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

Updated: 27 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):

• Risk-Based Decision Making for Blood Safety

RBDM - A PARADIGM SHIFT?
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:

• Thomas Kuhn: the man who changed the way the world looked at science

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:

• Leach Bennett J, Blajchman MA, Delage G, Fearon M, Devine D. Proceedings of a consensus conference: Risk-Based Decision Making for Blood Safety. Transfus Med Rev. 2011 Oct;25(4):267-92. 

And now this 2014 paper

• Menitove JE, Leach Bennett J, Tomasulo P, Katz LM. How safe is safe enough, who decides and how? From a zero-risk paradigm to risk-based decision making. Transfusion. 2014 Mar;54(3 Pt 2):753-7.

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.

SMOKE AND MIRRORS?
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:

• Cost of USA wars through 2013: $3.1 trillion and counting

That said, 2 papers on the precautionary principle:

• Alter HJ. Pathogen reduction: a precautionary principle paradigm. Transfus Med Rev 2008 Apr;22(2):97-102.
• Wilson K. A framework for applying the precautionary principle to transfusion safety. Transfus Med Rev. 2011 Jul; 25(3):177-83.

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

• Menitove JE, Leach Bennett J, Tomasulo P, Katz LM. How safe is safe enough, who decides and how? From a zero-risk paradigm to risk-based decision making. Transfusion. 2014 Mar;54(3 Pt 2):753-7.

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.

GESTALT SWITCH
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. 

INNOVATION BAFFLEGAB
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

• Managing your innovation portfolio (Harvard Business Review, May 2012) 

Looks like Monitor Deloitte has moved from consulting for Libya's Muammar Gaddafi to the world's TM community, among others.

BOTTOM LINE
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:

• Purchased plasma safe, essential (8 May 2014)

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:

• Trial and too many errors: ‘Evidence-based’ medicine can be built on opinion and selective evidence

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:

• Aprili G. Safety in transfusion medicine. Blood Transfus 2008 Jul; 6(3): 121–6.

Updated 23 July 2014
In reply Anonymous (x2), about latest news on Ontario's plan to ban paid plasma clinics in Canada:

• Bill to safeguard blood reintroduced in ON legislature

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.

Updated 27 July 2014
In response to the Comment below about two quotes by CBS CEO Graham Sher, I've decided to write a new, separate blog. This one is getting a bit long.

FOR FUN
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:

• Turn! Turn! Turn! (Judy Collins)

And here's the man himself, age 93:

• Turn! Turn! Turn! (Pete Seeger, 2012) 

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.

If you could read my mind (Musings on 'acceptable risk' & who pays the price)

This month, seeing as it's the 'dog days of summer', I'll muse on multiple related items about transfusion risks and economics that made me ponder days gone by. The blog's title comes from an old Gordon Lightfoot song.

Everywhere you look these days, transfusion journals and newsletters are filled with discussions on cost-effective and how organizations need to find ways to reduce costs while maintaining or improving blood safety. The clichéd business jargon of the 1990s is pervasive in the TM literature, now used by physicians in suits (as opposed to lab coats) to whom it has come, albeit late.

I've long been an advocate of risk management as applied to test rationalization in the transfusion service and taught students about the health care piggy bank not being bottomless. Choices must be made and, when we fund some tests and procedures, it automatically means others cannot be funded.

But something about the current discussion on cost, benefit, and risk as applied to protecting the safety of the blood supply disturbs me.

1. AIDS AT 30

June's issue of AABB News features '30 years of fighting AIDS' and focuses on major advances in blood safety resulting from nucleic acid amplification testing (NAT).

Michael Busch notes that 99.999% of HIV cases are being detected and "The risk curve is approaching zero, but it's never going to be zero exactly."

AABB president James Aubuchon  is also quoted in 'AIDS at 30':

"We should congratulate ourselves on what we have accomplished...in our approach to infectious diseases and these accomplishments have allowed us to turn our attention to other problems such as bacteria in platelets and TRALI."

Presumably "our approach to infectious diseases" includes applying the precautionary principle to blood safety.

2. RISK-BASED DECISION MAKING

A consensus conference on risk-based decision making for blood safety was held in Toronto in Oct. 2010 and will be discussed at the 2011 AABB meeting in San Diego. The proceedings were published in July.

• Leach Bennett J, Blajchman MA, Delage G, Fearon M, Devine D. Proceedings of a Consensus Conference: Risk-Based Decision Making for Blood Safety. Transfus Med Rev. 2011 Jul 13. [Epub ahead of print]

Also see

• Wilson K. A framework for applying the precautionary principle to transfusion safety. Transfus Med Rev. 2011 Jul;25(3):177-83.

In this paper, Wilson, who also participated in the consensus conference on risk-based decision making, offers the following factors as a standardized way to decide which type of precaution, if any, to implement for a given transfusion risk:

1. Is the extent of the exposure large?
2. Is the consequence of the exposure serious?
3. Is the consequence of the exposure irreversible?
4. Is there minimal cost associated with the removal of the exposure?
5. Is there a minimal negative health effect associated with removing the exposure?

Assuming that definitive data are available (not always possible), using these guidelines presumably means do something if a big exposure, serious and irreversible consequences exist (e.g., HIV infection). How cost and negative effects on the donor supply influence decisions and interact with the other factors is less clear.

The precautionary principle, while improving blood safety, has inevitably produced increased blood costs and led to 'push-back' in the form of questioning whether it has gone too far.

As noted in an earlier blog, "The principle implies that there is a responsibility to protect the public from harm if research discovers a plausible risk, especially if it is a severe risk. But the proof of harm need not be certain, and cause and effect do not need to be fully established."

To me, the report on the consensus conference (Risk-Based Decision Making for Blood Safety) indicates the direction of future decision making:

• Cost is becoming increasingly important and the precautionary principle as applied to transfusion medicine will be shaped to fit what is financially desirable.

3. COST REDUCTION

Ongoing evidence exists that blood suppliers are in trouble and need to reduce costs.

• Three Florida blood banks to merge to provide the "the safest blood supply at the lowest possible cost"
• Florida blood banks fight a turf war over blood donors

June's AABB News also features a report on the 9th Annual National Blood Foundation Leadership Forum held in April 2011 in Miami. Richard Gundling, VP of Healthcare Financial Management Association, is quoted as saying that

• organizations that merge or form partnerships "can benefit from higher margins, greater expense control and economies of scale."  

The July issue of Journal of Blood Services Management (published with Transfusion) includes this article:

• 'A roundtable discussion: from thoughts on supply and demand to what keeps us up at night' 

A sample comment:

Each merger is unique, but in general, mergers are driven by a rationale to lower costs, grow geographically and access hospital markets that are crossing current blood center lines. Often it's about pricing strategies. (Stacy Sime, President and CEO, LifeServe Blood Center)

4. HISTORICAL PERSPECTIVE

In this 1998 CMAJ article written on the eve of CBS taking over the blood system in English Canada ("Concerns mount as transfusion medicine loses its lustre"), Noel Buskard and other luminaries in Canada's TM firmament discussed not only the legal risks involved in transfusion medicine but also a trend toward

• "a 'pharmaceutical model' in which the physician is based in-house, reports to a CEO-style business manager and doesn't have a connection to patients or other institutions."

What would the physicians quoted in this 1998 article think of the current emphasis (ascendancy?) of the economics of transfusion medicine, especially when juxtaposed with managing risk? If they want to thrive in the current system, I imagine they would keep pretty quiet.

Today the guys who get air time at AABB and other conferences are those who promote strategies to achieve cost-effectiveness.

From Jeffrey McCullough's presentation (Consensus Conference on Risk-Based Decision Making):

• In response to a variety of developments over the past 25 years, the culture and structure of blood organizations have evolved. These organizations have moved from a medical model involving individualized decision making resembling patient care to a systems-based pharmaceutical manufacturing model, with new approaches to quality assurance. Organizational structures have been transformed; and new kinds of leadership are now valued, such as manufacturing and business expertise.
• Governed by the principle that “safety of the blood supply is paramount”, these organizations have achieved significant improvements in blood safety. However, that paradigm is evolving and potentially conflicts with other principles, such as the notion that “decisions…will be made within a health risk management framework, which places on an equal footing the 3 critical elements of cost, benefit, risk”. (Words in quotation marks are from referenced sources)

REMEMBERING

• An outspoken patient advocate - Dr. Noel Buskard angered authorities, but was beloved as teacher, clinician

Noel Buskard was the medical director of Vancouver's Canadian Red Cross blood centre during the early years of the AIDS tragedy in which 1000s across Canada and around the globe were infected with HIV and hepatitis from blood transfusions. He quit the Red Cross in 1991 saying it had developed a "fortress mentality" when confronted with the AIDS tragedy.

Noel was the President of the CSTM (1998-2000). For speaking publicly about safety issues throughout his career, he was awarded the 2001 Whistleblower Award from the B.C. Freedom of Information and Privacy Association.

For a fascinating trip down memory lane, see

• 1984: Noel Buskard saying there is no evidence of AIDS being transmitted by a blood product in Canada and discussing the cost-benefit ratio in giving hemophiliacs factor VIII. (CBC news video)
• An Annotated Chronology of the History of AIDS in Toronto: The First Five Years, 1981-1986 (based on Toronto newspaper reports of significant events that occurred in Toronto and elsewhere)

5. PATIENTS - RISK BEARERS WHO PAY THE PRICE

Lest we forget:

• 1994: The Tragedy of Factor VIII concentrate (CBC news video)

Reading the current papers on blood safety and talk of 'acceptable risk', and balancing risk and cost, I cannot help but remember this interview of the daughter of a Manitoba hemophiliac, Ed Kubin.

Many moons ago when I worked at the Winnipeg Red Cross, Ed and his brother Barry would regularly pick up their supplies of cryoprecipitate from the lab. (Yes, it was just pre-factor VIII concentrate)

Writing this blog brings to mind this gem by Canada's Gordon Lightfoot

• If you could read my mind

I'm pretty sure you can read my mind on where I stand on the issue of 'acceptable risk' and who pays the price.

BOTTOM LINE
So, what is it about the current discussion on risk management and the safety of the blood supply that disturbs me? It's that those doing the talking seem to be leaning towards cost being the main determining factor, despite the lip service paid to safety.

We know that credible evidence is needed to show that an intervention to prevent a given risk may add to blood safety, but evidence need not be overwhelming, according to the precautionary principle. Did the AIDS and HCV tragedies not teach us that? Unfortunately, emerging threats to the blood supply do not often come with good data on how large the true exposure is and evidence is often unclear in the early days.

If cost is given too much weight, as seems likely, we are doomed to commit the errors of the past. And it isn't the docs making the decisions who will pay the ultimate cost.
---------------------------------

As always the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice.  This blog was updated 7 Aug. 2011.

"Boogie Woogie Bugle Boy Of Company B" - Back to the future!

Transfusion medicine colleagues - get ready for a sea change:

• It's back to the future (silly, but you get the idea)

The tide has finally turned. All the griping heard over the years about ineffective and costly measures to protect the blood supply will soon bear fruition. Something will finally triumph over the impossible desire for zero risk and the associated measures that were implemented and fueled by the HIV and HCV tragedies of the 1980s and '90s.

How do I know?

• Well, I heard it through the grapevine
• Love the beat of this golden-oldie

The April issue of Transfusion has no less than 5 papers that discuss

• tests that have outlived their usefulness
• ineffective donor deferrals
• proposed measures that are over-kill

These papers continue the drum beat of two papers discussed in earlier blogs:
(i) "The Rapa Nui caveat" in the Feb. 2009 issue of Transfusion, which argued for a more flexible approach to the precautionary principle, an approach that did not defer and turn off younger donors who could spread their discontent via social networking, and called for a national workshop to review donor restrictions.
(ii) "Cost-effectiveness analysis: what it really means for transfusion medicine decision making" in the Jan. 2009 issue of Transfusion Medicine Reviews, which proposed using cost effectiveness as a key driver of decisions on donor safety measures.
This blog will briefly and selectively review the growing drum beats for modified blood donor screening in the April Transfusion. I call it, "Boogie Woogie Bugle Boy Of Company B - Back to the future!" The blog presents musings on scrapping several blood donor screening tests and policies.
Obtaining a complete understanding of each paper's nuanced content will require reading the originals, which are rich in details not presented here.
Reader Challenge - Identify the Real 'Perp'
As you read, determine what you believe is the 'something' that is primarily responsible for the current increasing calls for a major shift in donor screening, namely scrapping several existing tests and policies. Why is there a push on now? Potential answers are sprinkled throughout the papers, much like clues and red herrings in a mystery novel.
THE PAPERS
Paper #1 (Research paper)

Goldman M, Xi G, Yi Q-L, Fan W, F. O'Brien SF. Reassessment of deferrals for tattooing and piercing. Transfusion 2009;49(4):648-54.

Today, tattoos and piercing are increasingly frequent in donors. After Canada decreased its deferral period for tattoos from 12 to 6 months in 2005, Goldman, et al. conducted a study to determine the prevalence of tattoos and piercings in donors, the impact of the decreased deferral on viral marker rates, and changes in blood availability.
They found the following donor rates (% performed in the past 6 mths):

• Tattoos - 14% (0.4%)
• Pierced ears - 54% (0.7%)
• Piercings of other body parts - 10% (0.3%)

Transmissible disease test results were unchanged (21.6 versus 19.2 per 100,000 before and after). The number of tattoo- and piercing-related deferrals declined by 21% and 32%, respectively.
Their conclusions:

• Data suggest that donor deferral for recent tattoo or piercing contributes little to blood safety in Canada, since decreasing the deferral period did not change the TD marker rate.
• The value of other temporary deferrals should similarly be reassessed.

Paper #2 (Research paper)

• Zou S, Notari EP, Fang CT, Stramer SL, Dodd RY. Current value of serologic test for syphilis as a surrogate marker for blood-borne viral infections among blood donors in the United States. Transfusion 2009; 49(4):655-61.

The authors used the American Red Cross (ARC) database to demonstrate that a confirmed positive serologic test for syphilis (STS) would have detected zero new HBV, HCV, or HTLV infections among more than 3 million fully tested repeat donors during 2006 - 2007. They estimate that STS might identify approximately 0.1 HIV 'window-period' (w-p) donations every 2 years among ARC donors.
Conclusion - the current surrogate value of the syphilis test appears to be negligible.

Paper #3 (Editorial)

• Katz LM. A test that won't die: the serologic test for syphilis. Transfusion 2009; 49(4): 617-9.

This editorial reviews the long history of screening donors using an STS. Introduced in the 1950s, STS has survived as a surrogate test for other transfusion-transmitted diseases, despite the multitude of additional tests and policies that identify T. pallidum infection in donors.
Katz reviews the many reasons why the continued use of STS as a surrogate test makes little sense. He also contends that surrogacy is no longer the driver for continued STS donor screening. Rather the test remains entrenched due the TM community's inability to prove a negative, namely that transfusion-transmitted syphilis will not occur if the test is removed.
Moreover, although the direct cost of donor STS screening is trivial, the cost of the test's non-specificity is substantial, resulting in needless destruction of 1000s of blood components annually. Other approaches that he sees as similarly wasteful include

• Deferral of tens of 1000s of US donors for tourist travel to Mexico for a tiny malaria risk
• Year-round WNV testing
• Opting for near universal testing for infection with T. cruzi

Paper #4 (Review)

• Lefrère J-J, Hewitt P. From mad cows to sensible blood transfusion: the risk of prion transmission by labile blood components in the United Kingdom and in France. Transfusion 2009; 49(4):797-812.

The authors review human prion disorders, the etiology of vCJD, vCJD cases in transfusion recipients, the precautions taken to reduce that risk, potential future safety precautions such as filters and a test, and all the uncertainties therein.
Some of their interesting assertions:

• Study of transfusion-transmitted (TT) vCJD is difficult given that it requires transfusion traceability of 10-30 years, perhaps almost as long as the human life span.
• Even if TT vCJD becomes a certainty, transfusion benefits greatly outweigh any risk.
• Never before have so many measures been taken in transfusion medicine to counteract a risk that is numerically so low, some taken even before the first case of TT vCJD had been reported.
• The precautionary principle has not just gone into the law: it has also penetrated the senses.

Paper #5 (Editorial)

• Menitove JE. Accepting donors with tattoos and other in-favor changes. Most of the change we think we see in life is due to truths being in and out of favour. (The Black Cottage—Robert Frost 1914). Transfusion 2009; 49(4):615-6.

Menitove's editorial initially comments on Goldman's tattoo / piercing study but then discusses the broader issue of scientific truths being in and out of favour.
Three arguments are particularly instructive:

• Patient and donor safety remain priorities but since 2008 it is unquestionably "in favor" to use dollars wisely. The USA should adopt selective testing strategies. i.e., test donors only once for T. cruzi rather that test every donation, discontinue syphilis testing, and investigate selective testing for HTLV antibodies.

• Tension between evidence-based decisions and those based on the precautionary principle, both are in vogue and seemingly diametrically opposed, confound the discussion. Perhaps the emerging change in [USA] national politics to pragmatism and empiricism will reengage efforts to resolve this disconnect and permit acceptance of some risk.

• Patient and donor care are primary concerns, but indifference to economics will stifle growth and discourage investment. Dialogue with emerging suppliers must emphasize long-term opportunities in transfusion medicine and cellular therapies.

Conclusion: Today's challenging climate presents an opportunity to bring about significant change and accept more risk. Sufficient future donors and dollars will not meet patient needs unless we reevaluate and revise truths longing to be in favor.

MUSINGS
A few random musings on these papers:
#1. Today, tattoos and piercing are increasingly frequent in donors and constitute a significant cause of deferrals among young blood donors, who are desperately needed to keep the system sustainable. Goldman and colleagues provide evidence for safely decreasing the time deferral on tattoos and body piercings.
Note that tattoo parlors still present a potential risk of transmitting infectious diseases:

• Public health warning issued over Mississauga tattoo parlour (10 Mar. 2009)

#2. Zou et al. provide evidence that syphilis testing, retained mainly as a surrogate for other infections, has little value as a surrogate for HBV, HCV, or HTLV infections, although in the USA it could perhaps detect 1 HIV w-p unit every 20 years.
So many syphilis studies, so little action, and as Katz notes in his editorial:

• It's impossible to prove a negative, i.e., no STS, no transfusion-transmitted syphilis, which perpetuates inefficient tests and policies.

Lumping in other tests and policies such as malaria deferral for travel to Mexico, screening for WNV year-round, and near universal T. cruzi testing as similarly ineffective and costly seems almost anecdotal, given that the author did not provide much, if any, evidence to support these contentions.
#3. Lefrère and Hewitt bemoan the example of safety precautions for TT vCJD, claiming that "never before have so many measures been taken in transfusion to counteract a risk that is numerically so low."
I am reminded of Churchill's words about RAF fighter pilots during the Battle of Britain in WWII:

• Never in the field of human conflict was so much owed by so many to so few.

As applied to TT vCJD, this would perhaps become,

• Never in the field of transfusion medicine was so much owed by so few to so many.

Lefrère and Hewitt's point is that vCJD precautions are over-kill given the rarity of the condition.
It's worth recalling that the once orthodox position of TM experts was that the human form of "mad cow disease" was not transmitted via transfusion, that is until the discovery of vCJD in 1996 and the first transfusion-associated case of vCJD reported in 2003.
For a superb examination of the complex issues involved in implementing a test for vCJD, see:

• Mapping out the consequences of screening blood donations for PrPSc (UK DOH)

#4. Menitove's editorial initially comments on the tattoo / piercing study of Goldman, et al. but then discusses the broader issue of scientific truths being in and out of favour.
In a way, Menitove is talking about the concept of scientific paradigm shifts as first postulated by Thomas Kuhn in The Structure of Scientific Revolutions, but on a much smaller, even minuscule, scale.Okay, it's a stretch, but I've been wanting to get the cliche paradigm shift into one of these blogs for a long time.
The fact that today hepatitis C is no longer significantly associated with tattoos is not so much a truth that has fallen out of favour as a truth that is no longer valid. Truths change when enough evidence points to their fallacy. Truths being in and out of favour implies that they are still valid but no longer popular with the scientific community.
The precautionary principle (PP), evidence-based medicine (EBM), and cost-effective analysis can be in and out of favour, but truth, not so much.

PP vs EBM?

Menitove also sees the PP and EBM as diametrically opposed competitors for making decisions. To me, the conflict is not as extreme.
First, there is not much in transfusion medicine that is evidence-based. Many of our practices reflect historical precedent, physician beliefs and preferences based on their teachers, and happenstance.
To protest strongly that a particular donor deferral policy or screening test is not evidence-based is disingenuous, given that hardly any transfusion practices are. And it's not as if needless transfusions do not cause significant harm and cost vast sums of money. That said, two wrongs do not make a right.
Second, the PP does require some evidence, just not higher level evidence. The principle implies that there is a responsibility to protect the public from harm if research discovers a plausible risk, especially if it is a severe risk. But the proof of harm need not be certain, and cause and effect do not need to be fully established. Indeed, for serious threats, lack of scientific certainty should not be a reason to postpone preventative interventions.
Many transfusion risks constitute plausible and serious risks worthy of applying the PP. Surely we are obligated ethically to apply interventions that help prevent transmission of serious diseases.
Third, often unstated in the PP are the notions that interventions should be

• effective
• not make things worse, e.g., not dry up the supply of available donors to the point where patient lives are at risk
• not cost so much time and money that other equally or more important safety measures are threatened

As they say in the law, res ipsa loquitur - the thing speaks for itself.
Unfortunately, the devil is always in the details.That's where EBM studies help. They do not so much compete with the PP for which test or policy should be implemented, but rather act to

• Identify if a particular threat is indeed plausible and serious and thereby worthy of applying the PP AND then
• Identify which intervention options are effective and do not cause harm

EBM supports the validity of PP-motivated interventions. Treating EBM and PP as mutually exclusive opposites is easy to do (I have done it myself) but it only serves to undermine the basic goodness of the PP.
I have not read anywhere that the PP is meant to implement ineffective, costly, harmful safety measures. But neither do PP-motivated measures need to be perfectly effective and cheap. That's a standard not applied to other interventions.
Also, I noticed that Menitove used, "Patient and donor safety remain priorities / are primary concerns, but..." twice. This reminds me of Queen Gertrude in Hamlet saying, "The lady doth protest too much, methinks."

Shovel-ready?

Lastly, Menitove presented an argument that I have not seen used before, at least not directly - that indifference to economics will stifle growth and discourage investment.and that suppliers need to be told about long-term opportunities in TM. In other words, TM health professionals need to help grow the biotechnology sector, so that it will be there when needed for emerging threats.
In particular, those involved on the blood centre side of the business need to nurture suppliers so that the commercial infrastructure is in place for 'shovel-ready' projects should they be urgently needed. Otherwise the industry may migrate to more profitable ventures in the transfusion service and other sectors.

BOTTOM LINE

The tide has turned and it's back to the future. Who knows what year we will be beamed back to. When syphilis testing is dropped, as it inevitably will be, it will be early days, indeed:

• Boogie Woogie Bugle Boy Of Company B
• For interest, this song is ranked 6th on the Songs of the Century

The Real 'Perp'

So, what do you believe is the 'something' that is primarily responsible for the current increasing calls for a major shift in donor screening policies - a shift that involves scrapping several existing policies and tests? Why have the drum beats increased now?

What is the real 'perp' and what are the red herrings?

• Dedication to patient safety?
• Belief in evidence-based medicine?
• Need to save money?

Of course, the above choices may not include the most plausible explanation. It's possible that the real key driver is something else.

FURTHER READING

Tattooing & piercing in Canada (2004 backgrounder)

Alter HJ. Pathogen reduction: a precautionary principle paradigm. Transfus Med Rev. 2008 Apr;22(2):97-102.

And do not forget this paper - it spells out just how complex blood safety policy decisions are:Mapping out the consequences of screening blood donations for PrPSc (UK DOH)

Earlier related blogs:

• Rapa Nui meets Generation X, eh?
  

• Dr. Strangeblood or How I learned to start worrying and hate the numbers

Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

Rapa Nui meets Generation X, eh?

By chance, I recently read a commentary in Transfusion

• Sayers M. The Rapa Nui caveat. Transfusion 2009 Feb; 49(2): 385-7.

and a book

• Wright R. A short history of progress. Toronto: House of Anansi Press, 2004.

that both featured Easter Island (Rapa Nui in Polynesian).What struck me as ironic was that Sayers uses the example of Rapa Nui to argue against the precautionary principle, while Wright uses the same event to argue for it.

Below is a tale that leads from an ecological disaster on a Polynesian island to making a case against the precautionary principle to how not to alienate generation Xers on Facebook or My Space .... or, as I think about the saga,

• Rapa Nui meets Generation X, eh?

-->(Musings on the pros & cons of loosening blood donor criteria to maintain supply) Background - Rapa Nui
In brief, Easter Island is an extreme example of deforestation and how it happened is open to debate. One theory, (and the one put forth by Wright in 2004) holds that Easter Islanders deforested the island in the process of transporting and erecting their statues (aka moai), a situation made worse by rats eating palm seeds.

Accordingly, Wright postulates that there may have come a time when islanders chopped down the last tree knowing it was the last tree, but they were captive to worship of the moai, who represented their deified dead ancestors.

Since then research has shown that this hypothesis needs "tweaking" since University of Hawaii researchers have shown that the island was colonized much later than earlier thought:

• View of Easter Island disaster all wrong, researchers say

In the Transfusion commentary, Sayers uses the Rapa Nui deforestation as a metaphor for the misfortunes that can happen if a limited resource such as the blood donor supply is mismanaged.

Sayers' main tenets [my comments]:

1. Viewing blood shortages as due to inadequate recruitment (60% eligible but only 5% donate) is wrong because the true number of eligible donors is closer to 40% or less.

(Reference: Changing age distribution of the blood donor population in the United States)

[Even at 30 or 40% eligible, there's room for recruitment improvement.]

2. The idea that greater deferral equals greater safety is wrong. Sayers writes,

It was certainly important to emphasize that the principle had been overlooked when decisions were being made about reducing the risk of transfusion-transmitted acquired immunodeficiency disease. However, since then, many new justifications for temporary or permanent deferral reflect an inflexible application of the principle.

[Implication: The precautionary principle has outlived its usefulness.]

3. When the precautionary principle guides policy, “competing uncertainties” must be reconciled. i.e., when considering a new deferral, potential improvement in transfusion safety must be weighed against a further shrinking of the donor pool.

AND, if the deferral will result in a donor loss that threatens the supply, a "more flexible application of the precautionary principle" should be recommended.

[Flexible is undefined.]

AND, even if new eligibility criteria will have little effect on supply, taken together their cumulative effects could be significant.

[Implication: Even potential safety criteria with minimal effect on donor supply should be discouraged.]

4. Temporary deferral is a powerful disincentive for deferred donors, whose numbers are growing (now at 15-20%). Moreover, disgruntled deferred donors could spread the word via social networking.

AND, since civic disengagement is a characteristic of the newer generation of donors, we should not do anything that turns them off.

(Reference: Putnum RD. Bowling alone. The collapse and revival of American community. New York: Simon and Schuster; 2000)

[In other words, baby boomers (born between 1946-1964) and Generation Xers (born between 1965 and 1980) are less likely to respond to a civic duty to provide an adequate community blood supply - and if disenchanted - their anger can quickly spread via the Internet. ]

Interestingly, Sayers did not cite this 2003 Transfusion commentary, which extensively discusses Putnam's views.

• Kolins J, Herron, R Jr. On bowling alone and donor recruitment: lessons to be learned. Transfusion 2003 Nov;43:1634-8.

5. A national workshop is needed to review donor restrictions, including deferrals, and reverse unnecessary ones.

6. Do not assume that compromised availability will be corrected by enhanced recruitment.

7. The UK has plans to reevaluate the relevance of some of the “more stringent” requirements for donor eligibility and their actions could be a model for others.(Reference: Shepherd A. The donor selection guidelines. Blood Matters. 2007 Summer;22:4-5)

Sayer also explains:

These comments could be regarded as capitulation to laxity in donor standards or resistance to the precautionary principle, but that is not their purpose. They are intended more to encourage acknowledgment that donor management must focus not only on the eligible, but also the deferred, the deferral process, and deferral outcomes.

MUSINGS
The call to reexamine blood donor criteria is widespread. The issue is succinctly described by Elizabeth Caffrey in this 2007 editorial in the UK newsletter, Blood Matters:

Many of the blood donor selection criteria are specified in the EU Blood Directive and are now written into UK legislation in the Blood Safety and Quality Regulations (2005). These tend to be cautious both in respect of donors’ health and recipient safety.

This may have been laudable when there was an excess of volunteers, but in the current climate it is recognised that they need critical review and analysis as part of the wider blood safety versus sufficiency debate. The new legal status of these criteria adds further complexity to any proposals to relax them.

The issue is often framed as balancing safety against the practicalities of maintaining the supply. The arguments all skew in favour of loosening or abandoning the precautionary principle in favour increasing the donor supply or improving cost effectiveness

(See Dr. Strangeblood or How I learned to start worrying and hate the numbers).

Sayers' commentary has several weaknesses:

1. He emphasizes supply while ignoring demand. Specifically, he does not mention the possibility of a more rational use of blood components, decreasing transfusion using evidence-based principles for blood management.

It's like a war on drugs that firebombs the crops in Columbia, Afghanistan, etc., to decrease supply but does little about the demand for drugs within one's own borders. Dealing with supply alone is unlikely to succeed.

2. Nor does he allow for the rise of the "Millennial Generation" (born between 1981 and 2000), who are just entering the prime blood donation years, age 25-45, and who seem more socially engaged, as shown by Barack Obama's use of social network sites.

3. Sayers discusses social networking as having a potentially negative impact (deferred donors dissing blood centres), with no mention of the incredible power of sites such as Facebook and My Space to motivate donation.

For example:

• CBS's innovative use of social media with its Thank Your Donor website
• Facebook helps promote blood donation

BOTTOM LINE
Arguing for a loosening of the precautionary principle is widespread and seems justified if we assume that it has been applied indiscriminately and foolishly. No doubt many transfusion professionals believe this. They see a more flexible approach, whatever that is, as being a return to rationale decision making based on evidence-based principles.In A Short History of Progress, Wright writes (Sorry, I could not resist the homonym):

The great advantage we have, our best chance for avoiding the fate of past societies, is that we know about those past societies. We can see how and why they went wrong. Homo sapiens has the information to know itself for what it is: an Ice Age hunter only half-evolved towards intelligence; clever but seldom wise....

Now is our last chance to get the future right.

Blood shortages are reported in the news weekly. The current economic crisis is likely to exacerbate shortages. As offices and plants close, the number of work-place donation sites will also decrease. Employers will be less likely to let employees take time off to donate. This has already been reported:

• Irish blood banks feel effects of credit crunch

With all these pressures to loosen donor criteria, we still have a chance to use history to get it right.When Rapa Nui (as an analogy of how to mismanage a limited resource) meets Generation X and successive generations of blood donors, the message is surely to opt for blood safety over expediency, even in the face of uncertainty, providing there is a plausible risk as explained by the precautionary principle.

Isn't that the lesson of history?

• At first there was no evidence that AIDS was transfusion-transmitted, although it was soon implicated.
• Transfusion professionals in some countries denigrated non-A, non-B (HCV) surrogate tests as leading to a needless decrease in the blood supply.
• Later some sneered at the idea that BSE could be transmitted by transfusion and called the risk theoretical at best.
• Today some transfusion professionals ridicule the vCJD deferrals as being useless.

If we abandon the precautionary principle, won't it be deja vu all over again? Simply put, we don't know what we don't know.

Just for fun, see

• O Rapa Nui E (which as a Canuck, I read as O Rapa Nui, eh?)

FURTHER READING

Millennial* values, involvement, and social capital

Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

Dr. Strangeblood or How I learned to start worrying and hate the numbers

As we enter a new year, money and the economy are on the minds of many people. Certainly economics is an obsession in the developed world. Accordingly, I could not resist a money-themed blog. Like it or not, money, money, money makes the world go round.

THE PAPER
As it happens there is a recent publication involving economics and transfusion medicine (TM):

• Custer B, Hoch JS. Cost-effectiveness analysis: what it really means for transfusion medicine decision making. Transfus Med Rev 2009 Jan;23(1):112. (PDF, free full text)

Brian Custer, lead author, is with the Blood Systems Research Institute.

-->This blog examines the issue of cost effectiveness analysis and its role in influencing blood safety policies. As always, ideas are presented as food for thought.

The authors discuss cost-effectiveness analysis (CEA) in TM, with a focus on blood safety and infectious diseases. For example:

• CEA can help policy makers decide whether or not to implement a test such as HIV-1 p24 antigen (as was done in 1996 but was discontinued ~2003 after HIV NAT testing was licensed).
• CEA can also provide a framework for comparing HBV NAT testing with pathogen inactivation of blood components.

The paper's so-what statement:

"Blood safety may be different, but the economic concept of efficiency does apply. It is better to pay $10,000,000 to save 1,000 people than to pay 10 times that amount to save 1 person, and it is surely better to reach this decision after looking at the costs and the benefits rather than before."

With economics, like statistics, many people’s eyes glaze over. But read on – it’s fascinating stuff. Below are but a few of the paper's key points.

ECONOMIC CONCEPTS
Economics is about the efficient use of scarce resources and a CEA is one tool that can help decision makers decide which new blood safety test or process to implement.

CEA involves 3 key concepts:

1. Since there are insufficient resources to support all possible activities, we must make choices.
2. We must decide whether or not to adopt a given intervention and how to allocate resources between competing alternatives.
3. In choosing, we must factor in the "opportunity cost", i.e., the value of forgone benefits. In other words, the true cost of something ("A") is not just what "A" costs but also the value of what we did without (the lost opportunity, "B") because we chose "A".

Quality-Adjusted Life Year
CEAs range from narrow (impact on the budget) to broad (factoring in the cost of human life and the quality of life). The latter analysis is termed cost utility analysis (CUA). CUA results are often given as a ratio of cost to health benefits and are reported as cost per quality-adjusted life year (QALY).

The cost per QUALY is a tool that allows for comparisons of health benefits across diseases. The value of what is considered a cost- effective QALY varies greatly between developed and undeveloped countries, as well as among disciplines.

In general, a cost-effective QALY is considered to be

• Clinical medicine: $50,000 to $100,000/QALY
• WHO: up to 3 times the GDP per person = ~$94,000 in USA & Canada and $72,000 in Europe (in year 2000 $)

QALY & blood safety
Larger QALY ratios are accepted in some areas such as blood safety because of several factors:

• First, do no harm implies a high priority to prevent outcomes such as diseases caused by contaminated blood.
• Society places a relatively high value on preventing low-probability risks with serious consequences.
• Society is willing to support interventions that target identifiable individuals e.g., blood recipients.

As a result, blood safety policy makers in developed countries consider and accept interventions that cost well more than $1 million/QALY. As a rule, tests become more cost-effective if the disease being screened for has a higher prevalence in the donor population and if it cannot be detected to some extent by existing tests and screening procedures.

For example:

• Anti-HIV screening when first adopted: $3600/QALY (due to higher HIV prevalence in donors & limited use of donor selection strategies)
• HIV p24 antigen testing (since abandoned): $2.0 million/QALY
• HIV NAT: $2.0 million/QALY (even using a NAT minipool, multiplex format with HCV and even with HBV too)
• HCV NAT: >$1.8 million/QALY (minipool)
• WNV NAT: $500,000/QALY (2003 - highest outbreak year)
• HBV NAT: additional $1 million/QALY or more (in multiplex format with HIV and HCV)
• HBV NAT: $66 million/QALY (separate test without HIV and HCV)

Since the AIDS tragedy of the 1980s, safety has focused on preventing transfusion-transmitted infectious diseases and more common transfusion life-threatening risks have taken a back seat even though preventing them is more cost-effective, e.g.,

• Mechanical barriers to prevent misidentification errors leading to transfusing the wrong ABO group: $197,000/QALY

MUSINGS

The following ideas are not particularly profound or original but seem worth stating.

1. Statistics can be used to prove anything.

If you want to inspire confidence, give plenty of statistics. It does not matter that they should be accurate, or even intelligible, as long as there is enough of them.
- Lewis Carroll, mathematician, clergyman, author (1832 – 1898)

Don’t get me wrong, I love statistics. However, as we know, CEAs and their sub-type CUA generate many statistics and, depending on the assumptions chosen, can be used to justify just about anything.

This is especially true when decisions involve costs or benefits whose price is unclear or varies, which limits the generalizability of many studies. For example, consider this paper and its assumptions:

AuBuchon JP, Littenberg B. A cost-effectiveness analysis of the use of a mechanical barrier system to reduce the risk of mistransfusion. Transfusion. 1996 Mar;36(3):222-6.

Note that costs could change dramatically if the study's few assumptions changed. As a result economic studies have to be assessed carefully and taken with a huge block of salt.

Unfortunately, critical assessment of economic papers is often beyond the grasp many health practitioners.

• Whenever statistics are tossed about, the potential for Taurus excreta cerebrum vincit exists. (Latin is incorrect, but you get the idea.)

2. Desire for zero risk

Undoubtedly, the history of the "tainted blood" scandals of the 1980s and 1990s involving HIV and HCV have influenced society's willingness to accept interventions that are not cost effective when compared with other areas of medicine. As has been noted so often by the TM community, citizens have come away from the HIV/AIDS tragedy with the impossible desire for a zero-risk blood supply.

Regrettably, in attempting to achieve zero risk, with tests for infectious diseases with common risk factors, we run into the law of diminishing returns. Because each test or intervention is layered upon previous ones, we inevitably spend more and more to detect fewer and fewer infections until the "bang for the buck" is minimal and the QALY cost is prohibitive.

3. Legal concerns

The threat of legal action remains influential in TM policy decisions, as in all of health care, and contributes to higher costs. As quoted by Custer and Hoch, regarding the decision to implement leukoreduction in Belgium:

The core problem proved to be legal. The blood banks are legally accountable for blood safety. This accountability is absolute, based on avoidance of all possible risks, regardless of costs. This strategy leads to inefficiencies in health care (i) blood safety management is guided by available rather than cost-effective technology, and (ii) private insurance premiums for civil liability are sharply increasing, while they are in no way related to the expected returns and the high and increasing [cost of] blood safety.

Source: Cleemput I, Leys M, Ramaekers D, et al: Balancing evidence and public opinion in health technology assessments: The case of leukoreduction. Int J Technol Assess Health Care 22: 403-407, 2006.

Government settlements to victims of transfusion-related diseases have been substantial, for example:

• Irish Hep C payout tops €818m
• Japan payout over tainted blood
• Angelotta C, McKoy JM, Fisher MJ, Buffie CG, Barfi K, Ramsey G, et al. Legal, financial, and public health consequences of transfusion-transmitted hepatitis C virus in persons with haemophilia. Vox Sang 2007 Aug;93(2):159–65.

TM organizations continue to fight and present a unified front to those attempting to sue:

• Florida WNV case
• AABB, ABC, ARC brief in support of defendant (PDF)

4. CUA versus the precautionary principle

Cost utility analysis (CUA) is about allocating resources between competing alternatives. CUA calculates a ratio of cost to health benefits that is reported as cost per quality-adjusted life year or QALY.

Custer and Hoch write:

• It is better to pay $10,000,000 to save 1,000 people than to pay 10 times that amount to save 1 person….

This assumes that the options are framed as an either / or choice within a specific field such as TM. Such clear cut choices become relatively easy. Opting for cost-effectiveness under such circumstances is like being for Mom and apple pie.

Unfortunately, real world choices are almost always much messier. Then there is the precautionary principle, which was extensively reviewed in an earlier blog:

• "I'm the decider" & the doctrine of preemptive strikes

This CMAJ commentary (The Krever Commission – 10 years later) discusses Canada’s approach to the precautionary principle:

• The tainted blood tragedy was arguably the worst public health catastrophe in Canada's history.
• Guided by the Krever Commission findings, Canada's reformed blood system has restored public confidence in blood safety by proactively addressing infectious risks.
• Two influential concepts from the Krever Commission have contributed to the reformed blood system's success: the adoption of precautionary measures and the creation of a governance system with clearer roles and responsibilities, including the separation of funding from decision-making concerning safety.

The author further notes:

The adoption of the precautionary approach has partly contributed to a mentality that is highly averse to risk that has led to the introduction of some safety measures considered to be cost-ineffective, with costs per quality-adjusted life-years sometimes in the millions…. Now that Canada has distanced itself from the tainted blood tragedy, and that public confidence in the blood system has been re-established, officials have the luxury of re-examining safety priorities and the correct balance between safety and cost.

I interpret the author as saying that we in Canada went overboard with the precautionary principle - now let’s get with the correct balance, whatever that is.

5. History as prologue

I cannot help but recall a few quotations about history:

• Those who cannot learn from history are doomed to repeat it. (George Santayana)
• History repeats itself, first as tragedy, second as farce. (Karl Marx)
• The charm of history and its enigmatic lesson consist in the fact that, from age to age, nothing changes and yet everything is completely different. (Aldous Huxley)
• History will be kind to me for I intend to write it. (Winston Churchill)

The history of transfusion-related HCV in Canada is instructive.

From 1986 to 1990 Canada, like many other countries, did not implement surrogate tests for what was then called non-A, non-B hepatitis. If an extensive CEA had been done of surrogate tests, the results would probably have been that the tests (anti-HBc and ALT screening) were not cost-effective. Regardless of the sensitivity and specificity of both screens (poor), the CEA's key assumptions would likely have been wrong. They would have underestimated the extent of the disease and its eventual health consequences. Regardless, such a CEA was not done.

• See this excerpt from the Krever Report (p. 695)

How many infections the surrogates could have prevented is also impossible to tell. That’s because other screening measures during 1986–90 may have coincidentally also contributed to a reduction in HCV transmission. Nothing evolves in a vacuum and blood safety improvements, like many diseases, are multifactorial.

BOTTOM LINES

1. GIGO. One of the main challenges with CEA and CUA is, as the computer nerds say, GIGO, Garbage in, garbage out or more likely where computer-generated statistics are concerned, Garbage in, Gospel out.

2. QALY. Statistical gobbledegook involving numbers, poorly understood concepts, and loads of money can baffle even the most astute among us. Fess up – do you really understand QALY?

“The idea of QALY is to put a value on treatments that may not save lives but improve them. For example, if a blind person’s quality of life is “worth” 0.75 points per year, a treatment that would restore him to perfect vision — and raise his quality of life to 1 per year — is worth 0.25 per year of life. If the person lived another 30 years, the treatment would be worth 7.5 QALYs, or 30 times 0.25.”

Source: Berenson A. Pinning down the value of a person’s life (see Further Reading)

Say what? QALY, schmally, this type of creative number crunching is perverse even without all the iffy assumptions that go into producing the final numbers.

3. Dr. Strangeblood. Perhaps it’s because the transfusion-associated AIDS tragedy seems very recent to me, but whenever people start to promote cost effectiveness studies for blood safety measures, I get nervous.

Judicious use of public money is only common sense given that the money pot is finite. But, inevitably, when suits with calculators take control, even Dr. Strangebloods in suits with stethoscopes around their necks, humanity seems to fade.

People become numbers, money becomes paramount, and medicine becomes just another business. Is that what will protect the blood supply from another HIV tragedy?

Maybe I’m just a bleeding heart but I’m starting to worry and hate the numbers. I cannot get around the concern for love nor money. Take your pick:

• Money
• Love

ADDENDUM: Statistical tidbits (see paper's references for sources):

Infectious disease risks (USA)
HIV:1 per 2.3 million donations
HCV: 1 per 1.8 million donations
HBV: between 1 per 63,000 to 205,000

Non-infectious risks (examples of interventions)
TRALI from plasma:1 per 100,000 (male-only plasma)
Fatal septic transfusion reaction from platelets: 1 per 140,000 (mandatory testing)
Major mismatch of ABO type:1 per 600,000 (mechanical barriers, bar coding, RFID)

FURTHER READING

Government of Canada. Hepatitis C - Compensation for Tainted Blood Victims

Krever H. The blood supply system in Canada: systemic problems in the 1980s. Commission of Inquiry on the Blood System in Canada. Final report. Ottawa: Canadian Government Publishing; 1997;989.

(click "continue to the document")
Krever - Vol. 1: The background
Krever - Vol. 2: Where much of the "nitty-gritty" controversy is investigated and discussed
Of particular interest and relevance:
#24 - Canada's rejection of surrogate testing
Krever - Vol. 3 - International responses to the risk of HIV in the blood supply

Hill B. Zero risk at all cost in blood transfusion. Biomed Scientist, April 2005. (PDF)

Berenson A. Pinning down the value of a person’s life. New York Times, June 11, 2007.

Staginnus U. Health economics research on blood transfusion safety measures - an introductory primer. In Peterson BR.ed. New Development in blood transfusion research. Nova Science Publishers, 2006.

Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice.