Thursday, November 30, 2017

Always on my mind (Musings on lack of transparency in Canada's blood system)

Updated: Dec. 1, 2017 (Fixed typos)
For November I had to write a blog on a current controversy in Canada related to paid plasma. Yes, I know I've written a lot about it already but 20 years ago this month, specifically Nov. 26, 1997, this was published:
  • Final report of the Krever Commission of Inquiry on the Blood System in Canada
This blog will be briefer than usual, partly because I wrote two blogs for October, but mainly because I invite readers to draw their own conclusions by reading the resources in Further Reading.

Executive version: Seems that Health Canada has not been transparent in its dealings with Canadian Plasma Resources and has exceeded its role as regulator. And who knows what CBS has been doing behind the scenes on the paid plasma file because they've been inconsistent on the issue.

Why read the blog? For Canadians it matters because of the fiascoes of the 1980s and '90s, which we do not want to repeat, ever:
  • 2000 Canadians contracted HIV via transfusion, 1980-85;
  • 30,000 transfusion recipients were infected with HCV,1980-90;
  • See Krever Report (Further Reading) for the errors made by Canada's faulty blood system and its experts.  
20 years later Canadian Blood Services brags that we have a transparent, accountable blood system.

Readers in other nations may find the Canadian lessons learned (and not learned) useful.

The blog's title derives from a 1972 ditty about a love story gone wrong.

The report that stimulated the blog is
  • A bloody mess: The story behind paid plasma in Canada (Further Reading). 
Using Freedom of Information, Macleans reporter Anne Kingston discovered that communications between Health Canada, CBS and CPR (private plasma paid company) between 2009 and 2016 raise new questions about blood governance in Canada and its ties to industry. 

What follows includes tidbits in the Macleans article and Health Canada's response that I see as key.

1. Documents show Health Canada and the private plasma company agreed on the need to co-ordinate their responses to media questions.
My take: If true, that's unacceptable collusion and damning to HC.
2. Health Canada instructed Canadian Plasma Resources to monitor donor history of prior blood donation to ensure there is no negative impact on voluntary blood donations.
My take: Since when does a regulator (HC) rely on a private company to determine facts used to formulate public policy. Too stupid for words.
3. HC: The Dublin Consensus Statement was convened by a group of patient organizations, not an industry lobby group. International blood operators, including Canadian Blood Services also attended the conference, as well as...the Plasma Protein Therapeutics Association.
My take: Big Pharma's paid plasma companies fund patient groups big time and it's not always transparent. Patient groups invariably support Big Pharma's views, whether because of fear their therapies are at risk or because they need the funds. Some patient group execs seem to be in the back pocket of industry.
4. CBS is not innocent in all of this. Why you may ask? Mainly because its views and actions are erratic and Canadians have to wonder why. Examples:
  • For years CBS rightly emphasized paid plasma manufactured into blood derivatives such as IVIG were safe. Their views were echoed by HC but it seemed a united front in favour of, almost promoting, paid plasma;
  • CBS closed its Thunder Bay plasma collection centre, citing lack of demand for transfusion plasma, not the reality that outsourcing to USA for plasma-derived products was cheaper;
  • Then CBS pivoted 180o. In January 2017, it announced a 7-year, $855-million strategy to increase Canada's plasma self-sufficiency from 17% to 50%, requiring up to 40 new plasma collection sites;
  • CBS also changed its view on paid plasma clinics decreasing volunteer donations. First it was no, then yes.You have to ask why all the changes. 
As André Picard asks, have we forgotten the lessons of history, namely Canada's tainted blood scandal? To me neither CBS or Health Canada has been transparent. And the organizations are closely tied, given that HC has always relied on experts, including those at CBS, to determine policies.

I chose this song because I like it and as a lifelong blood banker who lived through Canada's tainted blood scandal - where only Canadian Red Cross took the rap in courts -  it hurts when those we rely on let us down and folks die as as a result. And that is always on my mind.

The beautiful song was released in 1972 and covered by Willie Nelson in 1982.
As always, comments are most appreciated.

A bloody mess: The story behind paid plasma in Canada (22 Nov. 2017, Macleans)
Freedom of information documents (859 pages)
Have we forgotten the lessons of the tainted blood scandal? (André Picard, 28 Nov. 2017)
André wrote The Gift of Death: Confronting Canada's Tainted Blood Tragedy, to be made into a TV miniseries, Unspeakable,  in 2018
André's entry on the the Krever Report (Canadian Encyclopedia)
Health Canada assisted private plasma clinics, newly released documents say (28 Nov. 2017)

Statement from Health Canada in response to Maclean's article on paid plasma (24 Nov. 2017)

1 comment:

  1. Anonymous9:01 PM

    Another case of a lack of transparency by the CBS and Health Canada? My understanding is that one of the replacement products has not yet been approved by Health Canada but somehow managed to pass through the RFP process at the CBS. What the heck?

    An Open Letter to the Canadian Hemophilia Community Regarding the Continued Availability of Eloctate® and Alprolix®