Eastern Health confirmed Thursday nine breast cancer patients got the wrong results from a test to determine their treatment.
Due to the wrong results, eight of those patients were taking a drug called Herceptin, while one opted not to take the medication, which has a potential side effect of cardiotoxicity, possibly leading to congestive heart failure.
The patients have been taken off the drugs and the testing related to the errors halted.
The Telegram broke the news at www.thetelegram.com Thursday that several women had new information about their test results. But Eastern Health would not confirm the details until the late afternoon news conference it said it had initially planned for today but rushed be-cause of media being tipped off.
All nine women were told of their new results Thursday. The authority knew something was amiss in December through a quality-assurance check, but said it did not have confirmation of the nine errors in the immunohistochemistry lab until Tuesday, after consulting an expert in Miami, Fla., and having further testing done in an outside lab.
“This is a tough message. This is not good news, for sure. Nine people’s lives are affected,” Eastern Health CEO Vickie Kaminski told reporters.
In her written statement Kaminski apologized to the patients. “This is a very distressing time for our patients and their families and we are offering whatever support they need at this time,” she stated.
NDP health critic, St. John’s Centre MHA Gerry Rogers, called on Eastern Health later Thursday to put in place a phone number for concerned breast cancer patients.
“This is what people need at a time like this,” Rogers said, adding patients should not panic, either. “They need to not just be assured and placated, but given clear and accurate information.”
Rogers, a breast cancer survivor, was among patients affected by a scandal that rocked the province and led to the Cameron Inquiry into botched hormone receptor test results. Between 1997 and 2005, 386 patients received wrong results from hormone receptor testing from Eastern Health.
Many of those patients have since died and the inquiry into the scandal led to mass changes in Eastern Health’s pathology lab and administration.
Rogers noted the staff, training and resources that have been put in the lab, and said nobody wants an adverse event and she’s glad Eastern Health is moving to determine the root cause of these new errors.
Although also related to breast cancer treatment, the new errors are different than those that led to the 1997-2005 mistakes.
Kaminski said it was improvements made as a result of Cameron Inquiry that led Eastern Health to pick up on the problem this time swiftly and set steps in motion to deal with it. She was adamant that the numbers released Thursday on the errors will not change and there aren’t potentially any other patients not identified.
Health Minister Susan Sullivan also met with reporters Thursday and apologized to the patients, but said she’s happy with the way Eastern Health has handled the matter, crediting also the Cameron Inquiry with improving quality assurance.
“I certainly want to apologize to them, to tell them the health-care system is there for them,” Sullivan said.
“My reaction is always around patients and concern for the nine women here. We are deeply sorry for what has happened for those nine women.”
As heart-breaking story after story of patients and the missteps and debacle inside Eastern Health were revealed to the 2008 Cameron Inquiry, trust in the lab and Eastern Health in general was decimated, so any new mistakes make for bad optics.
“We have never, ever said we will be completely error free, and as long as we have a system that is based on interpretation and people’s interpretations and humans, we will have a potential for this kind of issue,” Kaminski told reporters, adding the quality assurance strategies as a result of Cameron are clearly working.
The authority doesn’t know yet what exactly in the lab process caused the errors — there will be an internal probe that will re-examine all the steps — but the Miami expert did disagree with the interpretation that Eastern Health pathologists made on the nine patents’ results.
The tests this time around are related to human epidermal growth factor receptor 2 (HER2) and were started at Eastern Health in April 2013 instead of sending them out of province. For certain of those cases, a further test called HER2 Dual ISH is needed and that’s the one that determines whether patients take Herceptin. The errors are all related to those who initially received positive results on the test, indicating aggressive tumours. So those patients affected by the errors did not have as aggressive tumours as was first thought because of the wrong results. Their breast cancer diagnosis does not change, however.
Kaminski told reporters that between April and December 2013, 68 results required further testing. Of those 68, Eastern Health sent 34 for further testing to the expert in Miami. Of those, the nine required a change in treatment.
Kaminski said the oncologists are working with the nine patients on new treatment plans. Meanwhile, HER2 testing is being done out of province again until the cause of the errors is determined. This means breast cancer patients waiting on those tests have a further three-day wait for results.
They are also being monitored for any problems, said Dr. Jehan Siddiqui, clinical chief of the cancer-care program.
“There is nothing to suggest they suffered any permanent damage from the treatments that have been done,” he said.
Siddiqui said patients who are on the drug don’t take it for longer than a year.