or 6 in 1 combinations (depending on the province) at one “well baby visit”?
Dedicated to Pierre Morin, Penta Project parent, who died in October of 2010
Rt. Honourable Justin Trudeau, Prime Minister of Canada email@example.com
Honorable Kathleen Wynne, Premier of Ontario firstname.lastname@example.org
Dr. Barbara Law, Chief Vaccine Safety, PHAC
Dr. Richard Schabas, MOH, HPE Public Health
Dr. Lynn Noseworthy, MOH, HKPR District Health Unit
Dr. Monica Naus
Dr. Brian Ward
Dr. Kumanan Wilson
Dr. David Williams Chief Medical Officer of Health, Ontario
Dr. Gregory Taylor
Dr. John Spika, Senior Medical Advisor to the Assistant Deputy Minister of the Infectious Disease Prevention and Control Branch
Dr. Scott Halperin
Dr. David Scheifele
Dr. Ron Gold
Dr. Philippe De Wals
Dr. Pierre Dery
Dr. William Albritton
Marie Adèle Davis, Executive Director, Canadian Paediatric Society
Dr. Allan Becker
Dr. Kelly Moher, Gateway Community Health Centre
Dr. Alex Hukowich (retired)
Dr. Granger Avery, President, Canadian Medical Association
Food Allergy Canada
Vaccine Choice Canada
The Penta Project
My reply to Minister Philpott’s letter linked above dated February 13, 2017
Subject: In response to your correspondence / 16-013578 – 522 – ss
Date: Mon, 13 Feb 2017 17:09:19 -0500
From: Rita Hoffman <email@example.com>
To: Jane.Philpott@parl.gc.ca, Minister_Ministre <Minister_Ministre@hc-sc.gc.ca>
CC: firstname.lastname@example.org, Heather Fraser, Vaccine Choice (Canada)
Dear Health Canada / Minister Philpott,
Thank you for the correspondence from Minister Philpott dated February 8, 2017 (attached) 16-013578 – 522 – ss regarding my letter dated December 12, 2016 regarding “PENTA 5 in 1 vaccine injected into babies in Canada (except Manitoba) from 1994 to 1997 and its relationship to the epidemic of anaphylaxis in children and young adults” which was sent to Minister Philpott via E-mail and also via Registered Mail. This letter can be read here: http://deadlyallergy.com/2016/12/penta/
My correspondence may have been confused with Heather Fraser’s package of information sent to Minister Philpott via Heather’s Member of Parliament, Nathaniel Erskine-Smith in the summer of 2016, who is cc’d on my correspondence (attached). Mr. Erskine-Smith is not my Member of Parliament. The title of Heather Fraser’s Binder of information was “Request for an investigation into the unlicensed PENTA vaccine & its long term consequences” and she included a copy of her book The Peanut Allergy Epidemic, two CDs with over 25,000 pages of AEFI reports made by doctors documenting adverse reactions and injuries in children who had been vaccinated with the PENTA vaccine.
My letter from the Minister states “enclosed copy of The Peanut Allergy Epidemic”. I never sent a copy of The Peanut Allergy Epidemic to Minister Philpott, though I did offer to send her a copy upon request, as stated in my December 12, 2016 letter. Can you please advise if these two different correspondences were confused as I did not send the Minister a book and my MP is not Mr. Erskine-Smith?
Also, I am very disappointed to read information in your attached letter that is contradictory to what is known as the law in Canada. The PENTA vaccine 5 in 1 combination did NOT have a DIN #, which is required for licensing of a vaccine product in Canada. You state, “No safety concerns were identified that warranted any action regarding the PENTA Vaccine”. You must not have read my letter or you would have NEVER have said this, as my child’s lot # received hundreds of reported injuries and NOTHING was done. It’s time to acknowledge that Canadian children were, in fact, guinea pigs between 1994 and 1997, and it’s time to launch an investigation as Heather Fraser requested many month ago to ensure that this travesty never happens again in this country.
I look forward to your reply at your earliest convenience.
——– Forwarded Message ——–
|In response to your correspondence / 16-013578 – 522 – ss|
|Wed, 8 Feb 2017 11:28:58 -0500|
Please find attached a response to your correspondence sent to the Minister of Health.
To view this file you will need Adobe Reader – http://get.adobe.com/reader/
(See attached file: 16-013578-522 FINAL.pdf)