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Here we go again.

The FDA recently issued a warning letter to Total Thermal Imaging, Inc., of La Mesa, California, and Linda Hayes, its president and co-owner, for illegally marketing and distributing an unapproved thermography machine as a sole screening device for breast cancer and other diseases. The FDA also issued a Safety Communication to warn patients, health care providers, and cancer treatment advocacy organizations that thermography is not cleared by the FDA as an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis. This is one of several actions the FDA has taken in the last few years against marketers who misrepresent thermography’s utility for breast cancer screening, a subject we’ve covered several times on SBM (also here and here).

In my view, these and prior actions chasing scofflaws who flout the FDA by making false claims regarding thermography for breast cancer detection are insufficient to confront this threat to women’s health. Instead, the FDA should use existing law to ensure that this scam cannot continue. How this might be accomplished is an issue we’ll return to in a moment.

Briefly, thermography measures differences in temperature using infrared imaging. As Dr. David Gorski explained, there are several reasons why the temperature of breast cancers might be higher than the surrounding normal breast tissue and therefore potentially imaginable using infrared thermography. Unfortunately, thermography has proven an unreliable means of detecting breast cancer and the American Cancer Society, the American College of Radiology, and the American College of Obstetricians and Gynecologists do not recommend thermography for breast cancer screening. According to the American Cancer Society, thermography, including the newer digital infrared thermal imaging, failed to detect three out of four breast cancers known to be present. In addition to the high false negative rate, it has a high false positive rate as well.

The FDA regulates medical devices based on their intended use (what the device’s label says it is to be used for) and their indications for use (the conditions or reasons for using the device). Since 1982, “telethermographic systems” have been regulated as Class I devices when used as an adjunctive diagnostic screen for detection of breast cancer or other diseases. Class I devices, per the FDA, “present minimal potential for harm to the user” and include items like bandages and enema bags. If used alone for diagnostic screening, they are Class III, devices that “sustain or support life, are implanted, or present potential high risk of illness or injury”. HIV diagnostic tests are Class III, for example. No telethermographic system has received Class III approval, an event that is highly unlikely given the lack of evidence of effectiveness as a stand-alone screening method.

Class I medical devices receive a pre-market clearance from the FDA through one of several methods, each of which requires some demonstration of safety and effectiveness, even if only through claiming similarity to a previously-cleared device. That requirement makes this language in the FDA’s Safety Communication especially interesting:

There is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition including the early detection of breast cancer or other diseases and health conditions.

[Emphasis in original.]

And:

the Society for Breast Imaging notes a lack of evidence that thermography has any effective role in breast cancer screening.

So, if thermography is not effective as a screening tool “for any medical condition” even “when used . . . with another diagnostic test,” why should it retain its Class I clearance for use as adjunctive diagnostic screening for breast cancer detection or any other disease or condition? It shouldn’t, especially given the continued disregard of the FDA’s limitations on thermography’s use by companies and health care practitioners who have no business advising women on appropriate screening methods in the first place, a problem the FDA’s Safety Communication acknowledges:

The FDA is aware that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis.

The FDA has received reports that these types of facilities provide false information that can mislead patients into believing that thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.

None of these claims are true or have any valid scientific evidence to support them.

Total Thermal Imaging (TTI) was cited by the FDA for marketing its Thermography Business Package, a combination of infrared cameras and software, as a sole screening device for breast cancer and other diseases. According to the warning letter, TTI claims:

Thermal Imaging is intended for early detection of the diagnosis of many disorders including breast cancer, inflammatory breast cancer, pre-stroke, heart disease, deep vein thrombosis, reflex sympathetic dystrophy/complex regional pain syndrome, back, leg or headache, and even unexplained pain, TMJ, and other disease.

You can’t prevent or cure breast cancer until it is detected. DON’T WAIT! Schedule an appointment with a certified clinical thermographer today. Start by visiting www.totalthermalimaging.com and find a thermal imaging center near you.

Share with your friends & family that there is an alternative to mammography that doesn’t involve any patient (no pain), will not cause cancer (no radiation), and is far more efficient at detecting cancer.

Breast Screening . . . This scan looks for inflammation, lymphatic congestion, hormonal imbalances. Early detection saves lives and breasts!

In the case of TTI, the harm caused by making false claims such as these is not just theoretical. ABC’s Good Morning America busted TTI in an investigative report featuring a woman, Morganne Delain, who went to TTI for a thermogram after discovering a lump in her breast. Linda Hayes’s TTI partner, chiropractor Greg Melvin, who we’ve met on SBM before, read the report, which

indicated she had a ‘mild to moderate risk of developing aggressive tissue.’ Melvin recommended exercises, a cleanse, and that she came back in three months for a comparative scan — his protocol for new patients.

Delain returned to TTI four months later, after worsening symptoms, but refused further scans. She was uninsured and unemployed and waited three more months for a mammography appointment. Her diagnosis: Stage 3 breast cancer. (According to ABC, she is now cancer-free after treatment.) Asked by a reporter why he didn’t immediately refer Delain, Melvin said “that they must wait three months to do a comparative scan to understand the results.”

Hayes’s and Melvin’s other excuse was that

they make it clear to patients that thermography is not meant to detect disease via a line at the bottom of the intake form: ‘The report will not tell me whether I have an illness, disease, or other condition.’

Really? Then why recommended it to a woman with a breast lump? (Delain says she never saw this disclaimer.)

In fact, ABC caught Hayes at a business conference saying “no one needs a mammogram.” A TTI brochure encouraged customers to schedule a thermal scan, stating “You can’t cure cancer until it is detected. Don’t wait.”

Unfortunately, while exposing thermography’s deficiencies, the ABC report does not mention the obvious: the lack of chiropractors’ qualifications to advise women on appropriate diagnostic methods and treatment in the face of breast cancer symptoms.

The exact statements quoted by the FDA are no longer on TTI’s website. However, TTI still claims that thermography can “distinguish dysfunction even when conventional blood tests and radiographic tests were negative”, “offers reproducible and scientifically valid information,” and “clearly shows future disease tendencies of [sic] those in the process of development.” These claims do not square with the FDA’s conclusion that there is no valid scientific data to support the use of thermography as a screening tool for any medical condition, either alone or as an adjunct to another diagnostic test.

TTI’s website also says that thermography “is an FDA approved adjunctive diagnostic device so the results can be trusted.” Actually, thermography devices are FDA-cleared, not approved, a much more rigorous process. TTI does not tell patients what “adjunctive diagnostic device” means: that it should be used only alongside a primary diagnostic test.

Thermography is not the only dubious healthcare service offered by TTI. Melvin still practices there, offering chiropractic “adjustments”, as well as “cranial facial release,” an oxygen bar (to – you guessed it – “boost your immune system”), and an infrared sauna (for “detoxification”). It appears TTI also offered what looks like thermographic facial reflexology (a new one on me) although this image has been removed from the website (but not the Wayback Machine).

In any event, correction of its original misrepresentations is not TTI’s only problem – according to the warning letter, TTI never obtained the necessary pre-market clearance for the thermography device it is marketing for any use. TTI is also cited for failure to comply with good manufacturing practices and for failure to register with the FDA.

The warning letter demands that TTI immediately cease distribution of the Thermography Business Package and take prompt action to correct the identified violations, and states that failure to do so can result in seizure, injunction, and civil money penalties. Other than changing claims on its website, we do not know what remedial action TTI has undertaken, if any. It is still marketing thermography for $250 to $550 a pop and does not take insurance. (Actually, insurers are unlikely to pay for it anyway.) TTI also offers a mobile thermography unit to health care practitioners, which includes a 15-minute presentation on what thermography is, how it works, and how it will benefit both patients and the practitioner, the latter by “growing” the practice and sending a check each week “for assistance in spreading the word about thermography”.

The FDA’s solution for all this is for the public to “be aware” that thermography is not a substitute for regular mammograms and should not be used in their place. The agency is calling on health care providers to “educate patients about the limitations of thermography”, including its high false negative and false positive rates, and to discourage its use.

The FDA says it will take additional steps necessary to address the risks associated with the use of thermography. Given thermography’s lack of valid scientific support and its continued misuse at the hands of marketers, including practitioners offering dubious healthcare advice like chiropractors and homeopaths, the additional step that would best protect the public is to reclassify thermographic systems used as an adjunct to other diagnostic methods from Class I to Class III. Class III requires a far more stringent FDA review, a review thermographic devices are highly unlikely to survive given the FDA’s own view about their lack of reliability.

Medical device regulation is nothing if not complicated, and there may be other means by which the FDA can take thermography devices off the market. However it gets there, the FDA has an obligation to the public to do more that ask patients to “be aware” of thermography’s dangers and health care practitioners to discourage thermography’s use. The FDA has the legal tools at its disposal to rid the public of this health scam and the scientific evidence to support its action.

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Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Sivasucakbileti (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.