'Cease and desist' letter stops diagnostic test cold

A private physiotherapy and holistic treatment clinic in St. John's has stopped offering a thermal imaging test promoted as a way to identify breast cancer years before a mammogram can detect a tumour.

Newfoundland and Labrador Health Minister Susan Sullivan says she wrote the clinic Tuesday — the same day a CBC News investigation into the service, called thermography, was aired.

“Thermography is not regulated in the province of Newfoundland and Labrador, which is precisely why I have indicated to this particular company that they should not be offering this particular service in Newfoundland and Labrador, and I’ve asked them to cease and desist," Sullivan said.

“They have contacted me since I’ve sent that letter to them, and they have told me that they will be fully compliant. And as of right now, they are no longer offering the service.”

The minister says she was unaware thermography tests were being provided in the province.

“Frankly, a service like that ought not to be offered here in the province unless they have written permission and consent from the Department of Health and Community Services to offer that particular service," Sullivan said. "They had not requested that.”

She says the health department plans to set up meetings to have further discussions with the company.

Asked if the service could be offered again if the department is satisfied by those talks, Sullivan said: “I’m not going to speculate on that. We need to have the conversations.”

Cancer experts worldwide say there is absolutely no proof thermography works, and they are warning women to have nothing to do with it.

Those experts say the procedure is a waste of time and money.

"It's not effective at detecting breast cancers,” said Gillian Bromfield, senior manager of cancer control policy at the Canadian Cancer Society.

“It misses the large majority of breast cancers and, on top of that, it also detects cancers when there actually are none."

Locally, the service is offered by Avalon Laser Health in east end St. John’s.

Thermography uses a heat-sensitive infrared camera to take images of the body.

While experts are critical, those behind the camera defend the service they offer, and say it’s all about how thermography is presented.

"There's a lot of misinformation out there everywhere, and there are a lot of people who are relatively unethical about what they express to their clients,” Clare Barry of Avalon Laser Health told CBC News.

“We're very careful. It is simply additional information. It is a screen that provides information about the function of the breast. It does not provide any anatomical information whatsoever.”

To find out what happens at the clinic, CBC News sent an undercover reporter to Avalon Laser Health.

The CBC’s undercover reporter paid $215 recently for a nurse to take thermal images of her breasts.

When the reporter returned to get her results, she was told that she had a hormone imbalance — something that's usually found with a blood test.

She was not advised to get a mammogram, but instead return for another thermogram in three months time.

The images are not interpreted in Newfoundland — or in Canada, for that matter.

They are sent to a company based in Florida.

The undercover reporter’s results were sent on from there for review to a family physician in Texas.

Back in St. John’s, Clare Barry of Avalon Laser Health concedes that thermography is not licensed as a diagnostic test by Health Canada.

“To my knowledge, it is not approved as a breast screening tool," she said.

But on its website, Avalon Laser Health does sell thermography that way.

Under the heading “early disease detection,” the company notes that thermography “is best known for its role in screening for breast cancer.”

A video promoting thermography — and making negative claims about mammography – is part of that sales pitch.

But, in the United States, when a similar video was used by a company to make the same claims, the federal health watchdog jumped in.

The Food and Drug Administration issued a letter warning the claims are “a violation of the law.”

Within days of CBC News asking Avalon Laser Health about its online claims, they were scrubbed from the company’s website.

The new message in its place: “This section will be updated shortly. Sorry for any inconvenience.”

Contacted afterwards, the clinic said the nurse provided the wrong information.

Local health officials have a big problem with claims touting the benefits of thermography in diagnosing breast disease.

Nancy Wadden is a St. John’s doctor who chairs the mammography accreditation program of the Canadian Association of Radiologists.

“There are companies that are charging over $100 for a test that is actually useless,” Wadden said.

Wadden, who created the provincial breast screening program, says relying on thermography is akin to calling heads or tails to find out if you have a deadly disease.

"This is of no use whatsoever,” she told CBC News.

“You might say, ‘Well, this makes me feel better.’ Well, it really shouldn't make you feel any better. It's just like flipping a coin. If the thermogram is positive, it really means absolutely nothing."

In fact, Wadden says, companies like Avalon Laser Health are making her job harder.

"These women have a significant number of false positives, so then they are coming and they are clogging up my ultrasound list and my mammogram list and then displacing the people who really need to have the test, who are waiting there,” Wadden said.

“Their length of time to get a diagnosis is prolonged, because we’ve got people who have had this useless test that has given a false positive result.”

Thermography appears to fall into a regulatory grey area in this country.

Health Canada approves medical devices and prohibits false or misleading advertising of health claims.

A federal spokeswoman says Health Canada would take action if a manufacturer was making misleading claims.

There is no evidence that has happened in relation to thermography devices.

The feds say it is up to the provinces to take action against clinics which are doing the same thing.

A CBC News investigation has identified dozens of clinics providing the service across the country.