A provincial judicial inquiry has been struck to determine how and why hundreds of breast cancer patients received inaccurate hormone receptor tests at Newfoundland and Labrador's main medical laboratory.
Meanwhile, about 100 patients and surviving family members are pursuing a class-action suit against Eastern Regional Health Authority, the agency responsible for the lab where the faulty tests were done. The patients claim false-negative results wrongly disqualified them from receiving a potentially beneficial treatment. The class-action suit was certified in the Supreme Court of Newfoundland on May 28th.
Both the inquiry and the class-action law suit stem from an estrogen-receptor testing debacle that has erupted within the province over the course of the past few weeks after it was learned that over 40% of 763 samples of breast cancer tumours taken from living patients had been erroneously identified as hormone-receptor negative.
Concerns raised by St. John's oncologist Dr. Joy McCarthy in 2005 had resulted in 939 samples collected between 1997 and 2005 being sent for retesting to a lab at Toronto's Mount Sinai Hospital. The results indicated that 317 of the 763 retests done for living patients were false negative. Retests were undertaken for 105 of the 176 breast cancer patients who received hormone negative results since 1997. Some 36 were found to be false negative.
A breast cancer patient's hormone receptor status helps an oncologist determine treatment options. If a patient is hormone positive she may be offered an anti-hormonal treatment such as Tamoxifen or an Aromatase Inhibitor. The drugs have risks but have been shown to increase survival rates for breast cancer patients.
Details of the debacle began emerging when Eastern Health filed documents in response to the proposed class-action suit. They indicated that the health authority hadn't publicly revealed the extent of the problem. Last December, it reported that treatment for 117 patients changed after it received all the results of the retests by Mount Sinai, but it didn't reveal that more than 300 tests were false negatives, or that at least 36 patients who received false-negative results have since died.
Opposition members in the provincial legislature pounced and after days of raucous debate, Health Minister Ross Wiseman relented and announced the judicial inquiry.
“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 Wiseman. “Through an independent review, we will endeavour 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 transparent manner.”
In the wake of the controversy, Premier Danny Williams also appointed a task force to examine government management of adverse events in the health system. Dates have not been set to start the judicial inquiry or the class-action suit. The commissioner's report for the judicial inquiry is expected to include recommendations about how to improve accuracy at Eastern Health's laboratory.