Wednesday, April 17, 2013

Heart of Gold (Musings on pimping for paid plasma)

This blog is the fifth in the series of commercialization of the blood supply. It outlines why I think paying for plasma is not where Canada wants to go. Paying for plasma makes me wonder 
 It doesn't sit right. Everything about it seems anti-Canadian. As youngsters quip, 'It's not your parent's Canada."

The title derives from Canadian Neil Young's 1972 classic, 'Heart of Gold.'

From the prior blog:
“From Health Canada’s perspective this is not a safety issue. The paid plasma issue is public policy that has to do with our culture and our values. And that needs to be addressed as a collective community.... 
But as we're looking at that, we should realize that 70 per cent of what we need is imported from the United States, where the donors are paid. So isn't this a bit of a double standard? You can't pay at home, but you can pay abroad."
Fact is, Canadians are being asked to allow blood donors to be paid for their plasma. Indeed, major players now pimp for paid plasma:
  1. We need paid plasma to supply the plasma derivatives that Canadians need. (CBC CEO Graham Sher)
  2. There's nothing unethical about it. (CHS President David Page)
  3.  70% of what we need is imported from the USA, where donors are paid. So to deny Canadians the right to be paid would be hypocritical. (Robert Cushman, director general of Health Canada’s Biologic and Genetic Therapies Directorate)
AND....Health Canada wants to hear from Canadians whether paying for plasma fits our culture and values. That doesn't exactly translate into the government regulator wanting to know if we think selling our plasma is ethical or moral. Those are weighty topics (see Further Reading below). 

No, it's whether selling part of our body parts fits with Canada's culture and values. 

My, oh my. My first reaction is what is Canada's CULTURE. Has anyone figured this out yet? My best guesses on our culture is:
Secondly, how do we reconcile Quebec's CULTURE and VALUES with the Rest of Canada (ROC)? In Quebec, selling plasma is illegal. In Manitoba it's been done for years. Now powerful forces want it to be the norm for the ROC.

MUSINGS
I view paying for run-of-the-mill plasma as anti-Canadian for 4 reasons.

#1. IT'S ANTI-CANADA's HEALTH CARE SYSTEM
Plasma and its expensive derivatives are definitely part of Canada's health care system. 

CBS spends much taxpayer money on plasma derivatives. The money goes directly to Big Pharma.

DOES THIS JIVE WITH CANADIAN HEATH CARE PRINCIPLES?

One thing that sets us apart from our USA neighbours, where plasma is routinely bought, is the Canada Health Act and its 5 principles. 

1. Public administration means its non-profit and run by a public authority (government).
2. Comprehensiveness means all NECESSARY services are covered.
3. Universality means EVERYONE is covered to an equal level. 
4. Portability means you can TAKE IT WITH YOU within Canada and when travelling abroad. 
5. Accessibility means REASONABLE ACCESS to services without financial or other barriers. 

These principles can be interpreted as Canadian culture and values. Where do commercial plasma collection clinics - which would become part of our health care system - fail to meet Canada's values?

Simply put, commercial plasma clinics fail because they go against the spirit of the Canada Health Act in that they are for-profit. 

We already pay mega-bucks to private firms (Big Pharma) for IV immunoglobulin and a myriad of other plasma derivatives. 

Today, CBS, Health Canada, and patient advocacy groups like the Canadian Hemophilia Society propose to add to commercialization of our blood supply by allowing plasma clinics to pay the poor for plasma and re-sell to Big Pharma at a profit. 

#2. IT'S HYPOCRISY
Commercial plasma collection clinics fail because they create a HYPOCRITICAL situation.

If paying for plasma is acceptable, why not allow paying for whole blood donations? How about paying for other tissues like skin? How about paying for organ donation? 

Plasma is no different than any other body tissue. To say otherwise would surely be HYPOCRITICAL.

But wait - I can hear the protests. Plasma derivatives are different than other body tissues and organs. Besides screening donors with questions and near fool-proof infectious disease testing, plasma derivatives undergo a manufacturing process guaranteed to wipe out viruses and bacteria. 

Oh, I get it. If we can nuke other body tissues and keep them viable, then it's perfectly acceptable to pay for them too?

#3. IT UNDERMINES VOLUNTARY BLOOD DONATION

Commercial plasma collection clinics fail because they undermine our volunteer blood donor system. Forget that volunteer and paid donors co-exist in the USA. The USA has always been more business, for-profit, oriented than Canada. 

When it comes to private health care and making a buck any which way, Canadians are 'just not that into it.'
Dr. Lois Shepherd of Queen's University in Kingston, Ont. and past-CSTM President, is dismayed by the move away from the altruistic donation model previously embraced in Canada. She considers the safety concerns surrounding volunteer versus paid donors to be somewhat moot since all blood is thoroughly checked for transmissible diseases.
"For me, the bigger concern is that we do rely on volunteer blood donors in Canada, and if we're attracting younger people to be paid donors as plasma donors they are going to be pulled out of a population of people that might potentially be committed red cell whole blood donors."
Shepherd noted that Canadian hospitals are top users worldwide of drug products derived from plasma and demand is constantly increasing. She said it's hard to watch the voluntary system be "nibbled away."
#4. IT EXPLOITS THE POOR 
To me, paying for plasma or any body tissue and organ is wrong. Why? 

Because paying exploits the vulnerable. Oh, advocates can claim it's just university students earning a few extra bucks, perfectly harmless. But to the poor who donate plasma, it's exploitation, plain and simple, similar to medical tourism.

Sadly, medical tourism now flourishes:
Do Canadians want to pay for plasma donations? Since we accept plasma derivatives from paid plasma donors elsewhere, must the answer be Yes to avoid the hypocrite label?

Many of my colleagues are likely to acquiesce to the big kids on the block, who not only support it, but actually pimp for paid plasma. 

Prevailing orthodoxy says, get on board. Why fight the inevitable?

My view is that “Lost causes are the only ones worth fighting for” as Jimmy Stewart's character intimates in the classic film, 'Mr. Smith Goes to Washington.'

BOTTOM LINE
Paying for plasma is no different than paying for any body tissue. Is this where Canadians want to go? 

Blood, plasma, and any part of the human body should not be a commodity. To commercialize it, cheapens us all.

Nothing wrong with entrepreneurs. Canada has many. But their main benefit is to create a significant number of jobs and increase government tax coffers, so that the entire society benefits, not just company shareholders, 

Plasma clinics don't do that. Rather they suck money from tax payers to Big Pharma. The number of jobs created is minimal. 

It's all about the GOLD, not the heart of gold.

FOR FUN
Canada, like the UK, and other Commonwealth countries, has a strong history of volunteer blood donations. We take pride in our tradition of believing the role of government is to ensure the good of all. We know that our citizens care for each other and do not need monetary incentives to do the right thing.

The sentiment is epitomized by Neil Young's Heart of Gold.

I want to live,
I want to give
I've been a miner
for a heart of gold.

It's these expressions
I never give
That keep me searching
for a heart of gold
And I'm getting old.
FURTHER READING
As always, comments are most welcome.

Sunday, April 14, 2013

Still my guitar gently weeps (Yet more musings on commercialization of our blood supply)

This is the 4th blog in a series on commercialization of Canada's blood supply. The title is from an old George Harrison ditty. 

The previous blog noted that Health Canada had a closed-to-the-media roundtable on paid plasma donors in Canada.

Who knows what was said in that meeting but now we learn that 
Yowsa! The government wants to hear from Canadians. My guess is that then they can claim they listened and followed the will of the people, or at least those with the most vested interest. 

Fascinating stuff from these news reports.

Health Canada's Viewpoint
“From Health Canada’s perspective this is not a safety issue,” said Dr. Robert Cushman, director general of Health Canada’s Biologic and Genetic Therapies Directorate. 
“The paid plasma issue is public policy that has to do with our culture and our values. And that needs to be addressed as a collective community,” he said after the meeting. 
“But as we’re looking at that, we should realize that 70 per cent of what we need is imported from the United States, where the donors are paid. So isn’t this a bit of a double standard? You can’t pay at home, but you can pay abroad.”
So...to HC, safety is apparently a done deal. Plasma derivatives are safe, folks, thanks to pre-donation questions, excellent infectious disease screening tests, and manufacturing processes. No worries, mate. 

It's all about our Canadian culture and values. Oh, but if Canadians reject paid plasma donations, we're hypocrites. 

CBS CEO Graham Sher's Viewpoint
"The issue really is one of security of supply and having sufficient access of these drugs for the patients that need them. About 70 per cent of the patients who depend on these products get them from the commercial paid plasma industry, so without that there would be a potential shortage of product. We've offered no opinion and it's not our role to offer an opinion on whether or not this particular facility should be licensed to operate in Canada."
Well, for someone who offers no opinion, CEO Sher seems to offer quite a few: Oh, by the way, if you don't allow paid plasma donations, patients would suffer terribly from the resulting shortage. But that's not for us to say....

As an aside, Big Pharma, whose blood derivatives are paid for by Canadian tax payers, funds several Canadian Blood Services programs

I've been on the receiving end myself. A website I helped develop was only possible because a drug company on contract to CBS for plasma derivatives gave 'x' % to CBS as a 'kickback' for education as a part of its contract. 

Canadian Hemophilia Society Viewpoint
David Page, national executive director of the CHS, supports donor payment and says CHS sees no safety, supply or ethical argument against paid donation in Canada. 
He says it’s already a reality at Cangene, where the company works with a very specific group of plasma donors to make specialized hyperimmune drugs.
“Collecting more plasma from Canadian donors, paid or unpaid, would add to the world’s supply of a scarce resource.” 
Oh, we already pay plasma donors in Canada. They're so needed. It's both safe and ethical.

As an aside, CHS relies on the generosity of 'corporate philanthropy', i.e., receives much funding from the companies who, interestingly, manufacture plasma derivatives.


Take-home message
The writing is on the wall, folks. The fix is in. All those with a vested interest have the government's ear. Even the regulators are on board, suggesting to reject paid plasma donations would be hypocritical. 

The saga continues. If you think run-of-the-mill plasma should not be a commodity to be bought and sold, let the government know. 
For interest, the prior blog in this series has an interesting comment from Penny Chan, who worked on the Krever Commission of Inquiry on the Blood System in Canada and served as the scientific liaison officer for the National Blood Safety Council from 1997 until it was disbanded in 2003. 

For Fun
I don't know how someone controlled you
They bought and sold you.
With every mistake we must surely be learning
Still my guitar gently weeps. 
As always comment are most welcome. 

Friday, April 12, 2013

We are the world (More musings on commercialization of the blood supply)

Updated: 13 April 2013

This blog is an update to the two blogs below this one: 'Stop children what's that sound' (Musings on commercialization of our blood supply) and the CSTM's reply to it.  

The title derives from an American charity recording in 1985 for African famine relief, We are the world

If some readers are growing bored by 3 blogs in a row on the same topic, so be it. To me the history and current developments in Canada's blood system are fascinating in the extreme. 

The Krever Report into Canada's 'tainted blood scandal' was released in 1997. CBS, which succeeded Canadian Red Cross (with most of the same staff), celebrated its one year anniversary in 1999 and, having been lured to leave a long teaching career to go back into the trenches, I was there as an 'assman'. Actual title was 'assistant lab manager' but the quality dept. addressed all my internal mail as 'assman'. Must admit I loved it!

A mere 15 years later, we have the CEO of CBS practically 'pimping' for paid plasma as the way to go. Fascinating stuff, this.
Latest development 
TRANSPARENCY?
Health Canada convened a round table of key stakeholders to meet in Toronto 10 Apr. 2013. The meeting was closed to the media. Post-Krever Inquiry, the goal was to create a system that was safe, accountable and fully transparent to consumers and the public. You gotta love the transparency of Canada's blood system today. 

Excluding the media reeks of, 'Let's control the message. The media will only confuse the public and get the poor dears upset about nothing.' Father knows best?
SAFETY?
On the matter of blood safety, CBS CEO Graham Sher says there are many safety mechanisms in place today that make plasma products safe, regardless of whether donors are paid.
“It's a very different environment today from 25 or 30 years ago.... If one looks at this purely from the safety point of view, the safety of the finished product that goes into a patient, there is no evidence whatsoever that paying donors result in a less safe product. There is no evidence whatsoever. And there have been numerous studies around the world looking at this.”
 Note the repeat of 'no evidence whatsoever'. No doubt that's to emphasize that scientists have this under control and all is evidence-based, as opposed to media scare tactics and the gullible public's response. 

Of course, given today's manufacturing processes and donor screening tests, plasma derivatives have an excellent safety record. Except for the times they didn't, as with Rh immune globulin (RhIg).

RhIg

The plasma derivative RhIg is instructive. RhIg is one of medicine's biggest success stories. It's produced from the plasma of donors who have a strong anti-D and its purpose is to prevent production of anti-D in Rh negative women who deliver Rh positive infants. 



RhIg is a relatively safe blood derivative and products made in NA have never transmitted infections. 


However, in the 1970s in Ireland and the former East Germany, several 100 women were infected with hepatitis C by batches of contaminated intravenous RhIg before donors were screened for the antibody to hepatitis C virus (HCV). That's because at the time we didn't know that HCV existed. [But there was a type of hepatitis called non-A, non-B hepatitis (NANBH). Only in 1989 was NANBH found to be caused by hepatitis C virus.]
Also, in 1994 in Ireland HCV RNA was detected in intravenous RhIg batches manufactured since 1991; a single donor was implicated and 19 women were found to have the same HCV strain as the donor. Sources:
RhIg for IM injection only' is manufactured from human plasma pools and can potentially transmit infectious agents such as viruses and prion diseases (e.g., vCJD). However, donor screening, donor testing and manufacturing processes significantly reduce these risks. Today we consider RhIg and other plasma derivatives to be safe for several reasons. 
RhIg for IM use is prepared by Cohn cold ethanol fractionation, which includes heat(60C for 10 hours), low pH treatment, and a solvent detergent step that inactivates lipid-enveloped viruses such as hepatitis B, hepatitis C, and HIV. The process also uses a nanofilter that physically removes viruses, including non-lipid enveloped viruses such as hepatitis A and parvovirus B19. 
The combination of inactivation and filtration greatly reduces viral load but does not entirely eliminate all viruses, some of which may be unknown. 
'RhIg for IM or IV injection' is manufactured from human plasma pools using an anion-exchange column chromatography method. The resulting product contains almost no contaminating non-IgG protein. Like the IM-only products, manufacturing includes a virus nanofilter that removes lipid-enveloped and non-enveloped viruses based on size and solvent/detergent treatment that inactivates lipid-enveloped viruses.
Sounds great, right? 
Except in the case of blood donors, we can only try to prevent transmission of infectious diseases in cellular products (red cells and platelets) or plasma derivatives if
  1. We are aware of the emerging transfusion-associated disease (For hepatitis C, there was only the fuzzy, 'non-A, non-B' for the longest time.)
  2. We know key risk factors so as to develop useful predonation screening questions (Non-A, non-B hepatitis had probably the same risks as hepatitis B or HIV, so experts believed the issue was at least partly covered by existing questions.)
  3. A screening test exists for the putative organism (Not until tens of 1000s of transfusion recipients were infected worldwide)
  4. The test has good sensitivity and specificity, i.e., can detect true positives and negatives, respectively, with reasonable accuracy. Implementing a new test is costly. Moreover, we cannot afford to reject donors needlessly. 
In Canada, unlike the USA, blood experts decided that the initial 'non-A, non-B' (hepatitis C) surrogate tests lacked proper sensitivity and sensitivity (and  tests were costly to implement). As a result, perhaps as many as 10,000 Canadians were infected. Victims were compensated, at least financiallyAlso see compensation packages.
PAID DONORS
We know from earlier tainted blood scandals that paid blood donors (often those who donate because they need money, e.g., young, sexually active donors and the poor) carry more risks for infectious diseases than volunteers. 

Those pimping for paid donors say today's plasma derivatives, mainly sourced from paid donors, have a good safety record - and they do. But this assumes that screening questions and tests and manufacturing processes are 100% protective or close to it. And they are pretty good for the transfusion-transmitted diseases we know about.

PATIENT ADVOCACY GROUPS
Advocacy groups represent patients whose lives depend on blood components and derivatives. To them, the issue of paid vs volunteer donors seems of minor concern so long as the products they need are available and safe. And the 'powers that be' assure them that the products are safe AND Canada needs paid donors to insure availability.

SUMMARY
We await the results of Health Canada's round table discussions on April 10, 2013 that were closed to the media. Given the CBS position and that of patient advocacy groups, can there be any doubt that paid plasma donors are not only the future but are absolutely the savior for patients needing plasma derivatives? Who knew?

CBS has already made it know that closing a Canadian plasma collection centre and importing plasma derivatives from the USA is more cost effective. Actually, they didn't say that. They dissembled with crapola about how demand was down for plasma, omitting the reality that demand is up, BIG TIME, for plasma derivatives, and it was more cost-effective to buy from the USA instead of operating a Canadian facility. 

As to emerging infectious diseases, we won't concern ourselves with them. They do not fit the current orthodoxy being preached by our gurus that blood has never been safer. Oh, and there is no evidence whatsoever that paid donors present a safety risk. You see, we have all these near perfect tests now....

As to the ethics of selling blood, that's not on anyone's agenda, certainly not CBS or Health Canada's closed-to-the-media round table. It's all about the money, folks. But the cover story is selling a story about safety. 

FOR FUN
We are the world, we are the children.
We are the ones who make a brighter day
So let's start giving.
There's a choice we're making.
We're saving our own lives.
It's true we'll make a better day
Just you and me.
 As always, comments are most welcome.