Showing posts with label Unspeakable. Show all posts
Showing posts with label Unspeakable. 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

Thursday, January 31, 2019

Unforgettable (Musings on the CBC's Unspeakable about Canada's 'tainted blood scandal')

Updated: 9 Feb. 2019 (New videos,comments +at blog's end)

January's blog was stimulated by two ongoing current events: UK's Infected Blood Inquiry and Unspeakable, a television series based on Canada's 'tainted blood scandal.' The blog's purpose is to provide those interested with a range of selective (not all inclusive) resources in one place. (Further Reading). 

The blog's title derives from a song recorded by Nat King Cole in 1951. Surely, these blood scandals must stay unforgettable forever. But in Canada a recent survey showed 61% of Canadians were unaware of the Krever Inquiry and the Canadian 'tainted blood' tragedy of the 1980s and '90s that led to establishing a new blood system.

Unspeakable has caused a bit of a stir. For example, the series resulted in Graham Sher, CEO of Canadian Blood Services, writing this oped:
As someone who lived the scandal and its antecedents while working in Canada's blood system, I know all the real-life physicians in Unspeakable. Also read the three volumes of the Krever Report, all of which gives me an advantage in following the series.

Also knew hemophilia patients Barry and Ed Kubin (teenagers at the time) when working for Canadian Red Cross Blood Transfusion Services in Winnipeg in the 1960s and '70s. They'd come to the blood service to pick up cryoprecipitate and later the Factor VIII concentrate that was to kill them. Ed died from AIDS in 1996, his younger brother Barry before that. Human interest news feature:
Some of the characters in the TV series are fictionalized. I'm guessing that the bigger-than-life character in episode 4 (29 Jan. 2019), a hemophiliac from Manitoba, who carries a rifle around, is a take-off on Ed Kubin.

I may add to the blog as the series progresses. Hope you find the resources below useful.

FOR FUN
Believing these blood scandals must stay unforgettable forever, I chose this oldie-goldie.
  • Unforgettable (Natalie Cole with video recording of her late father Nat King Cole)
As always comments are most welcome. See those below in Comments section and this one in the text of the blog.

ADDENDUM - REPLY to Dr. Neil Blumberg (8 Feb. 2019)
...Must admit it's a complicated business and at my advanced age I'm trying to stick to the BIG PIC. Easy to get wrapped up in the trees and forget the forest. First I'll deal with HCV, then HIV and FVIII concentrate/ cryoprecipitate. Appreciate Neil taking the time to present alternative views to mine. Hope readers appreciate his contributions to the ongoing discussion. 

There is no doubt in my mind that Justice Horace Krever got it right in his extensive 'Royal Commission of Inquiry on the Blood System in Canada' (1993-7), culminating in the Krever Report, 26 Nov. 1997, after which Canada got a new blood system (CBS and Héma-Québec).

Open Letter to the Honourable Commissioner Judge Horace Krever (retired) by CBS CEO Graham Sher (23 Nov. 2017):
"Sadly, an entire generation is largely unaware of the extent to which the system failed, and perhaps more significantly, why and how it has been rebuilt. In a recent poll conducted by Ipsos on our behalf, fewer than half of Canadian respondents indicated some level of awareness of the Krever Inquiry and its findings."
1. NON-A, NON-B HEPATITIS (HEPATITIS C)

The gift of death: Confronting Canada's tainted-blood tragedy
Source: Canadian Encycopedia (Time Line)

1981:Canadian Red Cross rejects "surrogate" tests (meaning testing not for a condition itself but for indicators generally associated with it) being developed for non-A, non-B hepatitis in blood. It cites controversy over their reliability and the lack of Canadian data, but no Canadian studies are undertaken.

1985:Canadian Red Cross starts screening blood for HIV, the AIDS virus.

1986:U.S. blood banking organizations start surrogate testing for non-A, non-B hepatitis based on research indicating it can drastically reduce the incidence of transfusion transmission. Canadian Red Cross remains unconvinced, estimating surrogate testing would prevent only a small number of cases, at a cost of up to $20 million in the first year.

1990: Canadian Red Cross (and U.S. organizations) start direct screening for hepatitis C virus. But unscreened plasma in blood products still reaches some patients, possibly for as long as two years.

1993: Federal government appoints Ontario appellate court Justice Horace Krever to investigate the contamination of the public blood supply in the 1980s.

Nov. 21, 1997: Krever releases his report, slamming the Red Cross and governments for ignoring warnings and acting irresponsibly as HIV and hepatitis C transmissions continued. He calls for prompt no-fault compensation for "all blood-injured persons." Krever concludes that 85 per cent of the approximately 28,600 hepatitis C infections from the blood supply from 1986 to 1990 could have been avoided.

Feb. 12, 1998: The RCMP launches a criminal investigation into the tainted blood scandal.

March 27,1998: Federal Health Minister Allan Rock and his provincial counterparts announce a [HCV] compensation package of $1.1 billion ($800 million from Ottawa, $300 million from the provinces), available only to those infected between 1986 and 1990, when screening could have been in place. Details of individuals' compensation are still to be worked out.

From 'Blood officials knew in '81 of hep-C [surrogate] test, memos show' (12 Nov. 2003) by André Picard, author of 'The gift of death: Confronting Canada's tainted-blood tragedy' (1985) 
  • ...Much of the discussion focused on using a surrogate, or indirect, test for alanine amino tranferase. ALT is a blood enzyme that indicates liver dysfunction, a telltale sign of hepatitis infection.
  • The test was far from perfect. It would detect only about half the cases of HCV, resulting in the loss of about 3 per cent of blood donations, and would cost about $3 per unit of blood. But HCV was becoming such a widespread problem that the meeting concluded: "Blood-collection agencies in the U.S. should prepare to test ALT levels of all blood units."
  • John Derrick, director of operational research at the Canadian Red Cross, said testing was "premature" but blood banks in the U.S. were "gearing up" for the move. He noted that as long as the ALT test was not part of standard operating procedures, the Red Cross "can not be held legally responsible for any illness resulting from transfusion of blood with high ALT levels."
  • Dr. Derrick concluded the memo by saying there was a "general strong feeling . . . that no one should test on a routine basis since all blood centres would be obligated to test.
  • In May, 1981, Dr. Patrick Moore, director of the National Reference Laboratory of the Canadian Red Cross and one of the country's foremost experts on hepatitis, had demanded immediate implementation of surrogate testing. But his recommendation was rejected by his superiors, largely for financial reasons. They decided instead to do more testing.' 
It took the USA a long time to implement surrogate tests (ALT, anti-HBc) because of the balance between risk and benefit (Harvey Alter) and Canada never did.
Perfect example of the precautionary principle abandoned and it's not so much that transfusion physicians in the 1970s-80s were such staunch proponents of evidence-based medicine, although some were, because I must have missed that. EBM existed before but got huge impetus from McMaster University in Canada about 1992.
The precautionary principle applies where after assessing available scientific information, reasonable grounds for concern exist for the possibility of adverse effects on human health [or the environment], yet uncertainty persists. Risk management measures can be adopted, without having to wait until the reality and seriousness of adverse effects become fully known. In other words, in risk management, err on the side of human safety.
Based on the evidence of the Krever Inquiry, in Canada and perhaps elsewhere, the over-riding principle was minimizing costs at the expense of human lives. Yes, the transfusion medicine community were dealing with many unknowns about non-A, non-B hepatitis (hepatitis C), its incidence, cause and seriousness, but Canadian leaders and funders opted (conscious decision) to do nil about hepatitis C despite calls from many inside the system

Who knows how many of the estimated 20,000 cases of hepatitis C (1985-90) could have been saved by surrogate testing of the Canada's blood supply and those infected by blood before 1985. 

2. HIV and AIDS
Will try to keep this reply shorter. In reply to my comment, "But why not cryoprecipitate made from one donor not 20K+ as for FVIII concentrate?" Neil Blumberg commented, "The capacity to generate cryoprecipitate was nowhere near what it needed to be to replace all the factor VIII concentrate that was in use. Would have required a year or two (my guess) to ramp up production."

I've only a sketchy idea of what increased cryoprecipitate production would have taken in Canada. Based on my 13 years as a medical lab technologist at Canadian Red Cross BTS in Winnipeg (combined blood supplier and regional transfusion service) for Manitoba and northwestern Ontario, maybe more large refrigerated centrifuges to separate plasma from red cells, a few more blood component staff? What I don't know is what percentage of donated blood was typically processed into cryoprecipitate.

First, did CRC-BTS even try to ramp up cryo production, given it had decided to distribute its already paid-for stockpile of known HIV-infected, non-heat-treated FVIII concentrate? I think not.
Kinda reminds me of CBS's decision to close a plasma collection site because it was cheaper to buy plasma derivatives like intravenous immune globulin (IVIG) from USA. CBS has since decided that securing a Canadian supply chain for donated plasma is a good thing but to date no government funding has been announced.  
Second, some CRC-BTS centres and medical directors in Canada decided to distributed more safe heat-treated FVIII conc. and fewer HIV-infected products and also promoted cryoprecipitate, as did some hematologists, versus giving HIV-infected stockpiles to patients. To my knowledge there were no hemophiliac bleeding disasters in cities like Calgary, Edmonton, St. John's, who did so.

BOTTOM LINES [BIG PIC]
Was there a shortage of heat-treated FVIII concentrate so that hemophiliac lives could only be saved by using up stockpiles of HIV-infected concentrates, else they'd bleed to death, and most were judged as already infected?
Based on Krever, it's an open question in Canada and a bit ironic, given the product meant to save hemophiliacs killed them. I've read evidence there was no shortage of heat-treated concentrate but don't know the reality. Also, CRC-BTS made no effort to increase production of safer (one-donor) cryoprecipitate. 
Was Canada deciding not to implement surrogate tests -against the views of some of its own medical experts- justified and honorable? No. Krever presented evidence to show decision was based on limiting costs not patient safety.

Agree with Neil that hindsight is 20-20 and real time is much fuzzier. And that folks, especially victims whose lives have been destroyed, naturally play the blame game because it's hard to accept, 'Oh well, sometimes bad things just happen.'

However, I do not agree that the worldwide 'tainted blood tragedy' of the 1980s-90s was unavoidable. Instead, I agree with Justice Krever. The tragedy's effects in Canada (perhaps elsewhere) could have been significantly decreased if transfusion leaders had not been so arrogant (yes, many were arrogant in thinking, as physicians in that era often did, we know best and some still do) and focused on the value of human lives, not the bottom line (cost-savings).

One last tidbit: In the past I read that minutes of a key meeting of Canada's government funders and CRC-BTS officials were inexplicably destroyed. Cannot get the reference now but it's real and did happen. Remind you of anything, e.g., missing minutes of a Nixon Watergate tape?

That's it for this oldster. Over and out.

RELATED BACKGROUND VIDEOS
FURTHER READING
CANADA
For followers of the CBC's Unspeakable, I recommend these resources:
Twitter:
Victims outraged by tainted blood trial acquittals (1 Oct. 2007)

Hepatitis C Package Controversy (The Canadian Encyclopedia, 2003, updated 2014)

André Picard tweets about Unspeakable, based in part on his book "The Gift of Death", shares some of his stories on 'tainted blood' scandal

Krever Report: Some Important Milestones: HIV and AIDS,1981-94 pp.xxi -xxviii

Krever Report: 14. The risk in Factor VIII concentrates

Capan K. There's more to Krever's report than the blood issue -- much more. CMAJ 1998;158:92-4.
  • See 'Therapeutic privilege' for lawsuit filed by Rochelle Pittman infected with HIV from husband, who got it from infected transfusion and was never told.
A systemic deconstruction of the Canadian tainted blood tragedy (Gilles Paquet and Roger Perrault. Oct. 27, 2015)
UK
For followers of the UK's Infected Blood Inquiry I recommend these resources:
Twitter