UPDATE: Nine breast cancer patients' treatment changed after follow up testing: Eastern Health

Bonnie Belec and Barb Sweet
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Eastern Health confirmed nine breast cancer patients have had a change in their treatment plans as a result of a test in a Miami lab.

CEO Vickie Kaminski told a news conference this afternoon that between April and December 2013, 68 results required further testing. Of those 68, Eastern Health sent 34 for further testing to Miami. Of those, nine required a change in treatment.

Kaminski said of the nine — eight of them took the drug Herceptin when they didn't need to.

She said while it isn't good news and nine lives have been affected by it, the quality assurance program put in place did catch the discordance quickly.

Kaminski said they have met with the nine patients and new treatment plans have been implemented.

“On behalf of Eastern Health, I want to publicly apologize to those nine patients,” said Vickie Kaminski, President and CEO.

“This is a very distressing time for our patients and their families and we are offering whatever support they need at this time.”

Speaking to reporters shortly after Eastern Health's announcement, Health Minister Susan Sullivan offered an apology to all the women affected by inaccurate testing results.

"I want to extend my deepest sympathies to these women," Sullivan said.

The minister also said she was happy with the new care plan Eastern Health has in place.

The Telegram’s Barb Sweet will have further details in Friday’s Telegram.

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(Previous story)

Eastern Health said today it has identified that nine confirmed breast cancer patients had a change in one of their follow-up tests that determines the course of treatment for the patient.

“On behalf of Eastern Health, I want to publicly apologize to those nine patients,” said Vickie Kaminski, President and CEO.

“This is a very distressing time for our patients and their families and we are offering whatever support they need at this time.”

A news release issued at the same time the news conference was being held, notes that once a patient has been diagnosed with breast cancer, a number of tests follow that help clinicians determine the appropriate course of treatment for the patient.

One of those tests is human epidermal growth factor receptor 2 (HER2) and among the tests being completed at Eastern Health is HER2 immunohistochemistry (IHC). For certain results of the HER2 IHC, a further test may be required should the results be unclear and that test is called HER2 dual in situ hybridization (Dual ISH).

The result of that test determines whether Herceptin would be included in the treatment plan for the patient. Eastern Health started doing the Dual ISH testing April 2013.

Through its Quality Assurance Program, the Laboratory Medicine Program at Eastern Health identified on Dec. 9 a discordant test result between the Eastern Health lab and its external proficiency testing.

Eastern Health stopped HER2 Dual ISH testing at that time and proceeded to send any new testing requirements to an external lab for reportable testing.

A review of the cases that had been subject of HER2 testing determined that between April 23 and Dec. 9, 2013, there were 65 cases that had only Dual ISH completed. Eastern Health set about to confirm whether there was an issue with the testing, establish a root cause analysis process, and determine next steps concerning the 65 cases.

On Jan. 31, a sample of 34 of those 65 cases were sent to a DUAL ISH expert to review the Eastern Health results. Among the 34 cases, there was 100 per cent concordance between Eastern Health and the expert for the 22 negative results. For the 12 cases that were initially positive, there was only concordance with three.

The expert recommended a further test called HER2 fluorescent in situ hybridization (FISH) to be completed on all 12. In addition to the 12 reviewed by the external expert, one additional case was determined by Eastern Health to be subjected to the FISH test. On Feb. 5, 13 cases were sent for FISH testing.

On Tuesday, Eastern Health received confirmation that of the 13 cases, nine were felt to be over-reported results. When a test result is reported as amplified, it means the tumour is aggressive and the recommended treatment plan would include Herceptin. Therefore, nine patients were on a treatment plan that needs to be changed.

Today, Eastern Health met with all nine patients to inform them of the change in their test result and to advise there will be a treatment change. Those discussions with patients will continue with their clinical team.

“I am very sorry that this has happened to these nine patients,” Kaminski said.

“However, this incident demonstrates that Eastern Health has a Quality Assurance program in place in its laboratory medicine program that is working. It allows us to detect any discordant results early; that we put a process in place to determine whether there is an issue and, most importantly, that we can adjust treatments for our patients if required. That is what we have learned from the errors in estrogen and progesterone receptors (ER/PR).”

•••

Eastern Health says nine confirmed breast cancer patients had changes in follow up testing.

Vickie Kaminski, president and CEO of Eastern Health, is presently speaking at a news conference called on the issue.

The news conference this afternoon talking about ERP testing and HER2 testing in cancer patients.

She is also speaking about scoring for breast cancer as a result of tests, and further testing once breast cancer is detected.

Kaminski says 65 cases were reviewed in December. Thirty-four went to a lab in Miami. Specialist agreed with all negatives but didn't agree with nine positives.

The nine still had cancer but require different treatment.

Kaminski says all nine have been met with and plans discussed for treatment.

Kaminski says quality assurance put in place since the Cameron inquiry has worked. Discordance in results discovered early.

•••

(Earlier story)

Eastern Health won’t confirm report of changed results; holding news conference at 4 p.m.

The Telegram has been told that several women who have been treated with a breast cancer drug had their results from Eastern Health reviewed in a lab outside the province, and have been given new information.

When contacted early this afternoon, Eastern Health didn’t respond but almost two hours later issued a media advisory saying Vickie Kaminski, president and CEO of Eastern Health, will hold a news conference at 4 p.m.

When asked if it was concerning the breast cancer test results The Telegram had asked about earlier, Eastern Health said via email, “There is no followup information available at this time.”

The advisory says the purpose of the news conference is to provide information about quality assurance activity in the laboratory medicine program.

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  • Maggy Carter
    February 13, 2014 - 21:23

    For a disturbing number of women, serious complications from unnecessary, aggressive treatments for breast cancer begin with a decision to do what they have been told for decades is the smart, responsible thing - go for a mammography. Regular screenings ensure early detection, faster treatment, and better outcomes - or so goes the myth. We now have proof beyond any scientific doubt that mammography screenings kill and maim more women that they help. A University of Toronto study is the most recent to conclude that mammography screenings offer no net benefit. The study prompted respected doctor Charles Wright to urge in today's Globe & Mail that mammography screenings be discontinued. Such screenings come with a high risk of false negatives, false positives, over-diagnosis, and over-treatments. Aside from the physical and psychological damage to women, the costs to taxpayers are enormous. Why don't provinces and health authorities heed science and abandon indiscriminate screenings? Because - like other dubious elements of modern medicine - mammography has long since established its own army of defenders, vested interests ready to pounce when they detect any threat to their livelihoods. As they have with each such study in the past, associations representing radiologists were quick to react - insisting that women should ignore the underlying science. We get it that the designers, manufacturers, technicians and operators of these machines insist on the status quo, but what excuse is there for the supposedly competent people who run our health care organizations to follow suit? How many billions in this country alone could be diverted to other measures to prevent, detect and treat cancers without putting women at risk? What's the connection between mammography and this latest controversy to hit Eastern Health. It is that mammographies are the precursor of these HER2 tests that have gone awry – weak links in a chain that all too often shows little efficacy and even less economic sense. Intended to identify those one-in-four breast cancers characterized by a protein excess, the HER2 test is the gateway to aggressive treatment with toxic drugs. Bad enough that women must sign on to the chemotherapy crap-shoot with its attendant risks of heart, lung and kidney damage, but to have done so based on tests now invalidated must be a bitter bill to swallow.

  • Susan White
    February 13, 2014 - 17:42

    Really??????? How many more mistakes are going to be made with the treatment of cancer patients? Having endured the loss of my husband from cancer, one immediately questions was his treatment correct or did someone misread his test results!!!

  • Guy Incognito
    February 13, 2014 - 16:39

    Are you kidding me? This again? What have we been paying Vicki a big fat salary for?? Wasn't she brought in to fix our health care system? Maybe they should have checked here references....they get payed more than anyone...... Get rid of some of these clueless bureaucrats who sit in their office all day between news conferences...

  • david
    February 13, 2014 - 15:17

    In any other jurisdiction on Earth, heads would roll, starting with Kaminski's. Here, it'll just be lawsuits, that the taxpayers get to pay.