Celsius42 TCS (Tumour Cell Solution) Inquiry
CFI Canada was recently copied on correspondence sent to MP Rona Ambrose of Health Canada. This correspondence certainly caught our attention which we provide (an edited version) here for your information:
I am seriously concerned over the use of localized hyperthermia devices in Canada to treat cancer. There are a number of EU companies that are marketing their devices here in Canada. They are being heavily promoted by naturopaths.
One of the devices is actually registered with the Device Branch and is called the EHY-2000. I have no idea how this device was approved for sale in Canada. There is no information on the MDALL database as to its intended or approved use, or whether there are any limitations on the claims that can be made.
As it turns out – Health Canada indicates that the Celsius TSC device was authorized under the “Special Access Program” and is not listed on MDALL. There are, according to Health Canada, three scenarios for authorization of sale of medical devices in Canada: 1) issuance of a Medical Device Licence 2) authorization of a custom-made device or a device to be imported and sold for Special Access. These are offered on a case-by-case basis for treatment of s specific patient 3) Medical devices sold for clinical trials involving people. Our member continues to research and inquire about these devices:However, after digging around for other hyperthermia for cancer devices in Canada, I found an even more interesting device that almost looks the same as the EHY-2000. It has recently been promoted by a Weyburn, Saskatchewan naturopath in a large newspaper article that actually shows the device.
The article is attached here: Naturopath Clinic home to new technology in cancer care – Local News – Weyburn This Week
The owner of the clinic is Toby Bridgman and his email is weyburn.naturopathic@gmail.com
His web site: www.drtobybridgmannd.com
Since Health Canada has not approved the device, and they don’t regulate naturopathic physicians in Saskatchewan, how in the world can he use this device? Where did he take training to use the TCS device? Who monitored the use of the device once it cleared Canadian Customs? Was it labeled a Class 3 device like the EHY-2000?
The German company Celsius42 has a web site for your review: http://www.celsius42.com/product.html
A link to their brochure: http://www.celsius42.com/PDFs/Celsius42_Brosch_EN.pdf
They do not have a distributor in North America except in Mexico. It is not approved in the U.S. as far as I can tell. If Health Canada was involved in this approval to import and use the device, where is that information at the Device Branch? If there was an arrangement to allow Bridgman to import this device has this been investigated by anyone at the Ministry of Health outside the Device Branch?
If what he says is true, who approved the importation of this device at the Device Branch? When was it approved? Are there other installations of the TCS device across Canada? If so, are these installations being monitored by the Device Branch?
American Cancer Society …… “Hyperthermia is a promising way to improve cancer treatment, but it is largely an experimental technique at this time. It requires special equipment, and a doctor and treatment team who are skilled in using it. Because of that, it’s offered in only a few cancer treatment centers in the US and Europe”
Canadian Cancer Society…….Because heat can make chemotherapy more effective, sometimes the blood containing the drugs is warmed slightly before it is returned to the limb. This is called regional hyperthermia or hyperthermic isolated limb perfusion or infusion.
National Cancer Institute….. A number of challenges must be overcome before hyperthermia can be considered a standard treatment for cancer
Check back often – we’ll post more information as we pursue this inquiry.Update # 1 – December 19, 2014
A Health Canada representative responded to our member’s inquiry with the following information:Under Section 32(f) of the Medical Devices Regulations, the clinical information required to support a device licence application consists of: (f) a summary of all studies on which the manufacturer relies to ensure that the device meets the safety and effectiveness requirements, and the conclusions drawn from those studies by the manufacturer;
There is no requirement under the Regulations that the clinical study information be generated in Canada. However, the clinical information should be generated according to the principles of good clinical practice, such as are set out under ISO standard 14155, “Clinical investigation of medical devices for human subjects — Good clinical practice”, which is on the Bureau’s List of Recognized Standards
Update # 2 – December 29, 2014
Another CFIC member sent us these comments when learning of our work to inquire into the science behind medical devices used in Canada: It is a good thing that CFI Canada brings up this issue and makes an effort to correct a growing problem. Before I retired…. I worked as a research scientist in the medical devices industry and many years with Heath Canada’s Medical Devices Bureau. In my last position I did quite a few investigations into the safety and effectiveness of medical devices, including fraudulent devices. Unfortunately my findings and recommendations were not always acted upon by upper management, because the number one -unwritten- rule was: “Make no waves”. With regard to bogus medical devices this is exactly where the problem is. It seems that Health Canada will licence for sale any medical device, no matter how fraudulent it may be, provided that the applicant submits the required paperwork and includes a check for cost of the licence. If only Health Canada would go back to doing what it is supposed to do as a Federal regulator and stop issuing licences for fraudulent devices which in themselves may be harmful, suspend licences already issued, and take legal action against those who deliberately violate the Medical Devices Regulations, this problem would soon disappear. The practises of faith healers, exorcists, chiropractors and other modern versions of the old snake oil salesmen could also be addressed in a similar manner. After all, it is against the law to practise medicine without a licence. All that has to be done is: Enforce the law. Politicians and other lawmakers, enforcement agencies, and last but not least the press should be contacted about this growing problem. Although I have been out of the field for several years, many of the things that I learned still apply today. Meanwhile Health Canada’s Medical Devices Bureau has closed its laboratories (Research and Standards Div.) where problems with Medical Devices were investigated. We did very good work but our efforts were not always appreciated by the civil service management.Update # 3 – December 29, 2014
a Regulatory Information Officer from Health Products and Food Branch of Health Canada has provided the following information:Information provided to Health Canada by manufacturers is subject to the provisions of the Access to Information Act. Application information containing trade secrets or confidential scientific, technical, commercial or financial information is protected from disclosure by this Act. According to the Therapeutic Products Directorate’s policy, information regarding device licence applications that have been received or are being processed is also considered confidential. Once a licence has been granted, basic information about a device, such as that listed in section 32(1) of the Regulations, is considered public information. Any other information is made available through the Access to Information process.
Advisories and warnings with regards to a health product are communicated by Health Canada through a variety of communication tools. The Recalls and Safety Alerts Database contains a list of all such communications: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index-eng.php.
It is up to the manufacturer to provide a statement of indications for use and/or intended use for the device as they appear in the device labelling. Contraindications for the device are also to be stated as presented in the device labelling. The statement of indications for use should describe the diseases or conditions the device will diagnose, treat, prevent or mitigate, and the clinical condition of the patient under which use is recommended. It may also specify the patient population for which use of the device is indicated. The statement of intended use should specify the therapeutic or diagnostic function provided by the device and may describe the medical procedure in which the device is to be used and whether the device is intended for single use or multiple uses. It may also specify the medical training the user should have (as recommended by the manufacturer). While the intended use statement on in our database does not always include all of this information, the manufacturer’s device labelling must include it and is therefore readily available to the purchaser of the device.
The Marketed Health Products Directorate is responsible for issuing advisories and warnings for health products and for managing mandatory problem reporting. The Marketed Health Products Directorate also reviews advertising claims when a complaint is signalled. For more information about the Marketed Health Products Directorate’s Regulatory Advertising Section, please contact them directly at the following coordinates: mhpd_dpsc@hc-sc.gc.ca or (613) 960-2868.
Canada’s Blasphemous Libel Law
Canada’s Criminal Code Section 296
296. (1) Every one who publishes a blasphemous libel is guilty of an indictable offence and liable to imprisonment for a term not exceeding two years
- (2) It is a question of fact whether or not any matter that is published is a blasphemous libel.
- (3) No person shall be convicted of an offence under this section for expressing in good faith and in decent language, or attempting to establish by argument used in good faith and conveyed in decent language, an opinion on a religious subject.
R.S., c. C-34, s. 260.
Many Canadians are unaware that Canada continues to carry an anti-blasphemy law in the criminal code. Criminal Code Section 296 is the law which has remained on Canadian books since 1892. Blasphemy laws are, by their very design, contrary to the idea of secularism – the separation of church and religion from the state and laws which govern people.
Resources To Learn about Canada’s Criminal Code Section 296
Law Now: In the Nov/Dec 2011 edition of Law Now, Peter Bowal and Kelsey Horvat describe blasphemous libel (Section 296) as one of three laws which “remain the most serious form of crimes (indictable), and contain broad, archaic wording which makes their criminal application and enforcement difficult as well as controversial today.” The article provides an excellent reminded of earlier “social control” mechanisms in Quebec. Bowal and Horvat also indicate that “there is no guidance in the criminal code or in any judicial interpretations as to what “publishes”, “decent language” or “a religious subject” mean, or generally what constitutes a blasphemous libel”.
Macdonald Laurier-Institute: The May 2013 asks the question: Is it Time to Overhaul the Criminal Code of Canada. Dennis Baker and Benjamin Janzen, the paper’s author assert “No prosecutor today would proceed with a charge that is so obviously constitutionally infirm.”
Derek James From: Derek James From, a lawyer currently associated with the Canadian Constitution Foundation has written on criminal code section 296 and has observed that “there is some irony here. While the Canadian government publicly defends the freedom to publish cartoons that mock a religious figure and looks abroad to protect religious minorities from oppression, section 296 of the Criminal Code makes it an indictable offence to publish blasphemous materials in Canada.
Jeremy Patrick: For a detailed overview of this legislation, we recommend reading Dr. Jeremy Patrick’s work. Dr. Patrick is a lecturer at University of Southern Queensland’s School of Law and Justice. He has written extensively regarding Canada’s blasphemy law, having studied law here in Canada (York University – Osgoode Hall).
If you have further information regarding Criminal Code Section 296, please forward any references or material to ned@cficanada.ca for inclusion in this reference article and our seminar.
Blasphemous Libel – Its Relevance Today
Many legal opinions seem to suggest that a successful application of blasphemous libel is unlikely. Repeatedly, however, lawyers have indicated that this law is “sleeping, not dead”. Canadians need only observe that religious leaders and authorities are eager to support laws which would place them beyond criticism or satire. Religious leaders seeking the privilege of exemption from criticism and scrutiny is to be questioned. There is also a need to be separate hate speech, which is an essential part of modern law from blasphemy.
There are also individuals who believe in a balance between freedom of speech and protecting people’s religious sensitivities. Anver Emon, Canada Research Chair on Religion, Pluralism, and the Rule of Law also wrote in 2005 that Ontario was mistaken to ban sharia. A push to protect Section 296 by a person who has also publicly pushed to include more religion in Canadian law is not unexpected.
Given the low probability of a prosecution in Canada, it is likely that it will take global events to create an environment where the Canadian government will abandon an outdated law. There is precedent for international events or attempts to censor art and entertainment to drive governments to modernise their laws. In 2015, CFI Canada has attempted to bring to Canadians attention the attacks and murders in Paris at Charlie Hebdo, the imprisonment and torture of Raif Badawi, and other events where individuals, groups or governments have attempted to justify their attempts to intimidate, silence, imprison, injure, torture and kill any person who expresses an opinion they do not agree with. Blasphemy Laws are an attack on freedom of speech.
Early in 2015, CFI Canada began work with organizations around the world to oppose blasphemy laws wherever they exist. As a key founding partner, CFI Canada helped to launch the International Coalition Against Blasphemy Laws. Playing a key role in the drafting of the ICABL charter, along with Atheist Ireland, Humanist Canada and International Humanist and Ethical Union CFIC also supported the End Blasphemy Laws website: (CLICK HERE)
For further details regarding CFIC’s response to world blasphemy laws, we have provided extensive links to media articles below as well as in our End Blasphemy Laws Now web-article.
On March 11, 2015 Canada’s Catherine Godin spoke at the United Nations Human Rights Council (see the video at 20:29 at this link http://webtv.un.org/watch/id-contd-sr-on-religion-21st-meeting-28th-regular-session-of-human-rights-council/4104613595001).
An un-official transcription of Ms. Godin’s comments is provided here:
Canada remains deeply concerned about the plight of persecuted religious communities globally, targeted because for their faith, either through government restrictions, terrorist violence, or extreme social hostilities.
Further Inquiry
3. https://firstlook.org/theintercept/2015/01/09/solidarity-charlie-hebdo-cartoons/
4. http://nymag.com/daily/intelligencer/2015/01/charlie-hebdo-and-the-right-to-commit-blasphemy.html
5. http://www.huffingtonpost.com/2015/01/07/charlie-hebdo-muslims-blasphemy_n_6433104.html
7. http://www.660news.com/2015/01/08/advocacy-group-calls-for-an-end-to-canadas-blasphemy-law/
9. http://www.ibtimes.com/saudi-blogger-raif-badawi-publicly-flogged-insulting-islam-1778528
11. http://www.vice.com/read/blasphemy-in-canada-217?utm_source=vicetwitterus
12. http://www.thestar.com/opinion/letters_to_the_editors/2015/01/20/blasphemy-law-not-being-used.html
13. http://www.torontosun.com/2015/01/17/scrap-canadas-blasphemy-law
17. http://www.theccfblog.ca/2012/09/canada-should-repeal-blasphemy-law.html
19. http://www.stcatharinesstandard.ca/2015/01/14/lafleche-time-to-ditch-blasphemy-laws
21. http://www.640toronto.com/2015/01/08/stafford-227/?sc_ref=l.facebook.com
22. http://www.ruleoflaw.ca/repealblasphemy/
23. http://www.reddit.com/r/canada/comments/2s3g2r/charlie_hebdo_attack_spurs_effort_to_abolish/
26. http://www.mysecretatheistblog.com/2015/01/cfi-canada-and-humanist-canada-call-on.html
27. http://www.leaderpost.com/life/Canada+urged+seek+release+journalist+flogged/10714134/story.html
28. http://www.unexplained-mysteries.com/forum/index.php?showtopic=276612
30. http://www.edmontonsun.com/2015/01/13/jason-kenney-rejects-crackdown-on-religious-satire
31. http://www.gopusa.com/news/2015/01/09/canadian-groups-seek-repeal-of-blasphemy-law/
33. https://damianpenny.wordpress.com/2015/01/08/blasphemy-is-a-crime-in-canada/
35. http://theglitteringeye.com/who-has-anti-blasphemy-laws/
36. http://www.mysecretatheistblog.com/2015/01/blogging-about-blasphemy-how-adults.html
37. Atheist Groups Around the World Have Formed a Coalition ToEliminate Blasphemy Laws Everywhere
38. http://www.bbc.com/news/world-europe-31047401
41. http://www.huffingtonpost.com/katrina-lantos-swett/blasphemy-laws_b_6603632.html
42. http://www.winnipegfreepress.com/opinion/analysis/the-limits-of-blasphemy-289752321.html
Winnipeg Bus Shelter Ads Highlight Human Rights Violations
CFI member (and former board chair) Richard Thain has been a tireless campaigner for the elimination of the publicly funded religious school system in Ontario. Richard’s most recent efforts have been successful in getting a series of ads on bus shelters in Winnipeg. His aim was to have the ads appear at the time of the official opening of the Canadian Museum for Human Rights in that city – unfortunately, the first advertising company approached to run billboards (Pattison Outdoor), though initially interested, refused to accept the job, citing concerns about violations of the Canadian Code of Advertising Standards. In the end, Outfront Media (formerly CBS Outdoor) accepted the message – a story mirroring that of CFI’s own billboard campaign.
Richard explains:
“This is a human rights issue here in Ontario. We all bear the same tax burden, but only people of one religious faith have their own school system. Let’s treat all the religious groups the same.”
When presented with the standard objection that funding for Ontario’s Catholic schools is entrenched in the constitution, and as such cannot be changed, Richard pointed out that the constitution previously did not recognize women as persons – “[the Constitution] is not carved in stone,” he said, “It can be changed.”
Read the article in the Ottawa Citizen here.
For more information, visit the One School System website, and Civil Rights in Public Education (CRIPE)
Carl Sagan Day 2014 at CFI Canada!
On or around Sunday, November 9th, 2014 CFI Canada honoured the late great Dr. Carl Sagan.
We thank everyone at our branches who pulled together a Carl Sagan Day event. It was great to see so many people come out and enjoy their time spent with other like-minded people who want to foster a thriving CFI Canada community.
Calgary
Jeff Ainslie at CFI Calgary reported that a hearty bunch of Calgarian members braved the weather and showed up to the branch’s Sagan event. The city’s first blast of winter started the night before with freezing rain turning to snow. Neither snow nor sleet nor gloom of night stayed these CFI Saganites!
Ottawa
At CFI Ottawa, 17 attendees including Diane Bruce, celebrated Dr. Sagan’s life as an exceptional skeptic, astronomer and science educator by meeting at the The Royal Oak pub on the Canal. Kevin Brown gave an inspiring talk and quiz.
Halifax
Taking a evening trip to the Halifax Planetarium to learn about the wonders of the universe was an excellent way for Shawn Wilson and 15 people at CFI Halifax to recognize Carl Sagan Day. To get things off on a good note, 10 of those people met up before the show and had an enjoyable dinner. Apple pie for dessert?
Toronto
Volunteers at the CFI Toronto branch and CFI Canada National Executive Director, Eric Adriaans, hosted an animated and engaged celebration of Sagan’s life at the national headquarters on Sunday afternoon.
Refreshments were served and clips of both Cosmos series were screened. It was a lively atmosphere as 20 attendees mingled and were greeted at the door by an unexpected…host.
Watch our announcements for 2015 Carl Sagan Day plans at CFI Canada!
Good Without God: Winter Clothing (etc) Drive
The first few flakes of snow are now falling in Kelowna and, thanks to our Good Without God Winter Clothing (Etc) Drive, some people in need will soon be receiving some winter clothing and other necessities.
Thank you so much to everyone who donated clothing, food, cleaning supplies and cash! And thanks to volunteers, Belle, Blythe, Dan and Nina, who drove around town picking up the donations. Thanks also to Cat, who let us use her space for storage.
