Saturday, July 23, 2016

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

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

As always, comments are most welcome. 

14 comments:

  1. As usual Pat an important message well said. As you know I have always been a person that questions everything I am told. I also ask, who is telling me? what vested interest do they have in saying it? What is the evidence? what if....? I agree whole heartedly, we need not only to be treated as though we are intelligent questioning individuals and prove that we are, Do not take anything for granted. As a scientist I was always uncomfortable with the zero tolerance of risk, however we have to constantly evaluate and re-evaluate and think of the consequences of Murphy's Law.

    I hope all who read your blog - stop and question the information we receive and assumptions we all make.

    ReplyDelete
    Replies
    1. Many thanks for the kind words, Penny. I appreciate your support of my blogging efforts to get folks to challenge current orthodoxies with critical analysis.

      Note: Penny Chan was the executive coordinator and scientific adviser of the Krever Commission of Inquiry on the Blood System in Canada and has consulted for the WHO in Asia.

      Delete
  2. Anonymous8:46 PM

    Thanks for this, even the patient groups have drunk the Kool-Aid.

    I was recently sent an article that included the following quote from the head of the Blood Safety Committee of the World Federation of Hemophilia in regards to the ongoing debate surrounding Paid plasma clinics opening in Canada.

    "But despite these efforts, “The debate goes on—it’s endless fun,” O’Mahony said sarcastically. “The problem is that there are some people whose views haven’t changed since the tragic events of the 1980s.”

    I can't help but feel sick inside. This may not be the 80's but the similarities are frightening.

    http://www.wfhcongressdaily.org/2016/07/wfh-launches-several-new-safe-treatment-product-initiatives/
    WFH launches several new safe treatment product initiatives

    ReplyDelete
    Replies
    1. Anonymous6:01 PM

      Patient group?
      Coincidence or connection?
      CHS - 82% of funding now comes from corporate
      http://www.hemophilia.ca/files/HT%20March%202016%20-%20final.pdf pg14& 15 “It’s now or never..”

      BIOTEST partnered with the CHS for Project Recovery
      BIOTEST not on supplier list to CBS
      BIOTEST is the strategic partner to Canadian Plasma Resources
      Dr. Barzin Bahardoust: “We were proposing to make a $400-million investment in Ontario to open 10 plasma collection centres and to build and operate a fractionation plant with our strategic partner Biotest AG….”.
      http://www.ontla.on.ca/web/committee-proceedings/committee_transcripts_details.do?locale=en&Date=2014-12-01&ParlCommID=9003&BillID=3015&Business=&DocumentID=28419#P291_65209

      Delete
    2. Thanks, Anonymous. That industry provides 82% of CHS funding astounds:
      Hemophilia Today (Mar. 2016). pp. 14-15

      Explains some of the Society's stances.

      Hearings on Bill 21, Safeguarding Health Care Integrity Act, 2014
      fascinates as it shows CBS CEO Sher answering questions for which he can be & CBS held accountable.

      Delete
    3. Anonymous9:42 PM

      O’Mahony and D Page of the CHS are regulars at the Plasma Protein Therapeutics Association contributing to the SOURCE magazine (a PPTA publication)

      Both are involved in PLUS (Platform of Plasma Protein Users)
      D Page also involved in the Network of Rare Blood Disorder Organizations (NRBDO)
      Wonder who funds these groups?

      Delete
    4. Anonymous7:26 PM

      Interesting, David Page of the CHS is a key player at the Network of Rare Blood Disorder Organizations (NRBDO). The website used to list him as Secretary and the Canadian Hemophilia Society as the mailing address but this information has been removed from the site.

      The NRBDO is the other "patient org" pushing for paid plasma in Canada. Are they an extension of the CHS?

      Looks like they are a lobby group funded by Pharma.

      Rob M

      Delete
    5. Anonymous7:32 PM

      The lure of Pharma dollars has the ability to corrupt the best of us.

      When does a patient group stop being a patient group?

      These groups wield influence over policy.

      How can GOV ignore this?

      Delete
  3. Thanks, Anonymous, for the feedback & the link:
    WFH launches several new safe treatment product initiatives

    Yep,as you say, the patient groups have drunk the Kool-Aid. Suspect it's because they are so reassured by TM leaders for reasons I suggested in the blog - Don't worry, be happy.

    ReplyDelete
  4. Anonymous6:10 PM

    Pharma money strikes again. The same small number of players appear wearing different "patient group" hats over and over - PLUS & APLUS are PPTA funded.

    This letter comes from a Canadian Hemophilia Society web link: Paying for plasma: a reality check
    http://www.hemophilia.ca/files/Letter%20from%20PLUS%20and%20A-PLUS.pdf

    BTW B O'Mahony is also the Chief Executive of the Irish Haemophilia Society & author of the Dublin Consensus among other things
    http://www.ipopi.org/uploads/Dublin%20consensus%20statement%20vox%20Sanguinis.pdf

    Oddly we don't hear Mr.O'Mahony pushing for paid plasma in his home land.

    ReplyDelete
  5. Thanks, Anonymous. It's hard to take a stance in opposition to those who fund you. That's made obvious by the documented influence of Big Pharma on medical research.

    Suspect it's also true that when patient groups hear industry and transfusion leaders like those in Canadian Blood Services and Health Canada say we need paid plasma, they believe them because they're the experts.

    How much industry funders vs leadership support and advocacy for paid plasma plays a role, who knows. They both do.

    And both diss skeptical analysts like you and I as living in the past, out of touch with today's reality. Sad but true.

    ReplyDelete
    Replies
    1. Anonymous7:21 PM

      We keep hearing it's not the eighties anymore. Ironically they are right but they also should take their own advice.

      Through the internet more concerned citizens are watching and documenting. A mass shredding will not be able to cover tracks this time around.

      Delete
  6. Anonymous7:34 PM

    This was sent to me the other day and I found it interesting. CTV - DEBATING PAID PLASMA

    After listening to David Page of the CHS I am left wondering how many more companies are preparing to move in and start harvesting Canadian Plasma? Yes, we purchase a large % of finished medicines from USA source plasma but the sad truth seems to be that CDN source plasma is available but the CBS is doing a poor job.

    The link below will take you to the CTV web page, once there look for and select the story labeled Debating Paid Plasma clinics:
    http://alberta.ctvnews.ca/video?binId=1.2002989


    ReplyDelete
  7. Anonymous8:29 PM

    The power of big pharma - more shill from their familiar source, will this nonsense ever end?

    No blood system is entirely non-compensated

    http://lethbridgeherald.com/commentary/letters-to-the-editor/2016/09/21/no-blood-system-is-entirely-non-compensated/

    ReplyDelete

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