Heart of Gold (Musings on pimping for paid plasma)

Updated: 15 Oct. 2017 (Fixed dead links)

This blog is the fifth in the series of commercialization of the blood supply. It outlines why I think paying for plasma is not where Canada wants to go. Paying for plasma makes me wonder 

• What is our body worth?

 It doesn't sit right. Everything about it seems anti-Canadian. As youngsters quip, 'It's not your parent's Canada."

The title derives from Canadian Neil Young's 1972 classic, 'Heart of Gold.'

From the prior blog:

“From Health Canada’s perspective this is not a safety issue. The paid plasma issue is public policy that has to do with our culture and our values. And that needs to be addressed as a collective community.... 

But as we're looking at that, we should realize that 70 per cent of what we need is imported from the United States, where the donors are paid. So isn't this a bit of a double standard? You can't pay at home, but you can pay abroad."

Fact is, Canadians are being asked to allow blood donors to be paid for their plasma. Indeed, major players now pimp for paid plasma:

1. We need paid plasma to supply the plasma derivatives that Canadians need. (CBC CEO Graham Sher)
2. There's nothing unethical about it. (CHS President David Page)
3.  70% of what we need is imported from the USA, where donors are paid. So to deny Canadians the right to be paid would be hypocritical. (Robert Cushman, director general of Health Canada’s Biologic and Genetic Therapies Directorate)

AND....Health Canada wants to hear from Canadians whether paying for plasma fits our culture and values. That doesn't exactly translate into the government regulator wanting to know if we think selling our plasma is ethical or moral. Those are weighty topics (see Further Reading below). 

No, it's whether selling part of our body parts fits with Canada's culture and values. 

My, oh my. My first reaction is what is Canada's CULTURE. Has anyone figured this out yet? My best guess on our culture is:

• Molson's Canadian beer commercial

Secondly, how do we reconcile Quebec's CULTURE and VALUES with the Rest of Canada (ROC)? In Quebec, selling plasma is illegal. In Manitoba it's been done for years. Now powerful forces want it to be the norm for the ROC.

MUSINGS
I view paying for run-of-the-mill plasma as anti-Canadian for 4 reasons.

#1. IT'S ANTI-CANADA's HEALTH CARE SYSTEM
Plasma and its expensive derivatives are definitely part of Canada's health care system. 

CBS spends much taxpayer money on plasma derivatives. The money goes directly to Big Pharma.

DOES THIS JIVE WITH CANADIAN HEATH CARE PRINCIPLES?

One thing that sets us apart from our USA neighbours, where plasma is routinely bought, is the Canada Health Act and its 5 principles. 

1. Public administration means its non-profit and run by a public authority (government).
2. Comprehensiveness means all NECESSARY services are covered.
3. Universality means EVERYONE is covered to an equal level. 
4. Portability means you can TAKE IT WITH YOU within Canada and when travelling abroad. 
5. Accessibility means REASONABLE ACCESS to services without financial or other barriers. 

These principles can be interpreted as Canadian culture and values. Where do commercial plasma collection clinics - which would become part of our health care system - fail to meet Canada's values?

Simply put, commercial plasma clinics fail because they go against the spirit of the Canada Health Act in that they are for-profit. 

We already pay mega-bucks to private firms (Big Pharma) for IV immunoglobulin and a myriad of other plasma derivatives. 

Today, CBS, Health Canada, and patient advocacy groups like the Canadian Hemophilia Society propose to add to commercialization of our blood supply by allowing plasma clinics to pay the poor for plasma and re-sell to Big Pharma at a profit. 

#2. IT'S HYPOCRISY
Commercial plasma collection clinics fail because they create a HYPOCRITICAL situation.

If paying for plasma is acceptable, why not allow paying for whole blood donations? How about paying for other tissues like skin? How about paying for organ donation? 

Plasma is no different than any other body tissue. To say otherwise would surely be HYPOCRITICAL.

But wait - I can hear the protests. Plasma derivatives are different than other body tissues and organs. Besides screening donors with questions and near fool-proof infectious disease testing, plasma derivatives undergo a manufacturing process guaranteed to wipe out viruses and bacteria. 

Oh, I get it. If we can nuke other body tissues and keep them viable, then it's perfectly acceptable to pay for them too?

#3. IT UNDERMINES VOLUNTARY BLOOD DONATION

Commercial plasma collection clinics fail because they undermine our volunteer blood donor system. Forget that volunteer and paid donors co-exist in the USA. The USA has always been more business, for-profit, oriented than Canada. 

When it comes to private health care and making a buck any which way, Canadians are 'just not that into it.'

• Payment for blood donors comes to Canada

Dr. Lois Shepherd of Queen's University in Kingston, Ont. and past-CSTM President, is dismayed by the move away from the altruistic donation model previously embraced in Canada. She considers the safety concerns surrounding volunteer versus paid donors to be somewhat moot since all blood is thoroughly checked for transmissible diseases.

"For me, the bigger concern is that we do rely on volunteer blood donors in Canada, and if we're attracting younger people to be paid donors as plasma donors they are going to be pulled out of a population of people that might potentially be committed red cell whole blood donors."

Shepherd noted that Canadian hospitals are top users worldwide of drug products derived from plasma and demand is constantly increasing. She said it's hard to watch the voluntary system be "nibbled away."

#4. IT EXPLOITS THE POOR 
To me, paying for plasma or any body tissue and organ is wrong. Why? 

Because paying exploits the vulnerable. Oh, advocates can claim it's just university students earning a few extra bucks, perfectly harmless. But to the poor who donate plasma, it's exploitation, plain and simple, similar to medical tourism.

Sadly, medical tourism now flourishes:

• Medical Tourism: the Reality, the Challenges 
• The state of the international organ trade: a provisional picture based on integration of available information

Do Canadians want to pay for plasma donations? Since we accept plasma derivatives from paid plasma donors elsewhere, must the answer be Yes to avoid the hypocrite label?

Many of my colleagues are likely to acquiesce to the big kids on the block, who not only support it, but actually pimp for paid plasma. 

Prevailing orthodoxy says, get on board. Why fight the inevitable?

My view is that “Lost causes are the only ones worth fighting for” as Jimmy Stewart's character intimates in the classic film, 'Mr. Smith Goes to Washington.'

BOTTOM LINE
Paying for plasma is no different than paying for any body tissue. Is this where Canadians want to go? 

Blood, plasma, and any part of the human body should not be a commodity. To commercialize it, cheapens us all.

Nothing wrong with entrepreneurs. Canada has many. But their main benefit is to create a significant number of jobs and increase government tax coffers, so that the entire society benefits, not just company shareholders, 

Plasma clinics don't do that. Rather they suck money from tax payers to Big Pharma. The number of jobs created is minimal. 

It's all about the GOLD, not the heart of gold.

FOR FUN
Canada, like the UK, and other Commonwealth countries, has a strong history of volunteer blood donations. We take pride in our tradition of believing the role of government is to ensure the good of all. We know that our citizens care for each other and do not need monetary incentives to do the right thing.

The sentiment is epitomized by Neil Young's Heart of Gold.

I want to live,
I want to give
I've been a miner
for a heart of gold.

It's these expressions
I never give
That keep me searching
for a heart of gold
And I'm getting old.

FURTHER READING

• Mcleod J. Is it ethical to pay blood donors? (blog) (15 Apr. 2013)
• Rodriguez del Pozo P. Paying donors and the ethics of blood supply. Journal of Medical Ethics 1994; 20: 31-35.
• The Canadian Bioethics Companion. Chapter 7: Organ Donation

As always, comments are most welcome.

Still my guitar gently weeps (Yet more musings on commercialization of our blood supply)

This is the 4th blog in a series on commercialization of Canada's blood supply. The title is from an old George Harrison ditty. 

The previous blog noted that Health Canada had a closed-to-the-media roundtable on paid plasma donors in Canada.

Who knows what was said in that meeting but now we learn that 

• Health Canada seeks feedback on payment for blood plasma
• Paid plasma donors approval could rest on Ontario government

Yowsa! The government wants to hear from Canadians. My guess is that then they can claim they listened and followed the will of the people, or at least those with the most vested interest. 

Fascinating stuff from these news reports.

Health Canada's Viewpoint

“From Health Canada’s perspective this is not a safety issue,” said Dr. Robert Cushman, director general of Health Canada’s Biologic and Genetic Therapies Directorate. 

“The paid plasma issue is public policy that has to do with our culture and our values. And that needs to be addressed as a collective community,” he said after the meeting. 

“But as we’re looking at that, we should realize that 70 per cent of what we need is imported from the United States, where the donors are paid. So isn’t this a bit of a double standard? You can’t pay at home, but you can pay abroad.”

So...to HC, safety is apparently a done deal. Plasma derivatives are safe, folks, thanks to pre-donation questions, excellent infectious disease screening tests, and manufacturing processes. No worries, mate. 

It's all about our Canadian culture and values. Oh, but if Canadians reject paid plasma donations, we're hypocrites. 

CBS CEO Graham Sher's Viewpoint

"The issue really is one of security of supply and having sufficient access of these drugs for the patients that need them. About 70 per cent of the patients who depend on these products get them from the commercial paid plasma industry, so without that there would be a potential shortage of product. We've offered no opinion and it's not our role to offer an opinion on whether or not this particular facility should be licensed to operate in Canada."

Well, for someone who offers no opinion, CEO Sher seems to offer quite a few: Oh, by the way, if you don't allow paid plasma donations, patients would suffer terribly from the resulting shortage. But that's not for us to say....

As an aside, Big Pharma, whose blood derivatives are paid for by Canadian tax payers, funds several Canadian Blood Services programs. 

I've been on the receiving end myself. A website I helped develop was only possible because a drug company on contract to CBS for plasma derivatives gave 'x' % to CBS as a 'kickback' for education as a part of its contract. 

Canadian Hemophilia Society Viewpoint
David Page, national executive director of the CHS, supports donor payment and says CHS sees no safety, supply or ethical argument against paid donation in Canada. 

He says it’s already a reality at Cangene, where the company works with a very specific group of plasma donors to make specialized hyperimmune drugs.
“Collecting more plasma from Canadian donors, paid or unpaid, would add to the world’s supply of a scarce resource.” 

Oh, we already pay plasma donors in Canada. They're so needed. It's both safe and ethical.

As an aside, CHS relies on the generosity of 'corporate philanthropy', i.e., receives much funding from the companies who, interestingly, manufacture plasma derivatives.


Take-home message
The writing is on the wall, folks. The fix is in. All those with a vested interest have the government's ear. Even the regulators are on board, suggesting to reject paid plasma donations would be hypocritical. 

The saga continues. If you think run-of-the-mill plasma should not be a commodity to be bought and sold, let the government know. 

• It is difficult to put a price on human blood (Margaret Somerville. Professor of Law and director of the McGill Centre for Medicine, Ethics and Law)

For interest, the prior blog in this series has an interesting comment from Penny Chan, who worked on the Krever Commission of Inquiry on the Blood System in Canada and served as the scientific liaison officer for the National Blood Safety Council from 1997 until it was disbanded in 2003. 

For Fun

• While my guitar gently weeps (George Harrison) 

I don't know how someone controlled you
They bought and sold you.

With every mistake we must surely be learning
Still my guitar gently weeps. 

As always comment are most welcome. 

We are the world (More musings on commercialization of the blood supply)

Updated: 13 April 2013

This blog is an update to the two blogs below this one: 'Stop children what's that sound' (Musings on commercialization of our blood supply) and the CSTM's reply to it.  

The title derives from an American charity recording in 1985 for African famine relief, We are the world. 

If some readers are growing bored by 3 blogs in a row on the same topic, so be it. To me the history and current developments in Canada's blood system are fascinating in the extreme. 

The Krever Report into Canada's 'tainted blood scandal' was released in 1997. CBS, which succeeded Canadian Red Cross (with most of the same staff), celebrated its one year anniversary in 1999 and, having been lured to leave a long teaching career to go back into the trenches, I was there as an 'assman'. Actual title was 'assistant lab manager' but the quality dept. addressed all my internal mail as 'assman'. Must admit I loved it!

A mere 15 years later, we have the CEO of CBS practically 'pimping' for paid plasma as the way to go. Fascinating stuff, this.
Latest development 

• Paid plasma donors debated in roundtable (10 Apr. 2013)

TRANSPARENCY?

Health Canada convened a round table of key stakeholders to meet in Toronto 10 Apr. 2013. The meeting was closed to the media. Post-Krever Inquiry, the goal was to create a system that was safe, accountable and fully transparent to consumers and the public. You gotta love the transparency of Canada's blood system today. 

Excluding the media reeks of, 'Let's control the message. The media will only confuse the public and get the poor dears upset about nothing.' Father knows best?

SAFETY?

On the matter of blood safety, CBS CEO Graham Sher says there are many safety mechanisms in place today that make plasma products safe, regardless of whether donors are paid.

“It's a very different environment today from 25 or 30 years ago.... If one looks at this purely from the safety point of view, the safety of the finished product that goes into a patient, there is no evidence whatsoever that paying donors result in a less safe product. There is no evidence whatsoever. And there have been numerous studies around the world looking at this.”

 Note the repeat of 'no evidence whatsoever'. No doubt that's to emphasize that scientists have this under control and all is evidence-based, as opposed to media scare tactics and the gullible public's response. 

Of course, given today's manufacturing processes and donor screening tests, plasma derivatives have an excellent safety record. Except for the times they didn't, as with Rh immune globulin (RhIg).

RhIg

The plasma derivative RhIg is instructive. RhIg is one of medicine's biggest success stories. It's produced from the plasma of donors who have a strong anti-D and its purpose is to prevent production of anti-D in Rh negative women who deliver Rh positive infants. 

RhIg is a relatively safe blood derivative and products made in NA have never transmitted infections. 

However, in the 1970s in Ireland and the former East Germany, several 100 women were infected with hepatitis C by batches of contaminated intravenous RhIg before donors were screened for the antibody to hepatitis C virus (HCV). That's because at the time we didn't know that HCV existed. [But there was a type of hepatitis called non-A, non-B hepatitis (NANBH). Only in 1989 was NANBH found to be caused by hepatitis C virus.]

• Hepatitis C virus infection from contaminated anti-D immune globulin in Ireland
• Wiese M, Berr F, Lafrenz M, Porst H, Oesen U. Low frequency of cirrhosis in a hepatitis C (genotype 1b) single-source outbreak in Germany: a 20-year multicenter study. Hepatology, 2000. 32(1): 91-6.

Also, in 1994 in Ireland HCV RNA was detected in intravenous RhIg batches manufactured since 1991; a single donor was implicated and 19 women were found to have the same HCV strain as the donor. Sources:

• Smith DB, Lawlor E, Power J, O'Riordan J, McAllister J, Lycett C, Davidson F, et al. A second outbreak of hepatitis C virus infection from anti-D immunoglobulin in Ireland. Vox Sang. 1999;76(3):175-80.
• Wintrobe's Clinical Hematology, volume 1 (scroll to 'Rh immune globulin safety record')

RhIg for IM injection only' is manufactured from human plasma pools and can potentially transmit infectious agents such as viruses and prion diseases (e.g., vCJD). However, donor screening, donor testing and manufacturing processes significantly reduce these risks. Today we consider RhIg and other plasma derivatives to be safe for several reasons. 

RhIg for IM use is prepared by Cohn cold ethanol fractionation, which includes heat(60C for 10 hours), low pH treatment, and a solvent detergent step that inactivates lipid-enveloped viruses such as hepatitis B, hepatitis C, and HIV. The process also uses a nanofilter that physically removes viruses, including non-lipid enveloped viruses such as hepatitis A and parvovirus B19. 

The combination of inactivation and filtration greatly reduces viral load but does not entirely eliminate all viruses, some of which may be unknown. 

'RhIg for IM or IV injection' is manufactured from human plasma pools using an anion-exchange column chromatography method. The resulting product contains almost no contaminating non-IgG protein. Like the IM-only products, manufacturing includes a virus nanofilter that removes lipid-enveloped and non-enveloped viruses based on size and solvent/detergent treatment that inactivates lipid-enveloped viruses.

Sounds great, right? 

Except in the case of blood donors, we can only try to prevent transmission of infectious diseases in cellular products (red cells and platelets) or plasma derivatives if

1. We are aware of the emerging transfusion-associated disease (For hepatitis C, there was only the fuzzy, 'non-A, non-B' for the longest time.)
2. We know key risk factors so as to develop useful predonation screening questions (Non-A, non-B hepatitis had probably the same risks as hepatitis B or HIV, so experts believed the issue was at least partly covered by existing questions.)
3. A screening test exists for the putative organism (Not until tens of 1000s of transfusion recipients were infected worldwide)
4. The test has good sensitivity and specificity, i.e., can detect true positives and negatives, respectively, with reasonable accuracy. Implementing a new test is costly. Moreover, we cannot afford to reject donors needlessly. 

In Canada, unlike the USA, blood experts decided that the initial 'non-A, non-B' (hepatitis C) surrogate tests lacked proper sensitivity and sensitivity (and  tests were costly to implement). As a result, perhaps as many as 10,000 Canadians were infected. Victims were compensated, at least financially. Also see compensation packages.

PAID DONORS
We know from earlier tainted blood scandals that paid blood donors (often those who donate because they need money, e.g., young, sexually active donors and the poor) carry more risks for infectious diseases than volunteers. 

Those pimping for paid donors say today's plasma derivatives, mainly sourced from paid donors, have a good safety record - and they do. But this assumes that screening questions and tests and manufacturing processes are 100% protective or close to it. And they are pretty good for the transfusion-transmitted diseases we know about.

PATIENT ADVOCACY GROUPS

Advocacy groups represent patients whose lives depend on blood components and derivatives. To them, the issue of paid vs volunteer donors seems of minor concern so long as the products they need are available and safe. And the 'powers that be' assure them that the products are safe AND Canada needs paid donors to insure availability.

SUMMARY

We await the results of Health Canada's round table discussions on April 10, 2013 that were closed to the media. Given the CBS position and that of patient advocacy groups, can there be any doubt that paid plasma donors are not only the future but are absolutely the savior for patients needing plasma derivatives? Who knew?

CBS has already made it know that closing a Canadian plasma collection centre and importing plasma derivatives from the USA is more cost effective. Actually, they didn't say that. They dissembled with crapola about how demand was down for plasma, omitting the reality that demand is up, BIG TIME, for plasma derivatives, and it was more cost-effective to buy from the USA instead of operating a Canadian facility. 

As to emerging infectious diseases, we won't concern ourselves with them. They do not fit the current orthodoxy being preached by our gurus that blood has never been safer. Oh, and there is no evidence whatsoever that paid donors present a safety risk. You see, we have all these near perfect tests now....

As to the ethics of selling blood, that's not on anyone's agenda, certainly not CBS or Health Canada's closed-to-the-media round table. It's all about the money, folks. But the cover story is selling a story about safety. 

FOR FUN

• Money makes the world go round (Liza Minnelli, Joel Grey) Reality for Canada's blood system today
• We are the world (Lionel Richie, TinaTurner, et al.)

We are the world, we are the children.
We are the ones who make a brighter day
So let's start giving.
There's a choice we're making.
We're saving our own lives.
It's true we'll make a better day
Just you and me.

 As always, comments are most welcome. 

CSTM reply to 'Stop children, what's that sound'

Updated: 27 Mar. 2013 ('More Musings' below)

I am pleased to post this reply from the Canadian Society for Transfusion Medicine to an earlier blog (immediately below this one), 'Stop children, what's that sound' (Musings on commercialization of our blood supply). My follow-up comments follow the CSTM's response.

CSTM REPLY

March 22, 2013 

Dear Pat: 

I am responding on behalf of the CSTM Board of Directors to your recent “musing” on the AABB Application to WHO to have blood added to the list of essential medicine. The request to provide a letter of support to the application came to the CSTM Board through Ms. Judith Chapman, Executive Director of the ISBT on November 5, 2012. 

Rest assured that the decision by the CSTM Board to support the AABB application was not taken lightly or in haste. Following a review of an email request from ISBT and the AABB document  (now online) during our board meeting in November, the board unanimously agreed to submit a letter of support. 

Upon review of the comments submitted to WHO relevant to the AABB application, it does become apparent that most of the letters of support are from “developed” countries, while those that are less than supportive come from the “developing” countries. In addition to the fear that having blood on the list of essential medicines may open the door to commercialization of blood and blood components, there also seems to be concern over the resources that would have to be put in place to support the more stringent standards as a manufacturer of pharmaceuticals. 

Our understanding of the intent behind AABB’s application is that if these standards were mandated, the governments within these developing countries would have to ensure the necessary resources would be put in place in order for the blood systems to meet them. 

What still needs to be teased out of the various comments is whether the fear of commercialization is real, or whether the driving factor is fear of inability to meet the standards. If it is the inability to meet the standards, should CSTM support lowering the standards for developing countries because they are difficult to meet, or do we encourage them to strive to meet the standards by whatever means they can? 

Debbie Lauzon 
President, CSTM

COMMENTS and MUSINGS 

Dear Debbie and CSTM BOD members,

Thank you for following up on the blog, Stop children, what's that sound and clarifying CSTM's position. I respect and support CSTM and value my relationships with colleagues who work tirelessly on its behalf.

My perspective derives from conversations with four health professionals who worked in developing countries in various capacities, e.g., Cambodia, Pacific Islands, Ukraine, Vietnam, Zambia. 

The bottom line is that developing countries lack resources to prevent millions of children dying from diarrhea and malnutrition. Finding resources to meet the blood safety standards that we in the industrialized world take for granted is difficult, if not impossible, without significant funding aid, e.g., USA's PEPFAR, as well as many European and WHO initiatives.

Many areas in such countries are lucky to have reliable electricity, let alone a supply chain for reagents to test donor blood and perform pretransfusion testing. Educating lab workers on even the basics is a challenge. Transfusion safety is WAY down the priority list for what's needed to save millions of lives.

In the developing world, replacement and paid blood donors are common. Donors are screened for transmissible diseases with rapid kits. The potential donor population is malnourished and disease ridden. 

Accordingly, health professionals in such countries must compromise and deal with realities as best they can. 

You ask, "Should CSTM support lowering the standards for developing countries because they are difficult to meet, or do we encourage them to strive to meet the standards by whatever means they can?"

1. We all want to encourage governments in developing countries to meet blood safety standards. How best to achieve this common aim is open to debate. 

Is adding blood to WHO's EML going to accomplish this? We don't know. It hasn't worked for blood derivatives such as IVIg. 

2. CSTM not supporting AABB's application to have whole blood and red cells added to WHO's list of essential medicines is not equivalent to CSTM supporting lower blood safety standards for developing countries. 

For example, does the stance of the European Blood Alliance to discuss further its effects mean that European nations support lowering standards for developing countries?

3. Suppose that blood is added to the WHO EML and, after time, developing countries still cannot meet western blood safety standards. 

Suppose they opt instead to continue to spend scarce resources on conditions that kill millions, which leaves inadequate funds to fully meet our blood standards? What then? Will blood have become more of a commodity to be bought and sold, as blood derivatives have become, with decreased access in developing countries?

4. Essential medicines are those that satisfy the priority health care needs of the population. To me, the key is priority, recognizing that governments do not have unlimited money pots. 

I await ongoing developments with an open mind. My purpose in writing these blogs is to challenge the orthodoxies of the day and provide food for thought. 

More Musings
It's always good to see other people's perspectives and 'walk a mile in their shoes.' Four more musings (27 Mar. 2013) on CSTM's response :

1) Those who made submissions urging caution, or outright did not support AABB's application, including many from developing countries, may be insulted that their concerns are dismissed so easily. Especially the suggestion that their fear of commercialization may not be real, and that the driving factor may instead be fear of not being able to meet Western blood safety standards. 

2)  CSTM believes AABB's intent is that 'if these standards were mandated, the governments within these developing countries would have to ensure the necessary resources would be put in place in order for the blood systems to meet them.' 

In a list of motherhood rationales in its application, the closest AABB comes to expressing that is 

• Underscore government's responsibility to ensure financially sustainable funding and support for a safe and adequate supply of blood 

If true, AABB wants to add blood to WHO's EML to force '3rd World nations' to come up with the bucks to make blood safe, even if they lack resources to make water safe and feed their citizens. 

Sounds paternalistic at best ('father knows best'), imperialistic at worst ('our way, or the highway'). 

3) Another AABB rationale is to enable appropriate regulatory oversight. And if developing nations cannot fund that huge enterprise, what then? 

Whole blood and RBC will become commodities in a free market and, since you cannot do it, we will sell you the 'essential medicines'?

4) From a developing country's perspective, ABBB's application can almost be seen as historically similar to that of Christian missionaries. We are coming to save you from yourself and your heathen ways. That strategy is not a winning one in the 21st Century. Wasn't in the 19th C either....

As always, comments are most welcome.

Stop children, what's that sound (Musings on commercialization of our blood supply)

Updated: 1 Nov. 2013 

Also see CSTM's reply to 'Stop children, what's that sound'

This month's blog has two sources:

• Application by AABB (and others) to have whole blood (WB) and red blood cells (RBC) added to WHO's Essential Medicines List (EML)

• Brouhaha in Canada over the possibility of for-profit blood donor plasma clinics opening

The blog's title derives from a 1966 Buffalo Springfield song written by Stephen Stills (later of Crosby, Stills, Nash & Young), 'For What it's Worth', better know by one of its lines:

• 'Stop Children What's That Sound'

The blog's sources are related. With apologies to Bill Clinton's 1992 'war room' election slogan, "It's the commercialization, stupid."

Below are my musings on both sources. First I'll try to make sense of the complexities of the AABB move to make whole blood and plasma 'essential medicines' and then briefly relate personal experiences with being paid for my plasma.

AABB APPLICATION TO MAKE WB and RBC 'ESSENTIAL MEDICINES'

Where to begin? First, let me admit that this is a complex issue beyond my pay grade, as the saying goes. I'm discussing it because something seems wrong, does not compute.

Navigating all the complexities of AABB's application for WB and RBCs to be included on WHO's essential medicine list (EML) would make your eyes glaze over. Here's the key points as I see them.

For the 'full monty', read AABB's Dec. 2012 application

AABB claims that adding WB and RBCs to the WHO ESL would do many good things, e.g.,

• Underscore government's responsibility to ensure financially sustainable funding and support for a safe and adequate supply of blood 
• Emphasize the need to ensure that blood is cost-effective, affordable and available
• Enable appropriate regulatory oversight of blood collection, processing, testing, storage and distribution to ensure the safety and quality of blood and the safety and efficacy of blood transfusion

On the surface, it seems like a no-brainer right? But perhaps all is not as it seems.

I call this the AABB application because it's on their letterhead. CBS seems not so much a co-sponsor as a co-opted, tag-along partner. Its CEO Graham Sher is AABB President-Elect.

And it turns out that the ISBT is not a co-sponsor. In a submission to WHO, ISBT notes that while the AABB application may have merit in principle (note reference to 'AABB application'), more time is needed to assess its full implications and ISBT never intended to be a co-sponsor in the first place.

Embarrassingly, on 8 Mar. 2013, the AABB CEO apologized that the application mistakenly included ISBT, a Yikes! if there ever was one.

Comments on the WHO website are informative. While there are many supporters, including CSTM, it's interesting that many developing countries do NOT support the AABB application. 

Indeed, the European Blood Alliance, which includes the UK and other Euro nations, does NOT support the application. EBA believes that more time is needed to assess the implications and that proven strategies to improve safety and sustainability in developing countries should be tried first.

Makes me wonder on what evidence my own country's professional association (CSTM) sent a letter of support. Was it a case of busy professionals more or less rubber stamping an initiative of the 'big boys on the block' (AABB, CBS)? [See CSTM's reply.] The same goes for other supporting individuals and associations who qualify as 'kids on the block.'

For complete details of pros and cons, read the comments on the WHO website.

In brief, the concerns are that labelling whole blood and RBC as 'medicines/pharmaceuticals' could lead to 

• Commodification (treating blood as a commodity to be bought and sold)
• Commercialization
• Decreased availability

Commercialization would threaten the volunteer, non-renumerated blood donor (VNRD) system. 

Dissenters from many countries point out that adding plasma derivatives such as immunoglobulin to the WHO EML has not brought about the 'goodies' that AABB claims in its application. For example, those advocating caution note that the commercial market for plasma products resulted in over-consumption in some countries and under-consumption in poorer ones.

The latest entry is from Harvey G. Klein of NIH. Dr. Klein is a past AABB president and strong proponent of the current initiative. 

• Comments from National Institutes of Health, USA, on Expert Review No.2 (13 Mar. 2013)

In his rebuttal to Expert Review 2, Klein writes, 'There is no evidence whatsoever that adding blood to the EML will encourage commercialization.' Then why do so many other experts raise the issue? Are they all paranoid? Klein would have us believe so.

So why has AABB applied? Why now? And why do they and their surrogates seem in such a rush? What's really happening?

Times are tough in the transfusion world. Blood centers and transfusion services alike are in full amalgamation and partnership mode to try to survive. (Perhaps more on this in another blog.)

Added 1 Nov. 2013: April 2013, final amendments Oct. 2013: WHO's Model List of Essential Medicines was amended to include blood and blood products (see p. 20), as championed by AABB. 

FOR FUN: The ongoing debate on adding blood to the WHO EML reminds me of The Empire Strikes Back. I leave it to you  to create a cast of actors for these key roles:

• Chewbacca
• Darth Vader 
• Han Solo
• Luke Skywalker 
• Obi-Wan Kenobi 
• Princess Leia
• Yoda

Perhaps I'll offer a prize for suggesting who best represents The Dark Side? (grin)

PAYING FOR PLASMA

This issue is relatively straightforward and I have personal experience with being a paid blood donor.

In the USA paying donors for whole blood donations stopped many years ago in the aftermath of the AIDS disaster in the USA and developed world. Canada's 'tainted blood' tragedy is well documented, but one occurred in every country.

In Canada paying for whole blood donations never existed. However, paying for plasma donations continued in USA until the present and first appeared in Canada in the 1960s.

Personal reflections on paid plasma donation in Canada

In Winnipeg at the Canadian  Red Cross Blood Transfusion Service (CRC BTS)  where I worked in ancient times, the so-called 'Rh ladies' with high titre anti-D (who had fetuses die from HDFN) got a small fee of the order of $15 per donation "for their time." Their plasma was processed into Rh immune globulin.

These women felt personally indebted to the Winnipeg Red Cross medical director, Dr. Jack Bowman, because most had infants saved by intrauterine transfusions performed by him.

Their anti-D was boosted and kept high by periodic injection of D+ rbc (cDe K-negative, to prevent stimulating anti-K and other Rh antibodies like anti-C or anti-E).

Today, Winnipeg-based Cangene pays plasma donors fees depending on how valuable their plasma is.

High titre anti-D donors are likely paid the most.

As a child prodigy medical technologist at CRC BTS in the mid-1960s, I earned $5 per donation for donating my group A plasma (containing anti-B) to prepare ABO typing sera. One of my  female group B co-workers similarly donated anti-A.

We were injected with group A and B substance to boost our titres. But staff plasma donations for ABO typing sera came to an abrupt halt when my pal delivered a newborn suffering from ABO hemolytic disease of the newborn.

My plasma donations were hardly big business. To my knowledge, the plasma was used to make in-house reagents for my employer, Canadian Red Cross BTS.

Now true for-profit plasma clinics are on the horizon in Canada, but not yet licensed by Health Canada.

Such commercial operations are common in the USA and elsewhere but do not exist in Canada. But Canada buys plasma products sourced from both volunteer Canadian donors and paid donors in other countries.

Paying for 'special' plasma with potent anti-D is one thing, especially if the fee is so low as to be paying an honorarium for a donor's time. 

Routinely paying every Tom, Dick, and Jane is another. It would undermine the volunteer donor sector. 

One leading light who strongly supports the need for paid plasma donors is CBS CEO Graham Sher (and AABB President Elect):

• Prohibiting pay-for-plasma would harm patients (13 Mar. 2013)

Dr. Sher points out that with modern screening and testing even products from paid donors are extraordinarily safe today. 

More Musings (16 March, 2013)

Interestingly, in March 2012 when CBS closed its plasma collection facility in Thunder Bay, Ontario they cited a decline in demand for plasma:

Over the past two years, new replacement products and a decline in hospital demand have led to a decrease in the need for plasma for transfusion. Based on current projections, Canadian Blood Services must plan for a reduction of approximately 10,000 units to our plasma collection program this year. 

Yet in its March 2011 Financial Report CBS noted:

In 2010/11 Canadian Blood Services started a pilot program to purchase surplus recovered plasma from the United States (collected by organizations with an FDA licence) which will continue in 2011/2012.

As I wrote in a blog at the time, While my guitar gently weeps (Musings on CBS's ongoing behavior):

So, what's the scoop? CBS needs less plasma OR CBS needs less Canadian plasma because operating a Canadian plasma centre is more expensive than buying surplus plasma from the USA? If true, why not just say so? 

....And what ever happened to Canadian plasma self-sufficiency? Has it been abandoned because it's too expensive?  

From the CBS Annual Report 2007-2008 (p.22): 

This year, we also re-introduced the collection of source plasma at our existing plasmapheresis sites across the country, laying the foundation for Canadian Blood Services to improve our plasma sufficiency - one of the basic principles of the blood supply as outlined in Justice Krever's report.

So.....CBS's stance on plasma collection has evolved, but not in a straight line. The official party line been all over the place: 

• Plasma self sufficiency (~2007)
• Buy surplus plasma from USA (~2010, ongoing)
• Close Canada's plasma centre because of decreased demand (~2012)
• Strongly support need for paid plasma donors (~2013)

Sadly, you need to take what our national blood supplier says with a huge grain of salt because they obfuscate what's really going on.

This news item from Indiana, USA is informative:

• New commercial plasma center to open to meet increased demand for plasma-derivative therapies (4 Mar. 2013)
• Frequent donors can earn ~$200/mth
• ARC believes paying donors runs risk of passing along contaminated blood and warns about emerging infections for which there are no tests.
• Today's plasma centers are locating in better areas “where donors are less likely to be infected.”

In contrast, Toronto's planned plasma centre is next door to a mission for the poor and homeless.  

Now the Canadian Hemophilia Society has entered the fray: 

• Draft policy on paid plasma donations (11 Mar. 2013)
• Background document
• Summary

The Society's draft position supports the opening of paid plasma clinics with these provisos | My comments:

• Collection of plasma from paid donors must not affect the ability of CBS or Héma-Québec to collect fresh blood components | Something that remains to be seen

• CBS and Hema-Quebec should increase the quantity of Canadian plasma for fractionation from non-paid donors | Héma-Québec, which plans to open a plasma centre in 2013, may increase the volume of Canadian plasma, but CBS closed its sole plasma centre in 2012 citing decreased demand (while at the same time buying surplus plasma from the USA to produce blood derivatives).

• Donors should not be exploited nor should their health be compromised. Incentives should not overwhelm their capacity to make an informed decision on donation. | Lofty ideal but Canadian Plasma Resources has located a Toronto collection centre next door to a homeless shelter. 

The CHS background Paper notes:

• Not-for-profit blood establishments do not consider it economical to recruit non-paid donors for a self-sufficient supply of plasma for plasma-derived products; 
• they choose to rely on the highly efficient for-profit global plasma collection and fractionation industries. 
• Therefore the reliance on source plasma from paid donors will only increase.
• If Ig receives an indication for Alzheimer's disease (it is currently in Phase III clinical trials), the demand for Ig (and plasma) will skyrocket.

In other words, time for Canada to get on the bandwagon, go with the flow? The flow of cash? A giant sucking sound of tax-payer money going to plasma centres and associated pharmaceutical companies who then fund research to create more demand for IVIG, et al? 

Hmmmm...sounds like a plan.

Philosophical issues

Margaret Sumerville, Director of the McGill Centre for Medicine, Ethics and Law, examines philosophical arguments related to commercializing the human body and the 'disturbing image of middle men making large profits out of one person's poverty and another's dire medical need.'

• It is difficult to put a price on human blood (11 Mar. 2013) 

LEARNING POINTS

To me, all is not as it seems with AABB's application to WHO. CBS as a co-sponsor seems a joke. Not Britain or Australia or New Zealand....Not any of the countries represented by the European Blood Alliance.

Why Canada? Because Graham Sher is AABB President-Elect? Because Canada is so much wiser then Germany, UK, etc?

More importantly, the nations supposedly most to benefit are skeptical or outright oppose it.

What's wrong with this picture?

As noted in past blogs, AABB as an organization is cozy with industry, indeed depends on it heavily for funds via advertising and exhibiting services and products at annual conventions. AABB Consulting is another business line and money earner.

Is AABB's application to add WB and RBC to the WHO ESL merely an altruistic desire to improve blood safety, accessibility, and sustainability for developing nations?

I'm a cynic. As George Carlin said, 'Scratch any cynic and you will find a disappointed idealist.' But cynic or lapsed idealist, the AABB move doesn't seem right. What's going down?

FOR FUN
The song that fits this blog is

• Stop Children What's That Sound

I think it's time we stop, children, what's that sound Everybody look what's going down

Comments are most welcome.