Patients at risk even after lab woes addressed: pathologist

Eastern Health was warned in 2005 that the way lab tests were being handled was threatening the safety of breast cancer patients, documents registered with a pending inquiry show.

Justice Margaret Cameron is expected later this month to begin a commission of inquiry on flawed hormone receptor tests, including hundreds which may have affected the course of treatment that breast cancer patients received.

The commission has obtained two 2005 letters written by Dr. Beverley Carter, a pathologist specializing in breast cancer, who flagged serious problems with Eastern Health managers' attempts to fix problems at the lab.

"I am quite concerned for the health of the people of Newfoundland and Labrador diagnosed with breast cancer if their treatment plans are based on … results generated in our laboratory," Carter wrote to former Eastern Health vice-president Dr. Robert Williams in a letter dated Dec. 7, 2005.

Months earlier, after Eastern Health determined that its lab had been producing faulty test results, Carter had resigned from what was to have been a sweeping review of results dating back to 1997.

Carter resigned from that review in August 2005, after she met with former chief executive officer George Tilley — who resigned amid controversy last summer — and other officials.

In a letter announcing that resignation, Carter wrote that it had become clear to her that administrators did not understand the laboratory tests or how to make them more accurate.

Carter is not doing interviews, but may be called as a witness when Cameron — a Newfoundland Supreme Court of Appeal judge appointed by the provincial government last year to study how the hormone receptor testing system failed — begins hearing evidence.

In her August 2005 letter, Carter said she was resigning to protect her local and international reputation as an expert in breast pathology.

She wrote that she was concerned that Eastern Health was allowing "decisions regarding the development of a reliable system to remain in the hands of para-professional staff."

In her December 2005 letter, Carter noted that several recommendations had been made on improving the quality and accuracy of the breast cancer tests.

"I am unaware that any of these have taken place," she wrote.

She called on the authority to prove that its results were "reliable, accurate and not dangerous to those Newfoundland and Labradorians having breast cancer."

Carter's concerns came to light earlier this year in a brief that the commission presented to Newfoundland Supreme Court, as part of its argument to ensure that two external reviews of the lab are made public.

Eastern Health is arguing that the reports are peer reviews, and thus cannot be publicly released because of provisions of the Evidence Act.

Justice Wayne Dymond has not yet decided on the matter.

In one of her letters, Carter described both the reports as "fairly damning," and noted that both authors noted "multiple major issues that must be addressed" before hormone receptor testing could continue.

A class action lawsuit against Eastern Health was certified last year on behalf of patients who feel their health was put in jeopardy because of inaccurate testing.

Cameron's commission was called amid a public and political uproar over Eastern Health's handling of the breast cancer test controversy, including a revelation in a court document that the authority knew that its error rate in hormone receptor testing was several times higher than it had acknowledged.