Saturday, July 12, 2014

Turn! Turn! Turn! (Musings on how the TM community now puts cost above all)

Updated: 23 July 2014 
Dearly beloved,

We are gathered here today because a change is happening, one that we in the transfusion medicine (TM) community should all be aware of, the death of the precautionary principle in transfusion medicine (TM). But life goes on, and now we see the birth of risk-based decision making (RBDM), which is probably at the toddler stage.

Lean and Sigma Six was the flavour of the decade in blood centres and transfusion services. I can only imagine how much money consultants made and still make off this cash cow. Now the new cash motherload for consultants is RBDM.

The blog's title derives from a Pete Seeger classic of the 1950s.

I decided to blog about RBDM because it was featured in the June issue of AABB News in the form of a report on the 2014 National Blood Foundation (NBF) Leadership Forum in Washington, DC on 28 April.

Although AABB News is 'news lite' compared to the full strength journal,Transfusion, I wonder how many working professionals (technologists, nurses, physicians) read the NBF forum report. I suspect few.

But here's the thing. It's worth reading on several levels, including the ability to pass top executives in the hallways of power and quip,
  • 'Hey, Graham. How's our transformational innovation going? And do we have any adjacent initiatives on the burner? 
Read on to discover more. The NBF leadership forum highlighted
  • Appropriate Use of Medical Resources, Risk-Based Decision Making and Strategies for Innovation
Leach Bennett's presentation (I searched for it on the web and found it and took the liberty of lifting a few diagrams from it. If inappropriate, let me know):
RBDM is a major initiative of the The Alliance of Blood Operators (ABO). ABO is international, at least for developed countries. ABO would not make sense for poor countries, which have little or no money to prevent kids dying from diarrhea, let alone effectively prevent risks to the blood supply.

From what I can tell, RBDM is a process for high level leadership dudes to decide things like whether to implement new blood safety measures or not. Its ascendancy signals that the precautionary principle is truly dead. As Thomas Kuhn may have said, there's been a paradigm shift, folks.

Sorry, I know using 'paradigm shift' to describe abandoning the precautionary principle for RBDM is an abuse of what Kuhn meant, but the phrase is one of the most abused ever.

By paradigm, Kuhn meant a 'set of assumptions, definitions, laws and techniques that are shared by the members of a scientific community.' That has since been expanded to relate to members of any community, including the transfusion medicine community and is used in the 2014 paper by Menitove, et al., cited below.

BTW, if you've never read The Structure of Scientific Revolutions, give it a try. It's accessible and fascinating:
By examining history, Kuhn explained why incorrect scientific ideas persist and how they're finally rejected. Because people believe what they know, science is inherently conservative. A current scientific theory ('paradigm') is hard to dislodge and takes much evidence or a powerful single piece of evidence to overturn. When this occurs, Kuhn called it a 'paradigm shift'.

So let's look at RBDM to see if it's a TM paradigm shift.

RBDM takes off
RBDM has been around for a few years but is now gaining steam in NA and all developed nations. For example, in Oct. 2010 a consensus conference was held in Toronto, Canada:
And now this 2014 paper
As Judie Leach Bennett, LLB, LLM, director of CBS's Centre for Innovation explains,
The goal is to optimize the safety of the blood supply by enabling the proportional allocation of finite resources to mitigate the most serious risks, recognizing that the elimination of all risk is not possible.
Leach Bennett is a lawyer whose earlier jobs at CBS included Executive Director, Legal and Risk Management, and Legal Counsel. (LLB is a Bachelor of Laws, LLM a Master of Laws.) The well respected Leach Bennett is also the Chair of The Alliance of Blood Operators (ABO) RBDM Steering Committee.

How did the supposed 'zero-risk paradigm' in transfusion medicine evolve to a paradigm of risk-based decision making (RBDM)? First, there never was a zero-risk paradigm in TM. The public may have wanted zero-risk but TM professionals knew it was impossible. If anything, what ruled after the HIV/HCV transfusion-related tragedies was a precautionary principle paradigm.

Discussing the nuances of the precautionary principle and the pros and cons of applying it (whatever 'it' means) is beyond the scope of this blog and my competence. To me it always meant
  • If there was considerable evidence that a serious risk existed, we should try to prevent it, even if it wasn't proven beyond a shadow of a doubt. 
And providing we can afford to do so, given that health resources are finite and priorities are necessary. And forgetting that the cost of wars fought since 9/ll have been huge for many countries, most of all the USA:
That said, 2 papers on the precautionary principle:
But back to the Menitove paper. Let's assume zero-risk was a TM paradigm. Was it a paradigm shift in the Kuhn sense, meaning zero-risk was dislodged over time by a preponderance of evidence or a single powerful piece of evidence? Not really.

Papers on RBDM suggest the paradigm has changed because the COST of preventing some risks is too expensive. For example the opening sentence of
Health care costs have risen to 17.4% of US gross domestic product, and health care economists urge a reversal of this unsustainable trend.
Leach Bennett in her presentation to the NBF's 2014 leadership conference, under 'Impetus for Change', references the precautionary principle as the TM response to the 1980s blood tragedies but then states:
  • [It's] Clear that pursuit of 'precaution at all costs' is unsustainable
  • Blood safety decision-making is increasingly complex: science,ethics, social values, economics, public expectations, context
Note how science is placed first, with economics in the middle. This graphic on 'health economics and outcomes' from her presentation is enlightening:

Instead of cost and effectiveness, many risk assessment models put safety first, i.e., consider the severity of a risk and its probability of happening:

Leach Bennett's NBF presentation is well worth reading because it explains where we are going. The science part ('Risk Intelligence'):
Comprehensive patient outcome and quality data, including hemovigilance, will guide decision-making and help define acceptable risk.
The 'Effectiveness and Cost' part:
Reliable information and tools will be readily available to balance risks, costs and benefits in a manner which optimizes donor safety and patient outcomes.
The entire RBDM Change Agenda: Source: Judie Leach Bennet's 2014 NFB presentation, Risk-Based Decision Making for Blood Safety

And note what's third on the Change Agenda: Blood operators will take an expanded leadership role in vein-to-vein blood safety. In Canada, that would be our national blood suppliers, CBS and Héma-Québec.

Sounds a wee bit like a unilateral power grab, no? And there's that word innovation again.

TM's abandoning the precautionary principle to protect blood safety, and now championing RBDM, is not a true paradigm shift, but could be called a 'gestalt switch'.

OMG, you say, not more jargon! Bear with me. I'm just 'tarting up' the RBDM movement to assess cost vs benefit in blood safety with bafflegab that's an alternative to 'paradigm shift'.

Gestalt is a German concept meaning the whole is greater than the sum of its parts. Gestalt means shape (or form) in English. Gestalt is used in psychology to describe an approach which aims to see something as a whole rather than its individual parts.

A gestalt switch requires an emotional and intellectual switch to think differently. For example, what do you see? A white vase? Or 2 black profiles facing each other? To see one or the other requires us to make a gestalt switch.

That's what our TM 'thought leaders' are doing with RBDM. Because of cost constraints, they've designed a completely different way of conceptualizing risks to blood safety and how to prevent them.
  • Zero risk is impossible (something we've long known).
  • Safety isn't paramount because it's too expensive. Safety is shades of grey.
  • Let's promote the change to RBDM as safety first, because that's what the (somewhat deluded) public wants.
  • Moreover, let's associate the cost-saving movement with a sexy name like innovation to make it more palatable. For example:
Judie Leach Bennett, once Director of CBS's 'Legal and Risk Management', now heads the CBS 'Centre for Innovation'.
Title of the AABB News report: Appropriate Use of Medical Resources, Risk-Based Decision Making and Strategies for Innovation. 
Another speaker at the NBF leadership conference was Brian Quinn, employed by a company owned by Deloitte Consulting, Chicago.

Quinn highlighted innovation in his closing talk, describing three types:
  • Core: existing products
  • Adjacent: new business areas adjacent to existing core strengths
  • Transformational: inventing products and creating new markets
I love the last, transformational. It's one of the words banned by the UK's Local Government Association in 2009. Yet it's a favorite of CBS leaders and usually features prominently in CBS's annual reports to Canadians.

 To read more about this new consulting bafflegab on innovation, see
Looks like Monitor Deloitte has moved from consulting for Libya's Muammar Gaddafi to the world's TM community, among others.

The RBDM movement means we've truly jettisoned the precautionary principle (whose application to TM has been flawed at times) for cost uber alles. It's reality and well foreshadowed.

If RBDM prevailed earlier, it's possible that much of what the TM community did since 1981* to protect the blood supply would never have been done. [*When the CDC's MMWR published a report describing cases of a rare lung infection, Pneumocystis carinii pneumonia, in 5 young, previously healthy, gay men in LA.]

Perhaps a good thing in some cases, but a quasi-cost-effectiveness approach was used decades ago and caused harm, e.g., Canada's decision not to implement surrogate tests for non-A, non-B hepatitis (hepatitis C) because they were too 'unscientific'/ineffective (poor sensitivity and specificity) and too expensive. This decision led to many thousands of Canadians being infected with HCV.

Or the blood supplier (then Canadian Red Cross), clinicians, and government deciding that most hemophiliacs were probably already infected with what became known as HIV, so should continue to receive non-heat treated factor VIII concentrate derived from tens of 1000s of blood donors. Gotta use up that expensive, paid-for stock on the shelves? Seems likely but we'll never know because minutes of crucial meetings were mysteriously shredded.

All of which identifies the flies in the RBDM ointment:
1. TM professionals don't always know what measures are more or less effective to enhance blood safety. Sometimes measures that seem costly at the time and are deemed flawed (ineffective) can save the health care system mega-bucks in the long run, to say nothing of human suffering, as in Canada's hepatitis C debacle.
2. Just like the public in general, health professionals sometimes get caught up in mob psychology. If thought leaders religiously proselytise a particular policy, it's hard for acolytes to dissent and be designated heretics. Definitely not a good career move. 
To everything there is a season. The old blood safety season (new season):
  • 'Above all, do no harm' (Only do no harm if it's cheap and effective.) Note: Doing harm can result from acts of omission.
  • 'If harm is suggested, but not proven beyond a shadow of a doubt, we should try to prevent it.' (If harm is possible, don't prevent it unless the measure is cheap and effective.)
Because the health care money pot is finite, it's now all about risk vs benefit, similar to return on investment (ROI) in the financial world.
  • Soon we will spend money only on cheap, effective blood safety measures. All else is no or maybe.
Of course, the RBDM model was developed by smart, well meaning transfusion professionals and is more complex than I've focused on here. Among other aspects, RBDM includes assessing science, ethics, social values, economics, public expectations, and context.

But it's human nature to go for the simplest tool and, because  economics fits the bill and is a driver for RBDM, it will likely carry more weight.
Updated 16 July 2014
In reply to Roger (see comment below): Invariably those making decisions promote safety above all but, when you examine what they say, often a different picture emerges. 

Note the words used to soothe the public that all is well, you can trust us. For example:

1) The goal is to optimize the safety of the blood supply by enabling the proportional allocation of finite resources to mitigate the most serious risks, recognizing that the elimination of all risk is not possible.
means, 'We'll spend $ only on the MOST SERIOUS RISKS and only if it's INEXPENSIVE because there's not enough $ to go around.' The other points are background noise to obfuscate the main point.
Key words to soothe the public: optimize, safety

2) Comprehensive patient outcome and quality data, including hemovigilance, will guide decision-making and help define acceptable risk.

means, 'We don't have a clue how to decide what acceptable risk is, but, trust us, because we'll use comprehensive, quality data and muddle our way through.'
Key words to soothe the public: comprehensive, quality, acceptable

3) Reliable information and tools will be readily available to balance risks, costs and benefits in a manner which optimizes donor safety and patient outcomes.

means, 'You can trust us to decide what's safe. '
Key words to soothe the public: reliable, readily, balance, optimize, safety

The soothing words didn't appear by accident but were carefully crafted. They're not quite weasel words to mislead readers into thinking that a meaningful, specific statement was made. But they do aim to mislead in that they're designed to create the overwhelming impression that RBDM leaders are on top of things, have all bases covered, and put safety first, not saving money.

They make the case that, by not spending money on ineffective, costly measures, blood safety will be enhanced. Hard to argue against that, assuming we know ahead of time what's ineffective (we didn't with surrogate tests for HCV). The rest is sheer 'trust us' territory and, if past is prologue, why would we?

Update #1 (17 July 2014)
In reply to Anonymous who wrote on the reality of scarce resources (see Comments below):

I agree the health care system must prioritize as funds are finite. That's a given. But you set up a false hypothetical in that everyone can agree not to fund your example.

It's the heavy emphasis on costly (cost is easy to determine) prevention measures where things can go awry, especially as history shows experts don't always know what's effective, or even true prevalence, witness HCV when it was non-A, non-B hepatitis.

In Canada, governments have long tried to curb the cost of transfusions, particularly plasma derivatives like IV immune globulin, which have many off-label uses, e.g., the BC PBCO's utilization management program.

Then there's looking at larger priorities for tax dollars in terms of $ spent on the Afghan war, fighter jets we don't even have yet, Canada's Senate, and on and on.

How to spend health resources effectively and fairly is challenging. That's why our TM experts should be challenged on their plans, especially when they choose to wrap it in quasi-weasel-language like transformational innovation.

Update #2 (17 July 2014)
In reply to Anonymous, who wrote, 'We seem to be getting arrogant again in thinking the science alone can manage risk':

My gut reaction is to quip, 'Getting arrogant again? Nope. We never stopped being arrogant.' But you make a point worth discussing.

Today's health professionals, including TM experts, stress evidence-based medicine (EBM), most recently CBS CEO Graham Sher on the issue of paid plasma collection in Canada:
We have created a safe and secure system that today is the envy of much of the world, and we did this using science, evidence and risk-based decision making as our core principles. It is important that these principles continue to be the driving force behind public policy and the blood system.
But EBM is not without its flaws, as explained in this 2011 Boston Globe op ed:
As the author notes, “Evidence-based medicine is only as strong as the evidence used to support it. The stark reality is that evidence can be weak, biased, or even fraudulent.” Amen.

For a comprehensive, straightforward, balanced look at the issues facing blood safety, one not into the current group-speak lingo propagated in many of the other cited papers, see:
Updated 23 July 2014
In reply Anonymous (x2), about latest news on Ontario's plan to ban paid plasma clinics in Canada:
Intriguing part is ON Dept of Health inspectors 'swooped in to seize records'. Those operating Canadian Plasma Resources clinics said the raid virtually halted operations.

Why a raid to seize records? Can't wait for more details. Stay tuned.

The theme made me think of Pete Seeger's Turn! Turn! Turn! The lyrics and final verse are adapted word-for-word from Chapter 3 of the Book of Ecclesiastes:
And here's the man himself, age 93:
To everything, turn, turn, turn.
There is a season, turn, turn, turn.

And a time to every purpose under heaven.
A time to be born, a time to die.
A time to plant, a time to reap.
A time to kill, a time to heal.
A time to laugh, a time to weep.
As always, the opinions are mine alone and feedback is most welcome.

Friday, June 13, 2014

If you could read my mind (Musings on hard-to-believe TM news)

Updated: 7 July 2014
June's blog is another take-off on cartoonist Gary Clement's weekly feature, 'Week in Review' in Canada's National Post, e.g., Week of May 18-24, 2014. They capture the week's news with a smile.

The blog's title derives from an old Gordon Lightfoot song that has been covered by many artists.

Topics include an eclectic selection of recent news items in TraQ's newsletter. All four have a whiff of unbelievability. Since some aspects seem unbelievable, my treatment of the stories is irreverent.

Also see my latest BBTS blog:
  • Do you believe? (Musings on cloud-based software services by a transfusion medicine techno heretic)
1. This is kinda gross (and does it work?)
The principal investigator said the enemas ensure hemoglobin levels do not go down drastically and research has proved it. Cases existed in which patient blood transfusion needs were reduced to half or even less.
I couldn't find the research in PubMed, but, if you can, let me know. Patient blood management is the flavour of the year as evidenced by the number of papers in TM journals and May's issue of AABB News:
According to the CEO message, AABB recently published Standards for a Patient Blood Management Program plus launched a new PBM consulting program. Indeed, no doubt smelling the ka-ching potential, AABB created a new PBM section on its website.

Perhaps all the blood management consultants aiming to make big bucks should wake up and smell the sheep dung?
2. This is turning a blind eye (or protecting one's butt?)
Australia's National Blood Authority (NBA), a well respected government organization that does much valuable work, appointed Shannon Farmer, a Jehovah's Witness, as the key consumer representative on a government panel developing new transfusion guidelines for Australia's hospitals. Nil inappropriate about that except Mr. Farmer didn't declare
  • Formally, or otherwise it seems, that he was a Jehovah's Witness. 
  • His consultancy work since 2007 to an Austrian business involved in commercial tendering for patient blood management projects around the world.
  • Receiving fees for consulting and lecturing from multinational pharmaceutical companies,e.g., J and J.
When informed, the NBA said it would review the details. Whether or not possible conflicting interests are of "sufficient conflict" is a moot point. 
Fact is they were not declared and at the time of his appointment Farmer was described as "consumer" and "independent consumer advocate". An NBA spokesperson is quoted as saying, "The NBA believes any potential conflict of interest, real or perceived, should be declared."
So far as I can tell Shannon Farmer is not a physician nor a PhD researcher, yet:
Yet it's hard to discover which degrees he has, where he went to school, or any of the normal qualifications of someone who's an author, lecturer, and expert on TM, with university appointments.

And none of the above profiles even hint that he's consulted for years to Austria's 'Medicine and Economics' business involved in commercial patient blood management projects globally.

How can you not know that someone you appoint to panels developing national blood transfusion guidelines is a member of a religion that forbids transfusion and earns big bucks implementing blood management programs internationally? How can you say, when information comes to light, 'These aren't sufficient conflicts'?

Isn't this equivalent to someone being appointed to a government panel on the future of private laboratories in Alberta (Canada, UK, you name it)
  • Who is a member of a political party whose policies are pro-private medicine (pro-private everything)?
  • Who consults for (perhaps partially owns) a private laboratory consortium bidding for government contracts?
Sorry, the non-physician Jehovah's Witness as TM expert and global blood management consultant who advises on transfusion guidelines, didn't declare potential conflicts, makes millions off blood management, and was initially listed as a consumer and consumer advocate doesn't meet the sniff test. 

Or...he's a fine fellow, does good work, and the NBA thinks it's okay that he didn't declare potential conflicts, despite their policies, because the conflicts are not serious ones?

3. This is glimpse into murky reality of paid plasma (and is it real?)
You know from past blogs that I'm against paid plasma clinics in Canada. But this account of paid plasma centers in the United States seems unbelievable. Examples (paraphrased):
Albuquerque's Yale Plasma, on a strip where panhandlers convene, resembles a pawn shop. 
CSL Plasma has no chairs. Donors crouch on the floor or stand in long lines until they plass. Asking a young man if he minded squatting, I’m told CSL removed the complementary seating to “keep the bums out of here.”
[Yale Plasma is part of DCI Biologicals. The center (pic via Google) is close to both a university and community college. Note 'Earn Big Cash' in window.]
Ron, an unemployed schoolteacher began regularly plassing 6 years ago to make ends meet for his new son. He was disqualified at a local center because he had many visible tattoos but accepted at another “that was less picky.”
At a CSL center “Bubba” said he was homeless and an alcoholic and had been plassing for nearly 15 years with no ill effects other than "sometimes my arm hurts really bad." He says he was unhappy when he drank too much to pass the protein level test, but claimed he later discovered, “If I swallow ketchup before going in I can pass any test they throw at me.”
For interest CSL is Australia’s chosen national plasma fractionator and under contract to Australia’s NBA.

This report of paid plasma centers seems unbelievable. Tattoos, donors crouching on floors, 'Bubbas' swallowing ketchup and thinking it tricks tests to measure plasma protein levels? On the other hand, You can't make this stuff up. Real life trumps fiction?
4. This is how to discourage feedback (mimics Health Canada on how to get feedback on paid plasma?)

The Canadian Standards Association (CSA) recently sent a notice via the CSTM that it seeks feedback on
I assume that when health or government organizations want feedback on things like transfusion guidelines, they make it easy for users since professionals are busy people. Whenever giving feedback is more difficult that it need be, several possibilities exist:
  1. Feedback isn't really wanted. 
  2. Feedback is wanted but the organization's convenience is placed above that of the users from whom feedback is asked.
  3. Those responsible for obtaining feedback for the organization are incompetent.
How does the way the CSA asked for feedback on Blood and Blood Components, Draft 3rd ed. strike you? Here's what I experienced:
First, the CSA notice of the third draft (dated 15 May 2014) and how to access it, was sent to CSTM members on 28 May 2014. How the 2-week delay occurred is unknown (but not critical).

Second, to access the draft, you must register (provide a valid e-mail address and password).

Third, you must confirm your e-mail address. This allows you to access and print your comments and to resume commenting later.

Fourth, presumably your identity can be tracked. If curious, CSA has a Privacy policy but it requires work to find:
  • Find and then click on Terms of Use, which is at the bottom of the page, then scroll all the way to the bottom of the next page to the last paragraph and click on Privacy:
  • With respect to the collection, use and disclosure of personally identifiable information, please see Privacy.  By using the Site, you consent to having CSA Group contact you in connection with additional draft standards that may be available at the Site. If you do not wish to be contacted, you may opt out by sending an email If you choose to opt out, you may lose some of benefits of which are associated with use of the Site.
Then on the NEXT (now 3rd page), you get to CSA Group Web Site Privacy Statement.

Fifth, there is no way to download the entire document. Instead you must access each section of the document on the website and submit comments separately for each of 23 sections, plus 5 tables and 2 annexes. And each section has multiple parts and sub-parts. 

As an example, section 4 alone (General) has spots for ~90 Comments, each of which must be clicked on to submit comments. Hmmm.... 
  • Alert: Expect digit finger to suffer from repetitive stress injury. Feel free to bill CSA for any lost productivity or needed splints? 
Sixth, apparently 60 days is the time used by CSA for obtaining feedback. But having the 60 days occur in June and July when many Canadians are on vacation seems perverse. 

Do you believe CSA truly wants maximum input from users into its blood standards? If yes, then possibility 2 or 3 above must be in play, ie., either it's all about them (not you) or they're incompetent.

Perhaps Health Canada is the role model for CSA? We know how HC tried its best to get feedback from Canadians on paid plasma clinics: 
  • Day tripper (Musings on HC's instructions to the jury on paid plasma)
Added 7 July 2014
Anonymous (see below) added an update to Canada's paid plasma saga:

It's a battle of the pro-business federal Conservatives with Canadian Blood Services and Health Canada as their surrogate poodles.

I'm aware of the case for paid plasma but it's wrong for Canada. If paid plasma is good, why not paid red cells, stem cells, and organs like kidneys, etc.

And don't bring up the Cangene case in Winnipeg where paid plasma has long existed. I was there (Canadian Red Cross) at the beginning. Paying women for their plasma containing potent anti-D, who had fetuses die of Rh hemolytic disease of the fetus and newborn, is so NOT like paid plasma clinics in the USA and what Canadian clones propose by setting up shop next to homeless shelters.

Some aspects of each item seem unbelievable:
  • Goat blood enemas are effective in preventing anemia in thalassemia patients?
  • Australia's NBA didn't know about potential conflicts of a key consumer rep on a government panel developing transfusion guidelines and then didn't care?
  • Paid plasma clinics in the USA, one of which (CSL Behring) is a major supplier to Australia's NBA, 'plasses' homeless alcoholics and offers no chairs for donors waiting to be bled?
  • Canada's CSA wants input so much it opts for feedback on the 3rd ed. of Blood and Blood Components that requires users to give feedback over June and July and enter data into 100s and 100s of web-based forms? 
What do you think about all this? For me, a song by Canada's Gordon Lightfoot comes to mind:
If you could read my mind, love
What a tale my thoughts could tell....
As usual, comments are most welcome.

Saturday, May 10, 2014

C'est si bon (Musings on TM news that is so good and not so good)

Updated: 29 May 2014
May's blog is a take-off on cartoonist Gary Clement's weekly feature, 'Week in Review' in Canada's National Post, e.g, Week of Apr. 20-26, 2014. I love them because they capture the week's news with a smile.
The blog's title derives from an old ditty by Eartha Kitt, C'est si bon (It's so good).

The topics include an eclectic selection of news items in TraQ's newsletter in the first quarter of 2014. C'est si bon is an attempt to write shorter blogs. I'd love your feedback. Shorter is so good or not so good? Keep returning because I'll add the odd 'So...' periodically.

A version of the blog (without some of the Comments below) is available on the BBTS website.

1. So creepy

You take your dog to a vet and are told that the pet needs to be euthanized within 24 hours. Six months later you get a call from a former employee of the veterinary clinic who tells you that your pet was still alive and being bled for plasma to transfuse to other dogs. Say what?

2. So deserving
The CSTM promotes excellence in TM for Canadians. The 2014 CSTM award recipients are, indeed, deserving. I'm fortunate to know them all. 
  • Wendy Owens
  • Dr. Lucinda Whitman
  • Ann Wilson
  • Crystal Oko
3. So nerdy (added 11 May 2014)
Clever and simple, this is the type of chemistry trick we used to love in school. The kid in us still smiles, especially if we're nerds at heart.

4. So overdue

By the end of 2014, the USA's Physician Payment Sunshine Act will require drug companies to report every transfer of value (as little as $10) to doctors and academic hospitals on a public website. Canada needs to do the same.

Think it's overkill? Think again. See CMA President Dr. Louis Hugo Francescutti's take on doctors and drugs. Big Pharma's influence on docs has stunk for a long time.

5. So predictable
Dr. Sher's key points (my analysis):
  • After the tainted blood scandals of the 1980s and '90s, Canada created a safe and secure system that is the envy of the world and did it using science, evidence- and risk-based decision making.
  • Drs. Ryan Meili and Monica Dutt, the authors of Payment for plasma bad policy, may not understand that blood donation and plasma donation are distinctly different, so Dr. Sher will clarify.
  • Whether to allow paid plasma donation is a legitimate public policy debate about Canada's societal values and norms but is not an issue of product safety due to today's system and technologies.
So to all you 'worry warts' out there, don't sweat about whether paid plasma is safe. It definitely is. To Canada's elite evidence-based TM scientists, it's only about whether our values can embrace paying for plasma donations. Oh, by the way, without paid plasma patients will die.

As to the Ontario government's attempt to ban paid plasma, as predicted, the minority government has fallen and with it, all legislation.

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

6. So sad
The January 2014 issue of the AABB journal Transfusion reported that George Garratty, PhD, retired as associate editor of the Immunohematology section of Transfusion after 31 years of service promoting papers on red blood cell serology.

George was an icon to TM medical technologists. We will miss him dearly. 
IN REPLY to Anonymous (11 May 2014)

Anonymous finds CBS CEO Dr. Graham Sher's public pronouncements on paid plasma in Canada both confusing and unreliable. Me too.

CEO Sher says that he doesn't want paid plasma clinics to open in Canada but, at the same time, he contends that paid plasma is needed to meet current demands for plasma derivatives in Canada and globally. Canada can only meet 30% of its needs. Moreover, he suggests that, without paid plasma, patients would die.

Dr. Sher's key learning point: Like it or not, patients in Canada and the world need paid plasma.

The flaw in that argument is that Canada has never truly promoted plasma donation. Indeed, CBS closed a plasma collection facility because it was cheaper to buy plasma from the USA and (sadly and stupidly) obfuscated its reasons for the closure.

Dr. Sher also contends that today paid plasma is safe because of 'donor screening and testing, plasma quarantine, and technology that inactivates viruses, and several purification steps.' He's right, as far as it goes.

But this reasoning assumes that no emerging infectious disease agents will appear that may escape the detection, inactivation, and purification steps involved in producing plasma derivatives. It also assumes that manufacturing errors will never occur.  And that, with today's system,  a disaster like hepatitis C contaminating Rh immune globulin can never again occur.

Perhaps CEO Sher suffers from cognitive dissonance, i.e., discomfort from holding conflicting beliefs. He contends that paid plasma is safe, and patients need paid plasma derivatives, but he doesn't want paid plasma clinics in Canada because CBS's voluntary donation system works well. Huh?

Cognitive dissonance aside, Dr. Sher is a clever man and has CBS spin doctors (communication specialists) advising him. He knows what he's doing. Any obfuscation is covered by emphasizing evidence-based decisions.

Just like Canadian Red Cross medical experts did when rejecting surrogate tests for non-A, non-B hepatitis (now hepatitis C), which resulted in tens of thousands of Canadians being infected with HCV.

Who can argue against evidence and science? Anyone who questions the safety of paid plasma is automatically and conveniently designated as non-scientific.

In reply to Unknown (12 May 2014)

Unknown asked, 'Is there something in it for CBS and Dr Sher in supporting American paid plasma?'

Great question. What follows are possibilities. First, I believe CBS CEO Graham Sher to be an honorable man who mostly believes what he says or, paternalistically, believes he's doing the right thing for Canada by protecting our TM system from non-scientific types.

But it's not that simple. As AABB President it's possible he's drunk the Kool-Aid of American-style transfusion medicine, given the schmoozing he's no doubt done with Big Pharma and the laboratory diagnostic firms who support AABB, as well as with so-called not-for-profit transfusion labs that operate as businesses.

Or maybe he's into Real Politik, focussing on practical rather than ethical issues.

What's in it for CBS to support paid plasma? It prevents CBS from spending money to promote free plasma donation and to build and maintain plasma collection facilities. Both earn brownie points with CBS's provincial paymasters.

What's in it for Graham Sher to support paid plasma? It's about the money, stupid. Money CBS can save by NOT maintaining collection facilities and staff, as above.

IN REPLY to Anonymous (13 May 2014)

Thanks to Anonymous, who supplied a link to yet another lobby group to promote paid plasma in Canada and noted that Canadian Plasma Resources has deep pockets
The press release is classic PR spin (emphasis is mine):
Made up of deeply concerned Ontarians, the Ontario Plasma Coalition was launched to address the provincial government's irresponsible handling of Ontario's plasma supply and its attempts at banning compensated donations with Bill 178. In partnership with Canadian Plasma Resources, the Coalition was formed following thousands of responses received through
Who knew that 1000s of deeply concerned Ontario citizens were practically marching in the streets to protest its irresponsible government's move to ban paid plasma?

Sheesh, you'd think the world would come to an end if Canadian Plasma Resources (CPR) didn't operate its paid plasma collection facility next to a homeless shelter and a centre for addiction and mental health. 

CPR built its facilities without Health Canada's approval, at least without its official approval. Who knows what went on behind close doors, including possible collusion by CBS (as in, 'Would you object?' Answer: 'No'). 

To me, CPR should shove its PR campaign where the sun don't shine. Just kidding!

IN REPLY to Anonymous (26 May 2014)
Thanks to Anonymous who commented, 
"So sad" - that it has come to this - money and big pharma. Blood was one of the last vestiges of old fashioned medicine....
With the ability to manufacture fractionated plasma products, blood became big biz for Big Pharma more than 70 years ago. A few facts and figures (hope eyes don't glaze over):

According to CBS's 2012-13 Annual Report (Management Analysis) in Canada demand for plasma protein products (PPP), such as immunoglobulin (paraphrased):
  • Has grown exponentially, with annual growth averaging 8% 
  • Ig utilization represents ~43% of the total cost of the PPP program
  • Softening of Ig utilization is driven by the provinces and territories taking measures to manage escalating Ig demand 
  • For example, in British Columbia, all requests for Ig use are screened to make sure that Ig is used in accordance with provincial guidelines
  • Total Plasma Protein Products program expenses increased to $469.5 million in 2012/2013 
Since immunoglobulins represent 43% of the PPP program cost, that's ~$201.9 million of Canadian taxpayer money going to Big Pharma for this one product alone. That's small potatoes to the Big Pharma companies who supply CBS, who then supplies it free of charge to hospitals (and their patients). But Canada is but one of many customer countries who purchase products like intravenous immune globulin (IVIG).

Big Pharma pours mega-bucks into funding research aimed at increasing its use (and then convincing physicians to use their products). For example:
As noted, blood became big biz with the ability to fractionate plasma proteins:
  • Beginning in the 1940s with Cohn fractionation to produce albumin
  • Factor VIII concentrate to treat hemophilia in the 1960s (and we know the tragic consequences of that)
  • Business really took off in the 1980s with the ability to produce IVIG
  • See History of Plasma Fractionation
IN REPLY to Anonymous (26 May 2014)
Anonymous asked who AABB's corporate members were. I suspect Anonymous means commercial entities, as opposed to non-profit institutional members like  transfusion services and blood centres. See
To follow-up on the 'so' theme, enjoy these renditions of a popular jazz ditty from long, long ago:
As always, comments are most welcome.

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.

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.
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:


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.

Sunday, March 16, 2014

Hey Jude (Musings on why paid plasma makes it worse, not better)

Last updated: 29 May 2014 
This months blog is a two-fer. The title is a take-off on the best Beatles song ever, Hey Jude.

The blog was motivated by the recent decision of the Ontario government to introduce legislation to ban paid plasma. (Yikes! In the first version, I forgot the lead. Unforgivable. See BBTS blog's advice.)

I'm delighted and honoured to be a guest blogger for the BBTS:
Born to be Wild? (Musings on how to blog for transfusion professionals)

The BBTS blog is about how to blog as a transfusion medicine professional. Take a peek. The advice can be applied to e-mail messages too.

However, this month I cannot resist blogging on a recent development in Canada involving paid plasma clinics.

On March 14, 2014 one of Canada's provincial governments, Ontario, decided to ban paying for plasma (and all blood donations), as had already been done in Quebec (see Further Reading).

Humour me with a few simple thought experiments. Probably best to think of them as 'What If' games.

'What If' Game #1
What if I represented Canadian experts who told you that surrogate tests for non-A, non-B hepatitis used in the USA were scientifically unsound.

The tests had poor sensitivity (missed many true positives) and poor specificity (detected many false positives) and would threaten the blood supply by preventing many perfectly safe blood donors from donating. Plus the testing was expensive.

Then I asked for a vote on doing surrogate testing on all blood donations or not. Based on expert opinion, you'd probably vote not to do it, right?
Game #1 Outcome Turns out that because Canada's TM experts prevailed, thousands of Canadian recipients of blood donations were needlessly infected with what we now call hepatitis C. Despite the flawed surrogate tests, they would have prevented many HCV cases in transfusion recipients. See
'What If' Game #2
What if I told you that concentrated Factor VIII to treat hemophilia had several advantages over the existing treatment, cryoprecipitate, including a known quantity of Factor VIII and more convenient storage. Doctors touted it as 'latest and greatest' advancement.

Then I asked for a vote on using cryo or Factor VIII conc. Based on expert opinion, you'd probably vote for using only Factor VIIII concentrate, right?
Game #2 Outcome Turns out that Factor VIII concentrate was made from the plasma of 10s of thousands of blood donors and it only took one donor to be infected with the then unknown human immunodeficiency virus (HIV), that causes AIDS. The saviour of patients with hemophilia turned out to be a death sentence for many.
'What If' Game #3
What if I told you that Factor VIII concentrate transmits several deadly diseases but, when heat-treated Factor VIII became available, and was shown not to transmit HIV, we should still give the unheated product to hemophiliacs.

After all, experts contend that most hemophilia patients are likely already infected and we have mega-bucks worth of product in storage. As well, if we don't give the unheated product to them, many would suffer life-threatening hemorrhages.

Then I asked for a vote on transfusing the existing stock of Factor VIII concentrate to likely already-infected hemophilia patients. Based on expert opinion, you'd probably vote for using unheated Factor VIII concentrate, right? We have the stock, it'll save money, and they're already infected.
Game #3 Outcome Turns out that this expert decision cost the lives of many hemophiliacs who were NOT already infected. How the experts reasoned will never be known.
Unlike US President Nixon, minutes of key meetings by decision makers (Can. Red Cross physicians and their provincial paymasters) were destroyed. I kid you not. 
To their credit, a few Canadian physicians opted for using single-donor cryoprecipitate, thereby protecting their hemophilia patients from HIV.
We decide based on what we know at the time and rely heavily on perceived experts.But we only know what we know. We don't know what we don't know.

And experts can be oh so wrong, as expertly detailed by Canada's Krever Commission (see below) and, more superficially, in my What If games above. Which is why I'm not onside with our TM experts on Canada's further venture into paid plasma.

Of course, you can also make an ethical case that Canada should not go down the path of paying for plasma.

ONTARIO UPDATE (Added 17 Mar. 2014)
Canadian Plasma Resources is a private company in Ontario whose sole purpose is to pay for and collect plasma for further manufacturing.

In Canada the safety of the blood supply is a federal responsibility that falls to Health Canada but whether plasma donors can be compensated rests with provincial and territorial governments.

On March 14, 2014, the government of Ontario issued this press release:
Among other things, it plans to introduce legislation to ban paying for blood in Ontario (as Quebec does now). Canadian Plasma Resources has plans to open plasma clinics in Toronto and nearby Hamilton, Ontario.
See Further Reading for news items on the announcement and background info on the issues. I'll update with more news items as they become available.
The case against paying for plasma is discussed on Impact Ethics: Making a difference in bioethics:
The authors are from Dalhousie University, Halifax, NS, Canada:
  • Matthew Herder, Asst Professor, Faculties of Medicine and Law
  • Francoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy
Included in the article is a copy of their submission to Health Canada, which is well worth a read too:
Of course, the issue in Ontario is far from settled:
  • First, after wide consultation, the legislation has to pass in Ontario's legislature. 
  • Second, Ontario has a minority government with an election required by Oct. 1, 2015, with strong polling support for three parties
  • Third, there will be blowback from vested interests.
REPLY TO COMMENT(Added 18 Mar. 2014)
This is in reply to the comment below from 'Anonymous', a hemophiliac who contracted HIV and HCV in the 1980s. He ended by predicting that 'the smoking gun will be IVIG for our next round.' Please see my reply to him below, which I'll expand upon here.

I'll briefly comment on the safety and ethics of paid plasma, which is fractionated into plasma derivatives such as IVIG. 

First SAFETY. In a commentary that CBS CEO Graham Sher authored in the Toronto Star in March 2013 ('Prohibiting pay-for-plasma would harm patients'), Dr. Sher wrote (summarized by me):
  • Manufacturers must be licensed and meet stringent quality and safety standards.
  • Safety procedures built into fractionation are extensive, and include donor screening and testing, plasma quarantine, technology that inactivates viruses, and purification steps. 
  • These products are extraordinarily safe. 
  • Many studies show plasma products from paid donors are as safe as those manufactured from volunteer donors.
All medical experts stress that plasma derivatives such as IVIG are extremely safe when it comes to transfusion-transmitted infectious agents. They stop just short of claiming they are 100% safe, because such a claim could come back to haunt them.
No one wants to be in Dr. Noel Buskard's shoes when on behalf of the Canadian Red Cross he denied a link between AIDS and blood products. (2 min. CBC video. Sorry for the 45 seconds of ads).  
Dr. Buskard quit the Red Cross in 1991 saying that it had developed a “fortress mentality” when confronted with the tragedy. He became a noted whistleblower, who in 2001 was awarded the 'Whistleblower Award' from the B.C. Freedom of Information and Privacy Association. (Source: A tribute on his death in 2011)
Because plasma derivatives are relatively safe, some against paying for plasma say it's best to concentrate on the ETHICS of paid plasma. I'm not going to regurgitate the many complex rationales for and against paying for plasma. For one thing, it's above my pay grade and expertise.

To quote CBS CEO Sher, the ethical case for paying is that the derived products are 'extraordinarily safe' and patient lives would be threatened without paid plasma: 
  • The reality is that thousands of patients depend on these life-saving fractionated products, and without those produced using plasma from paid donors we would not be able to meet patients’ needs...When lives are at risk, that’s simply not an option.  
The ethical case against paying for plasma includes the reality that 
  • Commercial plasma collectors exist to make money. 
  • Exploiting the poor and vulnerable and selling to the highest bidder are what drives for-profit enterprises. 
  • Witness Canadian Plasma Resources building a clinic next to a homeless shelter. 
Is this really a path Canadians want to take? Matters not what happens in the USA or elsewhere. That's not us.

Some call this position hypocritical since we use products made from paid plasma in other countries. Perhaps. 

But is it any more hypocritical than CBS closing a Canadian plasma collection centre saying demand for 'plasma for transfusion' was down, and at the same time outsourcing plasma collection to the USA because it was cheaper? Then having its CEO claim that lives are at risk if we don't use paid plasma?

CBS Annual Report 2007-2008 (p.22): 
This year, we also re-introduced the collection of source plasma at our existing plasmapheresis sites ...laying the foundation for CBS to improve our plasma sufficiency - one of the basic principles of the blood supply as outlined in Justice Krever's report.
CBS Announces closure of Thunder Bay Plasma Centre (29 Mar. 2012)
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
CBS Financial Report March 2011 (p.32)
In 2010/11 CBS 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.
Report to Canadians 2012/2013, Management Analysis (p.43)
As self-sufficiency is not operationally or economically feasible in a volunteer, non-remunerated model, CBS strives to maintain a sufficiency of 30% for Ig. The demand for Ig continues to rise in Canada and internationally, and to meet our needs CBS purchases surplus recovered plasma (from voluntary donations) from the United States for fractionation, which increased by 4,572 litres or 17.0% in 2012/2013 over 2011/2012.  
'Don't let the perfect be the enemy of the good.'
So, yes, hypocrisy abounds on all fronts. It would be preferable (perfect) if we didn't need to use plasma derivatives sourced from paid plasma anywhere, but to me, banning paid plasma clinics in Canada is preferable (good). Not PEFECT, but GOOD.

To return to the comments made by Anonymous below, I've discussed the IVIG safety issue and that history shows we can never be certain about blood safety. About his introduction: I am a hemophiliac that got HIV and HCV in the 80's, I'd like to end with
  • The tragedy of Factor VIII Concentrate (19 min. CBC video you won't soon forget. Take time to watch it sometime. As transfusion professionals we owe it to Canada's hemophiliacs and to ourselves.)
Added 29 May 2014'Must read' on paid plasma
Hey Jude is a 1968 song by Paul McCartney, with an interesting origin.

Regardless, Hey Jude is about trying to make something that is bad better. Paying for body organs and tissue, including plasma, is a bad idea.
  • Hey Jude (Paul McCartney, Live in Red Square)
Hey Jude, don't make it bad. Take a sad song and make it better...
As always, the ideas are mine and mine alone. See comments below. More comments are most welcome.

Also, don't forget Born to be Wild? (my first blog for the BBTS)

Further Reading