The US Food and Drug Administration (FDA) has issued a statement that thermography is not an alternative to mammography. The warning comes after the FDA notified three providers to immediately stop making "false and misleading claims" about the device's effectiveness as a method of screening for breast cancer.
"The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease," according to an alert sent by MedWatch, the FDA's safety information and adverse event reporting programme.
"The FDA is concerned that women will believe these misleading claims about thermography and not receive needed mammograms."
In addition to patients and healthcare providers, the warning went out to cancer advocacy organisations and the National Association of Attorneys General. The FDA has approved thermography as an "additional diagnostic tool" for breast cancer screening and diagnosis, but not as a stand-alone approach to screening or testing.
The South African perspective
Professor Justus Apffelstaedt, Head of the Breast Clinic: Tygerberg Hospital. Associate Professor: University of Stellenbosch says that thermography is a just way of imaging temperature.
"Claims are being made that breast cancer generates “heat” and therefore is detectable by thermography. The attraction of thermography is that there is no radiation involved nor is there compression of the breasts. This makes thermography attractive in the eyes of laypersons but to anyone who understands the physics and biology involved in thermography on the one hand and cancer on the other hand, will quickly see the claims being made are bogus," he said.
Apffelstaedt added that breast cancer grows very slowly, taking years to become apparent so such a slow growing disease will not generate any temperature differences of note, certainly not such that they can be detected on the surface of the breast.
"Breast cancers detected by screening mammography are often only millimetres in size and even if they were to be three degrees Centigrade hotter than the surrounding tissue, it would still be impossible to detect such a temperature change from the surface of the breast.
"Indeed, with the slow growth of breast cancerous tissue, the temperature difference is likely to be less than a thousandth of a degree and easily covered by normal physiologic changes in the breast. The same holds true for the detection of premalignant changes in the breast, another claim often made for thermography.
Consequently, after generating a lot of interest in the 1960’s and 1970’s, thermography has failed to show any use in rigorous scientific evaluation and has no place whatsoever in sound breast health management. It currently is only used by unscrupulous operators on gullible members of the public for personal gain."
Warning letters sent out in US
Some providers falsely claim that thermography can detect precancerous abnormalities or find breast cancer long before mammography, the FDA states in the warning. Others make the "misleading" claim that breast compression during mammography will "cause or spread cancer by pushing cancer cells into additional locations in the body," the agency notes.
According to a March 22 letter from the FDA to Joseph Mercola, DO, a physician in Illinois, he also falsely claimed that his thermographic camera is more sensitive than machines used in mammography. The physician's website currently states that the approach offers "a radiation-free alternative to mammography," telling patients that "your breast cancer prevention should start as early as possible".
Warning letters have also gone out to providers at Meditherm in Parkland, Florida, and Central Coast Thermography in San Luis Obispo, California.
The FDA states that mammography "is still the most effective method of detecting breast cancer in its earliest, most treatable stages," citing support for the approach from American Cancer Society, the American College of Radiology, and the Centers for Disease Control and Prevention.
Ref: Medscape Medical News, Professor Justus Apffelstaedt, Head of the Breast Clinic: Tygerberg Hospital. Associate Professor: University of Stellenbosch.
(Health24. June 2011)
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