Friday, July 12, 2013

Day tripper (Musings on HC's instructions to the jury on paid plasma)

Updated:  28 March 2017 (Updated broken links)

Okay, one more time on paid plasma in Canada as there is a new development. Canadians have at last been asked by Health Canada (HC) for their opinions.

Having held a roundtable on paid plasma closed to the public in April, with invitees being stakeholders, including industry, HC on 27 June, 2 months later, invited Canadians to comment.

Goodie! Our govt comes through, albeit slowly. No doubt after it got all its ducks in a row to create the result it wants (she wrote, tongue in cheek).

The blog's title comes from a Beatles ditty, Day Tripper. One of its lines begins, 'She's a big teaser...'

HEALTH CANADA'S BACKGROUNDER
Ya gotta love Health Canada's 'backgrounder' to inform Canadians on what to think about paid plasma.

Key points that our 'balanced and fair' government agency chooses to highlight document its bias. They've laid out a one-sided view that makes it seem that you're nuts if you are against paid plasma. 


And on the webpage where HC requests and welcomes comments, studies, etc., the request itself comes ~2122 words down, at the very end, just before the appendices. If you didn't know it was there, you would NOT know HC was asking for feedback. Plain dumb about how to get feedback or deliberately done?

To me HC's background information is similar to a judge instructing a jury that the defendant is clearly innocent because 

  • The prosecution's case lacks even a scintilla of logic
  • Everyone does what he did. Where's the harm, what's the big deal?
  • If you find the defendant guilty, his long-suffering wife and kids will end up in the poor house and starve.
  • Oh, and we're going to keep the evidence against the defendant's claims secret. Uncover them if you can. You're on your own, suckers! 
  • In the meantime, let me parrot the defense arguments, ad infinitum
  • Sure, I've made prejudicial public statements to influence the case, but, hey, I'm fair and open, trust me.
Examples from HC's backgrounder [my interpretations]:

HC - #1: Payment is allowed in all provinces and territories except Quebec

[It's only the Francophones who've resisted and you know what they're like. Lefty, progressive types.]
HC - #2: Paying for plasma isn't new. A Winnipeg company [Cangene] operated SAFELY and has paid plasma donors for 30 years.
[HC doesn't explain that Cangene's plasma collection originally began to collect special plasma, e.g., potent anti-D to produce Rh immune globulin, and was originally called the Rh Plasma Center.
It did not begin as a schlock plasma collection facility in an inner city taking plasma from the poor. 
It collected plasma from women who had infants severely affected with Rh hemolytic disease of the newborn and fetus and who wanted to donate to prevent other mothers and babies from suffering, as discussed in an earlier blog, Dr. Jack Bowman (In Memoriam)
HC - #3: Canada's plasma products imported from U.S. are largely from paid donors
[Everywhere we look, it's paid donors, folks, so what's the concern, you daft dodos?]
HC - #4: Plasma collected from paid and unpaid donors is equally SAFE, because every donor is treated the same with screening, testing and techniques to eliminate viruses. Canada has not had a single case of HBV, HCV, or HIV transmitted by a plasma product in the last 25 years.
[Paid plasma is safe, safe, safe. Forget that HIV in the early 1980s was incorrectly thought to a gay disease.
Forget that our blood supplier opted to supply non-heat treated FVIII concentrates to hemophiliacs believing most of them were likely already infected and, hey, garbaging our extensive supply of untreated FVIII was too costly.

Forget that we didn't have a clue what non-A, non-B hepatitis was but Canada opted not to use surrogate tests as they did in the USA because such tests were too non-scientific  - not sensitive enough and not specific enough - and our scientists were so much smarter than those in the USA. Result: Tens of 1000s of HCV infections in Canada.]
HC - #5: USA is the largest plasma producer, with much of the world relying on its supply. ~70% of the immune globulins used in Canada are from U.S., most from paid donors.
[Canada's immune globulin supply already comes from paid donors. You're using them now, you fools. If paying donors is good enough for USA, it's good enough for us.]
HC - #6: Without access to products made from paid plasma, the health and lives of 1000s of Canadians who rely on their life-saving properties could be at risk.

[Pure fear-mongering. HC implies - with zero evidence - that without paid plasma, 1000s of Canadians would die. Sorry, sounds like bullsh*t.]

HC - #7: Demand for plasma continues to grow rapidly around the world.  Canada's need for immune globulins is growing at a rate of 5-10% annually. To collect this amount of plasma from voluntary Canadians donors, we'd need to increase these donations by 300%.

[Really? We're just to accede to the growing off-label uses of immune globulin?
Docs prescribe and Canadian taxpayers pay, no questions asked? That's not quite how it works, of course, as provincial governments monitor utilization and try to enforce good transfusion practices. But what a bonanza to commercial suppliers to have Canada's government agency in charge of regulating the blood supply appear to be such an industry poodle.

And has Canada tried to increase its plasma donations? No.  
Indeed, when CBS closed a plasma collection plant in Thunder Bay in 2012 it claimed a decrease in the need for plasma for transfusion. CBS did not mention that plasma was needed as a source for the incredibly growing, not shrinking, use of plasma derivatives like IVIg. 
In its 2011 Financial Report CBS noted it started a pilot program to purchase surplus, recovered plasma from the USA. Simply put, it was cheaper to buy the stuff than collect it ourselves but that's not what CBS said.
Crass obfuscation of presenting selected 'facts' to Canadians is now commonplace for our national blood supplier.
And has Canada tried to increase voluntary plasma donations? Not really. But let's not let uncomfortable facts spoil a good story.]
HC - #8: Canada is committed to maintaining a 100% voluntary, self-sufficient blood transfusion system EXCEPT for plasma donors paid by commercial companies to manufacture plasma derivatives. 
[Just like it's impossible to be a little bit pregnant, it's impossible to have a voluntary system when any and all plasma donors are paid. And we're not talking about donors with special goodies in their plasma. We're talking about ALL plasma donors being paid. 
Poor, sexually active young students? Yep.
Poor, drug-addicted homeless people? Yep.

No worries. Our screening questions are perfect. Donors desperate for $ don't lie.

Our screening tests are perfect. There's no such thing as windows of negativity. 
Our manufacturing processes kill ALL bugs. Except when tests don't, because we don't know what the bugs are. 
And don't worry about exploiting the poor. We need them, else tens of 1000s of us might die. 
Ethics, schmethics. Let's set plasma clinics up next to centres for addiction and mental health, homeless shelters, and the like. 
International organ trade already thrives. Let's contribute to it by paying for all body tissue, inc. plasma.]
HEALTH CANADA'S PROCESS
WHO admirably showed all submissions to its 'Expert Committee on Selection and Use of Essential Medicines' on its website. 

That made for a transparent process in which everyone could follow the arguments, both pro and con.

In contrast, Health Canada - that paragon of non-transparency
after you've scrolled through over 2100 wordsasks that we send an e-mail to BGTD.OPIC@hc-sc.gc.ca. The request could not be more obscure. Why not mention it right at the top of the page?

And send an e-mail? Result is that no one will know who has commented, what they said, what their arguments are. No doubt this suits HC just fine. 


Totally non-transparent, but it fits our government perfectly. Sadly it also fits CBS, our national blood supplier's modus operendi. Both behave like industry poodles who obfuscate to Canadian citizens. 

Why? Because, in their wise, all-knowing view, the public are children incapable of grasping complex, nuanced issues? For crying out loud, show us some respect.

It's deja vu all over again from the 1980s, with Canadian Red Cross Blood Transfusion medical experts (see my backgrounders below) saying

  • We know best
  • We're medical experts who assess based on evidence
  • We're arrogant, but we've a right to be 
BOTTOM LINES
As noted earlier, HC has prejudged the case for and against paid plasma. If HC were a judge instructing a jury, they'd be guilty of judicial misconduct for their prejudicial conduct. As a Canadian, I'm disappointed and give HC a failing grade on its pathetic feedback process.
As to the precautionary principle - whose application to the blood system is admittedly complex - that's so 20th C. 

Yes, plasma derivatives have a good safety record recently, with multiple screening, testing, and manufacturing safety processes in place. 

But blood system experts were uber-confident earlier and things did go horribly wrong (see backgrounder and earlier blogs below). And they can again.

And it's not all about safety. It's also about 
  • Ethics of paying the poor for their body tissues
  • Facilitating commercial interests whose main motivation is profit and whose history has shown profit always comes before safety, despite parroting 'safety comes first'.
  • Potential effects on voluntary donations
  • Slippery slope of where commercialization of the blood supply will go
FOR FUN
Health Canada's conduct reminds me of the 1965 Beatles ditty, Day Tripper. It's how I think of HC's bungled handling of public feedback on paid plasma.

They teased us with thinking a real discussion would happen, then took the easy way out by becoming poodles of industry and their surrogates, who increasingly seems to include our publicly funded blood suppliers. Who knew?

  • Day tripper (Paul McCartney, live in New York Mets stadium, 2009)
Got a good reason, for taking the easy way out. Got a good reason, for taking the easy way out, now. 
She was a day..... tripper, one way ticket, yeah!
It took me so..... long to find out, and I found out. 
She's a big teaser, she took me half the way there She's a big teaser, she took me half the way there, now. 
She was a day.... tripper, one way ticket, yeah! It took me so.... long to find out, and I found out.
Comments In reply to comment below from Anonymous: 
Health Canada doing this in the summer is classic. It's equivalent to governments releasing info on Friday, especially Friday of a long weekend, where an announcement will surely get buried in the news cycle. 
Plus they hardly advertised the opportunity for feedback. And then 'buried the lead' at the end of a biased background paper. To say nothing of offering thoughtful commentary on the issues involved of the kind outlined in Dr. Alena Buyx's paper below.
Sadly, Health Canada reveals themselves as industry poodles, as well as shallow, non-reflective thinkers. As a Canadian, I'm embarrassed. 
FURTHER READING

Resources added 26 July (Thanks to Anonymous - see Comments below)
1. UK’s state-owned NHS plasma supplier sold to USA private equity firm Bain Capital founded by Mitt Romney  (Belfast Telegraph, 26 July 2013) Former Minister of Health Lord Owen:  
  • “The world plasma supply line has been in the past contaminated and I fear it will almost certainly continue to be contaminated.” 
2. For-profit plasma clinics risky business ('Healthy Debate', 22 July 2013)
2 papers added 20 July 2013
1. Buyx AM. Blood donation, payment, and non-cash incentives: classical questions drawing renewed interest.Transfus Med Hemother. 2009;36(5):329-339. 
Thoughtful article by Dr. Alena Buyx, Senior Researcher in health care and medical ethics at the Institute for Ethics, History and Philosophy of Medicine, University of M√ľnster in Germany.
2. Farrugia A, Penrod J, Bult JM.  Conclusion: 'Current systems of compensation and replacement are needed to maintain supplies of essential products and lead to safe products in controlled environments.'
Authors provide services to the Plasma Protein Therapeutics Association, which represents private sector manufacturers of plasma protein therapies and the collectors of source plasma used for fractionation
Key backgrounders:
1984: Red Cross denies link between AIDS and blood products [Listen careful to Dr. Noel Buskard's words]
1997: Krever Report on tainted blood lays blame (short video)  
My 5 earlier blogs on paid plasma (some external links may be broken): 
  1. Heart of Gold (Musings on pimping for paid plasma)
  2. Still my guitar gently weeps (Yet more musings on commercialization of our blood supply)
  3. We are the world (More musings on commercialization of the blood supply)
  4. CSTM reply to 'Stop children, what's that sound'
  5. Stop children, what's that sound (Musings on commercialization of our blood supply)
Related blogs by DiaBlogue (Project of the OPSEU Health Care Divisional Council)
Health Canada's Backgrounder Paper (documenting its 'judicial misconduct')

Added 11 August 2013 (thanks to Anonymous)
As always, comments are most welcome.