FOLLOW-UP; BOTCHED BREAST CANCER TESTS; ACCOUNTABILITY? NEWFOUNDLAND HEALTH MINISTER PAYS PRICE; DEVELOPMENTS IN QUEBEC BREAST CANCER TEST SCANDAL;

"THE PREMIER, HOWEVER, DEFENDED THE EMBATTLED CABINET MEMBER. HE SAID WISEMAN HAD WRONGFULLY TAKEN THE BLAME FOR THE ERRONEOUS LABORATORY TESTS. TRANSFERRING WISEMAN TO ANOTHER AGENCY WOULD PROVIDE HIM SOME RELIEF AND REMOVE HIM FROM THE PUBLIC HEALTH SECTOR."

AHN;

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All Headline News reports that Newfoundland and Labrador Health Minister Ross Wiseman has been removed from his post;

The flawed pathological tests conducted in hospitals in Newfoundland, Quebec and several other part of Canada are a reminder that serious problems in Canada's pathology system are not confined to the criminal justice sector;

"Newfoundland and Labrador Health Minister Ross Wiseman was removed Thursday from his post by Premier Danny WIlliams and given another assignment to head the Ministry of Business. Wiseman was replaced by Paul Oram," the AHN news report, issued earlier today, begins;

"The move, part of Williams' ongoing cabinet shake-up, is seen as a result of heavy criticism hurled on Wiseman over botched breast cancer test of thousands of Newfoundland women from 1997 to 2005," the report continues under the heading, "Newfoundland Removes Health Minister Criticized For Botched Breast Cancer Tests."

"The premier, however, defended the embattled cabinet member. He said Wiseman had wrongfully taken the blame for the erroneous laboratory tests. Transferring Wiseman to another agency would provide him some relief and remove him from the public health sector.

Williams, said in a statement, "I would like to welcome these minister to their new portfolios and wish them well as they take on these new challenges.... I want to thank both Ministers Wiseman and Oram for their outstanding work in their previous departments and I look forward to their continued contributions individually as ministers and collectively around the Cabinet table."

Before Wiseman's transfer, Williams replaced the Eastern Health chief executive officer who was also implicated in the controversial breast cancer tests.

Meanwhile, Quebec which also recently had a breast cancer test problem, will make the first batch of 630 residents go through a retesting to check if the medicine Herceptin could help them. The order for retesting came from provincial Health Minister Yves Bolduc.

The 630 women are part of the 2,730 who will repeat their breast cancer tests. The women are from Montreal, Monteregie and Laval."

Harold Levy...hlevy15@gmail.com

Part Two: Crisis Deepens: (Even Further); Prince Edward Island And Manitoba Added To The List; Data Questioned At Princess Margaret;

"PATIENT SAFETY AND QUALITY CARE ARE OUR TOP PRIORITIES AND THAT'S WHY THIS REVIEW IS HAPPENING," SAID HEALTH MINISTER DOUG CURRIE. "WE KNOW EXACTLY WHICH IMAGES WERE READ BY THE RADIOLOGIST OVER THE PAST FOUR MONTHS AND ALL OF THEM WILL BE EVALUATED AGAIN TO ENSURE AMENDED REPORTS ARE SENT TO ATTENDING OR REFERRING PHYSICIANS IF NECESSARY."

PRINCE EDWARD ISLAND HEALTH MINISTER DOUG CURRIE:

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In a recent posting "Part One: Canadian Pathology Crisis Deepens," I recorded Dr. Andrew Padmos' observation that systemic problems in hospital laboratories and are not likely isolated to the cases under investigation in Newfoundland, New Brunswick, and now Ontario.

Padmos should know: He is the Chief Executive Officer of the Royal College Of Physicians and Surgeons of Canada;

As if to prove the point, Prince Edward Island and Manitoba have now been added to the disturbing list which appears to be spreading across the country like an infection - and problems concerning clinical drug trial data have risen at a Toronto hospital;

These developments have been recorded in three recent newspaper stories;

First, Prince Edward Island;

A story in the Charlotte Guardian, April 28, 2008, by Colin Foley, headed: "High error rate sparks review of P.E.I. radiologist's work."

"CHARLOTTETOWN -- Prince Edward Island has ordered a review of a radiologist's work after a preliminary sample audit of the tests read by the doctor showed an unacceptable error rate of between 8% and 19%," the story begins.

"About 4,500 patients who had regular X-rays, MRIs, CT scans or ultra-sounds are affected and 5,700 images will be re-evaluated. That process is expected to be completed in the next couple of weeks," it continues;

"The radiologist began work on the island on Dec. 2, 2007, and on April 2, 2008, there was an agreement for a leave of absence while a review took place.

"Patient safety and quality care are our top priorities and that's why this review is happening," said Health Minister Doug Currie. "We know exactly which images were read by the radiologist over the past four months and all of them will be evaluated again to ensure amended reports are sent to attending or referring physicians if necessary."

The radiologist's name is being withheld because "identification of the radiologist would not have a bearing on the outcome of the evaluation or provide any benefit to patients," the health ministry said.

The results of the evaluation so far show that the majority of cases were not of a serious nature.

There are no plans for this radiologist to return to work in P.E.I. Health officials contend that the physician is well qualified and has as an excellent career track record and has been extremely co-operative in this process.

It is standard practice on Prince Edward Island for radiologists to monitor each other's diagnostic imaging tests.

Earlier this month, when three tests were reviewed by the radiologist's colleagues and amended reports had to be issued, a sample audit was carried out as a quality review check.

This preliminary sample audit, consisting of 10% of the diagnostic imaging tests read by the radiologist, showed an unacceptable error rate, averaging 12%, so a decision was made at that time to do a further evaluation of all images read by the radiologist.

Nuclear medicine, bone mineral densitometry and mammography exams were not affected.

"It is very important to remember that diagnostic imaging tests are only a part of a patient's care and treatment," said Dr. Colin Foley, provincial medical director, diagnostic imaging services. "Patients typically go through a variety of tests leading up to their diagnoses and have more than one health care professional collaborating in the overall care."

Letters will be sent to every patient whose tests will be evaluated.

The review is the second to be conducted in Atlantic Canada into the work of a radiologist.

Last November, a review in Newfoundland into suspect radiology reports found the radiologist who conducted them missed tumours and fractures in some of his patients.

In total, 6,412 diagnostic imaging orders were reviewed -- including X-rays and CT scans. The review found problems with 11% of those. While that number falls within the accepted variance rate for radiologists, the review discovered much higher discrepancies for certain tests.

For instance, one in four CT scans required further assessment. Some 3,781 patients had at least one report reviewed. Some had multiple tests reassessed.

The Prince Edward Island review also comes as Newfoundland conducts a public inquiry into breast cancer tests carried out at a St. John's pathology lab.

Another inquiry is set for New Brunswick into the work of a Miramichi pathologist, where alleged errors have led to some 24,000 cases being re-examined."

Second: Manitoba;

A Canadian Press story dated Friday May 2, 2008 and published under the heading, "Winnipeg Health Authority reviewing pathologist's findings after mistakes found."

"WINNIPEG — A Manitoba pathologist has been placed on leave while more than 700 diagnostic tests he performed over the past year are reviewed," the story begins;

"Out of the 142 cases that have been re-examined so far, nine errors have been uncovered, the Winnipeg Regional Health Authority announced Friday," it continues;

""Of the nine cases where errors were found, we do not know what the clinical impact on patients will be yet," said health authority spokeswoman Heidi Graham. "We are waiting to hear back from physicians."

Though the review is still in its early stages, the health agency decided to publicize some of its details because of pathologist evaluations in other provinces.

In Newfoundland, almost 400 patients received the wrong breast cancer test results between 1997 and 2005. An inquiry has been told a former deputy health minister knew about the situation but didn't tell the cabinet secretariat or the premier's office.

The issue became public when a newspaper in St. John's reported on the problem in October 2005.

"One of the things we've learned from other provinces ... there's been a lot of criticisms of the systems if they don't disclose early in the process," said Dr. Brock Wright, vice-president of the Winnipeg Regional Health Authority.

In Manitoba, the pathologist in question handled 735 cases. They are being reviewed by a pathologist hired specifically for the task from outside the Winnipeg health agency.

Most of the tests were for cancer, said Wright.

"Some of the diagnostic errors relate to whether it was one sub-type of cancer or another," Wright said, adding "it may or may not be clinically significant."

Physicians and their patients are being contacted directly to discuss the changes in their diagnoses. The health agency has also set up a special phone line for patients who have questions about the review.

However, the health authority declined to release the pathologist's name, and other than noting he is an "experienced" pathologist, they also would not say how long he has worked in the field.

"There's nothing to be gained by releasing his name right now. In fairness to him, we won't do that unless there is a substantive issue," Wright said.

Wright wouldn't speculate on what sort of sanctions the pathologist could face, although he noted further training and early retirement are two options.

For complex diagnostic tests, there is an expected error rate of 15 per cent, said Dr. Amin Kakabani, the chief medical officer for Diagnostic Services of Manitoba.

"Sometimes calling it an error rate implies a clear black and white, and there isn't. For some of the cases, people never agree. Some people call 'x,' the other calls 'y.' "

Manitoba's review came to light the day after Grey Bruce Health Services in southwestern Ontario announced it will expand a probe of a pathologist's work following an initial review of 600 tests found a high rate of error.

Dr. Barry Sawka, who voluntarily withdrew from practice in February after a routine test identified an error in one of his findings, is estimated to have overseen about 40,000 cases over 14 years at the hospital.

In New Brunswick, some 24,000 pathology tests are being reviewed and a judicial inquiry has been called after an audit said there were incomplete or misdiagnosed results in the work of pathologist Dr. Rajgopal Menon.

Menon, who called the review "unjustified and unfair," has filed a civil suit against the regional health authority.

Diagnostic imaging tests of about 4,500 patients are also being reviewed in Prince Edward Island after questions were raised about the work of a single pathologist."

Lastly, Toronto;

The Canadian Press reported on April 14, 2008 - surprisingly with no public reaction - that mistakes had occurred in clinical drug data involving three hundred patients at Toronto's Princess Margaret Hospital;

"An investigation of mistakes in clinical drug trial data involving 300 patients at one of Canada's premier cancer centres has turned up no evidence of deliberate tampering, the hospital says," the story, under the heading, "Hospital blames cancer study errors on carelessness" begins..

"There's no evidence of fraudulent activity here, it's more a matter of carelessness of data management," Dr. Robert Bell said Monday, referring to errors discovered in records for three trials of breast cancer treatments at Toronto's Princess Margaret Hospital," the story, by Sheryl Ubelacker, continues.

""There's no systematic changing of results that would make it look like it was a fraudulent attempt to alter an outcome of a study," said Bell, president and CEO of the University Health Network, which includes Princess Margaret.

The problem with incorrect data came to light in November when ``an external sponsor" noticed some problems with data for a few breast cancer trials, which led Princess Margaret to order an external audit of all its breast cancer studies.

Women who participated in the trials comparing different drugs were informed by letter of the problems, but Bell stressed "there was no harm done to any patients."

"First of all, the clinical records and the clinical treatment for these patients was absolutely according to protocol and the documentation and the clinical record was appropriate. But the transcription of some data values into what's called the research record in some cases was inaccurate."

In some cases, numbers were transposed in records, so that the wrong date of treatment was entered, Bell explained. In other cases, medical scans that should have been done on some women were not carried out.

"They've now either been done or are being ordered to be done," he said. "But there were a few missing data points based on scans being missing."

Those scans of such organs as the kidneys and heart were aimed at determining any long-term effects of drugs being tested and were not diagnostic in nature.

Bell said the hospital is still looking into which personnel were involved in the errors, which affected between 20 and 30 of the 300 participants whose charts were investigated.

"But we don't want to point the finger at anyone personally, we simply want to make sure it never happens again."

Still, those responsible for the mistakes could "potentially" face disciplinary action, he acknowledged.

"But I think the most important lesson for us is the requirement first of all to ensure that we have standard operating procedures in place of data validity," Bell said, noting that the hospital will implement ongoing random audits of all patient trials in the future.

He called the new policy an "unusual step to take, but one that we think is appropriate for this organization."

Princess Margaret Hospital, which along with Toronto General and Toronto Western hospitals makes up the University Health Network, bills itself as one of the leading cancer treatment and research centres in the world.

Dr. Ralph Meyer, director of the clinical trials group for the National Cancer Institute of Canada (NCIC), said problems with accuracy of data such as those detected with the Princess Margaret studies rarely occur.

"Conducting clinical trials is complex and because of their complexity, there are levels of scrutiny that are done within an institution and by the people who are sponsoring the trial in terms of how data is reviewed," said Meyer, confirming that NCIC was the external sponsor that alerted the hospital about accuracy problems while reviewing the data.

But the fact that the errors were caught shows review processes built into the system are working and shouldn't undermine patients' confidence in research or stop them from volunteering to take part in trials, he said.

"For those patients who are going into clinical trials, I think it's important that they know the system did work and that the data that should be used will be used.""

Ontario, New Brunswick, Newfoundland, Prince Edward Island, Manitoba. Pathology. Pathologists; Radiology. Radiologists.

Next?

Harold Levy...hlevy15@gmail.com;

Part One: Canadian Pathology Crisis Deepens; Tests Being Reviewed In Ontario; College Head Says Patients May Be At Risk Throughout Country;

"IN ONTARIO, AN INTERNAL REVIEW FOUND A 6-PER-CENT ERROR RATE IN DR. SAWKA'S WORK ON CANCER AND OTHER MEDICAL TESTS, MUCH HIGHER THAN THE 1-PER-CENT ERROR RATE THAT IS CONSIDERED ACCEPTABLE FOR PATHOLOGISTS, ACCORDING TO THE HOSPITAL. THE MISTAKES MAY HAVE ALTERED FURTHER INVESTIGATION OR TREATMENT FOR PATIENTS."

CARLY WEEKS; GLOBE AND MAIL; MAY 2, 2008;
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The Crisis in Canadian pathology documented in the Blog in recent months has taken a turn for the worst with revelations of widespread errors and missed cancer diagnoses made by a pathologist in Ontario.

Indeed, the crisis has reached such an extent, that head of the Royal College of Physicians and Surgeons in Canada, now says systemic problems in hospital laboratories and is likely not isolated to the handful of cases under investigation in Newfoundland, New Brunswick, and now Ontario.

The latest scandal - centering around an pathologist named Dr. Barry Sawka - is detailed by reporter Carly Weeks recounts in a story published in today's Globe and Mail under the heading, "Major Investigation: Pathology errors spark concern over safety net in hospital laboratories;

"A major investigation into widespread errors and missed cancer diagnoses by an Ontario pathologist is sparking new concerns over the absence of a national quality-control system that may be unnecessarily putting patients across Canada at risk," the story begins.

"This just is another expression of when the system safety net is thin and patchy," said Andrew Padmos, chief executive officer of the Royal College of Physicians and Surgeons of Canada," it continues.

""I think this will add significantly to the overall concern of Canadians about the depth of services and security of services in the health system."

Grey Bruce Health Services, which serves the Owen Sound area, announced it is launching a major investigation to determine how many patients may have been affected by medical testing problems after a review of 600 cases found a "widespread series of errors" in some of pathologist Barry Sawka's work.

Now, hospital officials are racing to notify patients involved and expand the review of Dr. Sawka's work to determine the scope of the problem and how many patients may be at risk.

The alarming revelation comes as health officials in several areas of Canada grapple with medical testing scandals that are fuelling fears hospital laboratories are too understaffed and overworked to ensure quality of results.

In St. John's, a high-profile inquiry is under way to determine how more than 300 women received inaccurate results on a critical breast cancer test that could have altered their course of treatment.

This week, a pathologist working for the health board involved in the inquiry announced he would resign - the second one to do so since the inquiry began in March.

In a separate incident in St. John's last fall, a review of a suspended radiologist's work found he misread 708 out of nearly 3,800 exams and routinely missed tumours, broken bones and pneumonia.

In Miramichi, N.B., the RCMP have been asked to investigate and authorities are preparing to open an inquiry into the work of pathologist Rajgopal Menon. About 24,000 of Dr. Menon's cases are being reviewed to determine the scope of problems after an audit found 18 per cent of tests were incomplete and 3 per cent were inaccurate.

In Charlottetown this week, health officials said they are launching a review of nearly 6,000 tests after an audit of a radiologist's work found an unacceptably high error rate.

The rash of mistakes and problems emerging from hospital laboratories reflects chronic, serious problems with staff shortages, lack of funding and inadequate quality controls that need urgent attention before more Canadians are affected, Dr. Padmos said.

"I think that there's lots of reasons to be concerned enough that we should start having thorough and comprehensive reviews," he said.

"[The problems are] consistent with our underlying concern about the strength and reliability of the laboratory system and the pathologists and other health-care professionals that work in it under trying circumstances," Dr. Padmos said.

In Ontario, an internal review found a 6-per-cent error rate in Dr. Sawka's work on cancer and other medical tests, much higher than the 1-per-cent error rate that is considered acceptable for pathologists, according to the hospital. The mistakes may have altered further investigation or treatment for patients.

"There was a widespread series of errors. Some of them were missed cancers," Don Eby, the hospital's chief of staff, said in a teleconference yesterday.

"[In] some of them, the staging of the cancer was incorrect. Sometimes there would be inflammation present that wasn't identified or inflammation that wasn't present that was identified."

The pathologist who led the external review of Dr. Sawka's work said the recent problems reflect the fact hospital laboratories are under increasing pressure to produce high-quality results on complex tests without adequate resources.

"I think understaffing and underfunding of laboratories has taken its toll," said Meg McLachlin, deputy chief of pathology at London Health Sciences Centre.

"I think we need to take a much closer look at funding of pathology and all laboratory medicine."

The Ontario College of Physicians and Surgeons is launching an investigation to determine what, if any, disciplinary action must be taken against Dr. Sawka, who was asked by the hospital to stop practising in mid-February.

The review examined 600 cases, which represent about 20 per cent of Dr. Sawka's annual workload. He examined about 40,000 cases during his 14 years at Grey Bruce Health Services.

"I recognize the anxiety and worry that accompanies news such as this," said Pat Campbell, the hospital's president and chief executive officer.

"On behalf of GBHS, I sincerely apologize for the errors of this individual pathologist [that] may have resulted in harm to patients."

One of the refrains this Bloggist keeps hearing is that the current crisis - with its tragic impact on the lives of some patients - was predictable because of a shortage of pathologists and a lack of financial resources in many juridictions;.

If that is the case, why weren't measures taken by health officials and governments to tackle the problem before it began taking lives?

And to what extent are other areas of Canada's health care system vulnerable to similar assaults because its flaws have been papered over and hidden from the public?

Harold Levy...hlevy15@gmail.com;

Three Deadly Scandals: A Sad Testament To Canadian Pathology;

"THREE MAJOR ONGOING SCANDALS IN ONTARIO, NEWFOUNDLAND AND LABRADOR AND NEW BRUNSWICK — WHICH HAVE COLLECTIVELY BEEN LINKED TO HUNDREDS OF DEATHS, TENS OF THOUSANDS OF SUSPECT TEST RESULTS AND DOZENS OF QUESTIONABLE IMPRISONMENTS — AND THEIR REQUISITE HIGH-PROFILE PUBLIC INQUIRIES, HAVE HIGHLIGHTED THE PATHOLOGY SYSTEM'S SERIOUS FAILINGS."

NATIONAL REVIEW OF MEDICINE STORY; SAM SOLOMON;

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The National Review Of Medicine - a publication for Canadian physicians - has published an article that echos this Blog's conclusion that the three on-going Inquiries - including the Goudge Inquiry which center's on Dr. Charles Smith's flawed work - signal a "crisis" in Canada's health care system.

The story, by Sam Solomon, appears today, under the heading "Canadian pathology mired in crisis" - and the sub-heading "Three deadly scandals expose gross failings in training, oversight...

Sir William Osler famously said, "As is our pathology so is our practice... what the pathologist thinks today, the physician does tomorrow," the story begins;

"If Dr Osler — a pathologist himself — was right, then Canada's entire medical system is in deep trouble, says Canadian Association of Pathologists president Dr Jagdish Butany," it continues;

""Over the last 20-plus years, we have not paid enough attention to laboratories and pathology and pathologists," he says.

"[The healthcare system has] relegated pathologists to the basement and given them that same priority."

The result of that chronic disregard is now becoming readily apparent: Canadian pathology is in crisis.

SYSTEMIC PROBLEMS

Three major ongoing scandals in Ontario, Newfoundland and Labrador and New Brunswick — which have collectively been linked to hundreds of deaths, tens of thousands of suspect test results and dozens of questionable imprisonments — and their requisite high-profile public inquiries, have highlighted the pathology system's serious failings.

As a result, an expert panel of leading medical authorities are now in the process of setting up a comprehensive review of the current deficiencies in pathology in Canada.

The details of the review haven't been finalized yet, says Royal College of Physicians and Surgeons of Canada CEO Dr Andrew Padmos, but the report will have another goal as well: to restore the public's severely shaken confidence.

The three scandals have done grievous damage to the profession's reputation.

"They've given us a black eye," Dr Butany admitted to the National Post last month as he and Dr Padmos dutifully denied a crisis exists and reassured reporters across the country that Canadian pathology is indeed trustworthy and can be repaired.

In conversation, however, cracks appeared in the veneer of their everything's-under-control exhortations.

After explaining that Canadian health human resources problems are having a particularly acute effect on the field of pathology — "We are concerned the problem is going to become worse and more widespread and we don't have in place an effective pan-Canadian action to stop it" — Dr Padmos quickly sought to quell any possible anxiety.

"Is it an absolute knockdown crisis? Of course not. What they need is some hope and some planning."

The shortage of pathologists and lab technologists is already putting pressure on the system.

"People are working too long hours, or past your threescore and ten, even," says Dr Butany, "so that makes for an increasing potential for mistakes. You don't have time to critically analyse previous work, to sit back and think."

But the real culprit in all three scandals appears to be a lackadaisical approach to quality assurance and training.

ONTARIO

Dr Charles Smith was once considered the epitome of expertise when it came to pediatric forensic pathology.

If a child died under suspicious circumstances in Ontario, all eyes turned to Dr Smith.

If Dr Smith served as an expert witness in a homicide case, people listened.
But that trust was misplaced.

Dr Smith is now at the centre of a public inquiry into the entire field of pediatric forensic pathology in the province.

Many child murder convictions that Dr Smith helped resolve have been thrown into question and the provincial Chief Coroner's office is now suggesting a total of 142 cases be reviewed.

Although Dr Smith made a dramatic apology to his victims at the inquiry, he wasn't actually on trial.

In fact, there's one thing he and his victims seem to be able to agree on: the balance of the blame should go to the pediatric forensic pathology system itself and the lack of oversight, training and quality assurance.

The inquiry's closing arguments wrapped up April 1. Justice Stephen Goudge is due to submit his final report and recommendations to the government by September 30.

NEWFOUNDLAND AND LABRADOR

In a strange twist of fate, the Ontario inquiry has come to a head at almost exactly the same time another inquiry, this one potentially just as broad as the Ontario one, is just getting underway in Newfoundland and Labrador.

This inquiry, headed by Justice Margaret Cameron, is looking at how 383 women were given incorrect estrogen and progesterone hormone receptor breast cancer test results (which determine whether the patient should receive tamoxifen) over an eight-year period from 1997 to 2005. Over a hundred of those women are now dead.

Again, the absence of standardized quality assurance — a problem that still persists today, says Dr Padmos — appears to have contributed significantly to the errors.

There have also been suggestions that a St John's lab may have misinterpreted the results of a now-outmoded method of immunohistochemical testing on biopsy tissue; a 2003 internal memo by pathologist Gershon Ejeckam called the lab's technique "unreliable and erratic" and said diagnoses based on those tests "will surely jeopardize patient care."

Amidst allegations of a politically motivated coverup, some have called for Health Minister Ross Wiseman's resignation. The inquiry's final report is due no later than July 30.

NEW BRUNSWICK

The New Brunswick investigation is slightly different from those in Ontario and Newfoundland in that it focuses more specifically on the work of one pathologist, Dr Rajgopal Menon of Miramichi, who was found to have a misdiagnosis rate of 3% and an incomplete diagnosis rate of 18% in a recent audit.

Another report released late last month said Dr Menon's "vision seemed to be failing," his hands were shaky and his work "fails to meet the current standards of surgical pathology."

Already, Dr Menon's lawyer, Mel Norton, has employed the same tactics that Dr Smith's have in Ontario, blaming the pathology system and the lack of oversight.

"[It's] too convenient just to aim the gun at one person," he told the Telegraph-Journal in February.

The government has ordered reviews of all 24,000 of Dr Menon's cases, from 1995 until 2007, and the RCMP has also been asked to consider charges of criminal negligence against Dr Menon.

Retired judge and former provincial Tory health minister Paul Creaghan, who is heading the inquiry, is due to submit his final report by August 22."

Harold Levy...hlevy15@gmail.com;

Wednesday April 9; Part Two: It's All About Trust;

It's all about trust:

While patients trusted their health system - officials protected tax-payers and reputations.

They statyed quiet because they didn't want to be sued.

That evidence came from the Newfoundland Inquiry Wednesday from 000 the official incharge -----------

It came along with an apology - which has been becoming more and more common since the Smith Inquiry began;

Into the CP story;

Board knew of cancer problems in 2005, inquiry hears
Updated Wed. Mar. 26 2008 8:15 PM ET

The Canadian Press

ST. JOHN'S, N.L. -- Newfoundland's largest health board was discouraged from telling patients about problems with breast cancer tests to minimize the threat of litigation, despite a plea from the province's health minister months earlier to warn the public of the emerging debacle, a public inquiry heard Wednesday.


A series of notes, e-mails and meeting minutes were entered as evidence that provide a glimpse into how the Eastern Health authority learned of the errors, what it did to inform the public and its failed attempts at damage control.


In an e-mail dated Oct. 18, 2005, St. John's lawyer Daniel Boone advised the board against sending patients a letter informing them that their breast cancer tests were being reviewed at Mount Sinai Hospital in Toronto.


"There is a possibility that we could be sued in a class action by those people who receive this proposed correspondence whose test results do not change. Otherwise these people would not have a cause of action, so sending the letter actually exposes us to a liability which does not now exist,'' Boone wrote to Heather Predham, Eastern Health's risk management consultant.


"I do not see how the letter advances the health care of the affected patients and it increases our exposure to claims for damages. I would recommend against sending it.''


Instead, Eastern Health phoned patients to tell them their breast cancer tissue samples were being retested "to allow for dialogue and to ensure understanding,'' according to minutes of a board meeting a week later.


But that account contrasts with testimony from patients and relatives of deceased patients who have told the inquiry that Eastern Health wasn't keeping them in the loop about the test results.


The inquiry is focusing on Eastern Health's handling of hormone receptor tests, which are a valuable tool that doctors use in determining the course of treatment for breast cancer patients.


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.


Another e-mail entered as evidence Wednesday indicates that three months before Boone's letter was written, Eastern Health was under pressure to tell the public of growing concerns with the quality of its breast cancer testing.


"We potentially have a major clinical issue on our hands, which pertains to the accuracy of laboratory testing for women who have been diagnosed with breast cancer,'' George Tilley, then Eastern Health's CEO, wrote in the July 20, 2005 note.


Tilley said John Ottenheimer, the provincial health minister at the time, was urging Eastern Health to go public about the errors.


"Very sorry to hear of the situation,'' Joan Dawe, chairwoman of Eastern Health's board of trustees, wrote in a response to Tilley, dated that same day.


"I agree with making this public asap when you have the details. Let's plan for briefing the board via conference call before this info becomes public.''


But the issue wasn't made public until an independent weekly newspaper in St. John's published a story on Oct. 2, 2005.


And the full scope of the errors wasn't understood until May 2007, after court documents were filed showing more than 300 patients were affected by botched tests.


More than 200 people have since become part of a class-action lawsuit against Eastern Health.


The inquiry, launched last year, is examining how 383 patients were given inaccurate results on their breast cancer tests, and whether Eastern Health responded to them and the public in an appropriate and timely manner.


Earlier Wednesday, Dawe apologized to patients who may have missed proper treatment because of the inaccurate tests.


"I'm very sorry for the pain and anxiety that patients and their families have endured,'' Dawe said in an opening statement. "For this, Eastern Health apologizes.''


Dawe said she remains confident that medical officials with Eastern Health carried out their duties to the best of their abilities.


"Their motivation was first and foremost to provide the very best patient care,'' she said. "That remains Eastern Health's objective today.''

Dawe will continue her testimony Thursday, to be followed by Ottenheimer.

Into: Parallels with Smith?


May not have been about disease;

Disclosure would have put other cases in jeapardy - and look badly on the people who were supposed to supervise him for the public..

More specifically - pocket of secrecy -when hospital decided Smith's performance onhospital analysis of tissues fo living patients was so bad - they wanted him retrained and demoted -

And someone was harmed - cplostomy girl -


No evidence it was even referred to thec College;


Refer to the postings;

Email to top;

Parallel to Smith secrecy to top;

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Part Three: Extraordinary Development: It's All About Trust;

"I'M VERY SAD HOW THIS HAPPENED, HOW IT'S PLAYING OUT. I'VE LOST TRUST, I SECOND GUESS EVERYTHING."

ROSALIND JARDINE TO THE NEWFOUNDLAND BOTCHED BREAST CANCER TESTS INQUIRY;

It's all about trust - whether one is talking about a forensic pathologist who testifies in court or about the unseen pathologists who quietly work away in their labs processing the breast cancer tests.

Why, for example, would any Canadian involved in the administration of criminal justice distrust a pathologist Dr. Charles Randal Smith - or, for that matter, any other forensic pathologist testifying on the government's behalf?

Dr. Smith was being offered by the Crown as a dispassionate man of science who is dedicated to making his training, expertise and integrity available in a neutral, objective and dispassionate way to the jurors.

That's what the Canadian public expects of the Crown's forensic pathologist experts in criminal cases.

Nothing less;

And why would any Canadian woman undergoing a routine breast cancer test question the ability of the pathologists to correctly read the results?

Canadians have grown up to expect the trained individuals who conduct these tests to be well-trained, well-supervised, well-resourced and subject to quality controls - and that our government will level with us when things go wrong.

Rosalind Jardine, had no reason to question her province's breast cancer testing system before it failed her.

Like so many other Newfoundland women she once trusted the system

Jardine, who was diagnosed with breast cancer in 1999, told the Newfoundland Inquiry into cases involving erroneous pathological results that and her doctor cried when they learned the tests were inaccurate.

As the Canadian Press reported today, (Tuesday, March 25) Jardine told the Inquiry that although she is doing "very well" now, the handling of her case by the Eastern Health Authority has shaken her faith in the system."

"I feel they have not handled it well, in fact, very poorly," Ms. Jardine, 60, testified.

"I'm very sad how this happened, how it's playing out. I've lost trust, I second guess everything.""

The Canadian Press also reported that Jardine had received a lumpectomy, chemotherapy and radiation treatment - and that her initial tests ruled out the hormone therapy drug Tamoxifen.

"In 2005, she was admitted to emergency and had surgery of the bowel, where the cancer had spread," the article says.

"Ms. Jardine said that at around the same time, retesting of her tumour tissue samples at Mount Sinai Hospital in Toronto showed her original hormone receptor tests were wrong.

She said her oncologist, Kara Laing, apologized to her.

"I cried, she cried," Ms. Jardine told the inquiry, now in its second week.

By that time the cancer was in her bones and she was placed on other drugs because she was no longer eligible to take Tamoxifen.

The inquiry is examining why hundreds of patients received inaccurate results from hormone receptor tests used to determine their course of treatment from 1997 to 2005.

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."

In recent postings this Blog has questioned whether the three on-going public inquiries looking into the botched work of pathologists constitute a mere crisis in pathology - or a crisis in Canada's overall health care system.

But Jardine is telling us through her evidence at the inquiry, that one thing all three inquiries have in common is a massive betrayal of public trust.

Canadians are waking up to the reality that they have been poorly served by the officials that were supposed to be protecting them.

Harold Levy...hlevy@gmail.com.

Part Two: Extraordinary Development: The Three Inquiries: How Far Does The Crisis Extend?

I recently suggested that the three separate public inquiries involving the work of pathologists which are currently under way in Canada reveal a crisis in Canadian pathology.

(See previous posting: "An extraordinary development in Canada: Three inquiries based on flawed pathology in one country at the same time; Crisis?" Tuesday, March 18);

The Gazette - a Montreal newspaper - goes even further;

The Gazette suggests that the crisis may extend to Canada's overall health care system in an editorial published on Monday March 24, under the heading "How good are our medical laboratories?"

"What a dreadful tale of incompetence and dismal medical practices is emerging from the Newfoundland inquiry on botched breast-cancer tests," the editorial begins;

"Perhaps most appalling is how long the debacle lasted -- from 1997 to 2005. Testimony from victims is now pouring out, and it makes for painful reading," it continues.

"It took Newfoundland and Labrador's health department far too long to advise the victims about the mistakes.

Beyond sadness and anger for the women involved, Canadians should all also be feeling alarm.

Are comparable laboratories elsewhere in the country more reliable?

In these days of long waits and an overburdened medical system, can we be sure there are not more such problems waiting to be discovered?

We think we can be confident in other labs, and we hope so.

But there is no acceptable threshold for system-wide ineptitude.

Over eight long years, hundreds of Newfoundland women were given wrong diagnoses from a lab in St. John's after breast-cancer screening tests.

That lab conducted the province's high-priority breast-cancer tests, the most urgent ones.

After problems were discovered with the lab's methodology, tissue samples were sent for retesting to Toronto's Mount Sinai Hospital, which unmasked the errors.

Since 2005, at least 108 of these women have died, although it's not known yet if their deaths can be surely linked to the botched tests.

What makes this so horrifying is that the tests largely determined what treatment the patients got.

One result would mean chemotherapy; another would steer the patient to hormone therapy. Many, given the wrong diagnoses, ended up taking the wrong treatment.

Beverly Green, 45, was told she was not a good candidate for Tamoxifen, so she did what anyone would have done under the circumstances; she underwent the ordeal of radiation chemotherapy.

Imagine being told after all that pain and emotional anguish that the diagnosis had been wrong and the pills would have been better treatment.

Also looming over the proceedings is the possibility of falsified evidence.

Several women insist that entries made in their medical files by doctors saying that they had been notified of wrong diagnoses or that they had refused a certain treatment, are wrong.

The conversations never happened, the women say.

That will demand its own investigation, which could lead to criminal charges.

Mistakes happen, but an eight-year mistake reveals serious flaws in the monitoring or accreditation process.

Confidence in the Canadian health system and related services has been shaken repeatedly in recent years by alarming errors - the blood supply crisis, the shocking record of Ontario coroner Charles Smith, this affair in Newfoundland, and more.

It would be soothing to believe that these have all been isolated incidents.

But it's hard to avoid the interpretation that they are all symptoms of a truly troubled public health system."

Harold Levy...hlevy15@gmail.com;

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