Always on my mind (Musings on infected blood inquiries)

Stay tuned - Updates likely to occur

The idea for this blog has roots in the UK Infected Blood Inquiry now in the news and the CBC's Unspeakable, an 8-part television series (Jan. 9-Feb. 27) about Canada's 'tainted blood scandal' of the 1980s-90s.

I will not go into too much detail as some topics discussed are emotional minefields for folks, eliciting strong opinions. The purpose is to offer food for thought and leave it to you, the reader, to think about the issues, according to your background and experience.

The title derives from a 1969 ditty that Willie Nelson covered with much success in 1982.

As you read, please monitor your reactions, since what we think and how we react to events largely depends on the emotional baggage we each carry. As one example of many, my reaction to blood inquiries is shaped by having worked for Canada's first blood supplier (Canadian Red Cross) for 13 years and for decades as a transfusion science educator. Also my views are shaped by being a bit of a contrarian who tends to challenge orthodox opinions of transfusion medicine's 'biggies' (thought leaders).

PURPOSE/PRINCIPLES OF INQUIRIES
First, inquiries into infected blood tragedies are not concerned with criminal or civil liability. Supreme Court Decision of Canada (Attorney General) v. Canada (Commission of Inquiry on the Blood System) specifies

• Intent of the Krever Inquiry (Hearings1993-5; Report1997)

Second, the same Supreme Court decision specifies

• Principles applicable to inquiries ~Krever's 

Note that inquiries can make findings of misconduct if they fall within the inquiry's terms of reference. If the same is true for the UK's inquiry, then folks looking for criminal and civil blame to be assigned will be disappointed. But misconduct that occurred or actions that failed standards of conduct will be identified and open to further investigation by the justice system.

Given that memories fail and records disappear over time, especially sensitive ones, and self-interest makes few reveal their errors, based on Canada's experience, criminal prosecution is next to impossible. But civil suits, requiring a lower standard of proof beyond a reasonable doubt, may succeed.

As in most legal matters, credibility of witnesses is crucial where no hard evidence exists. It's complicated because of self-interest. Few,if any, admit, 'I screwed up and made a bad decision, I'm partly to blame. Forgive me.' Those involved are far more likely to say, ' I did the best I could under difficult conditions. I didn't know all the facts or what would happen. No one did. Hindsight is 20-20.'

From Canada's experience, an added key factor is that so many different players are involved, sometimes operating in silos, with no one ultimately responsible, that it's easy to claim, 'Not my responsibility.' All very convenient and I suspect Canada's blood system still has this fatal flaw despite its transmogrification, post-Krever.

PURPOSE/PRINCIPLES OF CRIMINAL JUSTICE SYSTEM
Not being a lawyer, I hesitate to include this section but include it as food for thought. Here's how I see Canada's justice system, its purpose and principles. Note: My opinions may well differ with those of many Canadians, particularly regarding incarceration and punishment.

• Ensures public safety by protecting society from those who violate the law. Defines unacceptable behaviours and the nature and severity of punishment for a given offence. 

• Presumes innocent until proven guilty and those charged have the right to legal representation and a fair trial. Burden of proof is on the prosecution and defendant must be proven guilty beyond a reasonable doubt. 

• Acts as a deterrent to criminals, with incarceration being the last resort, reserved for the most serious offenses and where mitigating factors do not exist.

• Purpose is not to punish offenders but to act with compassion and rehabilitate, if possible. Fact: Most people who come in contact with criminal justice system are vulnerable or marginalized individuals who struggle with mental health and addiction issues, poverty, homelessness, and prior victimization. (See 'What we heard - Transforming Canada's criminal justice system,' Further Reading)

TIDBIT: When I read news items or information on the UK Blood Inquiry, it's my impression, rightly or wrongly, that, as in Canada, many victims and their families are out for blood so to speak. They clearly want those whose professional misconduct and negligence  - unproven but it's how they see it - led to loved ones being infected brought to justice and punished. In other words, the NHS and its medical professionals and officials seem to have been prejudged as guilty. (Further Reading)

ANALOGIES
Analogies are offered to stimulate thought.

#1. Tragic Humboldt bus crash (Further Reading)
On April 6, 2018 sixteen people were killed and thirteen injured when a bus carrying members of the Humboldt Broncos, a Canadian junior hockey team, struck a semi-trailer truck. The driver passed four signs warning about the upcoming intersection yet the semi-trailer went through a large stop sign with a flashing red light.

The driver of the semi-trailer, 29-year-old Jaskirat Singh Sidhu was charged with 16 counts of dangerous operation of a motor vehicle causing death and 13 counts of dangerous operation of a motor vehicle causing bodily injury.On January 8, 2019, Sidhu pleaded guilty to all charges.

The Crown is asking for a sentence of 10 years with a 10-year driving prohibition. Sentencing is March 22, 2019. It's possible Sidhu could be deported after serving his sentence.

Sidhu followed his girlfriend to Canada in 2013 and is now a permanent resident. He's a newlywed who grew up on a farm in India and earned a commerce degree. He worked at a Calgary liquor store before he started driving a truck. He started work at a small trucking company only three weeks before the crash, after undergoing a week of training and spent two weeks driving a double-trailer with the owner before driving on his own.

Canada and its provinces, except for Ontario, have no compulsory training for new 'class 1' truck drivers and no mandatory training standards.

TIDBIT: Sad but it seems Sidhu will take the full blame for his horrific error, despite mitigating circumstances, namely the entire trucking driver safety system failed. Trucking companies and governments now say they'll do better, but they suffer no consequences, only the ill-trained driver of the truck. Sidhu is the scapegoat.

Reminds me that Canadian Red Cross was the scapegoat of Canada's 'tainted blood tragedy.' The newly created CBC and Héma-Québec operated with many of the same transfusion professionals because you cannot educate and train new experts overnight.

Truck companies can save money by offering minimal training and put unsafe drivers of large semi-trailers behind the wheel. Only one provincial government required mandatory training or considered standardized training. Of course, now some provincial governments have but it will be a pathetic patchwork, ignoring that semis regularly drive across provincial borders.

Did the justice system provide a deterrent to prevent a tragedy like the Humboldt bus crash from happening? If a similar tragedy occurs, will it all fall on the driver again?  Will the justice system rehabilitate the dysfunction system that played a key role in the crash?

#2. Sexual abuse by Roman Catholic clergy (Further Reading)
Happened globally in 20th and 21st centuries, and likely for centuries before that. Scandal is so well exposed it needs no documentation, though see Further Reading. Clearly a systemic problem, yet who is held accountable?

Bishops transferred known offending priests to other jurisdictions to abuse more children. Everyone in the Church worked to protect the Church at the expense of children, and now it turns out, even nuns were abused.

Who is ever held accountable other than the odd defrocked clergyman? Who in the Catholic Church's patriarchal hierarchy should be held accountable and what would justice for victims, providing a deterrent to future crimes, and making the public and society safe entail?

Does 'We did the best we could in difficult circumstances, wanting to protect both the perpetrators and victims equally' cut it, because there's good people on both sides (to use a Trumpism)?

BLAME GAME
Healthcare, including transfusion medicine, supposedly has adopted a quality system that promotes a blame-free culture where individuals are able to report errors or near misses without fear of reprimand or punishment. (Further Reading, Culture of Safety)

"The culture of individual blame still dominant and traditional in health care undoubtedly impairs the advancement of a safety culture. One issue is that, while "no blame" is the appropriate stance for many errors, certain errors do seem blameworthy and demand accountability. In an effort to reconcile the twin needs for no-blame and appropriate accountability, the concept of just culture is now widely used.  

A just culture focuses on identifying and addressing systems issues that lead individuals to engage in unsafe behaviors, while maintaining individual accountability by establishing zero tolerance for reckless behavior. It distinguishes between human error (e.g., slips), at-risk behavior (e.g., taking shortcuts), and reckless behavior (e.g., ignoring required safety steps), in contrast to an overarching "no-blame" approach still favored by some. " 

Yet the blame game still exists in medicine, as exemplified by the Dr. Bawa Garba case in the UK (Further Reading), although the injustice was ultimately rectified.

A key part of human nature is to want to know and understand why things happen. Humans (we Homo sapiens) have done it since we emerged as Great Apes, along with orangutans, gorillas, and chimpanzees. Later in our history it's one reason astrology emerged.

If bad things happen, it's natural to assign blame. Take footie (soccer in NA). If a team loses 1-0 because of a goal from a penalty kick due to the referee penalizing our player, many fans see it as the refs fault, it wasn't a penalty, the opponent dived. Definitely not that our club couldn't score even one goal.

And it's much more satisfying and easy to grasp if we can assign blame to fellow humans as opposed to some amorphous system failure. Another factor at play: if we look for something, we often find it. For example, can be as simple as being a new VW Beetle owner and suddenly noticing them everywhere. Or more relevantly, if I suspect that a person is a misogynist, I may interpret their perhaps innocent words and actions as misogynistic.

REVENGE 
When I told a good pal that I considered writing this blog, she encouraged me (as she always does) and suggested I include what a desire for revenge does to a person.

Good example exists in the CBC's Unspeakable series, in the character Ben Landry, to me a fictionalized version of one of two book authors (along with Krever Report) the series is based on: Vic Parson, who wrote Bad Blood: The Tragedy of the Canadian Tainted Blood Scandal. In the fictionalized version, Landry's behaviour drives away his wife and son with hemophilia and misses out on celebrating the birth of his grandson.

It's a given that hatred and the desire for revenge eats away at people and can destroy their lives if left unchecked. Know this from personal experience of a relative who physically abused his wife and sexually abused many children. Revenge seldom, if ever, gives the solace we need.

LEARNING POINTS
Just want folks to think about what would constitute justice for victims of infected blood scandals around the globe. Are thousands of deaths from HIV and HCV the fault of no one, just a system failure that no one could prevent? No one can be faulted for decisions because they didn't know enough? If preventable errors were made, what does justice look like?

FOR FUN
Chose this ditty because it fits how I feel about the blog's issue. To me, transfusion professionals always had patient well-being on their minds yet they failed them, as the lover admits in this song:

• Always on my mind (Willie Nelson)
• In particular, note these words 

COMMENTS: As always, your comments are appreciated and welcome. See below.

FURTHER READING
Canada's blood scandal 
If you view only one resource, make it this one. From Canada's blood tragedy: Tragedy of Factor VIII concentrate (19:14 mins. well worth watching. See Randy Conners words at 18 min. mark)

• Acquittal in tainted blood scandal outrages survivor
• Nova Scotia compensates victims for 'tainted blood'

Criminal Justice System Purpose

• Transforming Canada's criminal justice system

UK Infected Blood Inquiry News 

• Latest here

Humboldt Broncos bus crash

• Included more links as case may be unfamiliar to many outside Canada
• Only Ontario requires truck driver training, but Humboldt crash could change that
• Semi-driver in Humboldt Broncos crash a newlywed with business education
• Crown wants truck driver sentenced to 10 years in Broncos crash
• Semi-driver in Humboldt Broncos crash will likely be deported, says immigration lawyer
• Sidhu apologizes to families as Crown asks for 10-year sentence in Humboldt Broncos bus crash
• Semi-driver in Humboldt Broncos bus crash had 70 regulation violations

Catholic Church Sexual Abuse

• Sexual abuse and the culture of clericalism
• Sexual abuse cases

No Blame Culture

• Culture of Safety

Bawa-Garba Case

• Dr Hadiza Bawa-Garba wins appeal against being struck off (13 Aug. 2018)

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:

• CBS decision to decrease its MSM ban to a 5-year deferral
• Because of the low prevalence of HIV+ Canadian blood donors, it takes years to get good data upon which to base decisions.
• No doubt the same criteria will apply to changing the one-year ban to no ban at all.

NEWS (JUNE-JULY 2016)
Examples of news that triggered this blog:
HIV

• CDC Press Release (July 20, 2016) : Gay and bisexual teen males no more likely than heterosexual teen males to engage in sexual risk behaviors but at substantially higher risk of HIV infection:
• HIV diagnosis rates are 57 times higher among men who have sex with men (MSM) than among heterosexual men.

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:

• USA: The tragic history of AIDS in the hemophilia population 1982-1984
• Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic 

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

• 2007: Four doctors on criminal negligence charges and a U.S. blood-product company of common nuisance acquitted of charges related to the worst public health scandal in Canadian history.
• Lawyer with hemophilia infected with HIV and HCV describes judge's ruling that there had been "no conduct that showed wanton and reckless disregard" as "ludicrous".

FOR FUN
The blog's theme perfectly fits this 1988 Bobby McFerrin song:

• Don't worry, be happy (Bobby McFerrin) 

As always, comments are most welcome. 

To dream the impossible dream (Musings on TM research)

As always, stay tuned for updates

November's blog is based on an abstract from AABB's 2014 meeting in Transfusion. I always read 'Education and Training' abstracts (one of the smaller sections - go figure!), and this one caught my eye:

• A14-030D: Chargé SB, Walsh GM. Bridging the gap: knowledge mobilization and transfusion medicine research. Transfusion 2014 Sept;54(2S):231A. 

The authors are from CBS's Centre for Innovation. 'Leading edge' on the Centre's website grates but at least it isn't 'bleeding edge.' As soon as I read 'knowledge mobilization' in the abstract I thought, 

• 'OMG, not more management bafflegab by Canada's national blood supplier!' 
• If there's a new buzzword out there like knowledge mobilization, you can bet CBS management will jump on it. 

That said, reading the abstract, I lost my skepticism, well at least some of it. The project to educate front-line CBS staff about the organization's research initiatives and research team is admirable.

The blog's title derives from the principal song of the musical 'Man of la Mancha' based on Cervantes' 17th C classic, Don Quixote. I hope that transfusion professionals the world over can relate to the blog's musings on the nature of research.

ABSTRACT 

Here's my version of the CBS research initiative. (Read full abstract for more details) 

Title: Bridging the gap: knowledge mobilization and transfusion medicine research

Why do it?  To transfer knowledge generated by basic and clinical research to those whose work it may affect. Unfortunately, journal publications and conference presentations have limited access.

What did they do? CBC developed these tools:

• Summaries in plain language of notable publications were published online monthly and aimed at all stakeholders, including donors.
• Knowledge to Munch On: Internal follow-up to major conferences, inc. 
• Displays of conference posters
• Distributing an electronic conference report
• Lunch and Learn national webinars highlighting conference presentations. 

What did they find? Summaries in plain language: Between March 2013 and March 2014, 10 Research Units were online and downloaded >1100 times.

Knowledge to Munch On:

• 66 conference presentations were available to staff who couldn't attend conferences

• 3 electronic conference reports were downloaded 747 times in the 3 months after publication

• Lunch and Learn: 8 presentations were attended by 263 staff.
•  96% agreed with, 'This event enhanced my knowledge.' 
•  76%felt that the knowledge was applicable to their practice.

What did they conclude? The programs' impacts are measurable and need more developing and monitoring to achieve a greater impact.

My take on the CBS research project

1. Demographics: Who viewed the posters, downloaded the summaries and reports, attended and participated (geographical locale and health profession)?
2. When were various components of the program available and accessed? During the work day vs lunch hours, coffee breaks, and after hours at home?
3. Plain language summaries of 10 research units downloaded a total of  >1100 times over a year is NOT very much. 
4. Was a Likert 5-point scale used to assess participant feedback? e.g., 96% agreed with, 'This event enhanced my knowledge' and '76% felt that the knowledge was applicable to their practice.'

Seems like a good start. Wonder how much time, effort, funds were spent and how committed CBS is to maintain the project, given the organization's overpowering emphasis on cost cutbacks, even related to its core business lines.

MUSINGS on RESEARCH

1. Research means being incurably curious about the world. Researchers, especially those involved in basic research, conduct many experiments year after year with failure after failure and little hope of success, until it happens, if it does. 

2. How many researcher dudes have you even heard of (and they are mainly dudes)? You may recognize the names of the luminaries who publish in leading journals and present often at conferences. 

But if you are a front-line transfusion professional, whether lab technologist /biomedical scientist, nurse or physician, you likely do not read papers or attend sessions on basic research, whose titles are often indecipherable. Even applied research gets little readership unless it directly affects us.

3. Many types of research exist. See this primer on medical research. On a simplistic level

• Basic research is wondering if inherited traits might make different groups of people more or less susceptible to the same disease.
• Applied research is trying to develop a screening test for HIV once we know it causes AIDS, and possibly making mega-bucks in the process.

4. It's easy for people to slag researchers as egg heads divorced from reality. These guys and gals get to attend conferences and seemingly live a charmed, stress-free life compared to those in the trenches. 

Indeed, I live in a university city where some politicians have long dissed academics as not living in the 'real world'. Anti-intellectualism is popular among populist politicians and a sure vote winner with some.

5. What the public does not see is the stress of researchers: 

• Proving their worth annually by winning scarce research funds
• Keeping spirits up in the face of experiments extending for years 
• Defending criticism from peers when they publish findings
• Facing condescension by some who perceive them as pampered 'ivory tower' dwellers.

6. Basic research, often derided, has a record of producing major scientific findings. One example:

Hepatitis BApplied research is all the rage among politicians these days, but basic research rivals it via serendipity. 

Hepatitis B kills more than 700,000 people annually. Prevalence is highest in sub-Saharan Africa and East Asia, where most people become infected during childhood and 5-10% of adults are chronically infected. Vertical transmission from mother to child is common. About half of all cases of hepatocellular carcinoma are attributed to chronic HBV infection.  

Today all blood donations are screened for HBV thanks to its discovery by Dr. Baruch S. Blumberg . 

In 1976, Dr. Blumberg won the Nobel Prize for Physiology and Medicine for his discovery of the hepatitis B virus. He and his colleagues discovered the virus in 1967. 

But Blumberg began as a medical anthropologist interested in the genetics of disease susceptibility. He wondered if inherited traits might make different groups of people more or less susceptible to the same disease. The research had nil to do with hepatitis.

His research involved using antibodies from multi-transfused hemophiliac patients to test blood samples collected around the world. When an antibody from a New York hemophiliac reacted with an antigen in the blood of an Australian aborigine, they called it the 'Australia antigen', and the serendipitous path to a life-saving discovery was made. 

The Au antigen was subsequently found in the serum of many multi-transfused leukemia patients. Was it related to causing leukemia? Then Blumberg's laboratory technologist developed hepatitis B. And ultimately it became clear that the Australian antigen was the hepatitis B surface antigen. 

Soon a lab test was developed to screen blood donors and a vaccine was developed.

BOTTOM LINES

• Basic research, with unknown outcomes, often trumps applied research, despite applied research being the flavour of the decade. 
• A researcher's life is not all roses. Far from it. 
• All health professions should get to know each other better, including the researchers who work behind the scenes and whose work can affect us all.

FOR FUN
The blog's title derives from the musical, Man of La Mancha, based on Cervantes' Don Quixote, and its song, 'To dream the impossible dream'. 

Like Don Quixote, researchers are sometimes seen as impractical, naive, idealist dreamers. Researchers dream the dream daily. It keeps them going. They never know when something momentous will be discovered, something to improve the lives of people, like Blumberg's Australian antigen did.

• The Impossible dream

As always, comments are most welcome.

FURTHER READING

• Research
• Canadian Blood Services researchers

• For Students: The research process

• Thomas Kuhn. The Structure of Scientific Revolutions (Highly recommended) 

• HBV
• Hepatitis B infection in Canada

• WHO Fact Sheet on HBV

• Baruch S. Blumberg

• 1976 Karolinska Institutet press release 

• Baruch Blumberg, who discovered and tackled hepatitis B, dies at 85 (NY Times, 2011)

• Meet Dr. Blumberg (1925 - 2011)

• The Australia Antigen and role of the late Philadelphia General Hospital in reducing post-transfusion hepatitis and sequelae(Hepatology, Sept. 2011)

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

A timely post for November 4, 2008, presidential election day in the USA...

Late night comedians have satirized George W. Bush for his "I'm the decider" statement, although what he said was true. And the U.S. President's most consequential decision appears to have been based on faulty information about weapons of mass destruction (WMD) in IraQ but it fits with his doctrine of preemptive strikes.

An informative and entertaining paper in the Oct. 1st issue of Blood, which features ASH 50th anniversary reviews, reminded me of issues surrounding being a decider and how the validity of decisions depend on the quality of information and how the precautionary principle can easily go awry.

Alter HJ, Harvey G. Klein HG. The hazards of blood transfusion in historical perspective. Blood 2008 Oct 1;112(7): 2617–26.

This paper by two giants in transfusion medicine reviews historical and current transfusion risks. From an historical perspective, as someone who worked in a blood centre when the Australian antigen (now HBsAg) was discovered and testing of blood donors was implemented, the authors' tale of its discovery revived old memories, as did their review of the entry of HIV into the blood supply.

However, this blog entry is NOT a trip down memory lane but a glimpse at what history tells us that today's transfusion recipients should expect when it comes to blood safety.

Two statements in the Blood review caught my eye because they remain topical and have ongoing relevance. The authors note that the blood bank community has been chastised for its perceived failure to act during the early days of the AIDS epidemic and outline the "real time" difficulties and pressures present during1982-84. They state:

• "We write this not as apologists for early inaction, but to portray the immense, seemingly insurmountable dilemmas present at the time."

As an aside, I may be a bit cynical, but when someone says it's "not about the money," it almost always is, especially if they were not asked about money and bring it up out of the blue. In this case I'm sure the authors are sincere but the suspicion remains.

PRECAUTIONARY PRINCIPLE
The second statement concerns the precautionary principle:

• "One positive outcome of the AIDS tragedy was adoption of a new paradigm in blood transfusion, the precautionary principle, which states that 'for situations of scientific uncertainty, the possibility of risk should be taken into account in the absence of proof to the contrary' and that 'measures need to be taken to face potential serious risks.'" (definition comes from ref. 1)

What does this mean in practice? In essence, the precautionary principle is a preemptive strike.
It 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. Moreover, the proof of harm need not be certain and cause and effect do not need to be fully established.

In some ways the precautionary principle conflicts with an evidence-based medicine approach. To protect public safety, you do not need high-level evidence - safety is paramount and preemptive strikes are warranted. And it implies that financial considerations should not take precedence.

Put into the context of transfusion-associated HIV and hepatitis C in Canada, Justice Krever wrote (2):

• "The slowness in taking appropriate measures to prevent the contamination of the blood supply was in large measure the result of the rejection, or at least the non-acceptance, of an important tenet in the philosophy of public health: action to reduce risk should not await scientific certainty.

• When there was reasonable evidence that serious infectious diseases could be transmitted by blood, the principal actors in the blood supply system in Canada refrained from taking essential preventive measures until causation had been proved with scientific certainty.

• The result was a national public health disaster."

In the aftermath of HIV and HCV, the precautionary principle has been applied to protecting the blood supply from vCJD and WNV ( 3,4). However, its application remains a challenge since it involves a volatile mix of

• fear
• risk
• uncertainty
• finite financial resources

See, for example:

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

• Although remarkable advances have been made in the prevention of the major transfusion-transmitted diseases, long intervals have transpired between the first recognition of transfusion risk and the implementation of a preventive strategy.

• For hepatitis B virus, that interval was 30 years; for non-A, non-B/hepatitis C virus, 15 years; and for human immunodeficiency virus, West Nile virus, Trypanosoma cruzi, and bacteria, 3, 4, 5, and 18 years, respectively

• In our existing reactive approach, there is a fundamental and inevitable delay before we can react; and thus, infections are destined to occur. The continued emergence or reemergence of transfusion-transmitted infections calls for a new paradigm of preemptive pathogen reduction (PR).

• Two PR systems, psoralen/UV-A and riboflavin/UV-A, have shown efficacy and safety for platelets and plasma; and psoralen/UV-A technology has been successfully implemented for platelets in Europe. Pathogen reduction can eliminate or reduce the risk for any nucleic acid containing agent, including bacteria, and thus will be effective for all but prion diseases. It is possible to introduce PR for platelets and plasma now and to concentrate resources on developing PR for red cells.

• This will require an intellectual and financial commitment from the National Institutes of Health, the Food and Drug Administration, industry, and the blood bank establishment, just as occurred for nucleic acid testing (NAT) technology. This can be done if there is sufficient will to do it.

It is inevitable that money continues to exert a strong influence on public policy decisions. But should it be the key deciding factor? It appears to have been a key concern regarding Canada's decision not to implement surrogate tests for non-A, non-B hepatitis (2):

• These estimated costs of surrogate testing did not take into account the medical, economic, or societal costs that would be saved by a reduced incidence of post-transfusion non-A, non- B hepatitis if surrogate testing were implemented. Cost, without recognition of the benefits of testing, continued to dominate the discussions during the next three years about whether to implement surrogate testing in Canada....

• The effect of the failure to implement surrogate testing in Canada is illustrated by the Blajchman–Feinman study itself, which confirmed that surrogate testing would have significantly reduced the incidence of post-transfusion hepatitis. The results of the study, published in The Lancet in 1995, support the conclusion that the implementation of both surrogate tests would have reduced the incidence of post-transfusion hepatitis by 75 per cent, and the incidence of post-transfusion hepatitis C by 85 per cent, in the period before the introduction of HCV-antibody testing in Canada.

• The decision of the Red Cross not to implement anti-HBc and ALT testing of blood donations in Canada as surrogates for non-A, non-B hepatitis was not an acceptable one.

INFORMED CONSENT
A related positive outcome of the AIDS tragedy not mentioned by Alter and Klein is implementation of an informed consent process specifically for transfusions.

Informed consent in general has evolved with the entire movement away from the earlier paternalism of the doctor-patient relationship in which the typically male doctor was seen as the loving father-who-knew-best who protected the child-patient. But the AIDS and hepatitis C debacle gave informed consent for transfusion a huge kick start.

Today the health care paradigm is ideally one of a team involving doctors, nurses, and other health professionals. And responsibility for medical treatment is shared, with the physician as interpreter and reliable guide, but with the patient as the ultimate decision-maker. See, for example

• Charles C, Whelan T, Gafni A. What do we mean by partnership in making decisions about treatment? BMJ 1999 Sep 18;319:780-2.

This informed consent model was absent during the AIDS crisis of the early 1980s:

• "From early 1983, it was clear that AHF concentrate was a risky product. The failure to tell hemophilia recipients of Factor VIII concentrate about the risks of this treatment and about alternative treatments seems especially serious in the light of present-day emphasis on the autonomy of patients in decisions involving their health." (5)

EXPECTATIONS
The odds are that one day we or our friends and loved ones will require a blood transfusion. As potential recipients of blood, what should we expect? We should expect

• physicians to have used evidence-based medicine methods to select treatment options;
• risks and benefits of transfusion to have been objectively assessed;
• alternatives to transfusion to have been considered;
• blood suppliers to have supplied blood components and products that are as safe as possible, including using the precautionary principle to protect the blood supply;
• to be asked to give our consent to transfusion and that it be informed consent.

BOTTOM LINES

#1. If I need a blood transfusion, just like 'Dubya,' I expect to be the decider. And I expect to receive reliable unbiased information from my doctors.

But are there risks involved in too much patient "decider" autonomy? How do we achieve an effective balance? These are topics beyond the scope of this blog entry.

#2. It's possible to interpret President Bush's decision about WMD as the precautionary principle gone awry - too much emphasis on fear and over-estimating the risk and too little on evidence-based assessments - a classic case of "err on the side of safety" with a preemptive strike gone incredibly wrong.

In contrast, in the 1980s the precautionary principle was all but ignored by blood systems around the globe with tragic results. Today the balance has shifted, but not totally.

How do we achieve the right balance of caution yet prevent paranoia, recognizing that zero risk does not exist? How do we balance fear, risk, uncertainty, and finite financial resources? These are difficult challenges.

In the end government plays a major role, because it funds research on adverse transfusion events and hemovigilance systems, regulates the blood system, develops public health policies that affect the blood supply, and in many countries almost totally funds the blood system.

So on this U.S. election day, and on any election day anywhere, the electors are also the deciders. They get to decide who

• best represents their concerns and philosophies on public safety issues that require balancing fear, risk, uncertainty, and resources;
• they most trust to apply the precautionary principle and launch a judicious preemptive strike against an imminent, emerging transfusion danger.

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

REFERENCES

1. Stoto MA. The precautionary principle and emerging biologic risks: lessons from human immunodeficiency virus in blood products. Semin Hematol. 2006 Apr;43(2 Suppl 3):S10-2.

• Also see Stoto MA. The precautionary principle and emerging biological risks: lessons from swine flu and HIV in blood products. Public Health Rep. 2002 Nov–Dec; 117(6): 546–552.

2. 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.

3. Vamvakas EC, Kleinman S, Hume H, Sher GD. The development of West Nile virus safety policies by Canadian blood services: guiding principles and a comparison between Canada and the United States. Transfus Med Rev 2006 Apr;20(2):97-109.

4. Wilson K. The Krever Commission — 10 years later. CMAJ 2007 Nov 20; 177(11).

5. Leveton LB, Sox HC, Jr., Stoto MA, eds. HIV and the Blood Supply: An Analysis of Crisis Decision Making. Committee to Study HIV Transmission Through Blood and Blood Products, Institute of Medicine 1995.