Friday, June 29, 2018

The Boxer (Musings on HC's Expert Panel Report on immune globulin & paid plasma)

Updated: 30 June 2018 
June's blog is about paid plasma in Canada, but don't start snoozing, it focuses solely on the Final Report of Health Canada's Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada (hereafter referred to as the Expert Panel). Goodness knows how much it cost Canadian tax payers. Suspect we'll never know.

Why the blog? Well, how many Canadian transfusion professionals have read the Expert Panel Report on their own time? Maybe inside CBS they've had a staff member précis the key points as its findings are critical to the blood supplier but wouldn't happen in busy, mostly under-staffed transfusion services where Report doesn't affect operations. So, in a way, it's my gift to colleagues who may never have the time to read it and reflect.

Just happens that in a one-day lull in the FIFA World Cup of football (soccer in NA)  - I'm a footie fanatic - I finally managed to read some of the Final Report entitled Protecting Access to Immune Globulins for Canadians (pub. May 2018). Oh, and initially folks had to write to Health Canada to get a copy as it wasn't online, but now is (Further Reading).

So far I've read mainly the Executive Summary, which is the longest exec summary I've ever seen totalling 3975 words over 8 pages. Supposedly, average readers can read about 200 words/min or 2 pages/min, both of which mean average Canadians would need 15-20 mins. to read just the exec summary. Now the Expert Panel was not tasked to make recommendations and perhaps this contributed to the long summary (or not).

What follows are a few things that stood out for me in the Executive Summary, which I've finally waded through. Are these the key points? Who knows after 3975 words? BTW, I've worked in Canada's blood system as a transfusion educator for decades. Granted, my neurons are aging by the minute, but identifying the Report's key take home messages based on the exec summary was difficult. The following jumped out at me.

Why read the blog? If you care about Canada's blood system, it's a summary of what Health Canada received from its Expert Panel. If you are not Canadian, it informs on the issue of the $multi-billion paid-plasma industry [Further Reading] and why it thrives, despite being inherently unethical and preying on the poor.

Page 6 - Who uses immune globulin (IG)
Patients receiving IG can be divided into 2 major groups: those for whom the drug is life-saving and for which there is no effective alternative at this time and those whose illness can be positively impacted by the use of IG but for whom there are other therapeutic alternatives also available. There are a relatively small number of conditions and patient groups for which IG has been definitively shown to be effective and they account for the majority of use of IG.
ME: Really? No third group? Those receiving IG for 'off label' uses for which few if any evidence-based studies exist?  Is all IG issued in Canada screened to prevent inappropriate use versus the physician wants it and gets it, especially if a 'biggie'? The screen has no holes? I'm surprised.

Page 7 - Audits of who uses IG
Given the high usage of IG in Canada, a number of audits have been carried out in different provincial jurisdictions to understand patterns of utilization of this expensive product. These audits show that a significant proportion of IG use falls outside established criteria and guidelines. Other jurisdictions, particularly the UK, have achieved more success than Canada in optimizing the appropriate use of IG for patients for whom it is indicated, and as a result have a much lower per capita utilization rate.
ME: Huh? Guess there is a third group of IG users in Canada.

Page 8 - Public view of paid versus volunteer donors
One of the important dynamics impacting the future of the global plasma supply is the strong public policy position for using volunteer unpaid donors for source plasma collection and a resistance to the use of paid donors. The rationale for this position includes concerns about safety of products made from paid donors, ethical concerns about the commodification of human plasma, and concerns that compensation for donating source plasma would diminish the commitment of volunteer donors of both whole blood and apheresis platelets.
ME: This sets out the 3 main reasons why some folks are against paid plasma. The Panel emphasizes safety is not an issue, indeed it's the only thing that's bold-faced in the exec summary (p. 9). Referring to fractionation of plasma derivatives:
The outcome of these changes has been dramatic: there have been no confirmed cases of disease transmitted through PDPs in over 2 decades.
To me, a transfusion professional, that's a no-brainer. What the statement did not say is that fractionation clearly kills all currently known transfusion-transmitted infectious agents. Regardless, plasma derivatives like IG have a good safety record, are safe for the time being, and for anti-paid plasma advocates to emphasize safety is non-productive.

ETHICS is all but unmentioned by Expert Panel: What I didn't see in the exec summary was a discussion of ethical concerns about the commodification of human plasma (Further Reading:The twisted business of donating plasma).

For this readers must go to p. 71:
Moral/ethical opposition to paying for blood or plasma due to the perception that it negates the benefits of a solely voluntary-based donation system, and that it targets vulnerable populations. These organizations declared their support for the CBS initiative to collect more plasma by opening 40 new voluntary donor plasma collection sites. They also called on the Government of Canada to halt licensure of paid plasma businesses in Canada, including CPR.  
In contrast to the other groups above, a group of >30 ethicists and economists submitted an open letter to the Panel expressing concerns about banning compensation for plasma donors and the resulting impact on the ability to secure a sustained and safe supply of IG for patients in Canada. This open letter also addressed key points frequently raised in the debate, including: wrongful exploitation, commodification, altruism, safety and security. Approximately half of the signatories were Canadian, while most of the rest were from the US (Appendix G).
ME: App. G is of course the letter written by Peter Jaworski (and others), author of Markets Without Limits, whose primary thesis is, 'If you may do it for free, you may do it for money' meaning selling body tissues and organs is moral because you can do it for free (voluntarily donate). And selling tissues / organs saves lives so must be good, conveniently ignoring and minimizing that it preys on the poor.

What's not said in the Report (did they know or care?) is the connection between Jaworski and others who have coincidentally written many letter and op-eds for Canadian media in an attempt to influence public opinion in favour of paid plasma. Jaworski co-founded the Institute for Liberal Studies and is an adjunct scholar at the [ libertarian ] Cato Institute.

Bottom Line: Expert Panel all but bailed in the issue of the ethics of paid plasma. There are many, including Canadians, who could have given an ethical perspective against paid plasma but they were not consulted. Shame on the Panel.

Page 9 - Self sufficiency requires paid plasma
Across Europe, Australia and North America, the only jurisdictions that have achieved 100% self-sufficiency for plasma collection are those that have permitted paid plasma donors. Jurisdictions that permit payment of source plasma donors have a significantly higher plasma collection capacity on a per capita basis compared to those jurisdictions where compensating source plasma donors is prohibited.
ME: Paying poor people increases donations/capita? Yes. Wonder how many nations, particularly Canada, might be closer to self sufficient if - CBS got funding to collect more plasma - and the main IG users were those for whom the drug is life-saving and for whom there is currently no effective alternative? Just a thought.

Page 9 - Volunteer plasma more expensive
In addition, the cost of collecting large volumes of source plasma utilizing volunteer donors is 2-4 times more expensive than the commercial plasma collection model and thus it remains more economical for jurisdictions to purchase IG and PDPs from the commercial market, all of which are made from plasma from paid donors. Finally evidence indicates that, notwithstanding the funding for blood operators to meet collection targets to achieve self-sufficiency, often source plasma programs based on volunteer donors just simply can't make their targets.
ME: Had to read further (search for it) on why volunteer plasma is 2-4 times cost of paid plasma. Found it on p. 64:
Different sources suggest that enhancing self-sufficiency through the collection of volunteer apheresis plasma by the blood service would seem to cost 2 to 4 times as much as that collected by commercial industry (Refs 36,114.)
NOTE: This statement of cost seems based on a submission by Canadian Plasma Resources (Ref. 36) and Ref 114, Noel S. How to reduce cost of apheresis plasma? First lessons of a benchmarking. Établissement. Français du sang. 2015. (no link provided). The Panel goes on to explain:
In part this relates to the limits on donation frequency which appear to be inherent in a volunteer donor based source plasma  operation –  for example: a commercial operator in the US achieves an average paid plasma donor frequency of 17.3 donations per year, while non-profit operators across Canada, the US, the EU and Australia average from 4-7 source plasma donations per year per volunteer donor.

The collection volumes per source plasma collection site run by non-profit operators range from 4,000 - 15,000 litres in Canada and the EU, while in the US and EU commercial sector the volumes per site range from 40,000 to 50,000 litres.
ME: So the increased cost of volunteer plasma is based ('in part') on 17.3 donations/yr for paid plasma versus 4-7/yr from volunteers. In other words, because paid plasma companies mostly operating in the USA suck the maximum volume of blood out of America's poor, paid plasma is cheaper to produce and plasma companies make $billions.

Page 9 - Notion of 'volunteer' is evolving
Other evidence revealed the evolving nature of a voluntary donor – data from the European Union reveal that in Europe, incentives for voluntary donors are diverse and in many instances have a value equivalent or even greater to what would be considered payment in Canada and other jurisdictions – thus the definition of a volunteer donor is shifting.
ME: Good point. Also think it's similar in most of USA's non-profit blood centers. They offer goodies ranging from Walmart gift cards to credits if friends and relatives ever need blood transfusion so they don't need to pay.

Page 10 - Self sufficiency in Canada
The question of whether Canada should increase its self-sufficiency in plasma collection and to what degree was a major focus of the Panel. The Panel had a strong consensus that Canada needs to make a much more significant contribution to the collection of source plasma – the Plasmavie program and the desire of CBS to increase collection of source plasma from their donors are an appropriate response to the significant dependency on the US as a source of plasma.  
On the issue of what level of self-sufficiency should be targeted, it is appropriate for Canada at a minimum to be able to provide sufficient plasma to meet the needs of the one group who are truly life dependent on IG –  those patients with primary immunodeficiency (PID). This would ensure that these patients are protected in the unlikely event of a severe shortage. Volume targets beyond this minimal expectation should reference priority clinical needs.
ME: Another key question un-addressed by the Panel: What percentage of Canada's IG supply do PID patients - who truly need it - use? If CBS greatly increased its collection of plasma could their needs be met? Versus just allowing non-evidence based 'off label' uses to grow, thereby enriching the paid plasma industry, as currently exists.

Page 10 - Solid business principles and partnerships with private sector
Importantly, the move to collect more source plasma by CBS and H-Q needs to be based on solid business principles and learnings and/or partnerships with the private sector who have significant expertise. Increased source plasma collection by CBS and H-Q cannot be undertaken at any cost. There is a significant premium related to the cost of collecting high volumes of plasma from volunteer source plasma donors (between 2-4 times more costly) –this is recognized by CBS and was reaffirmed by discussions with other jurisdictions. 
Given that there are a number of provinces in which commercial plasma operations are currently permitted, the Panel agreed that options could be carefully examined to ensure that all source plasma collected in Canada from Canadian donors (whether paid or volunteer) be made available for the needs of Canadian patients. There are a number of mechanisms whereby this could be achieved.
ME: This is the Expert Panel's bottom line - the recommendation that the Expert Panel could not make but did in its own way. Why is it on p.10 of 12 in the exec summary? Paid plasma is okay in partnership with Canada's existing voluntary blood system. And the Panel cautions governments: Do NOT spend too much tax money on increasing voluntary plasma donations.

Meaning, the Panel is advising the provincial/territorial funders of Canada's blood system not to give CBS too much of the extra funding it requested but give it some? Some funding is needed because the world should not be too dependent on the USA for plasma as it now is - discussed extensively elsewhere in the Report, mainly in 4.2 SECURITY AND SUSTAINABILITY OF SUPPLY OF PLASMA, pp. 59-64. Will be interesting to see how long CBS will need to wait to find out what funding it has and begin planning.

Page 11- Paid plasma has no effect on the blood supply
There is no compelling data to suggest that expansion of source plasma collection - whether with paid or unpaid donors - has negatively impacted the whole blood supply. However, we would caution that this is an issue which should be further researched and it requires ongoing oversight and vigilance. One particular issue worth monitoring is whether source plasma operations could affect recruitment of future volunteer apheresis platelet donors.
ME: What's with the focus on the whole blood supply? Why no mention of plasma donation, which can be done more often? And mentioning aphersis platelet donation also ignores the issue of targetted plasma donation.

Page 12 - Final page of Executive Report
In summary, much has changed since the release of the Krever Commission report in 1997. PDPs are safe...However, like most of the world, we are too dependent on one jurisdiction (US) for the supply of the vital raw material used to make these products.

Canada needs to do more to collect plasma and take other steps to enhance our self-sufficiency in meeting the needs of our citizens for PDPs. As discussed there are a number of decisions to be made and strategies to be considered. In the implementation of the strategies, there needs to be transparency for the public and stakeholders, adherence to good business principles with flexibility in the approach where appropriate, due consideration of the taxpayer, and ongoing attention to the outcomes with the capacity to adjust where necessary.
ME: The Panel correctly stresses that much has changed since the 'tainted blood' tragedy of the 1980s-90s in Canada and elsewhere. Most notably, the fractionation process of plasma derivatives such as IG kills all known infectious organisms. To me, one thing that hasn't changed is the certainty blood experts have that all is safe now, just as they had in the early 1980s before AIDS was proven to be transfusion-transmitted, something they resisted.

Also, the Panel re-affirms the long-standing blood supplier emphasis on cost-effectiveness seen in all CBS reports. Emphasize safety up front then pivot to the real emphasis - saving money.

BOTTOM LINE
To me the biggest fail of Health Canada's Expert Panel was not dealing with the ethics of exploiting the poor. Maybe that's because to me it's the main reason to be against paid plasma, especially as the plasma industry gets rich on the blood of the poor and needy.  Frankly, the Panel was set up this way, given its four members.

Did it never occur to any of them to independently solicit Canadian ethicists who didn't sign a letter promoting paid plasma? Guess not. Not part of their skill set? GIGO comes to mind and I suspect Health Canada is fine with this.

But the Report would be significantly enhanced - and provided a valuable educational service -  with a frank discussion of balancing the needs of patients with the reality of exploiting the poor. Examining in-depth all the options to increasing plasma donation without feeding the plasma industry's ever growing profits would also make the Report more informative. Instead the Panel concluded volunteers (however defined) cannot supply the need to be self sufficient, only paid plasma donors can, albeit the world needs to wean itself off the USA's poor.

Second fail: See above for the Panel's sloppy treatment of 'Who uses immune globulin (IG)' and 'Paid plasma has no effect on the blood supply,' focusing on whole blood donation vs plasma donation.

Third fail? Given the Panel's composition it would be expected that they would emphasize private sector involvement. Perhaps unfair for the two Canadian transfusion experts of the highest quality on the Panel but it crossed my mind and I offer it to you as food for thought.

FOR FUN
Again I chose a favorite Simon and Garfunkel ditty as it fits Health Canada's Expert Panel, specifically the lyrics: Still a man hears what he wants to hear / And disregards the rest.
  • The Boxer (Simon and Garfunkel, benefit concert in Central Park, NYC, 1981 before 500,000) 
I am just a poor boy
Though my story's seldom told
I have squandered my resistance
For a pocket full of mumbles, such are promises
All lies and jests
Still a man hears what he wants to hear
And disregards the rest

As always, comments are most welcome.

FURTHER READING
Final Report of Health Canada's Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada

Plasma fractionation market forecast to exceed US$ 26 billion by 2022

The twisted business of donating plasma (28 May 2014)
Tidbit: Since 2008, plasma pharmaceuticals have leapt from $4 billion to a more than $11 billion annual market.

2 comments:

  1. Anonymous10:26 PM

    Well, I did find the report without having to ask Health Canada:
    http://www.cipo.ca/wp-content/uploads/2018/05/Protecting-IG-for-Canadians-Expert-Panel-FINAL.pdf

    ReplyDelete
  2. Thanks. Initially, you had to write Health Canada. I've added your link to the Report under Further Reading.

    ReplyDelete

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