Wednesday, August 29, 2018

Take a chance on me (Musings on PROMs and PCOs)

Updated: 30 Aug. 2018
August's blog derives from a scientific paper by authors in Ottawa, Canada (Further Reading) that I added to TraQ and tweeted about.
Staibano P, Perelman I, Lombardi J, Davis A, Tinmouth A, Carrier M, Stevenson C, Saidenberg E. Patient-centered outcomes in the management of anemia: a scoping review. Transfus Med Rev. 2018 Jul 12. pii: S0887-7963(18)30051-8. [Epub ahead of print]
First, out of curiosity I wondered about the meaning of 'scoping review', something I wasn't familiar with.

Second, patient-reported outcome measures (PROMs) used to evaluate the quality of patient-centered outcomes (PCO) struck home in my personal life. According, I obtained the full article to read. Then, when one of the authors on Twitter asked me for an opinion, I replied as follows.

What follows are the key points I took from the paper according to my own interests and career as a medical laboratory science educator who taught critical analysis of scientific literature for years.

This blog concentrates on only three features of the paper. I didn't include Methods and Results for the sake of brevity and to keep the blog more accessible to readers. Obviously, they are key to the paper.
  • Scoping review (What's it all about?) 
  • PROMs and PCOs (Research often omits all mention of them)
  • Discussion (Great model for authors of research papers)
Don't expect an expert analysis because I'm unqualified to get into the review's nitty-gritty. What I present are generalizations within my personal and professional experience.

The blog's title derives from a 1978 ditty by Sweden's ABBA.

After reading several resources (Further Reading) on 'scoping review' I'm not all the wiser but see it as follows:
  • Relatively new approach; 
  • Purpose is to map the literature on a topic vs a systematic review designed to summarize the best available research on a specific question;
  • Scoping is broad, systematic is narrow.
If anyone can enlighten me further, please do so via Comments below.

PROMs and PCOs 
This is where it gets personal. Patient-reported outcome measures (PROMs) are used to evaluate the quality of patient-centered outcomes (PCOs - Further Reading). Both are usually absent in medical research on various treatments.

In this scoping review the most common PROM tools were Functional Assessment of Cancer Therapy (FACT) and Functional Assessment
of Chronic Illness Therapy (FACIT) scales (46.9% of studies).
See examples of PROMs in Further Reading. Headings typically include these types of well-being:
  • Physical
  • Social/Family
  • Emotional
  • Functional
The authors explain the concepts as follows:
'Patient-centered outcomes (PCOs) measure the impact of disease and treatment on a patient’s physical, social, and mental well-being.Tools used to measure such outcomes are known as patient-reported outcome measures (PROMs).'
'PROMs are necessary for understanding the holistic burden of various disorders from the patient perspective and for improving patient-physician communication, patient satisfaction, and treatment outcomes'
Five years ago my spouse was diagnosed with an incurable disease, idiopathic pulmonary fibrosis (IPF), with an average life span from diagnosis of  3-4 years, although some patients live much longer. At first the Alberta government did not cover the one drug that supposedly could help (Esbriet or pirfenidone). But later after more CADTH research gave it the okay, Alberta did fund the drug under certain disease conditions (at a cost of ~$43,000/yr). The studies that showed pirfenidone was useful were based on extenuating life, the so-called survival benefit.

In my opinion, pirfenidone's many side effects (See blogs in Further Reading) were downplayed in research articles and manufacturer's literature, saying they could be managed by lessening the dose. Perhaps for many but not in spouse's case, and who knows how many others.

Patient-reported outcome measures used to evaluate the quality of patient-centered outcomes related to the patient's physical, social, emotional, and functional well being were slim and mainly physical side effects. In reporting side effects outcomes were chosen that were mostly clear cut such as rash, sun-sensitivity, nausea, and of course, whether patients survived longer on the drug, the key.

As a result of my spouse's experience, if ever requiring treatment for a life-threatening condition, I hope health professionals will ask me for PROMs. I'm best qualified to assess my overall quality of life and well-being and would want those factors to be considered alongside how much my life and functionality were extended by the treatment.

I appreciated the paper's discussion for several reasons, especially how the authors extensively discuss limitations, some of which are presented below. This section could be used as a model for students learning how to evaluate literature. How the authors analysed the review's results follows.

Because the review analysed PCOs and anemia in mainly adult oncology patients (less than one-tenth evaluated pediatric or older adult
populations), authors note the limited generalizability of findings to those patients.

Although more than half of the included studies were RCTs,approximately 45% of these were open-label* and susceptible to patient allocation biases and biases related to the inherent subjectivity of PROMs (self-reported patient replies to survey questions).
*Open label clinical trials do not attempt to disguise the drug/treatment, meaning that no standard treatment or placebo is utilized. This can lead to bias, as both patients and physicians are aware of which groups are receiving which treatment. 
More than 75% of included studies investigated PCOs in anemic patients treated with erythropoiesis-stimulating agents (ESAs), whereas only 3.8% evaluated PCOs in studies of transfusions to treat anemia. The authors write,
 'As blood transfusions are one of the most common medical procedures in hospitals, are known to carry risk, and also use a limited resource, the lack of studies assessing how transfusion affects patient quality of life remains a troubling discrepancy.' 
I'm tempted to say, "It's the transfusions, stupid" as in the 1992 USA presidential race, where strategist James Carville ('the ragin' cajun') used  'It’s the economy, stupid' to focus the minds of Clinton's campaign workers.

Study Outcomes
Published studies evaluating ESAs to treat anemia, regardless of etiology, have nearly all had change in hemoglobin levels as the primary study outcome. Those related to the appropriate threshold at which to administer transfusion nearly always have mortality as the primary outcome.

To assess treatments for anemia or any condition, having a standardized set of core outcomes would help.

Bottom Line
My view: Using patient centered outcomes in research of any treatment for a specific condition faces many challenges. But they are essential if patient-centered care is to go beyond the cliché it often is today. Developing validated PROMs and requiring consistent and full reporting are key. Lots of work is needed to make this a reality.

Could not resist choosing this ABBA song. I see it as asking medical researchers to take a chance on me and all patients. We patients should have a say in what the full outcomes of our treatment are. Plus ABBA songs are fun.
As always comments are most welcome.

Staibano P, Perelman I, Lombardi J, Davis A, Tinmouth A, Carrier M, Stevenson C, Saidenberg E. Patient-centered outcomes in the management of anemia: a scoping review. Transfus Med Rev. 2018 Jul 12. pii: S0887-7963(18)30051-8. [Epub ahead of print]

What is a scoping review?

Pham MT,et al. A scoping review of scoping reviews: advancing the approach and enhancing the consistency. Res Synth Methods. 2014 Dec; 5(4): 371-85. EPub 2014 Jul 24.

Patient-centered outcomes research from PCORI

PROMs (from Canada's CIHI)

PROM Examples
   All FACIT questionnaires
   FACT-L: For patients with lung cancer [Download pdf]

Personal Blogs
To be or not to be (Musings on IPF and Esbriet) Mar. 2016

IPF and Esbriet (Musings on extended life vs quality of life) Sept. 2016

Saturday, July 28, 2018

Everything I do, I do it for you (Musings on the UK's Bawa-Garba case)

In July's blog I offer brief comments on an item in TraQ's July newsletter. The title derives from Canadian Bryan Adams' 1991 song.

UK's Bawa-Garba case, dating to 2011 and still unresolved, has gained attention of health professionals worldwide (right click, open in new tab,for clearer graphic).
Source: What impact will the Bawa-Garba case have on community pharmacy? (Further Reading)
Source: The Bawa-Garba case, BMJ (Further Reading)

The case gives rise to so many points of discussion, including
  • Racial bigotry;
  • Culture of blame vs encouraging health professionals to report errors honestly without fear of reprisal;
  • Responsibilities of senior staff supervising junior staff;
  • Consequences of one serious error by an otherwise competent practitioner;
  • Stifling the recording of written reflections about mistakes made (tool for personal learning) because they may be used in court;
  • Facility responsibility for errors made by overworked staff in understaffed health facilities;
  • Should public perceptions trump justice and dictate harsh sentences so faith in the safety of the health care system won't be lost.
As an ex-med lab science (transfusion) educator, I'm especially interested because I was involved in case where a student error hastened a patient's death:
  • TraQ's Case A8: Severe Hemolytic Transfusion Reaction Involving a Student (Further Reading)
Also, earlier as an experienced medical technologist in a stand-alone central transfusion service separate from hospitals, and working alone on a Saturday night, I once crossmatched a pre-op patient who surprisingly typed as group AB when records showed she was group O. The SOP of always checking prior records saved that patient as another sample was drawn at the hospital, which correlated with the historical group.

But what if I had been distracted or swamped by an emergency and somehow did not do the required patient history check? A disaster (serious hemolytic transfusion reaction) might have occurred, perhaps leading to patient death, and it would be due to my error for not following standard operating procedures. Perhaps I would have been charged with gross negligence manslaughter due to not doing what a reasonably competent technologist would do?

The Bawa-Garba case offers food for thought for all health professionals.

My lifetime experience is that health professionals put patient safety above all else and often sacrifice much to perform health care duties in an exemplary manner. That includes long years of study as students and, once registered, investing much personal time to keep up-to-date with the latest advances and best practices.

Could not resist using Bryan Adams' 1991 ditty, the third best selling Canadian single of all time:
What impact will the Bawa-Garba case have on community pharmacy?
The Bawa-Garba case, BMJ
Bawa-Garba news items (TraQ's 2018 July newsletter)
TraQ's Case A8: Severe Hemolytic Transfusion Reaction Involving a Student 
As always, comments are most welcome.

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.

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.

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.

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.

Wednesday, June 20, 2018

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

Updated: 21 June 2018 (Fixed all links; added more)
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 co-founded the Institute for Liberal Studies (Further Reading) and 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

Those ubiquitous libertarians (2014) - Discusses influence of the Koch Brothers in academia (much of it hidden); wonders about funding of Jaworski's Institute for Liberal Studies (ILS)

Multi-millionaire quietly funds network of right-wing groups active in fight to dismantle Canada’s public healthcare system (2017); Including funding ILS

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)