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

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

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

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

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

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

GOVT LEADERS
Examples of politicians assuring citizens all is okay:

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

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

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

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

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

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

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

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

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

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

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

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

ZIKA VIRUS
Several disconcerting anomalies exist about Zika virus transmission:

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

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

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

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

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

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

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

The results of economic-based calculations around the globe:

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

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

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

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

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

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

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

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

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

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

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

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

SIDE BAR (Food for Thought)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

As always, comments are most welcome. 

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

Updated: 28 Feb. 2015 (see CBS's Dr. Sher audio clip at end)

February's blog derives from news items in TraQ's monthly newsletter that resulted in my dreaming from a 'what if' perspective.

The title derives from a Eurythmics ditty that I've used several times before. Was reminded of it again from this Twitter post from @SantaCruzbio:

For links to news items and resources, see Further Reading at the blog's end.

I HAD A DREAM 
Dreamt I was a Canadian who had a blood transfusion in 2018 and contacted a debilitating, deadly disease. Turns out 1000s of folks around the globe got the same transfusion-associated disease and many died within a few years before they discovered a treatment that works for many, but not all, and not forever. 

THE DISEASE
The disease I contacted was named 

• Arrogant Scientific Syndrome by Highly Analytical Tossers after those who allowed it to happen (ASSHAT for short). 

At first ASSHAT appeared in homosexual and bisexual males, so was deemed sexually transmitted and soon it showed up in IV drug abusers, presumably via contaminated needles. 

Hence, the perspective developed that it was the victim's fault - THEM - and wouldn't affect WE- those of us outside those groups. In other words, the typical WE-THEY bigotry. 

I DREAMT THE NEWS TODAY, OH BOY...
In my dream, here are but 6 things that happened in Canada, and no doubt occurred elsewhere, given that government bureaucrats, medical administrators, and physicians (sometimes the same individuals wearing different hats) are similar the world over.

1. The transfusion medicine community naturally denied ASSHAT was transfusion-transmitted until the evidence was overwhelming. They knew the blood supply was safe, so much safer than before. After all, the new transmissible disease test for hepatitis B had been implemented ~10 years ago. We felt safe.

2. At first the blood supplier chose not to screen out high-risk donors for fear of blood shortages, aided by interest group lobbying.

3. The blood supplier and its government funders were so concerned about saving money that they cut corners, in secret, of course. Specifically, they chose

• Not to purchase a safer blood product for hemophiliacs in order to use up contaminated inventory, apparently thinking they were likely already infected, so what the hey! Or perhaps they thought better to give contaminated products than none at all, given the dangers of severe bleeding? Maybe they thought they were leveraging existing inventory to save money. Who knows?
• To delay implementing a test for ASSHAT because money was tight.

4. Someone, who knows who or how, destroyed key documents, minutes of meetings) of the Canadian Blood Committee. This group influenced, if not outright decided, most of the above decisions.

5. At an individual level, a paternalistic physician chose not to tell an older man's wife that her husband was ASSHAT-positive because the physician was sure they were not having sex. No doubt he thought he was being kind. Wrong! The wife came down with ASSHAT and sued the physician, which is how we found out about it.

6. Ultimately, police laid 32 criminal charges against senior scientists at Health Canada, the Canadian Red Cross Society and Armour Pharmaceutical Co. Guess how many were convicted?

OUTCOME
In Canada a commission of inquiry was set up ~12 years later in 2030 and completed its report in 2034. That was 16 years after I contacted ASSHAT. 

But I was one of the 'lucky ones' who was still alive. And I benefited because the federal government  offered $120K in 'humanitarian assistance' in exchange for a promise we would not sue. The provinces later offered $30K/year for life. 

Those who got variant ASSHAT, resulting from the blood supplier failing to use surrogate tests used in the USA, threatened to sue for equal treatment and the government paid out millions of dollars. 

Many of those affected by both diseases died before compensation was available. Sometimes I suspect maybe that was the idea.

Then I dreamt that I was British and had a worse nightmare. The inquiry into ASSHAT offered only one wimpy recommendation after 6 years of inquiry, held more than 25 years after the ASSHAT tragedy. I had died by then.

LEARNING POINTS
Think what happened in my horrific dream couldn't happen, that it's just too far out, too sci-fi? Think again. It already has. Think it couldn't happen again? Why? The physicians and blood administrators who made the decisions decades ago were smart, caring people. But not infallible when confronted with financial constraints, interest group lobbying, and political pressure.

Canada was one of the few, maybe only, countries that held an extensive legitimate inquiry into what is typically called in the media, the tainted blood scandal. 

Canada's Krever Commission had 50 recommendations. The first was to compensate victims. Recommendation 2:

• Blood is a public resource.
• Donors should not be paid.
• Sufficient blood should be collected so that importation from other countries is unnecessary.
• Access to blood and blood products should be free and universal.
• Safety of the blood supply system is paramount.

But apparently paying blood donors is now okay, at least for plasma, because we are so much smarter today and our technology is so much better. Sure it is. 

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

FOR FUN
I chose Sweet Dreams as the music for the blog because it's ironic. My dream was not a Sweet Dream but rather a nightmare. Nonetheless, I love this ditty:

• 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?
I travel the world and the seven seas
Everybody's looking for something.

Some of them want to use you.
Some of them want to get used by you.
Some of them want to abuse you.
Some of them want to be abused.

Thanks to Anonymous (see Comments below) for link to this video by CBS CEO Dr. Graham Sher:





Also thanks to Anonymous for 

• Audio clip (~10 mins): CBS CEO Graham Sher's interview (CBC, The Current, 25 Feb. 2016) 
• Transcript of interview
• Apparently, the manufacturing process for plasma derivatives kills anything and everything. Why even test plasma collected for fractionated products? Maybe the price of IVIg would come down?

FURTHER READING

• Videos
• If you watch only two, watch 
• The tragedy of FVIII concentrate (1994:19 mins 14 secs)
• Canadian Red Cross denies link between AIDS and blood products (1984:2 mins)
• And the band played on (Must watch movie - 2 hrs 21 mins)
• Canada's Supreme Court: Krever Commission can lay blame (1997: 2 mins 27secs)
• Canada: After 18-mth trial, judge rules "no crime" in actions of 4 doctors and U.S. pharmaceutical company (2007: 2 mins 57 secs)
• All acquitted in tainted blood scandal  (news item)
• NS, Canada, first to compensate victims (1993: 2 mins 34 secs) 

Canada

• If you read only one item, read this:
• Krever Inquiry (Andre Picard, 2006 (edited 2014), The Canadian Encyclopedia)
• Recent news
• Paid plasma clinic officially opens doors in Saskatoon (18 Feb. 2016) | CPR will pay donors $25 for plasma
• Op-ed: Plasma donation system needs vigorous debate (18 Feb. 2016)

• Krever Commission: Final report. Commission of Inquiry on the Blood System in Canada (1997)
• Volume 1 (For overview)

• Tainted-blood compensation incomplete as deadline nears (2010)

UK

• Background: 
• What is the Penrose Inquiry? (Mar. 2015)
• Key questions in Penrose Inquiry (Mar. 2015)
• Penrose Inquiry - Report (25 Mar. 2015)
• One recommendation: That the Scottish Government takes all reasonable steps to offer an HCV test to everyone in Scotland who had a blood transfusion before September 1991 and who has not been tested for Hepatitis C Virus.
• Contaminated blood victims ‘left to beg for compensation’ (Jan. 2015)
• Penrose report: Blood scandal inquiry branded a ‘whitewash’Contaminated blood scandal financial moves needed urgently, committee told (9 Feb. 2016)

The long and winding road (Musings on 30 years of transfusion-associated AIDS)

Updated: 13 Dec. 2013

AABB's Transfusion for October 2013 is a themed issue.

• Thirty years of progress since recognition of transfusion-associated AIDS

Since few transfusion professional will probably read, let alone scan, all 238 pages, this blog will review the two items (among several gems) that I found most interesting, a commentary and a letter to the editor from authors in Brazil.    

• Dubin C, Francis D. Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic. Transfusion 2013 Oct;53(10 Pt 2):2359-64. (Commentary)   
• Salles NA, Levi JE, Barreto CC, Sampaio LP, Romano CM, Sabino EC, Júnior AM. Human immunodeficiency virus transfusion transmission despite nucleic acid testing. Transfusion 2013 Oct;53(10 Pt 2):2593-5. (Letter)  

The blog's title derives from a 1970 Beatles tune. But why blog about an old transfusion issue like HIV/AIDS? I can see some of you yawning. After all, our blood supply in developed nations is the safest it's ever been.

We in the transfusion medicine community can congratulate ourselves on how safe we have made blood from viruses like HIV, HBV, HCV, and WNV. Fact is, we often do. 

Now the main threats for fortunate us exist elsewhere. As but two examples, transfusing an incorrect blood group (due to patient misidentification) and transfusing the wrong blood product (perhaps due to clinician lack of knowledge or communication errors between hospital departments).

Why blog on HIV/AIDS?

1. Because AIDS was in the news 30 years ago, it follows that health professionals age 45 or younger were children at the time and unlikely to be aware of HIV and AIDS.

2. We're told by transfusion experts that the era of transfusion transmitted infections is all but over due to these reasons:

• Better pre-donation screening
• Almost foolproof donor testing for infectious diseases
• Manufacturing processes such as viral inactivation and filtration

But it's not. Besides the situation in the 'third world' in which governments cannot afford expensive tests and do not have the infrastructure to support them, human and systemic errors happen, infectious disease tests are not 100% sensitive, and donors may lie about risky behavior on predonation screening questions.

3. Significant historical events should be acknowledged as a sign of respect.

4. George Santayana got it right: Those who cannot remember the past are condemned to repeat it.

DISCLOSURE: Be aware, what follows is not always politically correct. I mean no disrespect but will call 'em as I see 'em (or recall 'em). Also, the content is highly selective based on my biases. Lastly, there's more than a few 'tacky' aspects to the so-called tainted blood tragedy. Have barf bags handy.

For interest, the Transfusion special issue features 6 papers on HIV (from China, Hong Kong, Germany, South Africa, Zimbabwe, and the International NAT study Group). Also included are 7 papers on hepatitis, 4 on NAT, and 4 on other viruses.

BACKGROUND
A brief trip down memory lane... My early days at Canadian Red Cross were pre-AIDS. Then we screened blood donors only for syphilis and later the hepatitis B surface antigen (HBsAg). The 'good old days' of farcical government regulation, no SOPs. Training was sort of like the long-standing medical school model:

•  See one, Do one, Teach one.

Early infectious disease tests were far from perfect. For example, I have fond memories (nightmares at the time) of trying to visualize the white precipitin lines of positive HBsAg reactions between donor serum and anti-HBs wells after counterimmunoelectropheresis (CIEP). CIEP was a  'second generation' test that was the first test used to mass screen blood donors for hepatitis. To say such tests were subjective is an understatement.

HIV / AIDS ERA
A few historical highlights / lowlights:

1981: Then came AIDS, first reported as 'gay-related immune deficiency' (GRID) in 1981, and soon identified in sex workers, Haitians in the USA, and IV drug users. Cause unknown.

1982: The term AIDS first appeared when it was used by the CDC to describe a disease affecting the immune system. Cause unknown.

1982: Evidence for a blood-borne pathogen transmitted by transfusion emerged when reports of AIDS were reported in 3 hemophilia A patients who were heterosexual, had no other known risk factors, and were frequently transfused with Factor VIII concentrate. Cause unknown.

1984: The US government held a press conference to announce that Robert Gallo, a National Cancer Institute scientist, had discovered the cause of AIDS, which he named HTLV-III, and had invented a screening test worth mega-bucks.

1983: In truth the French research team of Luc Montagnier (who later delved into quackery) discovered HIV a year earlier and had sent Gallo a sample to investigate. They called it lymphadenopathy-associated virus (LAV). 

1984: Gaëtan Dugas dies. He was a French Canadian flight attendant linked by CDC to 40 of the first 248 reported cases of AIDS in USA, purported to be 'patient zero', a claim later disputed.

• The Appalling Saga of Patient Zero (Time Magazine, June 24, 2001)
• AIDS - The truth about 'patient zero' (Toronto Star, May 6, 2013)

1985: Once it became known that Ryan White, a hemophiliac, had contracted AIDS from a blood transfusion, school officials banned him from classes. Ryan died of AIDS at age 18 in 1990.

1985: US President Reagan, he of 'win one for the Gipper' fame, first used the word AIDS, expressing skepticism in allowing children with AIDS to continue in school although he supported their right to do so.

1985: Blood donor tests for HIV began in USA, Canada and elsewhere.

1985: The Pasteur Institute filed a lawsuit against the National Cancer Institute to claim a share of the royalties from the NCI's patented AIDS test.

1986: HIV is adopted as name of the virus that causes AIDS.

1994: The battle for patent rights to the HIV test lasted for more than a decade and ultimately favored the French claim, although all decided to play nicey-nicey in the end.

2008: Montagnier and Françoise Barré-Sinoussi shared the 2008 Nobel Prize in Medicine and Physiology for the discovery of HIV (along with  Harald zur Hausen, who discovered that human papilloma viruses can cause cervical cancer). Gallo was frozen out.

• Was Robert Gallo robbed of the Nobel Prize?

See amfAR for an interesting review of AIDS, 1981-2011.

TRANSFUSION'S SPECIAL ISSUE

My take on this commentary, written from a USA perspective, but applicable everywhere:

Dubin C, Francis D. Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic. Transfusion 2013 Oct;53(10 Pt 2):2359-64.  (Commentary) 

I love that AABB included a commentary by Cory Dubin and Dr. Donald Francis. Kudos!

• Corey Dubin is President of the Committee of Ten Thousand and also serves on the FDA's BPAC. Also see this 1996 interview: Blood, money and AIDS: Hemophiliacs are split. Liability cases bogged down in disputes
• Dr. Don Francis now sits on the Board of Global Solutions for Infectious Diseases. His work while at CDC on HIV/AIDS was chronicled in Randy Shilts' book, And the Band Played On. (You can rent the film. Well worth it.)

A few selected excerpts from Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic (which I've condensed):

AIDS devastated 4 generations of families with hemophilia. But the real story predates HIV/AIDS. Pharmaceutical firms are required to manufacture safe biologics, yet the blood community remained indifferent to the presence of hepatitis in the blood supply for decades.

That indifference set the stage for the HIV/AIDS catastrophe. It was as if a 'collective denial' spread through the blood community. Despite warning signals, the system allowed dangerous practices such as collecting plasma from prisoners and importing plasma from undeveloped countries. Plasma collection in prisons did not end until 1993. 

In hemophilia, factor concentrates were the 'Golden Goose' that revolutionized treatment. Concentrates brought independence from hospitals and convenient treatment. 

Widespread denial blinded the entire blood system. The CDC warned the blood community, but inertia prevailed. What followed was one of the worst medical disasters in history.

Authors' take home message
In 2013, 30 years after transfusion-associated HIV/AIDS was confirmed, we must not become complacent due to improved regulations and scientific gains. We must resist the influence of conflict of interest while rejecting the scientific and medical arrogance that contributed to the AIDS/blood epidemic. We must never forget the human cost. We must prepare for the unexpected and unforeseen.

MUSINGS

* Because Factor VIII concentrates were a god-send to patients with hemophilia, physicians kept transfusing the product, even realizing the danger, because they

(1) Thought most hemophiliacs were already infected (2) Believed the alternative was patients potentially bleeding to death

* Physicians were in denial about HIV / AIDS in the blood system, illustrated in this interview with Dr. Noel Buskard of Canadian Red Cross (Sorry about the short ads). Quote: Physicians and hemophiliacs must weight the cost benefit ratio in every therapy - If I give you an aspirin there is a risk...

* Canada's Krever Report makes it clear that transfusion experts, however well motivated, screwed up, big time.

The slowness in taking appropriate measures to prevent the contamination of the blood supply was largely due to experts rejecting, or at least not accepting, an important tenet of the precautionary principle.
When there was reasonable evidence that serious infectious diseases could be transmitted by blood, the principal actors in the blood supply system in Canada refrained from taking essential preventive measures until causation had been proved with scientific certainty. The result was a national public health disaster.

Best line from the Dubin and Francis commentary:
We must resist the influence of conflict of interest while rejecting the scientific and medical arrogance that contributed to the AIDS/blood epidemic.

Now to the themed issue's letter to the editor in Transfusion:

* Salles NA, Levi JE, Barreto CC, Sampaio LP, Romano CM, Sabino EC, Júnior AM. Human immunodeficiency virus transfusion transmission despite nucleic acid testing. Transfusion 2013 Oct;53(10 Pt 2):2593-5.     

Key facts: * The risk of HIV transmission by blood transfusion in a blood center in São Paulo, Brazil was estimated to be 0.68 per 100,000 donations [6.8/million] using nucleic acid testing (NAT) on minipools of six donations. 

[For reference, in Canada the residual risk of HIV is 1 per 8 million donations, where residual risk is estimated as the incidence multiplied by the window period.]

* In November 2012, a leukemia patient became HIV-positive after 47 transfusions of RBCs and platelets. Upon follow-up, one donor was found to be HIV positive, with a pattern that suggested he likely donated a few days after becoming infected.

* The donor had denied all risk factors in the interview when donating and continued to deny high-risk behavior in 3 subsequent visits to the blood bank, even after his HIV status was disclosed to him. He also did not self-defer by confidential unit exclusion before the implicated donation.

* The literature has several reports of transfusion-transmitted HIV in the NAT-negative window period, although this case may have the lowest documented viral load.

* This case shows that even individual NAT (not pools of 6 donors) by the most sensitive methods available might not detect HIV. Thus, we must to continue to understand motivations for blood donation and publicize the risk of donating shortly after risky behaviors.

MUSINGS
Blood donors lie and infectious disease screening test are not perfect. HIV windows of negativity still exist no matter how short. Transfusion-associated HIV is extremely rare. But if it's you or a loved one who becomes infected, you don't care how rare it is.

Transfusion professionals must resist becoming blasé about how protected the blood supply in developed countries is from HIV and other infectious agents. Unfortunately, many are blasé.

For example, in Canada we have Health Canada and the CEO of CBS saying that paid plasma donation is no big deal because infectious disease screening tests and manufacturing processes used to produce plasma derivatives like IVIg are foolproof.

As an aside, on a related issue in 2013 Health Canada decided to allow men to donate blood if they haven't had sex with a man in the last five years. 

For years the gay community has campaigned to drop the permanent ban on blood donation for MSM donors on the grounds the ban is unscientific and discriminates. 

CBS's Public Affairs put out an interview with Dr. Dana Devine, Vice President, Medical, Scientific & Research Affairs on the changed MSM policy.  She noted that it will take years to gather valid data set to evaluate impact of changed policy on blood safety as incidence of HIV+ donors is extremely low. 

The geek in me wants to suggest it's a matter of statistical power: The ability of a study to detect a real difference, if one exists. Power is affected by how big the difference is and sample size. If a difference is big, it's easier to detect. And large sample sizes make a real difference easier to detect .

I'll end on a personal note with a newspaper article that appeared in the Toronto Star, Feb. 18, 2006 but is no longer online. I hope the Star doesn't mind that I've reproduced it. 

• ©Toronto Star: `It's a fear that plays on all of us' 

When I worked at Canadian Red Cross in Winnipeg, Barry and Ed Kubin would drop by periodically to pick up cryoprecipitate and, later, Factor VIII concentrate.

FOR FUN
Admittedly, it's hard to say 'for fun' on an issue that has devastated so many. But please enjoy this 1970 ditty by The Beatles, the last one released shortly after they broke up and while all 4 were alive. 

* The Long and winding road (Paul McCartney and The Beatles)

As always, comments are welcome.