By Charlie Fidelman, Gazette Health Reporter, June 5, 2009
It will be weeks before Lauren Wolfe finds out whether her tissue samples will need to be retested for breast cancer. It will be months more before hundreds of Quebec women will finally get an answer: did I get the right treatment?
The provincial health department has ordered 2,100 new tests after a tiny pathology study exploded on the Quebec scene last week, suggesting that 15 to 30 per cent of breast cancer tests were botched – throwing patients in a panic about the reliability of their tests and health status.
These patients want results yesterday,” said Wolfe, 30, a Montreal resident. “I just had a biopsy a month and a half ago. … This is very scary coming after a mastectomy.
“Many women have gone on with their lives and now they have doubts. It’s brought it all back again and it’s frightening,” Wolfe said. “It’s a lousy situation for patients and pathologists, but maybe this is the way of progress?”
Some critics say breast cancer patients were being held hostage in a political spat between the province and its medical specialists. Additional wait times are a nightmare for patients already dealing with such a disease. But maybe it was all worth it because the end result will benefit patients.
Not only are Quebec’s ill-equipped, underfunded and short-staffed laboratories under a microscope, but the government was forced to revise its standards and is now setting up a universal quality control program.
Effective immediately, all provincial labs will be required to have external audits of their tests. Some labs are already doing that.
How did a study with only 15 samples go so far?
Pathologists have long warned of a potential crisis for patients because of poor equipment and understaffing – but no one was listening, said surgical oncologist John Keyserlingk, head of Ville Marie Women’s Health Center.
“The only way they felt they could get results – and fast – was to bring it out in the public,” Keyserlingk said.
It caused women enormous anxiety, but within days Quebec had an experts committee in place, he said.
The Health Department is juggling several files while pathologists are at work in hospital basements, largely forgotten, he said.
When Quebec Pathologists Association president Louis Gaboury unveiled his study on the faulty lab tests last Wednesday, he likened the Quebec situation to Newfoundland, where 100 women died because of misdiagnosis and wrong treatment.
Gaétan Barrette, head of Quebec’s federation of medical specialists, said problems in the labs are long-term and systemic. It’s not just breast cancer tests that are at risk but all cancer testing, Barrette said.
Health Minister Yves Bolduc lashed back with accusations of fear-mongering.
Quebec is already working on provincewide quality control measures for its pathology labs, he said.
In the interest of transparency and accuracy, Bolduc had a committee of experts review the study.
The experts’ report blamed the media for “contributing to general confusion” in reporting the results.
But then the association of laboratory technicians revealed a letter sent to Bolduc in February warning that non-professionals and untrained personnel processing lab exams were putting patients at risk.
“About 85 per cent of decisions that doctors make about the diagnosis and treatment of their patients are based on lab tests,” said Nathalie Rodrigue, president of the Ordre professionnel des technologists médicaux du Québec.
Rodrigue blamed budget cuts, understaffing and a profession that is unregulated. “The danger is that anyone can do the analysis.”
Some 6,000 women are diagnosed with breast cancer in Quebec every year. They are entitled to know that they are getting reliable results, said Carol Secter of Breast Cancer Action Montreal, an advocacy group.
“The issue was not blown out of proportion,” she said. “Don’t enfantilize us – give us the information.”
André Robidoux, the experts committee’s chairman and breast cancer researcher at the Centre hospitalier de l’Université de Montréal, said variations are not necessarily errors but reflect differences in reading pathology reports.
Also, the Quebec situation differs from the one in Newfoundland where abnormalities in hormone receptor tests were found in a single lab, he said.
In 20 to 30 per cent, there are disagreements between labs and individuals on whether a result is negative or positive because of variables in technique and interpretation, said Jared Schwartz president of the College of American Pathologists, a world authority on lab quality control and accreditation.
“The problem is that there is no gold standard anywhere on how you call a specific test positive or negative,” Schwartz said, also co-chair of an international team that’s developing universal guidelines on process and criteria that pathologists will use.
“We are trying to get rid of the variables to get it down to 10 per cent discordance.”
St. Mary’s Hospital Centre is the only Quebec facility to have a CAP accreditation, and it took a decade to achieve, said chief pathologist Ron Onerheim. No quality control program is a red flag, he said.
For Onerheim, the message at the end of the day: “It shone light on a chronic problem and I’m glad for that light because maybe we can move forward and start to improve. Something positive will come out of this for patients and the system as whole.”