Showing posts with label Canadian Plasma Resources. Show all posts
Showing posts with label Canadian Plasma Resources. Show all posts

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:
Posted by Blut at 8:21 PM 11 comments
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Sunday, July 27, 2014

Don't worry, be happy (Musings on the safety of our blood supply)

Updated: 1 Aug. 2014 (If you've visited before, refresh your browser)

 Below is a copy of a Comment made to the earlier bog, Turn,Turn, Turn. and my reply to it. I decided to write a separate blog because Turn was getting too long and the Comment stimulated other aspects of the paid plasma issue, most noteworthy, safety.

 The safety aspects I'll touch upon include 
  • Foolproofing. Our blood experts assume blood safety is now foolproofed (no longer susceptible to human incompetence, error, or misuse) because the blood tragedies of the 80s and 90s are of historical interest only. 
    • Put another way, many blood experts (thought leaders) developed an arrogance that exudes, 'We're so much smarter now.' 
    • They base it on implementing quality systems, improved blood screening tests, and more stringent government regulation. 
  • Cost constraints, mainly affecting the nature and number of staff.
    • Despite the best foolproofing tools (see Further Reading below), not all facilities can afford them.
    • And humans working short-staffed and under pressure, and those with less formal education, are more prone to human error, especially if the system itself is flawed due to cost constraints. 
The blog's title derives from a Bobby McFerrin ditty from 1988.

 First, Anonymous's comment from the Turn blog:
Anonymous wrote: Two quotes from G. Sher that appear 4 days apart in the media. PLEASE include this in a future blog!
“Canadian Blood Services has successfully managed the blood and blood products supply for Ontarians for more than 15 years. We are confident in the safety and sustainability of the current blood and blood products system in Canada, and we recognize Ontario’s role in preserving voluntary blood and plasma donation in this province.”
Dr. Graham Sher
CEO, Canadian Blood Services
Ontario official press release July 22, 2014
Anonymous: A quote from Friday just four days prior:
Dr. Graham Sher, CEO of Canadian Blood Services, is concerned about “the mischaracterization of this as a safety issue, as opposed to a public policy issue.” 
“People are caught in a paradigm from 30 years ago and are saying that paid plasma donors are unsafe and therefore we shouldn’t be allowing a paid facility in Canada because it’s an unsafe thing to do and people are going to die as a result. That, to me, is fear-mongering and it’s inaccurate.” 
Equating paid donors with an unsafe product would mean 80 per cent of the plasma drugs in Canada aren’t safe. And that’s simply not true, says Sher, calling them “extraordinarily safe.” 
“We may have moral objections and philosophical objections to paying,” he says. “But let’s not make it an issue about safety when it’s not about safety.”Sher says that as long as Canadian Plasma Resources operates safely and doesn’t impact the voluntary donor base, it would have “no objection to existing side by side with this company.” 
Toronto Star, Isabel Teotonio
Anonymous: To say that transfusion medicine with [is] totally safe is to believe in a perfect product. That is arrogant and dangerous. I want CBS to understand the ever present risk and be vigilant and consistently working to minimize this risk. To do less will lead down the dark road of the Red Cross and unknown catastrophes.
My response to Anonymous

To be fair, CBS CEO Sher called plasma derivatives 'extraordinarily safe' but I agree the impression he creates is that they are 'totally safe'.

And I suspect that his carefully crafted public comments inadvertently create mixed messages. Dr. Sher likely thinks he's been perfectly clear:
  • CBS supports a voluntary blood donor system.
  • CBS supports Ontario's right to protect a voluntary donor system.
  • Paid plasma is safe (as safe as voluntary donor plasma).
  • Object to it on moral and philosophical grounds, but not safety.
  • If a paid plasma company operates safely and doesn't adversely affect voluntary donation, CBS would not object to existing side by side with it.
That last bit is a tad weaselly. We may not know if paid plasma centres or manufacturers of plasma derivatives or non-profit blood suppliers like CBS operate safely until an inspection or 'tainted blood' disaster shows they didn't. Sure, they all must meet stringent government regulations and be periodically audited, but errors happen all the time. And not just historically.

Mistakes (systematic and individual) regularly occur today. For example:

#1. In 2012 the USA's FDA fined the American Red Cross $9.59 million for violating blood safety rules. Note this is 2012, not 1982 or 1992.

Sometimes audit findings seem trivial, i.e, nitpicking that's unlikely to translate to patient harm. But ARC violations were serious, not trivial. All of the violations merit discussing but I'll choose just one, one that health professionals, indeed everyone, can relate to:
  • Most of the regional operating centres of the Red Cross were seriously understaffed.
Understaffing has long been a reality in health care. Why? Cost constraints and cutbacks. The powers that be usually opt to cut staff or substitute more highly educated, and therefore more expensive, staff with less educated, cheaper staff that are trained on the job and supervised by fewer well educated, expensive staff.

A classic example is CBS's 'donor care associates' mentioned in my blog of Nov. 2013:
  • Lest we forget (Musings on accountability of national blood suppliers)
The blog dealt with CBS's 2013 Report to Canadians, which mentioned cost a whopping 747 times.  
Cost savings apparently applies to worker bees, not top CBS executives. In 2012-13 CBS executives earned $283,000 to $342,000, with the CEO Sher earning $560,000. No doubt all well earned. To get top talent, you must pay top dollar. Just odd how cost savings seldom translate to executives.
As a joke I created a cartoon about possible other CBS 'care associates'

Understaffing played a role in ARC's blood safety violations. Staffing levels invariably adversely affect blood safety. We often get away with it, until we don't.

#2. Another example of systematic and individual staffing issues and ineffective government regulation  is shown by this news item:
Note this happened in 2014 in Hazelton, PA, USA, not a third world nation. Besides inadequate staffing, among many findings the state Department of Health concluded:
  •  The governing body was ineffective in carrying out their responsibilities to approve, implement and enforce standards of quality management and improvement for the hospital by failing to ensure the chief executive officer provided a safe setting for patients receiving blood.
In Canada, our current government's commitment to science versus saving money (in the run-up to a 2015 election) is suspect. Not wanting to become too political, but our government has cancelled Statistics Canada's long-form census and been accused of muzzling scientists, even to the point of investigation by Canada's Information Commissioner. 

I wonder if Health Canada, the government body charged with regulating and protecting our blood supply, has been adversely effected by staff cuts due to the government's desire to balance the budget prior to an election. 

They've taken a long time to rule on Canada's paid plasma collection centres, having first held a round table (closed to the public) in April, 2013. In July 2013 I wrote a blog about it:
  • Day tripper (Musings on HC's instructions to the jury on paid plasma)
Still no answer a year later. Why?

#3.  A key part of expert certainty of the safety of our blood supply is all the pre-donation screening questions, post-donation tests and manufacturing processes used, especially for plasma derivatives like IVIg. The blood supply in developed countries is safe today, much safer than in the past. 

But the blood supply not totally safe. Many things can go wrong:
Seems foolproof, no? Except it isn't. The system only works for transfusion-transmitted infections we know about.

For example, in 1994 it was discovered that the plasma derivative Rh immune globulin in Ireland had been contaminated with HCV in 1977-78 from a singe donor. Plasma derivatives are made from 1000s of donors and it only takes one to escape detection.
  • HCV wasn't discovered until the late 1980s. 
  • At least 390 Irish women were shown to be infected with HCV-RNA. 
  • By 1998, €206 million (~$300 million CDN in today's money) was paid to these women and others infected with HCV via transfusion.
In Canada, at least 30,000 Canadians were infected with HCV between 1986 and 1990. And all because  Canada's experts failed to use surrogate tests for non-A, non-B hepatitis (as was done in the USA) because they judged the tests to be unscientific. Compensation to Canadians infected with HCV during this time totaled over $1 billion.

BOTTOM LINE
I dig that the blood supply in developed nations like Canada is exceedingly safe compared to 20-30 years ago. But I prefer to be skeptical vs championing, 'Don't worry, be happy,' as CBS CEO Graham Sher does.

ADDED 31 JULY (amended 1 Aug. 2014)
In reply to the Comment below from Anonymous (Curtis), whose main points were:

1. Anonymous: You state that he [Dr. Sher] inadvertently sends mixed messages. I contend that he rides the fence on purpose. I have it from reliable sources that CBS wants of offload the cost of collecting plasma. They are just not efficient at it and look to the US model as a way to achieve this. 
My reply: You're likely right that CBS CEO Sher tries to have it both ways, given how CBS closed Thunder Bay's plasma collection facility in 2012. I blogged about it, noting that CBS obfuscated its real reason for closing the centre: Operating a Canadian plasma centre is more expensive than buying surplus plasma from the USA.
2. Anonymous: This is why Ian Mumford of CBS was part of the Dublin Consensus Statement that everyone points to as a paper that outlines the successful co-existence of the private sector and the public sector in the plasma industry. 
My reply: The Dublin consensus is like politics in which we all agree on motherhood and apple pie:
  • Dublin Consensus Statement on vital issues relating to the collection of blood and plasma and the manufacture of plasma products
Reality is often different:
For interest, according to LinkedIn, Mumford is responsible for ensuring CBS consistently provides high quality transfusable, plasma protein and stem cell products to customers at the right time, at the right place, and at the right cost. Likely the last is most important, given CBS's focus on cutting costs to satisfy provincial pay masters. 
3. Anonymous: I contend that Dr Sher when asked by his employer... the government of Ontario he does what a loyal employee does and that is make them look good. 
My reply: CBS is funded by all Canada's provinces and territories except Quebec (which operates Héma-Québec), not just Ontario. According to CBS's website, Canada's Health Ministers are responsible for the overall expenditure of public funds but do not have the power to direct operational decisions of the Board of Directors or Canadian Blood Services staff.
But your point has merit. Sher's pronouncement on the Ontario government's proposed legislation to ban paid plasma was to be expected, in that there was no way he could be political and publicly contradict a provincial government's policies. 
4. Anonymous: However, I also know that he has been privately petitioning for the Ont Govt to let CPR open.
My reply: Assume you have it on good sources, but I can't give such an accusation credence without confirmation. All  can say is, if true, it would not surprise me. It fits with Sher's public statements:
FOR FUN
Love this song with the reggae beat I learned in Jamaica, circa 1969.
As always, the opinions are mine alone and feedback is most welcome.

FURTHER READING
These resources are for those who want to explore some of the issues affecting blood safety in-depth.

Plasma derivative safety
Foolproofing (Applies mainly to hospital based transfusion where computers are seen as answer to human error.)
Staffing
It's hard to find reports on inadequate staffing, mainly because overworked professionals, especially those in the laboratory, fear that, by speaking out, they'll suffer repercussions, not just to their current job but in their careers.



Posted by Blut at 3:50 PM 3 comments
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Saturday, April 12, 2014

I heard it through the grapevine (Musings on paid plasma's PR campaign)

Updated: 29 May 2014
This months blog is another two-fer. The title of this blog is a take-off on an iconic cover of a Marvin Gaye song by Creedence Clearwater Revival.

The blog was motivated by the blow-back from those who are pro paid plasma in Canada.

#1. BBTS BLOG
My second guest blog for the BBTS is online:
The blog is about a surprising similarity between football (soccer in NA) and transfusion medicine: both are incredibly tribal. I'm a huge footie fan, with my favorite English club being Chelsea.

Please give the BBTS blog a look. It should interest physicians, nurses, technologists, and pharmacists, indeed, anyone involved in transfusion medicine.

Note that, unlike these blogs, I cannot revise and add to the BBTS blogs, except for correcting typos.
One thing I'd like to add to Simply the Best is that I'm sure that physician and nurse tribes dealing with a severely bleeding  patient with a gunshot wound, about to exsanguinate, just wants the transfusion lab to give them the damn blood, not crab about what they see as picayune identity issues.
#2. APRIL BLOG
This month's blog is a brief follow-up to last month's blog on paid plasma in Canada. It was stimulated by comments to March's blog, Hey Jude (Musings on why paid plasma makes it worse, not better), which pointed out that Canadian Plasma Resources appears to be mounting a PR campaign to influence public opinion in favour of paid plasma in Canada. Not a surprise.

Notice how they brand their site as saving lives and use photos of families. Image is everything. Two components of the PR campaign are discussed below:

1. Plasma for Ontario
Check out the un-transparent site, Plasma For Ontario. I searched who owns the domain and funds it, but, of course, whoever it is hides their identity. But I think it's safe to assume it's Canadian Plasma Resources or its surrogates.

Rule of thumb: Never trust a website that doesn't state who they are in an About Us section and identify who funds it.

2. Article in The Whig, a Kingston ON paper owned by right-wing Sun Media (think Fox News for its political slant):
To the unsuspecting, this oped piece may seems to be a news report by a reporter even though it's clearly identified as an Opinion Column. The author is Stephen Skyvington, President of PoliTrain Inc., a public relations firm.

My bet is Canadian Plasma Resources hired him to write this BS. Or perhaps he's just a knight in shining armour out to remedy injustice wherever he finds it. He claims the government's ethicists spout BS. Well, here's some of his bullsh*t:
Canadian Plasma Resources is not out to exploit the poor, or put our blood supply at risk. They want to bring innovation and jobs to Ontario — something our province is in short supply of, thanks to the McWynnety Liberals’ 11-year reign of error. Far from being a threat to the people of Ontario, Canadian Plasma Resources is trying to do something truly heroic — if only these bonehead politicians would just get out of the way. 
Read the comments to the oped. They're informative. 
Canadian Plasma Resources is heroic? Right there Skyvington reveals himself as a paid hack. Either that or delusional.

 Bottom Line
The forces for paid plasma in Canada will do anything to skew the argument in their favour. 

And still we await Health Canada's decision on  paid plasma. They first said they'd seek feedback ONE YEAR AGO, for crying out loud. Recall their biased request for feedback:
  • Day tripper (Musings on HC's instructions to the jury on paid plasma)
Is Canada's blood regulator lazy or do bureaucratic wheels turn that slowly these days? Descriptors that come to mind about Health Canada's approach to paid plasma: farcical, incompetent, perhaps even gutless. Come on, HC - make us proud! Do something, anything...make a decision for gawd sake.

Added 29 May 2014: 'Must read' on paid plasma:

FOR FUN

Figuring the forces for paid plasma in Canada would not go down without a fight, I expected blow-back. But I heard it through the grapevine of blogging thanks to comments by a generous Anonymous to the prior blog.

I prefer Creedence Clearwater Revival's 1970 version to Marvin Gaye's 1968 classic version. Judge for yourself.

As always, the views are mine alone. Comments are most welcome.


Posted by Blut at 7:08 PM 3 comments
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