Showing posts with label Krever report. Show all posts
Showing posts with label Krever report. Show all posts

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

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

Tuesday, June 05, 2007

Informed consent for transfusions - take this job and shove it?

If you know someone who has had a transfusion recently, ask them if a physician or nurse explained the risks and benefits and, if during or after their hospital stay, they were notified in writing that they were transfused. Chances are, maybe not, even though both policies have been promoted as best practice for years now.

In Canada more than a decade ago Justice Krever (Commission of Inquiry on the Blood System in Canada), made recommendations on informed consent and documentation:

To quote Capen:

  • In March 1995 the Krever inquiry released an interim report, which contained a strong warning that the informed-consent requirement applies specifically to the administration of blood or blood products, and the routine consent form signed upon admission to hospital does not fulfil this requirement.
  • It also said physicians should prepare patients well in advance of scheduled surgery to give them adequate time to consider reasonable alternatives.
  • As well, doctors should provide information on these alternatives.
  • The interim report said doctors must ensure that documentation occurs every time consent is provided, and that all treatments or procedures are recorded in the chart.
Despite inclusion in blood safety standards, many transfusion services in Canada and around the globe are still developing processes for informed consent and documented notification of transfusion. A paper by Canadian authors and editorial in the April issue of Transfusion deal with these related issues:

  • Killion DF, Schiff PD, Shoos Lipton K. Informed consent: working toward a meaningful dialogue (editorial) Transfusion 2007 Apr;47 (4), 557-8.
  • Rock G, Berger R, Filion D, Touche D, Neurath D, Wells G, Elsaadany S, Afzal M. Documenting a transfusion: how well is it done? Transfusion 2007 Apr;47(4):568-72.
In brief, Rock and coworkers did a retrospective review of 1005 patient charts with these results for documentation of informed consent and transfusion:

  • In 75% of cases the physician had not documented that any discussion had occurred regarding the risks and/or benefits or alternatives.
  • Only 12% of charts included information that patients were subsequently told what blood components were transfused.
  • The discharge summary recorded transfusion information in 32.1% of cases whereas the consult note had this information in 26.3%.
If informed consent is still not a reality, why not? The editorial authors propose as possible mitigating factors (1) distressed patients in pain and (2) health professionals who are rushed. They offer the following suggestions as a follow-up to the Rock study:

  1. Perform more studies to determine how widespread informed consent is
  2. Change the current model of informed consent so that, instead of relying heavily on physicians, who bear ultimate legal responsibility for transfusion, trained transfusion staff be used to obtain informed consent.
The advantages are that transfusion staff understand the risks and benefits of transfusion, as well as patient needs, and are better equipped to follow through with documentation.

To meet best practice standards most transfusion services in Canada are actively promoting informed consent and documentation:

CHANGE THE MODEL?
Informed consent for transfusions - whose job is it, anyway? Is the answer to change the model and shift obtaining informed consent to trained transfusion staff? And who would these staff be? Nurse transfusion specialists? Transfusion safety officers, whether medical laboratory technologists or nurses? In some Canadian hospitals nurses already handle informed consent. What problems may this shift to transfusion staff potentially create for physician responsibility for transfusion when the inevitable mistakes are made?

In pondering the issue of shifting responsibility for informed consent, I could not help but think of a shift in responsibility that happens in some rural hospitals. In towns where the laboratory is not staffed after hours by technologists, nurses are asked to issue blood from the transfusion service. Presumably they are trained in issuing procedures, but how well is open to debate. And in some locales nurses have refused to issue blood, claiming it is an effort to shift work from the laboratory to the nursing staff, in effect making nurses subsidize the lab service, which saves money by not running the lab after hours.

Is the suggestion of a new model as proposed by the Transfusion editorial another example of offloading responsibilty to others, others who are supposedly less busy than physicians? Or is this view too cynical? With patient safety coming first (not politics), is the proposed model simply a pragmatic view - do what works best for the patient. Regardless, any new model must proactively deal with potential problems caused by a shift in responsibilty for informed consent to transfusion staff.

Lastly, how representative is the Rock study of Canadian hospital performance in obtaining informed consent from patients and providing written documentation of transfusion? We can only speculate. If you are not Canadian and think your hospitals perform better, my quess is, think again. The problem is likely widespread in the USA, the UK, and elsewhere. You will not know without extensive audits.

Clearly, much work remains to be done in fulfilling some of Justice Krever's most basic recommendations. In the meantime, informed consent seems to a case of take this job and shove it!

**Be sure to check out the "comments" section below.**