Health and Community Services
May 22, 2007
Undertake Judicial Commission of Inquiry on Estrogen and Progesterone
Receptor Testing for Breast Cancer Patients
In order to maintain confidence in the provincial
estrogen and progesterone receptor (ER/PR) breast cancer testing system
at Eastern Health, the Honourable Ross Wiseman, Minister of Health and
Community Services, today announced that the Provincial Government will
undertake a Judicial Commission of Inquiry on estrogen and progesterone
receptor testing for breast cancer patients.
On Friday, Eastern Health CEO George Tilley apologized
for the confusion that has ensued over this issue and stated that ‘at no
time did Eastern Health withhold any personal information from any of
the patients impacted by our decision to retest for ER/PR’ and that
‘Eastern Health has acted and will continue to act in the best interest
of our patients.’
“Government recognizes it is of the
utmost importance for those directly involved and the general public to
understand what happened to ensure that this situation does not
reoccur,” said Minister Wiseman. “Through an independent review, we will
endeavor to get those answers. It is critical that patients and their
families are assured that government takes this matter very seriously
and that any questions they have are addressed in an open and
A Judicial Commission of Inquiry will be established
by the Provincial Cabinet under Section 3 of the Public Inquiries
Act, 2006. Cabinet will appoint a commissioner, set the terms of
reference for the inquiry and authorize an appropriate budget. Once the
commissioner’s report is completed, it will be submitted to the Minister
of Health and Community Services and will be released publicly.
The review will address six key questions:
1. What went wrong with the ER/PR tests that resulted
in a high rate of conversions when re-tested?
2. Why was the problem with the tests not detected
until 2005? Could it have been detected at an earlier date? Were the
testing protocols during that period reasonable and appropriate?
3. Once detected, did the responsible authorities
respond in an appropriate and timely manner to those categories of
people who needed re-tests and those who were being tested for the first
4. Once detected, did the responsible authorities
communicate in an appropriate and timely manner with the general public
about the issues and circumstances surrounding the change in test
results and the new testing procedures?
5. Are the testing systems and processes currently in
place reflective of "best practice"?
6. Does Eastern Health currently employ an effective
quality assurance system to provide maximum probability that the testing
problems will not reoccur?
The Commissioner will provide recommendations as
necessary and appropriate to address the questions for the inquiry as
identified above. The minister will announce further details regarding
the Commission of Inquiry, including the appointment of a commissioner.
Minister Wiseman added, "I look forward to receiving
the commissioner’s report which will answer the many questions that have
arisen with respect to this issue."
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Director of Communications
Department of Health and Community Services
Backgrounder – ER/PR Testing for Breast Cancer
This issue is not about breast
cancer screening. At no time has there been a question of accuracy
of mammograms or biopsy results to diagnose breast cancer.
Estrogen and progesterone testing
(ER/PR) takes place after a breast cancer diagnosis to determine
whether cancer cells have estrogen or progesterone receptors. Breast
cancers that are either ER-positive or PR-positive (or both) may
respond to hormone therapy, such as the drug Tamoxifen. Hormonal
therapy, chemotherapy and radiation are considered to be adjuvant
therapies. The aim of adjuvant therapy is to decrease breast
recurrence rates and improve overall survival rates. Adjuvant
therapies are generally additional treatments given after
potentially curative surgery.
Eastern Health first became aware
of a problem with ER/PR test results in May 2005 and immediately
conducted an internal review. In July 2005 it made a decision to
retest all negative ER/PR tests done between May 1997 and August
2005 to ensure that if there was one patient who could benefit as a
result of a change in their test result and subsequent treatment
change that it was important that this be done. Eastern Health also
suspended their own testing at that time.
The process to retest and conduct
external and internal reviews in the lab took about one year to
complete. Once test results came back, the results were assessed to
determine if a recommended treatment change was necessary. The
assessments were conducted by a panel of experts in cancer care,
including oncologists, pathologists and surgeons. The first test
results were received by Eastern Health in October 2005. All test
results were received by February 2006.
There were a total of 939 patients
with ER negative reports. Of the 763 patients reviewed, 317 patients
had a change in result. Of that number, 117 of the patients had a
resulting change in treatment. A further 176 patients, of the total
939, originally reported as negative are deceased.
Eastern Health contacted each
patient who was affected by the ER/PR test review or their family
physician to make sure they received all the information and support
they required. They were told either one of three things:
That their tissue had been
retested and there was no change in the original results;
That their tissue had been
retested and that Eastern Health was recommending a change in
their treatment; or
That although there was a
change from their original test result, no change in treatment
was full disclosure to patients and their families once test results
became available. Unfortunately, test results came back at different
times and there was a delay in the retesting process which led to
some patients feeling they were not informed in a timely fashion.
Ultimately, Eastern Health’s primary concern was notifying all
Eastern Health held a media briefing in December 2006. At the time
the focus was on the 117 patients who had a change in test result
and a change in treatment plan and this was communicated to the
media. Unfortunately, the media were not provided with the number of
test results that had changed (317).
Eastern Health has committed to retest results for the 176 patients
who are deceased and to ensure that all patients’ families are
contacted for follow up.
Eastern Health apologized on Friday for the confusion created by not
disclosing all of the information to the media in December. Although
the media were not informed, the 317 patients who were directly
impacted were informed of their individual circumstances.
Eastern Health has implemented a
number of measures to provide a high standard of ER/PR testing for
new breast cancer patients. These measures include a quality
management program, seeking national accreditation for the
laboratory and ensuring all technologists and pathologists receive
special training. In addition, as a measure of quality control, a
random sample of tests are sent to Mount Sinai to ensure the
accuracy of Eastern Health test results. Eastern Health resumed
ER/PR testing in St. John’s on February 1, 2007
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