Wednesday, January 20, 2016

Simply the best (Musings on paid plasma & TM colleagues I've know)

Updated: 23 Jan. 2016
January's blog is a two-fer, derived from a news item in TraQ's monthly newsletter and a blog series written for the Canadian Society for Transfusion Medicine (CSTM).

The title derives from a 1989 Tina Turner classic. And it relates to the CSTM blogs, not paid plasma. But I suspect you could figure that out. Paid plasma and its Canadian players are the antithesis of the best.

Although this blog and the CSTM blogs are from a Canadian perspective, I'm confident you will see how the content and issues relate to you, no matter where you practice.

For links to news items and resources, see Further Reading at the blog's end.


#1. MUSINGS - HONORING COLLEAGUES / RECORDING HISTORY
I encourage readers to read this new series of blogs on the Canadian Society for Transfusion Medicine site. To date there are two blogs, with many more to come.  As I wrote to introduce the first blog:

Each blog begins with my musings on the individual, followed by a brief background on the person's career, sometimes with my comments throughout. 
If you're looking for a rah-rah, rosy view of Canada's transfusion medicine field, this ain't it. Why? Although all participants enjoyed their careers and love the transfusion profession, they also speak honestly about both the ups and downs. Perhaps their reflections will resonate with your experiences.
Take a peek. Blogs present real experience with honest opinions that challenge the 'powers that be'. I encourage you to comment on the CSTM website and give your experiences, whether similar or different.

Now for the NOT BEST. 

#2. MUSINGS - PAID PLASMA REDUX

Oh, no, I can hear you scream. Not paid plasma in Canada again! Yep, because it's in the news again. To me, it's like whack-a-mole or the gift that keeps on giving, blog-wise. So much to learn from this Canadian saga, and most of it BAD.

Don Davies, a federal MP with a centre-left Canadian political party (NDP) has called on paid plasma clinics to be banned. Already not allowed in 2 provinces (Ontario and Quebec), a company, Canadian Plasma Resources, now has plans to set up in the Canadian province of Saskatchewan and has the approval of its right-of-centre government.

Party characterizations are mine. Feel free to disagree. Note that in Canada's political system, jurisdiction over health care belongs to the provinces.
Bottom line, and one reason why I think writing about this again is useful:
  • MP Davies bases objections on safety. Since Canada has one of the safest blood systems in the world, this is a hard sell. More credible arguments against paid plasma are nuanced.
Safety
In a nutshell, the safety risks of paid plasma are exceedingly small but not zero. Any remaining risks are rare and relate to the 

  • Poor and needy potentially lying on blood donor screening questionnaires to get the money, combined with 
  • Reality of window periods of negativity (even short ones), such that screening tests may not detect early infection.
Another risk factor is that of unknown new and emerging infections that may be transfusion-transmissible. You can bet they exist, just as death and taxes are sure things.

In both cases, the infections would need to escape existing donor screening questions and tests, as well as current processes in the manufacture of plasma derivatives (e.g., albumin and immune globulins such as IVIg and Rh immune globulin), including

  • Plasma quarantine
  • Technology to inactivates viruses
  • Purification steps
Can transfusion-associated risks happen with plasma derivatives? Yes. Likelihood? Extremely low. One unknown is the human factor. Humans make mistakes, otherwise known as 'shit happens'.  

But, similar to winning the USA's Power Ball $1.6b lottery (odds are ~1 in 292 million), eventually someone will do it. If you're the unlucky patient  who gets a transfusion-transmissible disease, no matter how unlikely, it matters not.

Moral/philosophical
Canada, like many nations, adopted an altruistic view of blood donation, meaning paid plasma donation is an anathema.

But paid plasma donation has existed since the 1960s in Canada, something paid plasma advocates love to point out:


As far back as the 1960s, the Rh Institute in Winnipeg paid Rh negative women with potent anti-D causing severe HDN and fetal death a small honorarium for their time in donating plasma by plasmapheresis. 
Side-Bar: Never mentioned in the literature - something that fell under the radar: In the 1960s Canadian Red Cross Blood Transfusion Service (CRC-BTS) bled employees for blood typing antisera and paid us. How much? A whopping $5/donation.
As a group A CRC-BTS medical lab technologist employee, I donated plasma for anti-B antisera and was injected with soluble B antigen to increase my anti-B titre. My group B co-worker had her anti-A similarly boosted and plasmapheresed for anti-A. 
Such donations ceased when my co-worker's first child had severe ABO-HDN. Physician in charge realized it was not a good idea to boost the strength of ABO antibodies in young women of childbearing age. Doh!
Back to anti-D: Donation initially occurred at CRC-BTS (now CBS). As someone involved I can testify that the 'Rh ladies', many of whom had fetuses stillborn due to severe hemolytic disease of the fetus and newborn (HDN or HDFN) did not donate for the small honorarium. 
Rather it was to help other woman not have to suffer their pain and in gratitude to Dr. John Bowman, who donated his own group O Rh-negative blood for exchange transfusions, pioneered inter-uterine transfusions (IUTs), which gave them living children, as well as pioneering antenatal Rh Immune globulin manufactured from their plasma, which prevented HDFN in others.
  • So, please, don't buy the guff that today's poor who donate for money are in any way similar to these women donating anti-D in Winnipeg. 
Since then a commercial company (Cangene, now defunct and part of Emergent Biosolutions) expanded to paying not only the 'Rh ladies' with potent anti-D, but others with special antibodies to manufacture plasma derivatives such as hepatitis B immune globulin (HBIG). 

Canada's approach to commercialized, private medicine
To some extent Canadians have looked our collective noses down on the commercialization of blood donation (and health care in general) in our U.S. neighbour.
Ignoring the ethics of paying the poor for plasma and charging those unfortunate enough to be sick for health care, many Canadian medical lab technologists/scientists who work in the USA are astounded at the bureaucratic nightmare associated with hospital transfusion services charging patients for each and every pretransfusion test.
  • Need a type and screen? Ka-ching!
  • Have an antibody to identify? Ka-ching! 
  • Need antigen-negative red cells? Ka-ching! 
  • Need multiple red cell, plasma, and platelet transfusions? Ka-ching! 
  • Require special blood products like irradiated red cells? Ka-ching!
Patients can be billed $1000s of dollars. Many don't have private insurance associated with employment or are not poor enough to get Medicaid or are elderly (Medicare).

For more on USA's system of paid blood donation and private healthcare, see Further Reading (Domen and AABB and Deciphering USA's Health Insurance System (an information page I created with significant help from a MEDLAB-L subscriber).


What does 'paying' donors mean?
Today USA's so-called 'non-profit' blood banks do not directly pay whole blood and plasma donors money. It's done via various incentives. 


Sample 'non-profit' blood bank incentives (via Oklahoma Blood Institute):

Paid plasma collection centers, some operated from abroad, e.g., Australia's CSL, are different. They prey on the poor and make a lot of money doing so. Even they now have sense enough to shy away from the filthy lucre ($$$) and do not pay donors directly. It's usually done by prepaid debit cards, as explained here:
BOTTOM LINE: Many Canadians think this is the way to go. I do not.Those promoting paid plasma lay on the fear and guilt: people will die without a sufficient supply of plasma derivatives. Then they play the hypocrisy card, noting that CBS buys products made from paid plasma donors. 

What they don't say is 'Let's build the plasma collection centres next to homeless shelters so we can get our supply 'on the cheap'. Renting or buying a facility will also cost less. Value-added! Let's leverage the location to improve our bottom line and pay higher dividends to our investors.' Because it's all about the money, stupid!

For interest, someone sent this as a comment to an earlier blog and it's never been more relevant:

"Regarding Paid Plasma and the potential go ahead in Saskatchewan (SK):

We have had no public consultation in SK. and we are still don’t know what happened to the results from the Health Canada Public Consultation on the Safety of Paid Plasma Donations.
The CBS doesn’t collect as much as they could because of cost not donor availability but this reality gets stood on its head to appear that there are not enough donors and we actually need this. 
CHS and CBS support the deal adding credibility not to a Baxter or Octapharma but instead to a bunch of guys that really do not appear to be very credible. 
It's all incredibly interesting. Can't help but wonder who will be handling the testing of samples for CPR?"
MY TAKE. Health Canada and CBS both come across as a joke in this sorry saga:
Can HC make a decision that doesn't ebb and flow in the wind depending on how key stakeholders lean? And if profit-motivated Canadian Plasma Resources opens for business in SK, who will do the transmissible disease testing?

Can CBS please stop with the weasel words that they support voluntary blood donation but, hey, paid plasma is safe and, by the way, we REALLY need it?


FOR FUN

When I write about my colleagues, I always think of Tina's song:
As always, the views expressed are mine alone. 

Comments are most welcome (you can do so anonymously). See below. 
FURTHER READING
My 5 prior bogs on paid plasma (Some internal links to news items may not work but you'll get the idea)
Paid plasma clinics must be banned: NDP (15 Jan. 2016)

AABB: Billing for Blood and Transfusion Services: Frequently Asked Questions and Answers

Deciphering USA's Health Insurance System  (Generous help with links supplied by James Pusavat, a MEDLAB-L subscriber from the USA)


Domen RE. Paid-versus-volunteer blood donation in the United States: a historical review. Transfus Med Rev. 1995 Jan;9(1):53-9.

What is USA's Medicare vs Medicaid? / Also see 
Investopedia

This next paper is a beauty. Gives all you need to know about paid plasma in Canada, and its advocates: