Picco orders review of Rankin Inlet cancer clinic scheme

Facing political pressure from Ottawa, Ed Picco, Nunavut’s health minister, told his officials this week to “review the status” of a controversial scheme to set up a private diagnostic service in Rankin Inlet for breast cancer.

Piruqsaijiit Ltd. of Rankin Inlet, owned by a group of Kivalliq-based real estate firms, wants to import a new computerized laser scanning device from a manufacturer in Fort Lauderdale, Florida, and then use it to provide a for-profit service.

The device uses a new technology called Computed Tomography Laser Mammography, or CTLM. It works by using a laser beam to send a full-colour, three-dimensional image to a computer screen.

Picco said officials from the federal health department have already called his office to ask questions and express concerns that Piruqsaijiit’s for-profit proposal would violate the Canada Health Act.

“I want to say that, politically, there have been concerns raised by the federal government with regards to this clinic,” Picco said.

Under the Canada Health Act, private health-care providers may not accept fees from private clients and participate in provincial or territorial health insurance plans at the same time.

“Diagnostic screening by a private clinic would violate the Canada Health Act, and that red flag has already been raised by the federal government. I’ve already been contacted by the federal government asking if we are allowing this to occur,” Picco said.

It’s Ottawa’s policy to withhold funding from any provincial or territorial government that supports private clinics used by affluent clients who can afford to buy their way around lengthy waiting lists for diagnostic services.

Since Ottawa pays for virtually all of Nunavut’s health-care costs, this could have serious consequences for Nunavut, Picco said.

“In our case, 98 cents of every dollar, directly or indirectly, comes from the federal government,” Picco said.

Right now, Picco said, the Nunavut government’s health-insurance system covers the cost of diagnostic mammograms for any patient — as long as they’re medically necessary and recommended by a doctor.

But the health-insurance system won’t pay for tests requested by people who simply want peace of mind.

Since breast cancer rates in Nunavut are the lowest in the country, the number of Nunavut residents who have medically necessary mammograms is very small.

“The number of people who are medically referred for screening here in Nunavut is so minuscule it’s not even worth talking about,” Picco said.

Piruqsaijiit Ltd. may not legally use its laser scanner in Canada anyway. Neither Health Canada nor the United States Food and Drug Agency have given permission to use the device in either Canada or the United States.

The Nunavut government will not endorse an unproven technology, Picco said.

“Basically what we’re trying to do is to reiterate our point that for this type of diagnostic screening, we’re not trying to open up the flood-doors and let new technologies in here that have not been tried or tested,” Picco said.

A communications officer with Health Canada told Nunatsiaq News last week that the department cannot comment on any application for the approval of a medical device.

In the United States, the FDA is still waiting to receive an application from Imaging Diagnostics Systems Inc., the Florida-based company that makes the scanner.

Deborah O’Neill, ISDI’s vice-president of business development, said researchers have recently finished doing clinical trials on her company’s device, and that her company is putting that information into an application it will soon submit to the FDA.

She said those clinical trials are intended to test the machine’s efficacy. In plain language, that means they’re aimed at finding out if the scanner does what it’s supposed to do.

“Once we submit that pre-market approval application to the FDA, they can approve it in 45 days, 90 days, or take a full 180 days, but not take longer than 180 days or six months to come to their decision,” O’Neill said.

But U.S. law forbids O’Neill from stating what those clinical tests reveal. Because IDSI’s shares trade publicly on a stock exchange, it falls under strict security exchange rules aimed at preventing people with inside information from trading in the company’s stock before the information becomes public.

O’Neill said the Securities Exchange Commission, which regulates publicly traded companies in the U.S., won’t even allow her to say when their application will be sent to the FDA.

That, in turn, means that there’s no way for anyone to predict when the scanner will be licenced for general use in the U.S. — or in Canada.

She said, however, that her company’s scanner could turn out to be a useful complement to x-ray based mammography.

“It’s another added tool for a radiologist to further assist in what a result might be, or what that lesion is, or whether or not the woman has a lesion,” O’Neill said.

On the other hand, O’Neill said, her company’s machine may also have weaknesses.

“There are going to be limitations on our system, because there is nothing that is 100 per cent effective,” O’Neill said.

She did say that the machine will cost about US$300,000 for customers in the United States, but will likely carry a different price for export customers.

She also estimates that the base price for a single scan would likely be US$125.