The Sound of Silence (Musings on Health Canada's Expert Panel on Immune Globulin Product Supply)

Updated: 31 Oct. 2017  (Fixed typos) 

For October I've written a two-fer, one blog in two parts. This second blog focuses on Canada's blood regulator (Health Canada) setting up an Expert Panel on Immune Globulin Product Supply & Related Impacts. Musings will be on why the panel was set up, why now, and the impact of who its members are.

Part Two was stimulated by something I came across purely by serendipity (because Health Canada does not widely advertise to the public matters related to the blood system), namely, an update to Health Canada's Expert Panel on Immune Globulin Product Supply & Related Impacts. Discovering the new members of HC's expert panel sealed the two-fer deal. This too was a blog I had to write.

Why read the blog? To me, it helps if everyone involved in transfusion medicine in local, regional, national, global communities is aware of events occurring at a high level with 'biggies' (so-called 'thought-leaders') involved and driving the process and outcomes. That way, the 'hoi polloi', we trench workers, aren't blind-sided by decisions that seem to come out of nowhere from above.

Plus it's not so much that HC's panel is an example of GIGO (garbage in, garbage out):

• Computer science acronym in which bad input will result in bad output. Because computers use strict logic, invalid input ('garbage') may produce unrecognizable output ('garbage')

It's more that results can be determined by the folks deciding, because even the most well intentioned come with a ton of baggage (experience, biases, and hard-wired beliefs) that influence their views.

Consider for a moment if a US Supreme Court decision was to be made solely by Antonin Scalia vs Ruth Bader Ginsberg, both respected, honorable Justices of integrity. (Google them, if needed)

The blog's title derives from a 1964 Simon and Garfunkel song I've used several times before.

HEALTH CANADA'S EXPERT PANEL: WHAT WE  KNOW 
Or more likely, what we don't know.

Let's discuss why the  Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada was set up, why now, and the impact of who its members are.

WHY
Why was the expert panel set up? The stated aim:
The Expert Panel...will objectively assess the security and sustainability of Canada's immune globulin product supply.

There's that word again, sustainability. Also note the use of 'objectively', perhaps meaning the current catch-phrase of all health-related decisions, evidence-based. Interesting that HC used 'objectively' as if they needed to emphasize that. Who would ever think otherwise, that HC would assess subjectively? [She said, ROTFL]

WHY NOW
Who knows. My guess is that the USA's focus on a sustainable blood system played a role. Perhaps this motivated CBS CEO Graham Sher to ask provinces for $100 million over six years to
make CBS more self-sufficient in collecting plasma? (Further Reading) And less reliant on USA, more important than ever with unpredictable Trump as President?

Or maybe all the protests against paid plasma clinics motivated Health Canada to end the discussion once and for all? Remember in 2013 that they held a round table on paid plasma that was a farce (Further Reading):

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

PANEL MEMBERS
We now know all four of HC's expert panel members: a Canadian Chair and Deputy Chair, and two 'advisors' both working in the USA. Not that Health Canada advertised them. Fact is, I came across the update by chance. See Further Reading for their details and responses to competing interest questions.

First, the only panel member I've met F2F and talked to is Deputy Chair, Francine Décary, an award-winning transfusion medicine leader who I respect unconditionally. I know the Chair Penny Ballem by reputation only, an experienced physician-administrator. The two advisers are accomplished professionals, in many ways both 'forces of nature'. There is no reason to doubt their integrity.

Yet my skeptical meter is on high alert. Why you may ask? Reasons include HC's prior pro-plasma bias and its four expert panel members. See if you can discern my unease.

1. Chair, Penny Ballem,MD, FRCP, FCAHS 
Deputy Med Director CRC BTS, BC Deputy Minister of Health, Vancouver City manager, and several academic appointments.

Brilliant physician turned 'suit', at which she also excels. Civic and provincial government appointments involved finding ways to cut costs and still provide high level of service.

2. Deputy Chair, Francine Décary,MD, PhD, MBA
Much respected former CEO of Héma-Québec, epitome of person you'd love to have a beer with. Many honours including Order of Canada, was President of ISBT  and Chair of the Foundation for America's Blood Centers.

Dr. Décary is long-time blood system administrator - person responsible for running a business or organization - operating at the highest level in Canada, USA, and globally.

3. Adviser Patrick Roberts, PhD 
Roberts has been involved with the pharmaceutical industry that relies on paid plasma for years and his consulting firm specializes providing information on the plasma derivatives industry.

He was Bayer's (now Grifols) Marketing Research Manager of Plasma Products Division.

Also, he owns individual stocks in plasma companies: CSL Behring, Grifols, and Shire.

He's the President of Marketing Research Bureau (MRB), a supplier of information Big Pharma and more, including Canada's blood supplier, CBS. MRB is an associate member of the Plasma Protein Therapeutics Association (PPTA).

For reference, PPTA represents the private sector, a part of Big Pharma whose business involves collecting, manufacturing, and selling blood-derived plasma products.

From CBC 2013 news item, Paying for blood plasma raises new questions (Further Reading)

"Analyst Patrick Roberts has predicted that the industry will be able to meet future demand, even if a new market develops for IVIG, in treating Alzheimer's, a potential use that is still in clinical trials.  And now, with recent news that the largest placebo controlled clinical trial has been halted because IVIG did not show a statistically significant improvement in functional ability or a reduction in cognitive decline compared to placebo, this anticipated surge in demand for human plasma might never materialize."

Roberts' message: There's no imminent shortage of IVIG. Have conditions dramatically changed in past 4 years?

4, Merlyn Sayers, MBBCh, PhD
Dr. Sayers is President and CEO of Carter BloodCare in Dallas/Fort Worth, previously the Medical Director at the Puget Sound Blood Center in Seattle and was President of America's Blood Centers. Another experienced, respected physician who is a long-time administrator at the highest levels of USA's blood system.

BOTTOM LINE
All of Health Canada's panel members are impressive, accomplished individuals. No doubt HC chose Canadians Drs. Ballem and Décary with a view to shutting down criticism of the panel's conclusions.

Interesting that 3/4 panel members are long-time blood system administrators and one is a consultant who earns a living from the plasma-derivative industry. No doubt HC thinks they can OBJECTIVELY assess the security and sustainability of Canada's immune globulin product supply. I'm not so sure.

FOR FUN
I chose Simon and Garfunkel's song because it seems to me that Health Canada is too often silent on providing Canadians with access to major events involving the blood system. No press releases about updates, no tweets, no nothing. Plus HC has a history of skewing the playing field to get the results they want (Further Reading): Day tripper (Musings on HC's instructions to the jury on paid plasma)

• The Sound of Silence (Simon and Garfunkel, Madison Square Garden, NYC, 2009)

As always comments are most appreciated.

FURTHER READING
Health Canada: Expert Panel on Immune Globulin Product Supply & Related Impacts

Industry advisors to Health Canada's expert panel
MRB: CEO Patrick Robert

Biographies of HC's 4 Panel members

• Includes 'Questions asked to assess affiliations and interests' and replies.

CBC (25 April, 2013): Paying for blood plasma raises new questions

Canadian Blood Services calls for provincial funding for plasma clinics (26 Jan. 2017)

Day tripper (Musings on HC's instructions to the jury on paid plasma) (12 July 2013)

Take a chance on me (Musings on USA's unsustainable blood system)

Updated: 30 Oct. 2017 (Fixed typos)

For October I've written a two-fer, one blog in two parts. The first part was stimulated by three related items in TraQ's Oct. newsletter (Further Reading):

• Klein HG, Hrouda JC, Epstein JS. Crisis in the sustainability of the U.S. blood system. N Engl J Med 2017 Oct 12; 377:1485-8.
• Building a more sustainable U.S. blood system. (Rand Corporation, Research Briefs, Nov. 2016)
•  Mulcahy AW, Kapinos KA, Briscombe B, et al. Toward a sustainable blood supply in the United States: an analysis. Rand Corporation, 21 Nov. 2016.

PART ONE: This first blog is on USA's non-sustainable blood system. In a way the two blogs Oct. are related. Both involve protecting the SUPPLY of life-saving blood components and products and managing threats to that supply.

EXECUTIVE VERSION: This first blog will discuss sustainability issues in the US blood system. Quite a wake-up call that the American private, market-based blood system is failing.

Why read the blog? To me, it helps if everyone involved in transfusion medicine is aware of the big picture nationally and globally because it helps us interpret background noise that may otherwise fly under the radar.

Moreover, many health professionals outside the USA may not be 'into' the economic conditions that a private blood system, or private healthcare for that matter, operate in.

Allow me two anecdotes. Medical Laboratory Science graduates who went to work in the US in the 1990s told interesting tales of some of the differences between Canada and the US. For example, how each new transfusion service work-up on a patient with difficult red cell antibodies required careful documentation of codes (time-consuming major distractor) in order to charge Medicare / Medicaid properly or to add to the patient's increasing hospital bill.

Or how one grad worked in a Las Vegas mega-lab where technologists were more like factory workers on an assembly line and didn't need to worry about quality control because that was someone else's job. No doubt the huge private lab had wrung every efficiency out of the system in order to decrease costs and compete for business.

The blog's title derives from 1978 ditty by Sweden's ABBA, which I've used once before.

USA BLOOD SYSTEM 
Regarding the USA situation, I recommend viewers read the three fascinating items in Further Reading. The 12 Oct. 2017 'Sounding Board' piece by Klein, Hrouda, and Epstein in New England Journal of Medicine clearly derives from Rand Corporation Research done in Nov. 2016.

What follows are my take-aways about the U.S. blood system. Although I follow events there closely, my grasp of the intricacies of the business side of things is limited. Bear with me as I describe what I see as the 'big pic' of the U.S. system.

Many developed nations have a single, government-funded blood supplier, e.g., Australia, Canada, France, Ireland, New Zealand, UK, and more. The USA opted for a private system composed of non-governmental organizations (NGOs) that sell blood on the open market to hospital clients. The U.S. even has blood brokers who buy from the blood centers who collect and manufacture blood components and sell to hospitals who need components to treat patients.

In the USA's free enterprise blood system, markets rule. The price of blood components and products depend on supply and demand. Suppliers (blood centers) compete for hospital customers based on pricing and service just as for-profit businesses do.

The pressure is on blood centers to produce products more efficiently and reduce the price, or improve a key required quality, so that hospitals will pay more to get it.

Under such a system, assuming no new major injection of funds, businesses, including non-profit blood suppliers, will fail once expenses exceed revenues, and cash reserves and sellable assets are depleted.

THREATS TO SUSTAINABILITY
The following is my take on the NEJM article and related Rand search.

The U.S. free market in blood struggles for several reasons. These include decreased demand for blood components because of

• Patient blood management programs that reduce the need for transfusion and decrease healthcare costs, while ensuring that blood is available for patients who need transfusion;
• Less invasive surgical procedures;
• Development of drugs that reduce surgical blood loss and decrease the need for transfusion.

In business terms, demand for blood center products decreased. Data point: Blood transfusion decreased ~25% from 2008-2017 and may decrease by 40% by 2020. Accordingly, supplier (blood center) revenue decreased and their cost/unit increased.

The result has been that the client/consumer blood system (hospitals) have increased consolidation to decrease their costs. And blood suppliers now must deal with more large institutions with increased bargaining power, further driving down blood center revenues.

Another reality: Apparently U.S. blood collectors are reluctant to introduce new technologies that make the blood supply and transfusion safer because hospitals won't pay for them unless they are government-mandated, e.g., Zika virus and Babesiosis screening, red-cell genotyping.

Of course, today what determines introducing new blood donor screening tests is risk-based decision making, one factor of which includes economic realities. Decision makers look at factors such as

• Condition prevalence;
• How serious the condition/disease to be prevented is;
• Cost of preventing one case.

Bottom line
Most of America's Blood Centers and the American Red Cross  operate at a loss, provide blood components below cost. The American blood system has become unsustainable.

What to do? 
Rand Corporation proposed three alternatives. Let
1. U.S. blood system continue to function as it has;
2. Government play a more active role;
3. Government assume complete responsibility.

Of course, predictably, they opted for #2 in which the U.S. blood system remains privatized but with some additional government intervention. Translation: The government funds and takes care of safety issues for which a good business case cannot be made by the private sector. Perhaps a form of corporate welfare in a good cause?

MY TAKE-AWAY CONCLUSIONS
As the NEJM authors state (no-brainer, obvious to all)

• Adhering to supply and demand ignores the importance of safe, available blood because blood is more than just another consumer good.

I dig that USA will never opt for a government-funded blood system as many developed nations have. The transition would be too against the 'land of free enterprise' and too messy a transmogrification.

On one level it seems that USA wants to have its cake and eat it too. I'm reminded of private, for-profit healthcare clinics in Canada that the rich can access. They tend to 'cherry-pick' the healthiest patients, who are the easiest and cheapest to treat AND send those who are very sick and unprofitable to treat back into the government-funded public system.

Also seems similar to some businesses that carp about government intervention and regulations, even descend to diss folks on welfare, resent increases in the minimum wage because it affects their bottom line, yet are the first in line when their business is in trouble asking for a government bailout. But perhaps that's too harsh.

FREEDOM TO FAIL
To be philosophical for a moment, a private, free enterprise system based on markets, competition, supply and demand is messy and has proven to be the economic equivalent of democracy, the worst form of government, except for all the others. The quote is attributed to Winston Churchill but it's not his.

As an aside, an original Churchill quote, one that breaks me up:

• 'The best argument against democracy is a five-minute conversation with the average voter.'

Like all market-based businesses, a private blood system has many freedoms and one is the freedom to fail. To succeed and survive, businesses, including NGOs, must continually eliminate waste, increase efficiency, and offer competitive prices for goods and services.

Even government-funded national blood suppliers like CBS constantly strive to decrease costs. Examples include the

• Introduction of less well paid 'donor care associates';
• Consolidation of donor testing and component manufacturing to a few regional centres;
• Closing a plasma collection clinic because it was cheaper to out-source to the USA.

I wish the US blood system well as it struggle through its cognitive dissonance with upholding a private, market-based free enterprise blood system and realizing that government help in the form of funding is essential for the now dysfunctional system to survive. The market worked as it should for decades, then created a huge Oops!

FOR FUN
I chose this ABBA song as a message to the USA to take a chance on a government-based blood system. Guess I think the only causes worth fighting are the hopeless ones.

That's something U.S. will never do, just as they will never adopt universal healthcare system like Canada's even though it's proven to provide better outcomes at much less cost. They made their bed and are doomed to lie in it.

• Take a chance on me (Sweden's ABBA)

As always comments are most welcome.

FURTHER READING

Klein HG, Hrouda JC, Epstein JS. Crisis in the sustainability of the U.S. blood system. N Engl J Med 2017 Oct 12; 377:1485-8.

Building a more sustainable U.S. blood system (Rand Corporation, Research Briefs, Nov. 2016)

Mulcahy AW, Kapinos KA, Briscombe B, et al. Toward a sustainable blood supply in the United States: an analysis. Rand Corporation, 21 Nov. 2016.