Friday, February 19, 2016

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
Canada
UK

34 comments:

  1. Anonymous7:23 PM

    Federal Opposition Calls for Immediate Closure of Plasma Collection Centre

    "CEO of Canadian Plasma Resources Dr. Barzin Bahardoust says it has to go to the US to be process, but he personally guarantees all of it will be used for Canadians first…………"

    My God, the good Dr. who is not a medical doctor makes a personal guarantee, I guess that changes everything.

    ReplyDelete
    Replies
    1. Thanks, Anonymous.

      I wonder who are these CPR staff and who's doing the testing and where. Plus, will the results of their HC inspections be public as CBS's are?

      Delete
    2. Anonymous6:48 AM

      Questions about testing have been asked but no one seems to be providing any answers.

      CBS Management has entered the fray again this time making multiple you tube videos.https://www.youtube.com/watch?list=PLJqV63fVJdvP5V23QkO8NAxcZtXh3BZRi&v=vVtg4_ZKZXA&feature=player_embedded

      Timing is everything, and the release of these videos dovetails with the opening of the collection centers.

      Add in the exaggeration of the safety record on plasma products, 30-40 years or more is indicated(we have forgotten about Baxter Gammaguard in the early 90's - oh well that was just a few hundred, hardly important).

      One has to ask: Is it appropriate for the management of the countries blood supply to be using taxpayer dollars to produce videos that effectively lobby support for private interests??

      Delete
    3. Thanks, Anonymous.

      Yes, the timing is not coincidental. CEO Dr. Sher was likely told by CBS's PR dept. to get out there and calm any public fears about plasma derivatives, given the media coverage of those against the CPR paid plasma collection centre opening in SK.

      CBS video link: Are products made from plasma from paid donors safe?

      Agree, that private paid plasma firms have leveraged CBS's messgae to their advantage. In the process Dr. Sher comes off as a paid shill/lobbyist for Big Pharma.

      As an aside: Think Dr. Sher needs coaching on how not to come across as if he's lecturing toddlers or hard-of-hearing seniors.<;-)

      Delete
  2. Anonymous7:25 PM

    Well now, Jonathan Swift's 'A Modest Proposal' was written in 1729.

    Can your dream incorporate the added liabilities sure to surface? (or would consumers sign a waiver?)

    ReplyDelete
    Replies
    1. Thanks, Anonymous.

      Afraid I'm not up to Swift's satire. <;-)

      Impoverished Irish fattening up kids and selling them as food to rich landowners so they become useful to society...

      I dig the analogy, though.Let the poor sell their body tissue (plasma) for money so companies ~CPR benefit by becoming wealthy, and society creates a few jobs in SK & elsewhere. Hooray! Win-win-win.

      What could go wrong?

      Delete
  3. Anonymous7:40 PM

    Collectively Canadians have forgotten that the blood system is as safe as it is today only because so many died during the blood tragedy. We paid dearly for our current level of safety and we must not throw this equity away. Lowering the operation of our blood system to the lowest common denominator is simply not good enough for Canadians.

    I too have the nightmares you refer to with the difference being that when I wake up I’m still in it. As it turns out I am one of the dinosaurs still alive that was infected once with HIV then again with HCV. I watch this drama unfold and of course I fear the worst.

    I am told by my patient organisation that there is nothing to fear, there is regulation and the science is so much better – “it’s not the eighties anymore”. I watched individuals within the organisation bullied and coerced into accepting a policy statement created in response to paid plasma. I was also told that this issue doesn’t concern me as I now take synthetic product and I should stand down because it’s not my fight.

    Problem is I have been to too many funerals. My nightmare continues and even if I wanted to let this go, I simply can’t.

    Throughout this entire drama one theme has played out consistently at all levels–decisions are being made by a small number of individuals behind closed doors. Sask has now opened a collection center without public consultation, this is unacceptable. Health Canada has been withholding the results of the email based “Public Consultation on the Safety of Paid Plasma Donations” http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/plasma-consult-eng.php conducted back in the spring of 2013. Ask anyone in Gov where this data is and you will hear crickets in response. Where is this data, and why is it being withheld from Canadians?

    No one wants to remember the horror that was Canada’s tainted blood tragedy. I won't fault anyone in the general public for wanting to forget this chapter in our history. But I can’t accept that the key players at patient organisations, Health Canada, and Government forget.

    It’s time we remind the key players of their responsibilities. If we do nothing and decide to accept this in the end we will get what we deserve.

    ReplyDelete
    Replies
    1. Thanks, Anonymous, for sharing what happened to you and how you feel about paid plasma.

      Yes, Health Canada's farcical 'public consultation', which disappeared into thin air, is a disgrace.

      Even more disgraceful? Individuals in your patient organisation (think it's CHS bullied and coerced into accepting a policy statement created in response to paid plasma and being told the issue doesn’t concern you as you now take synthetic product (recombinant FVIII?) and you should stand down because it’s not your fight. Yikes!

      Appreciate your input.

      Delete
  4. Anonymous9:17 PM

    More Don't worry be happy from the head of the CBS. Here is a link to a recent interview with Dr.Sher on CBC's The Current (Feb 25)

    Dr.Sher says "But there are at least two or three steps built into the plasma fractionation process that are known as inactivation steps, where in fact, the plasma is rendered through a process that kills any living organism, any virus, any bacterium, any pathogen..."

    Now that's a statement! With this thinking, why bother screening donors at all?

    ReplyDelete
  5. Thanks, Anonymous. I'll add links here and on main blog, plus tweet about it. You're right. If the processing kills anything, why even test plasma collected for fractionated derivatives. Maybe the price of IVIg would come down. <;-)

    *Audio clip (~10 mins): CBS CEO Graham Sher's interview on CBC's The Current, 25 Feb. 2016

    * Transcript Dr. Sher's interview

    ReplyDelete
    Replies
    1. Anonymous5:47 PM

      It would seem Dr Sher's claim of being able to kill any virus, pathogen, living organism or pathogen is bunk. So much for "belts and suspenders", see below:

      Virologic and clinical features of primary infection with human parvovirus 4 in subjects with hemophilia: frequent transmission by virally inactivated clotting factor concentrates.

      http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2011.03420.x/abstract

      Delete
    2. Anonymous4:54 PM

      How does the head of our blood system get away with making these claims? Is the Federal minister of Health not watching? What will it take for her to wake up and smell the coffee?

      The fix has been in on this one for a very long time.....

      Delete
  6. Anonymous1:55 PM

    This is my favorite part of the interview:
    ELLEN BERKOVITCH: How much do you know, when they tell you that they haven't had tats in the last year, they haven't had piercings, or they don't have HIV or hepatitis, how much do you know about them?

    JOSHUA: Honestly, we don't know too much. We just make, you know, base it off judgments and what we see.

    Joshua does not really seem to be on the ball. I wonder how he asks the UK question? You know... since the BBC reprted that it is thought that one in two thousand in the UK harbour the vCJD virus, or about 32,000. With 323,000 people emigrating from the UK in 2015 I would think that this quesiton would be of utmost importace as we already know THAT vCJD GOES THROUGH PLASMA FACTOR VIII and it is unkonwn if these viral inactivation steps work on a prion. vCJD is a prion not a virus for those that don't know.

    ReplyDelete
  7. Anonymous7:38 PM

    http://thechronicleherald.ca/novascotia/1348084-pay-for-plasma-clinic-may-head-to-nova-scotia
    Pay-for-plasma clinic may head to Nova Scotia

    ReplyDelete
  8. Thx for comment, Anonymous. About prions, I think the evidence, while not definitive, leans heavily to manufacturing processes removing them. Evidence:
    1. Australian Govt on Producing Immunoglobulins

    2. CSL Behring

    3. UK Transfusion Medicine Epidemiology Review Study shows no new vCJD cases since 2007

    ReplyDelete
  9. Anonymous8:01 PM

    This story out of NS is interesting-"Glavine said while he supports volunteer donation clinics and the spirit behind those sites, there is nothing he can do as provincial minister to prevent a private entity from entering the province, nor would they require his approval..."

    It's one of those things that makes you say hmmmm.....

    http://www.localxpress.ca/news/2016/3/15/glavine-no-new-regs-needed

    Ian

    ReplyDelete
  10. Anonymous8:08 PM

    Dr. Sher etc.. keep saying safety will not be an issue with the paid donation model in Canada. Let's paint a mental picture for everyone of what the daily operations of a CPR collection center would look like:
    • CPR has been quoted in the media as needing to collect 30-40,000 litres annually to be viable so let’s take that to mean 35,000 litres
    • Assume the average plasma draw to equal 750ml
    • 35,000 litres / .75 (750ml) = 46,666 donations required per year (against Saskatoon’s population of 250,000)
    • The CPR web site indicates the hours of operation are 5days/wk (Mon-Fri). 5days wk x 52 wks = 260days of operation per year are available to collect this plasma
    • 46,666 donors / 260 days of operation = 179.48 donors per day
    • The Web site indicates they are open 8hrs/day (from 8:30am to 4:30pm)
    o 179.48 donors per day /8 hrs each day = 22.44 donors per hour are required to collect this volume of plasma, each day, every day, even in cities the size of Saskatoon

    Personally I can’t get my head around this image. Does Health Canada and the head of the CBS not know how do simple math?

     With demands to collect plasma set this high, from a business standpoint how many donors could CPR afford to turn away?
     It’s worth noting here that most people work during the day and they are not open on weekends so a large percentage of working people will not be able to donate, who will the target donors be?

    The reality is that CPR will be the first line of defense for the plasma collected. A group that appear disorganized, came from nowhere, with no history, and no track record. Viral inactivation and purification processes are only so good. Screening is the only thing that can stop something like CJD, and the latency on this is little cutie >15yrs.

    Yup, it sure isn't the eighties any more. Don't worry, be happy.

    ReplyDelete
    Replies
    1. Thanks, Anonymous. Love the calculations to show how many collections/dy. Wonder if CPR's 30-40,000 litres/yr relates to one collection centre or to many more if biz spreads across Canada?

      Regardless, you've shown one collection clinic won't do it, so they'll need more. 179 donations/dy at 2 hrs each=358 donation hrs/dy

      Also each new site carries with it significant expense, e.g., overhead costs, more staffing and equipment/supplies.

      The paid plasma companies that make a go of it such as Australia's CSL Plasma have many sites across the USA, suggesting economy of scale is key.

      Of course, we know little about CPR, its staff, biz plan, biz drivers, supply chain, TD testers, quality system, etc.

      Plus if CBS will eventually become involved, since CEO Sher has not ruled that out.

      And if Health Canada audits have occurred, when they will occur, and if they will be made public.

      The SOUND OF SILENCE is deafening.

      Delete
    2. Anonymous6:49 PM

      Each collection center needs to capture 30-40000liters annually.
      "Bahardoust, says that each plasma collection centre has to collect 30,000 to 40,000 liters of plasma annually to make the operation economically viable......" source-http://healthydebate.ca/2014/04/topic/cost-of-care/paying-plasma

      They want to open 10 collection centers across Canada.

      I am hearing one of the proposed locations is Kamloops BC (population approx. 86000).That's a lot of plasma on a small population base.

      Delete
  11. Anonymous8:11 PM

    Oh dear, isn't BC a net importer of blood? Can they afford any erosion of the donor base?
    http://www.vancouversun.com/news/Opinion+plasma+poses+threat/11827121/story.html

    ReplyDelete
    Replies
    1. Thanks, Anonymous.
      BC's Minister of health shills for paid plasma:
      Pay for plasma poses no threat

      She references CBS CEO Sher: "I’ve been assured by Canadian Blood Services that the technology and systems now in place — whether for products derived from public or private plasma donations — safeguard the supplies of these products."

      Oh, and "The safety of the donors and recipients is the top priority for both the B.C. Ministry of Health and Canadian Blood Services."

      As always, safety is what is mouthed as top priority....

      No mention of ETHICS related to sucking blood from the poor and needy. No musing about paying donors for run-of-the-mill body tissue and where that may lead. B/c CBS says it's okay, no worries, mate, be happy!

      Delete
    2. Anonymous7:37 PM

      4-8% erosion of the whole blood donor base to paid plasma has been mentioned.


      Can BC afford to loose approx. 6% of something they don't already have a sufficient qty of?

      Is this a responsible position for a Provincial Minister of Health to take?

      Delete
  12. Anonymous7:33 PM

    Something for your Twitter feed?
    http://www.stcatharinesstandard.ca/2016/04/03/selling-plasma-in-bc-thin-edge-of-dicey-wedge

    Selling plasma in B.C. thin edge of dicey wedge

    Ian

    ReplyDelete
  13. Anonymous7:39 PM

    more for Twitter?
    Company that pays $25 for plasma donations hopes to open N.S. location http://www.cbc.ca/news/canada/nova-scotia/canadian-plasma-resources-eyes-expansion-1.3521629

    Opinion: Blood must remain a public resource http://www.ottawacitizen.com/business/opinion+blood+must+remain+public+resource/11829520/story.html

    Ian

    ReplyDelete
  14. Anonymous7:09 PM

    Wow, CPR’s story keeps changing here is the latest:
    “…Our plan at the moment is to hopefully have some manufacturing facilities and laboratories in Alberta, hopefully within the next five years. Possibly a donor clinic as well…”.
    “….I’m very surprised, because Alberta, like any other Canadian province, is getting around 80 per cent of its plasma from compensated donors,…”
    http://www.metronews.ca/news/edmonton/2016/04/05/for-profit-plasma-company-says-alberta-uses-paid-donors.html
    Head of plasma company says Alberta dependent on paid U.S. donors

    Ian

    ReplyDelete
  15. Anonymous8:14 PM

    Spin control after the CBC National news story??
    https://www.youtube.com/watch?v=WxJ_u4ERBMg

    Canadian blood services
    Daily update ⋅ April 28, 2016
    VIDEO

    Is Canadian Blood Services planning on paying plasma donors?



    ReplyDelete
  16. Anonymous6:10 PM

    Wait a minute what about the video he made yesterday?....
    G.Sher- “If there’s a potential need to significantly increase the amount of plasma that is collected on a regular, frequent basis, we need to look at options but we have not made any determination in that regard yet,”

    http://globalnews.ca/news/2652140/pay-for-plasma-how-it-works-and-where-the-feds-alberta-stand/

    Pay for plasma: How it works and where the feds, Alberta stand

    ReplyDelete
  17. Anonymous8:54 PM

    Ian Mumford's new home is Therapure Biopharma. I bet these guys could put some Canadian Plasma to use. The fix on paid plasma has been in for a long time.

    http://www.businesswire.com/news/home/20160506005782/en/Therapure-Biopharma-Welcomes-Delegation-Levels-Government-State-of-the-Art

    Therapure Biopharma Inc. Welcomes Delegation from All Three Levels of Government to Its State-of-the-Art Facility

    ReplyDelete
  18. Thx Anonymous. Links related to your comment:

    * Therapure Biopharma Inc. welcomes delegation from all 3 levels of government to its state-of-the-art facility (6 May 2016)

    * Therapure Biopharma

    They're not showing ex-CBS's Chief Supply Chain Officer, Ian Mumford, on the leadership team yet. <;-)

    ReplyDelete
    Replies
    1. Anonymous6:57 PM

      See ref to Ian Mumford at Therapure here: http://www.investcom.com/cgi-bin/ipo/ipoprofile1.cgi?ID=1&string=Therapure+Biopharma+Inc&exact=yes&com=yes

      Delete
  19. Anonymous8:04 PM

    It's said Paid plasma is to be turned into ivig by Biotest then returned to CPR. Wonder if the CBS or Hema Quebec purchase any plasma based products from Biotest?

    ReplyDelete
  20. Anonymous8:49 PM

    recent media clips you might find interesting:
    http://thestarphoenix.com/health/diet-fitness/public-and-private-blood-agencies-to-duel-for-donations

    Here's why your paid plasma donation in Saskatoon might not make it to Canadian Blood Services

    AND a CBC audio clip:
    http://www.cbc.ca/news/canada/new-brunswick/programs/informationmorningfredericton
    Wednesday June 29, 2016
    Company Pays for Plasma
    The CEO of Canadian Plasma Resources is planning to open a facility in Moncton. The company pays people for their plasma. Barzin Bahardoust explains why want to set up in Moncton

    Let me see if I understand this. CPR spends millions to open a collection center in Saskatoon BUT the licence they have from Health Canada only allows them to sell to the Canadian market AND they don't have a buyer in CBS or Hema Quebec BUT they plan to open more collection centers just the same.

    This is either the most incredibly foolish business plan one could conceive OR clear evidence a deal has already been done behind outside of the regular tendering process to purchase from CPR.

    Pinch me, this is really happening in Canada right?

    ReplyDelete
  21. Anonymous7:25 PM

    An article you might be interested in. Sorry to send it to you this way but I don't have your email address & don't participate in Twitter:

    http://acsh.org/news/2016/07/19/zika-what-the-hell-is-going-on/

    Zika: What the Hell is Going On?

    ReplyDelete

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