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Archive for March 18th, 2008

The risk for recurrence in women diagnosed and treated for early-stage breast cancer may be linked to higher concentrations of serum estrogen, according to data published in Cancer Epidemiology, Biomarkers and Prevention.

To determine the relationship between recurrence-free survival and levels of estriol, testosterone and sex hormone binding globulin, researchers from the University of California in San Diego and other institutions, examined a case-control group of the 3,088 women enrolled in the Women’s Healthy Eating and Living Study, a randomized diet trial. Researchers followed these women for more than seven years after their diagnosis.

In the current study, 153 of the 3,088 WHEL participants whose cancer recurred were matched with 153 participants whose cancer did not return. Researchers found that concentrations of total estradiol, bioavailable estradiol and free estradiol were associated with recurrence risk in these 153 pairs of perimenopausal and postmenopausal women. The average estradiol concentration in women with a recurrence was twice that of women who did not have a recurrence (22.7 vs. 10.8 pg/mL; P=.05), according to the study.

Researchers did not find a link between risk for recurrence and concentrations of testosterone and sex hormone binding globulin.

ScienceDaily (Mar. 18, 2008) — Whether or not relatives talk about the family’s history of cancer significantly impacts attitudes and knowledge about genetic counseling and testing for those at moderate risk of developing breast cancer, according to a new preliminary study presented March 18 at the American Society for Preventive Oncology meeting in Bethesda, Md.

Prior research has shown that African Americans participate less often in genetic counseling and testing for the genes that put women at risk for breast cancer than Caucasians. Also, African Americans are often diagnosed with a later stage of breast cancer and thus are more likely to die from the disease. “It’s important to understand the many reasons for these differences so we can better address them,” said Kristi D. Graves, Ph.D., a clinical psychologist in the Cancer Control program at the Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center. “In this study, we evaluated the impact of socio-cultural variables on knowledge and attitudes about BRCA 1/2 counseling and testing. We hope to use this information to better understand why there’s a difference in testing uptake among black and white women.” Researchers conducted telephone interviews with 105 women who had a negative breast biopsy history and one or more relatives with breast and/or ovarian cancer (75 Caucasians, 30 African Americans). The researchers assessed cancer history, perceived risk, worry, medical mistrust, cancer fatalism, family/physician communication, race-based experiences, and knowledge and attitudes toward BRCA 1/2 testing. After controlling for education, income, and socio-cultural variables like medical mistrust and cancer fatalism, Graves said, “We didn’t find a statistical difference in knowledge or attitudes between African-American and Caucasian women. We did observe a difference, however, among women who said their families discussed their cancer history versus those families who didn’t discuss cancer. We asked the women if they had talked with their relatives about the family’s history of breast cancer. The more family members the women talked with, the greater the level of knowledge about genetic counseling and testing. “We also found that those who felt more vulnerable because they perceived a greater risk of developing breast cancer had less positive attitudes about genetic testing,” Graves said. Next, Graves will examine if the women in this study decide to take part in genetic counseling and testing after they receive educational materials. Funding for this research was provided by an Institutional Research Grant from the American Cancer Society.

Serious quality-control problems have plagued hospital laboratories across Canada for decades, causing an unknown number of patients to be misdiagnosed, say pathologists and lab workers who warn the current system is putting Canadians at risk.Pathologists and laboratory technicians say there is no way to measure the scope of potential inaccuracies or medical errors that may have resulted in misdiagnoses in recent years. But the problems now coming to light illustrate a patchwork of quality assurance in labs across the country and a lottery-like system of care that has persisted for too long.

“It’s a surprise that the system hasn’t cracked before now,” said Kurt Davis, executive director of the Canadian Society for Medical Laboratory Science, the certification body for medical lab technologists and lab assistants.

The major problems that have been allowed to fester unchecked for years – including poor quality control, critical staff shortages and inadequate documentation – are now coming under intense scrutiny as the result of a judicial inquiry into a breast cancer testing scandal in Newfoundland.

The inquiry, which has been postponed until tomorrow due to bad weather, will probe how test results were botched for hundreds of breast cancer patients. A slate of victims given wrong results is lined up to testify this week. However, it is still unclear whether the inquiry will examine whether similar tests for other cancers done at the lab were also marred.

But the probe is just the tipping point in a crisis that has been putting the health of patients in jeopardy for years, according to major Canadian health organizations and medical experts.

“I think the problems have been around and have been growing over the last 20 years,” Andrew Padmos, chief executive officer of the Royal College of Physicians and Surgeons of Canada, said yesterday.

Increasingly complex testing methods combined with greater demands on hospital labs and major staff shortages have only made it more difficult for pathologists to cope in recent years, Dr. Padmos said.

“[We're] coming to grips with the fact this isn’t a dream. It’s more like a nightmare and it looks like it’s going to get worse,” he said. “Suddenly it clicked. This is likely going to get a lot worse before it gets better.”

Other recent cases of botched tests or wrong diagnoses provide troubling evidence that problems identified in Newfoundland may be more widespread than many pathologists are willing to admit.

Last month, authorities in Miramichi, N.B., announced they must review about 24,000 patient tests after it was found some of the work by pathologist Rajgopal Menon was incomplete and inaccurate.

Last year, a Montreal woman sued her pathologist after she was misdiagnosed with cancer. The woman, Murielle Lavallee, underwent four months of chemotherapy before finding out that she didn’t even have cancer. In 2004, a Vancouver woman who had her right breast removed sued her pathologist after discovering she didn’t have cancer. Also in 2004, authorities in Winnipeg began an investigation after reports indicated a pathologist made nearly 50 diagnostic errors in a single year.

The college of physicians and surgeons estimates the country has a shortage of between 200 and 500 pathologists. Only about 30 new pathologists graduate from Canadian medical schools each year, according to the college. There are 1,082 pathologists working here, compared with more than 31,000 specialist physicians.

“We have about as many pathologists in Canada as we do cardiologists,” Dr. Padmos said, noting the majority of the country’s pathologists are over 55.

Many pathologists come to Canada from other countries and haven’t been certified by the college but are still working in the field. That’s an issue of increasing concern for Canadian medical organizations, and they hope to introduce requirements for all pathologists to be certified by the college in order to work here.

Pathologists have long known about the chronic issues that are compromising the ability of labs in some areas to interpret tests and ensure accuracy, but have been reluctant to demand action until now.

“It’s not that we haven’t shouted. We just haven’t shouted loud enough that there is a problem,” said Jagdish Butany, president of the Canadian Association of Pathologists.

But Medical Laboratory Science’s Mr. Davis criticized the silence of pathologists throughout the 1990s, as labs experienced major health-care cuts that were key contributors to the quality-control and staffing problems that have culminated in long-overdue calls for change.

“You didn’t hear from the pathologists at all. They are supposed to be the leaders in the laboratories,” he said. “We were disappointed with their leadership in that era.”

In the wake of the recent high-profile medical scandal in Newfoundland and Miramichi, the college of physicians and surgeons, the association of pathologists and the Canadian Medical Association are launching national reviews to address the problems and develop national standards for immunohistochemistry tests, the category that is coming under scrutiny in Newfoundland.

The St. John’s inquiry will likely provide at least some answers to how breast cancer patients may have received the wrong treatment or even died as the result of faulty lab tests. But no one will ever know how many Canadians have died in the past as the result of misdiagnoses, Dr. Butany said.

“You would probably need to be God or to have a crystal ball to tell you that.”

Judy Janes waited five years to hear the proper results of her breast cancer test. Now the Newfoundland woman is dying of bone and lung cancer.

First diagnosed with breast cancer in 2001 and tested that same year, it wasn’t until 2006 that Janes received a letter informing her that her cancer had been wrongly diagnosed. As a consequence the resident of Boswarlos on Newfoundland’s west coast said she received the wrong treatment.

Her case – and more than 1,000 others – are the focus of a Newfoundland and Labrador government public inquiry into eight years of faulty breast cancer screening tests that begins in St. John’s Wednesday.

Janes, 58, hopes the inquiry will answer some questions she has. “I want to know what value does the health care system put on a human life? I want to know what these guys down there value us women at?” Janes said.

“These guys down there” are the pathologists for the province’s Eastern Health district, who between 1997 and 2005 issued 1,013 inaccurate test results to Newfoundland women. Since the faulty reports came to light, 322 women have died.

Newfoundland Supreme Court Judge Margaret Cameron will lead the hormone receptor testing inquiry that will delve into problems with estrogen and progesterone hormone receptor tests – which are supposed to help indicate whether women have breast cancer – over the eight-year period.

Some of the areas the inquiry will examine include when the problems first appeared, whether they could have been detected earlier and what steps – if any – the responsible authorities took when they found out about the problems.

A second portion of the inquiry will look at policy issues such as whether the testing systems for hormone receptors and processes in place in Newfoundland reflect best practices.

The inquiry is expected to last 40 days with dozens of witnesses scheduled to be heard. The testimony will start with women who were misdiagnosed and it will also include doctors, the provincial breast cancer society and even an insurance agency. Janes won’t testify unless the inquiry pays to fly her and her husband in.

“The heavy lifting of figuring out what within a complex industry went wrong will be done by the commission,” said Ches Crosbie, a St. John’s lawyer representing 366 women in a class action against Eastern Health. “To that extent, it’s a boon to everybody who is a member of the breast cancer testing class action.”

Crosbie cautioned that the Newfoundland experience is not an anomaly. “The concern is, this is not an isolated incident out in the boondocks of Newfoundland. What people should be concerned about is, is this happening in my backyard?”

In New Brunswick, a commission of inquiry is underway into the work of a former Miramichi pathologist. They’re reviewing 24,000 cases after it was discovered in an audit of 227 breast and prostate cancer biopsies that 18 per cent of the cases were incomplete and three per cent misdiagnosed.

Louise Jones, interim president and CEO of Eastern Health, said the medical body welcomes the inquiry. Jones said the inquiry would answer many of the questions concerning the testing and would result in recommendations that would “allow us to continue to move forward.”

Like Jones, Janes wants to see the mistakes corrected. For Janes that means other women in the future will have a chance that she has been denied.

“I want to make sure nothing like this happens to them,” Janes said.

Janes’ lung cancer is terminal and inoperable, diagnosed by an Alberta doctor after five months of testing who concluded the cancer in her lungs, chest wall and bone sprang from her breast cancer.

“The dice was thrown when the pathologist did the wrong report and I was given the wrong therapy,” Janes said. “Right from then on, my fate was sealed.”

“I just turned 58. I’ve got young grandchildren. All that is going to be taken away from me. I’m a little bit young to start planning my own funeral.”

03 18th, 2008

A Norfolk surgeon spearheading a national study of mastectomy and breast reconstruction practices has told how the findings would help set standards across the world.

Jerome Pereira, who was a pioneer for the East of England when he began offering reconstruction at the time of mastectomy at Gorleston’s James Paget Hospital in 1997, said he hoped the four-year audit would massively raise women’s awareness of the possibility and potential of immediate breast reconstruction.

And in the wake of the study’s first findings – given national prominence earlier this month – that only one in 10 patients with breast cancer are currently getting access to reconstruction at the time of mastectomy, he said he hoped his work would help to end the postcode lottery.

Despite recommendations from the National Institute for Health and Clinical Excellence in 2002 that it should be available to all patients, the study has found that more than 25pc of hospitals nationally do not even offer immediate reconstruction.

Mr Pereira said: “It is not suitable for all patients, for example if they have advanced cancer, and some will still choose not to take it up, but increasing public awareness will put women in a position to make an informed decision.

“We are looking at life after breast cancer and the message we want to send out is that you don’t have to live life in mutilation.”

The JPH already offers immediate reconstruction to 20pc of patients – twice the national average and a similar proportion to the Norfolk and Norwich University Hospital – but Mr Pereira is keen to see that rise even further and highlighted some units where they had already achieved a figure of one in three.

Thousands of patients nationally will be interviewed in the audit – being carried out for the Healthcare Commission – before it comes to an end in 2010.

The study will focus on access to breast reconstruction, the quality of information given to patients to help them make decisions on types of operation and surgical outcomes and satisfaction rates.

Mr Pereira said no such study had ever been done before anywhere in the world and it would help to establish new standards of care.

Its importance was shown by the fact that as many as 40,000 breast cancer patients were diagnosed each year and one third of those underwent mastectomies.

He added that the number of women undergoing breast cancer operations in the past decade had increased by one-third.

Patient Valerie Streames, 63, of Geldeston, near Beccles, who underwent immediate breast reconstruction at the JPH eight years ago, endorsed Mr Pereira’s campaign to make it more accessible.

She said: “It is a shock when you are told you have cancer and to be able to come into hospital with two breasts and go out with two breasts is psychologically brilliant. We all want to be normal and yet when you are diagnosed you feel very much different from other women.”

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