In 2011, the Indian Council of Medical Research reported that breast cancer in India is doubling every 24 years. One in 11 and one in 8 women in Delhi are at risk of developing breast cancer by the time they are of age 64 years and 74 years respectively. The data for other cities are similar.
Early detection of cancer is important for effective treatment. Mammography, an x-ray imaging method continues to be the recommended one to diagnose the disease. On September 18, this year, the U.S. Food and Drug Administration approved the first ultrasound device for use in combination with standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. No one can ignore the arrival of ‘No Touch BreastScan’ (NTBS) imaging device, based on thermography, which looks for temperature hot spots at the surface of breast. Increased metabolism in cancer cells leads to increase in temperature.
NTBS may not have sufficient clinical backing but commercial considerations prevail.
Promoters of NTBS aggressively highlight the deficiencies of mammography. Squeezing breasts to get a mammogram is painful; it involves radiation exposure; cancer in dense breast tissue is difficult to diagnose etc. The promoters lament over the shortage of radiologists in India but ignore the lack of experienced thermographers to use NTBS. They seldom reveal the drawbacks of NTBS as a stand-alone tool (http://www.notouchbreastscan.com/pdfs/HEAL%20India.pdf).
In the May 10, 2010 issue of the European Journal of Surgical Oncology, Dr Wishart and co-workers from Cambridge Breast Unit, Addenbrooke’s Hospital, Cambridge, U.K. reported that No Touch BreastScan (NTBS) and mammography in women under 50 gave encouraging results suggesting a potential way forward for a dual imaging approach in this younger age group.
At the American Society of Breast Surgeons’ annual meeting in Phoenix on May 4, 2012, Dr. C.M. Guilfoyle, a researcher at Bryn Mawr Hospital in Pennsylvania concluded that in a study of about 180 women who had biopsy proven breast cancer, NTBS unit missed about 50 per cent of cancers! It delivered too many false positives. False positives may lead to trauma.
Drs Anita Fitzgerald and Jessica Berentson-Shaw, Research Services, New Zealand Guidelines Group, Wellington concluded that currently there is insufficient evidence to support the use of thermography in breast cancer screening, nor is there sufficient evidence to show that thermography provides benefit to patients as an adjunctive tool to mammography or to suspicious clinical findings in diagnosing breast cancer (The New Zealand Medical Journal, 09 March 2012). They reviewed papers from 1984 to the end of April 2011.
“Despite widely publicized claims to the contrary, thermography should not be used in place of mammography for breast cancer screening or diagnosis,” the US Food and Drug Administration (USFDA) cautioned in an update on November 7, 2012. According to FDA, mammography is still the most effective way of detecting breast cancer in its earliest, most treatable stages.
The FDA has no evidence to support the claim that thermography is a replacement for mammography and that thermography can find breast cancer years before it would be detected by mammography.
American Cancer Society and National cancer Institute have similar views on the limitations of thermography.
In spite of well known deficiencies, a few private hospitals in India have purchased the imaging units.
“To make it comfortable for women to undergo check-up of breasts for detection of cancer, the Brihanmumbai Municipal Corporation (BMC) plans to buy ‘no-touch’ scan machines,” a section of the press reported on November 8, 2012.
The health committee chairman of BMC announced the civic body’s plans to buy the machines so that women “do not have to experience awkwardness while going through physical examination of breasts or pain while scanning through a mammography machine,” the report added.
Those associated with the proposal to buy NTBS seem to be carried away by the vendor’s words!
The No Touch BreastScan machine, developed in the USA by UE LifeSciences and installed at private facilities in Thane, Pune and Ahmedabad, may cost the BMC up to Rs75-80 lakh.
Critical review needed
There is a need for critical appraisal of such expensive tools before they are purchased. Such reviews must include the experience in using the device internationally.
It is inappropriate and unethical to spend scarce resources on fancy equipment where its benefit to users has not yet been proved.