Is Canadian Blood Services rolling the dice on the future security of needed plasma products?

Their employer fled town, but the workers are still there.

Canadian Blood Services wasted no time in vacating the premises formerly occupied by the Thunder Bay Plasma Donor Clinic up until April 12.

While CBS maintains closure of the clinic was in the works for some time, they had to break their lease and other contracts to make their quick getaway out-of-town. We have no idea what that cost, but along with the layoff of 28 managers and staff, I’m sure they regard it as “just business.”

Initially selling the public on the idea that they had too much plasma — this in a country that has never been self-sufficient in plasma – it has become clear that the real reason behind the closure is financial.

Put simply, it’s cheaper to buy products with source plasma collected from other countries than it is to collect it here and have it fractionated abroad.

This does raise numerous issues, not the least being the security of the supply when Canada becomes reliant on other nations.

CBS has continually misled the public about Thunder Bay.

Claiming they had 10,000 units of plasma too many nation-wide, Thunder Bay would close with its 10,800 units of annual production.

If only it were that simple.

The reality is there is a surplus of plasma for transfusion only.

For “source plasma” to be sent for fractionation into products used for cancer treatment and other medical uses, Canada has had to rely heavily upon the United States for most of the content. That includes intravenous immunoglobulin (IVIG), which has a wide range of usages, including building up the immunity of patients undergoing chemotherapy.

CBS recently revealed that demand for IVIG is rising by about 9 per cent per year.

In 2004 the Deputy Ministers of Health agreed that this reliance on the U.S. posed issues of supply security. In 1997 there was a world-wide shortage of IVIG after U.S. based fractionators were required to meet more stringent standards from the U.S. Food and Drug Administration. As a result of the plan, CBS agreed to increase Canadian content in IVIG to 40 per cent from 24 per cent over three to four years. That never happened.

More recently Canada experienced its own supply challenges with the spread of West Nile disease in this country. Worries that West Nile could be carried through the blood system were realized – as of February 2003 19 cases of West Nile Virus had been confirmed in individuals who had recently had blood transfusions. As a result, CBS launched Operation Stockpile which was intended to increase fresh frozen plasma collections before mosquito season began. Plasma collected during mosquito season would be sent for fractionation, given the processing was expected to kill the virus.

The stockpiled plasma was kept in Thunder Bay and PEI prior to the availability of a test for the supply.

Before Operation Stockpile, Thunder Bay only collected source plasma for Canadian content in fractionated products. Since then, it has been a dual collection site, shipping needed plasma for fractionation to the United States for processing as well as generating fresh frozen plasma for transfusion to both Winnipeg and Toronto.

Prior to closing, the Thunder Bay plasma donor clinic regularly sent between 400-450 units of plasma for fractionation every six weeks, shipping it to the Grifols plant in South Carolina. Grifols is one of several manufacturers of IVIG. That would increase to 600 units when CBS indicated it had an oversupply of certain kinds of plasma for transfusion. Once processed, Grifols sent the plasma back to Canada as IVIG.

CBS says there is enough international supply of IVIG for now.

However, early studies have shown that IVIG can be effective in the treatment of Alzheimer’s disease. “In some of these studies patients showed actual cognitive improvement not just a slowing or halting of deterioration,” states one American pharmacy website. If further studies confirm this, it could dramatically change the equation and create significant shortages of the product. If that turns out to be the case, will the U.S. decide the domestic supply comes first?

CBS maintains importing products containing source plasma from other countries is safe.

An expert panel of Canadian scientists looked at this question in the mid-2000s as part of a report on the appropriate use of IVIG. At that time there were concerns about escalating cost, demand and our ability to access sufficient product to meet Canada’s needs.

“The risk of infectious complications from IVIG is extremely low,” the panel states. “The requirements for donor screening and transmissible disease testing of input plasma are stringent… nevertheless, IVIG is a product made from large pools of human plasma and it is not possible to claim with certainty that there is no risk of infectious disease transmission.”

Does that mean we don’t need to be as stringent in our screening?

CBS maintains that source countries have similar standards to Canada.

But CBS has prohibited donations from individuals who have lived in Europe for more than three months since 1980 due to concerns around the transmission of Creutzfeldt-Jacob disease, the human variant of Mad Cow. Therefore, it was surprising to learn that CBS is now looking at importing product based on source plasma from Europe. Would it not be the case that European donors would have lived in Europe since 1980?

Canada has also long maintained that any blood or plasma donations be without compensation. The World Health Organization has been recommending the elimination of paid donation due to problems around donor screening. Paying for a donation is an incentive to lie to screeners to gain a monetary benefit.

Surprisingly, with a new comprehensive set of regulations before the Canadian Parliament, there is no mention of prohibiting paid donation.

This coincides with an application for licensing to Health Canada by a new private for-profit company to set up two massive plasma donor clinics in Toronto to address Canada’s shortage of plasma. The company, EXApharma, is hoping to attract large numbers of donors by offering to compensate them for their plasma.

CBS says it has no relationship with EXApharma. The reality is even though they and Hema-Quebec are the most logical clients for EXApharma, there is nothing stopping the private company from selling their product to U.S. fractionators – the same companies that in turn sell finished IVIG and other products back to CBS and Hema-Quebec.

When we rely on other countries there is no guarantee that their procedures will be applied to exports.

That’s what the Red Cross thought in the 1980s when the U.S. FDA approved the export of plasma to Canada and other countries. The exported plasma came from an Arkansas inmate plasma program (1964-1991) and contained both HIV and Hepatitis C. This was the beginning of Canada’s own tainted blood scandal. No explanation was ever given why the U.S. FDA would approve this product for export when in 1984 they banned prison blood from being sold within the United States.

Given the decision by CBS is largely about cost, it is surprising that they are more willing to become reliant on international supplies given swings in the value of the Canadian dollar. In 2007, the IVIG expert panel noted then current costs of IVIG ranged between $51 and $64 (Cdn) per gram. “But in past years, with a less favorable U.S. exchange rate, the cost has been as high as $75 to $80. The cost of one infusion of 1 g/kg of IVIG for a 70 kg adult is approximately $4,000.”

Ultimately, CBS saw the quantity of source plasma shipped from Thunder Bay as not very significant. This is despite the fact that more units of plasma were targeted for annual collection in that city than any other centre in Canada. What they really meant to say is Canadian content in source plasma products is not very significant.

Ian Mumford is the Chief Operating Officer for CBS. He is also a former executive with the Canadian Red Cross.

Mumford recently sent staff a memo “setting the record straight on Thunder Bay.”

He writes three weeks after the closure: “What has confused some people is that demand for tranfusable plasma is declining while demand for pharmaceutical products made from plasma is on the rise. The two uses for plasma are very different, and not as interchangeable as some have assumed.”

Yet that was exactly what was taking place in Thunder Bay. It was initially set up to supply fractionators with Canadian content. Then it switched to address the shortage of fresh frozen plasma as a result of the West Nile Virus. Then it became a dual site, adjusting usage according to need.

“What makes the Thunder Bay closure difficult is the negative impact it has on employees, the local economy, and the community that has supported us for so long,” Mumford writes. “Some staff have asked me if we have plans to close other sites, or reduce plasma collections in other centres. We don’t have plans for either right now (emphasis added).”

Mumford says he’s happy to report some of the employees have found new jobs. Given the OPSEU local reports only two of 23 unionized employees have found work, he need not be so happy.

The recent closure of Canadian Blood Services operations in Thunder Bay and Saint John, New Brunswick are having an impact on staff. Who will be next and when?

Will we even recognize the service that was begun out of the scandal that enveloped the Canadian Red Cross two decades ago? Staff tell us the CBS is now thinking about changing their name to take “blood” out of it. Are we setting the table for another crisis?

As a public agency, perhaps these are all questions that should be debated before other centres close.

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Join us for one last rally in Thunder Bay this Thursday, May 17 between 4-6 pm at the Labour Centre, 929 Fort William Rd.

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