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 firstname.lastname@example.org
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?
Well done to our members for asking important questions. Canadians deserve clinically-proven health care and protection by the government from those who are willing to sell any unproven product or service. Will hyperthermia prove an effective treatment for cancer? Do these devices work? It seems that we don’t know yet:
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
And Health Canada has received some good and important questions in reply:
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: email@example.com or (613) 960-2868.
(Picture is from Celsius42 website).