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.