Showing posts with label blood safety. Show all posts
Showing posts with label blood safety. Show all posts

Saturday, July 23, 2016

Don't worry, be happy (Musings on how TM leaders mimic politicians)

Updated: 25 July 2016 (See highlighted text under Musings)

Do you know what government politicians and transfusion medicine (TM) leaders have in common? No matter what the threat, both repeatedly assure their constituencies, 'Don't worry, be happy.' 

July's blog takes its theme from recent transfusion-transmissible disease news. The title is from a 1988 ditty by Bobby McFerrin.

For readers who choose not to read the full blog, here's the executive version. The blog's aims are to
  • Encourage readers to be skeptical about how safe our blood supply is;
  • Hold our TM leaders to the highest standard, one higher than we expect from politicians;
  • Credit us with the intelligence to understand nuance.
GOVT LEADERS
Examples of politicians assuring citizens all is okay:
  • Canada: PM Justin Trudeau reassures Canadians that the economy is in a good position to weather the storm in the wake of Britain's Brexit vote. (June 2016)
  • UK: Home Secretary Theresa May assures Brits that the UK has taken steps to amend powers and increase capabilities to deal with developing terrorist threats. (Aug. 2014)
  • USA: Obama assures Americans the highest priority is their safety following a string of terror attacks (Dec. 2015)
TM LEADERS
Similarly, all involved at top echelons of the blood industry in the developed world constantly reassure us that our blood supply is the safest it ever has been.

Unstated is the blood supply is the safest it has ever been for the KNOWN OLD infectious disease risks, the ones that figured in the so-called 'tainted blood' scandals that plagued us in past decades. Experts assure us
  • We are doing all we can to minimize risks. 
  • Donor screening, improved transmissible disease (TD) tests, and manufacturing processes for plasma-derived products pretty much eliminate the old TD risks like hepatitis B, hepatitis C, HIV. 
  • The blood supply is safe. Don't worry, be happy.  
Need a  touchstone of how TM leaders now see our blood supply as bulletproof?
  • Today western nations have pretty much all moved from a total ban on blood donation for MSM males to a 5 year deferral to a one-year deferral, providing no MSM in the past year. 
  • Blood suppliers did so influenced by nation-wide, indeed global, campaigns by gay activists and others who support their cause. They decried the ban against gay/bisexual men donating blood, including the latest one-year deferral, calling it discriminatory and unjustified based on the evidence. 
  • Some even say the ban on MSM was unjustified from the get-go:
    • 'The new policy isn't any more scientific than the old policy. It's based on the same bigotry and gay panic defence that the ban has been based on since the beginning.' 
My belief is that CBS's evolving MSM policy is motivated by activist groups and worldwide policy changes (themselves motivated by activists) but is not discriminatory. See, for example, this 2013 interview with Dana Devine:
NEWS (JUNE-JULY 2016)
Examples of news that triggered this blog:
HIV
ZIKA VIRUS
Several disconcerting anomalies exist about Zika virus transmission:
  • What the hell is going on? (Well worth a read because we still don't fully understand Zika, just as we didn't understand in the early days of HIV and HCV)
MUSINGS
TM leaders' standard response (SOP?) to blood supply risks is analogous to politicians who ensure citizens that 'all is okay'. And TM leaders are more-or-less correct, just as politicians are about their claims of relative public safety from economic disasters and terrorism. Except when the next man-made disaster strikes, as it inevitably does.

For both groups, claiming safety makes sense and often is in the public interest. The last thing citizens need is to fear for their safety, fear to travel, fear that those who are different ('the other') are somehow dangerous. Politicians who fear-monger usually do so in their own self-interest and often are despicable in spinning tragedies to their crass political benefit.

TM leaders never-ever fear monger. It's not in their best interest or ours, whether as blood donors or transfusion recipients. For the best of reasons TM leaders correctly assure us that life-saving transfusions are the safest they have ever been. Such reassurances serve the public interest because we don't want folks to fear life-saving transfusions or stop donating blood.

Yet many in the TM community come across as complacent and overly confident. I'd love to be similar, live in a bubble, sing 'Don't worry, be happy.' But, having experienced Canada's 'tainted blood' scandals, I'm skeptical. Note, skeptical, not cynical.

Partly it's because TM leaders failed us in the HIV tragedy. Out of arrogance or being true-believers matters not:
  • And the Band Played On (full movie on Youtube - it's a beauty)
  • Canadian Red Cross denies link between AIDS and blood products (two-minute video)
    • In the 1980s a Canadian Red Cross (CRC) medical director uses 'cost-benefit ratio" to determine if hemophiliacs should be transfused with potentially infected products.
    • Reality: FVIII concentrates from thousands of donors were all infected with HIV. Yet even after safer heat-treated FVIII conc. was available, untreated products were transfused. Seems likely our leaders decided to use up CRC's expensive stock pile, in the self-serving beliefs that hemophiliacs (1) were probably already infected and (2) might die if left untreated. A few physicians wisely and bravely chose to give the safer single-donor cryoprecipitate. 
    • Note: Over 1100 Canadians were infected with HIV from blood transfusions, of which 700 had hemophilia and were treated with FVIII concentrates.
The results of economic-based calculations around the globe:
Decision making in the early days of HIV was complicated because of all the players had genuine concerns, all born of self-interest (see 'The tragic history of AIDS...' above):
"Homosexuals were major blood donors in the large cities on the east and west coasts. It was thought that singling out homosexuals for exclusion would unnecessarily stigmatize them without evidence that they were indeed transmitting the disease. The blood industry, threatened by losing a large donor pool, strongly supported the position of the gay groups on this.
The hemophilia groups expressed concerns that the data showing immune suppression in hemophilic patients could have reflected the effects of prolonged use of blood products and did not necessarily mean they had the new syndrome. They also feared the stigma of having a disease associated with homosexual patients and were concerned that reducing the use of clotting factor concentrates would bring back old issues of deformities and early death, the fate of hemophilic patients before concentrate treatment."
These same forces are still at work today among all the stakeholders. CRC's successor CBS - with most of the same trench-workers (but not staff forced out for being truthful to the Krever Commission) - are even more into cost-benefit. Indeed, they've refined cost-benefit into a science. Decisions are  evidence-based, so please don't waste our time by questioning them.

CBS and others now use data - based on prevalence and disease severity - that determine whether a blood supplier implements a blood safety test or not for a given transfusion-transmissible risk. Today's blood suppliers are all about metrics and cost-savings, and they're proud of it, even crow about it.

Just like the Canadian Red Cross was when it declined to implement surrogate tests for hepatitis non-A, non-B (now hepatitis C). Seems Canada's experts judged surrogate tests to lack sufficient sensitivity and specificity. That tens of 1000s of Canadian transfusion recipients were subsequently infected with HCV is a testament to 'expert' opinion. It ain't infallible, especially if driven by cost constraints.

Today, cost-savings pretty much drive our blood system and have for awhile. The public purse is not an unlimited money pot and tough choices must be taken. Moreover, zero-risk is impossible in TM, indeed in all of medicine. 

 The impossibility of zero-risk is one reason that patients sign consent to treatment forms. Despite informed consent, how much patients truly understand is debatable. My experience is the process is often rushed, matter-of-fact, with the implication being we have to do this so let's get it done quickly: Just sign this so I can get to more important tasks. Sort of like asking people how they are, expecting only, "I'm fine, thanks."

 Yes, I've written variations on this theme before. But I hope readers see how true the analogy of TM leaders being the same as political leaders who constantly reassure us - as a knee-jerk reaction - that we're safe because they're doing all they can to combat the risks we face.

BOTTOM LINE
I don't want folks to become fearful of our blood supply. It's safer than ever, although not bulletproof. Rather I encourage readers to be skeptical, i.e., to have some degree of doubt regarding claims that are normally taken for granted just because they come from our leaders.

In this case, please be skeptical about what our TM 'thought leaders' tell us about blood safety, especially given the ever-evolving transfusion-transmissible threats AND the fact that commercial vested interests (Big Pharma, the diagnostic test industry) are now - more so than ever - in bed with transfusion professionals.

SIDE BAR (Food for Thought)
Let's consider the small picture of vested interests. Many experts who present at company-funded continuing education events or any CE event have strong ties to industry.

Think about the issue on a personal scale. Have you ever attended a TM talk, workshop, seminar sponsored by Big Pharma or a diagnostic test firm? If yes, have you even once heard representatives discuss anything that casts any doubt whatsoever on their products and their benefits? Suspect not. 
When attending CE events do you assess what ties the speakers have to industry? Or mostly listen in awe to the acknowledged world-renowned experts who transitioned from their original health care careers and now more or less work for profit-driven private industry?
Let's say I've built a good career on specializing in DNA genotyping of red cell antigens. What are the odds I'd be for each and every use of molecular typing in TM and a strong proponent of so-called personalized medicine?
Suppose one of my roles is as an academic whose career and advancement depend on getting my research funded and published? How likely would I be to criticize industry partners who fund my research? Or try to publish negative studies that don't support the company's products? 
Now let's return to the big picture. I'm not suggesting TM leaders are consciously influenced by commercial interests - who often just happen to be their industry partners (although they clearly are influenced in many ways) - on matters of blood safety. Rather my point is that people invariably act in their own best interests. Human nature...

Those in charge of the safety of our blood supply cannot admit the supply is unsafe, even that tiny risks exist. Just as politicians responsible for public safety cannot say citizens are unsafe. It's impossible. This means that you and I must be skeptical and not meekly accept pronouncements from on high about anything, including government and TM decisions influenced by pressure groups.

 Wouldn't it be great if our TM leaders would credit the public with intelligence and consistently articulate blood safety with these six points? I challenge them to LEVERAGE our intelligence to their advantage.
  1. Our blood supply is the safest it's ever been but it's not risk-free. 
  2. We need to be vigilant with donor screening, both questionnaires and TD testing. Tests are not perfect and donors may lie about risk behaviors. 
  3. Hemovigilance is key to prevent and identify adverse transfusion events and because unknown risks, for which no screening exists, are certain to arise. 
  4. Human error exists despite the best education, training, and competency assurance programs.
  5. Due to cost constraints, we must prioritize blood safety measures and, accordingly, tolerate some risk (ideally rare and less serious risks), as we do in all medical fields.
  6. MSM policies evolve and will continue to do so based on considering horrific past mistakes and their victims (many now dead) and current realities of improved screening tests balanced by HIV prevalence and relative risk among different donor groups.
Instead our TM leaders (like politicians) all too often use this easy mantra, which both patronizes and disrespects and, worst of all, cuts off discussion before it even begins:
  • Our blood supply is the safest it's ever been.
  • Don't worry, be happy.
For an insight into the viewpoint of victims in the aftermath of Canada's blood scandal see
FOR FUN
The blog's theme perfectly fits this 1988 Bobby McFerrin song:
As always, comments are most welcome. 
Posted by Blut at 12:37 AM 14 comments
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Sunday, July 27, 2014

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



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

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):
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:
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.

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:
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.

 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
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:
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.

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:
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.
Posted by Blut at 1:58 PM 14 comments
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Saturday, October 10, 2009

Don't ask, don't tell... Time to fold 'em or bad moon rising?

It's not every day that a national blood supplier and blood donor are involved in a lawsuit involving blood, sex, duplicity, and a constitutional challenge. That's happening now in Ottawa and generating plenty of press coverage.

In brief, CBS sued a gay blood donor, Kyle Freeman, who lied repeatedly on his blood donor screening questionnaire, and the donor subsequently sued CBS and Health Canada. This blog examines the issues involved in the dueling lawsuits.

The blog offers musings on the MSM deferral policy for blood donors. Its title is a takeoff on


The Controversy
The key issue involves the MSM (men who have sex with men) deferral policy for blood donors. As described on the CBS website:
  • "...the policy excluding MSM is the subject of debate between the LGBTTQ (lesbian, gay, bisexual, transsexual, two-spirited, and queer) communities, who view it as a discriminatory policy and patient groups that depend on blood products, and who feel it is a critical safety measure."
In other words, is lifetime deferral for MSM scientifically justified to protect the blood supply because the incidence of HIV is much higher in men who have had sex with men than it is in individuals having exclusively heterosexual sex or is the policy discriminatory?
The controversy surrounding MSM policies has been widely reported, particularly protests on university campuses, which have tended to be full of passionate, hyperbolic political rhetoric, e.g.,
Note: The above SAQD pamphlet refers to the 2007 McLaughlin Report. Readers are well advised to read the original report below.
BACKGROUND
CBS, like many blood services worldwide, following the dictums of its government regulator Health Canada, bans donations from men who have sex with men, the so-called MSM policy. The CBS predonation screening question on the "Record of Donation" reads,
  • "Have you had sex with a man, even one time since 1977?"
Other Countries
MSM policies vary globally. From the CBS website:
  • Countries requiring indefinite deferrals: USA, UK, France, Germany, Switzerland, Holland, Norway, Denmark, Sweden, Finland, Iceland and Hong Kong
  • Countries with shorter deferral periods:
  • 1 year - Argentina, Australia, Japan, Hungary
  • 5 years - South Africa*
  • 10 years - New Zealand
  • Italy has a deferral based on specific activities

* According to the SA National Blood Service, the SA deferral was changed from 5 yrs to 6 mths in 2006.
The UK blood service also provides a Summary of International Policies relating to the Exclusion of Men who have Sex with Men from Blood Donation

In 2007 CBS reviewed its policy and decided to retain an indefinite deferral, effectively a permanent ban, as explained here
The UK has also recently issued a position statement on its policy:
THE COURT CASE
CBS's position on the lawsuit is provided on its website.
The main facts of the case as reported in the media:

  • CBS accused Kyle Freeman, a gay man, of 'negligent misrepresentation' for lying on the screening form.
  • Freeman then sued CBS and Health Canada for $250,000 claiming CBS violates his charter rights* and those of other gay men by asking male donors about having sex with a man.*Canada's Charter of Rights and Freedoms
  • Freeman donated blood 18 times between 1990 and June 2002 but the case focuses on the 4 times he donated following the creation of CBS in 1998, i.e., between June 1998 and June 2002. (Canada's blood supplier prior to 1998 was the Canadian Red Cross.)
  • In June 2002 Freeman sent CBS anonymous e-mails admitting he lied on the questionnaire.
  • CBS attempted to get his Internet service provider to reveal his identity.
  • Freeman's blood donor screening HIV tests were negative but he has had gonorrhea and late latent syphilis.
For more details, see TraQ's news reports.
Interested Parties
Two other organizations have weighed in on the case:
The Canadian Hemophilia Society has 'intervenor status' in the case. CHS supports the position of CBS and Health Canada in maintaining the current MSM donor deferral criteria. Individuals with hemophilia were devastated by the tainted blood scandal of the 1980s, as documented in the Krever Report and elsewhere.


The Canadian AIDS Society will appear as a 'Friend of the Court.' It contests the constitutionality of the lifetime deferral on
men who have sex with men and proposes an amendment.

THE DEBATE
Below are the arguments on both sides of the MSM policy.
USA

This document outlines the AABB, ABC and ARC position: They believe that the deferral period for MSM should be consistent with deferrals for those judged to be at risk of infection via heterosexual routes. i.e., 12 months.



CANADA
UK
Debate in the British Medical Journal:
BOTTOM LINE
If current blood donor screening tests for HIV and other agents leave no residual risk for transmitting infections then there would be no need for intrusive screening questions about high risk behaviors, i.e., a policy of Don't ask, don't tell.
Obviously there is some residual risk, albeit small, that make predonation questions essential.

The McLaughlin Report concludes this about MSM deferral periods:
  • Available evidence strongly suggests that a 1-yr deferral would "almost certainly give rise to an incremental risk of transfusion-transmitted infection"
  • Evidence is less clear for a 5- yr or 10-yr deferral partly because "current level of residual risk is so low that there are, inevitably, substantial ranges of uncertainties associated with the risk estimation."
  • "...there is no firm evidence that such a change in the deferral period ...would result in an incremental level of risk, although the possibility of a small increase in risk cannot be entirely ruled out."
  • "Under these circumstances, other social policy issues, relevant to the idea of changing the deferral period for MSM, become worthy of additional consideration."
This excerpt from the Report is instructive:
  • Therefore, would ...changing the MSM deferral period to 5 years pass the risk hurdle successfully? In the end, this is a matter of judgment, that is, a matter on which reasonable people may disagree.
  • What we can say with some assurance is that, at the very least, it may provisionally pass the risk hurdle. In other words, it is “within the ballpark” for discussion.
  • As a result, it is fair to ask if there may be other types of benefits that are likely to flow from making this policy change...
  • (1) ...possible impact on the size of the future donor pool, and
  • (2) ...potential social benefit attendant upon reducing the perceived stigma associated with homosexuality.
So....let's shorten the deferral for MSM to potentially get more blood donors and lessen a social stigma. And this based on a judgement on which reasonable people may disagree and is within the "ball park" of acceptable risks. Hmmmm......
The McLaughlin Report says that health risk data are equivocal and constitute very small risks so let's consider other worthwhile goals.

I'm always uneasy when someone suggests blood safety changes based on cost effectiveness or on politically expedient issues such as lessening social stigmas. Despite the clear desirability of such goals, patient safety should be the overarching, if not sole, determining factor.

The Gambler's wise advice is that you got to know when to fold 'em, know when to hold 'em.

Will the FDA, Health Canada and blood suppliers like CBS decide to fold 'em and change the lifetime MSM deferral policy to a shorter period?

Ladies and gentlemen, place your bets.

 I see a Bad Moon Rising if changes to blood safety policies are based on pressure from activists as opposed to evidence of no incremental risk, accepting that zero risk is impossible.

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





Posted by Blut at 6:46 PM 5 comments
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Thursday, April 09, 2009

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

Transfusion medicine colleagues - get ready for a sea change:
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?
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)
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)
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:
#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:
#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:
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:
Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

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