Historical Overview of Breast Thermography
Early infrared camera technology of the 1950's was primitive and produced poor quality images. It wasn't until the late 1970's that the thermobiology of the breast was sufficiently understood to permit the emergence of a credible, accurate and objective method for interpreting the thermal patterns of the breast. And, until 1983, there were there no published environmental controls or formalized patient pre-examination protocol. Thus, from breast thermography's earliest years until the early-1980's, breast thermograms were haphazardly acquired and subjectively interpreted by individuals with little or no understanding of the procedure.
When breast thermography was introduced in the early 1950's, several physicians and manufacturers touted it as the ultimate screening process that would replace the mammogram. The legacy of their eagerness to proceed without adequate expertise, equipment or environmental controls still haunts the science. The low quality images were subjectively interpreted resulting in an abundance of incorrect diagnoses, followed by unnecessary surgical procedures. When it was realized that thermography was not measuring up to the exaggerated claims of practitioners and vendors alike, the technology was dismissed as a non-specific and unreliable test for detecting the presence of breast cancers.
In 1972, the American Cancer Society and National Cancer Institute sponsored the "Breast Cancer Detection and Demonstration Project" (BCDDP), in which women were screened using a combination of medical history, physical examination, mammography, and thermography. Untrained radiologists with no knowledge of breast thermography performed the thermographic examinations and the subsequent subjective interpretation of the images. The resultant high error rate and low sensitivity quickly resulted in the discontinuance of thermography as a routine element of the BCDDP.
These two chapters in breast thermography's history explain and support the medical community's basis for not adopting breast thermography. They plainly illustrate that the subjective interpretation of breast thermograms leads to unusually high and unacceptable error rates. That which continues to fuel this adversarial argument is not so obvious.
The mid-1970's to the early 1980's appeared to promise the dawn of a new and promising era for breast thermography:
- After almost two decades of accumulating and analyzing clinical data on more than 110,000 breast cancer patients, Gautherie et al published an accurate and objective breast thermogram interpretation protocol. Gautherie's analytical methodology employing twenty thermal markers quickly became, and remains today, the gold standard breast thermogram assessment protocol.
- Shortly after the introduction of Gautherie's protocol, Jay, in collaboration with Gautherie, authored and published the first version of TAS's Breast Thermogram Evaluation program, embodying the Gautherie protocol. Clinical trials demonstrated 90% inter-reader reproducibility of results using the program, and soon, even the most vociferous opponents of breast thermography praised the program as the first and only objective interpretation method available.
- In 1982, a rigid pre-examination protocol was developed and published by Jay. It imposed various controls to breast thermography to maximize the integrity of the examination.
- Along with the advances in interpretation protocol, a new, low cost imaging technology was introduced – Liquid Crystal Contact Thermography – bringing an inexpensive solution to the breast thermography image acquisition.
The arrival of low cost contact thermography was also the harbinger of increased opposition to breast thermography by the mammography industry.
As advances in thermology were published, radiologists financed by manufacturers of mammography equipment and who were still influenced by the BCDDP experience, increased the assault against breast thermography. As a result, radiologists were not a viable market for contact thermography devices, so device manufacturers directed their marketing efforts to gynecologists. The rationale was that since gynecologists are the first front against breast diseases, the thermographic examination should be conducted during a woman's annual gynecological examination. This proved to be a disastrous marketing error. When the radiology community realized that gynecologists were being sold image acquisition equipment, it predicted results similar to the BCDDP, i.e., subjective interpretations of images by novices delivering erroneous results. The radiology community responded vehemently against the use of breast thermography by gynecologists.
The contact thermography equipment provided the gynecologists with easy access to reasonably good quality images, but left the question of image assessment unanswered. The computer system was costly, so a thermogram reading service using the early TAS program was established. Physicians mailed images to the reading service for an assessment of the images, which were supplied by return mail. Unfortunately, the physicians ultimately chose to not use the service, because the time and overhead involved in mailing the images along with the wait to receive reports proved burdensome. Unfortunately, the gynecologists made a decision antithetical to conventional wisdom and began to [subjectively] interpret the images themselves. The resulting barrage of appropriate criticism from the medical community forced the use of breast thermography to be put on hold by most practitioners.
Notwithstanding a continued onslaught by the mammography industry to impede the use of breast thermography, thermology stalwarts continued their efforts to demonstrate the efficacy of the technology. More than 800 peer-reviewed clinical studies comprising 300,000+ patients, some tracked for twelve years, have been reported in the literature since 1980, all with results favorable to breast thermography use. These include:
- Breast thermography has an average sensitivity and specificity of 90%.
- Breast thermography is able to detect early signs of breast cancer up to 10 years before other procedures are capable of.
- Breast thermography can augment long-term survival rates by as much as 61%.
While breast thermography advocates achieved demonstrable proof of the technology's efficacy, clinical studies of mammography screening were reporting mammography's lack of efficacy and health risk. Although mainstream medicine became somewhat aware of mammography's drawbacks, the mammography industry largely ignored or argued against the clinical studies, and continues to this day to promote mammography as though it is efficacious and free of health risk. Sadly, the mammography industry also ignores the progress made by thermologists and continues its attempts to squelch breast thermography.
Today, the vast majority of breast thermography screening examinations in the U.S. are performed by alternative medicine practitioners, primarily chiropractors. This situation was driven by three significant events:
- In 1982 the US Food and Drug Administration approved breast thermography for breast cancer risk assessment, but neglected to regulate the technology or limit its use to medical professionals.
- Chiropractors were using thermography to produce evidence in personal-injury lawsuits and Workers' Compensation claims. In the mid-1980's, due to the actions of some scurrilous attorneys and errant practitioners, thermography's acceptance was abruptly reversed by the courts and the insurance industry.
- The mammography industry succeeded in its campaign to thwart the use of breast thermography in the medical establishment.
In the early 1990's, an enterprising chiropractor ignored accepted standards and invented his own errant method of conducting breast thermography examinations. He went on to create a shell organization with a name evoking academic accreditation, anointed himself guru, and promoted his training and thermogram interpretation expertise to chiropractors that decided to add breast thermography examinations to their practice. Unwittingly, many enrolled in the promoter's weekend training sessions. The result is the widespread improper use of a good technology that can detect breast cancer years before it is detected by mammography.
Many practices adhere to proper examination protocol and like TAS, embrace internationally accepted thermogram evaluation standards. Others, such as those discussed, unknowingly, but regularly violate proper examination protocol and use errant interpretation methods or services. This debacle provides fodder for breast thermography's detractors: A standard, accurate and objective method for interpreting breast thermograms is of unparalleled importance, but lacking in many breast thermography practices. Given such conditions, breast thermography continues to lack credibility.
Breast thermography continues to be unregulated and without certification requirements. Virtually anyone desiring to practice breast thermography, with or without proper training, may do so.
TAS promotes the widespread proper use of breast thermography examinations. We seek to alter the present course by offering breast thermography practices the best thermography camera; guidance in how to properly perform breast thermography examinations; plus a credible, comprehensive, economical breast and easy-to-use thermogram interpretation service.