For the times they are a-changing (Musings on COVID-19 global news)

Stay tuned: Revisions are sure to come

What to write about during COVID-19? It initially stumped me. Possibilities I considered include how coronavirus has impacted the blood supply worldwide and increased pressure from paid plasma advocates to promote paying for all plasma and other body tissues. 

Finally settled on a mini-survey of coronavirus news featured in May's TraQ's newsletter to see what, if anything, that might reveal..

The blog's title is based on a 1965 ditty by Bob Dylan, and yes, it can be read many ways given the news.

INTRODUCTION
The mini-survey is based on news items I selectively collated for TraQ's newsletter during March, April, and May 2020. As past blogs will show, the blogs are mine alone and reflect my personal biases. 

For May's blog I arbitrarily organized COVID-19 news items into four topics, which have some overlap:

• General (Information, industry news, search for treatments and vaccines)
• Blood supply (Risk of shortages)
• Convalescent plasma
• Journal articles

SUMMARY 
Results of TraQ's March to May survey:

TOPIC	MAR.	APR.	APR.	TOTAL
General	0	13	8	21
Blood supply	6	3	4	13
Convalescent plasma	6	14	7	27
Journal articles	0	23	15	38

Limitations
I could have calculated results incorrectly. My search alerts may not have identified all possible news items in each category. Also, in May the number of convalescent plasma news items soared and I decided not to include  many in the newsletter, as they often involved only a few people and were repetitive of earlier news. It's possible I haven't yet been alerted to the existence of more COVID-19 research articles published in May. 

LEARNING POINTS
So, as I recall from the 1966 film Alfie, it's time to ask, 'What's it all about Alfie?' Or as I once told my Med Lab Sci students, you should try to identify the 'so what' message of research papers. So too should blogs have a point. My biased musings on the results:

• So much money is being poured into research for a vaccine and improved COVID-19 testing. It's a race to get there first among nations, including to have the vaccine manufactured in a country, as presumably that would give priority access to its citizens. 
• Seems a rush to strike gold first. Potential for industrialized nation to get priority access and developing nations to be left out as often is the case. Think of recombinant FVIII being unavailable for ages in developing nations. Also countries like India where blood banks still use ELISA to test for HIV, Hepatitis B and C, rather than NAT.
• Convalescent plasma is the flavour of the year of COVID-19. Results look promising but final results not in yet. More troubling is the notion that having antibodies allows you to return to work as you are protected. But scientists don't know yet whether people who've been exposed will be immune for life, as for measles, or if COVID-19 can return again and again, like the common cold. 
• Big Pharma wants mega-money up front to fund COVID-19 research (Further Reading). Quote from article:
• Particular concern over poorer countries’ access to medical supplies was highlighted by G20 health ministers’ failure at the weekend to issue a declaration of solidarity after this was blocked by the US. 

FOR FUN
I chose this Bob Dylan song as it reflects what's called the 'new normal' during COVID-19 and also reflects the current protests happening in the USA over the killing of a black man by a police officer. Somehow I suspect, with zero evidence, that the protests may be stronger and more widespread because of the coronavirus lockdown. Or perhaps because murder of black people by police has become all too common in America?

Chose Joan Baez to sing it for several reasons, the most important being she has a much better voice than Dylan. Also this version has the song's lyrics. Tidbit: Joan and Bob were once an item (Further Reading).

• For the times they are a-changing (Joan Baez)

As always comments are most welcome.

FURTHER READING
TraQ's newsletters

• March
• April
• May

Big Pharma calls for ‘billions’ in upfront coronavirus funding (20 Apr. 2020)

Joan Baez finally gets her public apology from Dylan (21 Sept. 2009)

Nessun dorma (Musings on anti-paid plasma blogs over the years)

Updated: 14 Nov. 2018

Below is a list of the blogs I've written so far on paid plasma: 23 blogs over 6 years as of 14 Nov. 2018. Some blogs focus on it entirely, others touch upon it along with related issues. In total 2004-2018 I've written 174 blogs, and paid plasma constitute about 13% of them. This blog's sequence is different than others. The main content (list of earlier blogs) will come at the end.

INTRODUCTION
The blog's title comes from a famous aria for tenors in Puccini's opera Turandot, which premiered at La Scala in Milan in 1926 after Puccini's death. Like many, I love the classic for many reasons. One is my spouse and I heard Pavarotti sing it in person in Edmonton in 1995. The face of every person on the LRT ride home from the concert radiated with joy.

I chose Nessun Dorma for several reasons. The title and first lines translate as 'None shall sleep' and builds to the final, victorious cry of 'Vincero!' (I will win!). In the battle over paid plasma in Canada, and it is a battle, I'm against paid plasma, as explained in the 23 blogs below. We don't know who will win and what the win will look like.

I hope the eventual winners (Vincero!) will be

• Patients who need plasma derivatives and are prescribed products like intravenous immune globulin (IVIG) for evidence-based reasons, not because Big Pharma promotes it relentlessly to physicians. VERSUS patients being scared into panic by BIG Pharma, which supports their associations financially and is not beyond creating fear the world will end if paid plasma clinics cease to grow exponentially. 
• Blood donors in financial need, who will no longer be exploited at the risk of their health by Big Pharma, which makes $billions off their body tissue. Yes, not all see themselves as being exploited, but many, if not all, are exploited and it's unethical.
• Volunteer blood donor sector, which will recruit and be able to retain young donors, instead of having them slowly siphoned off to paid plasma, from which they are unlikely to return as they age.
• Canada's blood supplier CBS (outside Quebec), which can concentrate on ways to encourage more volunteer young donors, perhaps with token incentives as happens in the USA system, or maybe not. Hope that CBS gets funding to open plasma collection clinics to get Canada closer to meeting its plasma needs.
• Canada's government funders of the blood system, which should fund CBS plasma clinics, encourage voluntary donation, VERSUS now needing to spend megabucks to regulate ('police') the use of IVIG due its ever-increasing usage, as done by the BC PBCO and others, including for primary immunodeficiency. 
• Health Canada should do its duty to regulate blood safety as a win-win strategy for patients and blood donors, VERSUS encouraging Big Pharma to promote endless iffy uses of plasma derivatives by supporting its exploitative paid plasma growth in Canada. 

FOR FUN

• Nessun Dorma - Luciano Pavarotti, 1994 (3:14 mins)

PAST PAID PLASMA BLOGS (n=23)

2018

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

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

2017

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

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

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

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

We are the world (Musings on the humanitarianism of selling body tissues) 

The Boxer (Musings on lies & jests in the blood industry)

2016

Simply the best (Musings on paid plasma  and TM colleagues I've know) 

Sweet Dreams (Musings on a recent transfusion-related nightmare) 

Heart of Gold (Musings on donating the gift of life)

2015

Heart of Gold (Musings on sucking $ from body tissues)

2014

Don't worry, be happy (Musings on the safety of our blood supply) 

If you could read my mind (Musings on hard-to-believe TM news) 

C'est si bon (Musings on TM news that is so good and not so good) 

Hey Jude (Musings on why paid plasma makes it worse, not better) 

I heard it through the grapevine (Musings on paid plasma's PR campaign) 

Bridge over troubled water (Musings on what to be thankful for as TM professionals)

2013

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

Heart of Gold (Musings on pimping for paid plasma) 

Stop children, what's that sound (Musings on commercialization of our blood supply) 

We are the world (More musings on commercialization of the blood supply) 

Still my guitar gently weeps (Yet more musings on commercialization of our blood supply)

Don't worry, be happy (Musings on how TM leaders mimic politicians)

Updated: 25 July 2016 (See highlighted text under Musings)

Do you know what government politicians and transfusion medicine (TM) leaders have in common? No matter what the threat, both repeatedly assure their constituencies, 'Don't worry, be happy.' 

July's blog takes its theme from recent transfusion-transmissible disease news. The title is from a 1988 ditty by Bobby McFerrin.

For readers who choose not to read the full blog, here's the executive version. The blog's aims are to

• Encourage readers to be skeptical about how safe our blood supply is;
• Hold our TM leaders to the highest standard, one higher than we expect from politicians;
• Credit us with the intelligence to understand nuance.

GOVT LEADERS
Examples of politicians assuring citizens all is okay:

• Canada: PM Justin Trudeau reassures Canadians that the economy is in a good position to weather the storm in the wake of Britain's Brexit vote. (June 2016)

• UK: Home Secretary Theresa May assures Brits that the UK has taken steps to amend powers and increase capabilities to deal with developing terrorist threats. (Aug. 2014)

• USA: Obama assures Americans the highest priority is their safety following a string of terror attacks (Dec. 2015)

TM LEADERS
Similarly, all involved at top echelons of the blood industry in the developed world constantly reassure us that our blood supply is the safest it ever has been.

Unstated is the blood supply is the safest it has ever been for the KNOWN OLD infectious disease risks, the ones that figured in the so-called 'tainted blood' scandals that plagued us in past decades. Experts assure us

• We are doing all we can to minimize risks. 
• Donor screening, improved transmissible disease (TD) tests, and manufacturing processes for plasma-derived products pretty much eliminate the old TD risks like hepatitis B, hepatitis C, HIV. 
• The blood supply is safe. Don't worry, be happy.  

Need a  touchstone of how TM leaders now see our blood supply as bulletproof?

• Today western nations have pretty much all moved from a total ban on blood donation for MSM males to a 5 year deferral to a one-year deferral, providing no MSM in the past year. 
• Blood suppliers did so influenced by nation-wide, indeed global, campaigns by gay activists and others who support their cause. They decried the ban against gay/bisexual men donating blood, including the latest one-year deferral, calling it discriminatory and unjustified based on the evidence. 
• Some even say the ban on MSM was unjustified from the get-go:
• 'The new policy isn't any more scientific than the old policy. It's based on the same bigotry and gay panic defence that the ban has been based on since the beginning.' 

My belief is that CBS's evolving MSM policy is motivated by activist groups and worldwide policy changes (themselves motivated by activists) but is not discriminatory. See, for example, this 2013 interview with Dana Devine:

• CBS decision to decrease its MSM ban to a 5-year deferral
• Because of the low prevalence of HIV+ Canadian blood donors, it takes years to get good data upon which to base decisions.
• No doubt the same criteria will apply to changing the one-year ban to no ban at all.

NEWS (JUNE-JULY 2016)
Examples of news that triggered this blog:
HIV

• CDC Press Release (July 20, 2016) : Gay and bisexual teen males no more likely than heterosexual teen males to engage in sexual risk behaviors but at substantially higher risk of HIV infection:
• HIV diagnosis rates are 57 times higher among men who have sex with men (MSM) than among heterosexual men.

ZIKA VIRUS
Several disconcerting anomalies exist about Zika virus transmission:

• What the hell is going on? (Well worth a read because we still don't fully understand Zika, just as we didn't understand in the early days of HIV and HCV)

MUSINGS
TM leaders' standard response (SOP?) to blood supply risks is analogous to politicians who ensure citizens that 'all is okay'. And TM leaders are more-or-less correct, just as politicians are about their claims of relative public safety from economic disasters and terrorism. Except when the next man-made disaster strikes, as it inevitably does.

For both groups, claiming safety makes sense and often is in the public interest. The last thing citizens need is to fear for their safety, fear to travel, fear that those who are different ('the other') are somehow dangerous. Politicians who fear-monger usually do so in their own self-interest and often are despicable in spinning tragedies to their crass political benefit.

TM leaders never-ever fear monger. It's not in their best interest or ours, whether as blood donors or transfusion recipients. For the best of reasons TM leaders correctly assure us that life-saving transfusions are the safest they have ever been. Such reassurances serve the public interest because we don't want folks to fear life-saving transfusions or stop donating blood.

Yet many in the TM community come across as complacent and overly confident. I'd love to be similar, live in a bubble, sing 'Don't worry, be happy.' But, having experienced Canada's 'tainted blood' scandals, I'm skeptical. Note, skeptical, not cynical.

Partly it's because TM leaders failed us in the HIV tragedy. Out of arrogance or being true-believers matters not:

• And the Band Played On (full movie on Youtube - it's a beauty)
• Canadian Red Cross denies link between AIDS and blood products (two-minute video)
• In the 1980s a Canadian Red Cross (CRC) medical director uses 'cost-benefit ratio" to determine if hemophiliacs should be transfused with potentially infected products.
• Reality: FVIII concentrates from thousands of donors were all infected with HIV. Yet even after safer heat-treated FVIII conc. was available, untreated products were transfused. Seems likely our leaders decided to use up CRC's expensive stock pile, in the self-serving beliefs that hemophiliacs (1) were probably already infected and (2) might die if left untreated. A few physicians wisely and bravely chose to give the safer single-donor cryoprecipitate. 
• Note: Over 1100 Canadians were infected with HIV from blood transfusions, of which 700 had hemophilia and were treated with FVIII concentrates.

The results of economic-based calculations around the globe:

• USA: The tragic history of AIDS in the hemophilia population 1982-1984
• Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic 

Decision making in the early days of HIV was complicated because of all the players had genuine concerns, all born of self-interest (see 'The tragic history of AIDS...' above):

"Homosexuals were major blood donors in the large cities on the east and west coasts. It was thought that singling out homosexuals for exclusion would unnecessarily stigmatize them without evidence that they were indeed transmitting the disease. The blood industry, threatened by losing a large donor pool, strongly supported the position of the gay groups on this.

The hemophilia groups expressed concerns that the data showing immune suppression in hemophilic patients could have reflected the effects of prolonged use of blood products and did not necessarily mean they had the new syndrome. They also feared the stigma of having a disease associated with homosexual patients and were concerned that reducing the use of clotting factor concentrates would bring back old issues of deformities and early death, the fate of hemophilic patients before concentrate treatment."

These same forces are still at work today among all the stakeholders. CRC's successor CBS - with most of the same trench-workers (but not staff forced out for being truthful to the Krever Commission) - are even more into cost-benefit. Indeed, they've refined cost-benefit into a science. Decisions are  evidence-based, so please don't waste our time by questioning them.

CBS and others now use data - based on prevalence and disease severity - that determine whether a blood supplier implements a blood safety test or not for a given transfusion-transmissible risk. Today's blood suppliers are all about metrics and cost-savings, and they're proud of it, even crow about it.

Just like the Canadian Red Cross was when it declined to implement surrogate tests for hepatitis non-A, non-B (now hepatitis C). Seems Canada's experts judged surrogate tests to lack sufficient sensitivity and specificity. That tens of 1000s of Canadian transfusion recipients were subsequently infected with HCV is a testament to 'expert' opinion. It ain't infallible, especially if driven by cost constraints.

Today, cost-savings pretty much drive our blood system and have for awhile. The public purse is not an unlimited money pot and tough choices must be taken. Moreover, zero-risk is impossible in TM, indeed in all of medicine. 

The impossibility of zero-risk is one reason that patients sign consent to treatment forms. Despite informed consent, how much patients truly understand is debatable. My experience is the process is often rushed, matter-of-fact, with the implication being we have to do this so let's get it done quickly: Just sign this so I can get to more important tasks. Sort of like asking people how they are, expecting only, "I'm fine, thanks."

Yes, I've written variations on this theme before. But I hope readers see how true the analogy of TM leaders being the same as political leaders who constantly reassure us - as a knee-jerk reaction - that we're safe because they're doing all they can to combat the risks we face.

BOTTOM LINE
I don't want folks to become fearful of our blood supply. It's safer than ever, although not bulletproof. Rather I encourage readers to be skeptical, i.e., to have some degree of doubt regarding claims that are normally taken for granted just because they come from our leaders.

In this case, please be skeptical about what our TM 'thought leaders' tell us about blood safety, especially given the ever-evolving transfusion-transmissible threats AND the fact that commercial vested interests (Big Pharma, the diagnostic test industry) are now - more so than ever - in bed with transfusion professionals.

SIDE BAR (Food for Thought)

Let's consider the small picture of vested interests. Many experts who present at company-funded continuing education events or any CE event have strong ties to industry.

Think about the issue on a personal scale. Have you ever attended a TM talk, workshop, seminar sponsored by Big Pharma or a diagnostic test firm? If yes, have you even once heard representatives discuss anything that casts any doubt whatsoever on their products and their benefits? Suspect not. 

When attending CE events do you assess what ties the speakers have to industry? Or mostly listen in awe to the acknowledged world-renowned experts who transitioned from their original health care careers and now more or less work for profit-driven private industry?

Let's say I've built a good career on specializing in DNA genotyping of red cell antigens. What are the odds I'd be for each and every use of molecular typing in TM and a strong proponent of so-called personalized medicine?

Suppose one of my roles is as an academic whose career and advancement depend on getting my research funded and published? How likely would I be to criticize industry partners who fund my research? Or try to publish negative studies that don't support the company's products? 

Now let's return to the big picture. I'm not suggesting TM leaders are consciously influenced by commercial interests - who often just happen to be their industry partners (although they clearly are influenced in many ways) - on matters of blood safety. Rather my point is that people invariably act in their own best interests. Human nature...

Those in charge of the safety of our blood supply cannot admit the supply is unsafe, even that tiny risks exist. Just as politicians responsible for public safety cannot say citizens are unsafe. It's impossible. This means that you and I must be skeptical and not meekly accept pronouncements from on high about anything, including government and TM decisions influenced by pressure groups.

Wouldn't it be great if our TM leaders would credit the public with intelligence and consistently articulate blood safety with these six points? I challenge them to LEVERAGE our intelligence to their advantage.

1. Our blood supply is the safest it's ever been but it's not risk-free. 
2. We need to be vigilant with donor screening, both questionnaires and TD testing. Tests are not perfect and donors may lie about risk behaviors. 
3. Hemovigilance is key to prevent and identify adverse transfusion events and because unknown risks, for which no screening exists, are certain to arise. 
4. Human error exists despite the best education, training, and competency assurance programs.
5. Due to cost constraints, we must prioritize blood safety measures and, accordingly, tolerate some risk (ideally rare and less serious risks), as we do in all medical fields.
6. MSM policies evolve and will continue to do so based on considering horrific past mistakes and their victims (many now dead) and current realities of improved screening tests balanced by HIV prevalence and relative risk among different donor groups.

Instead our TM leaders (like politicians) all too often use this easy mantra, which both patronizes and disrespects and, worst of all, cuts off discussion before it even begins:

• Our blood supply is the safest it's ever been.
• Don't worry, be happy.

For an insight into the viewpoint of victims in the aftermath of Canada's blood scandal see

• 2007: Four doctors on criminal negligence charges and a U.S. blood-product company of common nuisance acquitted of charges related to the worst public health scandal in Canadian history.
• Lawyer with hemophilia infected with HIV and HCV describes judge's ruling that there had been "no conduct that showed wanton and reckless disregard" as "ludicrous".

FOR FUN
The blog's theme perfectly fits this 1988 Bobby McFerrin song:

• Don't worry, be happy (Bobby McFerrin) 

As always, comments are most welcome. 

I heard it though the grapevine (Musings on AABB promoting academia-industry partnerships)

Updated: 15 June 2015

June's blog is stimulated by May's issue of 'AABB News' featuring 'Advancing Cellular Therapies Together'. 

The blog's title derives from a Marvin Gaye classic covered by Creedence Clearwater Rival in 1970.

Frankly, the rah-rah! uncritical tone of the AABB articles surprised me. They mentioned logistical challenges to academia - industry partnerships but not one, repeat, NOT ONE, of the well known pitfalls when industry funds medical research. Didn't even allude to such problems existing.

Why no mention of pitfalls? Is it because of AABB's self-interest in promoting a business line?

• Standards for Cellular Therapy Services, 7th ed.

In her editorial, 'Advocating for Cellular Therapies', AABB president Lynne Uhl writes:

'AABB will continue to advocate for clear regulatory pathways that avoid overly burdensome requirements for existing cellular products and promote rapid translation of novel findings from CT and regenerative medicine research to treatments for diseases.'

Sounds logical that AABB would advocate for easier access of medical discoveries to the marketplace where they can help patients. But the stance aligns with industry's usual complaint that governments set up needless roadblocks and should just get out of the way because industry will ensure patient safety. Really? LOL!

Let's take a brief closer look at AABB News' cellular therapy features.

AABB NEWS ARTICLES
A few selected highlights from 3 articles:
1. Evolving partnerships between academia and industry (p.4)

'As state and federal government funding...has declined... industry support has allowed many academics to continue their research, and academic institutions ... justify such collaboration as a pathway for the commercialization of important discoveries for the common good.'

2. Academia and industry collaborate in cellular therapy partnerships (pp. 8-10)
This article is an interview with Yongping Wang, MD, PhD, scientific director of the stem cell laboratory at the Children's Hospital of Philadelphia (CHOP) and Deborah Sesok-Pizzini, MD, MBA, chief of the blood bank and transfusion medicine division at the CHOP.

'The partnership gives both parties a new outlook on their work. It also brings together the different strengths of the two enterprises, which hopefully results in synergy.'
'The ultimate goal of these partnerships is to develop a mutually beneficial relationship that will result in scientific advancements.'

3. Advancing cellular therapies through partnerships (pp. 12-17)

'Many institutions and companies form partnerships drawing on each other's strengths to ease and speed the journey to market.' 

California Institute for Regenerative Medicine (CIRM): 'We are working to remove the barriers that slow research, without compromising safety.'

WHY RESEARCHERS AND UNIVERSITIES LOVE INDUSTRY FUNDING

1. Government research grants are getting harder to obtain.
2. Researchers may lose positions without outside research money because public universities increasingly suffer from decreased government funding and expect staff to be self-funded, especially in medical faculties.
3. Industry funding combats the long-standing bias that universities are 'ivory towers' divorced from the real world.

WHY BIG PHARMA LOVES UNIVERSITY COLLABORATION

1. Outsourcing cheaper, as those in blood industry know
2. Adds credibility, especially if researchers are seen as 'thought leaders' 
3. Access to research facilities cheaper than building them
4. Well educated staff who work for free, inc. PhD students
5. Way to recruit scientists and see future staff in action
6. Form of advertisement, if researchers are in same field 
7. Free advertising as universities tout industry partnerships to combat 'ivory tower' stereotype

WHAT COULD GO WRONG?
The short answer is just about everything. Of course, just because Big Pharma funds a study does not invalidate it. Most studies with commercial applications are funded by industry. But the scientific community needs to assess every aspect of such studies carefully using the hallmarks of critical analysis of scientific literature.

I'll highlight two threats that industry funding poses to medical research:

1. Easier Research
Industry tends to fund technology- and drug-based research because they are its business lines and such research happens to be easier. Big Pharma and the biotechnology industry doesn't fund difficult qualitative research on soft skills such as communicating, conflict management, human relations, negotiating, team building, etc.  Why would it? 

Yet soft skills deficiencies account for serious errors in patient care. For example:

Communication
Communication deficiencies are common causes of adverse transfusion events. Patients with special transfusion needs such as those requiring irradiated or CMV-negative blood components are particularly at risk when communication fails.The spectrum of communication deficiencies includes the following failures:

• Physicians not communicating with nurses, technologists, pharmacists, etc., and vice versa
• Attending physicians not communicating with residents and interns
• Staff from one unit not communicating with another unit
• Staff on one shift not communicating with the next shift
• Documentation not accompanying patients from facility to facility

Which research would industry be more likely to fund?

• Educational research to improve health professional communication
• Technology-based mistake-proofing tools like Blood Loc, a combination-lock-secured disposable bag that ensures positive identification occurs before blood can be unlocked and transfused

No brainer, right? Funding techno-solutions involves easier research. No messy human traits to deal with. 

Research priorities
Of course, to make the point, I've given an apples-and-oranges example of competing research needs. But make no mistake, within transfusion medicine many pressing research needs compete for limited funds. 

For example, on 25-26 March 2015, the U.S. National Heart, Lung, and Blood Institute (NHLBI) hosted a conference on 'State of the Science in Transfusion Medicine', for which AABB provided highlights. Priorities identified included

• Need to integrate basic science within clinical trials design
• Research to determine how to make better products, whether synthetic, bioengineered or 'pharmed' 
• Several other themes: 
• Hemostasis
• Donor health and safety
• Transfusion requirements of different patient populations, particularly pediatric and neonatal patients

I cannot help but wonder where all the research on molecular blood typing fits in the priorities identified at the NIH conference. Immucor and others claim it will 'revolutionize blood bank operations' and they work hard to make that goal a reality. But is it the best use of scarce research funding? See my take:

• While my guitar gently weeps (Musings on the seduction of technology)

Having industry control which research 
gets done is not good.

2. Funding Effect
Financial interests can influence research outcomes in many undesirable ways. (See Resnick below) Besides outright fraud, well intentioned researchers may produce biased results unconsciously. 

For example, suppose I'm a university researcher who's increased my prestige and job stability because I've obtained a $1 million contract from Big Pharma to collaborate on investigating a new cellular therapy in what industry calls the 'niche area of oncology'. (Who knew cancer was a niche business line?)

A negative research result or one that shows only a marginal benefit will not further my career. But I'm ethical and have no intention of deliberately skewing results. Resnick below explains the nitty-gritty of what can go wrong from start to finish:

• Problem selection 
• Research design 
• Data collection 
• Data analysis 
• Data interpretation 
• Publication and data sharing 

A funding effect on medical research is real. I repeat, funding does not negate research, but we need to be aware of its insidious influence.

BOTTOM LINE
Collaboration and partnerships between academia and Big Pharma (and other health-related industries) are facts of life. Such collaboration has many benefits and many pitfalls.

Can the transfusion medicine community, particularly NA leading organizations such as AABB, please take its self-interest blinkers off and give members some credit for having a brain?

Vacuous, Rah! Rah! articles undermine AABB's credibility. I expect better from an organization I've respected and been a member of for 40 years.

Sidebar: Does 40 year membership mean I'm eligible for 'emeritus / life membership' in AABB?AABB proposed bylaw change:

"Emeritus Membership to be renamed Life Membership with the eligibility requirement to be changed from 10 consecutive years of Individual Membership in AABB to 30 consecutive years."

As always, comments are most welcome.

FOR FUN
The version of the blog's title song that I I prefer is CCR's.

• I heard it through the grapevine (Creedence Clearwater Rival, 1970)

Don't you know I heard it through the grapevine
Not much longer would you be mine
I heard it through the grapevine
I'm just about to love my mind

What did I hear via the grapevine of AABB News? That respected organizations like AABB now mindlessly promote academia-industry collaboration as if it was the greatest invention since sliced bread. And not a whisper, not a hint of the real possibility of down-sides. Clearly they're industry's poodles.

FURTHER READING

• Voicing concern that industry funding distorts academic research (ScienceNordic, July 4, 2014)
• Resnick DB. Ethical problems concerning academic-industry collaborations  Source: Conference: 'Science and Integrity in the Modern University' (Delft Technology University, The Netherlands, 28 Mar. 2013)
• As drug industry's influence over research grows, so does the potential for bias (Washington Post, 24 Nov. 2012)
• GlaxoSmithKline funded Avandia trial, a drug that was shown to raise the risks of heart attacks and caused 83,000 heart attacks and deaths before it was withdrawn. 
• Each of the 11 authors received money from GSK. Four were employees and held company stock. Seven were academics who had received grants or consultant fees from GSK.

C'est si bon (Musings on TM news that is so good and not so good)

Updated: 29 May 2014

May's blog is a take-off on cartoonist Gary Clement's weekly feature, 'Week in Review' in Canada's National Post, e.g, Week of Apr. 20-26, 2014. I love them because they capture the week's news with a smile.
The blog's title derives from an old ditty by Eartha Kitt, C'est si bon (It's so good).

The topics include an eclectic selection of news items in TraQ's newsletter in the first quarter of 2014. C'est si bon is an attempt to write shorter blogs. I'd love your feedback. Shorter is so good or not so good? Keep returning because I'll add the odd 'So...' periodically.

A version of the blog (without some of the Comments below) is available on the BBTS website.

1. So creepy

• Vet accused of secretly keeping family's pet alive for blood transfusions

You take your dog to a vet and are told that the pet needs to be euthanized within 24 hours. Six months later you get a call from a former employee of the veterinary clinic who tells you that your pet was still alive and being bled for plasma to transfuse to other dogs. Say what?

2. So deserving

• Canadian Society of Transfusion Medicine 2014 award winners

The CSTM promotes excellence in TM for Canadians. The 2014 CSTM award recipients are, indeed, deserving. I'm fortunate to know them all. 

• Wendy Owens
• Dr. Lucinda Whitman
• Ann Wilson
• Crystal Oko

3. So nerdy (added 11 May 2014)

• How to make fake blood cuts 

Clever and simple, this is the type of chemistry trick we used to love in school. The kid in us still smiles, especially if we're nerds at heart.

4. So overdue

• Big pharma's relationship with your doctor needs some U.S.-style sunshine

By the end of 2014, the USA's Physician Payment Sunshine Act will require drug companies to report every transfer of value (as little as $10) to doctors and academic hospitals on a public website. Canada needs to do the same.

Think it's overkill? Think again. See CMA President Dr. Louis Hugo Francescutti's take on doctors and drugs. Big Pharma's influence on docs has stunk for a long time.

5. So predictable

• CBS CEO Graham Sher: Purchased plasma safe,essential 
• The article is in response to Payment for plasma bad policy 

Dr. Sher's key points (my analysis):

• After the tainted blood scandals of the 1980s and '90s, Canada created a safe and secure system that is the envy of the world and did it using science, evidence- and risk-based decision making.
• Drs. Ryan Meili and Monica Dutt, the authors of Payment for plasma bad policy, may not understand that blood donation and plasma donation are distinctly different, so Dr. Sher will clarify.
• Whether to allow paid plasma donation is a legitimate public policy debate about Canada's societal values and norms but is not an issue of product safety due to today's system and technologies.

So to all you 'worry warts' out there, don't sweat about whether paid plasma is safe. It definitely is. To Canada's elite evidence-based TM scientists, it's only about whether our values can embrace paying for plasma donations. Oh, by the way, without paid plasma patients will die.

As to the Ontario government's attempt to ban paid plasma, as predicted, the minority government has fallen and with it, all legislation.

Added 29 May, 2014: 'Must read' on paid plasma: 

• Twisted business of donating plasma for money (The Atlantic, 28 May 2014)

6. So sad

• Passing of George Garratty, March 17, 2014

The January 2014 issue of the AABB journal Transfusion reported that George Garratty, PhD, retired as associate editor of the Immunohematology section of Transfusion after 31 years of service promoting papers on red blood cell serology.

George was an icon to TM medical technologists. We will miss him dearly. 

• See 2012 interview

IN REPLY to Anonymous (11 May 2014)

Anonymous finds CBS CEO Dr. Graham Sher's public pronouncements on paid plasma in Canada both confusing and unreliable. Me too.

CEO Sher says that he doesn't want paid plasma clinics to open in Canada but, at the same time, he contends that paid plasma is needed to meet current demands for plasma derivatives in Canada and globally. Canada can only meet 30% of its needs. Moreover, he suggests that, without paid plasma, patients would die.

Dr. Sher's key learning point: Like it or not, patients in Canada and the world need paid plasma.

The flaw in that argument is that Canada has never truly promoted plasma donation. Indeed, CBS closed a plasma collection facility because it was cheaper to buy plasma from the USA and (sadly and stupidly) obfuscated its reasons for the closure.

Dr. Sher also contends that today paid plasma is safe because of 'donor screening and testing, plasma quarantine, and technology that inactivates viruses, and several purification steps.' He's right, as far as it goes.

But this reasoning assumes that no emerging infectious disease agents will appear that may escape the detection, inactivation, and purification steps involved in producing plasma derivatives. It also assumes that manufacturing errors will never occur.  And that, with today's system,  a disaster like hepatitis C contaminating Rh immune globulin can never again occur.

Perhaps CEO Sher suffers from cognitive dissonance, i.e., discomfort from holding conflicting beliefs. He contends that paid plasma is safe, and patients need paid plasma derivatives, but he doesn't want paid plasma clinics in Canada because CBS's voluntary donation system works well. Huh?

Cognitive dissonance aside, Dr. Sher is a clever man and has CBS spin doctors (communication specialists) advising him. He knows what he's doing. Any obfuscation is covered by emphasizing evidence-based decisions.

Just like Canadian Red Cross medical experts did when rejecting surrogate tests for non-A, non-B hepatitis (now hepatitis C), which resulted in tens of thousands of Canadians being infected with HCV.

Who can argue against evidence and science? Anyone who questions the safety of paid plasma is automatically and conveniently designated as non-scientific.

In reply to Unknown (12 May 2014)

Unknown asked, 'Is there something in it for CBS and Dr Sher in supporting American paid plasma?'

Great question. What follows are possibilities. First, I believe CBS CEO Graham Sher to be an honorable man who mostly believes what he says or, paternalistically, believes he's doing the right thing for Canada by protecting our TM system from non-scientific types.

But it's not that simple. As AABB President it's possible he's drunk the Kool-Aid of American-style transfusion medicine, given the schmoozing he's no doubt done with Big Pharma and the laboratory diagnostic firms who support AABB, as well as with so-called not-for-profit transfusion labs that operate as businesses.

Or maybe he's into Real Politik, focussing on practical rather than ethical issues.

What's in it for CBS to support paid plasma? It prevents CBS from spending money to promote free plasma donation and to build and maintain plasma collection facilities. Both earn brownie points with CBS's provincial paymasters.

What's in it for Graham Sher to support paid plasma? It's about the money, stupid. Money CBS can save by NOT maintaining collection facilities and staff, as above.

IN REPLY to Anonymous (13 May 2014)

Thanks to Anonymous, who supplied a link to yet another lobby group to promote paid plasma in Canada and noted that Canadian Plasma Resources has deep pockets: 

• Ontario Plasma Coalition (press release 13 May 2014)

The press release is classic PR spin (emphasis is mine):

Made up of deeply concerned Ontarians, the Ontario Plasma Coalition was launched to address the provincial government's irresponsible handling of Ontario's plasma supply and its attempts at banning compensated donations with Bill 178. In partnership with Canadian Plasma Resources, the Coalition was formed following thousands of responses received through PlasmaForOntario.ca.

Who knew that 1000s of deeply concerned Ontario citizens were practically marching in the streets to protest its irresponsible government's move to ban paid plasma?

Sheesh, you'd think the world would come to an end if Canadian Plasma Resources (CPR) didn't operate its paid plasma collection facility next to a homeless shelter and a centre for addiction and mental health. 

CPR built its facilities without Health Canada's approval, at least without its official approval. Who knows what went on behind close doors, including possible collusion by CBS (as in, 'Would you object?' Answer: 'No'). 

To me, CPR should shove its PR campaign where the sun don't shine. Just kidding!

IN REPLY to Anonymous (26 May 2014)

Thanks to Anonymous who commented, 

"So sad" - that it has come to this - money and big pharma. Blood was one of the last vestiges of old fashioned medicine....

With the ability to manufacture fractionated plasma products, blood became big biz for Big Pharma more than 70 years ago. A few facts and figures (hope eyes don't glaze over):

According to CBS's 2012-13 Annual Report (Management Analysis) in Canada demand for plasma protein products (PPP), such as immunoglobulin (paraphrased):

• Has grown exponentially, with annual growth averaging 8% 
• Ig utilization represents ~43% of the total cost of the PPP program
• Softening of Ig utilization is driven by the provinces and territories taking measures to manage escalating Ig demand 
• For example, in British Columbia, all requests for Ig use are screened to make sure that Ig is used in accordance with provincial guidelines
• [See BC PBCO 'Intravenous immune globulin', including order forms]
• Total Plasma Protein Products program expenses increased to $469.5 million in 2012/2013 
• [See trends and usage information by provinces on CBS site]

Since immunoglobulins represent 43% of the PPP program cost, that's ~$201.9 million of Canadian taxpayer money going to Big Pharma for this one product alone. That's small potatoes to the Big Pharma companies who supply CBS, who then supplies it free of charge to hospitals (and their patients). But Canada is but one of many customer countries who purchase products like intravenous immune globulin (IVIG).

Big Pharma pours mega-bucks into funding research aimed at increasing its use (and then convincing physicians to use their products). For example:

• Phase 3 trial of IVIG to treat Alzheimer's Disease

As noted, blood became big biz with the ability to fractionate plasma proteins:

• Beginning in the 1940s with Cohn fractionation to produce albumin
• Factor VIII concentrate to treat hemophilia in the 1960s (and we know the tragic consequences of that)
• Business really took off in the 1980s with the ability to produce IVIG
• See History of Plasma Fractionation

IN REPLY to Anonymous (26 May 2014)
Anonymous asked who AABB's corporate members were. I suspect Anonymous means commercial entities, as opposed to non-profit institutional members like  transfusion services and blood centres. See

• List of current corporate affiliates
• Benefits of corporate affiliate program

FOR FUN
To follow-up on the 'so' theme, enjoy these renditions of a popular jazz ditty from long, long ago:

• C'est si bon (Eartha Kitt's French version)
• C'est si bon (Louis Armstrong's English version)

As always, comments are most welcome.

You don't own me (Musings on TM professionals as industry's poodles)

Updated 1 Nov. 2012

This month's blog is about how much of the TM information we consume is meant to inform, how much is crafted to persuade, and how much info purveyors assume we’re owned by them, i.e., their poodles. The title is from a 1964 Lesley Gore song. 

The blog was stimulated by 3 items:
1. Supposed news from new-medical.net in its 'Insights from industry' section:

• Blood banks: an interview with Celia Tombalakian, Worldwide Group Director, Immunohematology at Johnson & Johnson's Ortho-Clinical Diagnostics, Inc. (OCD) 

2. The article motivated me to visit OCD's 'On Demand' website and register to see its offerings. 

3. Then I was reminded of a recent research paper by OCD staff published in AABB's Transfusion:

• South SF, Casina TS, Li L. Exponential error reduction in pretransfusion testing with automation. Transfusion. 2012 Aug;52(8):81S-87S.

BACKGROUND
Increasingly, I suspect that industry owns the transfusion medicine community. In a way, it's natural given that TM was healthcare but now is business and has been for awhile. Businesses depend on each other to survive. You scratch my back and I’ll scratch yours.

Today's AABB is more and more cosy with commercial interests, which is also natural given the reliance of the former on the latter for advertising revenues and conference support. Plus, as noted in earlier blogs, some AABB luminaries have close ties with industry. It's one big happy family.

The blog’s components  - industry promoting automation via 3 mechanisms - are akin to a full court press in basketball in which industry pressures TM staff from every angle to buy into their false assertions about automation.

The blog's theme is how much industry thinks it owns us and attempts to baffle our brains with BS. 

A common thread in industry’s automation initiative is to create false arguments. For example, manual methods have more processes than automation (true), therefore automated instruments have fewer chances for human errors to occur (true). 

BUT… here’s the logical fallacy (the BS, if you will): Where do most serious TM errors occur? Are they related to manual testing? 

Read and assess for yourself.

1. INTERVIEW
First note where this interview was published: news-medical.net

As with many so-called health sites, news-medical's business model is not immediately apparent without reading the fine print. And let's face it, that's the first thing we do when visiting a website, right?

Part of the 3239 word, 27 point,Terms and Conditions:

News-Medical hereby discloses that a commission or listing fee may be payable by Experts to News-Medical for any fees received by them as a result of an introduction of a client through the Website.  

Unsurprisingly, the site's underlying purpose is to sell stuff.

Besides industry news, news-medical, based in Australia, cheaply repackages health information from several sources, including a heavy reliance on Wikipedia under the Creative Commons Attribution-ShareAlike License.

Below is my summary of a few highlights of OCD’s Celia Tombalakian's interview with news-medical.net in question and answer format, with my comments, aka musings, in italics. Readers are directed to the full interview for exactly what she said. 

The report is selective and my approach is facetious in places. But is it off the mark? You be the judge.

QUESTION: How is the blood banking industry currently being transformed?

CT's ANSWER

CT: Current focus is to improve transfusion safety and efficiency through technology solutions.  

Ah, safety and efficiency, with safety mentioned first. Who can argue?

CT: Over past 20 yrs, the number of highly skilled technologists and scientists entering the global TM workforce has shrunk. 

CT: Therefore, automation is becoming a standard part of blood bank laboratories because it eliminates many of the labor-intensive, time-consuming manual testing that requires specialized skills and significant experience to master.  

Really? Her response implies that automation arose because of staff shortages, which misleads in a chicken and egg sort of way.  

Why has the highly skilled technical and scientific TM workforce shrunk? Many reasons around the globe, inc. poor compensation for education involved (mainly USA), decreased health care funding, leading to regionalization and centralized testing, all facilitated by automation.  Automated instruments continue to be marketed on their ability to decrease absolute numbers of highly skilled staff.

CT: Ultimately, automation can increase a lab’s capacity and help it operate more efficiently, even with a smaller staff. 

A case can be made for how instruments are more reliable than humans, at least for some things. But notice there's no more mention of safety, only efficiency.

QUESTION. Tell us about the new Bloodbanker App and its benefits over traditional blood banking tools.

CT's ANSWER

CT: ORTHO's Pocket Blood Banker app is an educational reference tool that combines genotyping and antibody indexing. Users can quickly determine genotypes based on results with Rh antisera via the Genotype Calculator and learn more about antibodies with the Antibody Index.

CT: Prior to the app, blood bankers used reference tools such as cardboard slide rules. 

You gotta be kidding. Cardboard slide rules? Maybe that's what Ortho supplied customers back in the Jurassic age, but for decades I and many others taught MLS students how to determine Rh genotypes using their ... wait for it ... inbuilt computers, aka brains.

Reminds me of this exquisite Danish humour on computers: Medieval helpdesk

CT: Drawing from a deep understanding of the importance of and need for innovation in blood banking, OCD identified the need for more advanced tools and developed this new technology. The app reinforces our commitment to providing innovative solutions to our customers. 

OMG, classic marketing and branding. We're wise, we're innovative, we're dedicated to helping clients. Please bring us cute babies to kiss. 

QUESTION: Could you introduce Ortho ON DEMAND and how it fits with OCDs overall focus?

CT's ANSWER

CT: ON DEMAND is an innovative virtual engagement platform that enables blood bankers to learn from and connect with experts on topics central to achieving science-driven safety and efficiency in the blood bank. 

Attempt to reinforce Ortho's brand as innovative, Also love 'virtual engagement platform' and 'science driven.' Buzzwords convey modernity and objectivity, respectively. And note re-introduction of the safety and efficiency double whammy.

CT: With OCD’s strong TM history, we understand the importance of supporting industry through education and awareness. 

We're the pros, we understand. Trust us.

CT: Because many of today’s blood bankers work longer hours with fewer financial resources, many laboratories have had to cut costs that previously supported career growth opportunities. Through our new platforms, we hope to help prepare blood bankers to address growing demands for TM expertise. 

Excuse me? Labs have had to cut CE and CPD funding because staff work longer hours with less money? Does not compute. Pure bafflegab.

As for helping a growing demand for expertise, is there a growing demand for expertise? If so, it's to address what automation created in the first place, namely a diminished demand for technical and scientific expertise with fewer positions for TM specialists.

Frankly, automation and apps both contribute to and help alleviate a 'dumbing down' of the profession. I acknowledge that 'dumbing down' is a harsh catch phrase for staffing with less qualified personnel, not that such staff are dumb. I use the term to emphasize that apps do not contribute to developing expertise, but rather exist to alleviate lack of it.

QUESTION. What impact do you think these initiatives will have on blood bankers?

CT's ANSWER

CT: Many of today’s blood bankers struggle to do more with less, working longer hours with fewer financial resources. Concurrently, instrumentation is more complex and the number of transfusions is increasing globally. 

Meaningless bafflegab. Yes, cost constraints force blood bankers to do more with less.  

But instrumentation is more complex? More complex than what? Earlier instruments? Manual testing? Do sales reps' spiels include these words?  "Hey, our instrumentation is more complex. You need better trained dudes to operate it."   

Also, in an age of blood conservation and a kazillion studies on real and unproven potential transfusion dangers, what evidence exists that transfusion numbers have increased? Does not compute.

CT: With reduced resources, many labs cut travel costs to learning events that could better prepare staff to address growing demands for TM expertise. Ortho ON DEMAND addresses this challenge by offering TM professionals free access to education according to their own schedules.

Offering free online education has merit. But it's not exactly true that today's over-worked TM professionals are clamouring to access education on their own schedules. Employers allot no time during work hours. Staff who are under-paid and feel under-appreciated are increasingly less motivated to take time away from families to further their careers.

QUESTION: How do you think the future of blood banks will develop?

CT's ANSWER

CT: While technology has made many routine BB tasks faster and easier, the demand for blood continues to rise and the pace of processing blood continues to accelerate.  

Demand for RBC transfusions (type that automated instruments process in transfusion service labs) is increasing? Where's the evidence? Surely all the efforts on blood management, blood conservation, and improved utilization are having an impact on RBC usage.

Pace of processing blood continues to accelerate? What does this mean? I could speculate but she doesn't explain.  

CT: Hemovigilance and ensuring efficiency is of utmost importance to blood banks in maintaining a safe and accessible blood supply while keeping pace with accelerating demand for blood processing. 

Sounds good but what has hemovigilance to do with OCD's automation and apps? And again the unexplained 'accelerated demand for blood processing.'

CT: The future of blood banks lies in technological solutions that will allow blood bankers to increase safety and efficiency in order to provide the best possible outcomes for patients. 

Motherhood statement. But where is the evidence that automated ABO and Rh group testing and automated antibody screening have improved outcomes for transfused patients? Or that apps that generate Rh genotypes and describe antibodies have made a difference? 

Surely, getting patient identification correct when drawing blood samples and correlating patient identity to crossmatched donor blood when administering blood remain THE hallmarks of safe transfusion practice, the 'right patient, right blood product, at right time' mantra. 

QUESTION: What are OCDs plans for the future? Would you like to comment further?

CT's ANSWER

OCD is the global leader in Transfusion Medicine, stemming from a 70-year history of protecting the safety of the worlds blood supply. We intend to continue our leadership of the market into the future, both with our products and through our service and support of the blood banking community. 

Forgive me, but I'm jaundiced. Although I've known, liked, and respected many Ortho reps, having just read Blood Medicine (aka Blood Feud) about Ortho Biotech and Amgen's marketing of EPO products, protecting patient safety as applied to J & J or any Big Pharma company rings hollow.
Author Q & A

2. WEBSITE

Simply put, Ortho ON DEMAND offers varied worthwhile educational talks by respected TM professionals, but promotes automation. To illustrate, the first 4 talks in its Presentation section are about automation. 

I'm reminded that Ortho and its competitors such as Immucor operate on a razor-blade business model: cheap razors (instruments), with the real money made on expensive blades (reagents).

3. RESEARCH PAPER
This paper by OCD employees further shows how industry treats TM professionals like poodles, hoping to baffle brains with BS. 

• South SF, Casina TS, Li L. Exponential error reduction in pretransfusion testing with automation. Transfusion. 2012 Aug;52(8):81S-87S.

Interestingly, one of the authors, TS Casina, an OCD marketing manager, also penned these 3 articles:

Casina TS. Technologies to improve the future of blood banking. Med Lab Obs 2011 Oct;43(10):32. Excerpt:

• 'As the labor force shrinks, the rapidly evolving field of laboratory medicine is struggling to keep pace with the growing demand for blood and its components. Automation is becoming a standard part of blood bank laboratories because it can help eliminate the labor-intensive, time-consuming manual testing processes that require specialized skills and significant experience to master.'

Casina TS. What's new in transfusion services. Advance for Med Lab Professionals. Posted online 19 Sept. 2012. Excerpt:

• Transfusion of incompatible blood has the greatest potential for severe adverse events and health complications, including death. Fortunately, due to advances in transfusion medicine (TM) practices -improved blood testing, donor screening and the advent of automated systems - the blood transfused to patients is safer today than it's ever been.

Casina TS. References for "transfusion medicine reactions. Advance for Administrators of the Laboratory 2012 Oct;21(10):20. This paper is a reworked version of the one above. Excerpt: 

• A study conducted by Ortho Clinical Diagnostics provides quantitative evidence of how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thereby improve the safety of blood transfusion.  Evaluating the common testing methods above and leveraging failure modes and effects analysis (FMEA) to compare error potentials, the group concluded that automation significantly reduces defect opportunities in pretransfusion testing and could dramatically improve blood transfusion safety.

Can you see how marketing managers use a full court press and recycled material (with the help of willing publishers desperate for articles) to get their message out to industry's poodles, namely us?

Abstract Highlights (Transfusion paper)

BACKGROUND: Human error associated with manual pretransfusion testing is a cause of transfusion-related mortality and morbidity and most human errors can be eliminated by automated systems. 

STUDY DESIGN AND METHODS: Study’s goal was to compare error potentials of commonly used manual (e.g., tiles and tubes) vs automated (e.g., ID-GelStation and AutoVue Innova) group and screen (G and S) methods. G and S processes in 7 TS labs (4 with manual and 3 with automated methods) were analyzed to evaluate error potentials of each method.

Tiles?  Really? Well, they could be large welled plates. But who uses these in routine manual pretransfusion testing?  

RESULTS: Manual methods contained more process steps ranging from 22 to 39; automated methods contained 6 to 8 steps.  

Roughly 4-5 times more steps for manual methods. Authors then use ‘risk priority numbers’ (RPN)  - trust me, you don’t want to go there -  to show manual method RPNs ranged from 5304 to 10,976 vs 129 and 436 for automated methods, conveniently making manual tests away more than 4-5 times as risky as automation.

What the hey! Let's go there. A team (needed to reduce subjectivity) of OCD researchers and staff at 7 TS labs determined how many defects were likely at each process step (defect opportunities) and decided where failures could occur, the likelihood that the failure would be identified, how frequently the failures might occur, and what the effects of those failures (severity) were. The result was a 10 point scale. An example: 

Process Step 16 (tile or plate required tapping and rocking before reading reactions) had 18 defect opportunities. 18 represents 6 wells in the tile or plate in which it was possible to undertap reactants (6 defect opps), forget to tap the plate (6 defect opps), or overtap and splash reactants among wells (6 defect opps) for a total defect opportunity of 18 at that step (6 + 6 + 6 + = 18). The severity was rated 7 out of 10.

Wow! Talk about creative number crunching to get the results you want. The mind boggles....

CONCLUSION: This study provided quantitative evidence on how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thus would improve the safety of blood transfusion.

Oh sure. Is I or is I not your poodle?

MORE MUSINGS
This study’s logical fallacy posits (love that word!) that most, or even many, serious transfusion errors result from manual testing of ABO and Rh groups and manual antibody screening. It's true that manual testing has potential to create more errors than automated testing.

The best evidence of where TM errors occur comes from the UK’s annual SHOT Reports. For example, consider 

• 2011 SHOT Report

I’ll not bore you with too many specifics  - you can read for yourself - but believe me, it’s NOT all about lab staff making technical errors when manually testing. 

'Adverse reactions caused by errors' lists these causes of cumulative cases reviewed 1996-2011 (n=9925):

• Anti-D errors 
• Inappropriate & unnecessary
• Handling & storage errors
• Incorrect blood component transfused (n>3000)

To quote SHOT: Key lesson from 2011 is an emphasis again on the importance of the essential steps of the transfusion process:

• Taking the blood sample from the correct patient 
• Correct laboratory procedures
• Issuing of the correct component
• Identification of the right patient at the bedside at the time of transfusion
• It is clear from the SHOT 2011 data that identification of the correct patient remains a key issue and that this must become a core clinical skill.

BOTTOM LINE
So, what's it all about? Yes, automation can increase efficiency and increase safety by reducing human error. But is automation the TM saviour that industry reps and some TM professionals make it out to be? 

When you examine the arguments of proponents, such as OCD's Celia Tombalakian or the research of OCD employees, their arguments do not stand up to scrutiny. They continually overstate how automated testing can improve safety and propose it as magic it is not. 

Companies have a vested interest in promoting automated testing since the business model of cheap razor (instrument) and expensive blades (reagents) is what makes their industry viable. 

Their multi-media advertisements are relentlessly promoted to TM professionals using flawed arguments that show they think they own us and we are their poodles. 

FOR FUN

Industry's seeming hold on so many TM professionals brings to mind:

• You Don't Own Me (1964 ditty by Lesley Gore; this version in Australia, 1989)

• You Don't Own Me (Same song re-worked for 2012 USA election - thoroughly partisan. ALERT: Depending on your politics, you may be offended.)

• You Don't Own Me (Diane Keaton, Bette Midler, Goldie Hawn in 1996 movie The First Wives Club)

Comments are welcome but due to excess spam this section is removed. Please send comments to me personally.