GN health department says no to the latest stage in research on RSV

The Nunavut health department has said no thanks to an offer of free research on a lung disease that sends nearly a third of Nunavut children under six months old who live outside Iqaluit to hospital.

And every one of those children has to be medevaced, at great expense to the Government of Nunavut, and with no little anguish for both the child and family members.

Dr. Anna Banerji, from the University of Toronto, said the proposed research on the treatment and prevention of respiratory syncytial virus, or RSV, started this week in Nunavik, the Northwest Territories and Greenland.

It was to start in Nunavut at the same time, until the Government of Nunavut's health department said no.

The project has already been licenced by the Nunavut Research Institute, has been given the green light by Nunavut Tunngavik Inc. after a review, and has "support from all the community agencies," said Banerji.

Banerji and her researchers are collecting data on hospital admissions of Inuit children with lung infections from hospitals in Ottawa, Winnipeg, Yellowknife, Edmonton, Montreal, Toronto and Greenland.

They would like to gather data from the Qikiqtani General Hospital in Iqaluit, as well. Banerji said of all the jurisdictions in her study, Nunavut children suffer the most lung disease.

But the GN is not allowing it.

The project is "a non-interventional data collection study that wouldn't cost the GN anything in terms of human or financial resources," Banerji said.

She is writing a letter to the GN with about 20 signatures, asking them to reconsider.

This current project is part of ongoing research into the effects and treatment of lung infections among children that Banerji and her colleagues have been conducting in the north, including Nunavut, for over 13 years.

While GN officials would not comment on the issue, a Nov. 13 letter to Banerji from Cindy Roache, chair of the GN's health and social research review committee, says the committee's major concern is that the project is funded by Abbott Laboratories Ltd.

"For reasons of potential conflict of interest, we have reservations about supporting research that is wholly funded by pharmaceutical companies," Roache wrote in the letter.

She also said the Nunavut Department of Health and Social Services is doing some of its own research reviewing hospitalization for bronchiolitis, which is the name of the lung infection caused by RSV, and tracking children up to four years of age.

For those reasons, she said, the committee will tell Qikiqtani General Hospital not to provide access to hospital data for the team.

But "lung health is a big issue in Nunavut," Mary Ellen Thomas, the Nunavut Research Institute's senior officer, said.

Given the capacity problems that Nunavut faces daily, she said, "whatever funding we can find to assist research is of interest to me."

"I don't care where the funding comes from," Thomas added. "It's not even a question on our application forms." It's the quality of the research that matters.

Banerji said her group has always been upfront about the funding source for their research, but claimed that the study is totally controlled by the researchers themselves, and totally independent of Abbott.

The results will be published in a peer-reviewed medical journal, like results from previous, related work.

Thomas explained that when the NRI receives an application for a licence to do research, they send it out to a number of independent reviewers, including, in this case, the GN's department of health and other medical researchers.

If the NRI doesn't receive any objections within 45 days, as happened in this case, they licence the research.

If the NRI does receive objections, Thomas said, "often these kinds of research projects go back and forth several times before they make everyone happy.

"I'm sure they'll work it out."

Some of Banerji's proposed research centres around use on high-risk children of an expensive immunization agent called palivizumab. It's also produced by Abbott Laboratories under the brand name Synagis.

It's often referred to as a vaccine, although technically it is an antibody.

Synagis costs about $1,500 per single injection, which has to be administered monthly, often over six months, so it is usually only given to high-risk infants.

Banerji says that in Nunavut the rates of admission to hospital for the virus are four times higher than for high-risk groups who get the vaccine in the south.

Statistically speaking, she said, simply being Inuit already puts children in the high-risk group.

Other factors that increase risk include premature birth, living in overcrowded housing, not being breast-fed, and being in an environment with smokers, all conditions associated with poverty and all common in Nunavut.

Most children in the Baffin region who need to be medevaced for bronchiolitis go to the Qikiqtani Regional Hospital in Iqaluit, but one in 10 is medevaced to Ottawa, to the Children's Hospital of Eastern Ontario, or CHEO.

The average cost per child admitted to the Qikiqtani hospital was $12,029, according to a study done in 1999 to 2002.

The average cost for a child admitted to CHEO was $45,688.

The total cost of treating bronchiolitis babies from 1999 to 2002 was nearly $3 million.

Banerji said one of her previous studies showed that if the health department gave the vaccine to all infants in certain high-risk communities, it could save $6,000 per admission avoided

The current study, she said, should collect data to help answer more questions like:

• Is RSV the only problem, or the major problem;
• What other viruses are involved, and to what extent;
• How many children would be eligible for the vaccine;
• How many are already receiving it;
• How effective is the vaccine;
• When does the RSV season start; and
• When is the optimal time to both start and stop giving the vaccine?

The study would establish base lines of data across the Arctic, she said, in the NWT, Nunavik and Greenland – and, they hope, in Nunavut too.