Fatal Canadian bungling goes on for years

The Newfoundland laboratory that botched hundreds of breast cancer tests has not investigated whether results of other specialized lab work done during the same period were correct, leading experts to question whether the province's testing tragedy is more extensive than has been revealed.

The scandal has invigorated national concerns about the lack of regulations for immunohistochemistry, or IHC. The Royal College of Physicians and Surgeons of Canada and the Canadian Association of Pathologists are set to launch nationwide reviews to address critical gaps in quality assurance that put patients at risk. “The issues that have been brought to light reflect on the system,” said Andrew Padmos, chief executive officer of the Royal College of Physicians and Surgeons of Canada. “This is not a blame game. We're here to fix the problem.”

In Newfoundland, a public inquiry set to begin next Tuesday will examine how problems in the lab at St. John's Health Care Centre led to incorrect diagnoses for more than 300 breast cancer patients. However, experts set to testify told The Globe and Mail that tens of thousands more cancer patients might have been put at risk by faulty testing methods. “Because there's been an error detected in one test, there's a burden of proof on the system to show all the tests are safe,” said Michael Goodyear, an oncologist and associate professor of medicine at Dalhousie University who specializes in patient safety studies.

Nebojsa (Nash) Denic, clinical chief at Eastern Health, the lab in question, disagreed and said it would be an overreaction for his facility to do more back-checks on tests without clinical proof there is cause for concern. “You just don't go blindly asking whether a stain worked or not,” he said. “… If you buy a new car, unless you press the brakes, you don't know whether the brakes work. That's your indicator.”

In this case, the indicator seems indisputable: Many patients were misdiagnosed. And the systemic problems in the Newfoundland lab, exacerbated by a high staff turnover and strained resources, went undetected for nearly a decade. Now, they have caught the attention of lab workers and cancer specialists across Canada. “Every pathologist and pathology department in the country is examining what they do and the way they do it in light of this,” said Sylvia Asa, chief pathologist at Toronto's University Health Network. “It's opening up a lot of questions about what we do and how we do our jobs.”

IHC involves a family of complex, sophisticated tests in which tissue samples are stained with antibodies that bond to antigens in cancer cells, opening a window for pathologists who interpret the tests to examine the cell's unique molecular characteristics and issue a refined description of the cancer. Oncologists rely heavily on the pathologist's interpretations to make decisions about patient care. “The pathologist gives the clinical oncologist the correct diagnosis and correct direction for how to treat the patient,” Dr. Asa said. “Without that, you just can't navigate.”

The tests include more than 40 sensitive steps and are known for being extremely vulnerable to errors in the absence of strict quality control. For patients, that spells the possibility of getting incorrect test results, which could lead to a false diagnosis, wrong treatment plan and a compromised prognosis. “There's a potential for this sort of thing to occur anywhere,” said Carol Sawka, a medical oncologist and vice-president of clinical programs for Cancer Care Ontario.

Dr. Sawka said that over time, the field of immunohistochemistry has “outpaced the organization's ability to respond to it effectively.” The field has also outpaced regulators who have yet to set any kind of enforceable guidelines to ensure quality testing. “We don't have any gold standards,” said Emina Torlakovic, a Saskatoon pathologist who is leading a committee set up by the Canadian Association of Pathologists that is looking at developing national standards for IHC testing. “I don't think everybody understands what they're really doing. I know that everybody is trying to do their best. But what is the best isn't defined. And that's a problem.”

Leaked documents – key pieces of evidence expected to be examined at the inquiry – suggest that Newfoundland's lab, which does about 1,000 IHC tests a month, has battled problems for years. In a 2003 memo to administrators of the Health Care Corporation of St. John's (HCCSJ is the predecessor to Eastern Health) that was leaked last year, Gershon Ejeckam, the then-director of the lab, announced his decision to temporarily halt testing because of “erratic” results. He attempted to set off alarm bells about problems threatening the province's cancer care system. That year, after the lab made some changes, testing was restarted.

In his memo, Dr. Ejeckam (who now lives in Nigeria and was unavailable for comment) wrote that high staff turnover and the workload that lab staffers were shouldering made it “virtually impossible for them to devote the time required to master the intricacies of this procedure.” He pleaded with his bosses to dedicate resources for specialized staff. “To do less will simply become a gamble where you may win or lose. This obviously will spell disaster,” he wrote, adding that “crisp, reliable” results were “extremely important” in the diagnosis and treatment of several cancers. “Diagnosis based on inappropriate immuno stain will surely jeopardize patient care and may even expose the HCCSJ to litigation.” Dr. Ejeckam outlined a list of tests he viewed as having been jeopardized by problems in the lab. One was the breast cancer test for estrogen receptors at the centre of the public inquiry, also the subject of a class-action lawsuit. But he listed several more tests related to a host of other cancers.

In an interview yesterday, Eastern Health's Dr. Denic said those other tests are less vital. “It's bad practice if [the tests] are solely used in diagnostic purposes,” he said. It remains unclear whether the public inquiry will expand its mandate to explore them.

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The coming debate over health care

No matter who wins the Democratic presidential nomination, that candidate will have a significantly different prescription for the nation's health-care system than Sen. John McCain, the Republican nominee. Which is a good thing, since that means the country is in for a debate involving real substance.

Both parties agree that "the health system needs major repairs," reports Kevin Sack in a recent analysis of the candidates' proposals by The New York Times. As Sack noted, the Democrats are more interested in universal coverage, while the Republicans focus on cost containment. Those may be the points of emphasis, but McCain wants expanded access, too, while Barack Obama and Hillary Clinton claim they can rein in health-care costs.

One thing we've learned from state-based experiments in universal coverage: It's not cheap. In Massachusetts, taxpayer subsidies for its two-year-old program of mandated coverage will rise from $158 million in 2007 to $600 million this year and $870 million in 2009. Lawmakers are now scrambling to impose new cost controls. On the menu: lower payments to doctors, hospitals and drug companies. Meantime, a similar plan proposed in California died in January when the independent Legislative Analyst projected the program would cost at least $4 billion more in its first five years than proponents first suggested.

By contrast, McCain's agenda would primarily expand choices for consumers. Among other things, he would allow Americans to purchase health coverage from a licensed insurer in any state; individuals could shop nationwide for an appropriate policy and compare prices. He would also allow membership organizations (like AARP) or other non-employers to sell group policies.

Most dramatically, he would end the tax deduction that employers receive for providing health insurance; instead, individuals would receive tax credits they could use to either purchase policies or invest in Health Savings Accounts. They would no longer depend on their employers for medical coverage. Taken in combination, these proposals would give individuals more control of their health-care options..

Until the next president takes office, states would be well-advised to steer clear of comprehensive reform. But they can act on the margins. Indeed, we're encouraged to see several consumer-friendly initiatives in this year's legislature. House Bill 1061, with bipartisan sponsors, has passed both houses and would allow advanced practice nurses (who have specialized certification, such as in clinical practice or anesthesia), to provide a broader range of care - more like physicians.

Next, House Bill 1311 would establish two new, bare-bones insurance plans for any employer that does not offer its workers medical insurance. The proposal died in committee, but the lead sponsor, Rep. Spencer Swalm, R-Centennial, told us that House Speaker Andrew Romanoff has expressed interest in reviving it.

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