The way we were (Musings on TM history and its lessons for today)

Updated: 11 Aug. 2014

This month's blog discusses 3 recent news items (and associated scientific papers) related to men who have sex with men (MSM), HIV risks, and blood donation, plus a paper written by Canadian transfusion medicine experts on Canada's perspective on donor criteria for MSM.

The blog's title is from a 1975 Barbra Streisand classic (one of my favorites) and theme from an eponymous movie starring her and Robert Redford.

Please read the news items and papers as they provide fascinating, useful details beyond the brief reports presented in the blog. Although the specifics involve North America, the content and learning points apply everywhere.

1. USA: HIV positive man arrested and charged after donating plasma for $30

A man admitted to police that he donated plasma at BioLife in Elkhart, Indiana even though he knew he was HIV positive. He'd lost his job and needed money. 

Biolife pays $30 for plasma via a debit card and is a division of Baxter Healthcare. 

The plasma donor was charged with three counts of attempting to transfer contaminated body fluids and one count of transferring contaminated body fluids.

2. USA: Activists fight MSM policy (lifetime deferral if even once since 1977) with National Gay Blood Drive on 11 July, 2014.

The blood drive involves gay and bisexual men who want to donate bringing proxy donors who are eligible to donate and publicizes what activists believe is an outdated discriminatory and unscientific policy. 

The news item outlines the key issues on both sides of the argument with quotes from Paul Strengers, medical director at the Dutch Sanquin Blood Supply Foundation (anti-changing the policy) and the American Medical Association (pro-change). 

Related: AABB, ABC, ARC Joint statement on National Gay Blood Drive

Among other things, the US organizations were concerned that the event might disrupt blood center operations but support "rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities."

3. USA: 5 reasons HIV is on the rise among young gay and bisexual men

In brief, according to HIV researchers at CDC, the reasons include young gay and bisexual men's partners are more likely to

• Have and transmit HIV

• Engage in risky sexual practices

• Use drugs

• HIV's stigma could make people less likely to get tested

• Younger men weren't around for worst of the HIV/AIDS epidemic and are less likely to know the dangers

Related: Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in diagnoses of HIV infection in the United States, 2002-2011. JAMA 2014;312(4):432-4.

4. Goldman M, Lapierre D, Lemay L, Devine D, Sher G. Donor criteria for men who have sex with men: a Canadian perspective. (Commentary) Transfusion 2014 Jul;54(7):1887-92.

With other jurisdictions considering a change in MSM policies, this paper was written by Canadian blood experts who thought it might be of value to share Canada's experience. It outlines CBS and Héma-Québec's extensive processes to consult interest groups / stake holders to achieve a consensus to support Canada changing its long-standing permanent deferral for MSM to a 5-year deferral from last MSM contact. 

The 'Commentary' begins by outlining the history of the HIV/AIDS/HCV 'tainted blood' disaster in Canada, which led to the Krever Royal Commission of Inquiry into Canada's blood system and its 'damning' (my word) 1997 report.  

As a result, in 1998 CBS and Héma-Québec were created; blood was regulated as a drug with blood centres considered biologics manufacturers, with more stringent regulatory oversight by Health Canada. 

I'll present only a few key highlights of the paper, those selected through my biased eyes. Also note [my Comments].

HISTORY: [One of the most explicit mea culpas I've seen from Canadian TM experts]:

* There was a lag between implementing measures to reduce transmission of AIDS/HIV in Canada compared to the US and others, including donor deferral criteria, HIV antibody testing, and sole use of adequately virus-inactivated factor concentrates.

* Delays contributed to infection of many transfused patients, with the hemophilia population particularly devastated by HIV. Delays also occurred in adopting measures to reduce HCV transmission. 

* Anger and bitterness over the (mis)management of HIV and HCV risk by the blood system cast a long shadow over the new organizations, CBS and H-Q. 

[Why did the delays occur? What's the root cause? A focus on cost over safety? A belief in evidence-based science that failed to consider what experts did NOT know? Or?]

STATISTICS: As of 2011 PHAC reports there were ~71,000 prevalent and 2250-4100 annual incident cases of HIV in Canada. MSM risk was high for prevalent and incident infections, accounting for about half of new infections.

* Large MSM studies demonstrate seroprevalence rates from 10% to 20% but generally recruit participants in gay venues and focus on currently sexually active MSM, often with frequent partner change (not those in longstanding monogamous relationships or those sexually inactive for a long time).

[Incidence of HIV seroprevalence in gays in long monogamous relationships is unknown.]

* With sensitive antibody detection assays and minipool nucleic acid testing (NAT), the window period for HIV is estimated at 9 to 11 days. 

* Residual risk for HIV is estimated at less than 1 in 8 million units at CBS and in the USA is 1 in 1.5 million units, due to higher rates of HIV+ donors. 

[FYI, residual risk is the risk of an infectious donation being present in the blood supply after all donor and donation screening activities occur and unsuitable donations are removed and discarded.  See Current information on the infectious risks of allogeneic blood transfusion - Residual risk. Put another way, it's the OOPS! factor.]

RISKS

* Risk modeling in Canada found the incremental risk of a 5-year deferral for MSM was less than 1 infected HIV unit entering the blood supply in 1000 years. 

* A 5-year deferral for MSM would not substantially increase transfusion-associated HIV in Canada. Similar modeling studies were done in France, UK, and USA. 

[Sounds great, eh? Almost as if we can crow, 'Don't worry, be happy'. But the fly in the ointment...] 

* 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where data are often sparse. Additionally, they do not provide information on novel or emerging threats.' 

[Modeling involves many assumptions based on minimal data – so much for evidence-based. Plus, obviously new and emerging threats (unknown) are absent from modeling studies.]

MUSINGS
I'm not going to report the guts of the Canadian paper, which outlines the processes used in Canada in 2001, 2006, 2008, 2009, 2011, and 2012 except to mention the Kyle Freeman court case.

But please read the paper if you have access because it explains the science and politics of MSM and blood donation as few resources have and the emotions and tension that marked the debate historically and still do.

In brief, the Freeman case involved a gay man who informed CBS via an anonymous e-mail that he donated and lied about his MSM status. To trace the anonymous e-mail and apply the appropriate deferral code, CBS sued for negligent misrepresentation as a way to obtain his identity from his e-mail service provider. He counter-sued, claiming CBS violated his rights under the Canadian Charter of Rights and Freedoms.

Freeman lost. Key elements of the judgment in favor of CBS were that blood donation is a gift and not a right and that MSM policy is not discriminatory based on sexual orientation.

Relevant reading:

• Gay Ontario man loses blood donation negligence suit 
• Canadian Hemophilia Society view of the case
• Court Case

LEARNING POINTS
MSM, HIV, and blood donation continue to be controversial and political. To me, key points from the Transfusion paper and related news items include 

#1. Goldman paper: 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where evidence is lacking. As well, they do not provide information on new or emerging threats.

In other words, models of HIV and other infectious disease risks to the blood supply are based on assumptions backed up with more or less zero data and do NOT consider new threats. So much for evidence-based decisions touted by TM experts.

#2. The role that student and gay rights activists play in changing blood safety policy is pure politics.

They claim discrimination (and a case can be made based on MSM vs engaging in risky behaviors regardless of gender) but ignore that HIV-prevalence of MSM presents a real risk to the blood supply. Moreover, HIV is on the rise among young gay and bisexual men, current HIV tests have a window period of 9 to 11 days, and donors may lie on blood donor screening questionnaires.

#3. Goldman paper: 'For patient groups, many of whom are chronic users of the blood supply, the change meant putting aside their fears of the past, assessing the available scientific information, and trusting in the system.'

To me, this is 'Don't worry, be happy' time (see earlier blog). Trust us. We've got your back covered based on science. Oh yah!

#4. All this aside, blood suppliers worldwide will cave to the political pressure of activist interest groups, claim it's evidence-based, and it won't affect blood safety until it does.

UK PERSPECTIVE

For interest, the UK's NHSBT donor policy on MSM:

• Why men who have sex with men are deferred from blood donation for 12 months (Position Statement: Nov. 2011)

The change means that only men who have had anal or oral sex with another man in the past 12 months, with or without a condom, are asked not to donate blood. 

Men whose last sexual contact with another man was more than 12 months ago are eligible to donate, subject to meeting the other donor selection criteria.

Other nations have permanent (indefinite) deferral or a 5 year deferral.              
FOR FUN
The blog's topic is not funny. The 'for fun' bit is just for enjoying the song. Looking back on the HIV tragedy and its impact on blood transfusion, I'm reminded of the innocent way we were before HIV appeared.

• The Way We Were (Barbra Streisand, 1975) 

Mem'ries,
Light the corners of my mind
Misty water-colored memories
Of the way we were. 

Scattered pictures,
Of the smiles we left behind
Smiles we gave to one another
For the way we were.

Can it be that it was all so simple then?
Or has time re-written every line?
If we had the chance to do it all again
Tell me, would we? Could we? 

Mem'ries, may be beautiful and yet
What's too painful to remember
We simply choose to forget.

So it's the laughter
We will remember
Whenever we remember...
The way we were...

As always the views are mine and mine alone and feedback is most welcome.

Both sides now (Musings on transfusion medicine illusions)

Updated: 17 Nov. 2013

This month I couldn't resist a blog on abstracts from the 2013 AABB Annual Meeting in Denver, Oct. 12-15, published in Transfusion, Vol. 53, No. 2S, September 2013 Supplement.

Some people use People as bathroom reading. For ~38 years (since becoming an AABB member in 1975), mine has been Transfusion, with the meeting abstract issue offering many enjoyable hours 'on the throne'. Ok, cue the chorus of, 'Get a life!' 

What follows are random observations, covering a few of the many goodies that struck me in this year's abstract supplement. 

Because the AABB meeting is on when this blog is published, I realize that few North Americans will read it. Maybe after they return home and equilibrate? 

The blog's title derives from an iconic song by Canada's Joni Mitchell.

TRANSFUSION PROFESSIONALS
First, using electronic access to Transfusion as an AABB member, the following data was complied.

In the Administrative and Scientific sections, searches for references to health professionals yielded the following results, i.e., number of search 'hits':

Administrative (Scientific)

• Physician: 60 (54)
• Nurse: 37 (11)
• Technologist: 28 (8)
• Clinician: 8 (15)
• Medical director: 6 (2)
• Pharmacist 1 (0)
• Perfusionist: 2 (0)

Using the scientific section, the top four would be
* physician-clinician-nurse-technologist

What stands out is how physicians dominate both abstract sections. 

SO WHAT?
It follows that physicians dominate AABB meeting abstracts. They dominate AABB's Board of Directors and certainly dominate the ability to do research. 

AABB's 2012-13 Elected Board (n=19):

• 13 MDs (68%)
• 4 Medical technologists (21%)
• 2 PhDs (11%)

Is it an illusion that nurses and medical technologists are equal to physicians in the TM stratosphere or do they continue to be historical underlings?

AUTHOR COUNTRIES
Founded in 1947, in 2005 AABB changed its name from American Association of Blood Banks to AABB. The change reflected that AABB has members in many countries and includes all of transfusion medicine plus cellular therapies.

In the Administrative and Scientific sections, searches for references to author countries showed that the USA dominates abstract presentations at annual meetings. The AABB website gives this breakdown of meeting abstracts: 

2013 Abstracts	No. accepted	Acceptance rate
Domestic	445	90%
International	215	83%

These numbers make the meeting look very international and do not fit what a quick scan showed.

Administrative section: Most non-USA authors are Canadians with 6 abstracts. Other countries such as Italy have 2 abstracts.

Scientific section: Outside of American authors, Canadians have the most abstracts (sorry, no exact count but based on a quick review Canada is number two). This reflects that it's cheaper for Canadians to attend meetings in the USA than transfusion professionals in Europe, Asia, Africa, and Down Under. It would be interesting to know how many of the 'international' abstracts were from Canadians.

Another major factor influencing AABB attendance is that transfusion professionals from Australia, NZ, and European countries have major conferences of their own to attend:

• HSANZ, ANZSBT and ASTH Annual Scientific Meeting
• BBTS conference
• ISBT congresses in Europe and Asia

SO WHAT?
AABB is not as international as it likes to portray itself. Despite boasting of membership from ~80 nations, outside of Americans, Canadians predominate. Its 19-member Board has only three non-Americans: Canadians Graham Sher of CBS and Jeannie Callum of Sunnybrook HSC in Toronto, and Mike Murphy of the UK's NBSBT and Radcliffe Oxford University Hospital.

Annual meeting attendees are mostly Americans, followed by Canadians.

Is it an illusion that AABB is an international organization? Or is it really a NA organization dominated by Yanks, with a few token Canucks? 

AABB ABSTRACTS
Now to the three abstracts selected for this blog. 

1. AP123 Transfusion Audits: Looking Beyond the Obvious

Authors: R M Bhavnagri, S M Armstrong, K Sanford. Transfusion Medicine, Virginia Commonwealth University Medical Center, Richmond, VA, USA.

The authors noted that transfusion audits are required by regulatory bodies to assess nursing protocols. They decided to use audits to build better relationships between nursing and blood bank staff. 

They rotated audits among every technologist in the transfusion service. This allowed staff to form relationships with nursing staff on each shift. The result was that relationships between nursing and blood bank staff improved.  

Comment: I really liked this abstract because anything that fosters blood bank and nursing understanding is good.
Is this an illusion? Will nurses and laboratory technologists ever be blood brothers and sisters? Evidence grows that this is so, especially in countries where medical laboratory technologists form a significant portion of transfusion safety officers. [See abstract 3 below.]

2. AP76 Bridging the Gap: The Success of Daily Transfusion Medicine Meetings

Authors: A L Sutton, N K Case, K Sanford.Transfusion Medicine, Virginia Commonwealth University Medical Center, Richmond, VA, United States 

Pathology residents continually rotate through the TM laboratory and it's the responsibility of pathology physicians and medical lab scientists to guide residents through their rotations. A new director noted a communication gap between the lab, residents, and director and implemented daily meetings.

The 20-30 minute meetings are held in the director's office and attendance is mandatory for TM residents, the charge medical technologist, and TM supervisors. 
Meetings have a consistent agenda and include blood product inventories, antibody workups, and much more. They're also an opportunity for residents to ask questions. 

Comment: Daily meetings are a great opportunity to exchange information and keep everyone apprised of current TM activities and issues.  Daily meetings that include the medical director, pathology residents, and medical technologists help bridge communication gaps.  

Equally important, they can lessen status gaps in the health profession pecking order. Disrespecting colleagues is harder when you've spent time with them close-up and know them as people.
Is this an illusion? Do medical directors have the time, let alone the will, to spend 30 minutes in daily meetings with residents and lab staff? Only if they see it as time well spent. One of the value-added benefits would be that it promotes medical technologists becoming an integral part of the health care team. 

3. P11 2012 Transfusion Safety and Patient Blood Management Survey

Authors: C Slapak, K Gagliardi. Community Blood Center/Community Tissue Services, Dayton, OH, United States; Southwestern Ontario Regional Blood Coordinating Network, McMaster University, Hamilton, ON, Canada. 

In 2012~ 40 programs based on an informal network of transfusion safety and patient blood management professionals existed in the USA.  

An online survey was circulated to transfusion safety officers, blood management coordinators, or similar in the USA and Canada  using informal US networks and the Canadian 'Transfusion' mailing list.  

108 professionals replied: 62% from Canada, 32% from US, and 6% from other countries. Almost all Canadian programs have existed for over 5 years (95%) compared to just over half of US programs (54%). 

Professional backgrounds:  

• nursing (24% Canada, 77% US) 

• laboratory (72% Canada, 9% US) 

• 6% physicians or others

The most common words in the position titles were Transfusion Safety (50%).

Training is mainly via professional experience, networking, and attending meetings. Only 8% use a formal TSO training program. 

Comment: Canada has more experience with transfusion safety officers than the USA.The UK and Australia also have more experience than the US. Although the evidence is mostly anecdotal, as in the USA, nursing has no monopoly but tends to dominate TSO positions in the UK, Australia, and NZ. [If this is not so, I'd love to hear from colleagues there.]  For example, from 'Towards Better, Safer Blood Transfusion'. A Report For The Australian Council For Safety And Quality In Health Care (Feb. 2005):

These key individuals have various titles (Transfusion Nurse, Transfusion Nurse Specialist or Consultant, Transfusion Safety Officer, Haemovigilance Officer, Specialist Practitioner of Transfusion). They are usually recruited from nursing backgrounds. They act a vital 'bridge' between the different provider groups engaged in the transfusion 'safety chain', in particular those beyond the hospital laboratory.

In contrast, in Canada medical laboratory technologists outnumber nurses 3 to 1 as transfusion safety officers or equivalent.

Is Canada's experience an illusion? It seems not, but why the preponderance of 'transfusion safety' nurses outside Canada whereas medical technologists here hold their own? An added benefit of a good mix of nurses and technologists is that understanding the daily work realities of each profession grows, and with it, increased respect. 

FOR FUN
Lately, I've listened to many songs written by Canada's Joni Mitchell. The blog's title was selected to reflect the 'we-they' schism between nurses and transfusion service technologists, including the nursing - technologist TSO dichotomy in the rest of the world compared to Canada. 

But other potential illusions include:

• Are nurses and technologists 'equal' to physicians on the health care team? (where equal means valued and respected equally for their expertise)
• Is AABB a true international organization? Or more a NA group with delusions of grandeur and global aspirations to promote its standards and associated business line, AABB Consulting Services?
• Can nurses and technologists one day be blood brothers and sisters, treating each other with respect, even awe, for their respective skills?  
• Will medical technologists ever become an integral part of the health care team, as respected as professionals with direct patient contact?

Joni Mitchell songs:

• Both sides now (~600 'cover' versions by other artists and counting)

I've looked at life from both sides now 
From up and down and still somehow 
It's life's illusions I recall 
I really don't know life at all. 

Two other fabulous songs that Joni wrote:

• Big yellow taxi
• Woodstock

As always, comments are most welcome. And we have some...

Reply #1: Re-Dr. Gwen Clarke's comment below:

Appreciate the feedback. Nice touch to include weekly telecons for colleagues in Edmonton-area hospitals. Like you say, daily meetings help promote communication, a team approach, and opportunities to learn and teach.

I've always been struck at how communication failures play a role in so many adverse events in the UK's SHOT reports. For example (from p. 6 of the 2012 SHOT Report):  

The headlines from 2012 reporting are a continued high rate of error related to omission of essential procedural steps and communication failures. 

Suspect that communication improves outside meetings too as it's easier to phone someone you see every day and works both ways for physicians and lab technologists to consult each other more.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Reply #2: Re-Kate Gagliardi's comment below:

First, about including your abstract (#3 above: Transfusion Safety and Patient Blood Management Survey), my apologies. It's been on my to-do list to write and tell you it was in October's blog, but....

Believe it (or not) it would have happened today. <;-)

Suspect Canada's situation, where many who are not formal 'transfusion safety officers' share bits and pieces of the role, apply universally. 

Appreciate your frank comments on UK's SHOT ('gold standard') vs Canadian and American hemovigilance programs. Reminds me of a 2011 blog:

• Only in the UK & Down Under? Pity! (Musings on hemovigilance)

Sad that it's still relevant 2 years later. I keep looking for published, current data from Canada and USA. Doesn't happen.

About AABB holding meetings on Canadian Thanksgiving, that breaks me up. Case of, "If it didn't happen in USA, it didn't happen"? Unfair to American colleagues but AABB should take note, if only to maximize meeting profits.

As to TSO 'RN vs Medical Technologist' issue, I'd love to hear your views. In the meantime, I'll pursue it on other media such as Canada's TSO "transfusion" mailing list and report back here. 

Thanks again. Your input is much appreciated.  
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

I will remember you (Musings on realities for nurses and residents)

Updated: 13 Oct. 2013

September's blog was stimulated by recent personal experiences in a local inner city hospital with ~700 beds, treating ~ 450,000 patients/year. I spent much time in the hospital over 5 days and came away impressed with frontline health care staff. 

In contrast, I happened upon a news item about a lawsuit that did not impress: 

• SmithKline Beecham vs Abbott Laboratories: Abbott removes juror because he's gay in suit over hiking HIV drug price

The blog's title derives from an iconic song by Canada's Sarah McLachlin.

First the good news. Being naturally curious and a people observer, during the recent encounter with our health system, I learned many tidbits about work realities for Drs (surgeons and residents), RNs, LPNs, pharmacists, occupational therapists, respiratory technologists, nursing aides, cleaners, and more.

In brief, I have an enhanced appreciation of colleagues in the front lines of the interdisciplinary health care team. They work under incredible pressure, yet those I observed invariably put the patient first and were caring professionals. 

As background, as a medical laboratory technologist who worked in a transfusion service lab for many years, I've encountered many nurses, those I call 'pitbulls', because they aggressively challenge 'rules' the blood bank has related to identity that are designed to ensure patient safety. That makes my new found appreciation all the more sweet.

Thank you surgeons, residents, RNs, and all staff at Royal Alexandra Hospital (Nursing Station 31), Edmonton, Alberta, Canada.

Some things I observed:

• RAH entrance: 2 security officers holding what could be a homeless man with a beaten face, him screaming, 'I f*ckin' did nothing, you bastards.'

• Signs say 'No smoking on RAH property' but 'patio' outside main entrance always full of patients smoking. Not similar at University Hospital. Perhaps a losing battle in inner city?

• Most memorable image of RAH: Emaciated male exits nursing station 31 with fag in mouth, going for a smoke.  Frankly, despite being one of those ex-smokers who is now fanatically anti-smoking, I don't begrudge him his smoke. 

• Exiting RAH elevator on 3rd floor: Mother angrily screams at ~12 yr old girl that she needs to say something when asked a question. Mom walks towards the ward area and screams, 'Where the f*ck are we?' Then mutters, 'Wrong floor', and stomps away leaving child to follow. My heart ached for child. Mother obviously stressed but no excuse to abuse child. Miracle if kid survives a mom like that. 

• Respiratory technologist attaches a BiPap to patient in respiratory distress in ward's special 'observation room' (2 RNs for 4 post-op patients), all the while training a student. As a longtime blood bank clinical instructor, I was impressed by his expertise and patience. Later one of the RNs asked the respiratory tech if respiratory could give an in-service on use of the BiPap. Good stuff. 

• Patient in observation ward for those who need observing carefully post-surgery, and who are attached to many monitoring instruments (and where every few minutes machines beep loudly  - sleep is impossible in the  hubbub of activity) screams, 'Shut up! I'm trying to sleep.' Another patient comments, 'Stuff him in the closet' and he replies, 'Yes, please.'

• Elderly gent on observation ward, post-surgery, keeps screaming, 'Let me outta here. They've kidnapped me. I've got to go home' and tries to rip off his monitoring equipment. His elderly wife patiently says, 'No dear. You've got to stay.' 

• Several times a day a patient leaves the observation room for a regular hospital room and a new patient comes in. This is when two staff members enter and strip the bed, then wipe down (disinfect) every part of the bed, tables, and any surface the patient may have touched. It's a frenzy of cleaning, hard grunge work, but it's got to be done and quickly, to prepare for the new patient. 

You get the idea. Every day is total chaos but residents, nurses and all staff maintain their cool and keep caring for all their patients no matter how difficult they and the environment may be.

INDUSTRY
Now the bad news. Watching nurses and docs perform under trying situations makes me all the more disturbed to see how industry colleagues continue to put their interests ahead of patients and seemingly use every tactic to maximize profits and win lawsuits.

Indeed, I could recite many cases that definitively show that Big Pharma routinely behaves badly but I'll limit it to a current case.

Smithkline Beecham (SKB) v. Abbott Laboratories (USA)

SKB v Abbott is about whether it is permissible for a lawyer to 'strike' (remove) would-be jurors from a case because of sexual orientation.  In this antitrust lawsuit involving HIV medications, an attorney for one of the companies exercised a so-called peremptory strike, effectively removing a possible juror because he was or appears to be, could be, homosexual.

The case involves Abbott challenging the only known gay juror during voir dire for a trial in which SKB challenged Abbott's controversial 400% price increase for an HIV medication.

In other words, Abbott wanted to get rid of a gay juror presumably because it believed he would be biased against them for their exorbitant price for HIV meds.

How did Abbott know he was gay?
When the judge asked how they knew he was gay, Abbott pointed to his mannerisms, his residence in West Hollywood and his previous work as a freelance screenwriter.

What to say? Jesus wept? Oh, give me an effing break? Geez, if you're 'straight' what cases does that preclude you from?

Be aware that SKB is no better than Abbott. Name any Big Pharma company and it's easy to discover how they routinely behave badly. For example,

• SKB overcharged AIDS Healthcare Foundation $2.2 million for drugs, the nonprofit claims in court

BOTTOM LINE
Frontline health professionals work under incredibly stressful conditions and yet put patients first and remain cheerful and helpful. 

As someone who has worked in a transfusion laboratory and taught all my working life, I have new respect for the nurses. They carry the burden of dealing with patients who often are close to impossible to handle and may go into a life-threatening crisis at any time. To say nothing of the many bodily fluids they have to clean up with a smile and kind word.

As to Big Pharma, it seems the bottom line is all that matters. Frankly, drug and diagnostic reps are often fine colleagues. But they're at the mercy of their employers. 

For Fun
To all the nurses, residents, and other health professionals at RAH, Nursing Stn 31, in Edmonton, rest assured,

• I will remember you

Further Reading

• Norvir Price Increase -- Boycott Abbott
• Court to Decide if Lawyers Can Block Gays From Juries
• SmithKline Beecham v. Abbott Labs: Should Batson apply to gay jurors?
• WSJ Uncovers Abbott's Norvir-Busting Marketing Strategies
• Smithkline Beecham Plaintiff - Appellee/Cross-Appellant v. Abbott Laboratories Defendant-Appellant/
• Smithkline Beecham Corporation v. Abbott Laboratories ("Sexual Orientation of Jurors")

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

I've been everywhere, man (Musings on fast-tracking those with foreign credentials)

This blog is a revised version of a recent personal blog, 'Want to work in Canada as a medical technologist? Forget it!'

Last updated: 16 May 2012 (see Addendum below)

 As a promoter of international job mobility, it has long saddened me that foreign-trained medical laboratory technologists from English-speaking nations such as Australia, NZ, and the UK face so many obstacles when seeking work in Canada. 

Do physicians and nurses face similar obstacles? Perhaps not, because everywhere in Canada, I hear physicians with British, New Zealand, South Africa, and Aussie accents. And since 'Down Under' countries are always holding job fairs in Canada for nurses, I suspect that mobility may be reciprocated, i.e., Aussi and Kiwi RNs can work in Canada without too much difficulty. But for medical technologists, it's a different story. Working in Canada is onerous, indeed.

If you are a physician or nurse, I encourage you to read (even skim) the technologist-related details below to assess how job mobility for your profession compares.

This blog derives from a Dark Daily report: "Medical laboratory technologists with foreign credentials to get fast-track acceptance in Canada."

Its title derives from an old Hank Snow ditty, I've been everywhere, man.

I love Dark Daily, but its headline and article are misleading. If I were asked about foreign-trained medical laboratory technologists from AU, NZ, UK, and USA, where English as a second language is a non-issue, and where education and training are world class, my response would be:

• All the fast-tracking in the world won't help.

As background, Canadian employers (mainly government-funded health regions) are always moaning and groaning about the shortage (soon to become worse with impending retirement of baby boomers) of nurses and physicians, as well as other health professionals such as medical laboratory technologists and diagnostic imaging technologists. In response, governments have created various fast-track schemes that supposedly will allow faster immigration and employment of qualified needed health professionals. 

USA GRADS
First, USA grads do not qualify because their general certification does not include histotechnology. In Canada, besides clinical chemistry, hematology, clinical microbiology, and transfusion science, general certification requires education and a clinical rotation in histotechnology.

Second, obtaining subject certification for USA grads in the other 4 main disciplines is out because Canada offers subject certification only in clinical genetics and diagnostic cytology.

Reasons that CSMLS does not offer subject certification in other disciplines include

• Cost (subject exams are costly to maintain) 
• Employer preference for flexible grads who can work in all disciplines
• Fear that employers may use those with subject certification to work in lab sections for which they are untrained

Accordingly, the path to employment in a clinical laboratory for a USA-educated and trained medical technologist / clinical laboratory scientist is a torturous path:

• Step 1: Attend an educational institution (Canada or US) and take a course equivalent to an histotechnology course taught at Canadian institutions. For example, see MLS 250 at the University of Alberta.
• Step 2: Convince a potential employer to provide a clinical rotation in histotechnology. In Canada this is ~4 weeks. And it's next to impossible because employers can barely offer clinical rotations to Canadian-trained students.
• Step 3: Apply to CSMLS for a 'Prior Learning Assessment'.
• Step 4: If eligible, arrange to write the CSMLS general certification exam (based on a competency profile) covering the five disciplines specified on the CSMLS website.

AUSTRALIA, NEW ZEALAND, UK

Background

In my experience, education and training 'Down Under' and in the UK are excellent and in some ways exceed that of the typical Canadian graduate, since Canada rejected the BSc as entry-level several years ago.

This decision created barriers for Canadian medical laboratory technologists to work outside Canada. 

People who did not support the BSc were employers and bureaucrats in provincial government departments of health. Reasons for rejecting the BSc varied but included:

• They perceived the BSc as entry level for nurses  as credential inflation leading to increased salaries without sufficient return on investment and they were determined to stop this happening for medical laboratory technologists.

• Employers wanted the cheapest possible medical laboratory technologists, those who could be 'turned out' as quickly as possible and paid as little as possible. 

• In their short-sighted view, with the move to increased laboratory automation and centralized testing, who needed a technologist whose education and training took 4 years?

Exception

Canada has two programs that provide both a BSc and professional certification by CSMLS:

• MLS program at the University of Alberta (UA) is the longest existing program: its first BSc (MLS) degrees were awarded in 1961. MLS also offers a post-diploma BSc.

• University of Ontario Institute of Technology (UOIT), which opened in 2003, offers a Bachelor of Health Science (Hons) in MLS.

All other programs are 2- or 3-yr diploma programs at technical institutes or community colleges (equivalent of USA 'associate degrees').

For interest, UA MLS grads enjoy international job mobility. They are eligible to write the American MT(ASCP)* exams and many have. (*To change once the ASCP's Board of Registry and NCA merge to form a single USA certification agency.)

This allows UA MLS grads to work in the USA and many did during the mid-90s when laboratory jobs greatly decreased in Canada and many educational programs closed.

As well MLS is the only Canadian program whose grads are eligible to work in NZ without writing certification exams. 

What about job mobility for technologists trained in other English speaking countries besides the USA? Can university educated and trained UK, Oz, and NZ grads easily work in Canada as med lab techs?;

Unfortunately, no. The main reason is that programs in these countries, while providing education in the 5 basic disciplines, do not require clinical rotations in all 5 disciplines.

For example, NZ graduates of university programs  are ineligible to work in Canada because they may do a year's rotation in only 2 disciplines, e.g., 6 mth clinical rotations in their 4th year in each of 2 disciplines (e.g., hematology and transfusion science or clinical chemistry and hematology, etc.), as in the Massey University program.

In contrast, a typical Canadian grad may spend 3 mths in a hematology lab and one month in a transfusion service lab, only one-third of the total time spent by NZ grads in these labs, and in the case of transfusion science, one-sixth as much. But NZ MLS grads are not eligible to write the CSMLS general certification exam without obtaining equivalent clinical rotations in all 5 disciplines.

Is this not nuts, given that NZ MLS grads clearly have more basic education than most Canadian grads, as well as more practical experience in at least 2 clinical laboratories?

OZ and UK grads are similarly stymied if they want to work in Canada because graduates of Australia and UK's university programs can specialize. Examples:

• Australia: BSc in Laboratory Medicine from Curtin University's School of Biomedical Sciences 
• UK: Bradford University's BSc (Hons) in Biomedical Science (also see Details & Modules tabs)

Why do these medical laboratory technologists face significant barriers to working in Canada? Is it all about protecting public safety by ensuring medical laboratory professionals meet Canadian standards of education and training? Or is it about protecting Canadian jobs for Canadians?

And why do graduates of Oz, NZ, UK, and US programs who are certified by their county's professional body and have worked for years in one or more areas of a clinical laboratory, need to write the CSMLS general certification examination covering all 5 disciplines to work in Canada? Beats me.

CSMLS CERTIFICATION

If the educational programs of foreign-trained technologists are deemed equivalent to Canadian programs (or better), foreign-trained candidates must still write the CSMLS general certification exam to work in almost all Canadian medical laboratories.

Most Canadian provinces have regulatory bodies that de facto require that medical laboratory technologists be certified by the CSMLS as a condition of employment in a clinical lab that performs diagnostic tests on patients.

For lab professionals with experience (e.g., those who trained 10-15 yrs ago), and who have likely worked in one discipline (perhaps two) for years, writing an exam covering knowledge and competencies in 5 disciplines is not easy. And getting clinical rotations in Canadian labs is pretty much impossible.

MUSINGS
I personally know NZ-, UK-, and USA-trained lab professionals who are better educated and trained than many Canadian grads, have ample current experience, and would make valuable contributions to Canadian labs and be exemplary employees. But they cannot work here, despite the fast-track 'BS' of our governments.

True fast-tracking would allow

• Different routes that don't require candidates to re-learn  specific disciplines (e.g., histotechnology), which they will never work in;
• Restricted licenses to practice and work only in the area or areas for which they are well qualified.

The situation is different for those for whom English is a second language:

Besides becoming fluent in English, these technologists often need to upgrade their education and training to Canadian equivalency. As but one example, in transfusion science, the association of the Rh blood group system with severe hemolytic disease of the fetus and newborn would not have been taught in Asian countries where almost everyone is Rh positive.

Upgrading programs are rare but exist. If candidates pass English language competency tests, successfully complete whatever minimal upgrading is deemed necessary, write and pass the CSMLS general certification exam, they still may not be hired if their English remains weak. That's the reality of today's clinical laboratories where staff are stressed to the max, mainly due to under-staffing.  

If asked, I often advise foreign-trained grads to enroll in a Canadian medical laboratory technology program. It's a tough sell because they have to support themselves and their families. But in the end, this route can prevent much grief and frustration.

Not a pretty picture....

Talk of fast-tracking foreign-trained medical laboratory technologists / medical lab scientists / biomedical scientists is largely smoke and mirrors.

Your thoughts and experiences are valued. Please offer feedback anonymously (or provide your name in the body of your response) by commenting below.

 Whether medical technologist, nurse, or physician:

• Is there an impending shortage in your country that would benefit from greater international job mobility?
• Does international job mobility of needed health professionals work well in your country? 
• Do foreign-trained workers face significant barriers? 
• Is fast-tracking a reality? 

Similarly, have you tried to work in another country and what obstacles, if any, did you face?

For fun
'Golden oldies' by Canada's inimitable Hank Snow: 

• I've been everywhere, man 
• I'm moving on (Intro by Johnny Cash)

And just because I love it:

• Across the universe (Beatles)

 As always, the views are mine alone.

ADDENDUM (16 May 2012)

Thanks to 'Anonymous,' who left a comment but perhaps withdrew it:

Well, it seems that both nurses and doctors have to sit exams in Canada in order to work here.... I wonder if it is possible to flood the ears of those desperately in need of lab staff with credentials of American or Australian or New Zealand educated professionals, so that the potential employer is motivated to seek change in the requirements.

The comment motivated me to suss out the following info on foreign-trained physicians and nurses wanting to work in Canada.

PHYSICIANS
Source: Global Medics

The basic core requirements for medical registration in Canada: 

A medical degree from any country that is listed in the International Medical Education Directory (IMED)

GP or specialty training that has been completed in Australia, Canada, Ireland, New Zealand, UK or USA
Authentication of medical certification by the Physicians Credentials Registry of Canada (PCRC). 

Some provinces require full verification before they will issue your license. Others will allow you to complete PCRC verification after starting work in Canada. Most provinces also require completion of the Medical Council of Canada Evaluating Exam (MCCEE).

Before taking the MCCEE, internationally-trained physicians must apply to the Physician Credentials Registry of Canada (PCRC) and send a certified copy of your final medical diploma. The MCCEE is a computer-based examination available at 500 test centers in 72 countries. 

Also see Info for foreign-trained medical doctors

NURSES

See Info for foreign-trained nurses

Process is similar to that for medical technologists (assessment, national exam). Exam info:
Canadian Registered Nurse Examination

More....

• Foreign-trained nurses in Canada wasted during shortage
• Govt. help for internationally trained nurses
• Centre for Internationally Educated Nurses

We can work it out (Musings on public vs private health systems)

This blog muses on how transfusion medicine (TM) in the USA compares to the rest of the developed world, particulary Canada, in terms of overall cost, efficiencies, and clinical outcomes.

As a Canadian, monitoring the U.S. debate on health care is frustrating. Particularly annoying is hearing our system regularly trashed on U.S. cable shows, mostly be those who do not have a clue about Canadian health care, and occasionally by Canadian physicians heavily invested in private health care.

• See Canadian health care slurs dismissed as "rhetoric" (CMAJ, 13 Oct. 2009)

Of course, like any system Canada's is not perfect but it provides universal coverage (like the rest of the developed world) and we're trying to improve it.

Nonetheless, to me the lies and distortions south of the border are galling. The blog's title derives from an old Beatles tune that I hope comes true:

• We can work it out

Don't worry - This blog is not going to delve deeply into the U.S. - Canada health care debate, where views tend to be as passionately held as religious convictions.

The idea for the blog came from this journal article & news item (featured in TraQ's November newsletter):

• Schoen C, et al. A survey Of primary care physicians In eleven countries, 2009: perspectives on care, costs, and experiences. Health Affairs 2009;28(6): w1171­w1183.
• U.S. physicians lag behind those in other countries in IT use

The journal paper made me wonder if anyone had similarly researched TM in the USA and Canada, or TM in the USA vs TM in other countries with universal health care and a national blood service in which users do not pay for blood and blood products, i.e., the public pays via taxes and the burden does not fall to those unfortunate enough to get sick and require transfusion.

There have been reports published comparing such aspects between countries as blood donor screening criteria and overall structure and organization. And Vox Sang has international forums (fora for purists), which survey the basics of blood systems around the globe and international practices on just about every type of practice, e.g.,

• Autologous blood salvage
• Clinical indications for various blood components
• Hemovigilance
• Massive transfusion protocols
• Technical topics such as electronic crossmatching, routine Rh typing, hemolytic disease of the newborn serologic analysis

The types of studies I have in mind would compare TM-related costs, efficiencies, and clinical outcomes in various developed countries. Such costs are incredibly difficult to identify with validity. But in countries with national blood services, these figures should be determinable, albeit with many assumptions, provisos, limitations and perhaps even a glut of 'weasel words' as often appear in cost studies due to the many variables involved.
For example, Canadian Blood Services has only three testing facilities and 12 manufacturing facilities to serve all of Canada except Quebec. Canada is the 2nd largest country in the world, just behind Russia and just ahead of the USA in territorial size.
CBS's annual reports include an incredible amount of hard data:

• Report to Canadians (2008 - 2009)

Some tidbits from the report above:

• Whole blood collections: 915,858
• Staff costs constitute ~60% of total 'Transfusable Products' expenses
• Cost per unit* for year ending 31 Mar. 2009: $377.11
• *ratio of total expenses to shipments of all products

A few possible comparisons for international studies:

1. Relative cost of the overall blood system
We know that Canada's health system is less expensive than the U.S. system, because the administrative costs are less when there is a single payer. Indeed, The U.S. spends more per capita on health care than any comparable country. Does this apply to the blood system too?

2. Average cost per RBC transfused
In Canada, CBS and Hema Quebec collect and process all whole blood donations intended for allogeneic transfusion.What does a typical unit of RBC cost to produce in Canada and how does it compare with the same average cost in the USA, UK, Australia, etc.?

3. Utilization management of blood components and blood derivatives according to whatever clinical guidelines exist

For example, do countries with national blood services and government -supported provincial blood offices achieve equivalent or better clinical outcomes and financial savings compared to the USA? See

• BC PBCO
• Transfusion Ontario

ADDITIONAL MUSINGS
In the mid-1990s in Alberta, the Canadian province where I reside, the government decreased financing of the laboratory system by ~40%. Among many results, students in the MLS program where I taught had difficulty finding jobs in Canada. However, because they wrote the ASCP MT exam at the end of their program, many obtained employment in the U.S., including in transfusion service labs.

Canadian grads were amazed at the U.S. system in which an incredible amount of their time was spent on what to bill for various lab tests, something that was not required in Canada. Yet this emphasis on fees and cost did not result in more evidence-based test rationales.
Grads often reported that the U.S. labs they worked in were still routinely performing tests that had been abandoned in Canada in the 70s and 80s, tests that contributed little, if anything, to treatment or clinical outcomes.

Granted, it's a small sample, perhaps the anecdotal reports of a few dozen graduates. But even so, publicly funded TM laboratories in Canada had managed to implement evidence-based test rationalization before many American counterparts.

And government programs such as the BC PBCO have made impressive improvements in utilization management of blood and blood components.

Can a public system of transfusion medicine, and universal health care in general, possibly be equivalent, or even superior to, a private one? We can no doubt work it out, eventually.

Additional Resources
For more on health care comparisons in general, see:

• Comparing medical costs and results
• Sick Around the World - a profile of health care in 5 countries

As always, views are mine alone. Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

Dr. Strangeblood or How I learned to start worrying and hate the numbers

As we enter a new year, money and the economy are on the minds of many people. Certainly economics is an obsession in the developed world. Accordingly, I could not resist a money-themed blog. Like it or not, money, money, money makes the world go round.

THE PAPER
As it happens there is a recent publication involving economics and transfusion medicine (TM):

• Custer B, Hoch JS. Cost-effectiveness analysis: what it really means for transfusion medicine decision making. Transfus Med Rev 2009 Jan;23(1):112. (PDF, free full text)

Brian Custer, lead author, is with the Blood Systems Research Institute.

-->This blog examines the issue of cost effectiveness analysis and its role in influencing blood safety policies. As always, ideas are presented as food for thought.

The authors discuss cost-effectiveness analysis (CEA) in TM, with a focus on blood safety and infectious diseases. For example:

• CEA can help policy makers decide whether or not to implement a test such as HIV-1 p24 antigen (as was done in 1996 but was discontinued ~2003 after HIV NAT testing was licensed).
• CEA can also provide a framework for comparing HBV NAT testing with pathogen inactivation of blood components.

The paper's so-what statement:

"Blood safety may be different, but the economic concept of efficiency does apply. It is better to pay $10,000,000 to save 1,000 people than to pay 10 times that amount to save 1 person, and it is surely better to reach this decision after looking at the costs and the benefits rather than before."

With economics, like statistics, many people’s eyes glaze over. But read on – it’s fascinating stuff. Below are but a few of the paper's key points.

ECONOMIC CONCEPTS
Economics is about the efficient use of scarce resources and a CEA is one tool that can help decision makers decide which new blood safety test or process to implement.

CEA involves 3 key concepts:

1. Since there are insufficient resources to support all possible activities, we must make choices.
2. We must decide whether or not to adopt a given intervention and how to allocate resources between competing alternatives.
3. In choosing, we must factor in the "opportunity cost", i.e., the value of forgone benefits. In other words, the true cost of something ("A") is not just what "A" costs but also the value of what we did without (the lost opportunity, "B") because we chose "A".

Quality-Adjusted Life Year
CEAs range from narrow (impact on the budget) to broad (factoring in the cost of human life and the quality of life). The latter analysis is termed cost utility analysis (CUA). CUA results are often given as a ratio of cost to health benefits and are reported as cost per quality-adjusted life year (QALY).

The cost per QUALY is a tool that allows for comparisons of health benefits across diseases. The value of what is considered a cost- effective QALY varies greatly between developed and undeveloped countries, as well as among disciplines.

In general, a cost-effective QALY is considered to be

• Clinical medicine: $50,000 to $100,000/QALY
• WHO: up to 3 times the GDP per person = ~$94,000 in USA & Canada and $72,000 in Europe (in year 2000 $)

QALY & blood safety
Larger QALY ratios are accepted in some areas such as blood safety because of several factors:

• First, do no harm implies a high priority to prevent outcomes such as diseases caused by contaminated blood.
• Society places a relatively high value on preventing low-probability risks with serious consequences.
• Society is willing to support interventions that target identifiable individuals e.g., blood recipients.

As a result, blood safety policy makers in developed countries consider and accept interventions that cost well more than $1 million/QALY. As a rule, tests become more cost-effective if the disease being screened for has a higher prevalence in the donor population and if it cannot be detected to some extent by existing tests and screening procedures.

For example:

• Anti-HIV screening when first adopted: $3600/QALY (due to higher HIV prevalence in donors & limited use of donor selection strategies)
• HIV p24 antigen testing (since abandoned): $2.0 million/QALY
• HIV NAT: $2.0 million/QALY (even using a NAT minipool, multiplex format with HCV and even with HBV too)
• HCV NAT: >$1.8 million/QALY (minipool)
• WNV NAT: $500,000/QALY (2003 - highest outbreak year)
• HBV NAT: additional $1 million/QALY or more (in multiplex format with HIV and HCV)
• HBV NAT: $66 million/QALY (separate test without HIV and HCV)

Since the AIDS tragedy of the 1980s, safety has focused on preventing transfusion-transmitted infectious diseases and more common transfusion life-threatening risks have taken a back seat even though preventing them is more cost-effective, e.g.,

• Mechanical barriers to prevent misidentification errors leading to transfusing the wrong ABO group: $197,000/QALY

MUSINGS

The following ideas are not particularly profound or original but seem worth stating.

1. Statistics can be used to prove anything.

If you want to inspire confidence, give plenty of statistics. It does not matter that they should be accurate, or even intelligible, as long as there is enough of them.
- Lewis Carroll, mathematician, clergyman, author (1832 – 1898)

Don’t get me wrong, I love statistics. However, as we know, CEAs and their sub-type CUA generate many statistics and, depending on the assumptions chosen, can be used to justify just about anything.

This is especially true when decisions involve costs or benefits whose price is unclear or varies, which limits the generalizability of many studies. For example, consider this paper and its assumptions:

AuBuchon JP, Littenberg B. A cost-effectiveness analysis of the use of a mechanical barrier system to reduce the risk of mistransfusion. Transfusion. 1996 Mar;36(3):222-6.

Note that costs could change dramatically if the study's few assumptions changed. As a result economic studies have to be assessed carefully and taken with a huge block of salt.

Unfortunately, critical assessment of economic papers is often beyond the grasp many health practitioners.

• Whenever statistics are tossed about, the potential for Taurus excreta cerebrum vincit exists. (Latin is incorrect, but you get the idea.)

2. Desire for zero risk

Undoubtedly, the history of the "tainted blood" scandals of the 1980s and 1990s involving HIV and HCV have influenced society's willingness to accept interventions that are not cost effective when compared with other areas of medicine. As has been noted so often by the TM community, citizens have come away from the HIV/AIDS tragedy with the impossible desire for a zero-risk blood supply.

Regrettably, in attempting to achieve zero risk, with tests for infectious diseases with common risk factors, we run into the law of diminishing returns. Because each test or intervention is layered upon previous ones, we inevitably spend more and more to detect fewer and fewer infections until the "bang for the buck" is minimal and the QALY cost is prohibitive.

3. Legal concerns

The threat of legal action remains influential in TM policy decisions, as in all of health care, and contributes to higher costs. As quoted by Custer and Hoch, regarding the decision to implement leukoreduction in Belgium:

The core problem proved to be legal. The blood banks are legally accountable for blood safety. This accountability is absolute, based on avoidance of all possible risks, regardless of costs. This strategy leads to inefficiencies in health care (i) blood safety management is guided by available rather than cost-effective technology, and (ii) private insurance premiums for civil liability are sharply increasing, while they are in no way related to the expected returns and the high and increasing [cost of] blood safety.

Source: Cleemput I, Leys M, Ramaekers D, et al: Balancing evidence and public opinion in health technology assessments: The case of leukoreduction. Int J Technol Assess Health Care 22: 403-407, 2006.

Government settlements to victims of transfusion-related diseases have been substantial, for example:

• Irish Hep C payout tops €818m
• Japan payout over tainted blood
• Angelotta C, McKoy JM, Fisher MJ, Buffie CG, Barfi K, Ramsey G, et al. Legal, financial, and public health consequences of transfusion-transmitted hepatitis C virus in persons with haemophilia. Vox Sang 2007 Aug;93(2):159–65.

TM organizations continue to fight and present a unified front to those attempting to sue:

• Florida WNV case
• AABB, ABC, ARC brief in support of defendant (PDF)

4. CUA versus the precautionary principle

Cost utility analysis (CUA) is about allocating resources between competing alternatives. CUA calculates a ratio of cost to health benefits that is reported as cost per quality-adjusted life year or QALY.

Custer and Hoch write:

• It is better to pay $10,000,000 to save 1,000 people than to pay 10 times that amount to save 1 person….

This assumes that the options are framed as an either / or choice within a specific field such as TM. Such clear cut choices become relatively easy. Opting for cost-effectiveness under such circumstances is like being for Mom and apple pie.

Unfortunately, real world choices are almost always much messier. Then there is the precautionary principle, which was extensively reviewed in an earlier blog:

• "I'm the decider" & the doctrine of preemptive strikes

This CMAJ commentary (The Krever Commission – 10 years later) discusses Canada’s approach to the precautionary principle:

• The tainted blood tragedy was arguably the worst public health catastrophe in Canada's history.
• Guided by the Krever Commission findings, Canada's reformed blood system has restored public confidence in blood safety by proactively addressing infectious risks.
• Two influential concepts from the Krever Commission have contributed to the reformed blood system's success: the adoption of precautionary measures and the creation of a governance system with clearer roles and responsibilities, including the separation of funding from decision-making concerning safety.

The author further notes:

The adoption of the precautionary approach has partly contributed to a mentality that is highly averse to risk that has led to the introduction of some safety measures considered to be cost-ineffective, with costs per quality-adjusted life-years sometimes in the millions…. Now that Canada has distanced itself from the tainted blood tragedy, and that public confidence in the blood system has been re-established, officials have the luxury of re-examining safety priorities and the correct balance between safety and cost.

I interpret the author as saying that we in Canada went overboard with the precautionary principle - now let’s get with the correct balance, whatever that is.

5. History as prologue

I cannot help but recall a few quotations about history:

• Those who cannot learn from history are doomed to repeat it. (George Santayana)
• History repeats itself, first as tragedy, second as farce. (Karl Marx)
• The charm of history and its enigmatic lesson consist in the fact that, from age to age, nothing changes and yet everything is completely different. (Aldous Huxley)
• History will be kind to me for I intend to write it. (Winston Churchill)

The history of transfusion-related HCV in Canada is instructive.

From 1986 to 1990 Canada, like many other countries, did not implement surrogate tests for what was then called non-A, non-B hepatitis. If an extensive CEA had been done of surrogate tests, the results would probably have been that the tests (anti-HBc and ALT screening) were not cost-effective. Regardless of the sensitivity and specificity of both screens (poor), the CEA's key assumptions would likely have been wrong. They would have underestimated the extent of the disease and its eventual health consequences. Regardless, such a CEA was not done.

• See this excerpt from the Krever Report (p. 695)

How many infections the surrogates could have prevented is also impossible to tell. That’s because other screening measures during 1986–90 may have coincidentally also contributed to a reduction in HCV transmission. Nothing evolves in a vacuum and blood safety improvements, like many diseases, are multifactorial.

BOTTOM LINES

1. GIGO. One of the main challenges with CEA and CUA is, as the computer nerds say, GIGO, Garbage in, garbage out or more likely where computer-generated statistics are concerned, Garbage in, Gospel out.

2. QALY. Statistical gobbledegook involving numbers, poorly understood concepts, and loads of money can baffle even the most astute among us. Fess up – do you really understand QALY?

“The idea of QALY is to put a value on treatments that may not save lives but improve them. For example, if a blind person’s quality of life is “worth” 0.75 points per year, a treatment that would restore him to perfect vision — and raise his quality of life to 1 per year — is worth 0.25 per year of life. If the person lived another 30 years, the treatment would be worth 7.5 QALYs, or 30 times 0.25.”

Source: Berenson A. Pinning down the value of a person’s life (see Further Reading)

Say what? QALY, schmally, this type of creative number crunching is perverse even without all the iffy assumptions that go into producing the final numbers.

3. Dr. Strangeblood. Perhaps it’s because the transfusion-associated AIDS tragedy seems very recent to me, but whenever people start to promote cost effectiveness studies for blood safety measures, I get nervous.

Judicious use of public money is only common sense given that the money pot is finite. But, inevitably, when suits with calculators take control, even Dr. Strangebloods in suits with stethoscopes around their necks, humanity seems to fade.

People become numbers, money becomes paramount, and medicine becomes just another business. Is that what will protect the blood supply from another HIV tragedy?

Maybe I’m just a bleeding heart but I’m starting to worry and hate the numbers. I cannot get around the concern for love nor money. Take your pick:

• Money
• Love

ADDENDUM: Statistical tidbits (see paper's references for sources):

Infectious disease risks (USA)
HIV:1 per 2.3 million donations
HCV: 1 per 1.8 million donations
HBV: between 1 per 63,000 to 205,000

Non-infectious risks (examples of interventions)
TRALI from plasma:1 per 100,000 (male-only plasma)
Fatal septic transfusion reaction from platelets: 1 per 140,000 (mandatory testing)
Major mismatch of ABO type:1 per 600,000 (mechanical barriers, bar coding, RFID)

FURTHER READING

Government of Canada. Hepatitis C - Compensation for Tainted Blood Victims

Krever H. The blood supply system in Canada: systemic problems in the 1980s. Commission of Inquiry on the Blood System in Canada. Final report. Ottawa: Canadian Government Publishing; 1997;989.

(click "continue to the document")
Krever - Vol. 1: The background
Krever - Vol. 2: Where much of the "nitty-gritty" controversy is investigated and discussed
Of particular interest and relevance:
#24 - Canada's rejection of surrogate testing
Krever - Vol. 3 - International responses to the risk of HIV in the blood supply

Hill B. Zero risk at all cost in blood transfusion. Biomed Scientist, April 2005. (PDF)

Berenson A. Pinning down the value of a person’s life. New York Times, June 11, 2007.

Staginnus U. Health economics research on blood transfusion safety measures - an introductory primer. In Peterson BR.ed. New Development in blood transfusion research. Nova Science Publishers, 2006.

Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice.