Paying for blood plasma raises new questions

It was an 'invitation only' meeting at a downtown Toronto hotel.

The media were banished to the hallway. Inside, a handpicked group of people gathered, with no one sure who else was around the table. There was no official agenda, no list of the names of the presenters. The only record of the proceedings was the hand written notes scribbled by the participants.

Was this the promised public consultation about whether Canadians are okay with the idea that a human blood fluid can be bought and sold?

"It wasn't public, it was a closed meeting. You had to be invited to attend. The media weren't allowed in the room," said Sean Meagher, the executive director of Canadian Doctors for Medicare, and one of the invited guests. "We'd heard from others who are interested in the issue who had asked to come and they weren't allowed."

Sean Meagher, executive director of Canadian Doctors for Medicare, calls it disconcerting that no one could give a reason for changing the policy on paid plasma. (CBC)

It was a rushed meeting, on April 10, hastily called after a national outcry about a sudden change in the way Canada collects blood plasma. A change that was not that sudden, it turns out.

Anyone watching the expensive plasmapherisis machines being moved into the freshly painted storefront, beside the Scott Mission shelter in Toronto's downtown, might have wondered what was coming to the neighborhood.

Anyone peering through the glass, over on Adelaide Street, at the dozens of white lounge chairs lined up against a wall, at the reception area with its new coat of paint, might have had some questions.

And when they hung those bright orange 'Canadian Plasma Resources' signs outside, on two busy Toronto streets, didn't anyone wonder what exactly was about to open for business?

But if someone had started asking about the policy around paid plasma donations in Canada, they would have had trouble getting an answer. A search of Health Canada's web site would have turned up no information about private plasma collection, even though Health Canada officials had met with the investors two years earlier and heard about their plans to launch a chain of for-profit plasma clinics.

"In 2010 we did the site selection and we had some preliminary meetings with Health Canada to make sure that moving forward and obtaining licences would be fine with them," the clinic's general manager, Barzin Bahardoust said.

'There are times when the companies have had too much raw plasma, sometimes not enough, they turn the faucet on and off as they see fit.'— Patrick Robert

But it was all happening under the radar, until a reporter, riding on the Spadina streetcar, noticed the sign through the window and starting asking questions. Only after the headlines appeared, in late February, did the provinces' health ministers and others learn that Canada is on the brink of a development that is out of step with most of the world: allowing people to sell their blood plasma to a private company that would go on to sell it on the international plasma market to the highest bidder.

This is not a health story. There is no critical shortage in the supply of blood plasma or plasma products. Rather, this is a business story.

A private company wants to break into the already crowded international market by opening the tap on Canadian arms and trying to sell plasma for a profit. And it's a business venture that has thrust Canadians into an ethical debate about the trade in a human raw material.

Traditionally human body parts are not for sale in Canada. It's against the law to sell sperm, eggs, and organs. Quebec law forbids the sale of blood or plasma. It is the same in much of the world. The U.S. is one of a handful of countries that allow plasma donors to be paid. The question now is whether Canada will join that small group.

"The part of it that was really disconcerting is that no one could give us a reason for changing the policy," Sean Meagher said. "Canadian Blood Services says there's no shortage of plasma. The federal government said there's nothing driving this from the public sector."

READ: 16 participants at plasma donation meeting

Right now there's enough raw plasma being collected to meet manufacturing demand, according to an analyst who watches the international plasma markets. Is there a risk of a future shortage? Not really. If the industry needs more plasma, the manufacturers will simply increase the amount they collect from the clinics they already own in the U.S. and in Europe.

In fact, companies have shut down plasma clinics over the last several years.

"There are times when the companies have had too much raw plasma, sometimes not enough, they turn the faucet on and off as they see fit," said Patrick Robert, from The Marketing Research Bureau in Connecticut. In other words, the supply of plasma is tightly controlled, much like the supply of crude oil.

Why industry wants plasma

To understand the plasma industry, it's important not to confuse plasma used for manufacturing with plasma used in transfusions. Transfusion plasma must be fresh, it has a limited shelf life, and it is collected domestically, from unpaid, volunteer donors, because the risk of transmitting blood borne illness is considered to be lower if the donors are not motivated by money.

There is no shortage of plasma for transfusions in Canada. In fact, the agency responsible for Canada's blood supply, Canadian Blood Services (CBS), has closed volunteer plasma clinics because of a surplus in supply.

There is a second stream of plasma known as 'source plasma.' It's a raw material that must be harvested from humans, and it is processed to make a range of pharmaceutical products.

Large batches of plasma from thousands of people are pooled together, heated, filtered, and run through a series of processes to remove viruses and other contaminants. The pooled plasma is then separated into various components, to make intravenous immunoglobulin (IVIG), used in a wide variety of treatments for immune disorders, a series of coagulation factors used to treat hemophilia, and finally, albumin, used to treat burn victims.

These products are expensive, and they are marketed just like any other drug product. The industry is highly competitive, controlled by a handful of international firms, and rather than struggling to meet demand, the industry is constantly pushing its products into new markets, and working to expand the customer base.

Many of the companies harvest plasma through their own private clinics, allowing them to expand or reduce the supply of source plasma as the market dictates.

So this debate is not about averting an impending shortage of any life saving therapeutics. If shortages occur, they are the result of manufacturing decisions or production problems.

Analyst Patrick Roberts has predicted that even with the addition of a potential new market for IVIG, in treating Alzheimer's, a new use that is still in clinical trials, the industry will still be able to meet future demand.

Right now Canada is one of the largest users of IVIG in the world. It's estimated that there are about 150 off label uses, and many provinces are trying to reign that in, mostly because the products are expensive and because some of the off label uses have not been supported by science.

Despite the demand for IVIG, Canada has never attempted to make its own plasma products. It has always depended on the international market to supply them. And the international market has always manufactured plasma from both paid and unpaid donors.

This is why Health Canada is able to suggest that paid plasma is no big deal. In a freshly minted page on its website that appeared suddenly two weeks ago, Health Canada reports that "paid plasma donors are currently critical to ensuring a sufficient supply of plasma products in Canada." Paid American donors, that is. The nuance is important.

Because, even though the final products have contained plasma from paid US donors, never before have ordinary Canadians been able to walk into a clinic, offer up their arms, and receive money for their blood fluid.

There is one small exception, in Winnipeg, where a local drug company, making a particular niche product, pays for plasma from donors who have special blood antibodies. Some officials are pointing to the Winnipeg situation as proof that paid plasma donation is not a new practice in Canada, creating the impression that this has been happening all along.

But if that's true, then why did the provincial health ministers react so strongly to the news that private clinics were about to start paying Canadians for their plasma? Why did Ontario send an angry letter to Ottawa demanding answers?

"It's a bit disingenuous to say that this isn't a change in policy because almost everywhere in Canada this doesn't happen and that's been the core of our approach to gathering blood," says Sean Meagher.

Back at that closed door meeting in Toronto, the invited participants were surprised to learn that they were no longer talking about two clinics in downtown Toronto. In fact, they were told, the company is planning to establish a chain of private for profit plasma clinics across the country.

"Health Canada let us know towards the end of the discussion that these folks are planning to open ten clinics all across the country," Sean Meagher recalls.

"We have this massive roll-out of an untried approach in Canada with no public policy discussion, with no proof that it's going to be safe, with no evidence that it's going to protect the voluntary supply and not adversely affect it, and no evidence that we're going to get anything out of it," he said.

The individual investors who hope to profit from the clinics were not invited to the meeting. But the international plasma industry was there.

After several requests, Health Canada eventually released the guest list which included four patient advocacy groups, several doctor and nursing groups, a few government and blood agency representatives and the Plasma Protein Therapeutics Association, an industry lobby group that has declared one of its missions to be: "breaking down artificial barriers on trade and compensated donors."

PPTA refused to answer CBC questions about the importance of paid plasma donation to the international plasma suppy. In an email, Lisa LoVullo, Senior Communications Manager, told CBC, "PPTA declines the interview as our member companies are not involved in this story." It's not clear why then, the PPTA was one of the handpicked groups to attend Health Canada's round table discussion.

Perhaps it's because they have talked to Health Canada about plasma issues in the past. In a newsletter to the member companies, the PPTA reported: " The Source Division made progress on a number of fronts in 2011 that benefited the industry and cited issues to watch in 2012, including a Health Canada discussion about how much plasma could be collected from a single individual:

"In Canada, the regulatory agency for blood and plasma collection, Health Canada, held a workshop in late January discussing acceptable volume limits for plasmapheresis. PPTA presented information on the experiences of the industry in the US and will continue to monitor outcomes."

In other industry newsletters, the lobby group describes efforts advocating on the issue of donor remuneration in the Czech Republic, one of the few countries that allows paid plasma donations, a change that happened in 2007.

It's not easy to find people willing to talk about the international plasma industry. As industry analyst Patrick Roberts said, "to my knowledge, very few people do what I do." But he refused to answer questions about the effect of paid donations on the international plasma supply." I have had bad experience with journalists," he said.

Plasma industry practices investigated in U.S.

In 2011, the U.S. Federal Trade Commission moved to block a merger between two major players in the already highly concentrated plasma products industry. It was the second time the agency intervened to force competition under U.S. law, to protect consumers from unfairly high prices for IVIG and other plasma products.

"Historically, the plasma-derived products industry has operated as a tight oligopoly," the FTC said in its complaint, describing "intentional sharing of competitive information" by companies to avoid "oversupplying the market or starting a price war."

"The Commission's intervention twice speaks volumes about the Commission's level of concern with this industry," said Peter Herrick, from the Bureau of Competition Litigation Group at the FTC, who worked on the case.

"There was evidence of a history of coordinated activity in the industry, and that is going to raise concerns when you're reducing the number of competitors," he said.

And right now a class action suit is being launched in a U.S. District Court by a group of U.S. hospitals against two major plasma product suppliers.

The court document states that the "plaintiff alleges a multi-year nationwide conspiracy…to fix, raise, maintain or stabilize the prices of Blood Plasma Proteins sold in the United States." The lawyers refused to comment because the case is still before the courts.

It's an industry the Canadian investors behind Canadian Plasma Resources are eager to enter. Their long term goal is to one day establish a plasma manufacturing facility in Canada. "This is our hope," the company's Barzin Bahardoust said. "But it is a huge investment. Not comparable to setting up a few plasma centres. It needs to be feasible and needs to have a large portion of the raw material secured."

What Health Canada is saying about paying donors

Which brings us back to the reason why we're having this conversation. Will this company be able to pursue its business plan and set up a plasma collection and manufacturing company in Canada?

It's not clear who can answer that, because it's still not clear which level of government is in charge. When the story first broke back in February, reporters had difficulty figuring out if this was federal or provincial jurisdiction.

People who attended the invitation only meeting on April 10 said it wasn't clear to them either. Ottawa seems to be saying that it has the authority to license the clinics for safety but it's up to the provinces to decide if donors can be paid.

A month ago that seemed to be news to Ontario Health Minister Deb Matthews, who sent an angry letter to her federal counterpart demanding that the paid donor clinics be put on hold, until Canadians could be consulted.

But check Health Canada's new web page, and it says: "private clinics and companies may pay plasma donors provided it is permitted by the provincial and territorial laws."

And already the Ontario Health Minister has received an appeal from some of the people who depend on the plasma products. Hemophilia Ontario has written a letter to Deb Matthews, reminding her about the tainted blood scandal of the 1980's that left thousands of Canadians infected with HIV and Hepatitis C, "due to bureaucratic bungling and bad decision making."

The organization's president, Paul Wilton wrote that "we fear the proposed clinic has the potential to exploit vulnerable populations," referring to the locations of the clinics, near homeless shelters, and, in one planned in the city of Hamilton, near a substance abuse treatment centre for federal parolees.

David Page of the Canadian Hemophilia Society is not concerned about private paid plasma clinics. (CBC)

"The proposed location of this clinic demonstrates a lack of sensitivity to the history of our blood supply," Wilton wrote. "The collection of blood products from high risk populations contributed to the tainted blood tragedy."

It's a concern others share.

"The whole problem of paid blood is that it's going to draw people who might not be drawn to voluntary donations," said Sean Meagher. "People who might be riskier donors, that's a problem wherever you place it. The closer you place it to risky populations the worse it is and no planning has been done around that."

The controversy has split patient groups. The National Executive Director of the Canadian Hemophilia Society says the private paid plasma clinics are not a concern. "You know this is not going to make a huge difference one way or the other," David Page said.

"If these centres are allowed to collect, there'll be a small contribution to the world's supply of plasma. But it'll make a small difference. Canada will finally be contributing to the world's supply," Page said.

Who's going to buy this Canadian plasma? Canadian Plasma Resources doesn't know yet. It will start collecting the plasma first, paying people $20 per donation, up to twice a week. Then it will find a market. They'd like to sell it to the Canadian Blood Services.

"We've had two meetings with Canadian Blood Services, so far, but until we are licensed, there is really nothing on paper, no promises have been made" the clinic's general manager Barzin Bahardoust said. But Canadian Blood Services is making no guarantees. It depends on the price. "We purchase on the global market through competitive tendering," Dr. Graham Sher, CEO of Canadian Blood Services, said.

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Compounding pharmacies to be federally inspected under U.S. bill

Large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards, under a new Senate proposal introduced Friday.

The draft bill is the first effort by Senate lawmakers to address the outbreak tied to contaminated compounded drugs that sickened more than 700 Americans and killed more than 50 others.

A wave of deadly fungal infections in the U.S. was linked to a large Massachusetts compounding pharmacy that regulators said was operating more like a manufacturer. (Marshall Wolff/The MetroWest Daily News/Associated Press)

The wave of deadly fungal infections was identified in September and linked to a large Massachusetts compounding pharmacy, which regulators said was operating more like a manufacturer.

The new proposal would subject these large compounding operations to direct federal oversight by the U.S. Food and Drug Administration, rather than state pharmacy boards that have traditionally overseen such operations.

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Apotex warned by U.S. to raise quality control standards

Canadian generic drug maker Apotex Inc.'s exports to the United States could be blocked if the company doesn't correct quality control problems, according to a warning letter from a U.S. regulator.

The U.S. Food and Drug Administration's website includes a warning letter sent to Apotex describing "repeated deficiencies" in quality control, such as ensuring drug products at one of its Toronto-area plant were free of bacterial or fungal contamination.

One batch of Alysena-28 birth control pills contained an extra week of placebo sugar pills. ((CBC))

The FDA's letter from Feb. 21, 2013 raised question whether the company sufficiently addressed a "critical defect" with a partial batch of rejected tablets.

In another case, the FDA said some tablets were internally rejected due to black specks on them, but a definitive root cause was never found and the rest of the lot of tablets was released into the U.S..

Dr. Jeremy Desai, the president and chief operating officer of Apotex, said the company responded to the FDA in March, saying the bacterial contamination has been rectified.

Desai said he wanted to reassure Canadians that the products were never shipped to market.

"Canadians can feel very confident of the Apotex brand as a quality, affordable medication that has helped patients for close to 40 years," he said.

Regulations for quality control continually evolve and the company works to ensure its internal checks keep up to date, Desai said.

But news of the warning letter comes as the company and Health Canada face criticism over releasing one lot of birth control pills that may have contained an extra week of placebo pills, that raise the possibility of unplanned pregnancy.

Packages of Alysena-28 should have three rows of active pink pills and one row of white placebo pills but packages contained extra placebo pills, Health Canada said earlier this month. Apotex is the distributor of the pills, but not the manufacturer.

"This was really an unprecedented event to have faulty birth controls reach women," said Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynecologists of Canada in Ottawa.

"We were wondering how on Earth this could this have happened. Well maybe this is why," she said of the problems identified by the FDA. Canadian pharmaceuticals should be held to highest standards in the world, particularly as pills are increasingly manufactured overseas, Blake said.

The U.S. FDA has warned a Canadian generic drug maker three times about deficiencies. (Jason Reed/Reuters)

Prof. Amir Attaran of the faculty of medicine at the University of Ottawa studies substandard drugs. All drug companies have periodic quality issues, he said.

Attaran pointed to the deadly fungal infections that were identified in the U.S. in September and linked to a large Massachusetts compounding pharmacy. More than 700 Americans were sickened with meningitis and more than 50 others were killed.

Attaran faults Health Canada for not being more vigilant in its own inspections of Apotex's facilities, regardless of whether the products identified by the FDA made it to market in this country. He said the Canadian agency has one of the poorest records in the developed world when it comes to overseeing drug manufacturing.

"Today, history repeats itself," Attaran said. "The FDA has caught what are apparently very serious problems, potentially life-threatening problems with Apotex … and Health Canada appears once again, second."

Jean Saint-Pierre, manager of Health Canada's Health Products and Food Branch Inspectorate in Ottawa, said the department's inspectors were with the FDA during the inspections and there were no issues of concern.

Health Canada continues to monitor the effectiveness of the birth control recall to check it was done correctly and thoroughly, Saint-Pierre said, adding the regulator is getting good co-operation with the company.

The department said the products identified by the FDA never made it to the market in Canada.

With files from CBC's Kas Roussy and Amina Zafar

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Boy, 4, infected with H7N9 bird flu after father

Chinese health officials say the 4-year-old son of a man infected with a new strain of bird flu has also caught the virus.

Shandong province's health department says there is no evidence of human-to-human transmission, and that the boy is in stable condition at a hospital.

The H7N9 virus has infected 126 people in China. (Andy Wong/Asssociated Press)

The Jinan Times newspaper says the boy's 36-year-old father had no direct contact with poultry, but that the family lives near a market that sells live poultry.

The H7N9 virus has infected 126 people in China, killing 23 of them.

Experts are watching it closely for any sign it could spark a pandemic, but say so far there is no evidence it can spread easily among people. They believe infections are caused by some kind of contact with sick birds.

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Compounding pharmacies to be federally inspected under U.S. bill

Large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards, under a new Senate proposal introduced Friday.

The draft bill is the first effort by Senate lawmakers to address the outbreak tied to contaminated compounded drugs that sickened more than 700 Americans and killed more than 50 others.

A wave of deadly fungal infections in the U.S. was linked to a large Massachusetts compounding pharmacy that regulators said was operating more like a manufacturer. (Marshall Wolff/The MetroWest Daily News/Associated Press)

The wave of deadly fungal infections was identified in September and linked to a large Massachusetts compounding pharmacy, which regulators said was operating more like a manufacturer.

The new proposal would subject these large compounding operations to direct federal oversight by the U.S. Food and Drug Administration, rather than state pharmacy boards that have traditionally overseen such operations.

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HIV vaccine trial fails in U.S.

The latest bad news in the hunt for an AIDS vaccine: The U.S. government halted a large study, saying the experimental shots are not preventing HIV infection.

Nor did the shots reduce the amount of the AIDS virus in the blood when people who'd been vaccinated later became infected, the U.S. National Institutes of Health said.

While disappointing, the failed HIV vaccine trial does offer researchers important information, says Dr. Anthony Fauci. (Jonathan Ernst/Reuters)

"It's disappointing," said Dr. Anthony Fauci, head of NIH's National Institute of Allergy and Infectious Diseases. But, "there was important information gained from this" study that will help determine what to try next.

The study had enrolled 2,504 volunteers, mostly gay men, in 19 cities since 2009. Half received dummy shots, and half received a two-part experimental vaccine developed by the NIH. All were provided free condoms and given extensive counseling about the risks for HIV.

It's a strategy known as "prime-boost." A DNA-based vaccine made with genetically engineered HIV material is given to prime the immune system to attack the AIDS virus. Then a different vaccine, encasing the same material inside a shell made of a disabled cold virus, acts as a booster shot to strengthen that response. Neither vaccine could cause HIV.

The idea: Train immune cells known as T cells to spot and attack the very earliest HIV-infected cells in someone's body. The hope was that the vaccine could either prevent HIV infection, or help those infected anyway to fight it.

Monitoring of volunteers' health continues

A safety review this week found that slightly more study participants who had received the vaccine later became infected with HIV. It's not clear why. But the difference wasn't statistically significant, meaning it may be due to chance.

Overall, there were 41 HIV infections in the vaccinated group and 30 among placebo recipients. When researchers examined only participants diagnosed after being in the study for at least 28 weeks — long enough for the shots to have done their job — there were 27 HIV infections among the vaccinated and 21 among the placebo recipients.

The NIH said Thursday that it is stopping vaccinations in the study, known as HVTN 505, but that researchers will continue to study the volunteers' health.

Josh Robbins, 30, is among the participants who became infected. He said he is glad he was in the study, because its close monitoring meant he was diagnosed and treated much sooner than most people — and he is feeling great — and because the findings help science.

"We've got to keep moving forward," Robbins said. The study "certainly can lead us down a new direction to hopefully find something that might work."

Multiple attempts at creating an AIDS vaccine have failed over the years. A 2009 study in Thailand is the only one ever to show a modest success, using a somewhat different prime-boost approach. Newer research suggests another approach — to try creating powerful antibodies that could work a step earlier than the T-cell attack, before HIV gets inside the first cell.

Both approaches need continued research funding, said Mitchell Warren of the international AIDS Vaccine Advocacy Coalition.

"Clearly an AIDS vaccine remains critical," he said.

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Apotex warned by U.S. to raise quality control standards

Canadian generic drug maker Apotex Inc.'s exports to the United States could be blocked if the company doesn't correct quality control problems, according to a warning letter from a U.S. regulator.

The U.S. Food and Drug Administration's website includes a warning letter sent to Apotex describing "repeated deficiencies" in quality control, such as ensuring drug products at one of its Toronto-area plant were free of bacterial or fungal contamination.

One batch of Alysena-28 birth control pills contained an extra week of placebo sugar pills. ((CBC))

The FDA's letter from Feb. 21, 2013 raised question whether the company sufficiently addressed a "critical defect" with a partial batch of rejected tablets.

In another case, the FDA said some tablets were internally rejected due to black specks on them, but a definitive root cause was never found and the rest of the lot of tablets was released into the U.S..

Dr. Jeremy Desai, the president and chief operating officer of Apotex, said the company responded to the FDA in March, saying the bacterial contamination has been rectified.

Desai said he wanted to reassure Canadians that the products were never shipped to market.

"Canadians can feel very confident of the Apotex brand as a quality, affordable medication that has helped patients for close to 40 years," he said.

Regulations for quality control continually evolve and the company works to ensure its internal checks keep up to date, Desai said.

But news of the warning letter comes as the company and Health Canada face criticism over releasing one lot of birth control pills that may have contained an extra week of placebo pills, that raise the possibility of unplanned pregnancy.

Packages of Alysena-28 should have three rows of active pink pills and one row of white placebo pills but packages contained extra placebo pills, Health Canada said earlier this month. Apotex is the distributor of the pills, but not the manufacturer.

"This was really an unprecedented event to have faulty birth controls reach women," said Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynecologists of Canada in Ottawa.

"We were wondering how on Earth this could this have happened. Well maybe this is why," she said of the problems identified by the FDA. Canadian pharmaceuticals should be held to highest standards in the world, particularly as pills are increasingly manufactured overseas, Blake said.

The U.S. FDA has warned a Canadian generic drug maker three times about deficiencies. (Jason Reed/Reuters)

Prof. Amir Attaran of the faculty of medicine at the University of Ottawa studies substandard drugs. All drug companies have periodic quality issues, he said.

Attaran pointed to the deadly fungal infections that were identified in the U.S. in September and linked to a large Massachusetts compounding pharmacy. More than 700 Americans were sickened with meningitis and more than 50 others were killed.

Attaran faults Health Canada for not being more vigilant in its own inspections of Apotex's facilities, regardless of whether the products identified by the FDA made it to market in this country. He said the Canadian agency has one of the poorest records in the developed world when it comes to overseeing drug manufacturing.

"Today, history repeats itself," Attaran said. "The FDA has caught what are apparently very serious problems, potentially life-threatening problems with Apotex … and Health Canada appears once again, second."

Jean Saint-Pierre, manager of Health Canada's Health Products and Food Branch Inspectorate in Ottawa, said the department's inspectors were with the FDA during the inspections and there were no issues of concern.

Health Canada continues to monitor the effectiveness of the birth control recall to check it was done correctly and thoroughly, Saint-Pierre said, adding the regulator is getting good co-operation with the company.

The department said the products identified by the FDA never made it to the market in Canada.

With files from CBC's Kas Roussy and Amina Zafar

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MacNeil didn't die from hospital infection, says authority

Beloved Canadian singer Rita MacNeil did not die from a hospital-acquired infection, the Cape Breton District Health Authority said in response to a now-corrected article published in the Globe and Mail newspaper on Friday.

The 68-year-old singer died last week following complications from surgery after a recurring infection.

On Friday morning, Globe and Mail health reporter André Picard wrote an article entitled "Rita MacNeil's death should make us angry," in which he said the singer contracted an infection in the hospital days before her death.

The article has since been corrected.

Picard wrote that the precise cause of death is not known.

During MacNeil's stay part of the hospital was closed because of a Norwalk virus outbreak, Picard wrote. He also noted the health authority's 2011 Clostridium difficile (C. difficile) outbreak that killed 11 people.

"As strong as Ms. MacNeil was, she couldn't survive routine, minor surgery in a Canadian hospital. That realization should give us all a sickening feeling in the pit of our stomachs," Picard wrote.

He said people should be angry, and demand safer and cleaner hospitals.

In a release, the Cape Breton District Health Authority said it cannot violate patient confidentiality but said the article was incorrect.

"If things don't go right, we're committed to making sure they do go right. I feel very comfortable if my 86-year-old father or my 15-year-old daughter was sick, that if they came here they will receive safe and compassionate, quality care," said Andrew Lynk, the authority's vice-president of medicine.

MacNeil's family is not commenting. The health authority said the family has asked the matter be kept private.

The CBC flagship investigative program the fifth estate gave the Cape Breton Regional Hospital a D rating for its record on post-surgery mortality.

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Paying for blood plasma raises new questions

It was an 'invitation only' meeting at a downtown Toronto hotel.

The media were banished to the hallway. Inside, a handpicked group of people gathered, with no one sure who else was around the table. There was no official agenda, no list of the names of the presenters. The only record of the proceedings was the hand written notes scribbled by the participants.

Was this the promised public consultation about whether Canadians are okay with the idea that a human blood fluid can be bought and sold?

"It wasn't public, it was a closed meeting. You had to be invited to attend. The media weren't allowed in the room," said Sean Meagher, the executive director of Canadian Doctors for Medicare, and one of the invited guests. "We'd heard from others who are interested in the issue who had asked to come and they weren't allowed."

Sean Meagher, executive director of Canadian Doctors for Medicare, calls it disconcerting that no one could give a reason for changing the policy on paid plasma. (CBC)

It was a rushed meeting, on April 10, hastily called after a national outcry about a sudden change in the way Canada collects blood plasma. A change that was not that sudden, it turns out.

Anyone watching the expensive plasmapherisis machines being moved into the freshly painted storefront, beside the Scott Mission shelter in Toronto's downtown, might have wondered what was coming to the neighborhood.

Anyone peering through the glass, over on Adelaide Street, at the dozens of white lounge chairs lined up against a wall, at the reception area with its new coat of paint, might have had some questions.

And when they hung those bright orange 'Canadian Plasma Resources' signs outside, on two busy Toronto streets, didn't anyone wonder what exactly was about to open for business?

But if someone had started asking about the policy around paid plasma donations in Canada, they would have had trouble getting an answer. A search of Health Canada's web site would have turned up no information about private plasma collection, even though Health Canada officials had met with the investors two years earlier and heard about their plans to launch a chain of for-profit plasma clinics.

"In 2010 we did the site selection and we had some preliminary meetings with Health Canada to make sure that moving forward and obtaining licences would be fine with them," the clinic's general manager, Barzin Bahardoust said.

'There are times when the companies have had too much raw plasma, sometimes not enough, they turn the faucet on and off as they see fit.'— Patrick Robert

But it was all happening under the radar, until a reporter, riding on the Spadina streetcar, noticed the sign through the window and starting asking questions. Only after the headlines appeared, in late February, did the provinces' health ministers and others learn that Canada is on the brink of a development that is out of step with most of the world: allowing people to sell their blood plasma to a private company that would go on to sell it on the international plasma market to the highest bidder.

This is not a health story. There is no critical shortage in the supply of blood plasma or plasma products. Rather, this is a business story.

A private company wants to break into the already crowded international market by opening the tap on Canadian arms and trying to sell plasma for a profit. And it's a business venture that has thrust Canadians into an ethical debate about the trade in a human raw material.

Traditionally human body parts are not for sale in Canada. It's against the law to sell sperm, eggs, and organs. Quebec law forbids the sale of blood or plasma. It is the same in much of the world. The U.S. is one of a handful of countries that allow plasma donors to be paid. The question now is whether Canada will join that small group.

"The part of it that was really disconcerting is that no one could give us a reason for changing the policy," Sean Meagher said. "Canadian Blood Services says there's no shortage of plasma. The federal government said there's nothing driving this from the public sector."

Right now there's enough raw plasma being collected to meet manufacturing demand, according to an analyst who watches the international plasma markets. Is there a risk of a future shortage? Not really. If the industry needs more plasma, the manufacturers will simply increase the amount they collect from the clinics they already own in the U.S. and in Europe.

In fact, companies have shut down plasma clinics over the last several years.

"There are times when the companies have had too much raw plasma, sometimes not enough, they turn the faucet on and off as they see fit," said Patrick Robert, from The Marketing Research Bureau in Connecticut. In other words, the supply of plasma is tightly controlled, much like the supply of crude oil.

Why industry wants plasma

To understand the plasma industry, it's important not to confuse plasma used for manufacturing with plasma used in transfusions. Transfusion plasma must be fresh, it has a limited shelf life, and it is collected domestically, from unpaid, volunteer donors, because the risk of transmitting blood borne illness is considered to be lower if the donors are not motivated by money.

There is no shortage of plasma for transfusions in Canada. In fact, the agency responsible for Canada's blood supply, Canadian Blood Services (CBS), has closed volunteer plasma clinics because of a surplus in supply.

There is a second stream of plasma known as 'source plasma.' It's a raw material that must be harvested from humans, and it is processed to make a range of pharmaceutical products.

Large batches of plasma from thousands of people are pooled together, heated, filtered, and run through a series of processes to remove viruses and other contaminants. The pooled plasma is then separated into various components, to make intravenous immunoglobulin (IVIG), used in a wide variety of treatments for immune disorders, a series of coagulation factors used to treat hemophilia, and finally, albumin, used to treat burn victims.

These products are expensive, and they are marketed just like any other drug product. The industry is highly competitive, controlled by a handful of international firms, and rather than struggling to meet demand, the industry is constantly pushing its products into new markets, and working to expand the customer base.

Many of the companies harvest plasma through their own private clinics, allowing them to expand or reduce the supply of source plasma as the market dictates.

So this debate is not about averting an impending shortage of any life saving therapeutics. If shortages occur, they are the result of manufacturing decisions or production problems.

Analyst Patrick Roberts has predicted that even with the addition of a potential new market for IVIG, in treating Alzheimer's, a new use that is still in clinical trials, the industry will still be able to meet future demand.

Right now Canada is one of the largest users of IVIG in the world. It's estimated that there are about 150 off label uses, and many provinces are trying to reign that in, mostly because the products are expensive and because some of the off label uses have not been supported by science.

Despite the demand for IVIG, Canada has never attempted to make its own plasma products. It has always depended on the international market to supply them. And the international market has always manufactured plasma from both paid and unpaid donors.

This is why Health Canada is able to suggest that paid plasma is no big deal. In a freshly minted page on its website that appeared suddenly two weeks ago, Health Canada reports that "paid plasma donors are currently critical to ensuring a sufficient supply of plasma products in Canada." Paid American donors, that is. The nuance is important.

Because, even though the final products have contained plasma from paid US donors, never before have ordinary Canadians been able to walk into a clinic, offer up their arms, and receive money for their blood fluid.

There is one small exception, in Winnipeg, where a local drug company, making a particular niche product, pays for plasma from donors who have special blood antibodies. Some officials are pointing to the Winnipeg situation as proof that paid plasma donation is not a new practice in Canada, creating the impression that this has been happening all along.

But if that's true, then why did the provincial health ministers react so strongly to the news that private clinics were about to start paying Canadians for their plasma? Why did Ontario send an angry letter to Ottawa demanding answers?

"It's a bit disingenuous to say that this isn't a change in policy because almost everywhere in Canada this doesn't happen and that's been the core of our approach to gathering blood," says Sean Meagher.

Back at that closed door meeting in Toronto, the invited participants were surprised to learn that they were no longer talking about two clinics in downtown Toronto. In fact, they were told, the company is planning to establish a chain of private for profit plasma clinics across the country.

"Health Canada let us know towards the end of the discussion that these folks are planning to open ten clinics all across the country," Sean Meagher recalls.

"We have this massive roll-out of an untried approach in Canada with no public policy discussion, with no proof that it's going to be safe, with no evidence that it's going to protect the voluntary supply and not adversely affect it, and no evidence that we're going to get anything out of it," he said.

The individual investors who hope to profit from the clinics were not invited to the meeting. But the international plasma industry was there.

After several requests, Health Canada eventually released the guest list which included four patient advocacy groups, several doctor and nursing groups, a few government and blood agency representatives and the Plasma Protein Therapeutics Association, an industry lobby group that has declared one of its missions to be: "breaking down artificial barriers on trade and compensated donors."

PPTA refused to answer CBC questions about the importance of paid plasma donation to the international plasma suppy. In an email, Lisa LoVullo, Senior Communications Manager, told CBC, "PPTA declines the interview as our member companies are not involved in this story." It's not clear why then, the PPTA was one of the handpicked groups to attend Health Canada's round table discussion.

Perhaps it's because they have talked to Health Canada about plasma issues in the past. In a newsletter to the member companies, the PPTA reported: " The Source Division made progress on a number of fronts in 2011 that benefited the industry and cited issues to watch in 2012, including a Health Canada discussion about how much plasma could be collected from a single individual:

"In Canada, the regulatory agency for blood and plasma collection, Health Canada, held a workshop in late January discussing acceptable volume limits for plasmapheresis. PPTA presented information on the experiences of the industry in the US and will continue to monitor outcomes."

In other industry newsletters, the lobby group describes efforts advocating on the issue of donor remuneration in the Czech Republic, one of the few countries that allows paid plasma donations, a change that happened in 2007.

It's not easy to find people willing to talk about the international plasma industry. As industry analyst Patrick Roberts said, "to my knowledge, very few people do what I do." But he refused to answer questions about the effect of paid donations on the international plasma supply." I have had bad experience with journalists," he said.

Plasma industry practices investigated in U.S.

In 2011, the U.S. Federal Trade Commission moved to block a merger between two major players in the already highly concentrated plasma products industry. It was the second time the agency intervened to force competition under U.S. law, to protect consumers from unfairly high prices for IVIG and other plasma products.

"Historically, the plasma-derived products industry has operated as a tight oligopoly," the FTC said in its complaint, describing "intentional sharing of competitive information" by companies to avoid "oversupplying the market or starting a price war."

"The Commission's intervention twice speaks volumes about the Commission's level of concern with this industry," said Peter Herrick, from the Bureau of Competition Litigation Group at the FTC, who worked on the case.

"There was evidence of a history of coordinated activity in the industry, and that is going to raise concerns when you're reducing the number of competitors," he said.

And right now a class action suit is being launched in a U.S. District Court by a group of U.S. hospitals against two major plasma product suppliers.

The court document states that the "plaintiff alleges a multi-year nationwide conspiracy…to fix, raise, maintain or stabilize the prices of Blood Plasma Proteins sold in the United States." The lawyers refused to comment because the case is still before the courts.

It's an industry the Canadian investors behind Canadian Plasma Resources are eager to enter. Their long term goal is to one day establish a plasma manufacturing facility in Canada. "This is our hope," the company's Barzin Bahardoust said. "But it is a huge investment. Not comparable to setting up a few plasma centres. It needs to be feasible and needs to have a large portion of the raw material secured."

What Health Canada is saying about paying donors

Which brings us back to the reason why we're having this conversation. Will this company be able to pursue its business plan and set up a plasma collection and manufacturing company in Canada?

It's not clear who can answer that, because it's still not clear which level of government is in charge. When the story first broke back in February, reporters had difficulty figuring out if this was federal or provincial jurisdiction.

People who attended the invitation only meeting on April 10 said it wasn't clear to them either. Ottawa seems to be saying that it has the authority to license the clinics for safety but it's up to the provinces to decide if donors can be paid.

A month ago that seemed to be news to Ontario Health Minister Deb Matthews, who sent an angry letter to her federal counterpart demanding that the paid donor clinics be put on hold, until Canadians could be consulted.

But check Health Canada's new web page, and it says: "private clinics and companies may pay plasma donors provided it is permitted by the provincial and territorial laws."

And already the Ontario Health Minister has received an appeal from some of the people who depend on the plasma products. Hemophilia Ontario has written a letter to Deb Matthews, reminding her about the tainted blood scandal of the 1980's that left thousands of Canadians infected with HIV and Hepatitis C, "due to bureaucratic bungling and bad decision making."

The organization's president, Paul Wilton wrote that "we fear the proposed clinic has the potential to exploit vulnerable populations," referring to the locations of the clinics, near homeless shelters, and, in one planned in the city of Hamilton, near a substance abuse treatment centre for federal parolees.

David Page of the Canadian Hemophilia Society is not concerned about private paid plasma clinics. (CBC)

"The proposed location of this clinic demonstrates a lack of sensitivity to the history of our blood supply," Wilton wrote. "The collection of blood products from high risk populations contributed to the tainted blood tragedy."

It's a concern others share.

"The whole problem of paid blood is that it's going to draw people who might not be drawn to voluntary donations," said Sean Meagher. "People who might be riskier donors, that's a problem wherever you place it. The closer you place it to risky populations the worse it is and no planning has been done around that."

The controversy has split patient groups. The National Executive Director of the Canadian Hemophilia Society says the private paid plasma clinics are not a concern. "You know this is not going to make a huge difference one way or the other," David Page said.

"If these centres are allowed to collect, there'll be a small contribution to the world's supply of plasma. But it'll make a small difference. Canada will finally be contributing to the world's supply," Page said.

Who's going to buy this Canadian plasma? Canadian Plasma Resources doesn't know yet. It will start collecting the plasma first, paying people $20 per donation, up to twice a week. Then it will find a market. They'd like to sell it to the Canadian Blood Services.

"We've had two meetings with Canadian Blood Services, so far, but until we are licensed, there is really nothing on paper, no promises have been made" the clinic's general manager Barzin Bahardoust said. But Canadian Blood Services is making no guarantees. It depends on the price. "We purchase on the global market through competitive tendering," Dr. Graham Sher, CEO of Canadian Blood Services, said.

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Chemotherapy outsourcing done by hospitals across Canada

Hospitals in at least three provinces besides Ontario and New Brunswick outsource their chemotherapy preparation.

After about 1,200 people in New Brunswick and Ontario received lower-than-intended doses of the chemotherapy drugs cyclophosphamide and gemcitabine supplied by Mississauga, Ont.-based Marchese Health Solutions, the Ontario Hospital Association (OHA) surveyed its members about their reliance on external providers of pre-compounded intravenous medications, including those used for chemotherapy.

Federal and provincial governments are working to close a gap in oversight surrounding companies that prepare chemotherapy in bulk for hospitals. (CBC)

Newfoundland and Labrador, Saskatchewan and British Columbia contract out bulk preparation of chemotherapy drugs like cyclophosphamide to Baxter Canada. Manitoba and Nova Scotia said they prepare all chemotherapy in-house.

There is no suggestion that Baxter is involved in any overdilution of drugs.

The OHA found nine of 88 hospitals who responded said they bought pre-compounded IV medications from Baxter.

Hospitals in British Columbia buy cyclophosphamide and gemcitabine from Baxter, as does Saskatchewan's Cancer Agency. Eastern Health in Newfoundland and Labrador said it outsources bulk preparation of cyclophosphamide to Baxter Canada.

Health Canada says Baxter Canada is federally licensed for six drug activities:

• Fabrication.
• Packaging/labelling.
• Testing.
• Importing.
• Distribution.
• Wholesaling.

Regulatory oversight of admixing — the bulk mixing of drugs for multiple patients in different locations without individual prescriptions — needs to be tightened, federal and provincial health officials say.

"In terms of the activities themselves, admixing is not listed … [in Baxter's licence]. That's something that was deemed to be under provincial jurisdiction," said Steve Outhouse, director of communications for federal Health Minister Leona Aglukkaq.

Health Canada has inspected Baxter for the areas that clearly fall under federal jurisdiction, Outhouse said.

"In terms of admixing, that's something that under the federal government's view had been a provincial responsibility so there was no inspections that would have happened for those activities."

Alison Drinkwater, director of public affairs for Baxter, did not immediately respond to requests for comment from CBC News.

"In 1986, Baxter opened Canada's first out-of-hospital admixture facility," the company's website reads. "Featuring state-of-the-art quality control processes and clean room technology, Baxter's Central Intravenous Admixture (CIVA) pharmacy service provides Canadian hospital pharmacists and healthcare professionals with sterile parenteral therapies in a wide array of compounded formulations with extended shelf-life. Baxter's CIVA Pharmacy Services provides a range of IV therapies."

"It's important to note that Baxter is an established Canadian drug manufacturer which has been and continues to be regulated by Health Canada, serving patients across the country," said Zita Astravas, press secretary to Ontario Health Minister Deb Matthews.

A survey released this week by the Ontario Hospital Association suggested that hospitals in the province also buy precompounded IV medications such as epidurals, narcotics and antibiotics from Baxter CIVA, Marchese, Galenova, Gentes & Bolduc and others.

During question period in Ontario's legislature on Wednesday, NDP health critic France Gélinas asked Matthews about how long the oversight gap has existed and how it "extends to some of the biggest players in the health-care system."

Matthews called it a problem that requires a national solution, adding the federal minister has acknowledged that.

Matthews said she's posted regulations directing hospitals to purchase only from accredited suppliers.

Ontario's College of Pharmacists is also developing a regulation to give them access to inspect premises where pharmacists and pharmacy technicians practice, including where drugs are prepared.

With files from CBC's Renée Pellerin, Tari Wilson and Kamala Rao

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New bird flu show signs of direct jump to humans

There's evidence the new H7N9 bird flu virus is transmitted from chickens at poultry markets in China to humans, a small study suggests.

In Thursday's online issue of the medical journal The Lancet, researchers gave some of the first detailed information about how H7N9 affects people.

Scientists compared throat and lower respiratory swabs from four people who caught the virus to swabs from 86 birds at live markets in eastern China. They also examined the genetic sequence of the virus.

"Cross species poultry-to-person transmission of this new … H7N9 virus is associated with severe pneumonia and multiorgan dysfunction in human beings," Dr. Yu Chen of Zhejiang University in Hangzhou, China, and co-authors concluded.

The scientists found the virus from one patient was nearly identical to one found in a chicken.

The findings offered doctors and scientists clues to understanding the emerging virus, Marion Koopmans of Netherlands' Centre for Infectious Disease Control and Menno de John of the University of Amsterdam said in a journal commentary published with the study.

For example, the virus might not be detected in patients' throat swabs but could be found in lower respiratory tract specimens.

Unlike the H5N1 avian flu where most cases were in previously healthy children or young adults, the patients infected with H7N9 had a median age of 63.

Scientists from the World Health Organization who visited areas of outbreak of the new bird flu were told that older men in the household generally did the shopping for live birds, said Dr. Keiji Fukuda, the agency's assistant director for health security and the environment.

Earlier this week, Chinese doctors reported in the New England Journal of Medicine health that 54 of 71 (76 per cent) patients with available data so far had underlying medical conditions.

Similarly, 77 per cent of patients said they had recent exposure to animals while working at or visiting a live-animal market, including 45 who had exposure to chickens, 12 to ducks, and four to swine with the rest mentioning pigeons, geese, quail, wild birds, pet birds, cats and dogs.

The human and animal viral sequences are closely related but were diverse enough to conclude H7N9 has been circulating for a while, most likely among animals, the Lancet commentators said.

"I think it's fair to say that this avian influenza virus appears to be more infectious to people than any other avian influenza virus we know," Fukuda said of H7N9. It has genetic mutations that suggest it is better adapted to infecting mammals compared with other bird flu viruses.

Researchers are also looking for signs of sustained transmission to estimate the pandemic potential of the virus.

Experts had suspected birds in live markets to be the source of infection but it wasn't clear if other animals or wild birds might also be responsible.

"Aggressive intervention to block further animal-to-person transmission in live poultry markets, as has previously been done in Hong Kong, should be considered," Kwok-Yung Yuen of the University of Hong Kong, who led the study, told The Lancet.

It's hoped that wide culls of poultry carrying the disease will curb its spread, although H7N9 doesn't appear to sicken chickens.

To learn more, the Public Health Agency of Canada said it is has received a live sample of the H7N9 virus from the U.S. The agency is also preparing to receive samples directly from China.

Scientists at the agency's National Microbiology Laboratory in Winnipeg are conducting studies on this virus to:

• Determine if antiviral drugs are effective against the virus.
• Develop and test vaccines to determine if they protect against the virus.
• Develop important diagnostic tests, such as to detect antibodies against the virus and monitor for any changes in it.

So far, H7N9 has infected more than 100 people in China and killed more than 20.

With files from The Associated Press and The Canadian Press

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Compounding pharmacies to be federally inspected under U.S. bill

Large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards, under a new Senate proposal introduced Friday.

The draft bill is the first effort by Senate lawmakers to address the outbreak tied to contaminated compounded drugs that sickened more than 700 Americans and killed more than 50 others.

A wave of deadly fungal infections in the U.S. was linked to a large Massachusetts compounding pharmacy that regulators said was operating more like a manufacturer. (Marshall Wolff/The MetroWest Daily News/Associated Press)

The wave of deadly fungal infections was identified in September and linked to a large Massachusetts compounding pharmacy, which regulators said was operating more like a manufacturer.

The new proposal would subject these large compounding operations to direct federal oversight by the U.S. Food and Drug Administration, rather than state pharmacy boards that have traditionally overseen such operations.

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Taiwan reports 1st case of H7N9 bird flu in man working in China

Taiwan has confirmed its first case of a new strain of bird flu.

Taiwan's Centers for Disease Control said Wednesday that a 53-year-old man became sick with the H7N9 bird flu virus after returning from working in the eastern Chinese province of Jiangsu on April 9.

It did not identify him or provide details on his condition, except to say that he had suffered from a high fever for three days.

China and Taiwan have close trade and economic ties. An estimated 1 million Taiwanese live on the mainland and some 6,000 Chinese tourists visit Taiwan every day.

The H7N9 bird flu virus emerged in China over the past month and has sickened more than 100 people there. More than 20 people have died.

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Hospitals slow to learn from own mistakes

Anyone who has experienced the chaotic environment of a hospital has an acute sense of the many things that can go wrong. In a typical visit, most patients encounter dozens of small oversights — from a misspelled name on a medical chart to a misscheduled diagnostic test.

For Rupinder Pannu, the error was more serious. She left the delivery room of the Trillium Health Centre in Mississauga, Ont., after giving birth to a baby boy in July 2008 with an object inside her that shouldn't have been there.

"The second week, I start smelling myself as a dead fish," she told CBC's the fifth estate. "My youngest son would come over and sit on me and say, 'Mommy, you smell funny.' "

The smell, it turns out, was coming from a gauze sponge that had been left inside her after she underwent an episiotomy, a procedure sometimes done during childbirth in which an incision is made in the perineum.

It was Pannu herself who found and removed the sponge after weeks of enduring pain so bad that she said she found it hard to walk.

"I would just sit in the bathtub with Epsom salts so my wound would heal faster, but that didn't help," Pannu said. "People would come visit me, and I would feel very stressed out [because of the smell]."

No compensation

According to Pannu, she only discovered the sponge when she decided to examine herself after the antibiotics a family doctor had prescribed, thinking the stitches used to close her incision had gotten infected, didn't get rid of the pain or the odour.

The hospital and the obstetrician who performed the delivery and episiotomy, Dr. Dalip Bhangu, met with Pannu after she went to the emergency department and reported what she had found. Pannu said hospital administrators apologized but told her she was not entitled to financial compensation.

Pannu complained about the incident to the College of Physicians and Surgeons of Ontario. In a 2009 letter responding to the complaint, Bhangu said he felt sorry Pannu had to "endure discomfort" but that when he left the delivery room, the nurse, who is responsible for verifying that all instruments, needles and sponges are accounted for, assured him the sponge count was correct.

He also said in the letter that he had been called to another delivery a mere 10 minutes after Pannu gave birth.

"I definitely hold the doctor responsible, because he is trained to do these things, and he cannot ignore me because he's got another patient," Pannu said of Bhangu's explanation. "If he doesn't want to work on me, he could just leave me rather than just leave stuff inside me and kind of walk on to another one."

According to a claims management company representing the hospital's insurer, neither the doctor nor any of the staff present during the delivery are to blame for the mistake.

"We do not believe that there is any responsibility for this unfortunate incident that rests with the hospital and/or staff," the adjuster, Cunningham Lindsey, wrote in a letter dated July 10, 2009, preemptively informing Pannu that any claim for compensation would be denied — even though Pannu hadn't made any official claim.

The hospital refused to comment to CBC News on the Pannu case and said only that "any error that impacts patients is investigated and lessons are developed from the incident and built into action plans for patient safety improvement." Dr. Bhangu declined to comment on the incident.

Surgical errors common

Mistakenly leaving foreign objects in a patient's body is one of the most common errors that occurs during surgeries, followed by operating on the wrong body part. It's one of the reasons why hospitals have adopted surgical safety checklists, intended to ensure that doctors and nurses follow a set of standardized steps before and after each procedure.

Keeping track of the instruments used during a surgery is an important part of preventing errors. Hospitals have adopted something called a surgical safety checklist to help doctors and nurses do just that. (Pascal Lauener /Reuters)

Studies suggest surgery accounts for 40 to 50 per cent of all hospital-related adverse events, a catch-all term used to describe unintended injuries, complications or death related to the care received, not a patient's medical condition.

The checklists, devised by the World Health Organization in 2008, have been shown to reduce surgery-associated complications and deaths by more than a third and have been endorsed for use in birthing units by the Society of Obstetricians and Gynecologists of Canada.

The hospital where Pannu had her baby has been using surgical checklists since 2009 and in a statement said it uses two-person teams to perform supply counts and quality checks in its obstetrics units.

Studies spur change

Ever since the 1999 Institute of Medicine report To Err is Human raised awareness of the high incidence of preventable medical errors in the U.S., hospitals in many parts of the world have been trying to change what had long been a duck-and-cover approach to medical mistakes.

In Canada, the seminal study on hospital medical errors is a 2004 paper by Ross Baker, a professor at the University of Toronto's Institute of Health Policy, Management and Evaluation.

It found that 7.5 per cent of patients admitted to acute care hospitals in Canada in 2000 experienced one or more adverse events, which can include everything from reactions to wrongly administered medications to bed sores, falls, infections and surgical errors. Most of these events did not result in any serious harm, the study found, but almost 37 per cent were preventable.

More recent studies have shown rates of adverse events in hospital between 10 and 14 per cent.

"The groundbreaking nature of Dr. Baker's work in Canada and that of some of his colleagues internationally was to bring it out into the light of day," said Deb Jordan, executive director of acute and emergency services for Saskatchewan Ministry of Health.

No consistent reporting

Saskatchewan was one of the first provinces, along with Quebec, to introduce legislation in the early 2000s obliging hospitals to report critical incidents, adverse events that result in serious harm or death.

Most hospitals require critical incidents to be reported at least to the hospital board and the affected patient or family members, but such events represent only a fraction of the mistakes and close calls that occur in any hospital.

In general, Canadian hospitals have only a very vague idea of how many errors are made in the course of delivering care because there is no standardized system for measuring and reporting them.

Many hospitals rely on voluntary reporting of errors by staff, which has been shown to capture only a tiny proportion of errors.

"For most of our hospitals, the amount of staff that are dedicated to supporting patient safety is limited, and they often wear other hats and manage competing responsibilities," said Pat Campbell, president and CEO of the Ontario Hospital Association. "So, we could probably be making more rapid progress if we had more resources at each institution."

Some provinces, such as Ontario, require hospitals to report certain so-called patient safety indicators such as rates of hospital-acquired infections and patient deaths.

In 2002, Quebec became the first province in Canada to require mandatory reporting of what it calls "incidents and accidents," but it only began tracking them through a central online registry in 2011.

Medication-related errors, which are the second-most common medical mistakes after surgical errors, are tracked federally through the National System for Incident Reporting, but reporting is voluntary (although Ontario requires hospitals to report to the registry).

"We don't have a 'Canadian health care system'; we have a series of provincial and territorial systems," said Hugh MacLeod, president of the Canadian Patient Safety Institute, which has established guidelines for how hospitals should disclose errors to patients.

"So, our desire is that people disclose [errors to patients], people report, and we're not too fussed about the mechanisms that they're using. What's important to us is that they're reporting."

Voluntary reports catch less than 15% of errors

But in fact, despite the widespread adoption of "no blame, no shame" policies, health practitioners are not reporting errors as often as they should be — usually because they fear repercussions or have misperceptions about which incidents should be reported.

Jurisdictions like Quebec, Saskatchewan and Manitoba that have been tracking critical incidents for years have found that while the number of incidents being reported has risen since reporting became mandatory, it still remains far below what research indicates it should be.

And without a systematic way of spotting errors, it's likely to remain that way.

A 2012 study by the inspector general of the U.S. Department of Health and Human Services found that voluntary reporting caught only 14 per cent of adverse events suffered by Medicare patients in U.S. hospitals.

But a method called the Global Trigger Tool, which relies on systematic reviews of patient charts by at least two health care professionals, was able to catch 90 per cent of the errors.

"A trigger could be a notation indicating, for example, a medication stop order, an abnormal lab result, or use of an antidote medication," the study authors wrote of the tool, developed by the Institute for Healthcare Improvement in the U.S. "Any notation of a trigger leads to further investigation into whether an adverse event occurred and how severe the event was."

A flaw in the system

Getting hospitals to examine the processes that lead to errors and near misses is a huge challenge, one that countries like Australia and New Zealand have been better at meeting than Canada, says Wendy Levinson, chair of the department of medicine at the University of Toronto.

'Systems need to be redesigned in order to help individuals in the systems do better, not just try harder.'— Wendy Levinson, chair of the department of medicine at the University of Toronto

"We have very much a philosophy inside medicine of 'We will try harder'; learning is trying harder to do it better," she said. "But what we haven't inculcated until recently is that instead of individuals trying harder, systems need to be redesigned in order to help individuals in the systems do better, not just try harder. It's a big distinction for us."

One hospital that has dramatically redesigned its approach to medical errors is the University of Michigan Health System (UMHS) in Ann Arbor, which includes three hospitals and dozens of clinics and care centres.

"I knew that we were not learning any lessons from what was happening to our patients," said Richard Boothman, a trial lawyer who instituted the overhaul in 2001.

"I had represented hospitals for 20 years in Michigan and Ohio and not a single hospital asked what we should have learned from the cases I handled."

Boothman, the UMHS's head of clinical safety, put in place a new system of reviewing patient charts and getting each clinical service to report regularly on a series of patient safety indicators specific to their department.

"We asked every single clinical service to give us the 10 things that if you heard them happening in your service, you would have to at least raise an eyebrow about the quality of the care," Boothman said.

Red flags include things like the number of emergency department patients who end up in intensive care after being admitted to a ward or the percentage of surgical patients who are back in the operating room with 72 hours.

Voluntary reporting has increased from 2,400 incidents in 2006/07 to 20,000 last year, Boothman said.

Full disclosure

UMHS also adopted a full disclosure policy when telling patients about errors and changed its malpractice strategy from an adversarial "deny and defend" approach to one in which it tries to resolve cases without going to court.

The health centre now preemptively offers patients financial compensation when it feels the standard of care has not been met, a method pioneered by the Veterans Administration Medical Center in Lexington, Ky.

The strategy has significantly reduced UMHS's malpractice costs, cutting the average cost per lawsuit by nearly a half, and decreasing the number of claims that wind up in court.

A similar compensation strategy is used by the Winnipeg Regional Health Authority — although it has not been as frequently applied as the Michigan model.

It's a brave approach, says Baker, the author of the 2004 Canadian study on adverse events.

"Not many organizations want to do that," he said. "It's an admission that we're not perfect."

Posting error data online

Part of changing the instinct to hide or contest errors is a willingness to disclose mistakes not just to patients but also to the public, and more and more hospitals are doing so on their own websites.

Montreal's Jewish General Hospital was the first hospital in Quebec to start posting information about adverse events online in 2011, following in the footsteps of what the Ontario Ministry of Health had started doing a few years earlier.

"The initial reaction was a lot of concern from other institutions because it's not a requirement in Quebec for us to do this, so it wasn't something that individuals believed was the way to go," said Markirit Armutlu, co-ordinator of the hospital's quality program. "There was a lot of resistance because of fear of media reaction and public reaction."

Since then, other hospitals have come around to the idea and have started posting their own medical error data online.

Most don't reveal specifics but give only annual tallies divided into broad categories such as "medication," "falls" or "equipment-related" (though the Winnipeg Regional Health Authority reveals some details in the "learning summaries" it posts online).

Giving a public accounting of errors is a sign hospitals are being more accountable but doesn't necessarily mean they're any safer, warns Baker.

"The critical measure is how many changes are we making in the system as a result of what we're learning about these events," he said. "Saying how many reports we have is sort of like saying how many speeding tickets you got, not how many accidents you got."

To contact the Rate My Hospital team with tips or information related to the series, please email ratemyhospital@cbc.ca.

With files from Andrew Culbert

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Paying for blood plasma raises new questions

It was an 'invitation only' meeting at a downtown Toronto hotel.

The media were banished to the hallway. Inside, a handpicked group of people gathered, with no one sure who else was around the table. There was no official agenda, no list of the names of the presenters. The only record of the proceedings was the hand written notes scribbled by the participants.

Was this the promised public consultation about whether Canadians are okay with the idea that a human blood fluid can be bought and sold?

"It wasn't public, it was a closed meeting. You had to be invited to attend. The media weren't allowed in the room." said Sean Meagher, the executive director of Canadian Doctors for Medicare, and one of the invited guests. "We'd heard from others who are interested in the issue who had asked to come and they weren't allowed."

Sean Meagher, executive director of Canadian Doctors for Medicare, calls it disconcerting that no one could give a reason for changing the policy on paid plasma. (CBC)

It was a rushed meeting, on April 10, hastily called after a national outcry about a sudden change in the way Canada collects blood plasma. A change that was not that sudden, it turns out.

Anyone watching the expensive plasmapherisis machines being moved into the freshly painted storefront, beside the Scott Mission shelter in Toronto's downtown, might have wondered what was coming to the neighborhood.

Anyone peering through the glass, over on Adelaide Street, at the dozens of white lounge chairs lined up against a wall, at the reception area with its new coat of paint, might have had some questions.

And when they hung those bright orange 'Canadian Plasma Reources' signs outside, on two busy Toronto streets, didn't anyone wonder what exactly was about to open for business?

But if someone had started asking about the policy around paid plasma donations in Canada, they would have had trouble getting an answer. A search of Health Canada's web site would have turned up no information about private plasma collection, even though Health Canada officials had met with the investors two years earlier and heard about their plans to launch a chain of for-profit plasma clinics.

"In 2010 we did the site selection and we had some preliminary meetings with Health Canada to make sure that moving forward and obtaining licences would be fine with them," the clinic's general manager, Barzin Bahardoust said.

'There are times when the companies have had too much raw plasma, sometimes not enough, they turn the faucet on and off as they see fit.'— Patrick Robert

But it was all happening under the radar, until a reporter, riding on the Spadina streetcar, noticed the sign through the window and starting asking questions. Only after the headlines appeared, in late February, did the provinces' health ministers and others learn that Canada is on the brink of a development that is out of step with most of the world: allowing people to sell their blood plasma to a private company that would go on to sell it on the international plasma market to the highest bidder.

This is not a health story. There is no critical shortage in the supply of blood plasma or plasma products. Rather, this is a business story.

A private company wants to break into the already crowded international market by opening the tap on Canadian arms and trying to sell plasma for a profit. And it's a business venture that has thrust Canadians into an ethical debate about the trade in a human raw material.

Traditionally human body parts are not for sale in Canada. It's against the law to sell sperm, eggs, and organs. Quebec law forbids the sale of blood or plasma. It is the same in much of the world. The U.S. is one of a handful of countries that allow plasma donors to be paid. The question now is whether Canada will join that small group.

"The part of it that was really disconcerting is that no one could give us a reason for changing the policy," Sean Meagher said. "Canadian Blood Services says there's no shortage of plasma. The federal government said there's nothing driving this from the public sector."

Right now there's enough raw plasma being collected to meet manufacturing demand, according to an analyst who watches the international plasma markets. Is there a risk of a future shortage? Not really. If the industry needs more plasma, the manufacturers will simply increase the amount they collect from the clinics they already own in the U.S. and in Europe.

In fact, companies have shut down plasma clinics over the last several years.

"There are times when the companies have had too much raw plasma, sometimes not enough, they turn the faucet on and off as they see fit," said Patrick Robert, from The Marketing Research Bureau in Connecticut. In other words, the supply of plasma is tightly controlled, much like the supply of crude oil.

Why industry wants plasma

To understand the plasma industry, it's important not to confuse plasma used for manufacturing with plasma used in transfusions. Transfusion plasma must be fresh, it has a limited shelf life, and it is collected domestically, from unpaid, volunteer donors, because the risk of transmitting blood borne illness is considered to be lower if the donors are not motivated by money.

There is no shortage of plasma for transfusions in Canada. In fact, the agency responsible for Canada's blood supply, Canadian Blood Services (CBS), has closed volunteer plasma clinics because of a surplus in supply.

There is a second stream of plasma known as 'source plasma.' It's a raw material that must be harvested from humans, and it is processed to make a range of pharmaceutical products.

Large batches of plasma from thousands of people are pooled together, heated, filtered, and run through a series of processes to remove viruses and other contaminants. The pooled plasma is then separated into various components, to make intravenous immunoglobulin (IVIG), used in a wide variety of treatments for immune disorders, a series of coagulation factors used to treat hemophilia, and finally, albumin, used to treat burn victims.

These products are expensive, and they are marketed just like any other drug product. The industry is highly competitive, controlled by a handful of international firms, and rather than struggling to meet demand, the industry is constantly pushing its products into new markets, and working to expand the customer base.

Many of the companies harvest plasma through their own private clinics, allowing them to expand or reduce the supply of source plasma as the market dictates.

So this debate is not about averting an impending shortage of any life saving therapeutics. If shortages occur, they are the result of manufacturing decisions or production problems.

Analyst Patrick Roberts has predicted that even with the addition of a potential new market for IVIG, in treating Alzheimers, a new use that is still in clinical trials, the industry will still be able to meet future demand.

Right now Canada is one of the largest users of IVIG in the world. It's estimated that there are about 150 off label uses, and many provinces are trying to reign that in, mostly because the products are expensive and because some of the off label uses have not been supported by science.

Despite the demand for IVIG, Canada has never attempted to make its own plasma products. It has always depended on the international market to supply them. And the international market has always manufactured plasma from both paid and unpaid donors.

This is why Health Canada is able to suggest that paid plasma is no big deal. In a freshly minted page on its website that appeared suddenly two weeks ago, Health Canada reports that "paid plasma donors are currently critical to ensuring a sufficient supply of plasma products in Canada." Paid American donors, that is. The nuance is important.

Because, even though the final products have contained plasma from paid US donors, never before have ordinary Canadians been able to walk into a clinic, offer up their arms, and receive money for their blood fluid.

There is one small exception, in Winnipeg, where a local drug company, making a particular niche product, pays for plasma from donors who have special blood antibodies. Some officials are pointing to the Winnipeg situation as proof that paid plasma donation is not a new practice in Canada, creating the impression that this has been happening all along.

But if that's true, then why did the provincial health ministers react so strongly to the news that private clinics were about to start paying Canadians for their plasma? Why did Ontario send an angry letter to Ottawa demanding answers?

"It's a bit disingenuous to say that this isn't a change in policy because almost everywhere in Canada this doesn't happen and that's been the core of our approach to gathering blood," says Sean Meagher.

Back at that closed door meeting in Toronto, the invited participants were surprised to learn that they were no longer talking about two clinics in downtown Toronto. In fact, they were told, the company is planning to establish a chain of private for profit plasma clinics across the country.

"Health Canada let us know towards the end of the discussion that these folks are planning to open ten clinics all across the country," Sean Meagher recalls.

"We have this massive roll-out of an untried approach in Canada with no public policy discussion, with no proof that it's going to be safe, with no evidence that it's going to protect the voluntary supply and not adversely affect it, and no evidence that we're going to get anything out of it," he said.

The individual investors who hope to profit from the clinics were not invited to the meeting. But the international plasma industry was there.

After several requests, Health Canada eventually released the guest list which included four patient advocacy groups, several doctor and nursing groups, a few government and blood agency representatives and the Plasma Protein Therapeutics Association, an industry lobby group that has declared one of its missions to be: "breaking down artificial barriers on trade and compensated donors."

PPTA refused to answer CBC questions about the importance of paid plasma donation to the international plasma suppy. In an email, Lisa LoVullo, Senior Communications Manager, told CBC, "PPTA declines the interview as our member companies are not involved in this story." It's not clear why then, the PPTA was one of the handpicked groups to attend Health Canada's round table discussion.

Perhaps it's because they have talked to Health Canada about plasma issues in the past. In a newsletter to the member companies, the PPTA reported: " The Source Division made progress on a number of fronts in 2011 that benefited the industry and cited issues to watch in 2012, including a Health Canada discussion about how much plasma could be collected from a single individual:

"In Canada, the regulatory agency for blood and plasma collection, Health Canada, held a workshop in late January discussing acceptable volume limits for plasmapheresis. PPTA presented information on the experiences of the industry in the US and will continue to monitor outcomes."

In other industry newsletters, the lobby group describes efforts advocating on the issue of donor remuneration in the Czech Republic, one of the few countries that allows paid plasma donations, a change that happened in 2007.

It's not easy to find people willing to talk about the international plasma industry. As industry analyst Patrick Roberts said, "to my knowledge, very few people do what I do." But he refused to answer questions about the effect of paid donations on the international plasma supply." I have had bad experience with journalists," he said.

Plasma industry practices investigated in U.S.

In 2011, the U.S. Federal Trade Commission moved to block a merger between two major players in the already highly concentrated plasma products industry. It was the second time the agency intervened to force competition under U.S. law, to protect consumers from unfairly high prices for IVIG and other plasma products.

"Historically, the plasma-derived products industry has operated as a tight oligopoly," the FTC said in its complaint, describing "intentional sharing of competitive information" by companies to avoid "oversupplying the market or starting a price war."

"The Commission's intervention twice speaks volumes about the Commission's level of concern with this industry," said Peter Herrick, from the Bureau of Competition Litigation Group at the FTC, who worked on the case.

"There was evidence of a history of coordinated activity in the industry, and that is going to raise concerns when you're reducing the number of competitors," he said.

And right now a class action suit is being launched in a U.S. District Court by a group of U.S. hospitals against two major plasma product suppliers.

The court document states that the "plaintiff alleges a multi-year nationwide conspiracy…to fix, raise, maintain or stabilize the prices of Blood Plasma Proteins sold in the United States." The lawyers refused to comment because the case is still before the courts.

It's an industry the Canadian investors behind Canadian Plasma Resources are eager to enter. Their long term goal is to one day establish a plasma manufacturing facility in Canada. "This is our hope," the company's Barzin Bahardoust said. "But it is a huge investment. Not comparable to setting up a few plasma centres. It needs to be feasible and needs to have a large portion of the raw material secured."

What Health Canada is saying about paying donors

Which brings us back to the reason why we're having this conversation. Will this company be able to pursue its business plan and set up a plasma collection and manufacturing company in Canada?

It's not clear who can answer that, because it's still not clear which level of government is in charge. When the story first broke back in February, reporters had difficulty figuring out if this was federal or provincial jurisdiction.

People who attended the invitation only meeting on April 10 said it wasn't clear to them either. Ottawa seems to be saying that it has the authority to license the clinics for safety but it's up to the provinces to decide if donors can be paid.

A month ago that seemed to be news to Ontario Health Minister Deb Matthews, who sent an angry letter to her federal counterpart demanding that the paid donor clinics be put on hold, until Canadians could be consulted.

But check Health Canada's new web page, and it says: "private clinics and companies may pay plasma donors provided it is permitted by the provincial and territorial laws."

And already the Ontario Health Minister has received an appeal from some of the people who depend on the plasma products. Hemophilia Ontario has written a letter to Deb Mathews, reminding her about the tainted blood scandal of the 1980's that left thousands of Canadians infected with HIV and Hepatitis C, "due to bureaucratic bungling and bad decision making."

The organization's president, Paul Wilton wrote that "we fear the proposed clinic has the potential to exploit vulnerable populations," referring to the locations of the clinics, near homeless shelters, and, in one planned in the city of Hamilton, near a substance abuse treatment centre for federal parolees.

David Page of the Canadian Hemophilia Society is not concerned about private paid plasma clinics. (CBC)

"The proposed location of this clinic demonstrates a lack of sensitivity to the history of our blood supply," Wilton wrote. "The collection of blood products from high risk populations contributed to the tainted blood tragedy."

It's a concern others share.

"The whole problem of paid blood is that it's going to draw people who might not be drawn to voluntary donations," said Sean Meagher. "People who might be riskier donors, that's a problem wherever you place it. The closer you place it to risky populations the worse it is and no planning has been done around that."

The controversy has split patient groups. The National Executive Director of the Canadian Hemophilia Society says the private paid plasma clinics are not a concern. "You know this is not going to make a huge difference one way or the other," David Page said.

"If these centres are allowed to collect, there'll be a small contribution to the world's supply of plasma. But it'll make a small difference. Canada will finally be contributing to the world's supply," Page said.

Who's going to buy this Canadian plasma? Canadian Plasma Resources doesn't know yet. It will start collecting the plasma first, paying people $20 per donation, up to twice a week. Then it will find a market. They'd like to sell it to the Canadian Blood Services.

"We've had two meetings with Canadian Blood Services, so far, but until we are licensed, there is really nothing on paper, no promises have been made" the clinic's general manager Barzin Bahardoust said. But Canadian Blood Services is making no guarantees. It depends on the price. "We purchase on the global market through competitive tendering," Dr. Graham Sher, CEO of Canadian Blood Services, said.

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