Monday, October 30, 2017

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)
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)

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