Wednesday, September 16, 2015

Sweet dreams are made of this (Musings on personalized medicine)

Please stay tuned - revisions are sure to come
September's blog derives from increased marketing of medical treatments and clinical laboratory tests as personalized medicine tailored to the individual characteristics and needs of each patient. Seems like a great idea, right?  

After all, in the age of 'selfies' it's all about me. 

The title is from a 1983 ditty by the British duo, the Eurythmics (Annie Lennox and David Stewart). 

'Personalized medicine' is a term that drives me nuts.  This April I blogged about molecular blood typing being marketed as personalized medicine:
  • While my guitar gently weeps (Musings on the seduction of technology) [Further Reading]
Five years ago I had sniffed its perfumed allure with the blog
  • Snip, snip the party's over (Musings on the seductive rise of DNA typing of blood groups) [Further Reading]
Now a new variation has arisen, the latest and greatest 'term du jour' ('term d'année?') is Precision Medicine:
  • Red blood cell transfusion. Precision vs imprecision medicine  [Further Reading]
One sentence in the article stood out as a red flag:
'Although currently not practical, providing extended antigen matching by molecular techniques to all patients should improve typing accuracy and reduce alloimmunization.'
If past is prologue, even if impractical and relatively expensive, eventually molecular genotyping will be done for all transfusion recipients. After all, who can resist the sales pitch of personalized and precision medicine?

Certainly the United States, with its private health care system, cannot resist and has jumped on the bandwagon. Similarly, so has Canada, UK and other industrialized nations. 

As to the developing world, well they're stuck making do with 20thC medicine, un-personalized and un-precision.

Of course, a genuine case can be made to tailor tests and treatments to individuals, especially those with special needs such as blood group genotyping for sickle cell and thalassemia patients. 

But why the rush to personalized / precision medicine as embodied by molecular blood genotyping? It's likely because of the reasons cited in 'While my guitar gently weeps':
  • To be seen as 'with-it' hipsters on DNA's bandwagon vs being old-fogeys who resist change; 
  • Way for TM organizations to develop business lines and increase earnings in age of blood conservation; 
  • Self-interest for those who specialized in molecular technology; 
  • No humans interpreting serologic test results must be safer; 
  • High-throughput automation decreases costs by eliminating staff, with their salaries, benefits, and pensions.
Plus it's good for private enterprises that develop and market test systems and health profession leaders who want to be seen as in the real world of business efficiency. 

Today, many businesses promote and sell stuff that we do not  need. The aim is to trick us into thinking we need the latest and greatest. 

Consider Apple's iPhone. The premise is that potential buyers don't even know what they want until Apple tells them. They don't really need to market it because all geeks know they must have one to be part of the in-crowd. 
  • It's the same reason why all TM docs know their facilities must do molecular typing.
Apple builds beautiful products and justifies price with features and benefits no one else can match. Whether you need the features is another matter. But once you've seen them, Apple will make you think you do. 
  • Similarly, serologic blood typing cannot match molecular typing. Whether you need the benefits of molecular typing is a moot point.
Apple built one of the most hardcore fan bases of any product, called Apple fanboys/fangirls and, before the iPod/iPad/iPhone revolution, macophiles. I was one and would show disdain for Windows every chance I got. 
  • Today, molecular red cell genotyping fans abound and can barely suppress a sneer when mentioning serology and immunohematology. The fan base of influential TM leaders is hard to combat and develops a momentum all its own.
It's worth recalling that whether selling an iphone, tablet, used car or botox, a good sales rep will FOCUS ON

Some examples [My comments]: 

Before molecular genotyping transfusion service labs had to use inefficient, labor-intensive serologic assays. 2
[PL: Red cell serology is passé, based on inefficient testing that costs more because of paying laboratory technologists for their time.]
Now in the 21st century and with the emergence of precision medicine, inexpensive molecular typing paired with powerful bioinformatics has enabled mass-scale red blood cell genotyping. 2
[PL: Get with the 21stC. Molecular typing is cheap (really?) and it's twinned with bioinformatics. Bioinformatics sounds pretty darn impressive. We've got datasets coming out the wazoo.]
Web-based data storage and analytics are revolutionizing the provision of antigen-negative blood with an efficiency scarcely conceived of just a decade ago. 2
[PL: You'll be on the bleeding edge and very, very efficient. Plus it's analytics, for gawd sake. And 'analytics leverage data in a particular functional process (or application) to enable context-specific insight that is actionable'.  
Wowsa! Leverage,data, process, context-specific, and actionable in the same sentence. I'm in jargon heaven. Gotta love analytics.]
Blood incompatibility remains a significant problem with lifelong consequences that adds to the burden of healthcare delivery and may result in life-threatening delays in care.3

If an antigen-negative patient receives blood from an antigen-positive donor, it could trigger an immune reaction, where the blood recipient’s immune system develops antibodies that can attack and reject the donor RBCs.3
[PL: If you buy our product you will prevent the dreaded immune response and save patient lives. You don't wanna kill folks, do you buddy?]
With today’s dual focus on improving health outcomes and lowering healthcare costs, preventing alloimmunization is the ultimate goal in transfusion medicine. Accordingly, a best practice for the hospital or transfusion center is to create a patient phenotype profile with the PreciseType test before a patient receives his or her first-ever transfusion.3
[PL: Do you dig what TM's ultimate goal is? It's about preventing alloimmunization. (Who knew!) Are you into best practices, a thought leader? Because if you are, you better buy our kit right now, before some patient gets immunized!]
There are those who question the orthodoxy of personalized / precision  medicine and caution against potential pitfalls.  Two examples that examine personalized medicine from a broad perspective:

1) 'Why you shouldn't know too much about your own genes.' [Further Reading] Sample quote: 
  • Here is the under-appreciated corollary to the new age of personalized medicine: just because you can do a genetic test, doesn't mean you should.
2) Juengst ET, Flatt MA, Settersten RA, Jr. Personalized genomic medicine and the rhetoric of empowerment. Hastings Cent Rep. 2012 Sep-Oct; 42(5): 34­40. [Further Reading1Sample quote: 
  • 70 million Baby Boomers, now or soon-to-be over age 60, seek to live not just longer, but healthier and more productive lives. 
  • When they fully understand and embrace personalized medicine, it will create an unprecedented level of consumer demand. 
  • When physicians feel they may incur liability for not offering a test that provides information on optimal care, the impetus toward adoption will be even greater.
Eventually, everywhere in the developed world, red cell matching of patient and donors will routinely be done by molecular blood typing. It will be precision medicine, personalized medicine done using kits supplied by foreign companies and performed by minimally trained, inexpensive local staff supervised by a well educated lab professional.

If employers plan wisely, staff can be hired part-time or casual so they won't need to worry about benefits and pensions. 

In Canada government health care money will flow abroad, giving sustenance to anonymous investors of Immucor, et al. They'll leverage our health care dollars where they WON'T do the most good for our communities, all in the name of efficiency and safety.

Am I similar to 19thC Luddites, protesting against new labour-economizing technologies? Maybe, though I'm not against technology per se and have embraced computers and the Internet from the get-go.

But, hot damn! I'm gonna get my genome profile done because it's all about me. And I can get it done for $199 CDN by 23andme...not that I really want to know.

And if I ever need a blood transfusion, I'm not into being second class and will demand complete molecular antigen typing with donor blood. Not that I'll get it now but definitely one day. None of that passé serology for me!

A great song, one of my favorites, that highlights the allure of molecular blood typing and personalized / precision medicine. 
  • Sweet Dreams [are made of this] (Annie Lennox, Live 8, Hyde Park, London, 2005)
'Sweet dreams are made of this
Who am I to disagree?'
As always, comments are most welcome.


1. Juengst ET, Flatt MA, Settersten RA, Jr. Personalized genomic medicine and the rhetoric of empowerment. Hastings Cent Rep. 2012 Sep-Oct; 42(5): 34­40. (Free full text)
2. Klein HG, Flegel WA, Natanson C. Red blood cell transfusion. Precision vs imprecision medicine. JAMA. Pub online 10 Sept. 2015. (Free full text)
3. Immucor: PreciseType™ HEA Test 

Carolyn Johnston. Why you shouldn't know too much about your own genes. (Washington Post, 11 Sept. 2015)

USA FDA: Paving the way for personalized medicine. FDA’s role in a new era of medical product development  

US News & World Report. Personalized medicine

USA White House. Next steps in developing the precision medicine initiative

Prior Related Blogs
While my guitar gently weeps (Musings on the seduction of technology) |  April 2015

Snip, snip the party's over (Musings on the seductive rise of DNA typing of blood groups) | Dec. 2010

Saturday, August 15, 2015

The early days (Musings on educating young TM professionals)

Upfated: 18 Aug. 2015
August's blog was stimulated by the UK's Annual SHOT Report, which  has featured in past blogs many times. SHOT has long been the best hemovigilance program anywhere and is a treasure trove of educational goodies we can all learn from.

Since it's summer in the northern hemisphere, when many transfusion professionals will be enjoying the outdoors of our all too short summers (at least in Canada) the blog will consist of selected mini-musings on 2014 SHOT.

The blog's title derives from a song by Canadian folk singer/song writer, Chris Luedecke, known professionally as 'Old man Luedecke".

For perspective, in 2014 there were 2,663,488 blood components issued in the UK (74% RBC). SHOT received reports of 3668 cases or 13.8 reports per 10,000 blood components.
The following are but a few of my personal highlights. See Further Reading for the full SHOT Report.

Overview (What causes adverse events?)
In 2013, 77.6% of all incidents reported to SHOT were caused by errors & it's similar in 2014.
There is increasing concern about the impact of reductions in numbers and seniority of staff in the NHS.

SHOT 2013 reported that many, often multiple, errors are made during the transfusion process and data from 2014 were analysed similarly. As well, adverse events are grouped into 3 main categories. Failures relate to
  • Patient identification 
  • Communication 
  • Documentation 
Deaths (Worst transfusion-associated adverse event)
In 2014, there were 2 deaths definitely attributed to transfusion, 1 hemolytic transfusion reaction and 1 transfusion-associated circulatory overload (TACO). Delayed transfusion contributed to 3 deaths.

ABO-incompatible RBC transfused (Key because ABO mismatches can lead to patient death, major morbidity)
N=10 (0 deaths, 1 major morbidity). This compares to 9 in 2013 and 12 in 2012. All were due to clinical (not laboratory) error.

Near misses (Avoiding major patient consequences often due to luck)
Wrong blood in tube accounted for 686/1167 (58.8%) of all near misses, where a near miss is defined as,

"Any error, which if undetected, could result in the determination of a wrong blood group or transfusion of an incorrect component, but was recognized before the transfusion took place."
Below are musings on a few highlights in SHOT 2014 (edited for brevity). Some caught my imagination because they were odd, and some involved serious adverse events.

#1. False Identity
(p. 45) describes several cases where the 'patient' is responsible for giving false identity. For example:
Case 2: Staff member involved in deliberate identity fraud
A blood group did not match the patient's historical record. Concurrent Haematology and chemistry samples were rejected and repeats of all samples requested.
Investigation revealed that test requests were initiated by a staff member. Samples were from a family member but labelled with the staff member's own details. The staff member returned to work after suspension and re-training.

Musings: A similar case occurred years ago at UAH in Edmonton, where a medical resident labelled his own blood sample as that of a patient in order to discover a particular lab result. To my knowledge he was given a bollocking and educated on why this was NOT a good idea.
Case 3: Pregnant woman conceals her identity
  •  A 24 year old woman had an ultrasound scan at a hospital where she was advised to terminate a pregnancy. 
  • The patient attended another hospital giving a friend's name for identity but her own father as next of kin. 
  • She had a surgical termination which was complicated by 
    • Massive haemorrhage requiring transfusion with RBC, FFP, and cryoprecipitate; 
    • Emergency intervention and uterine artery embolisation; 
    • Followed by admission to the intensive therapy unit , all at the first hospital. 
  • When her father was called in he confirmed she was his daughter but that the name on her wristband was not hers.
Musings: Years ago, when I worked in Winnipeg for the then Red Cross centralized transfusion service/blood centre, a similar case occurred. I crossmatched blood for a young woman having a therapeutic abortion. She had assumed the identity of her friend, who just happened to have a blood group on record.

Interesting that patients providing false identity still exists. It likely occurs much more often than we know because we only catch the ones where the 'false patient' has a prior blood group record or the real patient requires blood in the future. 
I also wonder about false identity in the USA where universal health insurance doesn't really exist yet. Do people who lack insurance for a needed procedure use a friend's identity?

In Canada it's now standard practice for physician offices to require photo ID, not just a provincial health care card. 
#2. ABO-incompatible red cell transfusions (pp.23,44)
As noted earlier, of 10 ABO-incompatible red cell transfusions, all were caused by clinical (not laboratory) errors.

  • In 7/10 cases there was a failure in correct patient identification, with no bedside checks performed. 
  • Actions taken varied but in one case 2 nurses were dismissed, in others staff were supported, retrained and their environment modified. 
SHOT gathered evidence that staff do not follow protocols and procedures and needs to investigate why.
  • In 7/10 clinical errors, group A RBC were transfused to group O patients
  • 2 were transfused in emergencies, 3 others were 'urgent'
  • One event occurred in a young woman during a liver transplant. The group O patient was bleeding and a new anaesthetist, who was an observer, 'helped' by taking the unit of blood from the refrigerator and transfused it. It was group A blood. 
  • The OR practitioner noticed the error when less than 50mL had been transfused. 
  • The patient died from complications following respiratory arrest. 
  • Root cause analysis resulted in several changes to surgical procedures.
Musings: It's amazing that 7/10 wrong ABO transfusions involved failed patient identification, with no bedside checks performed by clinical staff (presumably mainly RNs but including Drs, as in the case of the anesthetist described above). Unsurprisingly, most (5/7) occurred with urgent transfusions.

In the one case where 2 nurses were dismissed, I wonder if their errors were the final straw in a list of major errors. Because firing staff does not fit with today's no-blame culture of support and retraining, as occurred in other cases.
As SHOT notes, when health professionals do not follow established procedures and protocols, we need to identify why to prevent future occurrences.
#3. Most adverse events caused by error
SHOT documents that in 2013 and 2014 more than 75% of all incidents were caused by errors and expresses increasing concern about the impact of reductions in numbers and seniority of NHS staff.
Musings: Cutbacks and increasing numbers of senior staff retiring are concerns worldwide. Remaining staff are overworked and often lack needed experience and expertise. 
Unfortunately, few senior staff exist to mentor them and share the practical knowledge and skills absent in journals and textbooks. That's if remaining staff even have time to read and consult them.
Although Canadian Chris Luedecke's touching song 'The Early Years' is about his children and family life, it resonates with me from a professional perspective. Listen to the lyrics. They're delightful.

In today's health care environment, despite many obstacles, educators must lead by example and take time to educate and train young transfusion professionals to instill values that ensure the next generation puts patient safety above all else. Knowledge and skills, of course, plus clear rationales for all those pesky 'rules' are key.

But ultimately it's DNA-ingrained ethics that protects patients so that even overworked, busy health professionals meticulously follow established SOPS such as routinely and always checking patient identity. 

Fact is, those early days when we train the next generation, they don't last. We must get 'em while the gettin' is good.

You got to hold on,
It goes so fast
These early days, well,
They don't last.
You got to enjoy [train] them.
They go so fast.
The baby days, well, they don't last.
As always, comments are most welcome.

Monday, July 13, 2015

Mommas, don't let your babies grow up to be hempaths (Musings on evolving TM careers)

Updated: 14 July 2015
July's blog was stimulated by a paper in ASH's journal, Blood (see Further Reading):
  • Wallace PJ, Connell NT, Abkowitz JL. The role of hematologists in a changing United States health care system. Blood. 2015 Apr 16;125(16):2467-70. Epub 2015 Mar 6. 
The blog's title derives from a 1970s ditty associated with Willie Nelson.

What follows is my brief take on ASH's initiative for hematologists, including possible parallels it has, or doesn't have, for transfusion-related nurses and medical laboratory technologists / clinical laboratory scientists worldwide. At core, it's a tale of how to promote your profession and earn a living when the universe does not unfold as you thought it would.

Keep in mind I'm not a physician, let alone a hematologist / hematopathologist, so my take is born of ignorance. But I've never let facts spoil a good story, so here goes.  First the paper's overview:

Major and ongoing changes in health care financing and delivery in the United States have altered opportunities and incentives for new physicians to specialize in nonmalignant hematology. At the same time, effective clinical tools and strategies continue to rapidly emerge. Consequently, there is an imperative to foster workforce innovation to ensure sustainable professional roles for hematologists, reliable patient access to optimal hematology expertise, and optimal patient outcomes.
The American Society of Hematology is building a collection of case studies to guide the creation of institutionally supported systems-based clinical hematologist positions that predominantly focus on nonmalignant hematology. These roles offer a mix of guidance regarding patient management and the appropriate use and stewardship of clinical resources, as well as development of new testing procedures and protocols.
MUSINGS #1  - Systems-based hematologists
The authors imply that nonmalignant hematology is a career path that's opened up for hematologists to earn a buck and sustain their careers. In the full paper they note that traditional roles (malignant hematology) are sucking up the jobs, leaving few for others, especially non-specialists.

Although this forum focuses on the United States health care system, similar issues exist elsewhere, including outside of Canada and Europe.

For example, Dr. Andrew Roberts commented that in Australia, where hematologists have traditionally been trained dually as internists and hematopathologists,

'Clinicians with high-level expertise in care of acute and chronic nonmalignant hematology have been squeezed out of appointments in both diagnostic laboratories and hospital departments dominated by subspecialized malignant hematology' (Andrew Roberts, Royal Melbourne Hospital, personal communication, January 27, 2015).
Hence, the authors propose what they call 'systems-based hematologists', ill-defined because associated expertise permutations are many. Using 'systems-based' is fascinating. I'm tempted to say it borders on bafflegab. 

What does it mean? In plain language please. Cut the weasel words. Does systems-based relate to
  • Systems thinking involving a holistic approach to all the parts of any health system? Even including, as stated in the paper,  non-medical areas such as information technology specialist, hospital quality control officer, and safety officer? In which case, perhaps systems-based is a jack-of-all-trades approach. One that encroaches on roles often fulfilled by other health professions, and even far-removed from medicine such as information technology?
Nice thought but uh-uh! Too ambitious for most hempaths. Best stick to nonmalignant hematology, where validated expertise exists.

MUSINGS #2  - Hematologists, pathologists, and weirdos

Interestingly, in Canada (and the USA), hematology is a sub-specialty of internal medicine:

Whereas hematological pathology education and training takes place in Departments of Laboratory Medicine and Pathology, at least at the University of Alberta where it is a 4-year post-graduate specialty. Likely many variations of education exists worldwide. 

For example, in the US, hematopathology is a board certified sub-specialty practiced by physicians who have completed a general pathology residency (anatomic, clinical, or combined) and an additional year of fellowship training in hematology. 

Pathologists identify diseases and conditions by studying abnormal cells and tissues.  A joke to illustrate:
In the grand scheme of medicine, historically pathologists have gotten a bad rap as Weirdos.

Perhaps it's performing autopsies on the dead that falsely defines them in the public's eye as docs who deal only with dead people, often in dingy basement labs. 

As opposed to the reality of physicians who diagnose disease and offer treatment options to front-line docs. And many treat patients personally, as front-line docs, in the case of hematologists as opposed to the more lab-focused hematopathologists.

Even today in the realm of 'sexy' forensic pathology TV shows such as NCIS, the pathologist is eccentric:

As an aside, I taught in a windowless basement lab for more than 20 years. Every spring it would flood as the snow melted. Trapping mice was ongoing entertainment. But so far as I know students were not brain dead from having so much information and problem solving thrown at them.
Personal anecdotes
1. Long ago a beloved and respected pathologist who headed a university department I worked in looked nothing like what he was. I once pointed him out to my spouse in a grocery store and asked him to guess what he did. Reply: Maybe down-on-his-luck, soon-to-be homeless dude?

He wore old baggy suits, bicycled to work, shyly looked the other way if you met him in the hallway. Superficially he was a odd-bod eccentric. In reality he was a brilliant pathologist and one of the kindest guys you could ever meet.

2. Once mentioned to university department head, a hematopathologist, that lab technologists/scientists were at bottom of the healthcare totem pole because we had little interaction with patients except as blood collectors (think Dracula), now not even that, as specialized phlebotomists are the norm. 

His response: 'Pat, it's similar for pathologists, we're at the bottom of the physician totem pole.'

3. Briefly worked with a hospital transfusion service medical director who's background was as a hematologist from the UK. He had a hard time in his job because he lacked the in-depth laboratory skills and transfusion medicine expertise of Canadian-trained hematopathologists. He thought it stupid and odd that NA MD training split the two:

4. When I think of all the physicians I know, the ones who stand out as exemplary are hematopathologists. Maybe it's because I taught them in a prior life or know them as colleagues and people. But equally likely it's because they are exemplary on many levels. Most are the antithesis of the weirdo stereotype, people-persons fully engaged with the world and their colleagues, making a difference.

Are there parallels in nursing or med lab technology/science with ASH's call to develop systems-based hematologists?

1. Nursing
Nurses, including transfusion specialists, are in demand and have done well by their venture into transfusion medicine. But funding of transfusion positions is always a challenge as in Australia's example below.

Source: Abstracts of ISBT Regional Congress and conjoint BBTS Annual Conference, London, UK, June 27-July 1, 2015 (See Further Reading)

2D-S08-01: My role as a transfusion practitioner in a UK NHS  teaching hospital (
2010 survey in England and North Wales: Transfusion Practitioners (TPs) made a significant contributions to improve transfusion practice at local, regional and national levels by promoting safe transfusion practice, appropriate use of blood, reducing wastage, and increasing patient and public involvement ensuring that Better Blood Transfusion has become an integral part of NHS care. 
Anecdotal evidence shows that the role and responsibility of the TP varies widely and has changed for most since it was introduced over 10 years ago, with significant variation in how TPs spend their time.
2D-S08-03: The role of the transfusion practitioner in Australia (Excerpt)
Currently there are 113 dedicated TP positions and many more staff involved as blood/transfusion champions. There are also 12 TP positions within the Australian Red Cross Blood Service (ARCBS). 
Education available in Australia to support the TP role and others working in the area including the Graduate Certificate in Transfusion Practice, BloodSafe eLearning Australia, and an extensive range of learning experiences offered by the ARCBS. In this tight economic environment there is constant pressure in all states regarding the funding of these positions.
Similar to American hematologists, perhaps transfusion-specialist nurses would benefit by highlighting more general ways they add value to the health care system?

2. Medical laboratory technology / clinical laboratory science
Several years ago there was a movement in Canada, perhaps elsewhere, to get med lab techs on healthcare teams that went on patient rounds. 

The discipline chosen for the experiment was clinical microbiology and the tentative name for the new category was clinical technologist, meaning health professionals who observe and treat patients rather than theoretical or laboratory studies.

Nothing much came of it. So far as I know, it failed. As an example, what's missing from this TOC?

Why did it fail? Maybe because clinical microbiologists exist higher up the totem pole, either with MD or PhD degrees.

From a broader perspective, lab professionals have a huge career liability, namely technology.  Anything that eliminates humans from the process (and concomitant human error), is valued above all. As is technology-associated automation that eliminates staff and their ongoing financial liabilities like benefits and pensions.

In a time of cost restraint, all health professions are wise to seek unique niches showcasing and promoting special skills that enhance patient well being and safety, as well as their own careers. Then we rely on health policy analysts who advise government to be objective / evidence-based and for politicians to put public good above partisan political dogma. 

At which point, I admit to ROTFL.

Perhaps one day physicians, like medical lab technologists, will be told the equivalent of

  • We've got a device that frees you up from many mundane tasks so you can concentrate on using your core skills to the max 
Actually, that's already happened. They're called nurses, occupational and physical therapists, pharmacists, etc. And, physicians often fight them tooth-and-nail to protect their turf and scope of practice, all under the umbrella of patient safety.

An exception is Alberta's Primary Care Networks, so maybe the times they are a changin'.

Update (14 July 2015): A recent news item on TraQ relates to changing times:
Iggbo is a US company similar to Uber, except the mobile app connects physicians with freelance phlebotomists in the locale who collect blood for the ordered tests. The idea for the business was stimulated by a government crackdown on the practice of paying process-and-handling fees to doctors that could be considered kickbacks. (See Further Reading for background)
The Iggbo app fits with an earlier tongue-in-cheek blog: 
Perhaps workforce innovation to ensursustainable professional roles for hematologists will one day include freelancesystem-based clinical hematologists. 
Hempaths who meld mobility, flexible lifestyle, and entrepreneurial spirit with tech-based logistics (apps) to support reliable patient access to hematology expertise.
Some songs apply to many professions, including health professions. This Nelson ditty epitomizes the issue, as does Dylan's. 
And you must admit that both icons overcame their nasal singing voices with content that resonates.
Or for a real trip down memory lane
As always comments are most welcome.
1. Wallace PJ, Connell NT, Abkowitz JL. The role of hematologists in a changing United States health care system. Blood. 2015 Apr 16;125(16):2467-70. Epub 2015 Mar 6. (Full free text)

2. How docs pick their residency (Scroll to Pathology)

3. Abstracts of ISBT Regional Congress and conjoint BBTS Annual Conference, London, UK, June 27-July 1, 2015 (See p. 8 for the transfusion practitioner abstracts)

4. As background for Iggbo: WSJ exposé puts HDL on the defensive

Saturday, June 13, 2015

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?

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.

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.'
  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.
  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
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 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:
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.

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.

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

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.


Monday, May 18, 2015

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

Updated: 27 May 2015
May's blog was motivated by three items in TraQ's May newsletterUse of 'liquid gold' in two news items and an EU-funded report that showed 'a clear tension between the plasma derivative (PD) and the blood/blood components sectors'. Links to articles are provided below:
  • Unregulated USA stem cell industry is 'wild west', in which liposuction fat was described as 'liquid gold' because patients pay big bucks for fat-based stem cells
  • Canberra Red Cross calling on donors to consider donating 'liquid gold' plasma
  • EU-funded report calls for changes to plasma regulation
The blog's title derives from a 1972 ditty by Canadian Neil Young.


A brief excerpt (revised for brevity and clarity): 
The liquid is a dark red 'soup', a mixture of fat and blood, that is pumped out of the patient's backside (fat ass?), treated with a chemical, run through a processor, and injected into knees, elbows, faces, penises, you name it. 
The 'soup'  is rich in stem cells, magic bullets that, according to some doctors, can be used to treat just about anything from anti-aging to face-lifts to multiple sclerosis to ALS.
It's quackery, critics say. But it's a mushrooming business,almost wholly unregulated. 
Those profiting call it "patient-funded research". Others say charging patients to participate in medical research is  unethical, unauthorized, for-profit human experimentation. 
The number of stem-cell clinics across the U.S. has surged from a few in 2010 to more than 170 today. Many clinics are linked to large, for-profit chains such as Cell Surgical Network.
Of course, it's quackery. Another example of medical professionals with vested interests promoting unproven treatments for gain.


The Australian Red Cross Blood Service (ARCBS) in Canberra promotes plasma donation via plasmapheresis because of a growing need.

A spokesperson said that plasma is used for 18 different treatments including burns victims, trauma patients and cancer patients, plus being used successfully as an immunity booster.

"We call it liquid gold because it can save so many lives."

Hard to decipher this news item. The spokesperson is likely referring to blood components (e.g., fresh frozen plasma, cryoprecipitate, etc.) and plasma derivatives. Most donated plasma in Australia is processed by the plasma fractionator, CSL Behring, to make many products that ARCBS buys back, I assume, and distributes to hospitals. If incorrect, please let me know.

And Australian donors are not paid, in the same way that Canadian plasmaphereis donors are not paid for plasma, although I assume some is sent for processing to manufacturers and sold back to CBS. From CBS's 2013-14 Annual Report (p. 40):

'Given that self-sufficiency is not operationally or economically feasible in a volunteer, unpaid model, Canadian, Blood Services strives to maintain a sufficiency of 30 per cent for immunoglobulin (Ig). 
The demand for Ig, continues to rise in Canada and internationally, and, to meet our needs, Canadian Blood Services purchases, surplus recovered plasma (from voluntary donations) from the United States for fractionation.' 
Seems that Canada supplies 30% of its own plasma for immunoglobulins, a plasma derivative / plasma protein product. But buys the rest --'recovered plasma' donated by unpaid, volunteer American blood donors  --  from non-profit US blood organizations. Really?

The worldwide PD market was estimated at $11.8b USD in 2009. Plasma truly is liquid gold, especially for manufacturing companies like Grifols with a global market share of about 20%. In 2013 Grifols net profit rose by a whopping 34.6% to 345.6 million.


An EU-funded report looked at the plasma industry and produced several recommendations based on what industry wanted.

Some of the highlights:
  • The International Plasma Fractionation Association railed against the trend for ever-larger clinical trials for new or modified plasma products, most pronounced for coagulation factor products, making it harder and more expensive to run clinical trials.
  • Call for harmonization of regulations covering the selection of donors and plasma in the USA and Europe because, for example, mutual recognition of inspection reports could cut costs.
  • IPFA expressed concerns and suggestions related to regulations on donation, e.g., legal status of eligibility criteria, mandatory presence of medical staff, recall/exclusion for (v)CJD. 
    • For example, they said a permanent presence of a physician in a plasmaphaeresis centre adds significant costs without adding any substantial benefit. Qualified health professionals (nurses or who knows who) can do the job. 
  • The Report also notes a clear tension between private, for-profit companies supplying plasma derivatives to a steadily growing market, including unproven clinical uses, and the public sector, supplying a relatively stable demand for blood and blood components.
In other words, for-profit plasma manufacturers want to minimize costs in any way to maximize already fabulous profits for their shareholders.

Stem cells, plasma, and even molecular blood typing as in April's blog, While my guitar gently weeps -- It's all about the money, folks. 

Are the quack fat-derived stem cell entrepreneurs all that different from the paid plasma industry shilling IVIg as the latest and greatest for who knows what? 

Or that different from molecular genotyping companies and their advisory TM experts implying that any blood transfusion without genetically matched donors is 'bad blood' or not 'best practice' or so 20thC? 

Those trying to influence decision makers are powerful lobbyists with vested interests in the $ billions. 

And sometimes with support and collusion from transfusion medicine's 'thought leaders'.

Rather than promote body tissues as 'liquid gold' I'd rather promote a 'heart of gold'. Silly me? A losing battle but one worth fighting.

As always comments are most welcome. 


Sunday, April 12, 2015

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

Updated: 13 April 2015
April's blog focuses on news items from TraQ's latest newsletter that have a commonality. 
  • The main item deals with a molecular assay to identify 35 red cell antigens from 11 blood groups. 
  • The other, included to illustrate the blog's theme but mainly here for fun, focuses on the clinical uses of platelet-rich plasma (PRP). 
I'll leave it to readers to ascertain what the stories have in common. The blog's title derives from a 1968 George Harrison ditty in the Beatles 'White Album'. 

Typing of blood group antigens at the molecular level has been in the works for years. Now it's moving beyond its original special uses because of technological advances, decreasing costs, and lobbying by vested interests. 

However, its cost-effectiveness is still unproven. Immucor's PreciseTypeTM HEA test costs ~$350 USD but that likely varies significantly depending on individual contracts. And any cost study I've read in journals like AABB's Transfusion is so dependent on assumptions as to be almost meaningless and needs to be read carefully and critically.

Also, molecular blood typing is not the be-all, end-all for the 100s of blood group antigens that exist, since not all are DNA-defined. But the list of antigens covered is impressive and includes nearly all clinically important blood group systems (see Further Reading). 

Of course, other companies besides Immucor compete in the molecular blood typing business, including BloodChip® by Progenika Biopharma.(Source: Greg Denomme's paper in Further Reading)

Regardless, molecular blood typing has no end of proponents, mild and strong. For example:
I wrote a blog on this topic years ago: 
  • Snip, snip the party's over (Dec. 2010) 
    • Suggest you read it later, if the mood strikes. My predictions have come true but they were no-brainers. 
Me Medicine
Now molecular blood typing is being marketed as personalised medicine, ie., the tailoring of medical treatment to individual characteristics of each patient. The idea derives from the 13-year, $3 billion Human Genome Project. For example, Immucor advertises PreciseType this way:
Makes it seem that anything less is substandard. Get with the program, health care providers, because it's all about me.

But many experts like Donna Dickenson, emeritus professor of medical ethics and humanities at the University of London and research associate at the HeLEX Centre, University of Oxford caution that
I'd read several news items over the years about PRP's use in orthopedics, particularly for athletes:
And recently the owner of a local restaurant I frequent mentioned that she had her own plasma injected into her knee but had to pay for it as it wasn't covered by Canada's universal health care system, at least for her. She said her knee caused a lot of pain (she's a 50-something server in the restaurant) but apparently it wasn't bad enough to be operated on yet. 

With that as background, recent news items on PRP's expanding clinical uses caught my attention. Medical tourism grows daily, at least for the rich. Seems Dubai now has more plastic surgeons per capita than any other city in the world and hopes to attract half a million medical tourists by 2020. 

The penis and vagina PRP nonsense was included just for fun. But really, Academy Award nominees got a coupon for a Priapus Shot? You cannot make this stuff up. 

Okay, I lied because I'm sure you've gotten the blog's theme by now:
  • Where there's a buck to be made or an agenda to be advanced, clinical uses of diagnostic tests and products will inevitably expand well beyond what's evidence-based. 
TM poster-child for phenomenon? Intravenous immunoglobulin (IVIg). 

But what's surprising, at least to me, is how few voices, especially in the TM community, question the *expanded use* of innovations like molecular typing of red blood cell antigens under the guise of me-medicine. Particularly since our so-called 'thought leaders' are so into evidence-based these days. 

I understand why advances that help solve real TM problems are celebrated. But why the uncritical approach? Is it because blood typing at the molecular level is 
  • A marvelous innovation and all want to be seen as 'with-it' hipsters on DNA's bandwagon? Versus being old-fogeys who resist change? 
  • Way to develop a business line and maximize earnings in a shrinking field like TM in age of 'blood conservation 'über alles', e.g., AABB? 
  • Outright self-interest for those who specialized in molecular technology and need to maximize their career's life-span?  
  • Seen as eliminating humans from the equation, such as interpreting serological test results, thus must be good? 
  • High-throughput automated innovation, another way to decrease costs by eliminating those pesky creatures, aka staff, with their costly salaries, benefits, and pensions? 
    • Better to give money to international companies than keep staff, aka tax payers and community builders, employed at home?
    • Plus many staff are probably contemplating retirement anyway and eliminating their jobs will help make that decision easier? 
  • Viewed as best thing since sliced bread, not just a significant innovation with specific uses, motivating proponents to abandon whatever critical thinking skills they ever had?  
Personally, I wholeheartedly agree that molecular blood typing is a useful, indeed marvelous, advancement that will make blood transfusion safer for many. Celebrate its potential but please don't promote it beyond clear clinical uses so that anything else seems sub-standard, as in this over-the-top headline: 
  • 'Boston Children’s Hospital ends BAD BLOOD between donors, patients' (Emphasis is mine)
'While My Guitar Gently Weeps':
  • #136 on Rolling Stone's "The 500 Greatest Songs of All Time"
  • #7 on its list of 100 Greatest Guitar Songs of All Time
  • #10 on its list of The Beatles 100 Greatest Songs. 
While my guitar gently weeps (Paul McCartney and Eric Clampton tribute to George Harrison, Queen's Golden Jubilee, London 2002) 
I don't know why nobody told you 
How to unfold your love 
I don't know how someone controlled you 
They bought and sold you. 

I look at the world and I notice it's turning 
While my guitar gently weeps 
With every mistake we must surely be learning 
Still my guitar gently weeps 

As always the views are mine alone and comment are most welcome.

References for those who want to delve further into the blog's topics. 
Molecular blood typing
Nice overview: Denomme GA. Prospects for the provision of genotyped blood for transfusion. Brit J Haem 2013 Oct;163(1):3-9.

For molecular blood typing in detail, see these papers from 2009. Info overload but fascinating insight into predicting the future (All papers free full text): 

Molecular blood group diagnostics.Transfus Med Hemother. 2009 Jun; 36(3): 154–155.(editorial) 

Five expert opinions on the question ‘Will genotyping replace serology routine blood grouping in the future?’ 
Interpretations are mine. (Author origins refer to where they worked then, not necessarily nationality.) 
  • Opinion 1: Only partly. Unlikely unless... (Germany) 
  • Opinion 2: Probably (Switzerland) 
  • Opinion 3: For some applications (Austria) 
  • Opinion 4: Personalized versus Universal Blood Transfusions – Combining the Efforts: Probably but in combination with enzymatic conversion (ECO) to remove A and B antigens (Sweden) 
  • Opinion 5: Yes (Netherlands) 
Platelet-rich Plasma