Crisis Up-Date: Creaghan (New Brunswick) Inquiry Into Pathologist Rajgopal Menon;

"THE PERSONS WHO ARE SERVED BY THE MIRAMICHI REGIONAL HEALTH AUTHORITY WERE UNDERSTANDABLY UPSET WHEN THEY LEARNED AND HEARD ABOUT THE SITUATION CONCERNING PATHOLOGY SERVICES AT THEIR HOSPITAL. I WANT TO GIVE THEM EVERY OPPORTUNITY TO BE HEARD," HE SAID, ADDING THEY MAY GIVE EVIDENCE WITHOUT LEGAL REPRESENTATION OR MAY HAVE COUNSEL AT THEIR SIDE, SHOULD THEY SO WISH."

JUSTICE PAUL CREAGHAN:

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The Miramichi Mirror reported earlier this week that the Creaghan Inquiry into 227 cases handled by New Brunswick pathologist Dr. Rajgopal Menon is set to begin hearing evidence tomorrow (Monday May, 5, 2008, in a story headed, "Pathology Scandal: Justice Urges Objectivity;"

The New Brunswick Inquiry is one of three probes involving flawed pathology that are now underway in Canada - including the Goudge Inquiry in Ontario's review of the botched work of Dr. Charles Smith - which have raised fears that the nation's health care system is in a state of crisis.

"Step back," the story begins.

"That was the advice of pathology scandal Commission of Inquiry Justice Paul Creaghan to a gathering of legal, provincial and federal representatives at a preliminary hearing in Moncton on Monday," (April 28) it continues.

""Step back," Creaghan said, "put aside personal agendas and consider the issues ..."

Creaghan delivered the advice while discussing the investigative process that will take place during the three phases of the inquiry scheduled for May, June and September of this year.

"This is an investigative process ... not a discovery process, not a trial and not an adversarial process," said Creaghan, adding what the intent of the hearings will be is to get to the bottom of the situation.

The inquiry will focus on cases handled by former pathologist Dr. Rajgopal Menon in 2004-2005, specifically, a review of 227 of Menon's cases by Dr. Rosemary Henderson initiated by management of the Miramichi Hospital.

Henderson found that 18 per cent of the 227 cases were incomplete and three per cent were misdiagnosed.

Creaghan said the inquiry will focus on quality assurance issues and quality control of services provided.

"Witnesses will testify with the constitutional protection that their testimony will not be used in any criminal or civil proceeding. Witnesses may have counsel with them when testifying, should they need assistance as to how to appropriately answer a question," he said.

During the meeting, Creaghan introduced other members of the commission, including principal counsel Marc-Antoine Chiasson, counsel Remy M. Boudreau and manager Pauline St.Laurent-Pinto, as well as lawyers representing the provincial department of health, the Miramichi Regional Health Authority, the College of Physicians and Surgeons, the Canadian Medical Professional Association, Menon, the Canadian Cancer Society and a class action lawsuit.

Creaghan said only Chiasson will be permitted to question witnesses without his leave — and he will grant leave to others only under special circumstances. He cited as an example of special circumstances testimony given by someone from out of province who may not be able to return to testify at a later time.

Phase one of the inquiry is set to begin tomorrow and run through to Tuesday, May 13, excluding the weekend. Expected to give evidence in phase one are former provincial deputy minister of health Nora Kelly, department of health physician resource advisor Lynn St. Pierre Ellis, hospital services executive director Lise M. Daigle, deputy minister of health Don Ferguson, MRHA chief of pathology Dr. Dariusz Strselczak, and former MRHA chief operating officers John Tucker and James Wolstenholm.

"This is an investigative and not an adjudicated process," said Creaghan before repeating his advice that everyone step back and remember "... this is a review intent to improve health issues in Miramichi, and indeed the the province."

He added the preliminary hearing was intended to help people feel comfortable with the process before the public hearings proceed and to introduce the parties given standing before the commission.

"I have pledged the process would be open ... [But] this is not a press conference and I do not intend to conduct this in the media," said Creaghan. "It is an opportunity to identify how we intend to proceed."

Phase two set for Miramichi

Phase two of the inquiry is set to be held in Miramichi in June. Creaghan said this phase will provide patients affected by the review of cases every opportunity to be heard.

"The persons who are served by the Miramichi Regional Health Authority were understandably upset when they learned and heard about the situation concerning pathology services at their hospital. I want to give them every opportunity to be heard," he said, adding they may give evidence without legal representation or may have counsel at their side, should they so wish.

"In that case, Chiasson may have some further questions to complete the witnesses' testimony. If the person is without a lawyer, he will lead the evidence."

Creaghan explained witnesses will be advised their testimony cannot be used in any criminal or civil proceeding that may ensue.

"George McAllister has been granted standing to represent any person who may wish to testify as an aggrieved party. Should a person who appears at this phase of the hearing wish to have McAllister lead his or her testimony, he may do so," said Creaghan. "Again, aside from follow-up questioning by Chiasson, there will be no cross-examination of these witnesses without leave."

Chiasson said to date there are 20-plus names scheduled to appear in phase two of the hearings in Miramichi. He said he anticipates these numbers will grow significantly.

Summer hiatus

The inquiry will be adjourned during July and August to afford the members of the commission an opportunity to review the information provided throughout phase one and two of the hearings.

The final phase is scheduled to resume Sept. 8 and will provide an opportunity for all parties with standing to present evidence they deem necessary and relevant under the restrictions imposed by Creaghan.

"To conclude this final phase of the public hearings, the commission intends to recall Henderson and will also call Dr. Heathcote, head of pathology at the Queen Elizabeth Hospital in Halifax. These witness will be available for questioning by all parties with standing," Creaghan said.

Lawyers with standing before the commission who wish to call witnesses in phase three must provide their names, addresses, telephone numbers and any other relevant information prior to August 4, 2008.

McAllister said a request for funding to assist individuals with the financial support they may need to proceed is currently before Premier Shawn Graham.

"I understand they are going to make a decision this week," said McAllister, adding he could not assess the amount of funding involved at this time because it will fluctuate with the length of the hearings and the number of individuals participating in the class-action suit.

"We haven't costed it out, but generally speaking, most of the parties here are going to have two lawyers; they are going to call experts and all of the rest of it. It is a very expensive commission and you cannot affect people here effectively without funding," he said."

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 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;