April 12, 2013
By: Isabel Teotonio
The large freezers, though humming loudly, contain no units of protein-rich plasma, the liquid gold that is transformed into life-saving medications — albumin to treat burn, trauma, shock from blood loss and transplant recipients; clotting factors for those with bleeding disorders such as hemophilia; and immunoglobulins for inflammatory and immune disorders, such as primary immune deficiency.
Canadian Plasma Resources spent $6 million on its two clinics — this one on Adelaide St. E. and another on Spadina Ave. Plans call for a third this year in Hamilton. Each site hopes to attract 2,000 regular donors. That is, if they get the go-ahead.
The outcome hinges on crucial discussions this week on whether Canadians can get money for their blood, specifically plasma. If the company gets the green light, it will signal a fundamental policy shift in a country with one of the safest blood systems in the world, the cornerstone of which is unpaid volunteers donating for altruistic reasons.
Thousands of Canadians rely on treatments made from plasma — and demand far exceeds the amount of plasma collected here. So to supplement the supply we rely on plasma drugs made from paid American donors. So why not let Canadians be paid for their own plasma to meet domestic demand?
Permitting paid plasma collection by the private sector raises difficult questions. Will it be safe? Will a plasma-for-profit system prompt fewer volunteers to donate blood? Can parallel donor systems co-exist? And what are the risks of privatizing blood collection?
There’s an ethical dimension, too. Because the clinics are located in inner-city neighbourhoods, where people welcome income supplements, there are concerns about exploitation and the worry that those deemed high-risk will want to sell their plasma for fast cash.
The Toronto-based company says it first informed Health Canada and the Canadian Blood Services in 2009 of its intentions. It prepared the clinics for inspection and applied last November for a licence from Health Canada.
But after a public outcry in February, following news reports about the private-sector clinics, Ontario Health Minister Deb Matthews urged her federal counterpart, Leona Aglukkaq, not to approve licensing without open consultation. (The clinics must also be licensed by the province.)
That consultation came to a head Wednesday, when the federal health department hosted a round-table discussion. It brought together representatives from the province, patient-advocacy groups, academia and the Canadian Blood Services (CBS), the non-profit agency that oversees blood supply in Canada, except Quebec where it’s managed by Héma-Québec.
But it may ultimately be up to the province whether the clinics open because the issue of whether blood donors can be compensated is a matter that falls under provincial legislation. Health Canada’s priority is to ensure safety of the blood supply and make sure the company meets specific safety standards.
Barzin Bahardoust, CEO of Canadian Plasma Resources, is adamant his private clinics will serve a vital public service and adhere to stringent safety standards set out by Health Canada.
“To meet the demand of Canadian patients we need these plasma-protein products,” he says. “It is logical that these products be produced locally in Canada instead of being purchased or imported from other countries.”
Currently, CBS sends its collected plasma to the U.S. and Switzerland to be transformed into drugs because Canada doesn’t have the manufacturing capability — the only G8 country incapable of producing immunoglobulin and albumin. It also imports plasma drugs from American, European and Australian companies that are reliant on U.S. paid donors.
Collecting plasma for fractionation — the process by which it is manufactured into drugs — requires a procedure called plasmapheresis. Whole blood is withdrawn from the donor and a machine separates out the plasma liquid from other blood components, which are returned to the person. The body replaces plasma in about 48 hours. In Canada, one can donate plasma once a week.
The company hopes eventually to operate 10 Canadian sites to produce about 400,000 litres of plasma annually — double what CBS collects — then open a fractionation plant in Ontario, a $1-billion project that would pit it against big international players.
Bahardoust addresses the exploitation concern by saying the company hopes to attract mostly cash-strapped university students. Those deemed high risk won’t be eligible to donate.
The company’s Canadian owners, the Riahi family, made its fortune in construction and real-estate development, and has experience in the blood business. They once owned three plasma-collection clinics in Austria and currently own a German consulting company that provides expertise on licensing and designing fractionation facilities.
Sensitivity to the idea of a private-sector blood industry is related to the tainted blood tragedy in the 1980s, when 30,000 Canadians were infected with HIV or hepatitis C after receiving transfusions of improperly tested blood and plasma drugs. Some of the drugs came from paid plasma donors in American prisons, mental institutions and skid rows.
A public inquiry by Justice Horace Krever overhauled Canada’s blood system. In his 1997 landmark report, Krever recommended Canada’s blood supply rely on unpaid donors, who are deemed to be safer, except in rare circumstances. (For example, since 1980 Cangene Corp. in Winnipeg has paid a select group of donors for plasma to make hyperimmune products.)
Krever also recommended Canada have an open and transparent blood system and consult with the public before changing the volunteer system.
Canada’s blood system was founded on the altruism of volunteer donors. Buoyed by the success of unpaid blood donation clinics that were set up to help the troops during World War II, the Canadian Red Cross went on to establish what would become our national volunteer blood system.
In 1998, following the tainted blood scandal, the CBS became the national blood operator – except in Quebec. (Neither the CBS nor Héma-Québec pays donors.)
“Do Canadians want to go down this road again?” asks Michael McCarthy, 54, a hemophiliac from Sebringville, Ont., who was infected in 1984 with hepatitis C after receiving a plasma drug that originated from paid donors in an Arkansas prison. “Are they ready to allow a parallel blood system to be put into place with the unknown risk?”
If Ontario permits a paid-donor model, McCarthy worries it will open the floodgates for similar private clinics in other provinces. (Quebec is the only province where payment for blood is illegal.)
“There’s almost a point of no return if we introduce this type of model into Ontario,” he says.
Currently, CBS collects enough blood and plasma from whole blood donations to meet the domestic need for transfusions. But it doesn’t collect enough plasma to fill the demand for medications. Plasma collection for pharmaceutical purposes is expensive and Canada simply doesn’t have the population size to keep up with the growing demand for plasma drugs.
Put simply, it’s more cost effective to purchase plasma drugs from donors, both paid and volunteer, in the populous U.S. than to collect plasma from Canadian volunteer donors and ship it to the U.S. to be made into drugs.
Hundreds of donations go into one patient’s treatment and Canada is one of the biggest users worldwide of plasma drugs. Currently, 70 per cent of immunoglobulins distributed to hospitals and 30 per cent of albumin is imported, mostly from paid donors in the U.S.
More than 50 per cent of the world’s plasma supply comes from the U.S.
Plasma drugs aren’t cheap. Last year, CBS spent $458 million — half its $1 billion budget — to buy them. And demand worldwide is increasing, especially for immunoglobulins. If studies show that immunoglobulins do indeed benefit Alzheimer’s and multiple sclerosis that demand will skyrocket.
Currently, Health Canada has approved intravenous immunoglobulins for six conditions: primary immune deficiency, chronic inflammatory demyelinating polyneuropathy, idiopathic thrombocytopenic purpura, pediatric HIV, allogenic bone marrow transplantation and B-cell chronic lymphocytic leukemia. It’s also used off-label to treat many more conditions.
Anyone CBS buys plasma drugs from is licensed by Health Canada and the U.S. Food and Drug Administration. Strict regulations, thorough screening procedures and advanced testing, go a long way to ensuring safety.
Prospective donors answer a questionnaire and undergo a physical exam. Their plasma is tested for viruses such as HIV and hepatitis and remains in quarantine at the clinic for at least two months to ensure subsequent visits by the donor also test negative before it is sent to the fractionation facility. There, it goes through other tests, including viral inactivation, purification and nanofiltration.
“Since the introduction of these remarkably safe steps (about 25 years ago) there has been no transmission of infectious disease through these products,” says Dr. Graham Sher, CEO of the CBS, which has taken no position on whether private clinics should open.
More precisely, he’s not aware of a single case anywhere in the world where someone has become infected with HIV or hepatitis from plasma drugs.
Fractionated plasma goes through numerous safety procedures – more than plasma used for transfusions. So even if someone lied about having an infectious disease, it should be caught with testing, says Dr. Alan Tinmouth, head of hematology and transfusion medicine at Ottawa Hospital and a CBS medical consultant.
“As a physician who cares for patients, safety is of the utmost importance,” he says. “So are we changing the safety? No, so I don’t have a concern on that level.”
For the past 15 years, Michael Whelan has relied on immunoglobulin therapy for primary immune deficiency. Four times a week, the 70-year-old B.C. man gives himself an injection of the treatment to protect him from viruses such as the common cold or flu, which would wreak havoc on his health.
He doesn’t care if his treatments come from paid or unpaid donors — so long as they meet Health Canada standards.
“I wouldn’t be (injecting myself) if I didn’t trust it,” says Whelan, the acting president of the Canadian Immunodeficiencies Patient Organization.
But for Ontario resident Michael McCarthy, the hemophiliac infected in 1984 with bad blood, the record for patient safety in the last two decades is cold comfort. Experts said the blood supply was safe back in the 1980s, he says. He worries about new viruses that could percolate undetected for years before emerging.
“Do you want to take a chance and collect from areas that could be the breeding ground of the next HIV virus?” asks McCarthy, who was the lead plaintiff in various lawsuits representing Canadians affected by tainted blood.
David Page, the national executive director of the Canadian Hemophilia Society, doesn’t object to donors being paid and says it is “absolutely hypocritical” for Canadians to say it’s unethical to pay people for plasma and then turn around and buy it from countries that pay donors.
“There should be enough (volunteer) plasma donors in the world to meet the need for plasma products, but that’s just not the case,” says Page.
“Collecting more plasma from Canadian donors, paid or unpaid, would add to the world’s supply of a scarce resource.”
Paying Canadians would make us less reliant on American paid donors, he says. Diversifying the supply would better protect us if, for instance, there was a virus outbreak in the U.S. that prevented people from donating. To this day, those who travelled or lived in the United Kingdom for three or more months between 1980 and 1996 cannot donate because they may have eaten beef infected by mad cow disease.
“If there were to be some (outbreak) like that in the U.S., for example, there would go the world’s supply,” says Page. “It would be a disaster.”
Critics of a paid private system want to see the CBS become self-sufficient and ramp up collection from the 3.7 per cent of Canadians who currently donate blood.
“We should be looking to find solutions to increase unpaid donor blood and plasma as much as possible and exhausting all of those solutions before we look at paying people for blood,” says family physician Dr. Danielle Martin, chair of Canadian Doctors for Medicare.
“How can we be sure when there’s a profit motive at play that organizations don’t cut corners when it comes to the safety of the public?”
Dr. Irfan Dhalla, a specialist in internal medicine at St. Michael’s Hospital and assistant professor at the University of Toronto, says for-profit entities aren’t monitored closely enough. “If we have to pay donors, I would much rather see Canadian Blood Services providing payment to those donors than for-profit companies.”
The big concern that volunteer donations of whole blood will drop may be unfounded. In countries such as the U.S., Germany, Austria, Australia and the Czech Republic, there has been a successful co-existence of the plasma industry and blood organizations with little effect on voluntary donations, says Health Canada. This is likely because the two models attract donors who are motivated for different reasons.
“Experience elsewhere does suggest that the two industries can and do coexist,” says Sher of the CBS. If Canadian Plasma Resources does open, the agency will closely monitor the impact.
One thing that both sides of the argument agree on is that demand for life-saving plasma drugs is on the rise. So Canadians are going to need to roll up their sleeves — and get busy working on how best, and safely, to reconcile supply and demand.
For the time being, the Canadian Plasma Resources clinics remain empty as Health Canada wraps up its consultation process and reviews input. If the clinics aren’t forced to shutter, they aim to be licensed and thrust open their doors sometime in the late summer. All that’s left to do is fill the cash registries with crisp $20 bills.
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