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Antiquated regulations and the refusal of some provinces to fund positron emission tomography (PET) scans means patients are denied a diagnostic tool that is standard in most industrialized countries, say Canada's leading radiologists and nuclear medicine physicians.
The Canadian Association of Radiologists (CAR) and the Canadian Society of Nuclear Medicine are speaking out about Canada's lag in using PET scanners, which they believe compromises patient care.
“I'm not proud to be in the diagnostic imaging field [in Canada],” says Dr. Jean-Luc Urbain, chair of nuclear medicine at St. Joseph's Health Centre in London, Ont. “I'm ashamed … not to be able to provide … the diagnostic imaging tool — the service — that [patients] not only deserve, but also pay for when they pay their taxes.”
There are 12 PET scanners in Canada, including 2 at private clinics in Quebec and British Columbia. Of the remaining 10, only 3 are available for clinical use; the others operate under research protocols for clinical trial participants.
There are 2 major barriers to wider use of PET scanners. First, only BC, Alberta and Quebec reimburse for the cost of the PET scanning. In other provinces, such as Ontario, physicians often have to send patients to the US for PET scans, at a cost of about $4600 per patient — a cost Ontario sometimes reimburses. Meanwhile, Urbain's facility was forced to shut down its PET scanner because of a lack of money from the nuclear medicine department. It would cost about $2000 per patient if Urbain could use his facility's machine. “It's ludicrous,” Urbain says.
The second barrier is the lack of availability of fluorodeoxyglucose (FDG), the radioactive tracer used to highlight molecular activity on the imaging scans. Health Canada has not approved the drug because, it says, no manufacturer has applied.
It's a classic Catch-22, says Dr. Karen Gulenchyn, chief of the department of nuclear medicine at Hamilton Health Sciences. Canada's lack of PET scanners means US manufacturers of FDG don't believe there's a market to warrant a drug submission here, but one reason for the paucity of PET scanners is the difficulty in securing FDG.
Hospitals such as the Hamilton facility, which can produce FDG, now have to submit a clinical trial application and apply to become manufacturers. That's the only way they can legally produce FDG to use when scanning patients in approved trials.
Gulenchyn and her staff recently spent 6 months preparing and filing a 17-volume clinical trial application for Health Canada so they can use FDG in their PET scanner. The process cost about $500 000.
“The regulations were never intended or promulgated to deal with this particular type of a drug,” Gulenchyn says. “These are very low-risk compounds.” FDG is approved in the US, UK, France, Germany and other European countries.
In 2000, Canada ranked last among 28 OECD countries in the number of PET scanners.
Gulenchyn sits on Ontario's PET steering committee, which is monitoring the development of the technology. Ontario contends that it does not yet have proof that using PET scanners as a diagnostic tool gets results superior to those produced by a CT scan.
The requirement for new clinical trials is a duplication of efforts, says Normand Laberge, CEO of CAR. “It is a proven tool for cancer cases. A lot of studies have shown that it saves money for the health care system.”
Urbain says there have been 5000 studies on PET scanners in the past 20 years. In his native Belgium, PET scans are reimbursed for 3 indications: myocardial viability, recurrence of colorectal carcinoma and the diagnosis of epilepsy. Turkey, China and Hong Kong also reimburse for scans. In the US, Medicare reimburses PET scans for the diagnosis and staging of Alzheimer's disease, as well as for use in oncology and cardiology.
PET scans can stage cancer and are extremely useful to assess the efficacy of chemotherapy and radiation, Urbain says. With a PET scan, doctors can see a tumour's response within 2–3 weeks. Cardiothoracic surgeons can use PET scans to assess myocardial viability.
As Canada continues to debate the use of this technology, PET scanners have been surpassed by the next generation of technology: combined PET/CT scanners. Canada's cautious approach means there is a “lag-time, when patients are receiving lower-quality health care than they should, which opens the door to privatization,” says Laberge.
Canada is also falling behind in training its radiologists and nuclear medicine physicians and technicians, say Urbain and Laberge.
“I can barely train my residents and fellows, because we don't do enough cases and we don't do enough cases because we don't get reimbursement for it,” Urbain says.
Meanwhile, Gulenchyn is left waiting for her CT application to crawl through the approvals process at Health Canada. “One therapeutic radiologic was just approved after having been in the pipeline for 1000 days — 3 years,” she says gloomily.