By Helen S. Sandven, MD
Medical Director of Breast Imaging, Mission Hospitals
Five years ago this month, the U.S. Food and Drug Administration (FDA) issued a warning that thermography was not a replacement for screening mammography. They issued “cease and desist” letters to businesses that claimed that thermography provided “reliable and accurate information for diagnosis, treatment and prognosis” of breast cancer. The FDA was “unaware 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 any other breast disease” (FDA Safety Communication, 6/2/11).
Finally, we breast imagers thought, an unbiased evidence-based organization has made it clear that women were being misled. It was thrilling to think that the FDA was stopping businesses from making false claims that could endanger women’s health! However, there is still a great deal of confusion surrounding thermography. Some communications even refer to it as “FDA approved for early breast cancer detection.”
It’s particularly disheartening to see this kind of misinformation being spread at a time when public information about mammography is so confusing. Let’s try to set the record straight.
A randomized controlled trial (RCT) is the gold standard for determining if a medical test or treatment does what it claims. While they are often expensive and take a long time to complete, RCTs are generally accepted as the most reliable and highest quality evidence. There have been eight RCTs evaluating mammography. They have followed hundreds of thousands of women, some for over 30 years. Seven of the studies have shown a decrease in death from breast cancer (typically around 30 percent) if a woman undergoes mammography. The one study that did not show a decrease in death (Canadian National Breast Cancer Screening Study, 1992) has been severely criticized for its flawed design. We can discuss when to start screening and how often, but no organization (not even the U.S. Preventative Services Task Force) disputes that mammography saves lives.
To date, there are no RCTs evaluating thermography. There is no trial that has shown a decrease in death from breast cancer in women screened with thermography. There are no reliable studies that have shown thermography is better than mammography. Please don’t waste your money or time.