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 proceedingswas 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."

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, andfinally, 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 the industry will be able to meet future demand, even if a new market develops for IVIG, in treating Alzheimer's, a potential use that is still in clinical trials. And now, with recent news that the largest placebo controlled clinical trial has been halted because IVIG did not show a statistically significant improvement in functional ability or a reduction in cognitive decline compared to placebo, this anticipated surge in demand for human plasma might never materialize.

All of that means, the Canadian debate about paying for plasma has not been sparked by the need to avert an impending shortage of a life saving therapeutic. Any shortages that occur in the supply of IVIG are the result of manufacturing decisions or production problems.

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?

"Its 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 invitedparticipantswere 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 listwhich 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 supply. 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, achange that happened in 2007.

It's not easy to find people willing to talk about the international plasma industry. Asindustry 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 conspiracyto 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.

• READ: Hemophilia Ontario's letter

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 thepaid 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 wrotethat "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.

"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 doesnt know yet. It will start collecting the plasma first, paying people $20per 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.