Newfoundland Judicial Inquiry into inaccurate breast cancer test results; The Third Pathology-Related Inquiry Now Under Way In Canada;

SHORTLY BEFORE THE INQUIRY BEGAN TO HEAR EVIDENCE ON WEDNESDAY (MARCH 19), THE NEWFOUNDLAND GOVERNMENT REVEALED THAT 108 0F THE 383 PATIENTS WHOSE TESTS HAD BEEN MISREAD HAD SINCE DIED - ALTHOUGH IT MAY EVER BE KNOWN HOW MANY OF THEM DIED AS A RESULT OF MISSING OUT ON APPROPRIATE TREATMENT;

The judicial Inquiry into inaccurate breast cancer test results given to 383 patients in Newfoundland - one of three public inquiries involving pathology now under way in Canada - was ordered by Ross Wiseman, the province's Minister of Health on May 22, 2007.

Shortly before the Inquiry began to hear evidence on Wednesday (March 19), the Newfoundland government revealed that 108 0f the 383 patients whose tests had been misread had since died - although it may ever be known how many of them died as a result of missing out on appropriate treatment;

Canadian Press reporter Tara Brautigam reported on the experience of two of the women affected by the misread test results in a story which appeared today in the Toronto Star under the heading: "Cancer patients tear into "sneaky board"..."Newfoundland inquest opens with angry stories of botched tests and the grief that has resulted."

"ST. JOHN'S, Nfld.–The Newfoundland health board responsible for botched breast cancer tests failed to fully inform patients of the flawed results and the consequences of the mistakes, a public inquiry heard," Brautigam's story began.

"The inquiry opened yesterday on a startling note when Beverly Green outlined events leading from her diagnosis of breast cancer in 2001 to the moment when she first discovered her test result was inaccurate six years later," it continued.

"The whole way it was handled was very unprofessional, very sneaky, deceiving," Green said.

The inquiry, headed by provincial Supreme Court Justice Margaret Cameron, was set up by the province to examine how almost 400 patients were given inaccurate results on their breast cancer tests.

At the time of her breast cancer diagnosis in January 2001, doctors told Green her test result meant she was ineligible for hormone therapy treatment, so she underwent chemotherapy, radiation and had part of her breast removed.

After her breast cancer test was sent to Mount Sinai Hospital in Toronto for retesting in the fall of 2005, it was discovered that her test result was misread. But Green said she didn't find that out until almost two years later.

In April 2007, Green asked her oncologist for a copy of her medical chart after learning another breast cancer patient had been notified her test was inaccurate.

"I was very disappointed. How come certain people had the privilege of getting a phone call and some of us did not?" said Green, wearing a knitted wool cap.

The inquiry is focusing on hormone receptor tests, which are critical because they can help determine the course of treatment for a breast cancer patient.

If patients are found to be estrogen- and/or progesterone-positive, they may respond to hormone therapy such as Tamoxifen. If not, they may be given other treatment, such as chemotherapy or radiation.

Green, whose cancer has since spread to her liver, said she would have chosen hormone therapy treatment had she known she was eligible for it.

"I know I have a disease that's probably going to destroy my life at some time," Green, 45, told commission counsel Sandra Chaytor.

"But the way this was handled, it was just unforgivable."

Later, Elizabeth White told the inquiry she wasn't made aware of her inaccurate test result until December 2007 – eight years after she was diagnosed with the disease.

White, who had her right breast removed and underwent chemotherapy, learned of the misread results through a phone message from an oncologist.

White, 65, said her husband knew of the mistake after Eastern Health contacted his sister, who was listed as White's alternate contact, but he decided to spare her the news.

"He didn't want to spoil my Christmas," she said. Like Green, White said she would have taken advantage of hormonal therapy if her breast cancer test was accurate.

"I fell through the cracks," she said.

"I certainly would have done what was necessary at the time."

Norman White, who was diagnosed with breast cancer in 1999, later testified that he received a call from an Eastern Health official in 2005 asking for his permission to have his test redone.

"I had no idea what was going on, so I just said yes," he said.

White, 70, said he was in Alberta for more than six months and asked his sister to forward important mail, but he didn't receive any correspondence from Eastern Health.

He said he didn't hear that his test results had changed until a doctor tracked him down in October 2006.

"I lost all faith, confidence in people we put a lot of trust in," he said.""


Brautigam notes that the Newfoundland Inquiry will also examine why the errors went undetected for eight years - and whether the Eastern Health authority responded to patients and the public in an appropriate and timely manner.

For the record: Here is Newfoundland Health and Community Service's Minister Wiseman's official announcement of the Inquiry -dated May 22, 2007, under the heading: "Government to 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 transparent manner."

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 time?

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."

A "backgrounder" to the calling of the Inquiry that was released by the government under the heading, "ER/PR Testing for Breast Cancer Patients" reads as follows:

"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 recommended.

There 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 affected individuals.

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. "Harold Levy...hlevy15@gmail.com