Food and Drug Administration building.
The FDA announced this week that it is taking action against 14 U.S.-based companies for illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. Products include pills, topical creams, ointments, oils, drops, syrups, teas and diagnostic devices, sold mostly on websites and social media platforms. In warning letters posted on the FDA’s website, the agency demanded responses within 15 days from the companies stating how the violations will be corrected. Failure to respond may result in legal action, including product seizure, injunction, and/or criminal prosecution. The FDA also posted “mug shots” of several of the products.
One of those letters went to Nature’s Treasures, Inc. In addition to selling quack cancer treatments for both humans and pets, Nature’s Treasures markets thermography for breast cancer detection. According to the FDA, the company’s claims for thermography “provides evidence that the device is intended for diagnostic screening for detection of breast cancer, including as a sole screening device,” which federal law prohibits.
The FDA’s warning letter says that “telethermographic systems,” as the agency calls them, are cleared as diagnostic medical devices only for adjunctive diagnostic screening for detection of breast cancer. The fact that Nature’s Treasure’s included the Quack Miranda Warning – that its “products are not intended to diagnose, treat, cure or prevent any disease” – was not the “get-out-of-jail-free” card the company apparently hoped for. As the FDA pointed out, that is exactly what the company claims for thermography: that it can diagnose disease.
We’ll get back to the company’s bogus claims in a minute, but first, some background on thermography.
Thermography’s deficiencies
SBM’s own breast cancer expert, Dr. David Gorski, covered thermography for breast cancer detection back in 2010:
What is thermography and how is it used to detect breast cancer? As its name implies, thermography measures differences in temperature. Most systems use infrared imaging to achieve these measurements. There’s nothing magical about it; the technology has been in use for various applications for decades. The rationale for applying thermography to the detection of breast cancer is that breast cancers tend to induce angiogenesis, which is nothing more than the ingrowth of new blood vessels into the tumor to supply its nutrient and oxygen needs. A tumor that can’t induce angiogenesis can’t grow beyond the diffusion limit in aqueous solution, which is less than 1 mm in diameter. These blood vessels result in additional blood flow, which results in additional heat. In addition, the metabolism of breast cancer cells tends to be faster than the surrounding tissue, and cancer is often associated with inflammation, two more reasons why the temperature of breast cancers might be higher than the surrounding normal breast tissue and therefore potentially imaginable using infrared thermography.
The problem is, as he pointed out, claims of “integrative” physicians, naturopaths, chiropractors and homeopaths notwithstanding,:
- There aren’t any baseline measurements of sensitivity and specificity.
- There are no widely agreed-upon standards for test performance and interpretation.
- Even if there were accepted standards, we don’t know whether thermography is cost-effective.
- There is the potential for over-diagnosis and over-treatment even if, as promoters claim, lesions are detected 5-10 years before mammography.
- Even as an adjunct, thermography doesn’t provide any information that a breast MRI doesn’t provide, and provide better.
Just this month, UnitedHealthcare issued a new Medical Policy on Thermography, reviewing the evidence. It included a 2012 systematic review finding that
currently there is insufficient evidence to support the use of thermography in breast cancer screening. The authors stated that there is also insufficient evidence to show that thermography provides benefit to patients as an adjunctive tool to mammography or to suspicious clinical findings in diagnosing breast cancer.
The Medical Policy noted that the American Cancer Society (ACS), the American College of Radiology, and the American College of Obstetricians and Gynecologists (ACOG) do not recommend thermography for breast cancer detection. According to the ACS:
Thermography failed to detect 3 out of 4 cancers that were known to be present in the breast. Digital infrared thermal imaging (DITI) which some people believe is a newer and better type of thermography, has the same failure rate.
The American College of Clinical Thermography says that women with dense breasts can benefit from thermography, a claim rejected by the ACOG.
UnitedHealthcare notes that Medicare won’t cover thermography and neither will it, for anything:
There is insufficient evidence to conclude that thermography has a beneficial impact on health outcomes. The available evidence is limited and weak, and standards for image evaluation and cut-off values that would allow clinical recommendations based on this technology have not been established.
The FDA’s own consumer information recommends that
despite widely publicized claims to the contrary, thermography should not be used in place of mammography for breast cancer screening or diagnosis.
The FDA notes that it has previously issued warning letters to practitioners making misleading claims, including well-known anti-vaccinationist and quackery promoter Joe Mercola. (The link to the letter is no longer good, but you can find out more about the case on Quackwatch and in the Chicago Tribune.)
In sum, practitioners cannot legally advertise that thermography is a substitute for mammography or promote it as a stand-alone diagnostic tool for breast cancer. However, thermography devices have been cleared by the FDA for use as an adjunct, or additional, tool for detecting breast cancer, even though there is no reliable evidence it is useful for that either. With that in mind, let’s look at how the FDA saw through Nature’s Treasures claims.
Nature’s Treasures: Quackery galore, including thermography
Nature’s Treasures is run by Los Angeles-area “holistic health counselor and natural health educator,” who, oddly enough, doesn’t tell us her name in her bio. We can presume she is Raya Shanazarian, the person to whom the warning letter is addressed. She claims she “studied naturopathy” at “Trinity College,” (maybe Trinity School of Natural Health?) and received a diploma from Ashworth College in 2015, the same year this online school settled FTC charges it misled students about career prospects and transferability of credits. (An $11 million judgment was suspended based on the school’s inability to pay.)
Shanazarian is not a licensed California health care professional of any sort and seems to be skating mighty close to the unlicensed practice of medicine, although she may come under the aegis of California’s generous quack protection act, otherwise known as a “health freedom” law. That someone so grossly unqualified to offer medical advice and treatment practices openly is a testament to the sorry state of healthcare regulation in California. At least the FDA is taking action.
Shanazarian advertises all sorts of quackery on her Nature’s Treasures website. This, also from her bio, will give you the flavor of where she’s coming from:
I want people to know that the root cause of disease stems from the accumulation of toxins in the body, and daily exposure to a toxic living environment. These toxins come from air, water, genetically modified foods, pesticides, meat, dairy, soy, white flour, table salt, MSG (Monosodium Glutamate), microwaved foods, refined sugar, artificial sweeteners, caffeine, alcohol, electromagnetic radiation, heavy metals, parasites, industrial chemicals, prescription drugs and more.
In addition to her thermography claims, the FDA is warning her to take down statements regarding various nostrums she sells, such as:
- “Oxicell is the best choice for Liver Disease or Cancer.”
- “Dysbiocide . . . treat[s] patients suffering from stomach parasites.”
- “Colostrum LD Capsules . . . eliminate[s] harmful pathogens and fight[s] infection.”
- “NeurO2 . . . support[s] during neurodegenerative states, hypoxia states, stroke recovery, brain injury recovery.”
Clicking on “Thermography” takes you to the website of Thermography Today, also owned by Shanazarian, which offers both full body ($375) or breast ($275) thermography. With each, you get a report of the results, a consultation with Shanazarian, and “nutritional advice based on the report,” an obvious pretext for recommending dietary supplements and other dubious remedies of the sort Shanazarian sells on the Nature’s Treasures website.
The thermograms are presumably read by the two “doctors we work with,” “Dr. Ben Johnson, MD, NMD, DO,” who lives in Georgia and owns his own thermography firm in Chattanooga, Tennessee, and Gregory Melvin, a chiropractor.
So, what is Shanazarian saying about thermography that got caught the eye of the FDA? From the warning letter:
On the webpage titled “Breast-Cancer-Awareness”:
- “[A]ll women 25 and older should get annual Thermography screenings…”
On the webpage titled “Mammography Vs Thermography”:
- “[T]hermography looks for the body’s physiological response to cancer cells. These changes can often occur 8-10 years before the cells are large enough to be seen by a mammogram.”
- “Thermography can detect the possibility of breast cancer much earlier…”
- “Breast Thermography has: 99% Sensitivity, 90% Specificity, 90% Accuracy.”
- “Thermography is far more sensitive than mammography.”
- “Thermography benefits all women. They may be particularly useful for young women who want to monitor their breast health should start as early as possible.”
On the webpage titled “What is Breast Thermography”:
- “As more and more women become knowledgeable in thermography they choose not to do mammography.”
- “I myself have not done mammography since 2006, but have gone through the procedure of ultrasound twice.”
The FDA also found fault with Shanazarian’s description of the thermography process:
The webpage titled “What to Expect” discusses step-by-step how your firm uses the devices during an appointment. For example, Step 3 explains, “Your pictures will be sent out to our reading physician for analysis,” and Step 4 states, “We will set up an appointment to see you in ten days after your results have come back to us. You can share the report with your medical doctor and if he has further questions he can contact the doctor who read your report…” Step 5 concludes that “You will be recommended when to do your second thermography by the reading doctor.” This discussion promotes the use of the thermographic system with a report provided based solely on the thermographic image.
I had to chuckle when I read the part about sharing the report with your medical doctor. I’ve wondered what real physicians do when confronted with these worthless reports by patients who are understandably alarmed by the results. How do you tell a patient who has just shelled out $275 for breast thermography (and who may have shelled out even more for dietary supplements presumably indicated by the report) that she’s just wasted her money without alienating the patient?
It is interesting to note that while Shanazarian touts the putative advantages of thermography over mammography and says that she doesn’t use mammography, she never comes out and says that thermography is an actual substitute for a mammogram or that it is alone sufficient for diagnostic screening. Note also the FDA’s language about promoting the use of thermography “with a report based solely on the thermographic image.” This tells me that, if a practitioner is going to offer thermography for breast cancer screening, she’d better steer clear of the type of statements Shanazarian used, or make it absolutely clear that it is no substitute for mammography and is approved for adjunctive use only, although there’s no guarantee a qualifier would overcome statements like Shanazarian’s. I even question whether, based on the FDA’s warning, a practitioner could recommend thermography prior to mammography and without some rationale for why another diagnostic method is needed and a clear indication of what diagnostic uncertainty thermography is designed to clear up. Otherwise, she risks running afoul of the FDA.
Unfortunately, based on this testimonial on Thermography Today, discouraging mammography appears to be exactly what is happening:
I want to thank everyone who has been involved in the science of thermography. I am in my late 30s and I know I should not do mammogram.
Nor did the FDA approve of Shanazarian’s claims that “Digital Infrared Thermal Imaging is approved by the F.D.A.,” a statement the agency found “misleading . . . because such statements create an impression of official approval” when, in fact, the “FDA has never approved any telethermographic system for sole diagnostic screening . . .”
Shanazarian has 15 days to come up with a plan to comply with the law. If the violations are not corrected, they are punishable by up to one year in federal prison, five years’ probation and a fine of either $100,000 or twice the gain from the offense.
It is good to see the FDA going after cancer quackery, a “specialty” the agency has, unfortunately, aided and abetted in other cases. It is also good that the FDA included thermography among products it considers as making illegal cancer claims. Not that quacks care all that much about regulatory compliance, but at least the FDA’s action should make it clear to them that even implying thermography is in and of itself efficacious for breast cancer detection may cause the FDA to pull the plug on their claims.
