Safety concerns have been raised about the increasing use of breast imaging devices for breast cancer screening that are not part of the mammography screening program.
At last Wednesday’s Senate Estimates hearing, Senator Judith Adams raised concern that clinics promoting imaging technologies, such as thermography, as pain-free alternatives to mammograms are targeting younger people and are “all really and truly getting beyond a joke”. She commented that consumers are being “misled into thinking the scans [are] able to detect cancers”.
Dr Rohan Hammett, Principal Medical Advisor for the Therapeutic Goods Administration (TGA), responded during the hearing that two of the devices had been removed from the Australian Register of Therapeutic Goods (ARTG) and they were “actively making inquiries for those remaining four”.
Dr Hammett added that once removed, “they will not be used in the community”.
But with no mandatory recall on cancelled devices, practitioners will undoubtedly claim that the original ARTG Listing maintains “currency” and will continue to use them. Costing upwards of $150 per appointment, practitioners state that they offer “the local community a safe option for mammography”.
The SureTouch system is based upon tactile imaging technology. Its listing on the ARTG states that it “should not be used for clinical decision-making” and that it is only “intended to document lesions as identified during a clinical breast exam”.
While claiming it is “suitable for any age, for any breast type or size”, therapists target younger women by stating that they offer an “accurate and comfortable screening solution” for the under 40s.
However, claims made for the device are that it “has been proven to be over 94% accurate in recognising malignant tumours in all breast tissue” and that it is capable of “detecting lesions as small as 5mm”.
The Meditherm device was recently removed from the ARTG. Despite the cancellation, this device is still being used and promoted as being listed with the TGA with the overseas sponsor claiming it is an “extremely valuable test to help with the early detection of breast disease”.
While there is some evidence to support the use of commercially-offered imaging technologies in certain settings around breast screening, such as an adjunct to a physical examination when conducted by a doctor, the evidence does not suggest the devices can, for example, diagnose small tumours or screen for breast cancer.
According to Brisbane breast surgeon Ian Bennett “thermography was a primitive form of imaging not much better for detecting breast cancer than self-examination” because the cancer has to be fairly large for thermography to pick it up.
Despite the best efforts of the Department of Health and Ageing (DoHA) to warn consumers, the number of practitioners promoting thermal imaging to diagnose breast cancer, continues to grow. Use Google and you get over 1000 hits.
Many of the therapists using thermal imaging have either no qualifications or have completed questionable ‘natural medicine’ correspondence courses. Some even claim that “mammograms cause breast cancer” and are more “hurtful than helpful”.
Queensland’s Chief Health Officer, Jeannette Young disputes this claim, saying the “radiation exposure from mammograms is ‘minuscule'”.
Other websites advertising thermal breast screening are also promoting the use of unproven alternative cancer cures such as Laetrile and Cansema.
The National Advisory Committee which provides policy direction for the BreastScreen program recently issued a statement that they “do not recommend the use of thermography for the early detection of breast cancer.”
Mammograms are free for women after their 40th birthday and are much more effective in picking up breast cancers at an early stage than any alternative imaging technique.
Speaking as a cancer survivor, who was diagnosed with early breast cancer, the BreastScreen program was of enormous benefit to me and may have saved my life, and surely this is what’s really important.
I would strongly discourage other women from relying on alternative breast imaging devices. This is not about choosing one procedure over another; it is about using the only program that is backed by solid evidence.
*Loretta Marron, a science graduate with a business background, was Australian Skeptic of the Year in 2007.
At Senate Estimates Dr Hammett also said, “A separate matter is how these devices might be used by professionals out in the community. I have to say that is really a matter for medical boards and specialist colleges to determine whether their members are using these things appropriately”.
However, as Loretta has pointed out, this ignores the fact that main problem with shonky medical devices lies with currently unregulated non-medical health professionals, especially naturopaths.
So why hasn’t the government pushed for appropriate registration and accountability of naturopaths as requested by the more responsible members of their profession? See: “Unregulated naturopaths putting lives at risk”, http://www.abc.net.au/unleashed/40276.html
In addition Dr Hammett failed to mention the TGA’s failure as the co-regulator to uphold promotional standards.
A number of web sites promoting these devices claim “TGA approved” when such claims are not permitted under Section 4(6)(b) of the Therapeutic Goods Advertising Code. Other sites make claims that appear to be in clear breach of Section 41FN(5) of the Therapeutic Goods Act 1989 (advertising material relating to medical devices must be consistent with the intended purpose).
We are left with a basic problem in the regulation of so-called “lower-risk” medical devices (and Listed medicines). The TGA does not assess these goods for efficacy; promotion often overstates their capabilities; self-regulation does not work as the sponsors are often not members of industry associations, and co-regulation (the Complaint Resolution Panel (CRP) and the TGA) have fundamental flaws; the CRP has no power to enforce its determinations and the TGA is non-transparent about what action it takes (if any) on proven offences of the Therapeutic Goods Act &/or Therapeutic Goods Advertising Code. In addition, the TGA lacks easily applied civil penalties which other jurisdictions such as the Dutch Health Inspectorate have.
These problems have been well documented in submissions to the TGA’s, “Consultation Paper on Advertising Therapeutic Goods in Australia” and the governments, “Position Paper on the Promotion of Therapeutic Goods”. They are also on the agenda of the government’s, “Working Group on Promotion of Therapeutic Products”.
It remains to be seen if a solution will result.
I can’t believe that anyone still operates a thermography machine, and promotes it’s use as an alternative to screening mammography.
When the first clinic in the world to add breast ultrasound to mammography and surgical examination, in the diagnosis of breast problems, opened in 1978, the use of thermography was so discredited that it was never part of the line up at the Sydney Square Breast Clinic, SSDBC.
Surely there is still an embargo on the use of such machines for breast cancer screening in 2010?
Dr Joan Croll
Founding Medical Director of the SSDBC
According to a July 2009 article in AUSDOC, the breast thermography business is an “absolutely a growing field”.
(Alternative methods a ‘tragedy’ – http://www.australiandoctor.com.au/articles/a0/0c0626a0.asp)
At that time Thermography Australia claimed that it had over 1000 breast thermography patients on its books.
Another remedial massage therapist had also just opened her third thermography facility in NSW.
At least one health fund, HBF in WA, offers a benefit for breast thermography.
These unregulated, uninsured and poorly trained therapists already use disproven diagnostic devices such as iridology cameras, hemaview (live blood analysis), electro-dermal allergy testing/bio-field mapping devices which sit alongside their magnets, TENS, Microcurrent, bioptron light therapy and ear candles.
Thermography, tactile imaging, electrical impedance & ‘mammographic computed tomography lasers’, with ARTG numbers, have been added to their long list of questionable money-making medical devices.
Where’s their evidence?
All these so-called alternatives have been encouraged by the scientific debate about the merits or otherwise of orthodox breast-screening mammography. Despite the intense focus of resources on breast cancer and the escalating community support we still have a common cancer of which we do not know the cause(s) so nor how to prevent it. All we have is screening mammography which those in most sectors of orthodox cancer control say is currently the only way to ‘manage’ the problem. It is therefore of paramount importance that governments and non profit agencies continue to expose these so-called ‘alternatives’ as ‘dangerous’ and their claims misleading. There is a developing parallel here to the issue of immunisation with anxious parents deciding not to have their children immunised based on cumulative stories in the media that have failed to balance the facts. Loretta Marron has provided an excellent summary which should be promoted far & wide.
Am J Surg. 2008 Oct;196(4):523-6.
Effectiveness of a noninvasive digital infrared thermal imaging system in the detection of breast cancer.
Arora N, Martins D, Ruggerio D, Tousimis E, Swistel AJ, Osborne MP, Simmons RM
Department of Surgery, New York Presbyterian Hospital-Cornell, New York, NY
BACKGROUND: Digital infrared thermal imaging (DITI) has resurfaced in this era of modernized computer technology. Its role in the detection of breast cancer is evaluated. METHODS: In this prospective clinical trial, 92 patients for whom a breast biopsy was recommended based on prior mammogram or ultrasound underwent DITI. Three scores were generated: an overall risk score in the screening mode, a clinical score based on patient information, and a third assessment by artificial neural network. RESULTS: Sixty of 94 biopsies were malignant and 34 were benign. DITI identified 58 of 60 malignancies, with 97% sensitivity, 44% specificity, and 82% negative predictive value depending on the mode used. Compared to an overall risk score of 0, a score of 3 or greater was significantly more likely to be associated with malignancy (30% vs 90%, P < .03). CONCLUSION: DITI is a valuable adjunct to mammography and ultrasound, especially in women with dense breast parenchyma.