NEWS

Canadian Province Seeks Control of Its Genes

Robert Longtin

It started 6 years ago with "the Texas vampires." That was the name that locals dubbed a team of researchers from Houston that had come to their small town in the far easterly Canadian province of Newfoundland and Labrador, "bled" them to collect DNA samples, and then vanished without a trace or ever relating the results of their study.

A year later, there was the group from Ontario involved in a little-known study of an inherited heart condition in another remote Newfoundland town. Their work prompted the front-page headline in a national Canadian newspaper, "`Doomed' Newfoundlanders opt to eat, drink, and be merry," suggesting that the townspeople now thought they were genetically determined to an early death.

"Everybody was wondering, what's going on here?" said Daryl Pullman, Ph.D., a bioethicist at Memorial University of Newfoundland in St. John's. "How many studies are taking place in the province that we aren't even aware of?"

That's when Pullman and several colleagues at Memorial University first proposed creating a special institutional review board, or IRB, to evaluate the ethics of all genetic studies proposed for the province. The ethics board would be the gatekeeper that decides which outside and resident scientists may legally proceed to collect DNA from the province's small, genetically isolated population that many consider fertile ground to prospect for disease genes and mutations, including many involved in colon, stomach, and other cancers.

If all goes well in the province's House of Assembly in the coming months, the ethics review board could become a reality as soon as 2005, marking the first grassroots-inspired law passed by a Canadian province to scrutinize genetic research for potential excesses. But some now wonder whether the board will have its intended effect. They say that, in general, researchers are turning away from studies of isolated, homogenous populations for a variety of scientific and economic reasons. Will an extra layer of scrutiny from an ethics board dissuade gene hunters from coming to the province and potentially benefiting its citizens with new discoveries? Or, as Pullman and others argue, is the ethics review board simply sound public policy in an age of potential genetic exploitation?

O Canada

Newfoundland and Labrador (the formal title of the province), which is nearly twice as large as Great Britain, is rich in oil, gas, minerals, timber, water power to generate electricity, and other valuable natural resources. But prosperity has been slow to reach Newfoundland's economically troubled shores. When the salt cod industry collapsed in 1992, unemployment soared, and a steady flow of mostly young Newfoundlanders fled to mainland Canadian cities for stable employment.

The disparity in natural and real wealth has turned the province, as Toronto Mail and Globe columnist Jeffrey Simpson derisively wrote, into "a culture of grievance." Many Newfoundlanders say Ottawa has plundered their natural resources through a flawed political process, pocketed too much of the profit, and left them to grovel for their fair share.

With so many Newfoundlanders feeling betrayed by outsiders, news of the Texas vampires absconding with another of the province's "natural resources" struck a raw nerve. Pullman and his colleagues raised all of the familiar ethical red flags about genetic studies—informed consent, confidentiality, and the unique nature of DNA as both commodity and shared human heritage.

But, as they built their case for an ethics review board, it was the economics of DNA that most riveted local politicians. In the late 1990s, biotech companies were beating paths to Iceland, Estonia, and other genetically isolated populations, where they cut attractive deals for a financial stake in the regions' genetic heritages.



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Newfoundland and Labrador, on the east coast of Canada, is home to about a half a million people. Many consider its genetically isolated population ideal for studying rare genetic diseases.

 

So some Newfoundlanders wondered, why not invest in genetics research here? Much of the Newfoundland population descended from the English Protestants and Irish Catholics who settled the land in mid-1700s. In fact, 98% of the province still claims either English or Irish roots, and 60% reside in isolated towns of under 2,500 people that have about the same rate of in-migration of new blood and DNA as insular Amish communities.

In fact, there are 27 conditions listed in the encyclopedic Online Mendelian Inheritance of Man database whose genetic basis has been advanced through studies of Newfoundland families, according to Proton Rahman, M.D., a scientist at Memorial University who is also affiliated with Newfound Genomics, one of the province's few biotech companies. Included among the data are founder effects—an initiating mutation passed to future generations—for multiple endocrine neoplasia type I and hereditary nonpolyposis colorectal cancer, and a relatively high rate of stomach and cervical cancers.

Policies and standards for genetic research had strong support from the minister of Health and Community Services in May 2000. But 5 months later, the Premier of Newfoundland, Brian Tobin, unexpectedly resigned, sending provincial politics into a flux from which it has yet to recover.

Since 2000, three premiers have been sworn into office, and Pullman said he has had to start from the top each time to create awareness of the issue. Pullman said the educational process can be especially slow because talk of an ethics review board "isn't much of a vote getter," and, with the government running a sizable debt, most politicians wrongly view the panel as an expense.

"We had to work through various jigs and reels to make this cost neutral to government," said Sharon Buehler, Ph.D., an epidemiologist at Memorial University, who has played a leading role in lobbying for the ethics panel. "We've just started collecting fees for review of industry-sponsored protocols, as do most research ethics boards. But we probably won't get any operating expenses from the government."

Buehler said the ethics panel now has enough support among a few career civil servants to hammer out appropriately worded legislation this fall. They hope to introduce a bill in the House of Assembly during its spring 2005 session. "It's just a matter of awareness," said Buehler. "We have to get a bill to the House and bring the issue of genetic research to their attention."

The Board's Mission

As currently envisioned, the board will serve as Newfoundland's primary institutional review board for all research proposals involving genetics and possibly clinical trials, marking the first province-wide ethics panel in Canada. "What will be especially important for us are the studies that are reviewed outside the province but are conducted here," he said. "We want to ensure that they also are reviewed locally." Pullman said the panel will maintain a much-needed inventory of all genetic studies conducted in Newfoundland.

In addition, the new law would clear the way for a complementary but independent panel called the "Resource Review Board." Consisting of individuals knowledgeable of the latest trends in genetic research, the board would advise the ethics panel on emerging scientific issues. It also would oversee a more controversial aspect of the proposed legislation: benefit sharing, or sharing with the province some of benefits that may accrue from their genetic studies.

"Private industry is right to expect a return on its investment," said Pullman. "But there is a solid rationale for saying that they must return some of the benefit back in a more direct way than the trickle-down market notion that society will benefit one day from a new product. In Newfoundland, we want to know up front what the benefit will be."

"It's not that we want a percentage of the royalties or a cash payment," he continued. "We've always been fairly open to an `in kind' benefit to our community, such as helping to develop the health infrastructure in some way. That would be highly beneficial."

Buyer's Market

In the late 1990s, when Pullman and colleagues first discussed ethics panels and benefit sharing, they presumed genetically homogenous populations like Newfoundland would be in great demand for years to come. But with reams of biological information now generated daily in laboratories world-wide, some have asked whether large-scale genetic epidemiology is practical. They say it is unclear how genetically homogenous these populations really are, nor are they sure how well data from Iceland or Tonga extrapolate more broadly to genetically mixed populations in London or Los Angeles.

"The only thing certain about these population-wide, genotype-phenotype resources is that they are staggeringly expensive," said Hank Greely, J.D., a lawyer and ethicist at Stanford University Law School in Palo Alto, Calif. "They might be essential to understanding the genetic links to complex diseases. But we don't know, and who wants to bet $10 million on it?"

With more of a buyer's market for genetically isolated research populations, can Newfoundland afford to adhere to a higher ethical standard than just about anywhere else in the world? Or, as some ask, will these extra restrictions repel not only the Texas vampires but industry itself, leaving no benefits, research or otherwise, to the province at all?

Buehler said it is well worth the risk. "The main ethical issue is: If people from outside want to use our population, they must disseminate their results to us, not exploit our citizens, and give something of value back to the province. That's not asking a lot."

Pullman noted that Newfoundland's experiment in research ethics also might serve as a template for other provinces, states, and countries. He drew a comparison with Tommy Douglas, the father of socialized medicine in Canada, pilot testing his historic idea in rural Saskatchewan rather than a more politically contentious province like Ontario. "We sometimes put the spin on it that if we can show that there is a model that is workable in Newfoundland as kind of a microcosm, it might be exportable elsewhere," said Pullman.

Charles Weijer, M.D., Ph.D., a bioethicist at Dalhousie University in Halifax, Nova Scotia, said he is not sure how well the spin applies. "I doubt that any straightforward application to other provinces exists," he said. "Provinces that have a greater population and greater intensity of research activity would find it difficult to sustain a single province-wide research ethics board... Heterogeneous communities in other provinces will demand differing solutions, and this fact will undermine solutions at the provincial level."

But he added, "I am sure other provinces are watching Newfoundland's efforts closely and that there will be lessons to be learned."



             
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