Sunday, March 16, 2014

Hey Jude (Musings on why paid plasma makes it worse, not better)

Last updated: 29 May 2014 
This months blog is a two-fer. The title is a take-off on the best Beatles song ever, Hey Jude.

The blog was motivated by the recent decision of the Ontario government to introduce legislation to ban paid plasma. (Yikes! In the first version, I forgot the lead. Unforgivable. See BBTS blog's advice.)

I'm delighted and honoured to be a guest blogger for the BBTS:
Born to be Wild? (Musings on how to blog for transfusion professionals)

The BBTS blog is about how to blog as a transfusion medicine professional. Take a peek. The advice can be applied to e-mail messages too.

However, this month I cannot resist blogging on a recent development in Canada involving paid plasma clinics.

On March 14, 2014 one of Canada's provincial governments, Ontario, decided to ban paying for plasma (and all blood donations), as had already been done in Quebec (see Further Reading).

Humour me with a few simple thought experiments. Probably best to think of them as 'What If' games.

'What If' Game #1
What if I represented Canadian experts who told you that surrogate tests for non-A, non-B hepatitis used in the USA were scientifically unsound.

The tests had poor sensitivity (missed many true positives) and poor specificity (detected many false positives) and would threaten the blood supply by preventing many perfectly safe blood donors from donating. Plus the testing was expensive.

Then I asked for a vote on doing surrogate testing on all blood donations or not. Based on expert opinion, you'd probably vote not to do it, right?
Game #1 Outcome Turns out that because Canada's TM experts prevailed, thousands of Canadian recipients of blood donations were needlessly infected with what we now call hepatitis C. Despite the flawed surrogate tests, they would have prevented many HCV cases in transfusion recipients. See
'What If' Game #2
What if I told you that concentrated Factor VIII to treat hemophilia had several advantages over the existing treatment, cryoprecipitate, including a known quantity of Factor VIII and more convenient storage. Doctors touted it as 'latest and greatest' advancement.

Then I asked for a vote on using cryo or Factor VIII conc. Based on expert opinion, you'd probably vote for using only Factor VIIII concentrate, right?
Game #2 Outcome Turns out that Factor VIII concentrate was made from the plasma of 10s of thousands of blood donors and it only took one donor to be infected with the then unknown human immunodeficiency virus (HIV), that causes AIDS. The saviour of patients with hemophilia turned out to be a death sentence for many.
'What If' Game #3
What if I told you that Factor VIII concentrate transmits several deadly diseases but, when heat-treated Factor VIII became available, and was shown not to transmit HIV, we should still give the unheated product to hemophiliacs.

After all, experts contend that most hemophilia patients are likely already infected and we have mega-bucks worth of product in storage. As well, if we don't give the unheated product to them, many would suffer life-threatening hemorrhages.

Then I asked for a vote on transfusing the existing stock of Factor VIII concentrate to likely already-infected hemophilia patients. Based on expert opinion, you'd probably vote for using unheated Factor VIII concentrate, right? We have the stock, it'll save money, and they're already infected.
Game #3 Outcome Turns out that this expert decision cost the lives of many hemophiliacs who were NOT already infected. How the experts reasoned will never be known.
Unlike US President Nixon, minutes of key meetings by decision makers (Can. Red Cross physicians and their provincial paymasters) were destroyed. I kid you not. 
To their credit, a few Canadian physicians opted for using single-donor cryoprecipitate, thereby protecting their hemophilia patients from HIV.
We decide based on what we know at the time and rely heavily on perceived experts.But we only know what we know. We don't know what we don't know.

And experts can be oh so wrong, as expertly detailed by Canada's Krever Commission (see below) and, more superficially, in my What If games above. Which is why I'm not onside with our TM experts on Canada's further venture into paid plasma.

Of course, you can also make an ethical case that Canada should not go down the path of paying for plasma.

ONTARIO UPDATE (Added 17 Mar. 2014)
Canadian Plasma Resources is a private company in Ontario whose sole purpose is to pay for and collect plasma for further manufacturing.

In Canada the safety of the blood supply is a federal responsibility that falls to Health Canada but whether plasma donors can be compensated rests with provincial and territorial governments.

On March 14, 2014, the government of Ontario issued this press release:
Among other things, it plans to introduce legislation to ban paying for blood in Ontario (as Quebec does now). Canadian Plasma Resources has plans to open plasma clinics in Toronto and nearby Hamilton, Ontario.
See Further Reading for news items on the announcement and background info on the issues. I'll update with more news items as they become available.
The case against paying for plasma is discussed on Impact Ethics: Making a difference in bioethics:
The authors are from Dalhousie University, Halifax, NS, Canada:
  • Matthew Herder, Asst Professor, Faculties of Medicine and Law
  • Francoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy
Included in the article is a copy of their submission to Health Canada, which is well worth a read too:
Of course, the issue in Ontario is far from settled:
  • First, after wide consultation, the legislation has to pass in Ontario's legislature. 
  • Second, Ontario has a minority government with an election required by Oct. 1, 2015, with strong polling support for three parties
  • Third, there will be blowback from vested interests.
REPLY TO COMMENT(Added 18 Mar. 2014)
This is in reply to the comment below from 'Anonymous', a hemophiliac who contracted HIV and HCV in the 1980s. He ended by predicting that 'the smoking gun will be IVIG for our next round.' Please see my reply to him below, which I'll expand upon here.

I'll briefly comment on the safety and ethics of paid plasma, which is fractionated into plasma derivatives such as IVIG. 

First SAFETY. In a commentary that CBS CEO Graham Sher authored in the Toronto Star in March 2013 ('Prohibiting pay-for-plasma would harm patients'), Dr. Sher wrote (summarized by me):
  • Manufacturers must be licensed and meet stringent quality and safety standards.
  • Safety procedures built into fractionation are extensive, and include donor screening and testing, plasma quarantine, technology that inactivates viruses, and purification steps. 
  • These products are extraordinarily safe. 
  • Many studies show plasma products from paid donors are as safe as those manufactured from volunteer donors.
All medical experts stress that plasma derivatives such as IVIG are extremely safe when it comes to transfusion-transmitted infectious agents. They stop just short of claiming they are 100% safe, because such a claim could come back to haunt them.
No one wants to be in Dr. Noel Buskard's shoes when on behalf of the Canadian Red Cross he denied a link between AIDS and blood products. (2 min. CBC video. Sorry for the 45 seconds of ads).  
Dr. Buskard quit the Red Cross in 1991 saying that it had developed a “fortress mentality” when confronted with the tragedy. He became a noted whistleblower, who in 2001 was awarded the 'Whistleblower Award' from the B.C. Freedom of Information and Privacy Association. (Source: A tribute on his death in 2011)
Because plasma derivatives are relatively safe, some against paying for plasma say it's best to concentrate on the ETHICS of paid plasma. I'm not going to regurgitate the many complex rationales for and against paying for plasma. For one thing, it's above my pay grade and expertise.

To quote CBS CEO Sher, the ethical case for paying is that the derived products are 'extraordinarily safe' and patient lives would be threatened without paid plasma: 
  • The reality is that thousands of patients depend on these life-saving fractionated products, and without those produced using plasma from paid donors we would not be able to meet patients’ needs...When lives are at risk, that’s simply not an option.  
The ethical case against paying for plasma includes the reality that 
  • Commercial plasma collectors exist to make money. 
  • Exploiting the poor and vulnerable and selling to the highest bidder are what drives for-profit enterprises. 
  • Witness Canadian Plasma Resources building a clinic next to a homeless shelter. 
Is this really a path Canadians want to take? Matters not what happens in the USA or elsewhere. That's not us.

Some call this position hypocritical since we use products made from paid plasma in other countries. Perhaps. 

But is it any more hypocritical than CBS closing a Canadian plasma collection centre saying demand for 'plasma for transfusion' was down, and at the same time outsourcing plasma collection to the USA because it was cheaper? Then having its CEO claim that lives are at risk if we don't use paid plasma?

CBS Annual Report 2007-2008 (p.22): 
This year, we also re-introduced the collection of source plasma at our existing plasmapheresis sites ...laying the foundation for CBS to improve our plasma sufficiency - one of the basic principles of the blood supply as outlined in Justice Krever's report.
CBS Announces closure of Thunder Bay Plasma Centre (29 Mar. 2012)
Over the past two years, new replacement products and a decline in hospital demand have led to a decrease in the need for plasma for transfusion
CBS Financial Report March 2011 (p.32)
In 2010/11 CBS started a pilot program to purchase surplus recovered plasma from the United States (collected by organizations with an FDA licence) which will continue in 2011/2012.
Report to Canadians 2012/2013, Management Analysis (p.43)
As self-sufficiency is not operationally or economically feasible in a volunteer, non-remunerated model, CBS strives to maintain a sufficiency of 30% for Ig. The demand for Ig continues to rise in Canada and internationally, and to meet our needs CBS purchases surplus recovered plasma (from voluntary donations) from the United States for fractionation, which increased by 4,572 litres or 17.0% in 2012/2013 over 2011/2012.  
'Don't let the perfect be the enemy of the good.'
So, yes, hypocrisy abounds on all fronts. It would be preferable (perfect) if we didn't need to use plasma derivatives sourced from paid plasma anywhere, but to me, banning paid plasma clinics in Canada is preferable (good). Not PEFECT, but GOOD.

To return to the comments made by Anonymous below, I've discussed the IVIG safety issue and that history shows we can never be certain about blood safety. About his introduction: I am a hemophiliac that got HIV and HCV in the 80's, I'd like to end with
  • The tragedy of Factor VIII Concentrate (19 min. CBC video you won't soon forget. Take time to watch it sometime. As transfusion professionals we owe it to Canada's hemophiliacs and to ourselves.)
Added 29 May 2014'Must read' on paid plasma
Hey Jude is a 1968 song by Paul McCartney, with an interesting origin.

Regardless, Hey Jude is about trying to make something that is bad better. Paying for body organs and tissue, including plasma, is a bad idea.
  • Hey Jude (Paul McCartney, Live in Red Square)
Hey Jude, don't make it bad. Take a sad song and make it better...
As always, the ideas are mine and mine alone. See comments below. More comments are most welcome.

Also, don't forget Born to be Wild? (my first blog for the BBTS)

Further Reading