Several months ago, infrared breast imaging, more commonly known as breast thermography, was in the news — and not in a favorable way.
In the spring of 2011, the FDA sent warning letters to Dr. Joesph Mercola, owner of the popular website Mercola.com, and Peter Leando, PhD, president of MediTherm, Inc instructing them to stop making claims about infrared imaging and breast thermography beyond the FDA approved use. The FDA noted that the Mercola.com website contains statements that represent or suggest that the MediTherm Med2000 camera is intended to be used as a stand-alone device to diagnose or screen for various diseases. The warning letter requested confirmation that these claims were removed. It is not clear from the FDA website if either company has responded to the FDA.
Across the Internet, claims are being made that infrared imaging can differentiate osteoarthritis, rheumatoid and fibromyalgia; identify immune dysfunction; and assist in recognition of bowel disorders such as irritable bowel syndrome, diverticulitis and Crohn’s disease. According to the FDA, infrared imaging is being advocated to identify bursitis, herniated discs, ligament or muscle tear, lupus, nerve problems, whiplash, stroke screening, cancer and “many others.” These are not FDA approved usages.
Unlike regulations for pharmaceutical drugs, the FDA does not allow off-label use of medical equipment, ie., it can only be used as specifically approved. It certainly is rare for the FDA to receive accolades from the natural health community. But this time, we really do need to say, “Good job, FDA.” This is exactly the type of policing you should be doing.
The FDA gave 510(k) clearance to infrared imaging devices to be used in conjunction with mammography. It was not intended to be a replacement for mammography and was *certainly* never approved to assess internal organs, such as the pancreas, the colon and the kidneys. Making claims far beyond the capability of the technology taints the usefulness of infrared imaging and gives it a bad name across many circles.
While infrared breast imaging (IRBI) is not intended to be a stand alone assessment, the painless, non-invasive scan really can identify areas of concern in the physiology years before an abnormality is localized on a mammogram. It is a valuable early warning indicator, especially for women who have had normal mammograms. Most women have heard stories of women who had several years of normal mammograms and then, the very next year, the mammogram identifies cancer. This did not happen in a mere 365 days! The abnormal cells were evolving for many years. Read the review I wrote of the textbook Breast Imaging — note that the fastest growing breast cancers materialize over 9 years; the slowest can take nearly 30 years to be seen on a mammogram. Valuable time for intervention is lost without an infrared health breast assessment.
IRBI is of particular value for women in their 40s, especially since initial mammogram screening has now been moved to 50 year of age. IRBI is also beneficial to women with dense breasts or with breast implants, where mammography is less reliable. For women who experience extreme pain with mammograms — and flat out refuse the test — a pain-free, no radiation scan can be lifesaving.
The right tool for the right job applies across the spectrum of life. For example, an MRI is better than a CT scan for identifying a herniated disc. Positioning mammography vs thermography is not in the best interest of women. A mammogram identifies structural changes that have been locked into the anatomy of the breast. Infrared imaging identifies areas of abnormal heat that can represent new blood vessel formation (angiogenesis) and release of nitric oxide (a cancer risk factor). Physiological changes precede changes in the anatomy. The physicians and PhDs at the FDA surely must understand this; they need to further embrace the value of infrared as a tool for assessing breast disease and promoting breast health.
Unless infrared breast imaging is properly used, my concern is that the FDA will increase the policing of this tool, and we could eventually lose its use for good. I’m not always a fan of the FDA, but in this instance, the regulators have definitely done the right thing.
Basic Recommendations for Healthier Breasts
- Diet: Eliminate caffeine, chocolate, MSG, aspartame, and estrogenic herbs. Eat organically grown foods as much as possible. Pesticides collect in fatty tissue, and the breast can become a reservoir for estrogenic chemicals. Limit alcohol as it depletes folic acid, a known risk factor for breast cancer.
- Exercise: Walking and arm swinging will get the lymphatics moving. Decongesting breast tissue reduces risks.
- Supplements: Many nutrientshave a positive effect on the breast tissue. Increasing the use if iodine, turmeric, calcium-d-glucarate and vitamin D is a place to start.