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.

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."

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.

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.

For followers of the CBC's Unspeakable, I recommend these resources:
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)
For followers of the UK's Infected Blood Inquiry I recommend these resources: