Monday, March 25, 2013

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.

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


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.

Thursday, March 14, 2013

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.


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. 
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)

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):
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:
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: 

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).
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? 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.'


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?

The song that fits this blog is

I think it's time we stop, children, what's that sound Everybody look what's going down
Comments are most welcome.