The FDA Speaks
Just recently, the Food and Drug Administration issued an officially-sanctioned statement discounting the usefulness of breast thermography as an aid in detecting breast cancer. While the FDA has not renounced its earlier approval of thermography as an adjunctive screening technology, this recent statement was a response to those who claim that breast thermography is a legitimate alternative to the mammogram as a stand-alone detection methodology. Attached to this statement were copies of three warning letters the FDA has sent - one to a manufacturer of thermographic equipment, the others to thermography medical providers - promising legal action if they do not cease and desist making assertions about the superior ability of breast thermography to detect breast cancer.
In 2004, the FDA commissioned a medical panel to decide whether or not to approve breast thermography as a primary screening method for the detection of breast cancer. Obviously, given the vehemence of this latest FDA edict, breast thermography was not approved as an alternative to the mammogram at the time. But curiously, the vote against breast thermography then was only 5-4. So four doctors on that panel were convinced enough by the evidence they examined to vote in favor of breast thermography as a stand-alone method. This is why it is strange to see the FDA come out so decisively against breast thermography as a primary screening method now, since the organization's own scientific panel was almost equally split on the question just a few years ago.
What the Most Recent Studies Show
This shift might be understandable if subsequent study has disconfirmed past positive findings. But as the technology of breast thermography has advanced, the latest studies seem to indicate this method holds great promise. In 2010, the American Journal of Surgery published the results of a study that showed breast thermography was able to accurately detect 97% of cancerous tumors in a group of 60 women who had been diagnosed with the disease following biopsy. This reinforced a 2009 analysis published in the Journal of Medical Systems and the National Institute of Health's PubMed that found breast thermography used in combination with the latest analytical software sensors was 95% effective in finding breast cancer.
Perhaps the most significant finding was a comprehensive meta-analysis published in the Index Medicus that looked carefully at the results of 800 peer-reviewed studies of breast thermography published in various scientific journals. What this study of other studies found is that when breast thermography is used together with clinical examination and mammography, 95% of all early stage breast cancers are detectable. Since early detection is the unquestioned key to curing breast cancer, a multi-modal approach that includes breast thermography as a part of the diagnostic picture clearly seems to be the best available option - especially if all insurance companies could be convinced to cover it. Since mammography has its problems and limitations, it does not seem to make much sense to reject a role for breast thermography out of hand, which amazingly it seems some in the breast cancer field would like to do.
More Research Needed?
When discussing promising developments related to breast cancer, the phrase 'more research is needed' is used constantly. In the case of breast thermography, however, it seems like enough research has been done to establish that this is indeed a promising technology, hostility from the FDA notwithstanding. At this point, breast thermography just needs to be given a complete chance to show what it can do; not as a replacement for the mammogram, but as a frequently used and widely accepted complementary method. And if the technology continues to improve, perhaps someday it really can replace or significantly reduce the use of mammography for breast cancer screening and detection.
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