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.

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