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Thermal Imaging for Breast Cancer Not Approved in Canada

Posted on June 7, 2016 By NED 1 Comment on Thermal Imaging for Breast Cancer Not Approved in Canada

 

Despite the fact that using thermography (also called thermal imaging) to screen for breast cancer is neither useful nor legal in Canada, several naturopaths and other outlets continue to promote and use the procedure. Health Canada has not approved thermal imaging for breast cancer screeningi and warns that “As such, it may present a potential risk to women relying on the results”. It is illegal to advertise or sell these imaging machines in Canada so it is bewildering and disappointing that naturopaths are permitted to continue to promote them. Even the College of Naturopathic Medicine disapproves. Their Clinical Therapeutics Committee issued the following statement in 2013 about screening breast thermography: “At this time existing evidence reveals no net value in DITI [digital infrared thermal imaging] breast screening for the purpose of promoting proactive breast health. Moreover, we are concerned about uncertain benefits in the face of substantial harm.”ii

Websites promoting thermography often mention that the procedure has been approved by the American Food and Drug Administration (FDA), but they fail to explain that the approval is awarded based on the non-invasive, and therefor presumably safe, nature of the procedure. It is not an endorsement of efficacy. In 2011 the FDA, alarmed by misleading advertising, issued several warning statements including statements such as: “The FDA is concerned that women will believe these misleading claims about thermography and not receive needed mammograms.”iii The FDA also issued warning letters to several individual companies and clinics including the Natural Health Center run by Dr. Joseph Mercolaiv, a well-known purveyor of health-related pseudoscience.

Manitoba’s Health Minister issued a “cease and desist” order to a Winnipeg thermography clinic in 2012, commenting that “It’s sort of the worst kind of exploitation, I think, and that’s the exploitation of somebody’s fear about cancerv“. Similar letters were also sent to clinics in St. John’s Newfoundland, Newfoundland and Labrador by Health Minister Susan Sullivan who said: “Thermography is not regulated in the province of Newfoundland and Labrador, which is precisely why I have indicated to this particular company that they should not be offering this particular service in Newfoundland and Labrador, and I’ve asked them to cease and desistvi“. Without appropriate oversite these clinics will continue to exploit vulnerable Canadians. Health Canada must take immediate action to enforce their own regulations and put a stop to these clinics across Canada. There are a growing number of standalone clinics across the country and the procedure is offered by many naturopaths. The average price is $250 for a basic scan and $7-800 for “full-body scans”. These clinics are allowed to get away with statements such as “[thermography is] an indispensable method of breast assessment and breast anomalies risk evaluation.” and “Thermography has been FDA approved as an adjunctive breast cancer screening tool since 1982. This means that it is approved to identify warning signs of an increased risk for cancer.”

We urge Health Canada and Health Ministers across Canada to crack down on this illegal and potentially dangerous activity.

i http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2012/15920a-eng.php

 

ii http://www.ccnm.edu/research/cancer/screening_breast_thermography_perspective_clinical_therapeutics_committee_canadian_c

 

iii http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm257259.htm

 

iv http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm250701.htm

 

v http://www.cbc.ca/news/canada/manitoba/winnipeg-thermography-clinic-ordered-to-stop-operating-1.1233696

 

vi http://www.cbc.ca/news/canada/newfoundland-labrador/cease-and-desist-letter-stops-diagnostic-test-cold-1.1140217

 

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Comment (1) on “Thermal Imaging for Breast Cancer Not Approved in Canada”

  1. Dr. Terry Polevoy says:
    June 7, 2016 at 4:49 pm

    Thank Eric. I’ve been following this for years, and recently have bombarded the Ontario Minister of Health, Eric Hoskins after the Federal Minister of Health MP Philpott took over SIX MONTHS to reply to my original complaint from last November.

    She told me to ask Hoskins to do something. Why is that?

    The devices have always been illegal. I reported them years ago when unregulated people started doing them in Kitchener-Waterloo. Nothing was done. The same people I complained about, and even more have continued to ply their illegal trade.

    How the hell did the totally incompetent Device Branch allow this to be imported?

    Now that NDs are using these right-left-and-centre across Canada, snubbing their nose at the Federal government, their own regulatory colleges, and the public it is MUCH WORSE THAN IT WAS IN 2012.

    I urge the members and interested parties to file complaints against any of the clinics, and when appropriate to write their colleges to file and official complaint.

    This has to stop.

    Terry Polevoy, MD, FRCP(C)
    Waterloo

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