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Wednesday, January 19, 2011

Health agency barred C. difficile treatment: MD

Several C. difficile deaths could have been prevented, specialist says
By Kathy Tomlinson, CBC News

A hospital physician from a major B.C. facility says several patients died in the last year from C. difficile — unnecessarily — after the health authority stopped her and her colleagues from giving an experimental, simple and highly effective treatment. "I can't offer it to [to patients]. I can't do anything for them," said Dr. Jeanne Keegan-Henry, a specialist in hospital medicine from Burnaby Hospital, which is run by the Fraser Health Authority. "And I've seen some of them die."

The treatment, called a fecal transplant, involves introducing stool from a healthy donor — usually a relative — into an infected patient's bowel, usually through an enema. Proponents say it works because so-called good bacteria, from the healthy donor's feces, kills the "bad" bacteria in patients who have recurring infection and where antibiotics haven't been effective."C. difficile is a wimpy bug. If there are other bugs around it dies, it gets beaten up. So all we need is the right bugs," said Keegan-Henry.

Treatment called 'no-brainer'

"The fact that it would save lives seems to me to be a no-brainer, but that isn't what is happening."
Dr. Jeanne Keegan-Henry says the Fraser Valley Health Authority is blocking her from giving life-saving treatments. (CBC)C. difficile is a debilitating bacterial infection in the bowel, often caught by elderly or frail patients while they are in hospital. In B.C., 3,437 cases of C. difficile were reported between March 2009 and March 2010. Fifty of those patients died within a month. In 170 reported fecal transplants outside Canada, more than 90 per cent of the patients were cured.

In Canada, 50 patients at St. Joseph's hospital in Hamilton, Ont. have undergone the transplant since 2008. Calgary physician Tom Louie gives the transplant to patients routinely, with consistent success rates reported.In addition, a full clinical trial, involving 146 patients, is underway through the University Health Network in Toronto.

Keegan-Henry believes the biggest obstacle to making the treatment widely available is what she calls the "ick factor.""[Heath care] bureaucracies don't like weird stuff. And this is something that sounds icky," she said.

Saved patient's life

Keegan-Henry gave a fecal transplant to 86-year-old Jane Thomas last year, which she believes saved her life."It was simple you know. And for the little bit I had to go through it was worth it," said Thomas.
Burnaby Hospital is run by the Fraser Health Authority, which says a formal proposal from doctors is needed before it will consider a fecal transplant research project. (CBC)The elderly woman said she suffered terribly for weeks with recurring infection. She lost 20 pounds and believed she was going to die.

"My heart goes out to these people that are going through it now, because I know what I went through," said Thomas. "I think the doctors should take charge because they know what they are doing. They are the medical doctors."Keegan-Henry said that after Thomas's transplant, administrators with Fraser Health decided she could not perform any more."I was told by our medical director that we were not allowed to use the hospital facilities to do it again," said Keegan-Henry. As a result, she said, "we lose people we don't have to lose."

She wrote up a treatment protocol, which she said was submitted to administration. She said she was then asked to write a business proposal, which she has yet to do."I think this is administration by exhaustion," she said. "[They] just keep asking people for one more piece of paper until they give up."

Others have died since

Since then, Keegan-Henry estimates at least 10 patients, who could have been saved by the treatment, died at Burnaby Hospital.Jane Thomas, 86, suffered from recurring C. difficile, but believes she was cured by a fecal transplant by Dr. Keegan-Henry. (CBC)"I am very angry sometimes. You look a family in the eye and say I am very sorry for your loss. Maybe I could have stopped it, but I'm not allowed to. It's not a very good place for me to be. Professionally that is very tough."

No one from Fraser Health was made available for an interview, but CBC News received a statement, attributed to Dr. Andrew Webb, vice-president of medicine."Patient safety is our primary concern. The safety of fecal transplantation has not been adequately studied. There must be strict controls to ensure other serious infections are not passed to the patient inadvertently," the statement reads.

"To date, we have not received a formal application for consideration to study the outcomes or benefits of fecal transplantation within a research protocol."Keegan-Henry countered that the risk of disease transmission can be virtually eliminated if donor feces are thoroughly tested beforehand.

"There are no cases of transmission of infection by this procedure — in the world — so far," she said.
Dr. George Sing, a gastroenterologist at Burnaby Hospital, also wants to provide the treatment to patients."We did table [a proposal], but it fell into the cracks," said Sing. "We have been through all the channels … but when it goes through committees it gets bogged down."Sing told CBC News the pushback he received was from a unit manager, who told him nurses were not insured to administer the treatment.

Fecal transplants involve introducing stool from a donor into the bowel of a C. difficile patient, where the healthy donor bacteria can kill the infection. (CBC)He estimated between 20 and 30 per cent of his C. difficile patients become resistant to antibiotics. Those are the patients, he said, who have nothing to lose by having a fecal transplant."A lot of people would benefit," he said. "And a lot of research supports this."

Keegan-Henry said she decided to go public with CBC News, in hopes of shaking up the "inertia" within Fraser Health."Just tell us we can go ahead," she pleaded. "I've got the equipment. Just tell us we can do it inside the hospital. We'll do it at the bedside if we have to. It's not that complicated."It's very bad for health care in this province and in Canada that good important ideas die on the table like this."

Read more: http://www.cbc.ca/health/story/2011/01/17/bc-fecaltransplants.html#ixzz1BPzmeZaA

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