Showing posts with label tainted blood scandal. Show all posts
Showing posts with label tainted blood scandal. Show all posts

Tuesday, February 26, 2019

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
Second, the same Supreme Court decision specifies
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:
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)
Criminal Justice System Purpose
UK Infected Blood Inquiry News 
Humboldt Broncos bus crash
Catholic Church Sexual Abuse
No Blame Culture
Bawa-Garba Case

Sunday, October 28, 2018

I will remember you (Musings on all those who died in tainted blood tragedies)

Updated: 5 Nov. 2018 
Canada's blood scandal, Further Reading
Responses to a Comments

Haven't written a blog for awhile and this one will be short. For October I'll  briefly comment on the ongoing attack on national blood suppliers like Canadian Blood Services and many others by gay activists. In Canada the designation is lesbian, gay, bisexual, transgender, queer, and two-spirit (LGBTQ2).

The blog was stimulated by two items at the AABB 2018 and the current UK Infected Blood Inquiry (Further Reading), both featured in TraQ's October newsletter under General and UK, respectively.

Recently, I've seen many attacks on Twitter accusing  CBS of discrimination. Almost all activists claim there never was a reason to ban or defer male homosexuals. When I've defended CBS by reporting the history of transfusion-associated HIV transmission in Canada, the blood supplier's perspective and its ongoing research, I've often been accused of being homophobic. Quite scary for an oldster but it won't ever stop me from voicing my opinions on controversial issues.

My take is that gays have suffered horrific discrimination over the years and many cannot differentiate blood supplier caution from larger societal historical wrongs. And most are too young to appreciate blood supplier's perspective and the need for nation-specific evidence-based policies. Suspect I'm being too generous here but won't elaborate. What the hell, I will. Could be dead wrong but sometimes when you've been unfairly repeatedly victimized, you see oppressors everywhere.

The blog's title derives from a 1995 song by Canadian Sarah McLachlan.

BACKGROUND
Activists worldwide see even a temporary ban of men who have sex with men (MSM) as discriminatory. Over the years in Canada the deferral has gone from permanent deferral to a 5 year deferral without MSM to a one year deferral without MSM and likely will soon become a 3 month deferral without MSM.

Gays see any deferral, no matter how short, as a holdover from an era of panic over AIDS in the early 1980s (Further Reading, NBC):
"They are just the latest chapter in a narrative that casts gay men as untrustworthy, promiscuous vectors of disease. We know scientifically we pose no greater threat than anyone else, but fear is a really powerful thing — especially fear of HIV."
I'll provide only this one news item but also see Google search for "gay blood donation discriminatory" in Further Reading, which yields 5,630,000 hits.

In Canada, Prime Minister Justin Trudeau was foolish to promise a change in CBS's MSM policy because it's not a political decision, it's science-based. Sadly, his error fueled much of the outrage by the gay community against CBS. The last thing our blood system needs is a political-based decision. We've been there, done that at the beginning of Canada's HIV/AIDS 'tainted blood scandal'.

BOTTOM LINE: As lifelong worker in transfusion as front-line medical laboratory technologist/scientist, supervisor-manager, educator, and consultant (54 yrs - Yikes!)  I've experienced the best of times and the worst of times. I firmly believe our blood supplier CBS is right to be cautious and base blood safety policies on evidence gathered in Canada (CBS MSM deferral policies, Further Reading).

As always, comments are most welcome. Please see the 4 comments below and my response to one (added Nov. 1, 2018).

ADDED Nov.1, 2018
Please see comments below. My reply to Shanta is as follows:

About your first point: If my comment that victimized LGBTQ2 see oppressors everywhere is true, it is probably because homophobia IS everywhere and doesn't magically stop at the front door of institutions because they reflect the values of the society that created them.

I'll grant that homophobia still exists everywhere in society, including in Canada as opposed to nations in which homosexuality is criminalised, including some nations where the death penalty applies. Source: Gay relationships are still criminalised in 72 countries, report finds. (The Guardian, 2017)

But I see it as more nuanced. Having worked for its predecessor Canadian Red Cross for 13 years, and for CBS over many years, mainly as a consultant with a brief stint as 'assman' managing CBS Edmonton's patient services laboratory, I do not believe Canadian Blood Services is a homophobic institution. I don't think CBS institutionalized policies of homophobia, including the ever decreasing ban on gay MSM donations. Individuals within any organization may be homophobic but I don't think there's evidence CBS per se is. Reasonable people can disagree on this point and I'll give my reasons below.

Shanta's second point relates to evidence-based policy-making. If the CBS MSM policy is purely based on evidence, we should be able to correlate each change over 30 years -- from permanent to 5-year to 1-year to the now anticipated 3-month deferral without MSM -- to the evidence that triggered each decision. If we can't do that, it's possible to conclude that policy-makers are influenced by more than just the evidence.

My view is that evidence-based policy-making on HIV and MSM is complex and affected by many factors including risk-modelling research, which is way above my pay grade (comprehension). For the record like many countries Canada moved from an indefinite deferral for any MSM to a five-year deferral in 2013, and to a 12-month deferral in 2016. Source: HIV donor testing. I believe the initial permanent deferral was justified and I've been labelled a homophobe on Twitter for it by  gay activists.

To be clear, national blood suppliers need to take into account many variables, including national HIV rates, data accumulated over many years because of the low prevalence of HIV, and the need to be cautious because of the incredible screw-ups that cost thousands of lives in what Canada refers to as the 'tainted blood tragedy,' the biggest PREVENTABLE public health disaster in our history.

CBS recognizes that 'MSM deferral is one of the most controversial deferral policies, and while blood safety remains paramount, issues of social justice and inclusivity highlight the need for its modernization.' See Developing more inclusive deferral policies for blood and plasma donors,

To Shanta's point, it's impossible for CBS to present clear cut evidence for each decision to decrease the deferral without MSM. The variables are too numerous. My view is that, yes, 'policy-makers are influenced by more than just the evidence.' But the elephant in the room is NOT homophobic discrimination, it's CBS's desire to err on the side of safety and caution to prevent a massive catastrophe of the 1980s (HIV) and 1990s (HCV) which resulted in Canada's blood supplier Canadian Red Cross Blood Transfusion Service being axed.

And let's face it, the emphasis on evidence-based medicine is relatively new.  Example: Choosing Wisely Canada launched on April 2, 2014.

FOR FUN
I chose a song by Canadian Sarah McLachlan to honour all those thousands who died and suffered from infected blood tragedies worldwide. Having lived through it in 1980s and 1990s I can never forget them. In early days of my career, I knew folks with hemophilia who came to blood centre to pick up their cryoprecipitate, then FVIII concentrate that killed so many. Two were Barry and Ed Kubin mentioned in Vic Parsons' book below.
FURTHER READING
It's still a ban': Gay blood deferrals still discriminatory, LGBTQ advocates say (NBC, 29 Nov. 2017)

Google search: "gay blood donation discriminatory"

AABB 2018
CBS on MSM Deferral Policies
Canada's Blood Scandal
UK Infected Blood Inquiry: October 2018 News

Wednesday, August 03, 2011

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

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


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

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

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

1. AIDS AT 30

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


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

AABB president James Aubuchon  is also quoted in 'AIDS at 30':
"We should congratulate ourselves on what we have accomplished...in our approach to infectious diseases and these accomplishments have allowed us to turn our attention to other problems such as bacteria in platelets and TRALI."
Presumably "our approach to infectious diseases" includes applying the precautionary principle to blood safety.

2. RISK-BASED DECISION MAKING


A consensus conference on risk-based decision making for blood safety was held in Toronto in Oct. 2010 and will be discussed at the 2011 AABB meeting in San Diego. The proceedings were published in July.
Also see
In this paper, Wilson, who also participated in the consensus conference on risk-based decision making, offers the following factors as a standardized way to decide which type of precaution, if any, to implement for a given transfusion risk:
  1. Is the extent of the exposure large?
  2. Is the consequence of the exposure serious?
  3. Is the consequence of the exposure irreversible?
  4. Is there minimal cost associated with the removal of the exposure?
  5. Is there a minimal negative health effect associated with removing the exposure?
Assuming that definitive data are available (not always possible), using these guidelines presumably means do something if a big exposure, serious and irreversible consequences exist (e.g., HIV infection). How cost and negative effects on the donor supply influence decisions and interact with the other factors is less clear.


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


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


To me, the report on the consensus conference (Risk-Based Decision Making for Blood Safety) indicates the direction of future decision making:
  • Cost is becoming increasingly important and the precautionary principle as applied to transfusion medicine will be shaped to fit what is financially desirable.
3. COST REDUCTION
Ongoing evidence exists that blood suppliers are in trouble and need to reduce costs.
June's AABB News also features a report on the 9th Annual National Blood Foundation Leadership Forum held in April 2011 in Miami. Richard Gundling, VP of Healthcare Financial Management Association, is quoted as saying that
  • organizations that merge or form partnerships "can benefit from higher margins, greater expense control and economies of scale."  
The July issue of Journal of Blood Services Management (published with Transfusion) includes this article:
  • 'A roundtable discussion: from thoughts on supply and demand to what keeps us up at night' 
A sample comment:


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


In this 1998 CMAJ article written on the eve of CBS taking over the blood system in English Canada ("Concerns mount as transfusion medicine loses its lustre"), Noel Buskard and other luminaries in Canada's TM firmament discussed not only the legal risks involved in transfusion medicine but also a trend toward
  • "a 'pharmaceutical model' in which the physician is based in-house, reports to a CEO-style business manager and doesn't have a connection to patients or other institutions."
What would the physicians quoted in this 1998 article think of the current emphasis (ascendancy?) of the economics of transfusion medicine, especially when juxtaposed with managing risk? If they want to thrive in the current system, I imagine they would keep pretty quiet.


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


From Jeffrey McCullough's presentation (Consensus Conference on Risk-Based Decision Making):
  • In response to a variety of developments over the past 25 years, the culture and structure of blood organizations have evolved. These organizations have moved from a medical model involving individualized decision making resembling patient care to a systems-based pharmaceutical manufacturing model, with new approaches to quality assurance. Organizational structures have been transformed; and new kinds of leadership are now valued, such as manufacturing and business expertise.
  • Governed by the principle that “safety of the blood supply is paramount”, these organizations have achieved significant improvements in blood safety. However, that paradigm is evolving and potentially conflicts with other principles, such as the notion that “decisions…will be made within a health risk management framework, which places on an equal footing the 3 critical elements of cost, benefit, risk”. (Words in quotation marks are from referenced sources)
REMEMBERING
Noel Buskard was the medical director of Vancouver's Canadian Red Cross blood centre during the early years of the AIDS tragedy in which 1000s across Canada and around the globe were infected with HIV and hepatitis from blood transfusions. He quit the Red Cross in 1991 saying it had developed a "fortress mentality" when confronted with the AIDS tragedy.
Noel was the President of the CSTM (1998-2000). For speaking publicly about safety issues throughout his career, he was awarded the 2001 Whistleblower Award from the B.C. Freedom of Information and Privacy Association.

For a fascinating trip down memory lane, see
5. PATIENTS - RISK BEARERS WHO PAY THE PRICE
Lest we forget:


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

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


Writing this blog brings to mind this gem by Canada's Gordon Lightfoot
I'm pretty sure you can read my mind on where I stand on the issue of 'acceptable risk' and who pays the price.

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

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

If cost is given too much weight, as seems likely, we are doomed to commit the errors of the past. And it isn't the docs making the decisions who will pay the ultimate cost.
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As always the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice.  This blog was updated 7 Aug. 2011.