Wednesday, June 20, 2018

The sound of silence (More musings on paid plasma pros & cons)

Updated: 20 June 2018 (Fixed links)
Wrote first version of this blog a few days ago then pulled it. Why? I wrote it when angry, never a good idea. What got me mad was the following reality:
If there's one thing that gets my goat (or, in the vernacular, pisses me off), it's a campaign that's clearly orchestrated and perhaps indirectly funded by the likes of USA's far-right Koch brothers (Further Reading). I say indirectly because Koch biz is well known as a hidden maze of covert operations. Tracing funding is impossible. Like crime investigators, I don't believe in coincidence as outlined below.
The reality is the many letters to the editors, and so-called opinion pieces/commentary, that support paid plasma have 'coincidentally' flooded many Canadian papers as Health Canada's Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada considered the issue. Interestingly, several op-eds 'coincidentally' cite the same letter written to the Panel by Peter Jaworski (co-author of 'Markets without Limits:  - Further Reading) and 32 ethicists and economists, including two Nobel Prize winners and a recipient of the Order of Canada, as we are ever reminded. Walks, talks, and quacks like coordinated to me. 
I've since cooled off and developed a second thesis for the blog. Advocates on both sides of the paid plasma issue are talking past each other, both sides being certain they are right. Like current USA politics, polarization is extreme and we're all partisans, endlessly pounding home the same points to those who agree with us and to convince the larger public via endless op-ed pieces.

Disappointed that CBS and Health Canada are not more transparent about where Canada is headed on paid plasma. Both HC's Expert Panel (bit of a joke) and CBS have been less than transparent on the issue. CBS's position is understandable, Health Canada's not so much. This is the origin of the blog's title, The Sound of Silence.

So the blog's aim is to outline what I find wrong and weak about both anti-paid plasma and pro-paid plasma advocacy. Yes, my position is clear and I've said similar before over many years. One more time....

My view is that anti-paid plasma advocates (I'm one) who sound alarm about safety issues that are iffy at best do not do the cause any good. Yes, some risk exists since zero risk is impossible. Although paid plasma is as safe as volunteer plasma, largely due to the processes that fractionated products like intravenous immune globulin go through, plasma fractionation destroys KNOWN 'deadly' risks (HBV,HCV,HIV) but not necessarily future unknown transfusion-transmitted infectious organisms. But to focus on safety is non-productive. Why?

Because focusing on safety undermines two main legitimate arguments:
1. Paying for body tissues is unethical because it preys on the poor;
2. Culture of paid blood donation will undermine volunteer donations over time.

For more on unethical, see Further Reading (Musings on how paid plasma mirrors Rumpelstiltskin).

FACT: Valid statistics about decreased voluntary donations are hard to come by since no one knows what they would be if (1) paid plasma didn't exist and (2) national blood suppliers like CBS had made concerted efforts over the years to encourage and facilitate plasma donation.

The pro-side argues as follows, exemplified by Jawarski in 'Markets without Limits':  '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 or minimizing that it preys on the poor (Further Reading).

Another position pro-plasma advocates pound away at is that anti-paid plasma advocates in Canada and elsewhere are hypocrites. Let's face it, we are all hypocrites in some ways. I'm a vegetarian who wears leather shoes, believes in transitioning to renewable energy yet has flown a lot around the world and taken cruises, which contribute significantly to greenhouse gas missions. 

To me, not wanting to make Canada a paid-plasma haven like the USA, sucking the blood from the needy, is a legitimate ethical view. More legitimate than fear mongering that patients will die if we don't pay for plasma that can be fractionated into life-saving derivatives. Fear mongering conveniently serves the needs of Big Plasma and its billions in annual profits, And means nil will change, we'll be forever captive to the plasma industry, instead of promoting voluntary donation and developing innovative alternative treatments, and reining in off-label uses of products like IVIg. 

Another pro-paid plasma position is that anti-paid plasma advocates are all about unions wanting to save their members' jobs. Seems a knee-jerk reaction to public service unions supporting voluntary donations, often citing the iffy safety rationale. But please answer this: Under what scenario would unionized CBS workers lose their jobs to paid plasma private clinic workers, who presumably would not be unionized and paid much less to maximize profits to shareholders, as well as having poorer working conditions? Beats me.

In the latest propaganda piece ('Why we should pay Canadian donors for their blood plasma donations,' 13 June 2018), the authors feel compelled to write:
'Neither of us is in any sense funded by 'big plasma' or any other commercial interest. We are professors at universities (one at a Canadian public institution, and one at a private American one). We have no financial stake in this issue. We are merely doing our jobs as philosophers and ethics professors: namely, putting forward what we believe to be the very best argument on a matter of substantial public importance.'
Reminds me of 'the lady doth protest too much, methinks' (Hamlet). Note that Jaworski is an adjunct scholar at the libertarian Cato Institute (Further Reading - Behind the Cato Myth), created by the Charles Koch Foundation. Cato is anti-minimum wage, anti-union, anti-universal healthcare. You get the picture. And it's fair to judge folks by the company they keep, isn't it?

Not all Cato Institute positions are obnoxious to progressives like me, but among other policy positions, Cato is pro-tobacco, pro-private schools, pro-private prisons, in other words, pro-private anything like pro-paid plasma. And, of course, Cato thinks man-made climate change is exaggerated.

All these philosophers writing to papers and volunteering to author op-eds may be sincere advocates that paid plasma is the way to go, and are prepared to put patient needs above the poor who subsidize patient treatment risking their own health. Kinda reminds me of Trump's 'Amerika First'. My needs trump yours.

And pro-paid plasma advocates ignore that Big Plasma makes billions off the blood of the needy because markets rule (Further Reading). Instead they focus on the needs of patients, a legitimate concern, but have closed minds that voluntary plasma donation can significantly help. Until recently, plasma donation has never been promoted by CBS. Volunteers may not be able to supply all the plasma needed but why not try instead of letting paid plasma become the norm?
  • Once paid plasma is part of the culture, why would anyone donate plasma voluntarily?
Just a coincidence that pro-paid plasma philosophers, who seem to know each other via various networks, flood newspapers with pro-paid plasma pieces, just because they're doing their jobs?

Perhaps but clearly a coordinated effort. They may be sincere but do not support a heart of gold. Instead they support Big Biz, earning gold on the backs of the poor. As befits anyone who's part of the Koch-Cato right wing propaganda initiative.

As always comments are most welcome.

Again I use Simon and Garfunkel's ditty:
Over the years I've written many blogs on paid plasma, the last previous to this one on Dec. 29, 2017:

Look what they done to my song (Musings on how paid plasma mirrors Rumpelstiltskin) Note relevant links in Further Reading:
  • Twisted business of donating plasma for money (The Atlantic, 28May 2014)
  • WHO: The state of the international organ trade: a provisional picture based on integration of available information
  • Meeting an organ trafficker who preys on Syrian refugees (BBC, 25 Apr. 2017)
  • The body trade - Reuters series ('The chop shop')
  • Search on Google for organ trafficking(1.3 million hits, 29 Dec. 2017)
A rare look inside the Koch brothers political empire

Behind the Cato Myth (2012)

Why we should pay Canadian donors for their blood plasma donations (13 June 2018)

'Markets without Limits: Moral Virtues and Commercial Interests' (positive review)


Wednesday, February 28, 2018

Musings on bullying in health care

Stay tuned: Revisions are likely to occur
Today, the last day in February, is #pinkshirtday in Canada, a day to stand up to and prevent bullying of any kind. Taking a stand against bullying with pink shirts began in 2007, when on his first day of school, a student wore a school pink polo shirt and bullies called him a homosexual for wearing pink and threatened to beat him up. Two other students decided enough was enough and began a 'sea of pink' campaign.

Earlier this month a biomedical scientist (aka clinical or medical laboratory scientist, medical laboratory technologist) working as a senior manager in the Haematology and Blood Transfusion department of a hospital in Dumfries, Scotland was suspended for 18 months after a campaign of bullying abuse, creating a 'culture of fear' in the workplace for over five years (Further Reading).

The full transcript of the UK Health and Care Professions Tribunal Service hearing of the Registrant's case is online (Further Reading). The Allegation, Finding, Order, Notes are well worth reading.

Just a few of the many allegations made against the Registrant:
  • Said to colleagues in the blood bank, 'Am I talking a foreign language?! Or am I working with a bunch of  f*cking thickos?!'
  • Referred to a colleague's flat shoes as 'lesbo' shoes.
  • Sent a text message to a colleague describing another  colleague as '‘a f*kin lying *rse wipe sh*te'.
  • Asked a colleague to sign off his competency log despite the fact she had not witnessed his competencies. 
  • In the presence of another colleague 
    • Referred to a colleague as a 'b*tch' ;
    • Threatened to slash a colleague's tyres; 
    • Referred to having a 'hit list' of people he would pay back. 
The Registrant did not attend the hearing despite five months notice and instead submitted a written response to the allegations. Some he denied and a few he sloughed off a merely banter. All but one allegation was found to be proven. The witnesses were found to be credible.

The issue was whether the proven charges of serious professional misconduct, including dishonesty, and creating a “culture of fear” were enough to be stricken off the Registrar or if some other sanction should be applied. Be aware that the purpose of a sanction is not to punish, but to protect members of the public and to safeguard the public interest.

The factors considered by the panel as mitigating factors are fascinating and informative. One that struck me in particular:
  • The Registrant’s increased workload appeared to increase his stress levels and cause a deterioration in his workplace behaviour.
Increased workload is a reality for clinical labs everywhere these days and has been for decades. Under the umbrella of cost effectiveness and cliches like 'working smarter, not harder', staff have long been expected to do more with less. Does it create stress? Of course, but I'm unsure that's a valid mitigating factor for abusing staff.
In Canada, CSMLS's CEO Christine Nielsen has said that 35% of society members report feeling stressed or burned out on a weekly basis while on the job (Further Reading). Educating new staff becomes difficult as finding clinical placements in short-staffed laboratories becomes increasingly onerous. The situation is complicated by an aging workforce and is likely to get worse before improving. 
The news item reveals the hearing's outcome, an 18 month suspension. To me this case is an ideal candidate for teaching professionalism to students in all health disciplines. If you are like me, you've experienced and witnessed bullying and unprofessionalism at work.

Sad but it happens in health care more often than we like to admit. And how often do we do something about it, given those bullying are usually in positions of authority?

As always, comments are most welcome. We have some - see below.

Dumfriesshire scientist suspended for 18 months for bullying staff (13 Feb. 2018)

UK Health and Care Professions Tribunal Service hearing (Jan. 29-Feb. 2, 2018) | See Allegation, Finding, Order, Notes

Medical lab technologists across Canada feeling the pressure of high job vacancies (15 Feb. 2018)

Sunday, February 25, 2018

Musings on review of CBS as an employer by a Donor Care Associate

Updated: 26 Feb. 2018 (expanded the ending)
Decided to write shorter blogs, perhaps one each week. We'll see how it goes.

I've always known shorter blogs were the way to go, because transfusion professionals, like most folks these days, are busy. Busy in their work lives, family lives, and often overwhelmed by the onslaught of digital input, whether via texting, e-mail or social media.

But I credit the motivation to write shorter blogs to a UK transfusion professional who tweeted about the blogs of Mary Beard: A Don's Life. Somehow I'd missed them.

So the first short blog is about a review of Canadian Blood Services by a 'Donor Care Associate" which I came across on my @transfusionnews twitter account. I'll begin with my tweets.

If you click on the review and get 'sign in with'...just click on the text outside the request or access the review here.
Now we can choose to dismiss such reviews because they're anonymous. For interest, many folks I know hesitate to critique employers until they retire and are no longer subject to a backlash.

Several points the reviewer made peaked my curiosity. First:

Note that the reviewer worked at CBS part-time for 3 years and included several pros about working for them. Frankly, I cannot dismiss her Cons as outright lies. In general, criticism works best if it contains helpful and specific suggestions for positive change.

In my teaching career, I'd explain to students that feedback is an indispensable tool to help both instructor and learner improve and, when given feedback, model appropriate responses such as, "Thanks for telling me that."  When MLS students entered their clinical internship year, I'd explain that they can improve only if supervisory staff tell them when they are doing something wrong or doing something that needs to be improved.

Can CBS take criticism in the same vein? (no pun intended)

As always comments are most welcome.

Thursday, December 28, 2017

Look what they done to my song (Musings on how paid plasma mirrors Rumpelstiltskin)

Updated: 5 Jan. 2018 
When I was a small child my grandmother always read me fairy tales and later had books for me to read. One of my favorites was Rumpelstiltskin originally published in 1812 by the Brothers Grimm, Jacob and Wilhelm (Further Reading). Since then the story has undergone many variations.

For the holiday season it seems appropriate to write a feel-good blog and I've done that in past years. (Further Reading) But recent news items made me think of Rumpelstiltskin. At its heart it's a fairy tale about greed and those who happily exploit others for personal gain.

What follows is my transfusion-related version of Rumpelstiltskin. Recall that fairy tales are often filled with scary, gruesome violence but somehow children thrive on them. Perhaps they're a way of exposing children to anxiety, fear, sorrow, and surprise and let them come away with new tools for managing their emotions?

Keep in mind that fairy tales are medieval (even prehistoric) morality tales and morality features in my Rumpelstiltskin tale. Of course, fairy tales derive from compelling stories told and retold over many centuries that have survived without being written, until folks like the Grimms put them on paper (Further Reading).

The blog's title derives from a 1970 ditty by Melanie Safka, known professionally as Melanie.

There's no executive version. Why read the blog? I hope it resonates with all transfusion professionals. If you disagree, I'm delighted and would love to see your comments. But you need to read the fairy tale to appreciate its meaning as a gestalt.

Once upon a time there was a poor man in America who had a beautiful 18-year old daughter. His wife had died years ago and he struggled to support himself and his daughter and worried how he'd pay for her upcoming post-secondary education.

Now it happened that he read an advertisement by a paid plasma collection company and saw that his daughter could transform her plasma into gold.

He couldn't donate because he didn't meet donation criteria, specifically he had spidery veins and blood draws were difficult. He called the blood collection facility and, to make an impression, he said, "I have a young daughter who can become a lifelong plasma donor."

The representative replied, "Great. If your daughter is as you say, then bring her to the plasma collection center tomorrow and we'll put her to the test."

When the girl went to the plasma collection facility, a staff member greeted her and asked for a current, valid photo ID, proof of her Social Security number, and proof of her current address. Then she underwent the standard process, as outlined in the example in Further Reading.

Even though she was afraid, she completed the online questionnaire and eventually donated her plasma, knowing she would please her Dad and would be able to pay for her own education. She vowed to do her best to transform her plasma into gold.

After multiple donations, because she could not afford protein-rich food, the young woman's protein levels fell below eligible plasma-donor criteria. It was then that her father introduced her to Mr. Rumple Stiltskin, a short man full of energy, indeed the prototype of an entrepreneurial hustler. Mr. S. said, "If plasma donation is kaput, I can help you transform your stem cells into gold. But I need a payment in return. What will you give me?"

"A body organ," said the girl, after thinking long and hard. She had a friend who donated a kidney to her brother, a living, directed donation, and the friend was doing well with one kidney.

Rumpel got her hooked up with a brokerage company overseas that brokered tissues and body organs for clients worldwide. The clients bought stem cells and used them to treat all sorts of conditions, even those for which evidence did not exist. But they touted themselves as helping patients, and who knows, maybe sometimes they did. Certainly they had many sports and entertainment celebrities praise their stem cell and platelet rich plasma injections as 'miraculous'.

She was paid a pittance for her stem cells compared to what recipients paid, but it helped since the plasma money-stream had dried up.

Later Rumpel came to collect on her promise. He said, "I'll harvest one of your kidneys. You'll earn a great deal for it. But in return I'll need another payment.'

The girl did not know what to do, but, now in too deep, and asked what she must do to collect her kidney money. I have nothing more that I can give you."

Rumpel replied, "Then promise me, whenever it happens, your first child."

Who knows what will happen, thought the poor man's daughter, Maybe I won't have a child. Not knowing what else to do, she promised the little man what he demanded. In return Rumpel once again paid for her body part, this time a harvested kidney.

A few years later, after graduating from college and getting a well paid job in Silicon Valley that supported her and her father, she met the love of her life. Within a year she delivered a beautiful child into the world. She had forgotten all about  the little man, Rumpel, but suddenly he appeared in her hospital room and said, "Now give me that which you promised."

She was frightened and offered the little man all the money she had saved if he would let her keep the child. But Rumpel said, "No. Something alive is dearer to me than all the money you now have. This kid will be a gold mine of body tissues and organs."

Then the young woman began crying so much that the little man uncharacteristically took pity on her and said, "I will give you three days. If by then you know my real name, then you shall keep your child." Of course, he felt certain she could not.

She spent the entire night thinking of all the names she had ever heard. Then she did a Google search on what names existed. When Rumpel returned the next day she showed him a huge printout of all the names she had retrieved. The little man scanned the pages and said, "None of these is my name."

The second day she sent inquiries to her Facebook, Instagram, and Twitter accounts as to what unusual names existed. Finally, she recited the oddest and most curious names she'd heard of to the little man.

But he always answered, "That is not my name."

On the third day someone on Twitter replied that he saw a comical little man in front of a house on his street dancing and chanting:
Today I'll bake; tomorrow I'll brew,
Then I'll fetch the new child,
It is good that no one knows,
 ____________ is my name. 
You can imagine how happy the young woman was when she heard that name. Soon afterwards the little man came in and asked, "Now, Madam, what is my name?"

She first asked, "Is your name 'Plasma for Humanity'?"
"Is your name 'If it Saves Lives It's OK'?"
"Is your name perhaps, 'First We Take Paid Plasma, Then We Take It All'?"

"The devil told you that! The devil told you that!" shouted the little man, and with anger he decided he needed to expand outside the USA.

 He set his eyes on the Great White North, Canada. Sure it was the land of universal health care, but these sappy socialist suckers could probably be sold anything if packaged right.

He concocted his plan of attack and called it 'The 7 Habits of Highly Successful Plasma PACs'. After all, he wanted to create a well funded, coordinated lobby group to influence decisions made by Canada's government on paid plasma. And plasma would be but the first step of many body tissues and organs.

1. Get well meaning stooges to tout the benefits of paid plasma. Probably right-leaning provincial politicians and the odd academic or two.

2. Pump up how Canada needs a more secure supply of plasma. A supply chain dependent on the USA has never been more at risk, given its current POTUS. He breaks long-standing negotiated international agreements in a New York minute. His protectionist, America first rhetoric suggests he's happy to tell the rest of the world to 'eff-off' so long as he can crow (tweet) to fans that he's made America great again, whatever that means.

Plus, of course, the Canadian dollar, with a fluctuating exchange rate vs the U.S. dollar, lately not to Canada's advantage, presented a major risk of unexpected cost increases.

3. Have the plasma industry fund as many research projects as possible to create markets for plasma and its derivatives that don't yet exist. For example, it doesn't matter if platelet rich plasma or IVIG works or not for a particular condition, so long as gullible, suffering folks think it might.

4. Encourage paid-plasma acolytes to fear monger. Promote that without an ever-increasing supply of plasma-derived products, 1000s of folks who depend on them will die. Make sure that patient groups funded by paid plasma's Big Pharma, and reliant on its plasma-sourced derivatives, see this as true. Post-truth arguments that play on emotion trump reality every time.

5. Get Health Canada to set up an Expert Panel to validate paid plasma as a good option under the guise of assessing the security and sustainability of Canada's immune globulin product supply. Be sure to have respected Canadian physicians on the Panel as well as U.S. reps, preferably someone with shares in Big Pharma.

6. Have the Panel apply the sexy, scientific 'risk-based decision-making framework' to the paid plasma issue and security of Canada's supply. (Further Reading) That's sure to clinch the argument.

7. Make the Panel's proceedings un-transparent and as hard to follow as possible. No need to upset the natives with what's truly happening. There's even a Canadian precedent. During times of regionalization and centralization, hospitals often kept staff in the dark because the powers-that-be didn't want to upset them, believing the 'poor little dears' couldn't handle the truth.

ORGAN TRAFFICKING  (See Further Reading for links)
Organ trafficking hasn't gone away, it's likely become more common. In 2007 the WHO published a paper on international trafficking in body organs. Excerpt:
The most common way to trade organs across national borders is via potential recipients who travel abroad to undergo organ transplantation, commonly referred to as “transplant tourism”....
“Transplant tourism” involves not only the purchase and sales of organs, but also other elements relating to the commercialization of organ transplantation. The international movement of potential recipients is often arranged or facilitated by intermediaries and health-care providers who arrange the travel and recruit donors. The Internet has often been used to attract foreign patients. Several web sites offer all-inclusive “transplant packages” – the price of a renal transplant package ranges from US$ 70 000 to 160 000 (Table 1).
The Middle East is increasingly a hot spot for the body organ trade. See 'Meeting an organ trafficker who preys on Syrian refugees' below. Here's an associated 2 min. 36 sec. video:
See Further Reading for more. 

Will Rumpel's Plasma PAC Plan work? Will my Rumpelstiltskin fairy tale come true? Or am I mistaken? Time will tell.

Musings: Is all change good? Selling plasma strikes me as morally wrong. Not just that it inevitably exploits the poor and earns Big Pharma $billions (spins plasma into gold) but that it diminishes us as humans when our body tissues are bought and sold (marketed) as commodities. And once you start it's a slippery slope. If plasma, why not stem cells? If stem cells, why not organs like kidneys? If body organs, why not everything?

As noted, organ trafficking flourishes today and involves live donors and recipients wealthy enough to travel and pay. And even once dead, your body parts have buyers. See 'The Chop Shop' in Further Reading below.

This song was written and recorded by Melanie Safka 47 years ago for her 1970 'Candles in the Rain' album. The ditty fits the blog because it expresses how I feel about the blood system I've worked in all my life and loved, and is now changing in ways I thought it never would.
I love this song for its clever lyrics:
Look what they done to my song, ma.
Look what they done to my song.
Well it's the only thing
That I could do half right
And it's turning out all wrong, ma.
Look what they done to my song.
Look what they done to my brain ma
Look what they done to my brain
Well they picked it like a chicken bone
And I think I'm half insane ma
Look what they done to my song.  
Wish I could find a good book to live in
Wish I could find a good book
Well if I could find a real good book
I'd never have to come out and look at
What they done to my song
As always, comments are most welcome.

Fairy tale origins thousands of years old, researchers say (20 Jan. 2016, BBC)

Fairy tale of Rumpelstiltskin

Dec. 2015 'feel good' blog: Islands in the Stream (Musings on how love of transfusion medicine unites us)

First time plasma donors (one example of paid plasma process)

Health Canada: Expert Panel on Immune Globulin Product Supply & Related Impacts 
      Members of the Expert Panel

WHO: The state of the international organ trade: a provisional picture based on integration of available information
Meeting an organ trafficker who preys on Syrian refugees (BBC, 25 Apr. 2017)
The body trade - Reuters series ('The chop shop')
Search on Google for organ trafficking (1.3 million hits, 29 Dec. 2017)
'Risk-based decision-making framework' (~ 2min. video, CBS's Judie Leach Bennett)

'Risk-based decision-making framework' (Multiple short animated videos: Alliance of Blood Operators)

Paying for stem cells: A bad idea (5 Feb. 2012)

Thursday, November 30, 2017

Always on my mind (Musings on lack of transparency in Canada's blood system)

Updated: Dec. 1, 2017 (Fixed typos)
For November I had to write a blog on a current controversy in Canada related to paid plasma. Yes, I know I've written a lot about it already but 20 years ago this month, specifically Nov. 26, 1997, this was published:
  • Final report of the Krever Commission of Inquiry on the Blood System in Canada
This blog will be briefer than usual, partly because I wrote two blogs for October, but mainly because I invite readers to draw their own conclusions by reading the resources in Further Reading.

Executive version: Seems that Health Canada has not been transparent in its dealings with Canadian Plasma Resources and has exceeded its role as regulator. And who knows what CBS has been doing behind the scenes on the paid plasma file because they've been inconsistent on the issue.

Why read the blog? For Canadians it matters because of the fiascoes of the 1980s and '90s, which we do not want to repeat, ever:
  • 2000 Canadians contracted HIV via transfusion, 1980-85;
  • 30,000 transfusion recipients were infected with HCV,1980-90;
  • See Krever Report (Further Reading) for the errors made by Canada's faulty blood system and its experts.  
20 years later Canadian Blood Services brags that we have a transparent, accountable blood system.

Readers in other nations may find the Canadian lessons learned (and not learned) useful.

The blog's title derives from a 1972 ditty about a love story gone wrong.

The report that stimulated the blog is
  • A bloody mess: The story behind paid plasma in Canada (Further Reading). 
Using Freedom of Information, Macleans reporter Anne Kingston discovered that communications between Health Canada, CBS and CPR (private plasma paid company) between 2009 and 2016 raise new questions about blood governance in Canada and its ties to industry. 

What follows includes tidbits in the Macleans article and Health Canada's response that I see as key.

1. Documents show Health Canada and the private plasma company agreed on the need to co-ordinate their responses to media questions.
My take: If true, that's unacceptable collusion and damning to HC.
2. Health Canada instructed Canadian Plasma Resources to monitor donor history of prior blood donation to ensure there is no negative impact on voluntary blood donations.
My take: Since when does a regulator (HC) rely on a private company to determine facts used to formulate public policy. Too stupid for words.
3. HC: The Dublin Consensus Statement was convened by a group of patient organizations, not an industry lobby group. International blood operators, including Canadian Blood Services also attended the conference, as well as...the Plasma Protein Therapeutics Association.
My take: Big Pharma's paid plasma companies fund patient groups big time and it's not always transparent. Patient groups invariably support Big Pharma's views, whether because of fear their therapies are at risk or because they need the funds. Some patient group execs seem to be in the back pocket of industry.
4. CBS is not innocent in all of this. Why you may ask? Mainly because its views and actions are erratic and Canadians have to wonder why. Examples:
  • For years CBS rightly emphasized paid plasma manufactured into blood derivatives such as IVIG were safe. Their views were echoed by HC but it seemed a united front in favour of, almost promoting, paid plasma;
  • CBS closed its Thunder Bay plasma collection centre, citing lack of demand for transfusion plasma, not the reality that outsourcing to USA for plasma-derived products was cheaper;
  • Then CBS pivoted 180o. In January 2017, it announced a 7-year, $855-million strategy to increase Canada's plasma self-sufficiency from 17% to 50%, requiring up to 40 new plasma collection sites;
  • CBS also changed its view on paid plasma clinics decreasing volunteer donations. First it was no, then yes.You have to ask why all the changes. 
As AndrĂ© Picard asks, have we forgotten the lessons of history, namely Canada's tainted blood scandal? To me neither CBS or Health Canada has been transparent. And the organizations are closely tied, given that HC has always relied on experts, including those at CBS, to determine policies.

I chose this song because I like it and as a lifelong blood banker who lived through Canada's tainted blood scandal - where only Canadian Red Cross took the rap in courts -  it hurts when those we rely on let us down and folks die as as a result. And that is always on my mind.

The beautiful song was released in 1972 and covered by Willie Nelson in 1982.
As always, comments are most appreciated.

A bloody mess: The story behind paid plasma in Canada (22 Nov. 2017, Macleans)
Freedom of information documents (859 pages)
Have we forgotten the lessons of the tainted blood scandal? (AndrĂ© Picard, 28 Nov. 2017)
AndrĂ© wrote The Gift of Death: Confronting Canada's Tainted Blood Tragedy, to be made into a TV miniseries, Unspeakable,  in 2018
AndrĂ©'s entry on the the Krever Report (Canadian Encyclopedia)
Health Canada assisted private plasma clinics, newly released documents say (28 Nov. 2017)

Statement from Health Canada in response to Maclean's article on paid plasma (24 Nov. 2017)

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.

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 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]

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)
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 DĂ©cary, 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 DĂ©cary,MD, PhD, MBA
Much respected former CEO of HĂ©ma-QuĂ©bec, 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. DĂ©cary 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.

All of Health Canada's panel members are impressive, accomplished individuals. No doubt HC chose Canadians Drs. Ballem and DĂ©cary 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.

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.

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.

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.

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?

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.

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!

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.
As always comments are most welcome.


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.

Wednesday, September 27, 2017

While my guitar gently weeps (Musings on recent transfusion-related news)

September's blog will feature four news items in recent TraQ newsletters, items that are a tad different but worthy of featuring, nonetheless. For links to all featured news items see Further Reading.

EXECUTIVE VERSION: There's no need for one because this blog is just a few comments on a series of 'odds and sods' news items that I find interesting. I hope you do too.

The blog's title derives from a 1968 Beatles ditty by George Harrison I used once before in a 2012 blog.

Why Canada needs USA sperm [and plasma] (13 Sept. 2017)

The article is by Peter Jaworski, who co-authored, 'Markets Without Limits', the primary thesis of which is, "Anything you may permissibly do for free, you may permissibly do for money."

Peter is a Canadian who teaches 'business ethics' (an oxymoron? - Just joking!) at Georgetown University in the USA and is associated with right wing organizations such as the Canadian Constitution Foundation.

He's getting his views that we should allow selling plasma, sperm, kidneys, indeed any body organ, published in many newspapers and journals. Same ideas, rehashed again and again. That's a well known marketing strategy for today's authors if they want to be successful. And it works because newspapers especially are desperate for free articles.

But in the latest oped to promote his book he (a 'business ethicist') doesn't mention - not one word - about the disgusting history of selling sperm in Canada. Facts (Further Reading), which include:
  • Donor lied about medical history, affecting 26 families;
  • Donors not fully screened for HIV and other infectious diseases;
  • Shortage of Canadian sperm is not that men are unwilling to donate without pay. It's about government health and safety regulations to protect people who use donated sperm and the children they conceive.
The donor who saved over 2 million children (25 Aug. 2017)

80-year-old Australian James Harrison donated plasma with potent anti-D for ~60 yrs. He recently made his 1157th donation. Until 2015, every batch of anti-D [Rh immune globulin] made in Australia contained his antibodies.

If Mr. Harrison lived in the USA he could have opted to earn significant money from his plasma. Who knows how much if he wisely invested it, since he's unlike most US paid plasma donors, who are need the money and are willing participants (victims) in their own exploitation.

But the Australian chose to donate voluntarily for free. To revise a phase from US politics, 'I'm with him.'

CSL (Australia): Bullying, sex toys and how CSL got rid of a complaining employee (6 Sept. 2017)

This is a fascinating case in which the employee being bullied was male and his boss was female. To get rid of him, CSL (world leader in the plasma protein biotherapeutics industry) started a campaign to find anything they could use against him, even to the point of discovering he sold sex toys on e-Bay. He was fired.

Australia's Fair Work Commission found that he was unfairly dismissed. His female boss apparently remains at the company.

Case of a transfusion medicine physician, who with her then spouse, bought 4,000 shares of Immucor in 1982 for $11,000 (7 June 2017)

This real case focuses on the doctor's tax woes in the USA after her share became $1,717,038 in 2011. The Court found the doctor's tax issues were not due to her errors but rather the person who prepared her taxes.

Interesting 'What if': Would the transfusion doc, when she was publishing in medical journals decades ago, have mentioned her Immucor shares? In the 1980s did medical journals have conflict of interest or competing interest requirements?

For interest, the physician in question is now a septuagenarian but still active.

I chose the song based on the first and third news items. In the first a 'business ethicist' promotes selling body tissues and organs without thought of where that will lead us. Especially how it will lead to the wealthy even more exploiting the poor people in this world.

And result in tissue/organ brokers getting rich off the misery of the poor and disadvantaged. Just as paid plasma companies gain incredible wealth from the needy selling their plasma.

All for the sake of a buck. But conveniently camouflaged under the guise of doing good by helping patients who need plasma-derived products. Kinda reminds me of Robin Cook's book, Coma, and the movie based on it.

In the third news item a man was judged to be unfairly dismissed but the issue is the company went after his private life to get evidence to justify firing him.
Love these words:
I look at the world and I notice it's turning
While my guitar gently weeps
With every mistake we must surely be learning
Still my guitar gently weeps 
As always, comments are most welcome.


Jawarski articles
  • Early Career Research Spotlight – Peter Jaworski (Journal of the American Philosophical Association,10 May 2016)
What Jaworski doesn't mention: