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One woman's ER/PR nightmare
Five
years ago Verna Doucette of Port au Port Peninsula,
Newfoundland, was diagnosed with having a small,
three-to-five centimetre cancerous tumour in her
right breast. Today she's at the centre of the
health scandal that's rocking the Rock.
Nearly
five years ago to the day, Ms Doucette, who was
47 at the time, had an open biopsy which led to
her being diagnosed with an infiltrating ductal
carcinoma. Tests to determine if the tumour was
receptive to hormone stimulation showed negative
estrogen receptors and progesterone receptors
less than 5%.
Almost
four years later, Ms Doucette received a letter
from her oncologist telling her that her samples
had been retested and the results were very different
indeed. Estrogen receptors were now showing 60%
and progesterone, 30%.
If
this had been known earlier, Ms Doucette would
have been offered tamoxifen, but instead she went
through a six-cycle course of chemotherapy. The
chemo brought on chest infections and reactivated
an old tuberculosis infection.
Ms
Doucette is the representative plaintiff named
in the class action lawsuit filed by lawyer Ches
Crosbie on behalf of the women.
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Shockwaves from the breast cancer
testing scandal that's rocked Newfoundland are shaking
up diagnostic standards in the province.
In late May Danny Williams' government
was forced to admit that more than 300 flawed estrogen/progestin
receptor (ER/PR) tests in the province had resulted
in inaccurate diagnoses and treatment of breast cancer
patients. At least 176 of the women are now dead.
The government is under fire because
the admission came only after the affected women launched
a class action lawsuit even though the government knew
about the problem for the last two years. Newfoundland
has now initiated a judicial inquiry to determine what
happened.
In the spirit of a new culture
of transparency, the health authority at the centre
of the scandal, Eastern Health, quickly announced the
unrelated suspension of a radiologist under review for
6,000 questionable reports on some 3,500 patients. The
government provoked the ire of the reviewing physicians
when health minister Ross Wiseman ordered them to complete
their review in just two weeks.
The two shocking cases have those
in health circles asking what happened — and what's
next?
CHILLING
DISCOVERY
The problem came to light, says Dr Kara Laing, Eastern
Health's cancer program clinical chief, when the situation
of one patient who had a negative ER/PR test made her
doctors question whether she might be positive. The
test was reordered.
Meanwhile Eastern Health had installed
a new automatic Ventana system in its immunohistochemistry
lab. Before, testing was done using a more complex semi-automatic
system. The second test with the new equipment confirmed
the doctors' suspicions. Based on this, Eastern Health
decided to do further retesting going back to 1997.
Negative samples were sent to Mount Sinai Hospital in
Toronto for an independent review.
A court analysis signed by Dr Charles
Hutton, a former provincial forensic pathologist and
currently a deputy medical examiner and forensic consultant,
suggests the number of false results could be as high
as 366; 176 of these patients have since died. Although
the cause of their deaths isn't known, 105 retests from
these patients' tissue samples also confirmed false
results.
PATHOLOGY
UNDER FIRE
No one knows yet how this happened, but the case has
highlighted two big problems on the Rock: suboptimal
testing standards and pathologist shortages.
Was Newfoundland using outmoded
equipment? Not necessarily, says Dr Jagdish Butany,
president of the Canadian Association of Pathologists
(CAP) and a pathologist at the Toronto General Hospital.
"Ten years ago, everyone was using semi-automatic systems,"
he says.
Dr Nash Denic, Eastern Health's
chief pathologist for its laboratory program, says the
health authority has since established a centre of excellence
for breast cancer pathology with a goal to improve standards.
Eastern Health will also continue sending some samples
to Toronto for quality control.
"What we should learn from this
Newfoundland case is that we need quality assurance
standards," says Dr Butany. "Ontario has standards in
place already. Why not set up a national system?" He
says CAP has struck a committee to look at standards
nationwide and he hopes to get recommendations in place
in the not-too-distant future.
PATH
DEARTH
"Newfoundland even now has the worst proportion of work
to pathologists and the worst salaries in the country,"
says Dr Butany. "They get people from everywhere who
come and stay for two years then move on. They never
have a full complement of staff so there's no continuity.
They're barely coping."
The Newfoundland and Labrador Medical
Association (NLMA) has been after the government about
the pathologist shortage for years. An NLMA spokesperson
emphasizes it's yet to be determined whether this shortage
was a factor in the false ER/PR test results.
"The shortages shouldn't affect
the quality of care," notes Dr Butany.
Health Minister Wiseman admits
there's been a 50% turnover in pathologists since 1997.
He says he hopes the province's new enhanced compensation
package for pathologists will boost recruitment and
retention.
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