Showing posts with label HCV. Show all posts
Showing posts with label HCV. 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
Posted by Blut at 6:09 PM 2 comments
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Saturday, July 23, 2016

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 Wouldn't it be great if our TM leaders would credit the public with intelligence and consistently articulate blood safety with these six points? I challenge them to LEVERAGE our intelligence to their advantage.
  1. Our blood supply is the safest it's ever been but it's not risk-free. 
  2. We need to be vigilant with donor screening, both questionnaires and TD testing. Tests are not perfect and donors may lie about risk behaviors. 
  3. Hemovigilance is key to prevent and identify adverse transfusion events and because unknown risks, for which no screening exists, are certain to arise. 
  4. Human error exists despite the best education, training, and competency assurance programs.
  5. Due to cost constraints, we must prioritize blood safety measures and, accordingly, tolerate some risk (ideally rare and less serious risks), as we do in all medical fields.
  6. MSM policies evolve and will continue to do so based on considering horrific past mistakes and their victims (many now dead) and current realities of improved screening tests balanced by HIV prevalence and relative risk among different donor groups.
Instead our TM leaders (like politicians) all too often use this easy mantra, which both patronizes and disrespects and, worst of all, cuts off discussion before it even begins:
  • Our blood supply is the safest it's ever been.
  • Don't worry, be happy.
For an insight into the viewpoint of victims in the aftermath of Canada's blood scandal see
FOR FUN
The blog's theme perfectly fits this 1988 Bobby McFerrin song:
As always, comments are most welcome. 
Posted by Blut at 12:37 AM 14 comments
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Friday, February 19, 2016

Sweet Dreams (Musings on a recent transfusion-related nightmare)

Updated: 28 Feb. 2015 (see CBS's Dr. Sher audio clip at end)
February's blog derives from news items in TraQ's monthly newsletter that resulted in my dreaming from a 'what if' perspective.

The title derives from a Eurythmics ditty that I've used several times before. Was reminded of it again from this Twitter post from @SantaCruzbio:



For links to news items and resources, see Further Reading at the blog's end.

 I HAD A DREAM 
Dreamt I was a Canadian who had a blood transfusion in 2018 and contacted a debilitating, deadly disease. Turns out 1000s of folks around the globe got the same transfusion-associated disease and many died within a few years before they discovered a treatment that works for many, but not all, and not forever. 

THE DISEASE
The disease I contacted was named 
  • Arrogant Scientific Syndrome by Highly Analytical Tossers after those who allowed it to happen (ASSHAT for short). 
At first ASSHAT appeared in homosexual and bisexual males, so was deemed sexually transmitted and soon it showed up in IV drug abusers, presumably via contaminated needles. 

 Hence, the perspective developed that it was the victim's fault - THEM - and wouldn't affect WE- those of us outside those groups. In other words, the typical WE-THEY bigotry. 

I DREAMT THE NEWS TODAY, OH BOY...
In my dream, here are but 6 things that happened in Canada, and no doubt occurred elsewhere, given that government bureaucrats, medical administrators, and physicians (sometimes the same individuals wearing different hats) are similar the world over.

 1. The transfusion medicine community naturally denied ASSHAT was transfusion-transmitted until the evidence was overwhelming. They knew the blood supply was safe, so much safer than before. After all, the new transmissible disease test for hepatitis B had been implemented ~10 years ago. We felt safe.

2. At first the blood supplier chose not to screen out high-risk donors for fear of blood shortages, aided by interest group lobbying.

 3. The blood supplier and its government funders were so concerned about saving money that they cut corners, in secret, of course. Specifically, they chose
  • Not to purchase a safer blood product for hemophiliacs in order to use up contaminated inventory, apparently thinking they were likely already infected, so what the hey! Or perhaps they thought better to give contaminated products than none at all, given the dangers of severe bleeding? Maybe they thought they were leveraging existing inventory to save money. Who knows?
  • To delay implementing a test for ASSHAT because money was tight.
4. Someone, who knows who or how, destroyed key documents, minutes of meetings) of the Canadian Blood Committee. This group influenced, if not outright decided, most of the above decisions.

 5. At an individual level, a paternalistic physician chose not to tell an older man's wife that her husband was ASSHAT-positive because the physician was sure they were not having sex. No doubt he thought he was being kind. Wrong! The wife came down with ASSHAT and sued the physician, which is how we found out about it.

 6. Ultimately, police laid 32 criminal charges against senior scientists at Health Canada, the Canadian Red Cross Society and Armour Pharmaceutical Co. Guess how many were convicted?

OUTCOME
In Canada a commission of inquiry was set up ~12 years later in 2030 and completed its report in 2034. That was 16 years after I contacted ASSHAT. 

But I was one of the 'lucky ones' who was still alive. And I benefited because the federal government  offered $120K in 'humanitarian assistance' in exchange for a promise we would not sue. The provinces later offered $30K/year for life. 

 Those who got variant ASSHAT, resulting from the blood supplier failing to use surrogate tests used in the USA, threatened to sue for equal treatment and the government paid out millions of dollars. 

 Many of those affected by both diseases died before compensation was available. Sometimes I suspect maybe that was the idea.

Then I dreamt that I was British and had a worse nightmare. The inquiry into ASSHAT offered only one wimpy recommendation after 6 years of inquiry, held more than 25 years after the ASSHAT tragedy. I had died by then.

 LEARNING POINTS
Think what happened in my horrific dream couldn't happen, that it's just too far out, too sci-fi? Think again. It already has. Think it couldn't happen again? Why? The physicians and blood administrators who made the decisions decades ago were smart, caring people. But not infallible when confronted with financial constraints, interest group lobbying, and political pressure.

 Canada was one of the few, maybe only, countries that held an extensive legitimate inquiry into what is typically called in the media, the tainted blood scandal. 

 Canada's Krever Commission had 50 recommendations. The first was to compensate victims. Recommendation 2:
    • Blood is a public resource.
    • Donors should not be paid.
    • Sufficient blood should be collected so that importation from other countries is unnecessary.
    • Access to blood and blood products should be free and universal.
    • Safety of the blood supply system is paramount.
But apparently paying blood donors is now okay, at least for plasma, because we are so much smarter today and our technology is so much better. Sure it is. 

 As always the views are mine alone and comments are most welcome.

 FOR FUN
I chose Sweet Dreams as the music for the blog because it's ironic. My dream was not a Sweet Dream but rather a nightmare. Nonetheless, I love this ditty:
  • Sweet Dreams [are made of this] (Annie Lennox, Live 8, Hyde Park, London, 2005)
Sweet dreams are made of this.
Who am I to disagree?
I travel the world and the seven seas
Everybody's looking for something.

Some of them want to use you.
Some of them want to get used by you.
Some of them want to abuse you.
Some of them want to be abused.

Thanks to Anonymous (see Comments below) for link to this video by CBS CEO Dr. Graham Sher:



Also thanks to Anonymous for 

  • Audio clip (~10 mins): CBS CEO Graham Sher's interview (CBC, The Current, 25 Feb. 2016) 
    • Transcript of interview
    • Apparently, the manufacturing process for plasma derivatives kills anything and everything. Why even test plasma collected for fractionated products? Maybe the price of IVIg would come down?
FURTHER READING
Canada
UK

Posted by Blut at 5:15 PM 34 comments
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Saturday, August 09, 2014

The way we were (Musings on TM history and its lessons for today)

Updated: 11 Aug. 2014
This month's blog discusses 3 recent news items (and associated scientific papers) related to men who have sex with men (MSM), HIV risks, and blood donation, plus a paper written by Canadian transfusion medicine experts on Canada's perspective on donor criteria for MSM.

The blog's title is from a 1975 Barbra Streisand classic (one of my favorites) and theme from an eponymous movie starring her and Robert Redford.

Please read the news items and papers as they provide fascinating, useful details beyond the brief reports presented in the blog. Although the specifics involve North America, the content and learning points apply everywhere.

1. USA: HIV positive man arrested and charged after donating plasma for $30
A man admitted to police that he donated plasma at BioLife in Elkhart, Indiana even though he knew he was HIV positive. He'd lost his job and needed money. 
Biolife pays $30 for plasma via a debit card and is a division of Baxter Healthcare. 
The plasma donor was charged with three counts of attempting to transfer contaminated body fluids and one count of transferring contaminated body fluids.
2. USA: Activists fight MSM policy (lifetime deferral if even once since 1977) with National Gay Blood Drive on 11 July, 2014.
The blood drive involves gay and bisexual men who want to donate bringing proxy donors who are eligible to donate and publicizes what activists believe is an outdated discriminatory and unscientific policy. 
The news item outlines the key issues on both sides of the argument with quotes from Paul Strengers, medical director at the Dutch Sanquin Blood Supply Foundation (anti-changing the policy) and the American Medical Association (pro-change). 
Related: AABB, ABC, ARC Joint statement on National Gay Blood Drive
Among other things, the US organizations were concerned that the event might disrupt blood center operations but support "rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities."
3. USA: 5 reasons HIV is on the rise among young gay and bisexual men
In brief, according to HIV researchers at CDC, the reasons include young gay and bisexual men's partners are more likely to
  • Have and transmit HIV
  • Engage in risky sexual practices
  • Use drugs
  • HIV's stigma could make people less likely to get tested
  • Younger men weren't around for worst of the HIV/AIDS epidemic and are less likely to know the dangers
Related: Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in diagnoses of HIV infection in the United States, 2002-2011. JAMA 2014;312(4):432-4.

4. Goldman M, Lapierre D, Lemay L, Devine D, Sher G. Donor criteria for men who have sex with men: a Canadian perspective. (Commentary) Transfusion 2014 Jul;54(7):1887-92.
With other jurisdictions considering a change in MSM policies, this paper was written by Canadian blood experts who thought it might be of value to share Canada's experience. It outlines CBS and Héma-Québec's extensive processes to consult interest groups / stake holders to achieve a consensus to support Canada changing its long-standing permanent deferral for MSM to a 5-year deferral from last MSM contact. 
The 'Commentary' begins by outlining the history of the HIV/AIDS/HCV 'tainted blood' disaster in Canada, which led to the Krever Royal Commission of Inquiry into Canada's blood system and its 'damning' (my word) 1997 report.  
As a result, in 1998 CBS and Héma-Québec were created; blood was regulated as a drug with blood centres considered biologics manufacturers, with more stringent regulatory oversight by Health Canada. 
I'll present only a few key highlights of the paper, those selected through my biased eyes. Also note [my Comments].
HISTORY: [One of the most explicit mea culpas I've seen from Canadian TM experts]:
* There was a lag between implementing measures to reduce transmission of AIDS/HIV in Canada compared to the US and others, including donor deferral criteria, HIV antibody testing, and sole use of adequately virus-inactivated factor concentrates.

* Delays contributed to infection of many transfused patients, with the hemophilia population particularly devastated by HIV. Delays also occurred in adopting measures to reduce HCV transmission. 
* Anger and bitterness over the (mis)management of HIV and HCV risk by the blood system cast a long shadow over the new organizations, CBS and H-Q. 
[Why did the delays occur? What's the root cause? A focus on cost over safety? A belief in evidence-based science that failed to consider what experts did NOT know? Or?]
STATISTICS: As of 2011 PHAC reports there were ~71,000 prevalent and 2250-4100 annual incident cases of HIV in Canada. MSM risk was high for prevalent and incident infections, accounting for about half of new infections.
* Large MSM studies demonstrate seroprevalence rates from 10% to 20% but generally recruit participants in gay venues and focus on currently sexually active MSM, often with frequent partner change (not those in longstanding monogamous relationships or those sexually inactive for a long time).

[Incidence of HIV seroprevalence in gays in long monogamous relationships is unknown.]

* With sensitive antibody detection assays and minipool nucleic acid testing (NAT), the window period for HIV is estimated at 9 to 11 days. 
* Residual risk for HIV is estimated at less than 1 in 8 million units at CBS and in the USA is 1 in 1.5 million units, due to higher rates of HIV+ donors. 
[FYI, residual risk is the risk of an infectious donation being present in the blood supply after all donor and donation screening activities occur and unsuitable donations are removed and discarded.  See Current information on the infectious risks of allogeneic blood transfusion - Residual risk. Put another way, it's the OOPS! factor.]
RISKS
* Risk modeling in Canada found the incremental risk of a 5-year deferral for MSM was less than 1 infected HIV unit entering the blood supply in 1000 years. 
* A 5-year deferral for MSM would not substantially increase transfusion-associated HIV in Canada. Similar modeling studies were done in France, UK, and USA. 
[Sounds great, eh? Almost as if we can crow, 'Don't worry, be happy'. But the fly in the ointment...] 
* 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where data are often sparse. Additionally, they do not provide information on novel or emerging threats.' 
[Modeling involves many assumptions based on minimal data – so much for evidence-based. Plus, obviously new and emerging threats (unknown) are absent from modeling studies.]
MUSINGS
I'm not going to report the guts of the Canadian paper, which outlines the processes used in Canada in 2001, 2006, 2008, 2009, 2011, and 2012 except to mention the Kyle Freeman court case.

But please read the paper if you have access because it explains the science and politics of MSM and blood donation as few resources have and the emotions and tension that marked the debate historically and still do.

In brief, the Freeman case involved a gay man who informed CBS via an anonymous e-mail that he donated and lied about his MSM status. To trace the anonymous e-mail and apply the appropriate deferral code, CBS sued for negligent misrepresentation as a way to obtain his identity from his e-mail service provider. He counter-sued, claiming CBS violated his rights under the Canadian Charter of Rights and Freedoms.

Freeman lost. Key elements of the judgment in favor of CBS were that blood donation is a gift and not a right and that MSM policy is not discriminatory based on sexual orientation.
Relevant reading:
LEARNING POINTS
MSM, HIV, and blood donation continue to be controversial and political. To me, key points from the Transfusion paper and related news items include 

#1. Goldman paper: 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where evidence is lacking. As well, they do not provide information on new or emerging threats.

In other words, models of HIV and other infectious disease risks to the blood supply are based on assumptions backed up with more or less zero data and do NOT consider new threats. So much for evidence-based decisions touted by TM experts.

#2. The role that student and gay rights activists play in changing blood safety policy is pure politics.

They claim discrimination (and a case can be made based on MSM vs engaging in risky behaviors regardless of gender) but ignore that HIV-prevalence of MSM presents a real risk to the blood supply. Moreover, HIV is on the rise among young gay and bisexual men, current HIV tests have a window period of 9 to 11 days, and donors may lie on blood donor screening questionnaires.

#3. Goldman paper: 'For patient groups, many of whom are chronic users of the blood supply, the change meant putting aside their fears of the past, assessing the available scientific information, and trusting in the system.'

To me, this is 'Don't worry, be happy' time (see earlier blog). Trust us. We've got your back covered based on science. Oh yah!

#4. All this aside, blood suppliers worldwide will cave to the political pressure of activist interest groups, claim it's evidence-based, and it won't affect blood safety until it does.

UK PERSPECTIVE
For interest, the UK's NHSBT donor policy on MSM:
The change means that only men who have had anal or oral sex with another man in the past 12 months, with or without a condom, are asked not to donate blood. 
Men whose last sexual contact with another man was more than 12 months ago are eligible to donate, subject to meeting the other donor selection criteria.
Other nations have permanent (indefinite) deferral or a 5 year deferral.              
FOR FUN
The blog's topic is not funny. The 'for fun' bit is just for enjoying the song. Looking back on the HIV tragedy and its impact on blood transfusion, I'm reminded of the innocent way we were before HIV appeared.
Mem'ries,
Light the corners of my mind
Misty water-colored memories
Of the way we were. 
Scattered pictures,
Of the smiles we left behind
Smiles we gave to one another
For the way we were.
Can it be that it was all so simple then?
Or has time re-written every line?
If we had the chance to do it all again
Tell me, would we? Could we? 
Mem'ries, may be beautiful and yet
What's too painful to remember
We simply choose to forget.
So it's the laughter
We will remember
Whenever we remember...
The way we were...
As always the views are mine and mine alone and feedback is most welcome.


Posted by Blut at 6:59 PM 0 comments
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Sunday, July 27, 2014

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



Posted by Blut at 3:50 PM 3 comments
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