← Bad Devices

What the Reading Laboratory Published

The clinics take the pictures. Somebody else reads them. In 2013 the man who runs the American laboratory at the far end of that chain published a two-part review of the breast thermography literature — and almost every claim used to sell the scan is contradicted somewhere in his own pages.

A breast thermogram is produced in two places. A clinic captures the image — often in a rented room, sometimes in a mobile unit, frequently by a technician who trained for a matter of weeks. The image is then sent somewhere else to be interpreted, and the interpretation comes back as a graded report. One reader, many clinics documents how few readers there are.

One of them is Therma-Scan Reference Laboratory of Mesa, Arizona, which describes itself on its own front page as the source of analysis and reporting for network partners in the United States and Canada. Its principal is Philip P. Hoekstra III. In 2013 he and a co-author published a two-part review of the breast thermography literature in Thermology international, the journal of the European Association of Thermology.

It is not a critical paper. It is written from inside the field, it is sympathetic to the technique, and it argues for a role for thermography as an adjunct. That is exactly what makes it useful. The concessions in it are not concessions extracted by a sceptic. They are the working assumptions of the industry's own reader, stated in a scientific journal, and they are irreconcilable with what women are told at the point of sale.

What this page is, and two things it is not.

It sets twelve marketing claims beside the passages of those two papers that bear on them. The left-hand column is drawn from breast thermography marketing published in Ontario and read in July 2026; the right-hand column is quoted or closely paraphrased from the published review, with page references.

It does not claim that any particular Canadian clinic sends its images to this laboratory. Some Canadian clinics have; the network documented in One reader, many clinics reports through a different hub in Toronto. The comparison here is between an industry's own published evidence review and that industry's own advertising. It is not an allegation about a commercial relationship.

It names no clinic. The claims below are all in current circulation and several appear on more than one site, but a claim quoted from a webpage needs a dated capture behind it before a name is attached to it. That is the same discipline applied on What the newspapers ran. If you operate a clinic and believe a claim here misstates what you publish, write to us and it will be corrected.

The two documents

Both parts appeared in volume 23 of Thermology international in 2013, under the same two authors, with a Therma-Scan Reference Laboratory address for correspondence.

The source documents for everything in the right-hand column below.
PartCitationWhat it contains
Part I Hoekstra PP III, Steffek AE. “A Review of the History of Thermography in Breast Cancer Detection — Part I: Thermography Facts and Statistics.” Thermology international 2013;23(1):5–16. A narrative review of twenty trials published between 1961 and 2004, with a large comparison table and recalculated diagnostic values for three of the studies. Received September 2012, accepted February 2013.
Part II Same authors, “… Part II: Questions and Answers.” Thermology international 2013;23(2):43–55. Five questions arising from the literature, each with a stated answer: whether thermal features define cancer, what size lesions are detected, whether malignant can be distinguished from benign, which lesion types are detected, and whether the technique is a useful risk-assessment model.
On the journal. Thermology international is published by the European Association of Thermology and indexed in EMBASE/Excerpta Medica. It is also the stated organ of the American Academy of Thermology and of the Brazilian, Polish and UK thermology bodies. It is, in other words, the field's own journal — not a hostile venue. Manuscripts are read by two reviewers and copyright passes to the publisher on acceptance, which is why this page paraphrases rather than reproduces.

Claim by claim

Twelve claims used to sell breast thermography, set against the published position of a reading laboratory that interprets the scans. Marketing read July 2026.
The claim What his own review says Comment
An early warning “up to 10 years” ahead of other methods.
Contradicted
Part I, Table 4b. Diagnostic values recalculated from a screening cohort of 10,229 women, for the cancers that appeared five years after the scan: sensitivity 28.3%, positive predictive value 0.7%, with 2,540 false positives. This is not an adjacent question, it is the same question. The claim is prediction of future cancer; the table measures prediction of future cancer. On those figures the scan misses roughly seven of every ten cancers that go on to develop, and more than ninety-nine of every hundred positive results are wrong.
It finds the smallest cancers, “even pre-cancer.”
Contradicted
Part II, answer to Question 3. Thermography does not consistently differentiate malignant lesions from benign breast conditions or from healthy tissue; what it identifies is heat asymmetry indicating the need for a follow-up examination. Part I adds that it gives no information about the cellular composition of a lesion, does not see depth, and does not define size. The pre-cancer claim and the review contradict one another. Both originate with the same company — the claim on its website, the review under its principal's name.
“FDA approval for breast thermography since 1982.”
Not accurate
Therma-Scan's own front page states the position correctly: the FDA lists thermology as an adjunctive modality alongside physical examination, mammography, ultrasound and MRI. There is no FDA approval of breast thermography, and the word matters. Under 21 CFR § 884.2980 a telethermographic system intended for adjunctive screening is Class I; one intended for use alone as the sole screening tool is Class III and has required premarket approval since 28 May 1976. The reading laboratory states the limit accurately. The clinic advertising does not.
Images are analysed and rated to determine the risk of developing cancer — the TH-1 to TH-5 scale.
Contradicted
Part I. Asymmetric thermal profiles are not, in and of themselves, indicators of any particular state of the breast tissue. The listed alternative causes include oral contraceptives, oestrogen-related vasodilatation, the menstrual cycle, pregnancy, trauma, infection, benign lesions and inflammation. A graded score tells a woman that the pattern in her image means something specific about her cancer risk. The review says the pattern does not carry that meaning. The scale converts an ambiguous finding into a number, and a number is what gets acted on.
Staff will assess the images and determine a course of treatment, then re-scan months later to show the breasts have responded.
Not supported
Parts I and II state the same endpoint in the same terms: thermal asymmetry is an indication for a follow-up examination. Neither paper supports treating a thermogram. The only action the field's own literature endorses is further examination. A lower grade on the second scan is also fully consistent with the confounders listed in the row above — a different point in the cycle would do it. Where the person setting the treatment plan holds a licence in a regulated profession, the scope-of-practice question belongs to their college.
“More than 800 peer-reviewed studies.”
Overstated
Part I is built on twenty trials published between 1961 and 2004, described by the authors as highly heterogeneous in design, evaluation criteria, populations and results. Twelve were weighted more heavily than the rest. The industry's own reviewer, setting out to assemble the best available evidence, found twenty usable studies — and none of them newer than 2004.
A “second line of defense”; women should stop the “wait for a lump” approach.
Contradicted
Part II, summary. As a stand-alone technique thermography has limited value, principally because it cannot consistently distinguish benign from malignant conditions, and it cannot give the location or size of a tumour to guide a biopsy. The review positions the scan as an adjunct to established imaging. The advertising positions it as an alternative entry point into breast care — something a woman does instead of waiting, and in practice instead of screening.
Scans are performed and interpreted by certified clinical thermographers.
Undercut
Part I names as probably the most confounding factor in the entire literature the absence of uniform criteria for what counts as an abnormal thermogram, for how scans should be interpreted — skill and experience vary widely — and for how data should be reported. Only six of the twenty studies stated any temperature threshold for normality at all, and those ranged from 0.5 °C to 1.5 °C. A certificate implies a standard to be certified against. The review says the standard does not exist. And where the body issuing the certificate, the person who did the training and the laboratory reading the images are the same commercial interest, there is no independent step anywhere in the chain.
High accuracy, usually traceable to a single study reporting about 97% sensitivity.
Named as misuse
Part II, discussing that study: private clinic websites offering thermography as a breast cancer screening tool often cite it as evidence that benign and malignant lesions can be distinguished — and every patient in it had already been referred for biopsy. False-positive rate about 86%; specificity 14%; overall accuracy 32%. He identifies the misuse himself, and identifies the category of website committing it. This is the row a clinic operator would find hardest to answer, because the objection is not ours.
An abnormal scan that finds nothing is an early warning justifying continued monitoring.
Unfalsifiable
Part I, Table 4a. In the same screening cohort, at the time of the scan: 2,444 false positives among 10,170 women without cancer — roughly one woman in four — with a positive predictive value of 1.5%. Reframing a false positive as an early warning makes the test unfalsifiable, because every wrong result becomes further evidence for the test. It also has a commercial consequence that should be stated plainly: it converts about a quarter of healthy clients into returning ones.
An abnormal result means the problem was caught early.
Reversed
Part II, Table 3. Cancers missed by thermography had better survival than those it detected — five-year survival 30% for the “hot” tumours against 80% for the “cold” ones (Isard, 1988). Accuracy was also higher in a deceased patient group (88%) than in a living one (65%). The technique preferentially detects fast-growing aggressive tumours and misses indolent ones. An abnormal thermogram is therefore closer to a poor-prognosis marker than to an early-detection success — which is the opposite of what the reassurance in the consulting room conveys.
Thermography was unfairly sidelined and modern equipment has vindicated it.
Half true
Part I. In 1978 the National Cancer Institute recommended that thermography be discontinued and it was removed from the Breast Cancer Detection Demonstration Project, largely because of inconsistent results from poor image quality and temperature resolution and high false-positive rates. The equipment has genuinely improved; that half is true. But the review's own figure charts the rise and fall of publication on the subject, and the twenty trials it rests on stop in 2004. Better cameras have not produced better evidence, and the false-positive problem that ended the BCDDP involvement is the same problem Table 4a describes.

The sentence in the abstract

The most damaging line in either paper is not buried in a results table. It is in the summary at the head of Part I, where the authors describe the state of the field before reviewing it.

They write that thermography is currently used to detect breast cancer predominantly in small private clinics, and usually as an early screening modality prior to mammograms. They then state that in spite of its low cost and its safety, there is little reliable, publicly available evidence on its effectiveness in detecting breast cancer.

The description of the business is exact, and the verdict on the evidence is delivered in the same breath.

Read that against the clinic sales pitch. A woman is told the scan detects abnormality years before a mammogram could, that it is a second line of defence, and that hundreds of studies support it. The laboratory principal writing in the field's own journal says the evidence for effectiveness is thin, that the technique cannot reliably tell a cancer from a cyst, and that the appropriate response to an abnormal image is another examination. Both statements were in circulation at the same time. Only one of them was addressed to the patient.

What Part I concedes about the field's own methods

Four admissions in Part I are worth separating out, because they concern the conduct of thermography rather than its results, and they answer the defence that the criticism comes from outsiders who do not understand the technique.

An operator said the same thing, twenty-four years ago and on the record. In June 2002 the naturopath hosting a thermography clinic in Owen Sound told the Sun Times that physicians took a dim view of the technique partly because it remained an unregulated occupation practised by people of varying qualifications using a range of different equipment. That is the operator end of the trade making the same admission as the reading end — a generation apart, and neither of them a critic. The full exchange is on What the newspapers ran.
QuackeryWatch comment

Everything above this line is checkable against two published papers. Everything below it is our argument.

The usual shape of a story like this one is that critics say a thing does not work and vendors say it does, and the reader is invited to choose a side. That is not the shape here. On every substantive question — whether the scan distinguishes cancer from a cyst, whether it predicts cancer years ahead, what an abnormal result should lead to — the vendor's own reviewer agrees with the critics. He simply publishes it in a journal that patients do not read, in language that patients would not be given.

We think that gap is the whole business model. It does not require anybody to lie. The laboratory can interpret images accurately and report them honestly; the review can be careful and hedged; and a woman in Milton or Kitchener can still be told she is buying ten years of warning, because nothing carries the review's caution down the chain to her. The clinic is not quoting the paper. It is quoting the brochure.

And the incentives all point one way. A grade of TH-1 sells reassurance and a repeat scan next year. TH-2 and TH-3 sell preventive therapies. A false positive — one woman in four — sells monitoring. There is no result on the scale that ends the relationship, and no result that sends the client anywhere else. A test whose every outcome generates further business is not being used as a diagnostic. It is being used as an intake.

None of that is an allegation of dishonesty against any individual. It is a description of what happens when the caveats live in one document and the marketing lives in another, and only one of them is written for the customer.

What would settle the remaining questions

  1. A dated capture behind every claim. The left-hand column above is quoted from live marketing but is deliberately unattributed. Archived captures with dates would let each row name its source, which is what turns a comparison into a citation.
  2. Confirmation of where Canadian images are actually read. The laboratory says it serves network partners in Canada; the Ontario network documented on this site reports through Toronto. Both can be true. A clinic's own consent form or report letterhead would settle it clinic by clinic.
  3. Whether the European Association of Thermology certifies facilities. Therma-Scan's site describes itself as a certified facility of that association. The association's own stated purposes — as reproduced on the company's website — are research, exchange between national associations, dissemination and contact-building. None of them is certification. A direct answer from the association would resolve it.
  4. The two papers carry no conflict-of-interest declaration. The article immediately following Part II in the same issue does carry one. A review of the evidence for a technique, written by the head of a laboratory that sells the reading of it, is exactly the case such declarations exist for.

What this page does not claim

Sources

Hoekstra PP III, Steffek AE. “A Review of the History of Thermography in Breast Cancer Detection — Part I: Thermography Facts and Statistics.” Thermology international 2013;23(1):5–16, and “Part II: Questions and Answers,” 2013;23(2):43–55. Both published by the European Association of Thermology and available from that association's journal archive. Figures for sensitivity, specificity, predictive value and accuracy are as printed in the authors' own tables. The classification rule is 21 CFR § 884.2980. Company statements are from the laboratory's public website, read July 2026. Marketing claims are from Ontario breast thermography clinic websites, read July 2026.

The journal transfers copyright to the publisher on acceptance and the company's website carries an express no-reproduction notice, so this page paraphrases throughout and quotes only short phrases.

Corrections

If any row misstates what the review says, send the page and line and it will be corrected the same week. If you operate a clinic and believe a claim in the left-hand column misstates your own material, write and we will amend or remove it. Corrections that weaken the argument above will be published on the same terms as any other.

Related pages